Computed Tomographic Angiography

I am a practicing cardiologist and nuclear medicine specialist (California license number A 23844) and director of nuclear cardiology and cardiac imaging at Cedars-Sinai Medical Center in Los Angeles. A full professor in residence at the UCLA School of Medicine for since 1986, I have been author of over 300 original manuscripts in the field of noninvasive cardiac imaging. My entire career has been devoted to noninvasive cardiac testing and I have over 30 years of experience in nuclear cardiology and 10 years experience in cardiac CT. I am a founding member of the Society of Cardiovascular CT (SCCT) and am currently its president-elect. I have experience with over 15,000 patients undergoing cardiovascular CT. and participated in development of the response to CMS regarding the proposed NCD from the multiple medical professional societies including SCCT.

While a National Coverage Decision regarding coronary CT angiography (CCTA) will eventually be appropriate, the proposed decision is premature at this time. Despite the youth of the method, CCTA has already been proven to be the most accurate noninvasive method for detecting or excluding the presence of coronary artery disease (CAD), as compared to the “gold standard” of invasive coronary angiography. CCTA has developed over a short period of time, during a period of rapid technological change in CT scanners. While initial reports showed that CCTA was feasible with 4 and later 16 slice CT systems, there is clear evidence that a higher level of accuracy is associated with 64 slice CT scanners, which have now become the standard for the field. At least 33 full published manuscripts in English have evaluated the accuracy of CCTA compared to invasive coronary angiography, but only 8—less than one fourth—were considered in the draft proposal. Furthermore, an even larger number of abstracts have been presented within the last year at national cardiology and radiology scientific meetings and a large number of manuscripts are currently in-press, such that the number of published manuscripts within one year is expected to be more than twice the number currently published. Among these manuscripts are two large multicenter trials that have documented the very high accuracy of CCTA compared with invasive coronary angiography. Given the large number of clinical trials of CCTA that are currently in the publication process and the size of the populations reported in these trial, the amount of published information dealing with the clinical value of CCTA will be far more than double the current amount within this coming year.

Among the many benefits of CCTA is that the procedure frequently is normal in patients who otherwise would have had to undergo invasive coronary anggigraphy with its attendant risks. The NCD would reduce access of CMS beneficiaries to this important benefit, as well as to many other benefits provided by the procedure.

I am sure that everyone in CMS involved in the process wants to do the right thing for the health care of CMS beneficiaries. The right thing is to delay the NCD for at least one year, so as to allow the available evidencepublished or in the process of publicationto be evaluated.

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I am greatly disappointed by the recent CMS NCD proposal regarding coronary CT angiography. While the goals of the proposal (presumably to avoid runaway imaging costs) are laudable, the authors have unfortunately missed their mark. Through an outdated literature review, a lack of understanding of daily clinical practice, and a rush to judgement of an exponentially improving technology, they have put forth a policy that if enacted will have a significant detrimental effect on cardiac care in the United States.

I practice cardiology in the setting of a managed care organization (Kaiser Permanente) and thus I have no economic incentive with regard to ordering imaging tests. Indeed, as resource stewards for Kaiser, my partners and I are concerned with appropriate, but cost effective care. In my daily practice I have found CCTA to be a very useful tool in the management of patients with possible ischemic symptoms and low to intermediate probability of CAD. When used in accordance with published appropriateness criteria, it has significantly decreased the number of normal (or non interventional) coronary angiograms in my practice, thus decreasing patient morbidity and mortality, as well as costs. At the same time it has identified many patients with non obstructive but diffuse plaque that are appropriate candidates for secondary prevention, thus presumably improving long term outcomes.

While the data regarding cost effectiveness and long term outcomes is in a nascent state, much of this recent data has been left out of the NCD analysis. Further data is certainly coming, and one way to ensure that this data is delayed by many years is to enact this NCD. By limiting patient access to prospective medicare approved research protocols, the flow of quality CCTA data will slow to a trickle. Neither echo, stress myocardial perfusion imaging, nor cardiac MRI were subject to such restrictions early in their development. If they had been, we certainly would not have the wealth of data that we have today to support their clinical use.

Thus I respectfully suggest that this NCD be withdrawn in favor of continued LCD''s, and continued accumulation of a wealth of data. The cardiology community, through the ACC, SCCT and other organizations, have been very proactive in putting forth appropriateness criteria and training standards to minimize overuse and poor quality performance of CCTA, and they will continue to be responsible overseers of this technology.

Lastly, we must always put patients first. As evidence grows of the benefit of this technology, medicare beneficiaries will experience "real" negative oucomes related to lack of access to this technology, either through morbidity related to unecessary invasive angiography, or through missed secondary prevention opportunities. Surely we owe it to patients to prevent these outcomes, by avoiding the enactment of this inaccurate, premature,and shortsighted policy.

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I am a board certified internist, radiologist and nuclear medicine physician. I have evaluated coronary artery disease one way or another for the last 25 years. Your decision is narrow and not supported by the clinical experience or the literature. CCTA saves lives. This study is the best available technique to prevent acute coronary syndrome/sudden cardiac death. Please reconsider this decision and broaden the indications to let us attack this disease earlier in the course to save myocardial function and to save lives.

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Penny-wise and pound foolish. A coronary CTA is much cheaper than a diagnostic catheter coronary angiogram. It will obviate the normal catheter study, thereby saving costs and cutting risks, as it is non-invasive. Coronary calcium scoring is much better at risk stratification than Framingham. These two modalities which are relatively inexpensive, will save lives and money. They will, with or without your help, eventually take their place alongside mammography and colonoscopy. Or is prevention of sudden death and disease not in your purview?

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I appreciate the opportunity to respond and provide comments regarding the CMS proposed NCD for Cardiac CT Angiography.

I was deeply saddened when I learned of CMS’s decision to issue a restricted NCD for Cardiac CT Angiography (CCTA). This action will effectively prevent millions of Medicare beneficiaries from obtaining the benefit offered by this technology and likewise prevent thousands of physicians from diagnosing coronary disease in the most efficient manner possible. In this era when the United States population is rapidly aging, we should embrace this new technology to more accurately and economically diagnose cardiac problems, not divert energy and funds toward pedantic research to reiterate what is already known about CCTA.

Numerous peer-reviewed publications have documented the correlation between CCTA and invasive angiography. These studies were conducted by recognized leaders in the field of cardiac imaging and their contributions should not be taken lightly. CCTA does correlate with invasive angiography and it’s accuracy improves with each iteration of the technology. Do we need to perform an “outcomes study” to assess the implication of normal coronary arteries? Recent prognostic studies indicate normal coronary arteries impart an excellent prognosis while the presence of coronary disease predicts cardiac events and death regardless of whether invasive angiography or CCTA was used to make the diagonosis.

Clinical application and appropriateness have been assessed and outlined by the American College of Cardiology and endorsed by other professional societies. The clinical utility is proven and documented almost daily in peer reviewed medical literature. Applications from evaluating atypical chest pain to assessing coronary stent and coronary bypass graft patency have been investigated and found to be valid. The utility of evaluating the ever increasing number of emergency department patients with CCTA has also been addressed with quite favorable outcomes clinically and economically. , Indeed, the economic impact of CCTA in patient management is documented in a large multicenter review of over 20,000 patients. This review documents a savings of over 7 million dollars in the cohort of patients in which CCTA was utilized for the diagnosis of coronary disease. Traditional non-invasive diagnostic studies are lacking in their accuracy. In fact, one recent study comparing CCTA to stress perfusion imaging suggests stress imaging is no better than a roll of the dice when it comes to diagnosing coronary disease. Literally, hundreds of peer-reviewed studies are available for review. These scholarly papers represent the work of recognized leaders in cardiology and radiology from around the world with publication in essentially every peer-reviewed journal, not a few individuals selected by CMS to conduct an “outcomes” study.

It seems CMS effort and funding would be better directed toward reviewing existing and emerging literature before embarking upon new projects.

In my region of the country, coronary artery disease remains the number one killer; not cancer, not AIDs, not vehicular accident, not homicide, but coronary artery disease. CCTA provides a rapid, accurate and cost effective method to diagnose CAD and intervene before stents or sternotomies are needed. Please do not deny my patients access to this life and cost saving technology. Reverse or modify the decision for an NCD before it is too late.

References:

Nieman K, Cademartiri F, Lemos PA, et al. Reliable noninvasive coronary angiography with fast submillimeter multislice spiral computed tomography. Circulation 2002;106:2051– 4.

Hoffman U, Moselewski F, Cury RC, et al. Predictive value of 16-slice multidetector spiral computed tomography to detect significant obstructive coronary disease in patients at high risk for coronary arterydisease. Circulation 2004;110:2638–43.

Achenbach S, Ropers D, Hoffmann U, et al. Assessment of coronary remodeling in stenotic and nonstenotic coronary atherosclerotic lesions by multidetector spiral computed tomography. J Am Coll Cardiol 2004;43:842–7.

Kuettner A, Beck T, Drosch T, et al. Diagnostic accuracy of noninvasive coronary imaging using 16-detector slice spiral computed tomography with 188 ms temporal resolution. J Am Coll Cardiol2005;45:123–5.

Mollet NR, Cademartiri F, Krestin GP, et al. Improved diagnostic accuracy with 16-row multi-slice computed tomography coronary angiography. J Am Coll Cardiol 2005;45:128 –32.

Leber AW, Knez A, von Ziegler F, et al. Quantification of obstructive and nonobstructive coronary lesions by 64-slice computed tomography: a comparative study with quantitative coronary angiography andintravascular ultrasound. J Am Coll Cardiol 2005;46:147–54. Raff GL, Gallagher MJ, O’Neill WW, Goldstein JA. Diagnostic accuracy of noninvasive coronary angiography using 64-slice spiral computed tomography. J Am Coll Cardiol 2005;46:552–7.

Raff GL, Gallagher MJ, O’Neill WW, Goldstein JA. Diagnostic accuracy of noninvasive coronary angiography using 64-slice spiral computed tomography. J Am Coll Cardiol 2005;46:552–7.

Ropers D, Rixe J, Anders K, et al. Usefulness of multidetector row spiral computed tomography with 64- _ 0.6-mm collimation and 330-ms rotation for the noninvasive detection of significant coronaryartery stenoses. Am J Cardiol 2006;97:343– 8.

Schuijf JD, Pundziute G, Jukema JW, et al. Diagnostic accuracy of 64-slice multislice computed tomography in the noninvasive evaluation of significant coronary artery disease. Am J Cardiol 2006;98:145–8.

James K. Min, MD, Leslee J. Shaw, PHD,‡ Richard B. Devereux, MD, Peter M. Okin, MD,Jonathan W. Weinsaft, MD, Donald J. Russo, MD, Nicholas J. Lippolis, MD,Daniel S. Berman, MD, Tracy Q. Callister, MD Prognostic Value of Multidetector Coronary Computed Tomographic Angiography for Prediction of All-Cause Mortality. (J Am Coll Cardiol 2007;50:1161–70)

CCT/CMR WRITING GROUP. Robert C. Hendel, MD, FACC, Manesh R. Patel, MD, Christopher M. Kramer, MD, FACC, Michael Poon, MD. FACCACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR
Appropriateness Criteria for Cardiac Computed Tomography and Cardiac Magnetic Resonance ImagingJACC Vol. 48, No. 7, 2006

W. Bob Meijboom, MD, Carlos A. G. van Mieghem, MD, Nico R. Mollet, MD, PHD,Francesca Pugliese, MD, Annick C. Weustink, MD, Niels van Pelt, MD,Filippo Cademartiri, MD, PHD, Koen Nieman, MD, PHD, Eric Boersma, MSC, PHD,Peter de Jaegere, MD, PHD, Gabriel P. Krestin, MD, PHD, Pim J. de Feyter, MD, PHD, FACC 64-Slice Computed Tomography Coronary Angiography in Patients With High, Intermediate, or Low Pretest Probability of Significant Coronary Artery Disease. JACC Vol. 50, No. 15, 2007:1469–75

Mariko Ehara, Masato Kawai, et al. Diagnostic Accuracy of Coronary In-Stent Restenosis Using 64-Slice Computed Tomography: Comparison With Invasive Coronary Angiography J. Am. Coll. Cardiol. published online Feb 16, 2007

Pache G, Saueressig U, Frydrychowicz A, Foell D, Ghanem N, Kotter E, Geibel-Zehender A, Bode C, Langer M, Bley T. Initial experience with 64-slice cardiac CT: non-invasive visualization of coronary artery bypass grafts. Eur Heart J. 2006;27:976 –980.

Judd E. Hollander, MD, Harold I. Litt, MD, PhD, Maureen Chase, MD, Aaron M. Brown, BS,Woojin Kim, MD, William G. Baxt, MD Computed Tomography Coronary Angiography for Rapid Disposition of Low-risk Emergency Department Patients with Chest Pain SyndromesACADEMIC EMERGENCY MEDICINE 2007; 14:112–116

Ronen Rubinshtein, David A. Halon, et al. Diagnosing Acute Coronary Syndromes and Predicting Clinical Outcome in Usefulness of 64-Slice Cardiac Computed Tomographic Angiography for Emergency Department Patients With Chest Pain of Uncertain Origin Circulation 2007;115;1762-176 8

Jeffrey J. Fine, M.S., Ph.D., Michael Ridner, M.D., FACC, Norbert Wilke, M.D., FACR, Jason Cole, M.D., FACC, Tracy Callister, M.D., FACC, P. Robert Myers, M.D., FACC, Lawrence J. Boxt, M.D., FACR, and Linda Gates-Striby . Coronary CT angiography saves lives and money: 20,000-plus cases prove it. Preliminary analysis of prospective multicenter study indicates that physicians utilize cardiac CTA appropriately and that test proves cost-effective. Diagnostic Imaging 2007

Joanne D. Schuijf, MSC, William Wijns, MD, PHD, J. Wouter Jukema, MD, PHD,Douwe E. Atsma, MD, PHD, Albert de Roos, MD, PHD,† Hildo J. Lamb, MD, PHD,Marcel P. M. Stokkel, MD, PHD,_Petra Dibbets-Schneider, MSC, Isabel Decramer, MSC,Pieter De Bondt, MD, PHD, Ernst E. van der Wall, MD, PHD, Piet K. Vanhoenacker, MD,Jeroen J. Bax, MD, PHD. Relationship Between Noninvasive Coronary Angiography With Multi-Slice Computed Tomography and Myocardial Perfusion Imaging. JACC Vol. 482006:2508–14

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I have 64 slice cardiac CTA in my office for last 1 year. It is eye opening experience. It is win- win scenario for patients,physicians and payor. It is very accurate and highly specific. We have reduced unnecessary invasive procedure more than 50%. It also icreased procedural oucome since you already know coronary antomy ahead of time. For bypass elderly patients, it is mandatory test, since by doing it you save so much time to identify bypass grafts. It cost 800-1200 dollars to payor. Cardiac cath procedure on the other hand can cost 16-22000 dollars just for cath. only. This technology has proven its benefits. we are giving much better patient care and saving money for payor.

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I am a board certified interventionalradiologist. This proposed Medicare position re Cardiac CTA is a really awful decision based simply on perceived utilization rather than the good it can do in saving American lives.There is good peer-reviewed literature that supports the use of this modality. Your selective use of the literature to make your decision (excluding some very good science) is inexcusable.Do not act hastily- non-invasive ways to detect disease and save lives is exactly the way medicine should be progressing in the USA.

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I am a board certified radiologist in New Hampshire who has specialized in invasive and noninvasive cardiac and noncardiac imaging for the past 21 years. I have personally interpreted over 500 CCTA exams in the past 2 years.

I STRONGLY urge you to reconsider you planned NCD regarding coronary computed tomographic angiography. Of all the new imaging modalities introduced in my career, CCTA clearly stands alone as a safe, robust, straightforward procedure which provides unique information regarding congenital and acquired coronary artery pathology. I have SAVED LIVES with the information from this procedure which COULD NOT BE OBTAINED ANY OTHER WAY (i.e. MIBI, cath).

I cannot express how strongly I believe that the proposal to severely limit access to this procedure will result in a major step BACKWARDS in the provision of cardiac healthcare in the United States.

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The proposed rules for national coverage of CCTA should be withdrawn and re-done in my view. They will make it nearly impossible for Medicare Beneficiaries to utilize this technology. If that occurs they will be deprived of new technology which many recent scientific articles have shown is a powerful tool to diagnose CAD in appropriately selected patients. The technology when correctly applied can avoid unnecessary invasive caths and diagnose significant disease that might otherwise be missed.

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I am a board certified radiologist practicing in California. I have personally performed over 500 coronary CTAs. I cannot stress enough the benefit of this examination to prevent sudden cardiac death and as a tool of performing preventative medicine. There exists a potential for incredible cost savings, in a setting of well in excess of 1 million ER visits a year for chest pain, when compared with inconclusive stress tests or invasive diagnostic cardiac catheterizations. Denying reimbursement for this procedure would be a classic case of cutting off ones nose to spite ones face. This procedure should not be the exclusive privilege of the well off.

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1. I am a board certified cardiologist. This proposed Medicare position re Cardiac CTA goes againstthe future of preventive cardiology and better management of pts with CAD. I spent $10000 for training without owing a machine just to learn the technology. This cuts inpayments will make impossible for anybody to offer a great diagnostic modalitu to our patients. Please do not act hastily and simply base your decisions on perceived increased use of technology. One must carefully weigh improved patient outcomes, earlier diagnosis and reduction in more invasive and costly procedures.

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I am a board certified interventional cardiologist. I have been practicing cardiology for over 20 years. This proposed Medicare position re Cardiac CTA is the worst decision re the care of the American public. Coronary artery disease is rampant and kills more Americans than any other single disease. Please re-evaluate by including peer review literature that you specifically excluded. One wonders what the true agenda is!?

2. We have not reduced the incidence of sudden cardiac death in 50 years. Cardiac CT is the only current way to find atherosclerosis early and treat it. If you wish to prevent sudden cardiac death approve Cardiac CT. Nothing else can do it.

3. Please do not act hastily and simply base your decisions on perceived increased use of technology. I firmly believe that allowing CTA will save lives and reduce cardiac death, still the number casue of death in the U.S. One must carefully weigh improved patient outcomes, earlier diagnosis and reduction in more invasive and costly procedures.

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CCTA coverage should continue to be covered for the following reasons:

1. based on our year and a half experience CCTA provides accurate and non-invasive diagnostic information regarding coronary artery disease and the risk of impending heart attack at a cost two thirds less than coronary angiography.
2. it is a non-invasive exam with less morbidity and mortality than coronary angiography.
3. based on our experience, many of these patients can be managed with drug therapy as opposed to surgery and/or stent placement (also much more expensive).

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This is a peer reviewed technology which has time and agin demonstrated its efficacy.

PLEASE change your decision!!!

Cardiovascular Computed Tomographic Angiography: What You Need to Know

• CCTA is appropriate:
  • The American College of Cardiology Foundation (ACCF) and other key subspecialty societies considered the available scientific evidence of 39 distinct clinical indications for the use of CCTA.¹ These diverse indications included coronary, non-coronary cardiac, and non-cardiac indications. Of the 39 indications, 13 were considered appropriate for use for CCTA and 4 of these represented indications dedicated to coronary artery examination. They were:
    1. evaluation of chest pain syndrome in adults with intermediate pre-test probability of CAD and uninterpretable ECG or inability to exercise
    2. evaluation of chest pain syndrome in adults with uninterpretable or equivocal stress test (exercise, perfusion or echo)
    3. coronary artery evaluation in adults with new onset heart failure to assess etiology
    4. evaluation of acute chest pain in adults with intermediate pre-test probability of CAD and no ECG changes and negative serial enzymes.
  • More recently, the Society of Cardiovascular Computed Tomography and the North American Society for Cardiac Imaging recently re-evaluated and reaffirmed the appropriate usage of cardiac computed tomography.³⁴
  • The American Heart Association Scientific Statement for the Assessment of Coronary Artery Disease by Cardiac Computed Tomography recommends the use of CCTA for the following clinical indications:
    1. Suspected CAD (class IIa, level of evidence B),
    2. Anomalous coronary arteries (class IIa, level of evidence C).²
• CCTA is highly accurate.
  • Recently, two open-label prospective multicenter trials were performed with blinded comparison of 64-detector row coronary computed tomographic angiography (CCTA) to quantitative coronary angiography (QCA) by invasive cardiac catheterization for the detection of either ≥50% or ≥70% stenosis.
  • The CORE 64 trial evaluated 291 primarily high-risk patients >40 years of age from 9 international centers who were being referred for invasive coronary angiography.⁵ Reported per-patient sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) to identify a ≥50% coronary artery stenosis were 85%, 90%, 91%, and 83%.
  • The ACCURACY trial enrolled 232 primarily high-risk patients from 16 US sites who were being referred for invasive coronary angiography.⁶ Blinded assessment of CCTAs resulted in per-patient sensitivity, specificity, PPV and NPV to identify a ≥70% coronary artery stenosis of 91%, 84%, 51%, and 98%, respectively, and per-vessel sensitivity specificity, PPV and NPV of 85%, 92%, 68%, 99%, respectively.
• A negative CCTA prognosticates an excellent outcome.
  • In a recent analysis of a 141 intermediate pretest risk adults with suspected CAD but normal CCTAs, event rates were 0% for mortality, 4.3% for invasive coronary angiography, and 0.6% for incident myocardial infarction.⁸ In this study, after a mean follow-up of almost 15 months, adults with normal CCTAs were able to be managed less invasively with excellent prognosis.
  • Amongst 254 patients with chest pain having low, intermediate, and high pretest likelihood of coronary artery disease, a negative CCTA was shown to have 100% negative predictive value for >50% stenosis compared with invasive coronary angiography in the low (n=66) and intermediate (n=83) pre-test likelihood groups.⁹
  • Of 994 adults by CCTA who were referred for chest pain symptoms or equivocal stress testing, 160 adults were further evaluated with invasive coronary angiography. Amongst adults not initially referred for invasive angiography, only 2 patients were found to have significant stenosis in the 6 month follow-up.¹⁰
• A positive CCTA risk stratifies future adverse outcomes.
  • A recent study examined 1,127 low-intermediate risk patients ≥45 years with chest pain syndrome who underwent CCTA examined the prognostic utility of coronary artery plaque identification for the prediction of all-cause mortality.¹¹ Coronary artery plaques were graded for stenosis as very mild (< 30%), mild (30-49%), moderate (50-69%), or severe (≥70%) for each coronary artery segment. Specifically, coronary artery plaques causing moderate (≥50%) to severe (≥70%) luminal stenosis by CCTA were associated with higher incident mortality risk compared to less critical plaques, and risk of mortality increased proportionally with the number of major epicardial vessels involved. Higher mortality risk was more associated with proximal disease severity, particularly within the proximal portion of the left anterior descending artery. Notably, adults with ≥50% stenosis in the left main artery had the highest mortality at 1.5 years (15%), compared with a low mortality rate for adults with a < 50%.
  • Of equal import, high negative predictive values of normal CCTAs were noted for incident mortality. In adults with no evident coronary artery plaque, no evident left main plaque, and no evident proximal left anterior descending artery plaque, the mortality was 0.3%, 2.1%, and 1.6% in the 15 month follow-up period, suggesting that CCTA can be used not only as an effective stratifier of future risk but also as an effective test to predict risk of all-cause death.
  • In a 5 year follow-up of 2,971 consecutive primarily low and intermediate risk chest pain patients undergoing CCTA, all-cause mortality was similarly examined.¹² Coronary artery plaque was assessed by the absence of detectable plaque, non-obstructive plaque and obstructive plaque. Compared to adults with no evident coronary artery plaque, adults with obstructive coronary plaque were much more likely to die if single vessel obstructive plaque (RR 5.6, 95% CI 1.56-18.9, p=0.01), two-vessel obstructive plaque (RR 6.9 95% CI 1.6-32.9, p=0.03), or three-vessel obstructive plaque (RR 26.0, 95% CI 3.6-92.1, p=0.001) was present. Importantly, even the presence of non-obstructive plaque conferred increased risk of mortality (RR 2.9, 95% CI 1.6-11.5, p=0.01). In keeping with other studies, the 5-year rate of death for chest pain patients without detectable coronary artery plaque by CCTA was low (1.8%).
  • In a separate study that examined a combined endpoint of cardiac death, nonfatal myocardial infarction, unstable angina requiring hospitalization, or target vessel revascularization, presence of >50% coronary artery stenosis by CCTA in 100 adults was associated with a 63% event rate compared to a 0% event rate for adults with no evident coronary artery plaque in a 16 month follow-up.¹³
• CCTA is cost-efficiento Low risk adults. In a recent analysis examining adults without known CAD undergoing CCTA under coronary heart disease-specific chest CT angiography with and without contrast (CPT 71275) between 2002-5.¹⁸ These CCTA adults (1,833) were matched 1:4 to adults undergoing SPECT (n=7,332) for age, demographics, cardiovascular risk factors, and cardiac-related medications. Economic endpoints including total healthcare costs, CAD-related costs, additional coronary testing costs, and medical and coronary revascularization costs were examined. In this low risk group of patients, CAD-related costs for adults undergoing CCTA were $1716 (95% CI, $361-$4,649) lower than in matched adults undergoing SPECT. Despite overall total healthcare and CAD-related costs, CCTA adults incurred slightly lower rates of CAD-related hospitalization (0.01 vs. 0.02, p=0.003) and myocardial infarction or angina (0.05 vs. 0.08, p< 0.0001).
  • Equivocal stress test. Cole and colleagues examined 206 patients with mildly abnormal or equivocal nuclear SPECT exams who subsequently underwent CCTA imaging first and “selectively” underwent invasive angiography if obstructive plaque was identified by CCTA.¹⁹ Sensitivity analysis demonstrated total cost savings if < 81.5% of patients ultimately required invasive angiography. In their cohort, 32% of patients exhibited potentially obstructive plaque by CCTA and only these adults underwent selective catheterization, resulting in a cost savings of $1,454 per patient. In standard practice, these patients frequently are sent for the far more costly invasive coronary angiographic procedures (Class IIa and IIb recommendations of the ACC/AHA Guidelines for Coronary Angiography)

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25. Abdulla J, Abildstrom SZ, Gotzsche O, Christensen E, Kober L, Torp-Pedersen C. 64-multislice detector computed tomography coronary angiography as potential alternative to conventional coronary angiography: a systematic review and meta-analysis. Eur Heart J. 2007 Nov 2; [Epub ahead of print].
26. Jones CM, Athanasiou T, Dunne N, Kirby J, Aziz O, Haq A, Rao C, Constantinides V, Purkayastha S, Darzi A. Multi-detector computed tomography in coronary artery bypass graft assessment: a meta-analysis. Ann Thorac Surg. 2007;83:341-8.
27. Goldstein JA, Gallagher MJ, O''Neill WW, Ross MA, O''Neil BJ, Raff GL. A rando

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Dear Dr. Phurrough and colleagues,
Thank you for the opportunity to address the proposed NCD. I am a cardiologist on the full-time faculty of Columbia University Medical Center and the lead author of the JAMA paper addressing radiation risk from coronary CTA, cited in the NCD. As part of my clinical duties, I both perform coronary CTA and refer patients for the test. I believe that the proposed NCD goes too far in restricting the access of patients to a diagnostic modality which for many can obviate the need for invasive angiography and its attendant risks. I also concur with the professional societies which have raised the point that the proposed NCD does not entirely reflect the current evidence base supporting the use of coronary CTA. From a radiation safety perspective, numerous technical advances offer the possibility to lower dose and cancer risk below the levels cited in the JAMA paper. While there are many who are better able than I to comment on the benefits side of the risk-benefit equation for this test, I have a good understanding of radiation risk associated with coronary CTA, and am frequently asked to speak across the country on this subject. I would be glad to offer my services to CMS in terms of assessment of radiation risk associated with this rapidly evolving modality, and the potential for structuring CMS reimbursement of coronary CTA, and cardiac imaging in general, to decrease radiation risk to the American population.
Respectfully,
Andrew J. Einstein, MD, PhD

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Since 2004 new patient encounters in our practice have increased by 22%. Yet in 2007 the number of caths performed dropped 38% below that of 3 years ago. The rate of normal caths has dropped from 23% to 13% in the same period. The overall rate of CTA followed by cath within 90 days is only 14%. Although these trends are driven by various factors, our involvement with CTA for several years has played a major role in expediting clinically efficient and cost effective care.

Although we understand that it is appropriate to study and analyze new technologies, we are very concerned about the CMS proposed approach regarding CTA.

The proposed “research study” process seems to be cumbersome for all parties involved. It is not clear that the efforts, time and expenses incurred by all will produce the clinical and economic value that CMS is seeking. Working together to develop criteria for a CTA registry would more likely minimize the impact on the delivery of appropriate care, while establishing a short term and long term data base and benchmarking for setting standards and policy.

This is also the first time that CMS will have required that procedures used for diagnostics would need to demonstrate improved health “outcomes”. This is not a good precedent, and will most likely be problematic in dealing with future policy and defining clinical indicators.

It also concerns us that many of the studies included in the previous CMS review were based on older technologies. More current literature needs to be examined, and centers involved in research and training need to be allowed to continue to show the clinical value for patients, as well as the positive economic value to the payers. The ACC, ACR, and SCCT have already outlined additional studies that CMS did not consider when issuing the memo of December 13, 2007.

Given the current CMS proposal, using CED for Medicare beneficiaries is very restrictive, and limits patient access to a procedure that can diagnose coronary artery disease faster, safer, less expensively and non-invasively.

In other areas of coverage, CMS has given authority to local Medicare intermediaries to work with clinical experts and specialty organizations to determine appropriateness. CMS should allow them to continue to work with physicians, advisory boards and clinical societies such as the SCCT, ACR and ACC to develop appropriate LCDs for the utilization of CTA in the diagnosis of CAD.

We recommend that CMS adopt accreditation guidelines, clinical appropriateness standards, and physician credentialing requirements that assure the appropriate utilization of CTA. Many of the specialty organizations have already worked on these, and continue to be proactive in assuring quality in the training and use of this technology. Our practice is already a qualified training center and meets or exceeds the standards currently set forth by such societies. If we partner in developing and implementing standards, any concerns of misuse and overutilization will be eliminated.

Note: please add the following study to those CMS is planning to review.

Min JK, Shaw LJ, Devereux RB, Okin PM, Weinsaft JW, Russo DJ, Lippolis NJ, Berman DS, Callister TQ. Prognostic value of multidetector coronary computed tomographic angiography for prediction of all-cause mortality. J Am Coll Cardiol. 2007;50:1161-70

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CT Coronary angiography is cheaper, less invasive than standard coronary angiography, and has been recently VALIDATED to be highly sensitive and specific. What would you rather have to diagnose your coronary disease, a cheap and simple arm IV with dye, then through a CT machine in minutes, OR an invasive and highly expensive procedure with an arterial puncture in your thigh and potential complications of excessive bleeding, heart attack, stroke, etc. This is a no-brainer; to deny Medicare coverage of CT Coronary angiography would be a step backwards in the diagnosis of our #l killer! Patients are tuned into this and can''t believe Medicare might not cover this very important diagnostic tool. J.P., MD

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January 10, 2008

To: Centers for Medicare and Medicaid Services (CMS)

RE: Proposed National Coverage Decision(NCD) for Cardiac Computed Tomography Angiography(CCTA)

The proposed NCD should be withdrawn as it will adversely affect the Medicare beneficiary population. The appropriate medical specialty societies including the American College of Cardiology, Society of Cardiac Computed Tomography and American Society of Nuclear Cardiology have formulated appropriateness criteria over the past 2 years based on current research data and expert opinion of cardiac imaging specialists. CCTA has appropriately had widespread media education to the American population, and patients are very cognizant that CCTA can replace invasive coronary arteriography in appropriate clinical situations.

The proposed NCD does not adequately reflect the current state of evidence in support of CCTA for symptomatic patients with chronic stable angina at intermediate risk of CAD. We have recently conducted a multicenter trial(submitted for publication) comparing CCTA with invasive coronary arteriography in a cohort of patients who underwent coronary revascularization, either percutaneous or surgical. CCTA correctly predicated the need for therapy in 100% of patients with previous bypass surgery, a patient population where minimization of more invasive procedures is appropriate. (see Table 1). CCTA corrected predicted the need for therapy in 94% of patients without previous bypass grafting. Given the increased expense of invasive coronary arteriography, even on an outpatient basis, there would be considerable cost savings to CMS for this cohort of Medicare beneficiaries.

The requirements CMS has established in the proposed NCD to obtain coverage for CCTA would have a severely negative impact on Medicare beneficiary access to this valuable service across the United States. It seems that CMS has not fully considered the full impact the proposed NCE will have on the Medicare beneficiary population. Implementation of the proposed NCD would in effect shut this valuable cardiac imaging tool down and place an inappropriate regulatory throttle on further research of this vital and exciting imaging technology. Keep in mind that the proposed NCD would add yet another hoop for clinician-researchers to jump through in further delineating the value of CCTA. It would be more appropriate if CMS worked with the above noted cardiac imaging specialty societies to develop future criteria for clinical research of CCTA, rather than imposing further regulation and bureaucracy.

Thank you for your consideration of these issues.

Table 1. Coronary and graft vessel-specific results. Comparison of CCTA and invasive coronary arteriography

Vessel # of Pts %LM 7/7 100 %LAD 64/68 94 %RCA 65/69 94 %Circ 63/69 91 %LIMA 16/16 100 %SVBG 37/37 100 %

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1. My license number is NY 179000. I am a board certified radiologist. This proposed Medicare position re Cardiac CTA is the single worst decision re the care of the American public I have seen in 20 years of front line practice dealing with atherosclerosis. Please re-evaluate by including peer review literature that you specifically excluded. One wonders what the true agenda is!?
2. We have not reduced the incidence of sudden cardiac death in 50 years. Cardiac CT is the only current way to find atherosclerosis early and treat it. If you wish to prevent sudden cardiac death approve Cardiac CT. Nothing else can do it.
3. Please do not act hastily and simply base your decisions on perceived increased use of technology. One must carefully weigh improved patient outcomes, earlier diagnosis and reduction in more invasive and costly procedures.
Sincerely,
Edward J Danehy MD

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Your possible indications for CTA to be studied are not appropriate. A normal CTA reliable excludes CAD in patients in whom atherosclerotic CAD must be excluded by angiography. A person with low liklihood of significant CAD clinically but a + non-invasive test, for example, could have a CTA which if normal will exclude disease. (Alternatively, they could have a far more expensive and risky traditional coronary angio which cannot visualize non-calcified placque not deforming the coronary lumen and thus is less sensitive than CTA.) Unfortunately the occasional appropriate use of CTA is to be mandated against it appears. CTA certainly may be used inappropriately but it has clear indications on the occasional patient.

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According to the Huntsville Times newspaper and Dr Michael Ridner of the Heart Center, CT scans for surgery free look inside the heart is the way to go. According to the Article Dr. Ridner has completed immense research into this area states that CT scans are much superior to the traditional invasive diagonistic angiogram. Dr. Ridner says "Blue Cross in Alabama pays about $650 for a cardiac CT scan compared to $2,500 to $3000. It appears this is a no brainer. Why not take a less invasive diagnost ct route rather than invading the body. CT Technology seems to be more superior.

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Re: Proposed Decision Memo for Coronary Computed Tomography Angiography (CAG-00385)

Dear Sirs:

I am writing to comment about the proposed national coverage determination for CT Angiography.

I object to Medicare’s proposed national coverage of determination. It appears from this memo that CMS has failed to take into account multiple recent peer reviewed evidence that demonstrates cardiac that CT Angiography is substantially more sensitive and specific then other non-invasive imaging for the diagnosis of coronary disease; and that it is less expensive and less risky than cardiac catherization. If this proposed policy were to take effect, care of Medicare patients would suffer Other letters have summarized the scientific evidence that support the position that CT angiography should be more available to Medicare patients than the proposed National Coverage Determination would allow. I will describe two real clinical cases, which illustrate the potential value of cardiac CT to Medicare patients.

(1) A 69-year-old male had vague chest discomfort and dyspnea. Nuclear stress test was said to be possibly mildly abnormal, with no perfusion defects and only mildly abnormal transient dilatation. Medical therapy was prescribed, but mild vague symptoms persisted. He and his physician considered cardiac catheterization, but were reluctant. Therefore, cardiac CT angiography was performed. This demonstrated a severe distal left main stenosis. He was then referred for cardiac catherization, which confirmed this finding, and he was sent to coronary bypass surgery. Symptoms resolved and he is doing well today.

(2) A 50-year-old African American female dialysis patient came to the emergency room with vague chest pressure. Electrocardiogram showed non-specific st and t wave changes. Cardiac enzymes were normal. Nuclear stress test was interpreted as normal, though with some artifact. She was discharged home on aspirin, beta-blocker, lipid lowering therapy, and a proton pump inhibitor. She returned several weeks later complaining of recurrent vague chest pain, with dyspnea. Lab and electrocardiogram were unchanged. Diagnostic cardiac catherization demonstrated entirely normal coronaries. Later that evening, she became weak, her blood pressure dropped, hemoglobin was found to have decreased significantly since admission. In spite of appropriate support, blood transfusions, she rapidly deteriorated and died.

These are just two of the many individual real world examples of how CT angiography can save lives. In both cases, the currently standard available non-invasive imaging did not sufficiently answer the clinical question. The physicians and patients involved were left with the difficult decision as to whether or not to proceed to cardiac catheterization, with its attendant risks and costs. The first patient was at high risk for sudden death, but the stress test did not reflect this risk. It is known that nuclear stress imaging can underestimate or miss important left main disease . The second case, occurred years before the availability of cardiac CT angiography. If cardiac CT angiography had been available, she would have had a normal CT angiogram, would not have had cardiac catherization, and would have lived.

CMS has indicated that they believe that we must justify imaging by outcomes research. Large statistically valid studies are likely to be costly and may not be necessary. I would argue that these individual cases demonstrate how cardiac CT can improve clinical outcomes in a substantial and cost effective fashion.

CMS is proposing a limited coverage with evidence determination, and with limited indications. I respectfully suggest that in the proposed National Coverage Determination:

1. CMS has failed to take into account a considerable evidence from peer review studies;
2. The step of requiring CT to demonstrate improved patient outcomes is not reasonable.
3. Indications proposed are too limited. In particular, an especially valuable use of CT angiography at this time, that is not proposed, is to be used in the setting of equivocal stress test.
4. The non-coverage of CTA for diagnosis of coronary disease will force Medicare patients to undergo more expensive and higher risk invasive studies.
5. CT angiography is highly sensitive and specific. It is particularly good for its negative predictive value, allowing patients to avoid invasive cardiac catherization.
6. CT angiography would reduce unnecessary downstream cost such as hospitalizations.

Therefore, along with others, I recommend that CMS consider:

1. Delaying a national coverage determination, and allowing local coveragedetermination, be ongoing for the next two years while further information is gathered.
2. CMS encourage and work with societies to develop and utilize CT registries.
3. That appropriate use of CT angiography be defined as studies that are felt to be appropriate by ACC guidelines.

1 Daniel S. Berman et al Journal of Nuclear Cardiology, July 2007 (Vol. 14, Issue 4, Pages 521-528)

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To Whom It May Concern:

Like many physicians involved in cardiac CTA, I am quite surprised by the newly proposed NCD by CMS for cardiac CTA. Multiple societies (ACC, ACR, SCCT, ASNC, ASNC, SCAI, NASCI, and SCMR) have been proactively involved in evaluating and putting forth the clinical appropriateness criteria for CCTA in 2006, which CMS has chosen to ignore. The statement put forth by CMS does not reflect the current state of evidence and has disregarded more than 40 studies that support the clinical usefulness of this imaging modality.^1-43 In fact, Medicare subsidiaries have issued LCD’s in all 50 states after carefully reviewing the existing evidence. Most major 3rd party payers have also issued national coverage policies. The vast majority of Medicare subsidiaries already accept the following indications for cardiac CTA: 1) Following an equivocal nuclear perfusion study. 2) Post-revascularization patients having CAD symptoms. 3) Pre-electrophysiology anatomic mapping. 4) CCTA as the first diagnostic test in patients with chest pain.

The main target population for cardiac CTA is low to moderate risk chest pain patients. Approximately 30% of Medicare patients are in the 45-70 year age group and therefore approximately 12 million patients would be affected by the NCD.^44,45 There are 6 million emergency department visits in the U.S. and the majority prove to have noncardiac chest pain. Cardiac CTA provides a an accurate, time efficient, and cost effective strategy to evaluate these patients compared to stress nuclear imaging.^41,46,47 With a 97% negative predictive value compared to cardiac CTA, a normal study provides a high degree of certainty that a patient has noncardiac chest pain.^4-29 In addition, cardiac CTA can also identify other potential serious causes of chest pain which is not provided by a nuclear study. Furthermore, several studies have shown that CCTA is more diagnostically accurate than nuclear stress imaging.^1-3

The safety of CCTA compared to invasive angiography has been demonstrated in several studies.^17,30 Anyone who has taken care of patients that have suffered an embolic event or a groin access complication understands that despite a relatively low complication rate with catheterization, it is a significant event for that individual. Outcomes data is also available for cardiac CTA. A benign outcome for patients with a normal CTA has been demonstrated in multiple studies.^48-50 A positive CCTA has also been shown to risk stratify adverse outcomes.^51-53

I am urging CMS to delay the NCD and work with the major societies, especially the SCCT, to consider a more reasonable coverage plan that reflects the current evidence. In my opinion, it would be irresponsible not to do so particularly when so many Medicare patients would be denied a clinically useful noninvasive imaging modality that could potentially avoid unnecessary cost and invasive testing.

Sincerely,
David R. Richards, DO, FACC, FASE
Director, Cardiac CT
MidOhio Cardiology & Vascular Consultants
Columbus, Ohio

References:
1. Gallagher MJ, Ross MA, Raff GL, Goldstein JA, O''Neill WW, O''Neil B. The diagnostic accuracy of 64-slice computed tomography coronary angiography compared with stress nuclear imaging in emergency department low-risk chest pain patients. Ann Emerg Med. 2007 Feb;49(2):125-36. Epub 2006 Sep 15.
2. Schuijf JD, Wijns W, Jukema JW, Atsma DE, de Roos A, Lamb HJ, Stokkel MP, Dibbets-Schneider P, Decramer I, De Bondt P, van der Wall EE, Vanhoenacker PK, Bax JJ. Relationship between noninvasive coronary angiography with multi-slice computed tomography and myocardial perfusion imaging. J Am Coll Cardiol. 2006 Dec 19;48(12):2508-14.
3. Budoff MJ, Rasouli ML, Shavelle DM, Gopal A, Gul KM, Mao SS, Liu SH, McKay CR. Cardiac CT Angiography (CTA) and Nuclear Myocardial Perfusion Imaging (MPI)-A Comparison in Detecting Significant Coronary Artery Disease. Acad Radiol. 2007 Mar;14(3):252-7.
4. Raff GL, Gallagher MJ, O''Neill WW, Goldstein JA.Diagnostic accuracy of noninvasive coronary angiography using 64-slice spiral computed tomography. J Am Coll Cardiol. 2005 Aug 2;46(3):552-7.
5. Meijboom WB, Weustink AC, Pugliese F, van Mieghem CA, Mollet NR, van Pelt N, Cademartiri F, Nieman K, Vourvouri E, Regar E, Krestin GP, de Feyter PJ. Comparison of diagnostic accuracy of 64-slice computed tomography coronary angiography in women versus men with angina pectoris. Am J Cardiol. 2007 Nov 15;100(10):1532-7.
6. Leber AW, Johnson T, Becker A, von Ziegler F, Tittus J, Nikolaou K, Reiser M, Steinbeck G, Becker CR, Knez A.Diagnostic accuracy of dual-source multi-slice CT-coronary angiography in patients with an intermediate pretest likelihood for coronary artery disease. Eur Heart J. 2007 Oct;28(19):2354-60. Epub 2007 Jul 21.
7. Pundziute G, Schuijf JD, Jukema JW, van Werkhoven JM, Boersma E, de Roos A, van der Wall EE, Bax JJ.Gender Influence on the Diagnostic Accuracy of 64-Slice Multislice Computed Tomography Coronary Angiography for Detection of Obstructive Coronary Artery Disease. Heart 2008 Jan;94(1):48-52. Epub 2007 May 31
8. Herzog C, Zwerner PL, Doll JR, Nielsen CD, Nguyen SA, Savino G, Vogl TJ, Costello P, Schoepf UJ. Significant coronary artery stenosis: comparison on per-patient and per-vessel or per-segment basis at 64-section CT angiography. Radiology. 2007 Jul;244(1):112-20.
9. Meijboom WB, van Mieghem CA, Mollet NR, Pugliese F, Weustink AC, van Pelt N, Cademartiri F, Nieman K, Boersma E, de Jaegere P, Krestin GP, de Feyter PJ. 64-slice computed tomography coronary angiography in patients with high, intermediate, or low pretest probability of significant coronary artery disease. J Am Coll Cardiol. 2007 Oct 9;50(15):1469-75. Epub 2007 Sep 24.
10. Cademartiri F, Maffei E, Palumbo A, Malagò R, Alberghina F, Aldrovandi A, Brambilla V, Runza G, La Grutta L, Menozzi A, Vignali L, Casolo G, Midiri M, Mollet NR. Diagnostic accuracy of 64-slice computed tomography coronary angiography in patients with low-to-intermediate risk. Radiol Med (Torino). 2007 Oct;112(7):969-81. Epub 2007 Oct 21
11. Scheffel H, Leschka S, Plass A, Vachenauer R, Gaemperli O, Garzoli E, Genoni M, Marincek B, Kaufmann P, Alkadhi H. Accuracy of 64-slice computed tomography for the preoperative detection of coronary artery disease in patients with chronic aortic regurgitation. Am J Cardiol. 2007 Aug 15;100(4):701-6. Epub 2007 Jun 21.
12. Leschka S, Alkadhi H, Plass A, Desbiolles L, Grünenfelder J, Marincek B, Wildermuth S. Accuracy of MSCT coronary angiography with 64-slice technology: first experience.Eur Heart J. 2005 Aug;26(15):1482-7.
13. Ghostine S, Caussin C, Daoud B, Habis M, Perrier E, Pesenti-Rossi D, Sigal-Cinqualbre A, Angel CY, Lancelin B, Capderou A, Paul JF. Non-invasive detection of coronary artery disease in patients with left bundle branch block using 64-slice computed tomography. J Am Coll Cardiol. 2006 Nov 21;48(10):1929-34.
14. Shabestari AA, Abdi S, Akhlaghpoor S, Azadi M, Baharjoo H, Pajouh MD, Emami Z, Esfahani F, Firouzi I, Hashemian M, Kouhi M, Mozafari M, Nazeri I, Roshani M, Salevatipour B, Tavalla H, Tehrai M, Zarrabi A. Diagnostic performance of 64-channel multislice computed tomography in assessment of significant coronary artery disease in symptomatic subjects.Am J Cardiol. 2007 Jun 15;99(12):1656-61. Epub 2007 May 2
15. Hausleiter J, Meyer T, Hadamitzky M, Zankl M, Gerein P, Dörrler K, Kastrati A, Martinoff S, Schömig A.Non-invasive coronary computed tomographic angiography for patients with suspected coronary artery disease: the Coronary Angiography by Computed Tomography with the Use of a Submillimeter resolution (CACTUS) trial. Eur Heart J. 2007 May 31;16. Mühlenbruch G, Seyfarth T, Soo CS, Pregalathan N, Mahnken AH. Diagnostic value of 64-slice multi-detector row cardiac CTA in symptomatic patients. Eur Radiol. 2007 Mar;17(3):603-9. Epub 2006 Sep 29.
17. Andreini D, Pontone G, Pepi M, Ballerini G, Bartorelli AL, Magini A, Quaglia C, Nobili E, Agostoni P.Diagnostic accuracy of multidetector computed tomography coronary angiography in patients with dilated cardiomyopathy. J Am Coll Cardiol. 2007 May 22;49(20):2044-50. Epub 2007 May 4
18. Pugliese F, Mollet NR, Runza G, van Mieghem C, Meijboom WB, Malagutti P, Baks T, Krestin GP, deFeyter PJ, Cademartiri F.Diagnostic accuracy of non-invasive 64-slice CT coronary angiography in patients with stable angina pectoris. Eur Radiol. 2006 Mar;16(3):575-82. Epub 2005 Nov 16.
19. Watkins MW, Hesse B, Green CE, Greenberg NL, Manning M, Chaudhry E, Dauerman HL, Garcia MJ.Detection of coronary artery stenosis using 40-channel computed tomography with multi-segment reconstruction. Am J Cardiol. 2007 Jan 15;99(2):175-81. Epub 2006 Nov 14.
20. Mollet NR, Cademartiri F, van Mieghem CA, Runza G, McFadden EP, Baks T, Serruys PW, Krestin GP, de Feyter PJ. High-resolution spiral computed tomography coronary angiography in patients referred for diagnostic conventional coronary angiography. Circulation. 2005 Oct 11;112(15):2318-23. Epub 2005 Oct
21. Busch S, Johnson TR, Nikolaou K, von Ziegler F, Knez A, Reiser MF, Becker CR. Visual and automatic grading of coronary artery stenoses with 64-slice CT angiography in reference to invasive angiography. Eur Radiol. 2007 Jun;17(6):1445-51. Epub 2006 Dec 16.
22. Johnson TR, Nikolaou K, Busch S, Leber AW, Becker A, Wintersperger BJ, Rist C, Knez A, Reiser MF, Becker CR. Diagnostic accuracy of dual-source computed tomography in the diagnosis of coronary artery disease. Invest Radiol. 2007 Oct;42(10):684-91
23. Weustink AC, Meijboom WB, Mollet NR, Otsuka M, Pugliese F, van Mieghem C, Malago R, van Pelt N, Dijkshoorn ML, Cademartiri F, Krestin GP, de Feyter PJ. Reliable high-speed coronary computed tomography in symptomatic patients. J Am Coll Cardiol. 2007 Aug 21;50(8):786-94. Epub 2007 Aug 6.
24. Leschka S, Scheffel H, Desbiolles L, Plass A, Gaemperli O, Stolzmann P, Genoni M, Luescher T, Marincek B, Kaufmann PA, Alkadhi H.Combining Dual-Source Computed Tomography Coronary Angiography and Calcium Scoring: Added Value for the Assessment of Coronary Artery Disease.Heart. 2007 Nov 21;
25. Brodoefel H, Reimann A, Burgstahler C, Schumacher F, Herberts T, Tsiflikas I, Schroeder S, Claussen CD, Kopp AF, Heuschmid M. Noninvasive coronary angiography using 64-slice spiral computed tomography in an unselected patient collective: Effect of heart rate, heart rate variability and coronary calcifications on image quality and diagnostic accuracy. Eur J Radiol. 2007 Jun 26; PMID: 17600648
26. Meijboom WB, Mollet NR, Van Mieghem CA, Weustink AC, Pugliese F, van Pelt N, Cademartiri F, Vourvouri E, de Jaegere P, Krestin GP, de Feyter PJ.64-Slice CT coronary angiography in patients with non-ST elevation acute coronary syndrome.Heart. 2007 Nov;93(11):1386-92.
27. Cademartiri F, Maffei E, Palumbo AA, Malagò R, La Grutta L, Meiijboom WB, Aldrovandi A, Fusaro M, Vignali L, Menozzi A, Brambilla V, Coruzzi P, Midiri M, Kirchin MA, Mollet NR, Krestin GP.Influence of intra-coronary enhancement on diagnostic accuracy with 64-slice CT coronary angiography.Eur Radiol. 2007 Oct 13;
28. Pontone G, Andreini D, Quaglia C, Ballerini G, Nobili E, Pepi M.Accuracy of multidetector spiral computed tomography in detecting significant coronary stenosis in patient populations with differing pre-test probabilities of disease.Clin Radiol. 2007 Oct;62(10):978-85. Epub 2007 Aug 7. PMID: 17765463
29. Ropers U, Ropers D, Pflederer T, et al. Influence of Heart Rate on the Diagnostic Accuracy of Dual-Source Computed Tomography Coronary Angiography J Am Coll Cardiol 2007 50: 2393-2398
30. Gilard M, Le Gal G, Cornily JC, Vinsonneau U, Joret C, Pennec PY, Mansourati J, Boschat J. Midterm prognosis of patients with suspected coronary artery disease and normal multislice computed tomographic findings: a prospective management outcome study. Arch Intern Med. 2007 Aug 13-27;167(15):1686-9. PMID: 17698693
31. Danciu SC, Herrera CJ, Stecy PJ, Carell E, Saltiel F, Hines JL.Usefulness of multislice computed tomographic coronary angiography to identify patients with abnormal myocardial perfusion stress in whom diagnostic catheterization may be safely avoided.Am J Cardiol. 2007 Dec 1;100(11):1605-8.
32. McCaig LF, Burt CW. National Hospital Ambulatory Medical Care Survey 2003: Emergency Department Summary: Advance Data from Vital and Health Statistics, No. 358. Hyattsville, MD:National Center for Health Statistics; 2005.
33. Sato Y, Matsumoto N, Ichikawa M, et al. Efficacy of multislice computed tomography for the detection of acute coronary syndrome in the emergency department. Circ J 2005;69:1047–1051.
34. White CS, Kuo D, Kelemen M, et al. Chest pain evaluation in the emergency department: Can MDCT provide a comprehensive evaluation? AJR Am J Roentgenol 2005;185:533–540.
35. Hoffmann U, Penal AJ, Ferencik M et al. MDCT in Early Triage of Patients with Acute Chest Pain AJR Am J Roentgenol 2006; 187:1240–1247
36. Hoffmann U, Nagurney JT, Moselewski F, et al. Coronary multidetector computed tomography in the assessment of patients with acute chest pain. Circulation 2006;114:2251–2260.
37. Gallagher MJ, Ross MA, Raff GL, et al. The diagnostic accuracy of 64-slice computed tomography coronary angiography compared with stress nuclear imaging in emergency department low-risk chest pain patients. Ann Emerg Med 2007;49:125–136.
38. Rubinshtein R, Halon DA, Gaspar T, et al. Usefulness of 64-slice cardiac computed tomographic angiography for diagnosing acute coronary syndromes and predicting clinical outcome in emergency department patients with chest pain of uncertain origin. Circulation 2007;115:1762–1768.
39. Hollander JE, Litt HI, Chase M, et al. Computed Tomography Coronary Angiography for Rapid Disposition of Low-risk Emergency Department Patients with Chest Pain Syndromes. Acad Emerg Med 2007;14:112-116
40. Johnson TRC, Nikolaou K, Wintersperger BJ, et al. ECG-Gated 64-MDCT Angiography in the Differential Diagnosis of Acute Chest Pain. Amer J Roentgen. 2007;188:76-82
41. Goldstein JA, Gallagher MJ, O’Neill WW, et al. A randomized controlled trial of multi-slice coronary computed tomography for evaluation of acute chest pain patients. J Am Coll Cardiol 2007;49:863–871.
42. Vrachliotis TG, Bis KG, Haidary A, et al. Atypical chest pain : Coronary, aortic, and pulmonary vasculature enhancement at biphasic singleinjection 64-section CT angiography. Radiology 2007;243:368–376.
43. Onuma K, Tanabe, Nakazawa G, et al. Non cardiac findings in cardiac imaging with multidetector computed tomography. J Am Coll Cardiol 2006;48:402–406.
44. website www.statehealthfacts.org/comparetable.jsp?nd=292&cat=6
45. website www.allcountries.org/uscensus;193_visits_to_hospital_emergency_departments_by.html
46. Min JK et al. Society of Cardioavscular Computed Tomography Scientific Sessions 2007.
47. Cole J, Chunn VM, Morrow A, Buckley RS, Phillips GM. Cost implications of initial computed tomography angiography as opposed to catheterization in patients with mildly abnormal or equivocal myocardial perfusion scans. JCCT 2007; 1:21-26.
48. Gilard M, Le Gal G, Cornily JC, Vinsonneau U, Joret C, Pennec PY, Mansourati J, Boschat J. Midterm prognosis of patients with suspected coronary artery disease and normal multislice computed tomographic findings: a prospective management outcome study. Arch Intern Med. 2007;167:1686-9.
49. Meijboom WB, van Mieghem CA, Mollet NR, Pugliese F, Weustink AC, van Pelt N, Cademartiri F, Nieman K, Boersma E, de Jaegere P, Krestin GP, de Feyter PJ. 64-slice computed tomography coronary angiography in patients with high, intermediate, or low pretest probability of significant coronary artery disease. J Am Coll Cardiol. 50:1469-75.
50. Lesser JR, Flygenring B, Knickelbine T, Hara H, Henry J, Kalil A, Pelak K, Lindberg J, Pelzel J, Schwartz RS. Clinical utility of coronary CT angiography: coronary stenosis detection and prognosis in ambulatory patients. Catheter Cardiovasc Interv. 2007;69:64-72.
51. Min JK, Shaw LJ, Devereux RB, Okin PM, Weinsaft JW, Russo DJ, Lippolis NJ, Berman DS, Callister TQ. Prognostic value of multidetector coronary computed tomographic angiography for prediction of all-cause mortality. J Am Coll Cardiol. 2007;50:1161-70.
52. Budoff MJ. Circulation 2007; 116: II-771.
53. Pundziute G, Schuijf JD, Jukema JW, Boersma E, de Roos A, van der Wall EE, Bax JJ. Prognostic value of multislice computed tomography coronary angiography in patients with known or suspected coronary artery disease. J Am Coll Cardiol. 49:62-70.

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I am a board certified interventional radiologist. This proposed Medicare position re Cardiac CTA is the single worst decision re the care of the American public conceivable. Please re-evaluate by including peer review literature that you specifically excluded. One wonders what the true agenda is!?

We have not reduced the incidence of sudden cardiac death in 50 years. Cardiac CT is the only current way to find atherosclerosis early and treat it. If you wish to prevent sudden cardiac death approve Cardiac CT. Nothing else can do it.

Please do not act hastily and simply base your decisions on perceived increased use of technology. One must carefully weigh improved patient outcomes, earlier diagnosis and reduction in more invasive and costly procedures.

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CCTA coverage should continue to be covered for the following reasons:

1. based on our year and a half experience CCTA provides accurate and non-invasive diagnostic information regarding coronary artery disease and the risk of impending heart attack at a cost two thirds less than coronary angiography.
2. it is a non-invasive exam with less morbidity and mortality than coronary angiography.
3. based on our experience, many of these patients can be managed with drug therapy as opposed to surgery and/or stent placement (also much more expensive).

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Such Draconian limitations on a new technology make it seem that all the frustrations on ballooning medical costs, declining funds, and financial scrutiny are serving up this promising modality as a sacrifice on the alter of sanctimonious politicians and insulated academicians. The fact is that this modality holds great promise to revolutionize cardiac care and greatly reduce unnecessary cardiac catheterizations and occulostenotic angioplasties.

Reasonable limitations might include board certification of readers by ACR or SCCT/ACC, reduced payment for diagnostic catheterization done within 90 days, limitations on repeat procedures, etc... Rather than halting progress, I would humbly suggest deferring an NCD for 1 - 2 years until more data is available and a better thought out plan of implementation can be formulated. Was Chest CTA to evaluate pulmonary embolism blocked until definitive studies were performed?

Thank you for your re-consideration.
Respectfully,
Adam Schussheim

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The NCD proposed by the CMS is premature, grossly unjust, and tries to crush a promising new technology such as cardiac computed tomography angiography (CCTA) without giving it ample opportunity to prove itself further in the diagnostic arena of coronary artery disease (CAD) and other indications. To date, CCTA has been the fastest growing technology compared to any form of cardiac imaging, and has repeatedly proved it’s high negative predictive value in ruling out coronary artery disease. This is exactly the characteristic which should be exploited, especially in patients without a high likelihood of CAD, so further unnecessary costs can be reduced. Instead the proposed NCD includes patient populations with a high pretest probability of disease. The more recent developments regarding significant reduction in radiation dose and contrast is another important aspect.

In certain population groups, such as women, with atypical presentations, and where conventional tests (bicycle ergometry) deliver a lot of false positives, CCTA is a superior technique (B Shivalkar et al, Ann Med. 2007;39(4):290-7). A cost analysis study in women (in a European setting, B. Shivalkar et al, manuscript submitted) showed that CCTA was cheaper and more accurate than stress myocardial nuclear perfusion imaging in diagnosing significant CAD. There was a 61% incremental chance of unneeded cardiac catheterization with CCTA allowing for average cost savings of € 1654.91 per patient. Presently there are ongoing studies at our centre in patients with atypical complaints and intermediate likelihood, asymptomatic high risk category patients etc. It is imperative that we perform large scale studies in various subpopulations to determine the diagnostic accuracy, clinical effectiveness, cost analysis and outcomes research.

To this end, we urge the following issues:

1. The proposed NCD should be withdrawn. If it is not withdrawn, substantial modifications should be made to provide coverage for appropriate indications and populations.

2. The proposed NCD does not adequately reflect the current state of evidence in support of CCTA in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD.

3. Data is rapidly accumulating for 64-slice CCTA and there are many additional studies in the peer-reviewed, published literature to cite. CMS has failed to recognize many of these critically important studies. It is premature to propose a new set of coverage criteria without a more thorough review of the available published evidence. Therefore, we request that CMS conduct a more complete and up-to-date assessment of this vital imaging technology before the NCD is finalized.

4. The requirements CMS has established to obtain coverage for CCTA will have a severe negative impact on Medicare beneficiaries’ access to the service across the country given the uncertain approval process and timeline for future clinical trial development. We believe CMS has not properly examined the full impact the NCD with CED will have on the Medicare beneficiary population.

5. The specialty societies have been working together for more than two years to define the appropriate indications for CCTA and we urge CMS to work with the relevant societies, specifically, the Society of Cardiovascular Computed Tomography (SCCT), to better develop criteria for the types of clinical research that is appropriate for CED to minimize the negative impact on quality patient care.

Thank you,sincerely,

Prof. Dr. B. Shivalkar MD, PhD, FESC

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Our group of 34 practicing cardiologists and surgeons has been using cardiac CTA for over 1 year now. We have seen significant declines in the number of patients requiring invasive catheterizations. When properly used under ACC/AHA guidelines and by trained readers, this technology has the potential to save the system millions of dollars. In our own practice, I would estimate that we have probably saved the "system" at least $500,000.00 in the first 3 quarters of 2007. We have a database that we hope to generate more robust numbers to share with the payers and perhaps even publish in the near future. We ask that you please reconsider this decision.

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January 11, 2008

Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group

Marcel Salive, MD, MPH
Director, Division of Medical and Surgical Services

Joseph Chin, MD, MS
Lead Medical Officer

JoAnna Baldwin, MS
Lead Analyst

Centers for Medicare and Medicaid Services
Department of Health and Human Services
P.O. Box 8014
Baltimore, MD 21244-8014

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

Dear Drs. Phurrough, Salive, and Chin and Ms. Baldwin:

On behalf of the Medical Imaging and Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), we are pleased to submit our comments regarding the Proposed Coverage Decision for Computed Tomographic Angiography (CTA) - CAG-00385N. MITA is the collective voice of medical imaging equipment manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 95 percent of the global market for medical imaging technology. We are pleased to provide the Centers for Medicare and Medicaid Services (CMS) with our perspectives on the clinical value of non-invasive cardiac CTA imaging tests for diagnosis of coronary artery disease (CAD). It is important for CMS to understand the genuinely adverse effects of restricted Medicare beneficiary access to this non-invasive imaging service, if widespread and existing coverage is suddenly withdrawn and confined exclusively to beneficiaries who have access to and agree to participate in studies approved by CMS. Our major recommendations and the basis for them are as follows.

Recommendations

Based on our concerns over a) the excessively restrictive Coverage with Study Participation (CSP) approach proposed by CMS, b) the risks of disruption in or uneven access to cardiac CTA even for proposed indications under the proposed NCD due to the CSP approach, c) the poorly specified, “wide-open” study options under the proposed NCD, 4) the ready availability of more moderate coverage and data collection approaches under statutory authorities, and 5) the growing body of clinical evidence refining the application of cardiac CTA imaging in diagnosing CAD, MITA offers the following recommendations to CMS.

As a former president of the North AmericanSociety for Cardiac Imaging (NASCI) and theSociety for Cardiac Angiography and Interventions(SCAI), a Fellow of the American College ofRadiology and the American College of Cardiology,someone who has been a leader in cardiac imagingtechniques for almost 40 years, and an author ofseveral recent consensus papers discussing thevalue of cardiac computed tomography, I urge youto give full consideration to the documentsubmitted to you jointly by the ACC, ACR, ASNC,NASCI, SCAI, and the SCCT.

The Societies make a strong case for you toreconsider the proposed NCD for coronary computedtomography angiography.

Rather than act hastily on insufficient andoutdated information and reports, CMS shouldmaintain the current coverage status for CCTA.

Thank you for considering my comments.

Lewis Wexler, MD
Professor Emeritus of Radiology
Stanford University School of Medicine
Stanford, CA 94305

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To Whom it May Concern,

I am greatly troubled by the new proposed CME NCD on cardiac CTA.

The proposed NCD does not fully reflect the current state of evidence in support of CCTA in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD. Data is rapidly accumulating for 64-slice CCTA and there are more complete studies in the peer-reviewed, published literature to cite. CMS has failed to include many of the critically important studies. It seems premature to propose a new set of coverage criteria without a more thorough review of the available published evidence.

Therefore, we request that CMS conduct a more complete and up-to-date assessment of this imaging technology before the NCD is finalized. The requirements CMS has established to obtain coverage for CCTA will have a very negative impact on Medicare beneficiaries’ access to the service across the country given the uncertain approval process and timeline for future clinical trial development. We believe CMS has not properly examined the full impact the NCD with CED will have on the Medicare beneficiary population.

The specialty societies have been working together for more than two years to define the appropriate indications for CCTA and we urge CMS to work with the relevant societies, specifically, the Society of Cardiac Computed Tomography (SCCT), to better develop criteria for the types of clinical research that is appropriate for CED to minimize the impact on the delivery of appropriate care to beneficiaries.

Furthermore, the SCCT, the AHA, the ACC have proactively written, guidelines for training, certification requirements and appropriateness criteria for this technique to proactively assure its appropriate use and to avoid its misuse. We have and will continue to act responsibly regarding the use of cardiac CTA.

In summary, this technique has greatly helped my practice of cardiology, has benefited patients, and has not led to layering of testing.

I greatly hope you reconsider this decision and work with the major societies including the SCCT consider a more reasonable coverage plan for cardiac CTA that appropriately takes into account the current available data base on the usefulness of the technique while further studies are undertaken.

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Thank you for the opportunity to respond to CMS''s proposed NCD.

I have used coronary CT angiography for 2 years to care for patients according to guidelines published by the American College of Cardiology. I am a cardiologist in practice for 21 years who performs diagnostic invasive cardiac catheterizations and have run a coronary care unit. While I am certified to read such CTA studies, they are performed locally by a tertiary care center because of the delayed authorization of payment by CMS and other payers in my state (Massachusetts).

I have found CTA helpful to avoid invasive studies in patients believed to be at increased risk for invasive angiography (e.g. a young frail woman with Friedrich''s Ataxia with abnormal stress test with multiple visits to the ER for chest pain. [Patient found to have normal coronary arteries on CTA]I have also employed CTA as a rational basis to proceed with invasive angiography in higher risk patient subsets whose catheterizations would incur risk and hospitalization (Patient s/p LIMA to LAD with aortic valve replacement with unexplainable wall motion abnormality and perfusion defect on stress testing and history of rare chest sensation [CTA showed tight tight stenosis in large unbypassed marginal branch fixed and stented]. CTA has demonstrated a myocardial bridge in a young jogger with atypical chest pain and several hospitalizations. CTA has demonstrated an occluded RCA in elderly man needing spinal stenosis surgery who refused catheterization but whose stress test was significantly abnormal and who had ventricular tachycardia [patient did well with surgery based on CTA findings]. CTA has established a rational basis of treating a patient with a mildy elevated LDL cholesterol but whose CTA demonstrated vessel wall atheromatous disease. Congenital coronary anomalies are easily defined or excluded and my patients who require atrial electrophysiologic ablation studies have their atrium and pulmonary veins mapped to improve the efficacy and efficiency of electrophysiologic studies.

The science that has accrued through randomized and observational studies with invasive correlation has been solid justifying the use of this new technology on behalf of patients and the greater good of the public. Professional societies have been formed to establish high quality for physician interpretation.

The restriction of CTA by CMS''s proposed coverage determination imposes an unexpected and unjustified burden on patients and the physician. Has CMS imposed this decision strategy on the use of CT for stroke, third generation cephalosporins for pseudomonas coverage, or for that matter the use of chest X-ray in general adult care?

I believe CMS should have standards for what is approved for payment based on science. The same standards however need to be applied for all services. One would think that the diagnosis and treatment of the nation''s number one killer would be on an even footing if not a priority. There is nothing wrong with answering the questions in the proposed NCD. This however has already been done in smaller studies. They could be further expanded upon as part of a carefully controlled registry.

I am a 56 year old married physician with grown children who has spent tens of thousands of dollars learning this new technology to help my patients and make a living while working full time in clinical practice. The unexpected imposition of CMS''s proposed regulations is deflating for it will stall the widespread implementation of this helpful technology and diagnostic modality aimed at helping the public and will essentially render the time spent in learning this modality cost-ineffective.

It is my impression that CMS''s proposed unusual and unexpected coverage decision which will derail the implementation of CTA and hurt patients, is designed to lower the rise of health care costs. While this goal is laudable CMS should review all CMS covered services and determine which services are needed most and use the same criteria for all reviewed services past and present. This would clearly be more work and incur other fallout but at least it would be rational and inclusive. The proposed NCD appears to be an end run around engaging in a thorny political process of health care spending in general. CMS appears to be hanging the noose around CTA to help with national budgetary considerations. These discussions are inherently political and not always based on science or medicine. CMS can do it better. Please listen to our medical societies and our medical leaders and have them at the table as these decisions are made. It is my sense from my own practice that CTA will decrease the need for repeat hospitalizations, unnecessary invasive studies or stress tests and in so doing will save money for the government, other payers and society.

CTA has gone through a laborious process of clinical research in peer based cardiology and radiology studies and is on the brink of giving patients and physicians options which they have never had before.

If CMS, the government and our society needs to ration health care, lets make it explicit and get everyone who should be represented present at the table patients, physicians, medical societies and the government.

Thank you

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I favor Medicare coverage for Coronary CTA(CCTA.CCTA can save patient morbidity and mortality by replacing cath with a non-invasive technique. The NPV of CCTA is unequalled by any other test. Recent 64 slice and better literature confims this and supports outstanding PPV as well. Radiologists have replaced invasive diagnostic carotid, abdominal, and peripheral angiograms with less expensive and risky CTA and MRA, and CCTA can do the same for cardiac cath. In low to moderate risk patients a negative CCTA precludes any further workup. Traditional stress testing has neither the NPV of CCTA and is fraught with false positive exams resulting in needless caths.

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CAT of the coronary arteries using 64 slice and above is a proven lifesaver that has the potential for big savings for CMS and all payors.

It''s negative predictive value is 98-99% and saves patients worry and annual testing for the symptoms of chest pain that frequently lead to cardiology consultation equivocal stress test that require risky complication prone Coronary catheterization.

In addition the negative stress echo or stress mibi exams touted by Cardiologists give a false security to patients that have significant disease in their coronary arteries but do not have 70% stenosis required for a positive stress exam.

Coronary CTA lets patients know if they have a burden of plaque and that they should change their lifestyle and possibly take cholesterol lowing drugs or aspirin.

This test is tailer made for individuals that have chest pain that needs evaluation but is not typical for angina. These patients are now being evaluated usually annually by test with low negative predictive value and a high false positive rate. It makes sense to use an objective test that can see the wall of the vessel. Yes testing is needed but I have seen many results on test using 64 or Better CT scans that prove the efficacy of this exam.

The criteria for payment under the proposal selects those patients that are least likely to benefit. Patients with known angina or coronary artery disease are precisely those least likely to benefit from this procedure which should be used in the low to moderate risk patient that so frequently leads to annual stress testing and an annuity for cardiologists.

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The decision by cms does not reflect the current data that is known in the literature. There currently very strong indications for ccta in particular situations which exploint the tremendous negative predictive value of the technique.

The indications endorsed by blue cross/blue shield of illinois are reflective of the current knowledge and are a model that should be followed by cms on the national level.

The decision that has been made should be revised. Alternatively, this should be a decision made on the local level.

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In our institution, we do cardiac CTA. With a careful triage of patients who meet criteria and would normally go to invasive catheterization but are relatively low risk, these patients are almost always cleared of obstructive coronary disease and therefore spared the invasiveness of cath.

There is no further concern in future encounters with that patient when they return to the emergency room or clinic and whether they will have to again be evaluated for coronary artery disease. The scan is quite clear; they do not have coronary disease and the workup can be directed elsewhere.

It also avoids the self-referral bias of cardiologists referring patients to themselves for cardiac cath. If they send a patient for CTA, that patient must have really needed that evaluation, since the financial self-referral bias has been removed.

Most studies on 64 slice equipment have shown the CTA to be accurate, safe, effective, with an especially high negative predictive value. The NCD did not evaluate much of the most recent and scientifically valid references, and therefore has arrived at the wrong conclusion regarding CTA and coronary disease.

Every month, new references are coming out further solidifying the role of CTA. Some recent ones are listed at the end of this letter. Their evidence-based results must certainly contest the decision made on older and incomplete data. Any analysis should be limited to 64 and 16 slice scanners, and perhaps best only 64 slice scanners. Data from 4-16 slice scanners should not be used to determine the NCD.

Most institutions have experienced a solid decrease in the number of normal angiograms performed in the cath lab since CTA has become available. It would be a real shame to send these folks back to the cath lab where they will be exposed to greater cost, greater risk, more anxiety, more complications, all of which are especially unfortunate in the person who proves to have no obstructive disease in the first place.

Respectfully, Irwin M. Feuerstein, MD

Jawdat Abdulla, Steen Z. Abildstrom, Ole Gotzsche, Erik Christensen, Lars Kober, and Christian Torp-Pedersen. 64-multislice detector computed tomography coronary angiography as potential alternative to conventional coronary angiography: a systematic review and meta- analysis. Eur Heart J 2007 28: 3042-3050.

Jörg Hausleiter, Tanja Meyer, Martin Hadamitzky, Maria Zankl, Pia Gerein, Katharina Dörrler, Adnan Kastrati, Stefan Martinoff, and Albert Schömig. Non-invasive coronary computed tomographic angiography for patients with suspected coronary artery disease: the Coronary Angiography by Computed Tomography with the Use of a Submillimeter resolution (CACTUS) trial. Eur Heart J 2007 28: 3034-3041.

EVIDENCE-BASED PRACTICE: Piet K. Vanhoenacker, Majanka H. Heijenbrok-Kal, Ruben Van Heste, Isabel Decramer, Lieven R. Van Hoe, William Wijns, and M. G. Myriam Hunink Diagnostic Performance of Multidetector CT Angiography for Assessment of Coronary Artery Disease: Meta-analysis Radiology 2007; 244: 419-428.

EVIDENCE-BASED PRACTICE: Michèle Hamon, Rémy Morello, John W. Riddell, and Martial Hamon. Coronary Arteries: Diagnostic Performance of 16- versus 64-Section Spiral CT Compared with Invasive Coronary Angiography—Meta- Analysis. Radiology 2007 245: 720-731

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I am a practicing cardiologist who has been trained in cardiac CT through fellowship at Washington University. I have published abstracts and interpreted hundreds of clinical and research cases. I am concerned not only about the possible implications of using cardiac CT to screen marginally symptomatic patients but also about the use of cardiac CT to evaluate patients with known coronary disease and stents. These are areas in research where there is no data that it would improve outcomes. In fact there is essentially no good data on prognostic abilities of cardiac CT or the ability to alter outcomes. There is only comparison to cath data in a very selected group of patients with typically very biased results and significant patient exclusions. The study also comes with a significant radiation dose and most trials did not use dose modulation which significantly increases radiation dose. I feel from my experience reading that I would limit my use of cardiac CT to the evaluation of coronary anomalies in patients who are less likely to experience long term side effects of the radiation or in who the risk of radiation is less then the risk of the potential coronary anomaly. I do not feel the cardiac CT is in anyway ready for the routine evaluation of coronary disease as it lacks accuracy in predicting severity of stenosis on a per lesion basis (shown in Gill Raff''s trial), excludes any exercise data or ability to diagnose ischmemia, involves a high radiation dose, will significantly increase the cost of medicine with no evidence that it will saves lives, will dramatically increase the number of unnecessary diagnostic caths and coronary interventions on incidentally found" lesions, lacks any good prognostic data, and is poorly studied in low risk patients and patients with known coronary disease. This modality is not ready for general use and I feel strongly that unleashing it on the public will increase the radiation load without saving lives. As exciting as it is , it should remain a research tool until more data is collected to answer the above questions. I find that the majority of the strong advocates for this technology are either getting research or honorarium dollars from the vendors or teaching courses on "how to read" cardiac ct at the cost of thousands of dollars per day. They all have a financial interest.

Brian Seeck Cardiologist

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I am a cardiologist in a 40 plus group and have been practicing since 1981. Cardiac CTA is one of the most useful diagnostic technologies I have seen developed in cardiology. Lack of coverage will result in:

1. Use of more invasive diagnostic techniques (ie cath)
2. Stifle the development of improvement in this technology which I suspect with time has the potential to replace most diagnostic cardiac caths.

Dr Harry L Bishop
East Tn heart Consultants
Knoxville, Tn.

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We read this proposed NCD with great disappointment. What CMS is proposing is not only unprecedented, but potentially seriously harmful to the Medicare population. It is remarkable that CT scanning of every body part (except for the heart) is already approved for funding, without every going through a CED process. It is equally remarkable that every diagnostic test of the heart (nuclear imaging, echocardiography, angiography, MRI, and electrocardiography) is covered by Medicare (again without a CED process), except for cardiac CT. Cardiac CT is a highly diagnostic test, with literally thousands of published articles in peer reviewed literature. In all studies comparing cardiac CT to nuclear testing, cardiac CT proved a more accurate test.^1,2,3 If nuclear imaging is going to be used, than a more accurate, less costly and lower radiation test such as cardiac CT should have the same indications. How only one small use of CT and only one diagnostic cardiac test now requires more evidence (evidence of outcome benefit) is both unprecedented and inappropriate. If CMS wants to change the standard requiring improving outcomes, every diagnostic test in cardiology would be uncovered. That would leave cardiologists with no method to determine if patients chest pain was cardiac related or non-cardiac. Given heart disease is the number one cause of death of Americans, and represents over 50% of the mortality of the Medicare population, CMS should be actively evaluating methods to improve diagnosis of heart disease, rather than limiting diagnosis of this deadly and prevalent disease. Cost retainment is important, but the experts associated with the scientific professional societies should determine if a test is appropriate for use. CMS should determine how much that payment is to be. CMS should not get in the business of independently (without input from the professional societies) assessing the scientific validity of a test. All professional societies related to cardiac imaging have endorsed cardiac CT (including guidelines from the: Society of Atherosclerosis Imaging and Prevention [SAIP],⁴ North American Society of Cardiac Imaging and European Society for Cardiac Radiology,⁵ American Society of Nuclear Cardiology,⁶ American College of Radiology,⁷ American College of Cardiology,⁸ American Heart Association,⁹ National Cholesterol Education Panel ¹⁰ and the European Society of Cardiology.¹¹

Each of the guidelines are referenced below. How this NCD has come to an opposite opinion (that there is not enough evidence for coverage at this time) as compared to each independent cardiac society statement should be cause for great consternation. Hundreds of experts in the cardiac imaging field have made recommendations for use in the form of societal guidelines (collectively endorsed by over a dozen societies), and CMS has chosen to forgo all of them. Also, the appropriateness criteria⁶ were developed by 8 societies, and came to a conclusion that CTA has multiple appropriate uses, while this NCD proposes only two uses. To demonstrate how the societies can positively contribute, the SAIP has found that less than one quarter of the available peer reviewed published evidence with 64 slice CT scanners has been considered in the draft NCD proposal. We understand that data collection and review is a time consuming process, and the Society of Atherosclerosis Imaging has a number of experts in CT angiography that would be glad to volunteer to assist in updating the science prior to implementing a NCD. A more comprehensive evaluation of the literature is required prior to making a national coverage decision. Some of the data that was not included in the NCD is not recent, studies of 64 slice CT that have been overlooked date back to 2005. This action is also potentially harmful to the CMS patient population. If CT angiography is not available (outside of some CED process), patients will be forced to undergo invasive angiography. This is a more expensive (10 fold) and more invasive test, with a measurable risk. Studies have demonstrated that CTA is safer than coronary angiography, and this is also self-evident.¹² An invasive test without cannulation of the arterial system must be safer than a non-invasive test. Most importantly, it is premature to propose a new set of coverage criteria without a thorough review of the available published evidence. This is especially true as data is rapidly accumulating for CCTA and at a much faster pace than many other imaging based indications approved by CMS. A large number of studies cited in the CMS report are based on older technology or depend on expert reviews which did not include the state of the art literature. There are two multicenter studies of 64 slices (CORE 64 and ACCURACY) which have been presented at national meetings with publications submitted to peer-reviewed journals. This will provide the missing information related to how this testGiven these shortfalls in the data analysis and data that will imminently become available, we suggest that CMS allow the coverage to remain at the local level until requirements outlined by the CMS are met and in the interim continue to work with all parties involved to facilitate the process with meaningful deadlines, data collection points and timelines for clinical trial development and approval process. Most importantly, CMS needs to work with specialty multidisciplinary societies (SCCT, ACC, and ACR) to define the appropriate indications for CCTA and to better develop criteria for the types of clinical research that are appropriate for CED to minimize the impact on the delivery of appropriate care to beneficiaries. The data from T codes should be made available with utilization and numbers of cases. CMS has ample data from the temporary codes, yet none of that data has been made available. It is entirely possible that the data that CMS has already collected (including outcomes in CMS beneficiaries who received CTA) could answer the questions being posed.

SAIP will continue to lend expertise and demonstrate our commitment to implementing quality for all imaging services and aiding in the determination and promotion of both efficient and cost-effective care.

Sincerely,

Matthew Budoff, MD
President, Society of Atherosclerosis Imaging and
Prevention

References
1 Gallagher MJ, Ross MA, Raff GL, Goldstein JA, O''Neill WW, O''Neil B. The diagnostic accuracy of 64-slice computed tomography coronary angiography compared with stress nuclear imaging in emergency department low-risk chest pain patients. Ann Emerg Med. 2007 Feb;49(2):125-36. Epub 2006 Sep 15.
2 Schuijf JD, Wijns W, Jukema JW, Atsma DE, de Roos A, Lamb HJ, Stokkel MP, Dibbets-Schneider P, Decramer I, De Bondt P, van der Wall EE, Vanhoenacker PK, Bax JJ. Relationship between noninvasive coronary angiography with multi-slice computed tomography and myocardial perfusion imaging. J Am Coll Cardiol. 2006 Dec 19;48(12):2508-14.
3 Budoff MJ, Rasouli ML, Shavelle DM, Gopal A, Gul KM, Mao SS, Liu SH, McKay CR. Cardiac CT Angiography (CTA) and Nuclear Myocardial Perfusion Imaging (MPI)-A Comparison in Detecting Significant Coronary Artery Disease. Acad Radiol. 2007 Mar;14(3):252-7.
4 Hecht HS, for the Society of Atherosclerosis Imaging* Practice Guidelines for Electron Beam Tomography: A Report of the Society of Atherosclerosis Imaging. Am J Cardiol 2000; 86: 705-706.
5 Stillman AE, Oudkerk M, Ackerman M, et al. Use of multidetector computed tomography for the assessment of acute chest pain: a consensus statement of the North American Society of Cardiac Imaging and the European Society of Cardiac Radiology. Eur Radiol 2007
6 Hendel RC, Patel MR, Kramer CM, et al. A Report of the ACC Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, ACR, SCCT, SCMR, ASNC, NASCI, SCAI, and SIR. 2006 appropriateness criteria for cardiac CT and cardiac MRI. J Am Coll Cardiol 2006;48:1475-1497
7 Jacobs JE, Boxt LM, Desjardins B, et al. ACR practice guideline for the performance and interpretation of cardiac computed tomography (CT). J Am Coll Radiol 2006;3:677-685.
8 Greenland P, Bonow RO, Brundage BH, Budoff MJ, Eisenberg MJ, Grundy SM, Lauer MS, Post WS, Raggi P, Redberg RF, Rodgers GP, Shaw LJ, Taylor AJ, Weintraub WS, Harrington RA, Abrams J, Anderson JL, Bates ER, Eisenberg MJ, Grines CL, Hlatky MA, Lichtenberg RC, Lindner JR, Pohost GM, Schofield RS, Shubrooks SJ Jr, Stein JH, Tracy CM, Vogel RA, Wesley DJ. Coronary Artery Calcium Scoring: ACCF/AHA 2007 Clinical Expert Consensus Document on Coronary Artery Calcium Scoring By Computed Tomography in Global Cardiovascular Risk Assessment and in Evaluation of Patients With Chest Pain. J Am Coll Cardiol 2007;49:378-402
9 Budoff MJ, Achenbach S, Blumenthal RS, Carr JJ, Goldin JG, Greenland P, Guerci AD, Lima JAC, Rader DJ, Rubin GD, Shaw LJ, Wiegers SE. Assessment of Coronary Artery Disease by Cardiac Computed Tomography, A Scientific Statement From the American Heart Association Committee on Cardiovascular Imaging and Intervention, Council on Cardiovascular Radiology and Intervention, and Committee on Cardiac Imaging, Council on Clinical Cardiology. Circulation 2006 ;114(16):1761-91.
10 Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Final Report. NIH Publication No. 02-5215. September 2002.
11 De Backer G, et al. European guidelines on cardiovascular disease prevention in clinical practice. European Heart Journal (2003) 24, 1601–1610
12 Andreini D, Pontone G, Pepi M, Ballerini G, Bartorelli AL, Magini A, Quaglia C, Nobili E, Agostoni P.Diagnostic accuracy of multidetector computed tomography coronary angiography in patients with dilated cardiomyopathy. J Am Coll Cardiol. 2007;49:2044-50.

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We performed a study that is accepted to be presented at ACC 2008: We evaluated 75 consecutive patients who were referred to our institution for further evaluation of a chest pain syndrome following an abnormal stress test.By CTA 41% were normal, 29% had non-obstructive disease, 11% had discordant obstructive teritories between stress and CTA, leading to 81% of patients not requiring any further evaluation.

CTA is an excellent gatekeeper for invasive angiography, while detecting early disease that leads to most of the myocardial infarction, while stress test is not able to identify it.

The proposed NCD should be withdrawn. The proposed NCD does not adequately reflect the current state of evidence in support of CCTA in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD.Data is rapidly accumulating for 64-slice CCTA and there are many additional studies in the peer-reviewed, published literature to cite. CMS has failed to recognize many of these critically important studies. It is premature to propose a new set of coverage criteria without a more thorough review of the available published evidence. Therefore, we request that CMS conduct a more complete and up-to-date assessment of this vital imaging technology before the NCD is finalized.The requirements CMS has established to obtain coverage for CCTA will have a severe negative impact on Medicare beneficiaries' access to the service across the country given the uncertain approval process and timeline for future clinical trial development. We believe CMS has not properly examined the full impact the NCD with CED will have on the Medicare beneficiary population.The specialty societies have been working together for more than two years to define the appropriate indications for CCTA and we urge CMS to work with the relevant societies, specifically, the Society of Cardiovascular Computed Tomography (SCCT), to better develop criteria for the types of clinical research that is appropriate for CED to minimize the negative impact on quality patient care.

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CMS finds itself in a dilemma between technological advancement and fiscal responsibility.

I am the CEO of a 20-person radiology group in Connecticut. We have been performing Coronary CTA (CCTA) in our practice on a strictly referral basis for four years. Our radiologists find the test to be accurate and demonstrate coronary anatomy extremely well. Over the past four years, indeed, as many of the other physicians who have this far commented to your proposal have asserted, the literature corroborates the potential benefits of the examination. Nevertheless, our referrals are scant, as the cardiologists in our community are loathe to adopt it, as they are with all imaging modalities which they do not control and for which they do not bill.

The literature has also been clear in another aspect of which CMS is surely aware, and that is that economic self-interest frequently dictates referrals for examinations, corroborating our practices experience noted above. As with other cardiac imaging studies, CCTA is especially prone to self-referral and it attendant overutilization. If this examination is inappropriately utilized, the economic cost could be catastrophic to our fragile Medicare Trust Fund.

Over the past year, the body of data demonstrating the effects of self-referral has been supplemented by several published research studies and submissions to CMS as comments to other proposed rules. These include:

1. Research by Professor Jean Mitchell of Georgetown University on specialty hospitals and on imaging which show how the presence of investment in hospitals and imaging affect practice patterns. These show that different physicians in the same region practice differently depending on whether they have ownership in the process. Also, the same physicians practice patterns changed, coincident with their acquisition of ownership interest in specialty hospitals and imaging equipment.
2. New York Times article Dec 1, 2006, “Profit and Questions on Prostate Cancer Therapy” whereby urologists get a $40,000+ “machine fee” for prostate radiation therapy and have consequently abruptly changed their pattern of practice. The article quotes Leslie Norwalk, Medicare’s chief administrator: ”…because of the potential conflicts, urologist-owned I.M.R.T. is the type of arrangement that Medicare should be watching.”The link to the article is http://www.nytimes.com/2006/12/01/business/01beam.html?_r=1&scp=1&sq=prostate+IMRT&oref=slogin
3. Comments submitted to CMS from Connecticut on the differential use of certain tests based upon whether the referring physicians own the technology - i.e., if not owned, they do not use it. On the other hand, ONLY doctors who own the equipment order the test. Here is the excerpt from the submitted comments:The first situation is that of an IDTF that received a CON to provide cardiac CT/PET. Immediately, the IDTF embarked upon a dual business model: leasing part of the time to cardiology groups who would provide services as if the machine belonged to them; and the rest of the time as an independent provider of the service. We have obtained information from three large private payers in Connecticut showing the following over the 18-month period through June, 2007:

a. 218 cardiac PET examinations were done in the entire state by these 3 payers.
b. the other sites are the two largest hospitals in the state, where the hospitals own and bill for the examinations done on the scanners.
c. 134 of the 218 (63%) were done at the site where the two cardiology practices provide services on leased time. These are the only two cardiology practices who have the ability to bill for PET. These two practices comprise less than 20% of the cardiologists in the stated service area of the IDTF, yet virtually all the examinations in the service area are referred by them, and none was referred anywhere by any of the other cardiologists. Similarly, they comprise a very small percentage of the cardiologists in the state, but perform (63%) of the total studies in Connecticut.
c.100% of all patients done at that address were authorized to be done by the physicians in those two practices as the providers.
d. Zero were done by the IDTF on patients referred by general medical community. This raises serious questions as to the need for this examination if the other cardiologists never order the examination from the IDTF.
e. 128 of the 134 (96%) were referred by physicians with same tax ID or practice address. Thus, only 6/134 might have been in non-self-referred situation. Even those might have been referred at the suggestion of the cardiologists.

Thus, we see an examination where the only demand comes from self-referring practices. NO other cardiology practices in the area ever order the test, which is readily available at an independent facility.

4. Anecdotes from Connecticut and Iowa on changes in patterns of care before and after acquisition of in-office imaging, i.e., if owned, they use it more than before ownership.

5. David Levin paper in JACR points out that noncardiac thoracic imaging has shown very little growth in recent years. The reason is that the non-radiologists haven''t gotten very involved in doing it. (Journal of the American College of Radiology, Volume 4, Issue 12, Pages 886-889)

6. David Levin paper on diagnostic angiography and the shift from an invasive and expensive procedure, diagnostic catheter angiography, to safer and lower cost MR angiography and CT angiography among radiologists. At the same time, the utilization of diagnostic catheter angiography by non-radiologists has increased markedly, thereby allowing them to bill for the expensive, outdated procedure. (The Effect of the Introduction of MR and CT Angiography on the Utilization of Catheter Angiography for Peripheral Arterial Disease. Journal of the American College of Radiology, Volume 4, Issue 7, Pages 457-460)

Items 1-6, above, show how economic interest not only causes increased utilization, but also leads to divergence of actual algorithms of care based upon the economic interest of the referring physicians. .

7. The well-known differential growth of imaging by radiologists and non-radiologists is well-known to CMS. The recent OIG report on the growth of imaging by the various specialties clearly shows that certain specialties are exponentially increasing their billing for imaging procedures. This growth cannot be sustained. Also, see the graph below. These growth rates cannot be sustained.

(If this chart does not come through, please tellme the email adress to which to send as an attachment.)

8. Below is a series of links illustrating examples of how entrepreneurs (some of whom are physicians) and industry are exploiting self-referral and capitalizing on the greed of physicians. The first of these actually offers to GIVE the CT scanner for free to the self-referring physicians!http://www.inofficeimaging.com/index.htmlhttp://turnkeydiagnostics.com/wp/in-office-imaginghttp://dximagingsupport.com/StrategicPlanning-In-officeImaging.html http://www.gehealthcare.com/usen/specialty/physician_office/ent/index.html

9. CCTA is a test whose dose of radiation to the patient can vary considerably, with the higher doses in the range being very high. CMS must be vigilant about the unfettered proliferation of its use. A recent article in the New England Journal of Medicine highlighted concerns about the potential dangers associated with medical radiation from diagnostic tests. While the methodology of the research is in some degree of question, radiologists have always had a "healthy respect" for the tests we oversee, and strive for lowest dose and appropriate exams. This link is to a segment of ABC news’ reporting the story and includes a comment by Timothy Johnson, the well-known ABC medical commentator. We urge you to watch this and heed his warning about who is doing the studies. Dr. Johnson (not a radiologist) rails against the added utilization that is causing patients to be exposed to potentially damaging radiation by physicians who are not qualified to oversee this machinery and who over-order because they have an economic interest.http://www.abcnews.go.com/Video/playerIndex?id=3927782

CMS’ national coverage decision (NCD) that coronary CT angiography not be covered at this time is both unfortunate and understandable. The clinical data clearly support its validity. Those of us who know the potential benefits of the test believe that the decision will restrict the availability of the procedure to the public and at the same time retard further refinement of the technique and technological enhancements. On the other hand, those of us who are aware of the situations in #’s 1-6 above, and who have seen self-referral thwart patient care and cause undue cost and radiation exposure realize the underlying dilemma at CMS. That this may be the beginning of an unfortunately restrictive stance on new technology is, perhaps, the most distressing aspect of the NCD. CMS must recognize that it cannot continue to allow the in-office ancillary services exception in the Stark laws, whose huge costs have such an overbearing effect upon the advancement of patient care, the huge cost of which is driving decisions on coverage that retard the development and adoption of innovations to the detriment of beneficiaries.

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I would like to encourage CMS to accept the position advocated by ACR and SCCT on the CCTA NCD. While I understand the concern about further accelerating the rising cost of healthcare, the anecdotal experience we have had in Kenosha with CCTA has made it very clear that this technology is good for patients. It does rapidly clarify whether a patient has CAD or not, speeds throughtput in the ED, reduces hospitalization, reduces stress tests and normal cardiac catheterizations, and more efficiently triages patients for therapeutic catheterizations or maximal medical therapy. It also frequently suggests an alternative explanation for chest pain in those without coronary artery disease. I believe strongly that the available data already establishes the efficacy of this test and it would be most inappropriate to withhold this technology from our medicare patients. While there are many examples in the literature which you have included in the NCD draft, I would like to specifically highlight Goldstein et al J Am Coll Cardiol 2007:40:863-71 as a key reference. As suggested by SCCT I would advocate:
* The proposed NCD should be withdrawn. If it is not withdrawn, substantial modifications should be made to provide coverage for appropriate indications and populations.
* The proposed NCD does not adequately reflect the current state of evidence in support of CCTA in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD.
* Data is rapidly accumulating for 64-slice CCTA and there are many additional studies in the peer-reviewed, published literature to cite. CMS has failed to recognize many of these critically important studies. It is premature to propose a new set of coverage criteria without a more thorough review of the available published evidence. Therefore, we request that CMS conduct a more complete and up-to-date assessment of this vital imaging technology before the NCD is finalized.
* The requirements CMS has established to obtain coverage for CCTA will have a severe negative impact on Medicare beneficiaries’ access to the service across the country given the uncertain approval process and timeline for future clinical trial development. We believe CMS has not properly examined the full impact the NCD with CED will have on the Medicare beneficiary population.
* The specialty societies have been working together for more than two years to define the appropriate indications for CCTA and we urge CMS to work with the relevant societies, specifically, the Society of Cardiovascular Computed Tomography (SCCT), to better develop criteria for the types of clinical research that is appropriate for CED to minimize the negative impact on quality patient care. For the health of our society please reconsider your plans. Respectfully, Lawrence Reif MD

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We appreciate the opportunity to comment on the proposed NCA for Computer Tomographic Angiography (CAG-00385N).

This memo represents a petition that is signed by 2861 persons, of which 746 are physicians and 2115 are concerned citizens. In addition to the signatures, there are over 950 comments from the signers of the petition that are being submitted as separate attachment to this posting.

We are writing to comment on the national coverage analysis recently announced by CMS to assess the available evidence regarding CCTA and the proposed use of coverage with evidence development (CED) for clinical indications in which research is currently limited. There is serious concern that CED is being misapplied to this case and that the future of CED as a methodology will be damaged if CMS makes this ruling. Specifically, the 2831 signers of this petition recognize that over 30 key peer-reviewed studies were overlooked in CMS’s initial review. Moreover, an “outcome” study cannot directly measure the effectiveness of a diagnostic modality, it is more appropriate for a treatment. By misapplying CED and “outcome” studies to a well-studied diagnostic tool (CCTA) that can be used in place of a more expensive, more dangerous, slower, and less accurate diagnostic test, this ruling will likely be met with widespread opposition from the public, the media, and the physician community. This response will reflect poorly on CED and the honorable principles it was founded on.

The signers of the petition emphatically request ask that the state-level LCD coverage remain in place for two years without the requirement of inclusion in a scientific study. Local Medicare boards that cover all 50 states, Aetna, Cigna, United Health Group, and BCBS in NY, NJ, PA, TN, and AL all performed both the medical, and the economic, cost vs. benefit analysis. All of these parties concurred that CCTA should be covered for their members. Due to fact that CMS came to a significantly different conclusion than all of the aforementioned groups, we believe that is grounds for a re-review of the data. We are confident that if CMS is properly informed by impartial groups who reference peer-reviewed data, and CMS examines the 30 peer-reviewed studies that were not included in the initial review, CMS might find it appropriate to reconsider of the proposed decision and leave the LCD coverage in place - to the benefit of our taxpayer’s health and our countries budget.

Certainly, numerous studies of all types will be conducted as a result of this proposed ruling. These studies will help ascertain the “impact” and “value” and CTA in an unbiased environment. Due to the lack of precedence of applying CED to a well-studied diagnostic modality, we would kindly ask CMS to consider using this 2 year time period that could allow a “soft launch of CED” under a non-partisan consortium (in other words, without the disastrous consequences of overruling state coverage). Understanding the emphasis CMS is placing on CED, and the advent of numerous new imaging technologies in the next 2-5 years, all stakeholders are significantly motivated to see a judicious and reasonable analysis of the risks and benefits of these new imaging modalities.

If CMS does require studies for coverage, we believe it to be only reasonable and fair to have scientific studies that are conducted by a truly impartial and nonpartisan group that has significant experience conducting studies. If CMS decides that studies are required for coverage, they should take the form of registry studies that allow involvement by all qualified practitioners using CCTA. Both CTA and CED are too important to the future of medicine and the future health of taxpayers to be sidelined by this ruling. Petition to CMS Regarding Coverage of CTA:

1. CMS should not rely on non-peer reviewed summaries of the data generated from payers (i.e. BCBS TEC). CMS should consider all studies that were not included in the CMS proposed NCD for the indications deemed “promising.” See attached email for this list.

2. The new requirements for an outcome study are unprecedented for a diagnostic modality. Outcome studies are reasonable when considering treatment modalities but not as appropriate for diagnostic modalities. Cardiac CTA has already compared extremely favorably with invasive catheterization and can accurately determine whether a patient has no disease, mild disease, moderate disease, or severe disease. Literature is already available on how to treat each of these subgroups and what the outcomes of treatment are in these subgroups.

Using CTA as a test case for CED could negatively impact the CED movement because CTA has significant science behind its effectiveness and cost-savings, widespread acceptance among physicians, as well as public and media support. Since outcomes studies cannot directly study a diagnostic tests effectiveness (say as compared to a controversial new medication or surgery), we feel CED is being misapplied in this case. CED opponents will use this ruling as ammunition against the use of CED for future tests and treatments. Therefore, while we think studies are important to conduct (and they invariably will), they should be done without the restriction on reimbursement, and therefore;

3. Do not issue a NCD for Cardiac CTA at this time. Leave LCD coverage in place to supply the patient populations for #4 below.

4. We acknowledge that payers should be involved in future CTA studies. However, the group that administrates the study should have a proven track record with administrating studies and a have history of being completely unbiased. Otherwise, the lay press, taxpaying public, and practicing clinicians will perceive these factors as imparting a large potential bias.

We believe that any group’s mission to form a “Neutral Panel” to administrate these trials is honorable, insightful, and a step in the right direction. However, since the perception is that any group that could be biased towards the Health Insurance Industry, we do not think the US taxpaying public, nor practicing clinicians, would support a potentially partisan organization having complete control over the future of this modality.

We present the following proposal with this tenet in mind: The CMS is charged with allocating public taxpayer funds to be used for maintaining and improving Medicare beneficiaries’ health. Therefore we believe this important issue deserves a higher degree of transparency and nonpartisanship. Please consider the following proposal:

CTA Review Committee Proposal

1. Registry studies, and possibly outcome studies, will be conducted in a highly standardized and regulated format that is accepted by a group comprised of 13 members. These 13 members will be representatives from:

A. (3 members) Payers
B. (1 member) CMTP (who would also be the organizer of the group)
C. (3 members) Medical Device and Equipment Industry
D. (3 members) ACC, ACR, SCCT
E. (2 members) Consumer/Public Representatives (with no ties to any of the parties above)
F. (1 member) One Mediator with an expertise in study design, outcomes and registries. This Mediator should be impartial with no financial ties to any of the parties above.

The individual members would be elected by the factions they represent. All members in groups A to E would nominate and elect the Mediator.

(Note: as a sign of our commitment to scientific integrity, the authors of this proposal would not participate in the CTA panel)

This review committee would have the following functions:

They would design and administrate both the registry studies and outcome studies (if they are deemed necessary). They will ensure the right indications are being studied and the right subgroups and endpoints are included in the studies.

All data that is obtained from the registry will be available to the parties who are involved in the studies for initial review; with the agreement that the data becomes a matter of public property six months after:

a. Approval from the CTA Review Committee majority vote, or
b. At the time of the first peer-review publication is published

This preferential access to the data will allow payer’s to create financial models and forecast technology utilization/trends.

When the registry results are finalized, CMS would re-consider implementing a NCD code for a limited set of indications. If the studies warrant, CMS would consider increasing or decreasing the covered indications.

We believe CTA is a good test case for this type of unbiased scientifically validated coverage approval system with the following consideration: due to the large amount of pre-existing data about the disease pathology, outcome data on comparable detection modalities and treatments, as well as the high incidence of the disease, removing CTA from CMS coverage and then relying only on outcome studies would result in an unnecessary level of patient death and excessive health care costs. Therefore, coverage should be left at the LCD level while registry and outcome studies are performed.

With the advent of many new imaging and genetic technologies coming on the scene in the upcoming decade, there is potential for a phenomenal reduction in lost lives, health care costs, and unnecessary suffering. However, the potential for profit gain or loss, as well as misuse, are high from all parties involved. Many countries in the world are quickly surpassing the US in health metrics, in part due to their streamlined technology adoption procedures. In order to keep the public’s confidence in the insurance industry, government agencies and medical societies, we need to ensure we all work in concert. Therefore, we believe the system we have outlined above represents a fair and balanced approach to ensure that payers, industry associates and physicians work together to serve patients needs.

Petition ends above

Note from Dr. Dan Gebow (not part of petition)

The review of the radiation risks are inaccurate in the CMS memo and unfortunately, disregard the majority of modern radiation biology’s and epidemiology’s body of knowledge. I have provided the following summary to serve as reference for your research:

The dose from modern 64 slice machines is 8-13 mSv. The average human gets 3mSV per year, therefore the radiation dose is approximately 3 years worth of radiation. By comparison, medical workers are allowed up to 50 mSV per year.

The alternative to CCTA, stress thallium, is 25 mSV per use. This test has the possibility of inducing an MI and provides a much lower sensitivity and specificity than CCTA. Therefore, concerns about CCTA repeat testing are hard to justify when you consider the alternative is higher dose coupled with less accuracy, higher cost, and risk of inducing a MI.

As for life time cancer risk, there are two aspects that need to be considered: patient age and to the quality of the scientific studies one chooses to site. The definitive source for radiation risk is the Bier VII (http://www.nap.edu/catalog/11340.html ).By only citing Hiroshima data, the majority of scientists will immediately dismiss the argument because its seen as a “scare tactic” and therefore biased. When all data is taken as a whole, expert radiation biologists and epidemiologist cannot detect an increase number of radiation induce cancers above background levels for doses that 64 slice machines would emit. Moreover, most data on radiation is for whole body dose where leukemia’s and lymphomas are the primary concern, especially in populations under the age of 18.

However, this is not the case for CCTA. The average patient age for a CCTA in the 24,000 person registry is 60 years old. If there was an increase risk of cancer by exposing someone to the 13cm area surrounding the heart, we are effectively dosing the heart and upper part of the lungs. Even if we could measure an increase risk of cancer, the latency period of any induced cancer would be several years. If you compare this risk to the risk of a MI, fatal MI, or other CHD event during that time period, I think you’ll see that a radiation risk is completely insignificant in the patient’s overall risk of morbidity and mortality.

Thank you for allowing the 2831 members of this coalition to have a voice in how our tax dollars are spent on our health.

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1. My license number is TX L2285. I am a board certified cardiologist. This proposed Medicare position re Cardiac CTA is the single worst decision re the care of the American public I have seen in years of front line practice dealing with atherosclerosis. Please re-evaluate by including peer review literature that you specifically excluded. One wonders what the true agenda is!?
2. We have not reduced the incidence of sudden cardiac death in 50 years. Cardiac CT is the only current way to find atherosclerosis early and treat it. If you wish to prevent sudden cardiac death approve Cardiac CT. Nothing else can do it.
3. Please do not act hastily and simply base your decisions on perceived increased use of technology. One must carefully weigh improved patient outcomes, earlier diagnosis and reduction in more invasive and costly procedures.

Sincerely,
Deepika Gopal, MD,FACC and on behalf of all members of CSANT group of cardiologists and cardiac surgeons( nearly 50 physicians) practising in the Dallas Fort Worth metroplex.

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After a nuclear stress test was abnormal, I have numerous cases who underwent Cardiac CTA which did not show significant obstructive cardiac diease. These patients did not undergo invasive cardiac catherterization with huge cost savings for medicare.
This is an excellent diagnostic modality which will help in specific diagnosis, rules out heart disease with 99% specificity and saving atleast a billion dollars judging by the prevalance of heart disease in United States.Ref.www.SCCT .org.

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I am a cardiologist in a large single specialty practice with 38-cardiologists and 10 mid level providers. I have used cardiac CT angiography for the past 3 years with remarkable improvement in the care of my patients with chest pain and CAD. I used to struggle daily with conflicting clinical data and uncertainty with my patients with the only good option being invasive cardiac catheterization. Stress testing even with echo or nuclear imaging is often unclear with an accuracy of 80-85%; this is not acceptable when dealing with potentially life threatening diseases. With the very high negative predicative value of cardiac CTA, I can often definitively answer diagnostic questions and better design the therapeutic care for my patients with less expense and less risk. Our professional societies have reviewed the scientific data and have agreed on the utility of cardiac CTA with clear guidelines, training requirements, and appropriateness criteria.
It would be a mistake for CMS to stop reimbursing for cardiac CTA. This year, virtually every other carrier in our state will be reimbursing for cardiac CTA. It would be treating our seniors like second class citizens, and we will actively let them know that.
It is ridiculous for CMS to step into the clinical development process of this technique at this late stage. To demand private practices to participate in new research trials and registeries will push the unfunded research expenses to private practices that are usually not set up to do this sort of research anyway. If CMS wishes to effectively drive new clincal techniques, it should be funding outcomes research in the early stages. At this point, cutting reimbursement to cardiac CTA would clearly be a delay tactic for cost cutting with disregard to clinical quality and a disservice to our patients.
CMS should continue funding cardiac CTA and work withthe professional societies to continue to maximize the efficient use of this great new clinical tool.

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Coronary CTA is beyond a shadow of a doubt, the single most effective and effecient test to detect or rule out coronary artery disease, the number one killer in the US. It costs about $1800 dollars to perform a stress test, which misses over half of significant coronary artery disease, and according to your own government sponsored site, the majority of positive tests are false positives (http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=10810&nbr=5635), resulting in cardiac catheterizations that cost between $2500 and 5000, and cause strokes of other injuries about 3-5% of the time.

Coronary CTA costs less than $600, has no false positives, and never causes a stroke or vessel injury.

The only reason you must be considering this foolish policy change is that someone in your family is a cardiologist who wants to hold onto their income by doing dangerous poor tests that do not serve the patients best interest.

I eagerly await your justification. You may as well reconsider the use of telephones or computers as CTA.

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I would like to most strongly protest against the proposed changes as intended in the NCD mentioned above. As program director for our cardiac CT program, I have extensive experience with the patients you are trying to restrict. Furthermore, I have been involved in drafting multidisciplinary guidelines that have been introduced through the North American Society for Cardiac Imaging (NASCI) in conjunction with the European Society for Cardiovascular Radiology (ESCR) through my membership in both societies.

I understand that you have opted for this NCD and change in coverage based on literature that were pertinent in 2005, perhaps the beginning of 2006. But, as shown by the lack of up to date medical literature used in your justification, this field has moved on considerably. Thus, a huge amount of additional data has now been generated using state-of-the-art 64 slice or even dual source CT scanner systems, that have been completely ignored in your decision making. I won’t need to go into details, but more than 75% of the current literature in this field has been generated AFTER your assessment leading to the proposed changes.

Your suggestions for research projects are surely outdated. If I were to try and set up some of the research you propose, I would neither get funded (NIH would recognize this as outdated) nor would it get published as it would be completely redundant.

I know that many societies have already put their response in. You will undoubtedly think that this is “spin”. From our experience, I can categorically state that a multidisciplinary approach to cardiac CTA did not increase our costs, rather it led to a significant number of patients who were discharged forthwith without the need for angiography. To give you an indication, of the 300+ cases I have been involved with over the past 2 years, 5-10% were for potential anomalous coronary arteries (of which 80% were normal and did not require further invasive angiography), some were for pediatric disorders (including Kawasaki syndrome in a child that was undergoing 6-monthly invasive coronary angiography requiring up to 1 week hospitalization due to need for stopping and restarting of anticoagulant therapy; this has now become an outpatient procedure without the need for angiography under general anesthetic or changes in anticoagulants!!!), 75% were for atypical chest pain with indeterminate or contradicting stress test (of which 80% were normal and did not require catheter angiography), 10% were for assessment of CABG graft patency in patients with recurrent chest symptoms (90% of these did NOT require revision CABG or angiography) and a few were for preoperative assessment prior to major thoracic surgery or valve replacement. In addition to these cardiac findings, we also detected a case with early lung cancer (curative surgery was performed, the patient is well), several cases with unsuspected disseminated malignancy (in one of these patients, an anomalous coronary artery was present, but surgery was obviously not performed given the additional diagnosis) and one patient with pulmonary embolism (whose treatment was anticoagulant therapy without further diagnostic tests required). I would be more than happy to share our data with you should you wish.

Given this fantastic new resource, I understand there is concern for over utility. I understand this concern, and it is largely based in settings where there is no multidisciplinary approach to cardiac imaging. Given our approach and experience, we have not seen a surge in cardiac CTA.

I hope that my comments are useful to you and would be very happy to discuss this further.

Best wishes,Also on behalf of my Cardiology colleagues,

Yours sincerely,

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We have found Cardiac CTA with 64 slice CT capability has significantly improved our ability to diagnose and treat coronary and cardiac disease in our population, an elderly basically Medicare population.

1. It offers a less invasive and less dangerous option for patients that might require intervention, an option that is appreciated by many older patients.

2. We have found it equal to or superior to traditional coronary angiography in several ways. 1) It provides a better overview of the entire disease; 2) CTA gives a much clearer picture of CABG graft, providing a superior assessment particularly of compromised and missing grafts; and 3) It eliminates the need for much diagnostic coronary angiography, which is the only modality available in our hospital since it does not have a coronary bypass or interventional coronary lab, but only a diagnostic cath lab. Patients requiring intervention must still be transferred elsewhere.

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Proposed National Coverage Determination for Coronary CT Angiography

Thank you for the opportunity to comment on the NCD.

The department of Radiology and the Sparrow Hospitals and Clinics strongly urge CMS to maintain the current coverage status for CCTA; that is, CMS should continue to allow local Medicare carriers to determine coverage through the Local Coverage Determination (LCD) process.

The LCD status has fostered the development of ground breaking clinical trial research and registry data collection to answer questions about the utility of CCTA.

The CMS’ conclusions in this proposed coverage determination are premature because the available evidence supporting the clinical utility of CCTA is dramatically different than it was during the AHRQ and MedCAC reviews of 2006 which was based on earlier generations of this technology. If implemented, the policy would have a profoundly negative impact on Medicare beneficiaries by limiting needed access to this technology for clinically appropriate indications

There is considerable current literature based on 64 channel technology that argues strongly against the conclusions reached by the review. A significant portion of this literature was published after the review was concluded. CMS did not conduct an adequate, thorough analysis of all available relevant evidence.

Clinically valuable indications for CCTA that are well supported by existing evidence are excluded from the proposed coverage and should at least be included in coverage without requiring further evidence development.

These include:

Symptomatic patients with chronic stable angina or anginal equivalent and an intermediate pre-test probability of CAD;Symptomatic patients with possible acute coronary syndrome (ACS), a low risk of shortterm death and an intermediate probability of CAD;Assessment for presence and course of coronary artery anomalies;Coronary artery evaluation in individuals in whom prior clinical non-invasive coronaryartery test data (e.g., ECG or imaging results) are equivocal or discordant;Assessment of bypass graft location (e.g., internal mammary artery) prior to surgicalintervention in patients undergoing repeat sternotomy; andCoronary artery evaluation in patients undergoing non-cardiac surgery.

These indications are supported by substantial existing literature and an implementation of the NCD would eliminate the benefit of this technology for Medicare beneficiaries.

The major societies, specifically, the American College of Cardiology, American College of Radiology, American Society of Nuclear Cardiology, North American Society of Cardiovascular Imaging, Society for Cardiovascular Angiography and Interventions, and the Society of Cardiovascular Computed Tomography are submitting the literature and the arguments supportive of this technology on behalf of Medicare patients. I urge you to consider this evidence and reconsider this decision.

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Several months ago I relocated from a large city in Florida where I practiced at a tertiary care hospital to a small critical access hospital in rural Maine.

The nearest city is Bangor, 80 miles, and two hours travel by car.

There is a large percentage of elderly patients in Washington County. The distance, weather, and socioeconmic conditions are barriers to these patients'''' access to a cardiac catheterization laboratory.

The trip to Bangor is an "ordeal" for many of them. Some make the trip, and the findings at the cardiac catherization were not helpful, perhaps exposed to an unneccessary risk. Some refuse to make the trip, and do not have the benefit of the information which would have altered their course.

There is enough validated information to confirm the accuracy of the findings of coronary CT angiography, and there is experience which has guided the formulation of appropriateness criteria.

This procedure should be available to Medicare beneficiaries in all areas of the United States, including rural communities. The procedure should not be limited to only those beneficiaries who are living in close proximity to an academic medical center participating in a Medicare sponsored clinical trial.

The proposal should not be adopted.

Lowell I. Gerber MD FACC
Machias, Maine

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The proposed NCD should be withdrawn. If it is not withdrawn, substantial modifications should be made to provide coverage for appropriate indications and populations.The proposed NCD does not adequately reflect the current state of evidence in support of CCTA in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD.Data is rapidly accumulating for 64-slice CCTA and there are many additional studies in the peer-reviewed, published literature to cite. CMS has failed to recognize many of these critically important studies. It is premature to propose a new set of coverage criteria without a more thorough review of the available published evidence. Therefore, we request that CMS conduct a more complete and up-to-date assessment of this vital imaging technology before the NCD is finalized.The requirements CMS has established to obtain coverage for CCTA will have a severe negative impact on Medicare beneficiaries’ access to the service across the country given the uncertain approval process and timeline for future clinical trial development. We believe CMS has not properly examined the full impact the NCD with CED will have on the Medicare beneficiary populationThe specialty societies have been working together for more than two years to define the appropriate indications for CCTA and we urge CMS to work with the relevant societies, specifically, the Society of Cardiovascular Computed Tomography (SCCT), to better develop criteria for the types of clinical research that is appropriate for CED to minimize the negative impact on quality patient care.

Thank you for your consideration.

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Coronary CTA has become an important part of my practice. It saves my patients from having unnecessary cardiac catheterizations, and avoids long stays in the emergency room. There is little doubt that coronary CTA is a cost effective and desirable addition to my diagnostic armamentarium. I follow the ACC/AHA/ACR appropriateness criteria, developed by respected experts in this field. I am disappointed that CMS would consider depriving my Medicare patients of this important new advance in cardiac imaging. Please do not change the rules to require a level of evidence never before demanded to declare a diagnostic imaging procedure "reasonable and necessary" under Medicare law. I ask that you withdraw the proposed NCD and leave the policies put into place by Local Carrier Medical Directors covering coronary CTA for reasonable indications and wait for the research process to take place as it always has before, and not issue this premature NCD.

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Comment: Please do not restrict access to CTA. We live in Washington County Maine - a remote rural area. A large portion of our citizens are poor and/or elderly. Our community hospital is small but well staffed: we have a cardiology team on staff. If the test is not available here, people must travel nearly 100 miles to the nearest large hospital, Eastern Maine Medical in Bangor. This places a heavy burden on patients, particularly the elderly, and on their families and care givers.

Please - help us to access the care we need.

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From John Hamlin, MD

I am a radiologist who was recently trained to interpret Cardiac CTA. During the learning process I viewed cases of patients that had both conventional coronary artery angiography and a CTA within a short period of time. For a lot of patients the conventional coronary artery angiogram was normal but the CTA showed substantial soft plaque. If there is soft plaque, treatment is necessary with statins and niacin. Therefore CTA will detect disease much earlier than conventional coronary artery angiography and for that reason CTA should be approved to be used in cases of people with chest pain.

The researchers that I know have developed CTA blood flow perfusion studies to the heart and the results will replace traditional expensive nuclear medicine perfusion studies. The CTA studies can be done in a few seconds where as the nuclear medicine studies cost more and take longer, 45 minutes compared to 30 seconds. The perfusion studies are in the process of FDA approval and could be approve in the next year.

The CTA can save money; a CTA can get to the bottom line of chest pain quickly where as conventional cardiology uses many expensive time consuming tests which when added together costs much more than CTA. The Society of Cardiovascular Computed Tomography can provide the clear cost difference between the conventional approach to chest pain and CTA.

Ask yourself the question; if you had chest pain would you want conventional evaluation or CTA. The more you know the more you know that your life will be saved with CTA.

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CT Angiography has been of great help to identify or ensure:

a. who in the low/intermediate group would need active medical attention to prevent myocardial infarction by visualizing the plaques. These patients typically have negative stress test. But by absolute a very large number of patients do come to the ER with MI from this group.

b. Compliance can be very high if the CT angio reveals plaques when treating hyperlipidemia. Primary prevention trials have shown therapy effective for hyperlipidemia.

CTangio has been shown that it can prevent unnecessary invasive cath procedures as a study is reported in the Dec 1 issue of Am J of cardiology. Budoff et al have published the calcium score and no of vessels involved with locations and then Min et al puublished in JACC, 2007 to assess prognostic significance and this is amazingly consistent with the DUKE database.

In addition, the CT angio can be of help to define coronary anomaly and assessment of grafts.

We should leave this unique technology to be used by the physicians who can readily be available to give the reason for the study.

Restricting the use by an executive decision and demanding this to be paid only when patients are under a study will definitely deprive the medicare beneficiaries.

Our experience have been very favorable to see how cardiac cath procedures can be avoided in many clinical situations when Coronary CT angiography procedures are utilized.

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January 11, 2008

Steve E. Phurrough, MD, MPA
Director
Coverage and Analysis Group, CMS
Re: CTA
Mailstop C1-09-06
7500 Security Blvd.
Baltimore, MD 21244-1850

Marcel Salive, MD, MPH
Director, Division of Medical and Surgical Services

Joseph Chin, MD, MS
Lead Medical Officer

JoAnna Baldwin, MS
Lead Analyst

Dear Drs. Phurrough, Salive, and Chin and Ms. Baldwin:

Comment on Proposed Decision Memorandum for Computed Tomographic Angiography (CAG-0385N)

This letter is on behalf of Siemens Medical Solutions, one of the leading manufacturers of modern high-resolution CT scanners. We are deeply concerned with the CMS Coverage and Analysis Group’s proposed finding that cardiac CTA is not currently “reasonable and necessary” for the diagnosis of coronary artery disease and its proposed essentially non-coverage determination.

This proposed national Medicare non-coverage determination would reverse determinations made by each of Medicare’s local contractors over the past few years which provide coverage for this technology for this diagnostic purpose. If implemented, this proposed determination would mandate a significant shift in medical practice - denying physicians the ability to provide precise early coronary artery disease diagnosis to Medicare beneficiaries. We strongly urge CMS to reconsider this proposed policy.

General Comments:

Cardiac CTA is a proven technology and is the only high resolution non-invasive way to visualize coronary artery disease - the leading cause of death of Medicare beneficiaries. All other technologies to diagnose coronary artery disease are either low resolution or invasive.

Cardiac CTA has gained wide spread acceptance and usage by thousands of physicians because it offers a combination of high diagnostic precision without the risk of the complications of an invasive procedure. Current Local Coverage Determinations as well as many private insurance coverage policies throughout the United States reflect the broad consensus among Medicare Carrier and private payer medical directors and practicing physicians regarding indications for this test. Given the widespread morbidity and mortality of complications resulting from late-diagnosed coronary artery disease, which include heart attack, congestive heart failure, and arrhythmias (each of which cost Medicare many billions of dollars per year), it is surprising that this relatively low cost, proven diagnostic technology has been singled out for “Coverage with Evidence Determination” standards that will effectively result in total non-coverage for the vast majority of Medicare beneficiaries who could benefit from the procedure. With American Heart Association statistics showing 325,000 Americans dying of sudden undiagnosed heart disease each year, it is difficult to understand the inference made by CMS that heart disease is over-diagnosed and in need of new diagnostic limitations. An NCD that effectively cuts off all coverage for cardiac CTA would be a precipitous event forcing physicians and patients to revert to higher risk, costlier and often more imprecise tests.

The standard articulated in the proposed NCD that this diagnostic test needs to have proven “health outcomes” establishes an unprecedented and unreasonable standard for diagnostic tests, such that each diagnostic test would potentially need to have all or most of the downstream treatments re-evaluated since there is no clear way of showing outcome changes from a diagnostic test in the setting of a clinical trial without evaluating the resulting treatments as well. While an insistence on outcomes for certain diagnostic testing situations where the test and subsequent treatment are investigational may well be appropriate, to insist that we currently have no “reasonable” idea on how to treat coronary artery disease discovered by cardiac CTA simply ignores much of modern coronary disease management. There are tens of thousands of peer-reviewed research publications on how to treat coronary artery disease with corresponding outcomes. There is no credible data to suggest that coronary lesions diagnosed by cardiac CTA are so materially different from those diagnosed by cardiac catheterization as to require reanalyzing treatment outcomes. In fact, modern high temporal and spatial resolution cardiac CT scanners have higher sensitivity and specificity than almost any other non-invasive diagnostic test used in modern medicine.

Clinically, we believe that the types of potentially fatal lesions that can be seen on cardiac CTA (such as a 90% left main coronary artery blockage) have an obvious impact on patient outcome in way that makes cardiac CTA “reasonable and necessary”. Conversely, with the significant morbidity and mortality risk with missed myocardial infarctions, the ability to efficiently evaluate a symptomatic patient and show that they have no coronary artery disease is valuable and “reasonable and necessary” as well. There is no better technology to safely, effectively, and efficiently rule out coronary artery disease. The NCD proposal document shows that with each of the modern cardiac CT studies where a Negative Predictive Value is cited (Ehara NPV 95%, Ropers NPV 100% per segment, Heuschmid NPV 99%, Weustink NPV 95%, Scheffel NPV 99.4%, Olivetti NPV 97.3%) that NPV and the corresponding ability to rule out CAD is extremely high.

We are also concerned that “Coverage with Evidence Determination” process as applied to cardiac CTA does not reflect the clinical context of medical decision making. Physician decisions for a patient presenting with symptoms that may well reflect lethal coronary disease are governed not by questions about the absolute perfection of one technology over another but by the relative merits of each possible choice. To evaluate cardiac CTA without putting it into context of competing choices such as the inherent high uncertainty and limited off-hours availability of nuclear studies, the risk of death with invasive catheterization or simply the risk of poor outcome if no testing is performed appears inconsistent with optimizing health for Medicare patients.

In addition to these overall issues that we see with the proposed NCD, we have identified a number of specific process and clinical issues.

Process Issues:

1) CT technology has evolved at a rapid pace. Much of the NCD deals with earlier generation 4 and 16 slice technologies. It is inappropriate to evaluate modern high temporal and spatial resolution CT scanners together with these older technologies as there are clear differences between the technical capabilities and clinical results of current and prior CT technology.

2) The literature review noted in the NCD appears to be selective. There appears to be a dismissal of the diagnostic test literature comparing cardiac CTA to competing technologies and limited consideration of practice settings and patterns. For example, though the NCD denies coverage for emergency department use of cardiac CTA to diagnose coronary artery disease, there are no citations from the peer-reviewed emergency medicine literature. In the emergency medicine setting, there is no sense of the disproportionate role that lengthy ER “soft rule-outs of MI” play in US ED overcrowding.

3) The proposal provides no criteria regarding how studies falling under the narrow coverage guidelines would be approved nor under what circumstances Medicare would reconsider its decision. There should be explicit acknowledgement that if only new studies, pre-approved by Medicare and published in the peer-reviewed literature, are to be considered, that this proposal effectively means at a practical minimum a three to four year delay in coverage for this life-saving test.

4) The process does not acknowledge the costs that someone has to bear of doing the mandated trials.

5) The process does not incorporate an analysis of costs to Medicare and Medicare beneficiaries if cardiac CTA is not covered. Competing Medicare covered technologies such as nuclear studies and cardiac catheterization are much more labor intensive and costly studies. Additionally, the NCD does not include outcomes modeling of the increased system and patient costs of heart attack, stroke, congestive heart failure, arrhythmias and premature death that will follow coverage denial extrapolating from today’s pattern of widespread under-diagnosis of coronary artery disease.

6) The tradition of the “coverage with evidence development” process has been just that – coverage WITH evidence development. This proposed NCD effectively changes that policy to “non-coverage UNTIL evidence development”.

Clinical Issues:

1) The described clinical scenarios (“symptomatic patients with chronic stable angina at intermediate risk for CAD” and “symptomatic patients with unstable angina at a low risk of short-term death and intermediate risk of CAD”) are clinically imprecise and confusing. Labeling a patient with the term “angina” (of any duration) suggests that the patient already has a diagnosis of coronary artery disease in the common usage of the word. This implies that cardiac CTA would be an add-on study following whatever type of study gave the patient the original diagnosis of coronary artery disease.

2) Coronary artery disease can present with a variety of symptoms, not just chest pain (“angina”). For example, research by McSweeney et al shows that women with an acute myocardial infarction are as or more likely to present with shortness of breath or fatigue (McSweeney JC et al. Circulation 108:2619-23; 2003).

3) Often CTA is ordered not just to assess coronary artery disease but for other life threatening syndromes such as aortic dissection or pulmonary embolus. The NCD provides no consideration to the broader indications around CTA that are simply unavailable with competing modalities such as treadmill, SPECT or serial cardiac enzymes and EKG’s.

4) Using the concept of Framingham Risk scores only makes sense with patients who are asymptomatic. As soon as you have symptoms, the risk of CAD changes dramatically. A Medicare patient presenting with “crushing, substernal chest pressure and diaphoresis” does not fit into a “low risk” or “intermediate risk” category no matter what their Framingham score.

5) There is an overall confusion in the NCD document between what the various CCTA studies generally cite as “high risk” (a worrisome set of symptoms in a patient at risk) with the NCD’s general use of the same “high risk” phrasing to refer to patients with clear indications to go to the cath lab (positive EKG, positive cardiac enzymes).

6) By selective use of terms such as “angina” and heavy reliance on cardiac cath as a gold standard, CMS is missing the opportunity to provide its beneficiaries with treatment based on the stunning revolution in understanding around the role of plaque in coronary artery disease. Cardiac CTA is the only high reliability non-invasive way to diagnose coronary plaque. “Lumen-based” testing such as nuclear studies, treadmill and cardiac cath can only diagnose plaque after cardiac muscle has been placed at immediate risk.

We think that the current real world use of CTA by physicians to diagnose coronary artery disease is something to build on to gather more evidence about specific situations where CTA can be used in place of invasive or inconclusive tests. To summarily cut off Medicare beneficiary access to CTA, as is proposed in the NCD, is the wrong course of action to answer the questions that CMS has expressed with respect to this technology.

Given the current widespread coverage of CTA in the United States, we believe that steps should be taken to use this practical experience to inform and guide a national Medicare coverage determination. We think that conditional coverage—coverage in return for evidence, explained in the agency’s Coverage with Evidence Development Guidance Document—provides a pathway to resolve outstanding evidentiary questions that exist with respect to CTA. We do not think that this coverage should end, as proposed in the NCD, while CMS entertains submissions for research studies that address the CMS concerns.

Recommendation:

We recommend that CMS reconsider its proposed NCD for Cardiac Computed Tomographic Angiography for the Diagnosis of Coronary Artery Disease. During this reconsideration, we suggest that:

The diagnostic information a physician receives from a CTA of the Thorax includes not only the standard Pulmonary Arteries, Lungs and Mediastinum, they are privileged due to the advances in technology, to receive information on the heart and coronaries. Cardiologist and Radiologist are obligated ethically and legally to report findings that are available for interpretation. This information is available for them. It is medically necessary and appropriate for patients with unexplained chest pain/discomfort, atypical chest pain, as well as the other "accepted" symptoms in which a CTA of the Thorax in preformed. I am asking for a reconsideration from CMS and allow medicare covered citizens and others to benefit from this technology.

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)
We represent Wyoming Cardiopulmonary Services, PC which provides Cardiology services to the greater Wyoming area. We have 6 physicians, 32 employees and serve approximately 300,000 patients annually. Wyoming Cardiopulmonary Services, PC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. WYOMING CARDIOPULMONARY SERVICES, PC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. WYOMING CARDIOPULMONARY SERVICES, PC strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). WYOMING CARDIOPULMONARY SERVICES, PC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, and many Blue Cross Blue Shield carriers.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

WYOMING CARDIOPULMONARY SERVICES, PC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, WYOMING CARDIOPULMONARY SERVICES, PC is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

In closing, WYOMING CARDIOPULMONARY SERVICES, PC respectfully requests that CMS:

January 11, 2008

Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mailstop C1-09-06
7500 Security Blvd.
Baltimore, MD 21244-1850

Re: Proposed National Coverage Decision (NCD) limiting coverage for cardiac CT

Dear. Dr. Phurrough:

We are writing on behalf of the University of Michigan Cardiovascular Center (UMCVC) and the 165 physicians and scientists who practice in our facility in response to CMS’ proposed National Coverage Decision for Computed Tomographic Angiography (CAG-00385N). The University of Michigan Health System (UMHS) is a major academic medical center located in Southeast Michigan. Our Health System includes a highly ranked hospital and medical school and, among its many excellent specialty care programs, the UMCVC, one of the premier cardiovascular centers in the country.

The faculty and leadership of the CVC are extremely disappointed in the CMS proposed restrictions on the use Computed Tomographic Angiography (CCTA), and strongly urge the Agency to rescind or alter its proposed NCD. The proposal would significantly limit access to a clinically appropriate technology for Medicare beneficiaries and is contrary to the local coverage determinations that have made CCTA available in all fifty states and the District of Columbia. This proposed restriction of a widely accepted, clinically appropriate and rapidly maturing technology is unprecedented, and unwarranted.

UMHS has been performing Cardiac CT examinations for a decade, including CCTA specifically since early 2005 on 64 detector CT scanners. We have found it to be a very useful, non-invasive method of coronary interrogation. One of the benefits of coronary CT is to avoid cardiac catheterization, a much more costly and invasive test. For patients with suspected coronary artery disease (CAD), cardiac catheterization is often the only other test that can provide evidence about the presence or absence of significant CAD. The very high negative predictive value of coronary CT allows patients to avoid the cost, expense and potential complications of cardiac catheterization. For coronary artery anomalies, cardiac CT is the test of choice of our cardiothoracic radiologists. The attached link http://www.asnc.org/imageuploads/finalmodelLcdforcctandctca.pdf has the American College of Cardiology (ACC) and American College of Radiology (ACR) paper on the efficacy and utilization of this discipline.

In reading the NCD document, it appears that CMS was selective in drawing conclusions about the evidence presented. The majority of the clinical studies cited in the document provided from partial to full support for the use of CCTA; and the majority of public comments were in favor of continuing to allow local contractors to dictate coverage. Furthermore, it is our understanding that the majority of studies based on the use of 64-slice equipment were not even considered in the CMS evaluation.

UMHS and the CVC are fully committed to providing appropriate evidence-based care, and we support more study of the effectiveness of CCTA for various defined conditions. In fact, CVC faculty has a leadership role in a Michigan-wide collaborative study sponsored by Blue Cross Blue Shield of Michigan. The collaborative has created a cardiac CT registry for the purpose of collecting data from each of the participating hospitals to define the role of this technology among of the among the number of cardiac tests that are available, along with establishing appropriateness and quality criteria.

If CMS believes that additional guidelines and/or appropriateness criteria are needed with respect to CCTA, perhaps it should consider an approach similar to what we have in place in Michigan, in lieu of virtual elimination of coverage that CMS has proposed. As part of the BCBSM Advanced Cardiovascular Imaging Consortium of Michigan we have implemented a regional consortium to improve the quality of care for patients undergoing CCTA as a collaborative quality initiative, encouraging the appropriate and judicious use of this and other emerging cardiac imaging technologies including the evaluation of practice
patterns associated with the use of CCTA and related clinical outcomes.

Again, we strongly urge CMS to allow the local coverage decisions to remain in force and not to implement the proposed NCD. Thank you for your consideration of these comments.

Sincerely,

Kim A. Eagle, MD
Linda R. Larin, FACHE, MBA
Albion Walter Hewlett Professor of Internal Medicine
Chief Administrative Officer
Chief of Clinical Cardiovascular Medicine
Cardiovascular Center
Director, Cardiovascular Center

David J. Pinsky, MD
Richard L. Prager, MD
J. Griswold Ruth MD & Margery
Professor of Surgery
Hopkins Ruth Professor of Internal Medicine
Division Head, Adult Cardiac Surgery
Professor of Molecular & Integrative Physiology
Director, Cardiovascular Center
Chief, Cardiovascular Medicine
Director, Cardiovascular Center

James C. Stanley, MD
Professor of Surgery
Marion and David Handleman Research
Professor of Vascular Surgery
Associate Chair, Department of Surgery
Director, Cardiovascular Center

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I would oppose the suggested proposal due to lack of information that would conclude extensive academic evidence about patient care outcomes. In addition, there would be additional cost associated with performing the procedure via invasive diagnostic cath compared to non-invasive CT Angiography. The CT Angiography procedure also provides greater ancillary information than a cath, and the CT Angiography requires less staff and time to perform. Finally, the patient experience is a more positive one via CT Angiography due to a simple five minute non-invasive exam rather than a day surgery visit with an invasive 45 minute procedure and post recovery.

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer- reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non- invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well- trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, we at CARDIOVASCULAR ASSOCIATES, SC respectfully request that CMS:

I am in a group of seven cardiologists on the East End of Long Island and have been using coronary CTA for two years. We have found coronary CTA to be very helpful in diagnosing patients with significant obstructive coronary disease as well as in identifying patients with significant but non-obstructive lesions which can be treated with aggressive medical therapy.

Coronary CTA has been highly accurate in diagnosing patients with significant left main coronary disease. Bypass grafts are easily evaluated. Cardiac CTA offers a very strong negative predictive value. We have found that coronary CTA has offered excellent correlation with coronary angiography.

We have found that this technology has helped us to offer better clinical care to our patients for several reasons:
1. We have saved a significant number of patients from undergoing invasive procedures by performing this test and finding moderate disease that did not require intervention but rather aggressive medical therapy instead.
2. Many of our patients who have undergone exercise stress testing, which were abnormal, have subsequently undergone cardiac CTA instead of an invasive procedure. A large number of these patients did not require invasive procedures and were subsequently treated with medical therapy. These patients in the past would have required a cardiac catheterization.
3. Our main office is greater than one hour from the nearest cardiac catheterization laboratory. The elderly population has been saved the invasive procedure of cardiac catheterization as well as the need to be transported to other hospitals, by using cardiac CT judiciously.
4. Due to recent trials, a greater number of our patients are being treated medically who do have symptoms, as long as we can be sure that they do not have left main or severe proximal coronary artery disease by CTA.

For the last two years we have found that the use of coronary CTA has given us a great deal of information to improve patient care and to avoid a significant number of invasive procedures. Therefore, coronary CTA has actually helped to decrease the cost for patients by reducing the number of hospitalizations for procedures.

Thomas A. Falco, M.D., F.A.C.C.TAF:ds

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I am in a group of seven cardiologists and found CT angiography of the coronary very helpful in diagnosing significant obstructive coronary disease as well as identifying patients with nonobstructive disease who would be treated with an aggressive medical regimen.

There is data in the literature to show that:
- there is strong negative predictive value for CT angiography;
- there is good correlation with coronary angiography;
- it is highly accurate for left main coronary disease;
- there is similar predictive value for outcomes in patients with one, two or three vessel coronary disease as there is with coronary angiography;
- it is an excellent tool for evaluating bypass grafts; and
- there is additional information regarding the lungs and mediastinal structures, the great vessels and pulmonary arteries.

I feel that CTA should be more widely available and could become the diagnostic test of choice, replacing many of the nuclear tests now being done. In many patients with abnormal nuclear stress tests which are due to motion artifact or soft tissue attenuation, CT angiogram can rule out significant coronary disease and reduce the need for invasive studies.

Our main office is one hour from the nearest cardiac catheterization laboratory. Our satellite office is one and a half hours from a cardiac catheterization laboratory. We cover a large geographic area in Eastern Suffolk County, New York on Long Island. We have a very large elderly population and a CT angiogram will, many times, obviate the need for them to go further away from home for invasive angiography. I have been reading CT scans for over two years and truly believe that this modality should be more available rather than less, and replace to a great extent nuclear stress tests.

John W. Pearson, M.D., F.A.C.C.JWP:ds

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I am a practicing cardiologist with subspecialty training in diagnostic testing and noninvasive imaging. The restrictive indications for coronary CTA proposted in the NCD by CMS will not serve the Medicare patient population well and should be reconsidered.

Stipulating that beneficiaries undergoing CCTA be at "intermediate risk of CAD" with an acute coronary syndrome or angina is nonsensical (it is taken clinical that the syndrome of angina is due to CAD)

The improved diagnostic accuracy of CCTA over stress testing, now well beyond any question, has impressed me in my daily practice (and by nature I am skeptical about newer technologies) - CCTA can lead to life-saving therapies or, perhaps more frequently, can reduce unnecessary invasive testing. An outcome based approach or clinical trial suggested by CMS would not value the latter role of CCTA, obviously, unless the additional invasive tests were quite hazardous. CMS appears to be taking an unprecedented step of requiring that a technology used for diagnosis should show improved patient outcomes.

I wanted to offer a practical, real-life example to show the benefits of coronary CT angiography (CCTA) in a Medicare beneficiary. I saw a female Medicare beneficiary back for follow up. Early last year she presented with new HF and a weakend heart (ejection fraction of 20%). Despite instituting appropriate medications and titrating the dosages to appropriate goal range, she remained with severe LV dysfunctiona dn HF syndrom about 3 months later. A stress study, showed breast attenuation and the ECG underlying LBBB that was chronic in nature. I esd concerned about the possibility of a false negative perfustion study and arranged CTA which showed a high grade LAD lesion. After successful stenting her EF is now 45%. Had she not undergone the CTA, I suspect she would have had implatation of an ICD. Thus in her case CTA impacted her care a great deal, and likely saved CMS funds in the long run (avoiding ICD)

I recommend the following:
1. Allow Medicare contractors to continue CTA coverage under their existing LCDs.
2. Eliminate teh propsed CED
3. Adopt the training guidelines, credentialing requirements, and appropriateness protocols for CTA proposed by the SCCTA

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Centers for Medicare & Medicaid Services,
Department of Health and Human Services,
Attention: Joseph Chin, M.D. and JoAnna Baldwin, M.S.
P.O. Box 8014
Baltimore, MD 21244-8018

Re: Medicare Program; Proposed National Coverage Determination (NCD) Memo for Cardiac Computed Tomography Angiography (CCTA), CAG-00385N

I am writing to express my concerns regarding the inpatient payment proposed rule and its recommendations to deny or reduce coverage for Cardiac Computed Tomography Angiography (CCTA).

After reviewing the proposed changes, I respectfully ask that CMS consider:

1) CCTA has substantial clinical utility in ruling out coronary disease in both acute care and non-acute care settings.

(2) The proposed NCD does not fully reflect the current state of evidence in support of CCTA in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD.

(3) Denying coverage for CCTA for the diagnosis of CAD will limit Medicare patients'' access to this valuable technology, resulting in the performance of more costly and invasive diagnostic tests.

(4) It is entirely inappropriate for CMS to demand evidence that proves that "coronary CTA improves health outcomes for patients with acute chest pain who present in the emergency room or other setting." Health outcomes depend on numerous factors, including, for example, the efficacy of treatment, patient compliance with medication protocols, the severity of disease, and other factors. For this reason, it is entirely inappropriate to demand that a diagnostic technology, such as CCTA, demonstrate an impact on health outcomes in order to be covered.

(5) In light of the difficulties involved in structuring randomized clinical trials to address the specific clinical issues identified in the proposed NCD, CMS should consider a registry approach instead of, or in addition to, the clinical trial approach.

(6) Rather than cutting off coverage precipitously, CMS should consider allowing local carrier decisions to remain in place, at least pending enrollment of the first clinical trial or establishment of an approved registry.

I respectfully request that CMS delay implementing the Proposed National Coverage Determination (NCD) Memo for Cardiac Computed Tomography Angiography (CCTA), CAG-00385N, and reconsider allowing local carrier determinations of coverage until the above are considered and incorporated into coverage determination recommendations.

Thank you for your consideration.

Sincerely, Bridget Lauro, MD

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OhioHealth is a not-for-profit organization providing healthcare services in 46 Ohio counties. As a leading healthcare provider in the Central Ohio community we are concerned with the proposed change in coverage for cardiac CT angiograms. Our physicians and clinicians have come to rely on this vital diagnostic tool in screening for many coronary conditions. A cardiac CT angiogram is more informative and less invasive than any other diagnostic procedure that can be used to screen for coronary conditions. We urge CMS not to implement a National Coverage Determination that would limit the availability of this vital diagnostic tool to our physicians and patients.

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Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

We represent Illinois Heart and Vascular which provides Cardiology services to the greater Chicago land area. We have 27 physicians, 92 employees and serve approximately 24,000 patients annually. Illinois Heart and Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart and Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart and Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart and Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart and Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart and Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart and Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing Illinois Heart and Vascular respectfully requests that CMS:

The Blue Cross and Blue Shield Association (BCBSA), an association of 39 independent Blue Cross and Blue Shield Plans that collectively provide health insurance benefits to 99 million Americans, appreciates the opportunity to provide comments on the proposed decision memorandum on Computed Tomographic Angiography (CTA). BCBSA supports the efforts of CMS to define the role of CTA through development of rigorous evidence. We concur with the conclusion that existing evidence is insufficient to determine whether CTA benefits symptomatic patients with chronic stable angina at intermediate risk of CAD (Coronary Artery Disease), or patients with acute chest pain syndromes. , We also agree that existing evidence does not support a role for CTA in screening asymptomatic individuals.

Despite the lack of evidence, many in the provider community express strong prior beliefs that CTA has an important diagnostic role in the evaluation of patients with CAD. Yet potential harms including radiation exposure and further unnecessary testing are real.

The need for evidence is imperative. However, evidence must be robust and convincing to patients, practitioners, and policymakers. It is therefore critical that studies be appropriately designed and conducted. A convincing unbiased comparison of diagnostic strategies evaluating symptomatic patients with and without CTA is needed.

As outlined in the AHRQ technology assessment, observational designs or randomized controlled trials could be considered. However, because a direct comparison is needed, randomized controlled trials enrolling representative samples will provide the strongest and most bias-free evidence. This is due to assembling comparable groups, thus minimizing potential biases while clearly defining interventions and outcomes.

Although observational study designs might be considered alternatives to randomized controlled trials, their potential weaknesses must be carefully weighed. Due to the lack of random assignment and potential selection biases in observational study designs, comparability between groups cannot be assured.. Statistical methods can be applied to control for measured between-group differences. However, those methods fall short of controlling for unmeasured differences, which may also distort the magnitude of benefit or harm. Accordingly, quantifying the utility of CTA may not be straightforward or possible to infer. Comparing outcomes of patients enrolled in a CTA registry to those of some other group (contemporary or historical) not undergoing CTA without random assignment will be accompanied by similar concerns of potential uncontrolled confounding and bias.

Because benefits of CTA are unproven in symptomatic patients, and harms are potentially important (e.g., radiation exposure, further testing), robust and convincing evidence is required. Our view is that a randomized controlled trial should be conducted to provide that evidence. Furthermore, investing substantial effort to conduct observational studies now may have the undesired consequence of delaying the conduct of necessary randomized comparisons.

Thank you for your attention to our concerns.

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We believe that the proposed NCD is a poor decision for Medicare beneficiaries for a number of important reasons:

I am not in favor of the CMS proposal for CTA Cardiac reimbursements. This proposal appears to be primarily based on the Blue Cross/Blue Shield Technology Center reports from April 2006. These are non-peer review reports produced for Blue Cross/Blue Shield.

Since April 2006 CTA technology has improved with the advent of multi-slice scanners. The current imaging technology is capable of diagnosing cardiac pathology, congenital anomalies and coronary artery disease in an efficient outpatient, non-invasive environment. This results in decreased overall healthcare costs.

The efficacy of the exam reaches about 99% in the negative predictive value. Thus, if CTA cardiac becomes the test of choice, other diagnostic examinations to determine the cause of “chest pain” maybe eliminated or at a minimum decreased, resulting in reduced overall healthcare costs.

As a director of imaging, I am in favor of using the appropriateness guidelines proposed by theACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR as a starting point for reimbursement. This eliminates the risks from insurers who fear that this test will be widely used as a screening test.

For example in our Chest Pain Center, patients first have a cardiac nuclear medicine exam. Our data of 1,600 patients shows 20% are admitted and receive a cardiac catherization. Of these, 80% were normal. Therefore, based on these 1600 patients, 320 had cardiac catherization with 256 of these exams being normal. CTA cardiac studies could have prevented these patients from having to undergone an invasive procedure which as we all know is more costly to all parties involved.

The healthcare of an individual should not be in the hands of insurance companies but in the hands of physicians who have been trained to take care of patients. These physicians need to have the reimbursement support of CMS, as well third party payers, to ensure existing and advancing technology is most appropriately utilized to meet each patient’s healthcare needs.

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It is well documented that CCTA has substantial clinical utility in ruling out coronary disease in both acute care and non-acute care settings. Denying coverage for CCTA for the diagnosis of CAD will limit Medicare patients’ access to this valuable technology, resulting in the performance of more costly and invasive diagnostic tests. Community Medical Center is located Ocean County NJ which has one of the largest Medicare populations in the country. This NCD would adversely affect our ability to provide this service to 65% of the patients in the community. In light of the difficulties involved in structuring randomized clinical trials to address the specific clinical issues identified in the proposed NCD, CMS should consider a registry approach instead or, or in addition to, the clinical trial approach. Rather than cutting off coverage entirely, CMS should consider allowing local carrier decisions to remain in place, at least pending approval of the first clinical trial or establishment of an approved registry.

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January 11, 2008

Attn: Steve Phurrough, M.D.M.P.A.
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services

From: The St. Paul Heart Clinic Physicians and Dave Rothschiller

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

We represent St. Paul Heart Clinic, which provides Cardiology services to the greater St. Paul Metropolitan area. We have 34 physicians, 300+ employees and serve approximately 55,000 patients annually. St. Paul Heart Clinic appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS’ final decision. St. Paul Heart Clinic believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. St. Paul Heart Clinic strongly opposes Medicare’s proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS’ proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). St. Paul Heart Clinic defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS’ memo, the conclusions made by CMS are disparate from the authors’.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians’ ability to gather the very data needed to prove CCTA’s additional efficacy.

2. CMS should rely on its local carriers’ judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Medica, HealthPartners, UCare, and PreferredOne also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes. St. Paul Heart Clinic appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient’s CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA’s application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS’ two clinical diagnoses being proposed as the basis for reimbursement and study are “chronic stable angina at intermediate risk for CAD” and “unstable angina at low risk for death and with intermediate risk of CAD.” These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by “risk of CAD.” Rather, guidelines for “acute chest pain” use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

“Unstable angina” or more commonly now “possible Acute Coronary Syndrome” likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, St. Paul Heart Clinic is unaware of guidelines that use the “risk of CAD” in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from St. Paul Heart Clinic, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, St. Paul Heart Clinic respectfully requests that CMS:
§ Allow local Medicare contractors to continue coverage of CCTA for the diagnosis of CAD under their existing LCDs to enable Medicare beneficiaries the benefits of this clinically proven, lower-cost and lower-risk technology.
§ Eliminate implementation of its proposed CED. St. Paul Heart Clinic recommends that CMS work with the specialty multidisciplinary societies (SCCT, ACC and ACR) to develop criteria for a CCTA registry to minimize the impact on the delivery of appropriate care to beneficiaries. There are several excellent CCTA registries already in existence that may be used as models for a CMS-approved registry to gather clinical data for longitudinal studies.
§ Adopt accreditation guidelines, physician credentialing requirements and clinical appropriateness protocols to promote appropriate utilization of CTA for the diagnosis of CAD. The medical specialty societies are at the forefront in the development of these important quality endeavors, and St. Paul Heart Clinic fully supports their efforts and encourages Medicare to work with them in developing similar guidelines.

St. Paul Heart Clinic appreciates this opportunity to comment on Medicare’s Proposed Decision Memo regarding Cardiac CTA. Please contact us at 651-292-0616 (main number), 651-726-2712 (Dave Rothschiller) or via email at drothschiller@stphc.com (Dave Rothschiller) if you have any questions.

Sincerely, Stuart W. Adler, M.D., Charles F. Alexander, M.D., Alan J. Bank, M.D., Kenneth W. Baran, M.D., Margaret M. Beahrs, M.D., Steven L. Benton, M.D., Thomas A. Biggs, M.D., Richard J. Brody, M.D., Charles M. Cliffe, M.D., David N. Dunbar, M.D., Michael D. Garr, M.D., Gregory A. Granrud, M.D., Richard B. Guthrie, M.D., Dennis W. Halbe, M.D., Priscilla A. Hedberg, M.D., Thomas H. Johnson, M.D., CEO, Maureen A. Kane, M.D., Patrick T. Koller, M.D., Spencer H. Kubo, M.D., Brian D. Mahoney, M.D., Thomas P. Nobrega, M.D., Jeffrey J. Olson, M.D., Michael A. Peterson, M.D., Kamalesh M. Pillai, M.D., Tarang B. Ray, M.D., Thomas E. Raya, M.D., Franz E. Reisdorf, M.D., Peter K. Rusterholz, M.D., Nazifa Sajady, M.D., Victor H. Tschida, M.D., R. Dent Underwood, M.D., Uma S. Valeti, M.D., Pierce J. Vatterott, M.D., Thomas A. Wiberg, M.D., COO, David D. Rothschiller, MBA, FACMPE, Executive Director
St. Paul Heart Clinic. P.A.
225 North Smith Avenue
Suite 500
Saint Paul, MN 55102
651-292-0616 main
651-726-2712 – Dave Rothschiller

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I. Does CCTA have the ability to diagnose CAD as well as Invasive Coronary angiography (ICAG)?

I believe that the evidence is definitely there to answer this question in the affirmative. Reported 64-slice CT meta-analysis (patient-level) sensitivity and specificity of 97% and 91% respectively provides clinically acceptable level of diagnostic certainly in majority of patients. Clearly cardiologists have traditionally relied on other non-invasive tests (stress testing) with similar or lower sensitivities and specificities to guide their decisions for decades. Due to the reported 96% negative predictive value in even relatively high prevalence population (61% prevalence in meta-analysis of Hamon et al, JACC 2006), is excellent. Please note that when applied to somewhat lower CAD prevalence populations in routine clinical practice, NPV is likely to be even higher. In other words well established performance characteristics of this test in the cath-correlation studies already qualify CCTA to be a clinically very useful test in vast majority of intermediate pre-test probability patients.

In other words, due to its non-invasive nature, CCTA does not have to 100% accurate to be clinically useful.

III. Does CCTA reduce need for ICAG?

This is a clearly a relevant and excellent question to ask of a non-invasive diagnostic test such as CCTA. As opposed to clinical accuracy (or efficacy) question addressed by cath-correlation studies mentioned above, this a clinical effectiveness question. Like all clinical effectiveness questions, however, this is best answered by collection and publication of downstream testing data form routine clinical practice. Trials, be they case-control or randomized, result in creation of significantly artificial populations which no longer represent general clinical patients. Therefore, any results obtained from such trials are likely to have only a narrow applicability to the concerned study population. In order to allow generation of information such as this it is important to allow CCTA to proceed in general cardiology practice guided by appropriateness criteria and other relevant guidelines.

In Michigan, we have a registry for CCTA under the auspices of Advance Cardiovascular Imaging Consortium sponsored by BCBS of Michigan. Several centers that meet certain quality standards are participating in this registry and we anticipate generation of a wealth of data soon. As one of the executive committee members overseeing this project, I am very concerned that our results will lose their generalizability, if due to CMS’ current proposed ruling, Medicare age patients are no longer able to be enrolled in this registry. Again, I wish to reiterate that data about reduction I downstream testing is best addressed by following a broad range of patients in routine clinical care and not by enrolling patients in clinical trails.

IV. Does CCTA improve Health Care outcomes?

This is the wrong question to ask of diagnostic test. Such questions are appropriate and indeed necessary fro therapies but not appropriate for the diagnostic tests. The following hypothetical example of a randomized trial with mortality as the outcome makes it clear that it is virtually impossible to demonstrate superiority of one diagnostic test over the others for hard clinical outcomes such as mortality. Let’s assume that we have 200,000 patients randomized to Coronary CTA (CCTA) and nuclear myocardial perfusion imaging (MPI) or stress echo (SE). They have an intermediate pre-test likelihood of CAD with true prevalence of obstructive CAD of 25%. CCTA has sensitivity and specificity of 95% and 97% respectively. MPI or Stress echo has sensitivity and specificity of 88% and 80% respectively. (I have intentionally exaggerated the difference between the performance characteristics of CCTA versus MPI/SE). This would lead to the following results: For CCTA: True Positive = 23,750; = True Negative 70,150; False Positive = 4850; False Neg = 1250 For MPI or SE = True Positive = 22,000; True Negative = 60,000; False Positive = 15,000; False Neg = 3000. To keep the argument simple we will focus on only the FN groups, i.e those in whom disease was missed. Of this group, approximately 20% (a generously high assumption) will have LM or 3V CAD, i.e. disease of the type in which survival can potentially be improved by revascularization. Therefore, in CCTA group 1250 X 0.20 = 250 patients with such disease will be inappropriately not given the benefit of revascularization. In the MPI/SE group 3000 X 0.20 = 600 patients will fall in this category. From CASS registry data of medically treated LM disease patients we know that 10 year mortality was approximately 40%; i.e. approximately 4% per year. Therefore, there will be 10 deaths per year in CCTA group (250 X 0.04) and 24 deaths per year in the control group. This means a difference of 14 deaths per year favoring CCTA in a randomized trial of 200,000 patients assuming no cross-over and perfect follow up. With background mortality rate which will be substantially higher, there is no hope of even such a large trial demonstrating CCTA or for that matter any diagnostic test for CAD demonstrating survival outcome benefit. Once again, it is because we are asking the wrong question. These questions should be asked of the therapeutic interventions and not tests such as stress testing or CCTA.

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CT Angiography is a valuable tool for Physicians to use to discern the need for cardiac surgical intervention, or catheter lab procedure. The value of CTA has been demonstratd at many medical facilities around the world. If Medicare will not pay for this study then it becomes only available to those who can pay cash - the wealthy or elite. An NCA at this point would drastically cut the use of the technology to the point of stopping the accumulation of data. Many, many more of our Physicians are responsible, wanting the best, safest care for their patients. This would take away a fabulous tool to diagnosis those patients.

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The availability of the CTA of the heart was great for our patient population. It gave patients a choice and it avoided invasive and costly cardiac catheterization in many of these patient. It is a great tool if it is used correctly. Like any other imaging modality, it can be misused. The attention should be on regulating it by providing strict credentialing, rather than prohibiting it for all. A lot of patients will avoid cardiac catheterization if the CTA is available. It is not fair for these patient to be punished.

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Dear Doctor Phurrough:

Thank you for providing Bracco Diagnostics Inc. (Bracco) with this opportunity to submit comments on the Proposed Decision Memo for Computed Tomographic Angiography (CTA). Bracco is a global manufacturer of contrast imaging agents and radiopharmaceuticals used in medical imaging procedures. The products that we offer are used in outpatient hospital procedures performed in radiology departments, cardiac catheterization laboratories, and nuclear medicine departments across the United States.

In its Proposed Decision Memo, CMS concludes that there is insufficient evidence that CTA is medically necessary, except for two indications: (1) symptomatic patients with chronic stable angina at intermediate risk of CAD; or symptomatic patients with unstable angina at a low risk of short term death and intermediate risk of CAD. We, however, respectfully disagree with the conclusions that the Centers for Medicare & Medicaid Services (CMS) made in its Proposed Decision. Currently, there are local coverage decisions (LCDs) in all 50 states and the District of Columbia that permit payment in a far broader range of situations than under the Proposed Decision. Even if CMS feels the current state of the evidence is inconclusive, it would be preferable to leave the current LCDs in place while new research moves forward.

Further, if CMS implements the Proposed Decision, and limits the coverage of CTA as described above, CMS will actually undermine current efforts that are designed to gather additional evidence on the value of CTA. For example, there are there are a number of randomized controlled clinical trials underway for cardiac CTA. These trials were designed to provide evidence to support appropriate clinical indications for cardiac CTA, beyond the two recognized by CMS. If CMS implements this Proposed Decision, these trials may be crippled, and hinder the ability to provide the evidence that CMS indicates it seeks to ensure that it is paying appropriately for covered services. Because these services will no longer be subject to the current LCDs, patients participating in these trials may find that their services will no longer be covered. As a result, these studies may not be able to continue, which seems contrary to CMS’ intent of obtaining sufficient evidence on CTA. In the posted comments, one commenter has already advised you that their “multi-center randomized trial is slimly funded and cannot be completed without continued LCD coverage of Medicare patients.” Thus, we urge CMS to not issue an NCD that will change the existing coverage of CTA while clinical trials are underway.

Bracco believes that it would have been more reasonable for CMS to have postponed any action on the current NCD proposal rather than to take the limiting action that it is considering. As noted, there are currently LCDs in place that govern coverage of this procedure. It would be preferable for CMS to simply leave those current policies in place while additional information is being developed. As this was an internally generated NCD request, it does not appear that any outside party would object to a delay. In the meantime, evidence development on this service could continue. Indeed, the cardiology medical specialty societies (American Hospital Association, the American College of Cardiology, and the Society of Cardiovascular Computed Tomography) have been working together for more than two years to define the appropriate indications for cardiac CTA. CMS should work with these medical specialty societies as these groups represent clinical expertise for this modality. We continue to urge CMS to leave current policies in place and then work with the relevant medical specialty societies to implement an appropriate Coverage with Evidence Development (CED) policy that minimizes the impact on beneficiary access and that is reflective of existing and on-going clinical research.

In addition, a policy that waits until further information is developed will also limit the unintended consequences that may otherwise result from this policy. For example, it is likely that CMS’ narrow ruling will adversely affect patients who are not even covered by Medicare. Aetna, United Healthcare (UHC), Cigna, and Empire Blue Cross Blue Shield are a few of the private payers who currently offer coverage for cardiac CTA. Many of these payers look to CMS for direction in setting coverage and payment policies for new technology. It is without doubt that this decision would influence existing and future private payer policies for cardiac CTA.

Bracco recognizes the challenges that CMS faces in developing new coverage determinations and would welcome the opportunity to meet with CMS to expand upon our recommendations in greater detail. Thank you for the opportunity to comment on this coverage analysis.

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CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS’ final decision. NOHC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. NOHC strongly opposes Medicare’s proposed decision

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I practice in a small rural town in southern Louisiana. We do not have an operative cath lab. The cardiac evaluation have been significantly helped with the availability of the MSCT in our local hospital. If this is no longer available, the patients will then have to travel over 30 miles to the next nearest hospital for a much more risky and costly invasive cath procedure. For the intermediate cardiovascular risk group this seems to be an unfair burden in view of multiple peer-review articles supporting the high negative predicative value of the CTA-coronaries.

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January 11, 2008

Joseph Chin, MD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Mail Stop C1-09-06
7500 Security Boulevard
Baltimore, Maryland 21244-1850

ELECTRONICALLY SUBMITTED
Subject: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

Dear Dr. Chin:

Philips Healthcare (Philips) strenuously urges CMS to reconsider its proposed Decision Memo for [Cardiovascular] Computed Tomographic Angiography (CCTA). Philips operates in five main business areas: Diagnostic Imaging Systems, Clinical Solutions, Healthcare Information, Customer Services and Home Healthcare Solutions. Our product line includes best-in-class technologies in X-ray, ultrasound, magnetic resonance, computed tomography, nuclear medicine, PET, radiation oncology systems, patient monitoring, information management, personal emergency response systems, and resuscitation products. Of greatest relevance to the issue here, Philips is a market leader in the manufacture and distribution of the medical equipment and related services used in the provision of CCTA.

Undoubtedly, CCTA represents one of the most important advances in the diagnosis of coronary artery disease in recent years. We are extremely concerned that the Proposed Decision Memo, if finalized without change, will eliminate Medicare patients’ access to this important diagnostic service even in those areas where, after careful consideration of the overwhelmingly favorable results reported in peer-reviewed medical journals, local carriers have decided to allow coverage for particular CCTA indications through well-researched and thoughtful local coverage determinations (“LCDs”).

While the proposed Decision Memo would authorize coverage of CCTA for the diagnosis of Coronary Artery Disease (CAD) when the CCTA is performed in conjunction with certain clinical trials, in light of the resources likely to be involved in designing the trials and the time likely to be involved in obtaining agency approval and funding, the Proposed Decision Memo is the functional equivalent of a negative national coverage determination. In this regard, we note that, while the Proposed Decision Memo appears to condition coverage on a provider’s participation in data-gathering, it does not appear to have been developed in a manner consistent with the “Guidance for the Public, Industry, and CMS Staff; National Coverage Determinations with Data Collection as a Condition of Coverage: Coverage with Evidence Development [CED]”(“Guidance Document”) which was issued on July 12. The Guidance Document, which was developed through a long and painstaking process involving extensive public comment, outlines two different types of Coverage with Evidence Development (CED)—Coverage with Appropriateness Determination (CAD) and Coverage with Study Participation (CSP). The Proposed Decision Memo fails to even acknowledge the applicability of the Guidance Document and appears to require data gathering that intertwine elements of a CAD and a CSP in a manner that is likely to prove extremely difficult to implement. Moreover, the decision letter, as it stands, suggests that coverage may be provided only in the setting of a randomized trial. This restriction will preclude participation of patients who may benefit from access to this technology according to the appropriateness criteria established by the ACC/AHA/ACR, but who do not meet all of the inclusion/exclusion criteria established for participating in a particular study or for whom randomization to an alternative diagnostic strategy may be inappropriate.

For the reasons set forth below, we respectfully request that CMS withdraw the proposed Decision Memo and continue to authorize coverage of CCTA based on local carrier policies. If CMS is unwilling to do so, we request that CMS, at the very least:

January 11, 2008

Joseph Chin, MD
JoAnna Baldwin, MS
Centers for Medicare and Medicaid Services
Department of Health and Human Services
P.O. Box 8014
Baltimore, MD 21244-8014

RE: Proposed Decision Memorandum for Cardiac Computed Tomographic Angiography for the Diagnosis of Coronary Artery Disease [CMS Administrative File: CAG 00385N]

Dear Dr. Chin and Ms. Baldwin:

Thank you for the opportunity to respond to the above-referenced memorandum. I appreciate the extensive, albeit incomplete (missing data from 25 full manuscripts using LCD-approved minimum 40-slice CT scanners), evaluation of coronary CTA research literature by CMS. CTA is a purely diagnostic examination for guidance of patient management, neither a preventive procedure nor a therapeutic intervention. I believe that the nature and purpose of coronary CTA may be misunderstood as the decision rendered is premised upon coronary CTA as an “intervention”(specific term on bottom of page 1 of 27, first listed clinical research study standard), i.e. medication or device clinical trial, or like a population-based screening study. To my knowledge, this standard has not been applied to any other purely diagnostic, noninvasive examination of any modality. (Frankly, the argument can be made that should screening mammography be subjected to the rigorous standard being applied in the National Lung Screening Trial for lung cancer, for example, it may fair quite poorly, but this concept has not resulted in an abrupt turn-around in health care policy for a so-called “evaluation period”.)

Having read the published responses to initial draft proposal from the medical community, specialty organizations, and equipment vendors (via the hyperlink found on the CMS website), I will not re-reference all the literature and other sources therein. However, based on those references and cogent remarks by the majority of the respondees, it is clear that the research data regarding coronary CTA in specific clinical contexts for appropriate patient cohorts is unassailable. Using evidence-based methodology, coronary CTA qualifies as a strong diagnostic test, with high specificity and sensitivity for significant luminal stenosis. In fact, more than a few currently reimbursed diagnostic studies, including imaging and laboratory, do not possess similar documented strength. Coronary CTA is a robust clinical decision-making tool when applied properly.

As others have pointed out, outcomes analysis is the incorrect endpoint for both short-term and long-term value of the test. To use one example, a “negative” interpretation of a chest radiograph for pneumonia does not result in any measurable benefit in health outcome per se, but the study is routinely ordered nevertheless. Similarly then, what is the value of a negative CTA examination if no “outcomes” benefit compared to a negative invasive coronary angiogram can be documented? The value of a negative CTA is in the decrease of downstream testing and interventions which would otherwise have been undertaken based on the patient’s symptoms (including higher costs and avoidance of catheter-based complications).

In addition to scientific methodology, common sense and precedent should also support coronary CTA, especially with respect to the value of a negative CTA. To bring down to the individual patient level, if your CTA results were normal, would you be happy that the test you had was much less costly, faster (just a quick outpatient visit), and did not involve an invasive procedure (an intra-arterial catheter) with all its risks, such as arterial damage resulting in more procedures (such as surgery) and an overnight hospital stay? Would the undeniable cost-savings also not be better for insurance carriers, including CMS and its contractors? CTA and MRA have revolutionized vascular imaging for all other vascular territories. Diagnostic invasive angiograms are now infrequently performed relative to their non-invasive counterparts. Peripheral vascular and neurovascular CTA have not had to undergo the rigors of the testing standards to which coronary CTA will apparently be subject to.

I do agree that the more data collected, the more the medical community can refine the appropriate application of the modality and further high-quality studies be undertaken. Rather than halting all coronary CTAs, would not development of a national registry (or other CMS-vetted registry(ies)) that meets the CMS standards for evidence development be a better option for patients and physicians who require accurate diagnosis in the most safe, cost-effective manner possible? Furthermore, in the true spirit of the ALARA (as low as reasonably achievable) principle, technological advances to reduce radiation dose are important and becoming more available even as other means are being developed by equipment manufacturers. However, to suggest that all clinical testing be stopped unless meeting very narrowly defined criteria and being performed in the setting of a research study seems an unsupported backwards step. Will similar standards set forth for access to coronary CTA then be retroactively applied to other diagnostic applications which have not been similarly vetted?

So the real question that needs to be asked is this: If excellent research data supports the strength of coronary CTA in appropriate patients and the test is cheaper, safer, and faster than its invasive counterpart, then the basis to limit its application and reimbursement must be found elsewhere, that is, what is the underlying motivation to generate this National Coverage Determination? In my personal opinion, this has more to do with a potential for an excessively high volume of studies being performed and the projected inability of CMS to reimburse providers, i.e. bankruptcy.

Are fears of millions of coronary CTAs being ordered and depleting financial resources unfounded? I submit that the answer is “no”. The loophole in the Stark self-referral legislation that allows non-radiologist physicians to own and operate advanced imaging modalities in their private offices represents a conflict-to-interest. Although coronary CTA is not necessarily a large revenue generator in and of itself, I realize, having previously practiced as a non-invasive cardiovascular radiologist in a large, office-based cardiology practice, that layered or redundant diagnostic testing is a significant problem. Does CMS have data on office-based self-referral patterns for coronary CTA in non-radiology practices versus outpatient radiology settings, and versus hospital settings? Is there any data documenting patterns of utilization in hospitals where cardiologists only versus radiologists only versus teamed cardiologists and radiologists perform the test? Despite the preceding sentences which admittedly convey a sense of territoriality, I work daily with some exceptional cardiologists who have a balanced, thoughtful, caring, and rational approach to patient care, including the place of coronary CTA, and who value the service I provide to their patients undergoing non-invasive coronary evaluation.

I feel strongly that coronary CTA has come under an unprecedented level of scrutiny because of the above-described over-utilization (“rapid adoption”) and its misapplication, not because of unsupported problems with scientific merit and clinical efficacy. The proposed NCD represents a great tragedy for those patients who are appropriately referred and for radiologists who perform the test without self-referral bias, just as they do many other routinely reimbursed tests, including CTA throughout the rest of the body. Unfortunately, letting “free markets” work, with self-referring, equipment-owing, office-based physicians left to “police” themselves, is a health care economics and policy blunder now rewarding innocent patients and undeserving physicians with a sound bureaucratic thumping. The biggest losers in all this are: 1. an otherwise worthy non-invasive tool for cardiovascular diagnosis, i.e. coronary CTA itself, 2. the honorable cardiologists and other physicians who appropriately refer patients, and, most importantly, 3. the patients who are grateful for having a non-invasive option for coronary imaging. Rather than limiting the ordering of the test itself under current LCD guidelines in all 50 states and the District of Columbia, I propose that limiting the setting(s) in which the test is performed, along with accreditation of facilities and providers according to American College of Radiology and American College of Cardiology guidelines, may be the best available and most sensible option that balances physician judgment and patient interests with CMS concerns.

Respectfully,

Julianna Czum, MD
Assistant Professor of Radiology and Medicine, Section of Cardiology
Director of Cardiac CT
Dartmouth-Hitchcock Medical Center

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I am a cardiologist and a partner in a 22 physician cardiology practice in Lansing, MI. On behalf of the physicians, staff and patients at Thoracic & Cardiovascular Institute (TCI) I am deeply troubled by the recently published National Coverage Decision (NCD) for Cardiac Computed Tomographic Angiography (CCTA). CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols. I strongly oppose Medicare's proposed decision for a number of reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose Coronary Artery Disease (CAD) that is less expensive and poses less risk to the patient than invasive cardiac catheterization. The American College of Cardiology, American College of Radiology, The Society of Cardiovasular CT, North American Society of Angiography and Imaging and many other organizations have worked with CMS over the last two years presenting evidence and indications. CMS appears to have ignored this work in the proposed NCD.

2. The Medicare carriers in all 50 states have already reviewed all the evidence for CCTA and unanimously approved it. The new NCD would overrule all 50 states. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) and keep the LCDs in place during its data-gathering phase.

3. In the clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes. It is entirely inappropriate to demand that a diagnostic technology, such as CCTA, demonstrate an impact on health outcomes in order to be covered.

4. The narrowly defined research parameters CMS proposes will greatly inhibit participation by cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups, including TCI, with well-trained CCTA physicians will not have the resources to apply and follow their patients in the ways described in the CMS memo. This would result in significant reductions in the amount of long-term, statistically significant data available to demonstrate the effectiveness of CTA.

5. Non-coverage of CCTA for the diagnosis of CAD will result in our Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD. Medicare beneficiaries would lose access to a procedure to diagnose CAD which is non-invasive, rapid, less expensive and safer than other technologies currently in use.

6. Several recent studies demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In summary, CCTA has developed into a tool that plays an important role in the diagnosis of cardiac disease in the Medicare patient population in my practice and many other cardiology practices across the country. Accordingly, I respectively request that CMS:

From: David H. Epstein, MD
Medicare Carrier Advisory Committee
Representative Florida (Radiology)

To: CMS

Re: National Coverage Determination for coronary CTA

Date: 1/10/2008

I urge CMS to reconsider its restrictive policy regarding the use of coronary CTA. While I am concerned about the potential for explosive overuse of this new technology, I am perhaps more concerned about denying beneficiaries the option of a non-invasive means of evaluating the coronary arteries. There has already been extensive research with the 64 detector scanners showing not only parity with coronary arteriography, but in many patients, superiority with its ability to assess the content of wall plaque, not just the lumen. When promulgating the recent NCD, CMS did not consider at least 25 of the academic manuscripts demonstrating the utility of 64 detector scans.

While abuse and overuse of any imaging modality is a significant concern, the LCD in place in Florida addresses this issue, by restricting use of Coronary CTA to patients at low to moderate risk, thereby excluding those most likely to need to proceed to invasive and perhaps therapeutic angiography. The Florida description of indications for coronary CTA is included below.

I, along with many others in the radiology and cardiology community, urge CMS to reconsider its NCD for coronary CTA, and follow the lead initiated at the carrier level. Of course, utilization will be scrutinized on an ongoing basis, and changes to policy at the local or national level can be implemented as needed at any time.

Thank you for your consideration.

Cardiac evaluation of a patient with chest pain syndrome (e.g. anginal equivalent, angina), who is at a low to moderate risk for coronary artery disease (CAD), if use of MDCT is expected to avoid performing diagnostic cardiac catheterization. MDCT and coronary angiography are not expected to be performed on the same patient for diagnostic purposes prior to the application of anticipated therapy. (If a high pre-test probability of disease exists, as if the patient has known CAD, it is assumed the patient would go to coronary angiography as the definitive test, where possible angioplasty and/or stenting could be performed at the same time).

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

We represent Illinois Heart and Vascular which provides Cardiology services to the greater Chicago land area. We have 27 physicians, 92 employees and serve approximately 24,000 patients annually. Illinois Heart and Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart and Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart and Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart and Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart and Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart and Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart and Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing Illinois Heart and Vascular respectfully requests that CMS:

Note: This letter with the table and references will be emailed as an attachment

Re: Centers for Medicare & Medicaid Services proposed National Coverage Determination for Cardiac Computed Tomography

We represent Brigham and Women's Hospital, a teaching hospital of Harvard Medical School. Our Cardiac Computed Tomography (CT) group has been headed by Frank Rybicki M.D., Ph.D. since 2003. Dr. Rybicki is an internationally recognized leader in cardiac CT and part of the very robust noninvasive cardiovascular imaging program headed by Marcelo DiCarli, M.D. Based on extensive, high-quality scientific evidence as well as our own experience, it is our firm opinion that cardiac CT provides our patients with better, less invasive, and less expensive diagnoses. As a testament to our dedication in cardiac CT, we recently installed one of two 320-slice CT scanners in the United States, and Dr. Rybicki was one of three physicians who introduced this technology globally at the Radiological Society of North America in November, 2007. We write regarding the recent CMS national coverage determination (NCD) for cardiac CT. This determination comes with great surprise and greater disappointment. Multiple respected societies have spent tireless hours advising CMS on indications and proper utilization of cardiac CT. All 50 states have coverage policies in place, a result of due diligence from multiple committees carefully reviewing the scientific data.

In arriving at the NCD, national CMS cites inadequate scientific data to conclude that cardiac CT is reasonable and necessary. CMS has asked for Coverage with Evidence Development (CED) in which outcomes studies are one criterion. While there are only two 'promising indications', excellent data is available on several more. In its review, CMS did not include over 40 of the most recent and important research papers on cardiac CTA. These appear as References (1-42) below. Cardiac CT is gaining acceptance in the United States and worldwide due to the broad consensus that this test offers improved safety, clear effectiveness and cost savings. In the United States, hospitals and physicians have demonstrated this consensus by investing their scarce resources to create the technical and professional infrastructure needed for cardiac CT. There are now over 2000 cardiac CT programs in the US with an estimated 10,000 doctors who are trained to perform this exam. The vast majority of these doctors voluntarily paid thousands of dollars out of their own pockets for cardiac CT training. Clearly our own medical community realizes the value of cardiac CT. Internationally, the adoption of this test has begun to accelerate. Government health programs in Pakistan and Mexico already recognize the medical and economic benefit of cardiac CT and pay for it. In Turkey, 40 scanners are slated for installation in 2008. The government of Qatar covers cardiac CT for its non-citizen immigrant worker population. Private insurers around the world cover CTA, including those in India. In fact, the health plans offered to employees of Medicare and congress members currently cover Cardiac CT and will continue to cover it. Only U.S. Medicare beneficiaries will not be covered. Analysis committees at United Health Group, Cigna and Aetna all recognize the efficacy and cost savings and have issued national coverage policies. Over 130 million Americans are covered for cardiac CT by their health insurance plan. Most major carriers cover it, except national level Blue Cross/Blue Shield. However, Blue Cross in NY, NJ, Pennsylvania, Tennessee and Alabama all provide coverage.

The suggestion that patients will undergo cardiac CT for profit motive (43) is largely unfounded. For our patient population in our region of the United States, the collections for cardiac CT make it entirely impossible for cardiac CT programs to have profit margins as a priority. Yet we still maintain enormous excitement and enthusiasm. The reason is that cardiac CT saves time, it is less expensive than cardiac catheterization, and it is the best way to exclude coronary artery disease in low and intermediate risk patients. This is supported subjectively in quotes throughout your commentary page. There is also abundant objective data (Table).

Cardiac CT has the potential for remarkable positive impact on the diagnosis and treatment of chest pain patients. There are over 6 million visits to emergency departments in the United States each year resulting in over $14 billion in costs. There are millions more who present to physicians office with chest pain. A non-invasive highly accurate test to rule out coronary disease that is more than 20% less expensive than standard evaluation would save billions of dollars a year. The potential costs can fit into the framework of current CT examinations that occur in the emergency room (44). Cardiac CT has also proven safer than invasive catheter angiography in several studies (1, 10) and more accurate than nuclear cardiac imaging in three papers (3, 8, 37).

Since one of the ideal uses of cardiac CT is in the 40-70 age group with intermediate probability chest pain, the majority of Medicare recipients (70%) would not be ideal candidates for this test. By analyzing U.S. census and Medicare statistics, eliminating Medicare coverage would result in about a 10-13% reduction in the total number of patients that are candidates for cardiac CT. Since CT is a well proven cost saving technology as compared to nuclear studies and cardiac catheterization, the decision actually could cost taxpayers as much as $1 billion per year extra to not cover cardiac CT.

Before we offer specific recommendations, we make the following additional comments and analysis of current data.

A. Technology that improves the net health outcome.
The only cardiovascular imaging study that clearly improves health outcomes is the study of aortic aneurysm. Yet, we study the pulmonary circulation for embolism using 64-slice CT over 20 times per day at our institution. The level of requested outcomes research could only be achieved by a study so large it would be implausible. Numerous papers (not considered in the NCD) that document improved health outcomes (less complications without increased adverse events).

B. Technology as beneficial as established alternatives.
The major strength is coronary CT angiography is its negative predictive value (>97%, assuming catheter angiography is the gold standard). This has been reproduced in thousands of patients. The common theme among 64-slice CT publications is that when referral to invasive catheterization is questionable, coronary CT angiography may identify subjects with normal angiograms and consistently decrease the number of unnecessary and expensive invasive procedures. This has already been demonstrated to result in less invasive angiograms in clinical practice, lower costs and better or equivalent health outcomes (as compared to a more expensive and invasive test).

C. The improvement should be able to be achieved outside of investigational studies.
Enough physicians have the training and desire to perform cardiac CT. Furthermore, the ACCURACY Trial, a multicenter trial recently presented at a national meeting, demonstrated a 99% negative predictive power in non-academic settings. The enrolling sites were almost exclusively private practice facilities.

D. Additional scientific data. Appropriateness of cardiac CT. The American College of Cardiology Foundation (ACCF) and other key subspecialty societies considered the available scientific evidence of 39 distinct clinical indications including coronary, non-coronary cardiac, and non-cardiac (45). Thirteen indications were considered appropriate, and four of these were dedicated coronary artery exams:
1. Evaluation of chest pain syndrome in adults with intermediate pre-test probability of CAD and uninterpretable ECG or inability to exercise.
2. Evaluation of chest pain syndrome in adults with uninterpretable or equivocal stress test (exercise ECG, SPECT, or echocardiography).
3. Coronary artery evaluation in adults with new onset heart failure to assess etiology.
4. Evaluation of acute chest pain in adults with intermediate pre-test probability of CAD and no ECG changes and negative serial enzymes. More recently, the Society of Cardiovascular Computed Tomography and the North American Society for Cardiac Imaging recently re-evaluated and reaffirmed the appropriate usage of cardiac computed tomography (46).

The American Heart Association Scientific Statement for the Assessment of Coronary Artery Disease by Cardiac Computed Tomography recommends the use of CCTA for the following clinical indications (47).
1. Suspected CAD (class IIa, level of evidence B).
2. Anomalous coronary arteries (class IIa, level of evidence C).

Accuracy of cardiac CT. Two recent open-label blinded prospective multicenter trials compared 64-detector row coronary CT angiography to quantitative coronary angiography (QCA) by invasive cardiac catheterization for the detection of either ≥50% or ≥70% stenosis. The CORE 64 trial evaluated 291 primarily high-risk patients >40 years of age from 9 international centers who were being referred for invasive coronary angiography (48). Reported per-patient sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) to identify a ≥50% coronary artery stenosis were 85%, 90%, 91%, and 83%.

The ACCURACY trial enrolled 232 primarily high-risk patients from 16 US sites who were being referred for invasive coronary angiography (49). Blinded assessment of coronary CT angiography resulted in per-patient sensitivity, specificity, PPV and NPV to identify a ≥70% coronary artery stenosis of 91%, 84%, 51%, and 98%, respectively, and per-vessel sensitivity specificity, PPV and NPV of 85%, 92%, 68%, 99%, respectively.

E. Cardiac CT is cost-efficient. A recent analysis examined adults with no known CAD undergoing coronary CT angiography under coronary heart disease-specific chest CT angiography with and without contrast (CPT 71275) between 2002-5 (50). These adults (n=1,833) were matched 1:4 to adults undergoing SPECT (n=7,332) for age, demographics, cardiovascular risk factors, and cardiac-related medications. Economic endpoints including total healthcare costs, CAD-related costs, additional coronary testing costs, and medical and coronary revascularization costs were examined. In this low risk patient population, CAD-related costs for adults undergoing coronary CT angiography were $1716 (95% CI, $361-$4,649) lower than in matched adults undergoing SPECT. Despite overall total healthcare and CAD-related costs, coronary CT angiography adults incurred slightly lower rates of CAD-related hospitalization (0.01 vs. 0.02, p=0.003) and myocardial infarction or angina (0.05 vs. 0.08, p< 0.0001). In another study, Cole and colleagues examined 206 patients with mildly abnormal or equivocal nuclear SPECT exams who subsequently underwent cardiac CT first and 'selectively' underwent invasive angiography if obstructive plaque was identified by CT (51). Sensitivity analysis demonstrated total cost savings if < 81.5% of patients ultimately required invasive angiography. In their cohort, 32% of patients exhibited potentially obstructive plaque by cardiac CT and only these adults underwent selective catheterization, resulting in a cost savings of $1,454 per patient. In standard practice, these patients frequently are sent for the far more costly invasive coronary angiographic procedures (Class IIa and IIb recommendations of the ACC/AHA Guidelines for Coronary Angiography)

In summary, we appreciate that the potential cost of cardiac CT is a major concern for CMS. There is also an assumption that increasing utilization must be based on inappropriate ordering or people seeking excessive profit (52). However, widespread adoption of cardiac CT in the U.S. (and around the globe) does not imply inappropriate use. In this is case it is revolutionary technology that will lead to better, less invasive, and less expensive diagnosis. This is the message of multiple physician societies composed largely of academicians who have already chosen a career of less profit for the good of medicine. The leadership teams of these groups are men and women who for the most part work on salary in academic centers. They are the least likely group to be biased. We recommend in the strongest possible terms a two-year suspension of the Medicare National Coverage Decision. During this time state policies should prevail, and Medicare beneficiaries will not be denied access to an important exam that will, in many cases, allow them to avoid invasive cardiac catheterization. The suspension will also enable a careful review of all available literature. We recommend that this review be performed in concert with leaders in academic medicine. Along this theme, we recommend an assembly of stakeholders to advise Medicare. This will help avoid misunderstanding and misinterpretation of cardiac CT technology, practice, and integration in the effective treatment of our patients.

Sincerely Yours,

Frank J. Rybicki, M.D., Ph.D. and Marcelo F. Di Carli, M.D.

On behalf of the Noninvasive Cardiovascular Imaging Program
Brigham and Women''s Hospital

This letter has been supported by electronic signature by the following staff members of Brigham and Women's Hospital: Anthony D. Whittemore, M.D.
Chief Medical Officer
Brigham & Women''s Hospital
Professor of Surgery
Harvard Medical School
Joseph Loscalzo, M.D., Ph.D.
Chairman, Department of Medicine
Brigham & Women''s Hospital
Hersey Professor of the Theory and Practice of Physics
Harvard Medical School
Steven E. Seltzer, M.D.
Chairman, Department of Radiology
Brigham & Women''s Hospital
Philip H. Cook Professor of Radiology
Harvard Medical School

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The role of Coronary CTA has been well proven in number of papers published in recent literature across a variety of scientific journals. It is of great benefit to the patient to have the evaluation of the coronary arteries performed with a peripheral Coronary CTA as apposed to the more riskier central coronary catheterization. CCTA offers excellent negative predictive value for CAD as well as high positive predictive value fro CAD. CMS is requested to revise the decision regarding the reimbursement for CCTA.

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

We represent North Texas Heart Center, P.A., which provides Cardiology services to the greater Dallas/Ft. Worth, Texas area. We have 15 physicians, 80 employees and serve approximately 15,000 patients annually. North Texas Heart Center appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. North Texas Heart Center, P.A. believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. North Texas Heart Center, P.A. strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). North Texas Heart Center, P.A. defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers (including BCBS of Texas), most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

North Texas Heart Center, P.A. appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, North Texas Heart Center, P.A. is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from North Texas Heart Center, P.A., demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, North Texas Heart Center, P.A. respectfully requests that CMS:

This response is in reference to the NCA/CAL Computed Tomographic Angiography position posted by CMS. On behalf of MEDRAD inc. I would like to express our concern with the position that CMS has taken relative to CT Angiography.

We have received input from the medical community, including our physician thought leader partners relative to the position of CMS. Based on that feedback, we are of the opinion that the position taken by CMS is not aligned with the position of those individuals.

In addition, MEDRAD has developed products to support the procedures that our customers are performing including Cardiac CTA. These products were developed in response to a clear need and perceived clinical benefit on the part of our customers to their patients. We continue to invest research and development dollars into advanced technology related to these procedures.

It is our opinion, that restricting access to these procedures is not in the best interest of the patient from either a cost of care or quality of care perspective. Based on our research and discussion in the clinical community, it does not appear as though the intent is to utilize Cardiac CTA as a broad brush screening tool, but rather to use it for specific clinical indications when appropriate. Examples of these indications include, but may not be limited to, Coronary Artery Bypass Graft assessment, functional cardiac imaging and evaluation for atypical chest pain to rule out Coronary Artery Disease. We believe there is more than adequate evidence that these indications, as well as others, are clearly supported in the current literature. That support includes evidence to indicate cardiac CTA as a significant tool to manage appropriate emergency department patients, in an efficient and cost effective manner. This is just one of several examples of how current literature supports a much broader use of cardiac CTA than CMS is recognizing.

Further, we feel that the body of knowledge and medical research that CMS is basing their decision on may not reflect the most current and up to date thinking and technology in the field. For example, most of the studies cited in the CMS Proposed National Coverage Decision were not performed using the latest scanner technology and latest imaging techniques. These techniques and technologies have shown significantly better results than those in the studies on which the CMS position is based.

The requirements CMS intends to apply to physicians in order to apply for reimbursement will quite likely result in reductions in research capabilities and advancements. This will be driven by cumbersome requirements related to patient selection, informed consent and the extensive limitations on indications that will be approved for research. Ultimately this will lead to a decline in research efforts thought the industry, further inhibiting the advancement of cardiac imaging capabilities in CT.

We would encourage CMS to reconsider it’s position relative to this NCD, and further evaluate the latest body of research available prior to making a definitive ruling on this issue.

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I would like to urge you to continue to reimburse for CT coronary argio studies. In our experience with this test it has proven to be a reliable, cost effective alternative to standard coronary angiography. For those people with eleveated risk of coronary stenosis, diabetic, atypical chest pain, or acute chest pain the advantage of having a realitivly inexpensive and far less risky procedure must be preserved. The number of patients that have an intervention done after routine angiography would indicate there is a substantial cost savings to be realized by using CT cardiac angiography for those patients without EKG changes. Many institutions have made substantial expenditures to have the advanced imaging equipment available to perform cardiac CT. If reimbursement is withdrawn, future expenditures on any advanced equipment will be suspect for fear of losing that reimbursement as well. ie. digital mammography equipment. If there needs to be a restriction to prevent over use, restrict physicians from billing for imaging studies done in their office or privatly owned clinics. Hospital based imaging departments can not self refer and therefore do not control the use or over use of any study. If the study has merit it will be ordered by a referring physician, if the physician feels the test is of no use then it will not be ordered as long as they can not bill for the technical portion.

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I believe the proposed Decision Memo for CTA is extremely poor public policy. CCTA is a valuable tool that is less expensive and poses less risk to the patient than the current standard of care, invasive cardiac catheterization. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.As someone who will soon be eligible for Medicare, I ask that you allow local Medicare contractors to continue coverage of CCTA for the diagnosis of CAD under their existing LCDs. This action will enable Medicare beneficiaries to realize the benefits of this clinically proven, lower-cost and lower-risk technology. Thank you.

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RE:Medicare''s announcement that a NCD will be overturning the current Medicare''s LCD''s covering cardiac CT angiography for the diagnosis of coronary artery disease, except when patient is enrolled in a research trial.

As a medical/radiology professional, I am ethically responsible to inform you that CT angiography and MRI angiography are the least invasive procedures I know of for the diagnosis of coronary artery disease.(blockages)The alternative angiogram is very invasive and expensive. With-holding coverage for these life saving, less invasive, diagnostic procedures will be a death sentence for many Americans. Pleasecut corners elsewhere.

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Wisconsin Heart and Vascular Institute, which provides Cardiology services to the greater Madison, Wisconsin area. We have 14 physicians, 75 employees and serve approximately 30,000 patients annually. Wisconsin Heart and Vascular Institute appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Wisconsin Heart and Vascular Institute believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Wisconsin Heart and Vascular Institute strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Wisconsin Heart and Vascular Institute defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Physicians Plus Insurance Corporation, Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Wisconsin Heart and Vascular Institute appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Wisconsin Heart and Vascular Institute, is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Wisconsin Heart and Vascular Institute, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Wisconsin Heart and Vascular Institute respectfully requests that CMS:

I am a pediatric radiologist who performs coronary CTA and Cardiac MR in pediatric patients with congenital heart disease, which includes patients who can have coronary artery anomalies, such as anomalous origin or to follow-up coronary artery aneurysms and stenosis in patients with known Kawasaki''s disease. Cardiac CTA for heart function and Coronary CTA are vital in patients who have limited windows by echocardiography and had unsuccessful evaluation of the coronary arteries by cardiac MRI or have a contraindication for having a cardiac MR due to an indwelling pacemaker or AICD. It is extremely important to have a way to assess patients noninvasively by CT, which can give a complete assessment of the heart and extracardiac vasculature in patients with congenital heart disease who have contraindications for cardiac MR. This is because the only other option to image these patents for heart function and vascular anatomy is to perform cardiac catheterization, which can be associated with significant complications and requires sedation or general anesthesia much more often than CT. In addition, cardiac catheterization has much more radiation exposure than gated cardiac CT for pediatric applications, because more imaging and contrast injections are needed at cath to evaluate congenital anomalies, which is much more so than adult cardiac catheterizations which are more often performed for only coronary artery assessment.

Please contact me directly for clarification of the above if you have further questions.

Thank You

Laureen Sena
Staff Radiologist
Children''s Hospital Boston
laureen.sena@tch.harvard.edu

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Coronary CTA is a very sensitive and specific test and should be reimbursed by Medicare. It has saved several pt''s lifes at our hospital over the past year. It''s cheaper and sometimes more accurate than the more expensive and invasive cardiac cath. If CMS is concerned about the runaway costs of imaging, they should ban self referral to CT''s purchased by cardiology groups. The argument has been that it''s done for patient convenience. The truth is that the patient has to come back for a separate visit to the office b/c of scheduling constraints, need for beta blockers, etc. Also, there are now many 64 slice scanners in medium and large size communities that are not cardiology owned that can accomodate these patients. This test should be promoted to detect coronary artery diseasy earlier and save lives and money for the healthcare system in the long run by substituting for more expensive and invasive tests.

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Dear Sir or Madam,

I am writing in regard to the recent situation with medicare not wanting to re-emburse for CTA studies.It really seems to me that medicare is not looking at the big picture on this matter.The idea of being able to have a CTA done instead of going through the invasiveness of an angiogram or heart catherization is such a fantastic advancement when it comes to patient options.What would you rather do as a patient?....Go into a hospital and go through all that an angio entails or simple go to an outpatient facility and have a cat scan performed? I can tell the ease of stress for the patient is something that can be priceless.Furthermore, from an insurance standpoint....the economics of this would be very cost effective.So I hope that you proceed with caution when you make any final decisions in regard to this.

Sincerely,

Jim Grace, rt ct

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THis is another example of CMS trying to control costs without knowing the real use of technology. As a healthcare executive I have already seen evidence that the presence of WELL RUN CTA programs, lowers use of other modalities; most notably MUGA. Which, by the way, is a higher reimbursement rate. By limiting the use of CTA, you will see an increase back in the nuclear medicine/stress test arena. CTA is NOT a screening tool, it is a tool, that properly used, determines if there is presence of CAD, in those cases of atypical symptoms or low risk presentation. The high risk or high symptoms are already on their way to the cath lab.

DO NOT allow this rule change to go through! It is improper and does not validate with field based experience. I.e the 43 year old man with no history, chest pain, who wound up with a 99% left main found thorugh CTA; which would otherwise have resulted in his death or emergency CABG surgery!

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

We represent the New York Heart Center (NYHC), which provides Cardiology services to the greater Central New York area, including Syracuse, Watertown Oswego and Massena, New York. The New York Heart Center is the largest and most advanced cardiovascular practice in Central New York and one of the largest in the state of New York with 8 offices and 16 cardiologists throughout the area. We are well known throughout the region and the country for having conducted many significant research projects and most importantly, for the quality of the care we provide our patients. The NYHC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

In our CMS coverage area, the local carrier approved CCTA for reimbursement in April of 2005. Up to that point in time, the doctors of the NYHC had intensively and extensively studied cardiac imaging for more than 3 years and had concluded that the new 64-slice, multi-detector, CT scanners were revolutionary and would provide their patients with a safer, less invasive, more efficient, faster and certainly less expensive diagnostic tool for diagnosing the severity of CAD. Subsequently, we decided to purchase a Philips Brilliance 64-slice CT scanner and began conducting CCTAs in October of 2006. The NYHC was the first private cardiology practice in New York State to purchase such a scanner and to-date we have conducted more than 1700 CCTAs.

We strongly believe that the 64-slice CT scanner is an incredible and revolutionary advancement in cardiac imaging. Given its advanced technology and speed, cardiologists are now able to take images of the heart and display, for example, clogged arteries which could only have been obtained several years ago by going to the hospital for an invasive, and relatively expensive catheterization. Now with the advent of the 64-slice CT scanner, this important diagnostic information can be obtained non-invasively, in 20 minutes and at one sixth the cost of going to the hospital. What more could one ask for in healthcare-better efficacy, safer, and much less expensive? Therefore, it is now amazing to us to see that CMS (on a national basis) would like to stop reimbursing for this procedure which we believe flies in the face of quality medical practices, financial logic, and patient care.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. The NYHC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. More specifically, he NYHC strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). The NYHC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including POMCO, MVP, Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

The NYHC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, the NYHC is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from the NYHC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, the NYHC respectfully requests that CMS:

This proposed change is far to limited. I believe many people will be denied a very beneficial non-invasive procedure. I believe this goes against the practice allowed under the current LCD guideline.I have beed a patient that benefited from this procedure, much easier and less risky than the coronary angiogram I had a few years before.

As a member of the medical community, far removed from this procedure, I cannot support this change. I do not believe it should be allowed as planned without further review and scrutiny.

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We represent Illinois Heart and Vascular which provides Cardiology services to the greater Chicago land area. We have 27 physicians, 92 employees and serve approximately 24,000 patients annually. Illinois Heart and Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart and Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart and Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart and Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart and Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart and Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart and Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing Illinois Heart and Vascular respectfully requests that CMS:

Dear Sirs: As a practicing cardiologist, I would like to strongly object to the proposed NCD and as that it be withdrawn. It is difficult to uned how this decision has been made in the face of a rapidly expanding data set which will better define the role of CT Coronary angiography (CTA). Moreover, the professional societies have made a concerted, responsible effort to define the role of Coronary CTA, and it is most appropriate for CMS to look to these specialty societies for consensus, rather than impose a significant restriction on the availability of this test.I would like to offer anecdotal data from our large, 18 cardiologist group regard a specific question - namely, does Coronary CTA reduce the need for invasive cardiac catheterization. Over a 45 month period in which we have been performing coronary CTA, 1260 patients have been studied. Most of these have been patients with abnormal stress test - in other words, patients who usually would be considered for cardiac cath. Of this group, only 106 patients (8.6%) have been referred for cardiac catheterization. This uncontrolled observational study suggests that coronary CTA reduces the need for catheterization, and does so with a commensurate reduction in cost and risk to the patient. And to further that point, I would add that our practice has an outpatient cardiac cath lab and 64-slice CT scanner in a free-standing building. In the same time period, the number of cardiac catheterizations has decreased approximately 15-20% while the number of coronary CTAs has increased. So, in this somewhat "closed-model", we have seen a clear preference by our physicians and patients for the less invasive diagnostic test.Finally, I would like to add that this procedure is strongly preferred by our patients. It is difficult to refer a patient with low to intermediate risk of heart disease who has an abnormal stress or ongoing chest pain to coronary angiography when we know that there is a high likelihood of ruling out obstructive disease with coronary CTA.Thank you for your careful consideration of these comments, and please do not abruptly withdraw this important diagnostic imaging modality.

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Ladies and Gentlemen, Aa the director of Radiology in a rural hospital, I see first-hand the multitudes of elderly patients who do not have the ways and means to travel to distant medical centers for diagnostic CAD procedures. One of the goals of the rural healthcare provider is to offer specific healthcare services to enhance the well-being of the community. For patients suspected of CAD and other cardiac disorders the most common diagnostic procedure is Heart Catherization. The cost and upkeep of a heart cath lab is out of reach for most rural areas. However, CCTA offers a viable alternative to LHC.

Rural healthcare providers like myself have moved forward with plans to offer CCTA in the immedicatefuture. The risks and costs of CCTA would indeed be much lower than that of a diagnostic LHC. I can see CCTA as part of a broader, more comprehensive delivery of healthcare in the rural areas. We have purchased the CT technology capable of performing CCTA''s. It is our intention to offer our patients with CCTA to determine the need for patients to travel for further cardiac examination or treatment. We see CCTA as viable diagnostic tool for rural applications. Respectfully submitted. Grover Taylor

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Steve E. Phurrough, M.D., M.P.A.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard, Mail Stop C1-09-06
Baltimore, MD 21244-1850

Re: Proposed National Coverage Determination for Coronary CT Angiography

Dear Dr. Phurrough:

I represent Virginia Cardiovascular Specialists, which provides Cardiology services to the greater Richmond and surrounding areas. We have 36 physicians, 120 employees and serve approximately 100,000 patients annually. VCS appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. VCS believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. VCS strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer- reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). VCS defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Southern Health, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Virginia Cardiovascular Specialists appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are 'chronic stable angina at intermediate risk for CAD' and 'unstable angina at low risk for death and with intermediate risk of CAD.' These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by 'risk of CAD.' Rather, guidelines for 'acute chest pain' use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

'Unstable angina' or more commonly now 'possible Acute Coronary Syndrome' likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina VCS is unaware of guidelines that use the 'risk of CAD' in their algorithms. Risk of short-term death and non- fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long- term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life- saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Virginia Cardiovascular Specialists, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Virginia Cardiovascular Specialists respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Cardiovascular Management of Illinois which provides Cardiology services to the greater Chicagoland area. We have 19 physicians and serve approximately 16,000 patients annually. Cardiovascular Associates appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Cardiovascular Associates believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Cardiovascular Associates strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Cardiovascular Associates defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Cardiovascular Associates appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Cardiovascular Associates is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Cardiovascular Associates, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Cardiovascular Associates respectfully requests that CMS:

January 11, 2008

Steve E. Phurrough, M.D., M.P.A.
Director, Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard, Mail stop CI-09-06
Baltimore, MD. 21244-1850

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

We represent Cardiovascular Associates, Ltd., which provides Cardiology services to the greater Hampton Roads area. We have 22 physicians, 115 employees and serve approximately 10,000 patients annually. Cardiovascular Associates appreciates the opportunity to comment on the Centers for Medicare & Medicare Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Cardiovascular Associates believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Cardiovascular Associates strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many ofthe cited studies used older technology (16-slice equipment). Cardiovascular Associates defers to the responses ofthe specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College ofRadiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate form the authors'.

The currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patient with indeterminate stress tests or with stress tests whose findings are discrepant with clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number ofpresenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness oflocal coverage decisions. The vast majority of coverage decisions with regard to specialty societies and their own advisory committees to develop LCDs that support the use ofCCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LDC created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, Optima, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Higbmark, beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Cardiovascular Associates appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of the response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of longterm data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronis stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Cardiovascular Associates is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a noninvasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologist, who currently performs a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMSmemo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote for greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will . be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive ofcoronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-ofthe- art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Cardiovascular Associates, demonstrates that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Cardiovascular Associates respectfully requests that CMS:

• Allow local Medicare contractors to continue coverage of CCTA for the diagnosis of CAD under their existing LCDs to enable Medicare beneficiaries the benefits of this clinically proven, lower-cost and lower risk technology.
• Eliminate implementation of its proposed CED. Cardiovascular Associates recommend that CMS work with the specialty multidisciplinary societies (SCCT, ACC and ACR) to develop criteria for a CCTA registry to minimize the impact ofthe delivery of appropriate care to the beneficiaries. There are several excellent CCTA registries already existence that maybe used as models for a CMS-approved registry to gather clinical data for longitudinal studies.
• Adopt accreditation guidelines, physician credentialing requirements and clinical appropriateness protocols to promote appropriate utilization of CTA for the diagnosis of CAD. The medical specialty societies are at the forefront in development of these important quality endeavors, and Cardiovascular Associates fully supports their efforts and encourages Medicare to work with them in developing similar guidelines.

Cardiovascular Associates appreciates this opportunity to comment on Medicare's Proposed Decision Memo regarding Cardiac CTA. Please contact me a 757-499-2825 or via email at vdonlon@cval.org if you have any questions.

Sincerely,

Less

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Cardiovascular Management of Illinois which provides Cardiology services to the greater Chicagoland area. We have 29 physicians and serve approximately 26,000 patients annually. Illinois Heart & Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart & Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart & Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart & Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart & Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart & Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart & Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Illinois Heart & Vascular respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Cardiovascular Management of Illinois which provides Cardiology services to the greater Chicagoland area. We have 29 physicians and serve approximately 26,000 patients annually. Illinois Heart & Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart & Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart & Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart & Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart & Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart & Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart & Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Illinois Heart & Vascular respectfully requests that CMS:

I''m very suprised that the availablity of the Computed Tomographic Angiography is being considered decreased access to medicare patients. I deal with these patients on a daily basis, The patients are so relieved when they find out that they can get the cardiac ct scan done instead of a cardiac catherization. It is not so limiting on their family''s time taking them for a invasive procedure and they have no recovery time. Family mimbers do not have to miss work and sometimes pay, which adds more stress on the whole family. We have this great diagnostic tool why would this even be a consideration of limmiting is beyond comprehension. Please continue to pay for this testing that we are lucky enough to have.

Less

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)
I represent Cardiovascular Management of Illinois which provides Cardiology services to the greater Chicagoland area. We have 29 physicians and serve approximately 26,000 patients annually. Illinois Heart & Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart & Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart & Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart & Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart & Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart & Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart & Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Illinois Heart & Vascular respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Cardiovascular Management of Illinois which provides Cardiology services to the greater Chicagoland area. We have 19 physicians and serve approximately 16,000 patients annually. Cardiovascular Associates appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Cardiovascular Associates believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Cardiovascular Associates strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Cardiovascular Associates defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Cardiovascular Associates appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Cardiovascular Associates is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Cardiovascular Associates, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Cardiovascular Associates respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Cardiovascular Management of Illinois which provides Cardiology services to the greater Chicagoland area. We have 29 physicians and serve approximately 26,000 patients annually. Illinois Heart & Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart & Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart & Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart & Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart & Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart & Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart & Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Illinois Heart & Vascular respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Cardiovascular Associates, which provides Cardiology services to the greater Elk Grove Village, IL area. We have 19 physicians, 75 employees and serve approximately 20,000 patients annually. Cardiovascular Associates appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Cardiovascular Associates believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Cardiovascular Associates strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment).

Cardiovascular Associates defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Cardiovascular Associates appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Cardiovascular Associates is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Cardiovascular Associates, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Cardiovascular Associates respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Cardiovascular Management of Illinois which provides Cardiology services to the greater Chicago land area. We have 19 physicians and serve approximately 16,000 patients annually. Cardiovascular Associates appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Cardiovascular Associates believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Cardiovascular Associates strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Cardiovascular Associates defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Cardiovascular Associates appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Cardiovascular Associates is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Cardiovascular Associates, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Cardiovascular Associates respectfully requests that CMS:

To whom it may concern: I am an invasive and clinical cardiolgist in private practice in Gainesville, Florida. We do CCTA in our office and it has changed the way we practice cardiology in that our overall care is less invasive, more effecient, and less costly for our patients. I am stunned and shocked by the recent CMS proposal for a NCD for CCTA. I would request that CMS withdraw or modify the proposed NCD to provide coverage for appropiate indicaations. The proposed NCD does not reflect accurately the evidence in the published literture supporting CCTA in regard to symptomatic patients at indeterminate risk. CMS has failed at a very basic level to evaluate properly the peer reviewed published literature that is available. It is inappropiate and premature to propose a new set of coverage criteria without doing so. If the proposed NCD is finalized it will have a severe negative impact on medicare beneficiaries access to the service throughout the country. I would urge CMS to work with the appropiate speciality societies, including SCCT,ACC, and the ACR to define the appropiate clinical indications for CCTA and to establish clinical criteria for further investigation prior to any final NCD.

Less

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Cardiovascular Management of Illinois which provides Cardiology services to the greater Chicagoland area. We have 19 physicians and serve approximately 16,000 patients annually. Cardiovascular Associates appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Cardiovascular Associates believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Cardiovascular Associates strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Cardiovascular Associates defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Cardiovascular Associates appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Cardiovascular Associates is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Cardiovascular Associates, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Cardiovascular Associates respectfully requests that CMS:

Cardiac CT Angiography (CCTA) is vital for the care of chest pain patients. This procedure provides a non-invasive, low-risk method of confirming coronary artery blockage without the invasive and high risk catheterization procedure. CCTA has been used with tremendous success to confirm coronary artery blockage over several years. This is a proven diagnostic procedure and the technology of coronary artery imaging using a 64 slice or a next generation dual source CT scanner is, by far, the fastest, non-invasive and most accurate method to confirm or refute arterial blockage. We would be taking a huge step backwards for our senior citizens by not providing coverage for CCTA. CCTA keeps most patients out of the Cath lab and enables the patients caregivers to better and more quickly care for their patients.

Less

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Cardiovascular Management of Illinois which provides Cardiology services to the greater Chicagoland area. We have 19 physicians and serve approximately 16,000 patients annually. Cardiovascular Associates appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Cardiovascular Associates believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Cardiovascular Associates strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Cardiovascular Associates defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Cardiovascular Associates appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Cardiovascular Associates is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Cardiovascular Associates, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Cardiovascular Associates respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Cardiovascular Management of Illinois which provides Cardiology services to the greater Chicagoland area. We have 19 physicians and serve approximately 16,000 patients annually. Cardiovascular Associates appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Cardiovascular Associates believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Cardiovascular Associates strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Cardiovascular Associates defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Cardiovascular Associates appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Cardiovascular Associates is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Cardiovascular Associates, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Cardiovascular Associates respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Cardiovascular Management of Illinois which provides Cardiology services to the greater Chicagoland area. We have 19 physicians and serve approximately 16,000 patients annually. Cardiovascular Associates appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Cardiovascular Associates believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Cardiovascular Associates strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Cardiovascular Associates defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Cardiovascular Associates appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Cardiovascular Associates is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Cardiovascular Associates, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. Th

In closing, Cardiovascular Associates respectfully requests that CMS:

1: Vanhoenacker PK, Decramer I, Bladt O, Sarno G, Bevernage C, Wijns W. Detection of non-ST-elevation myocardial infarction and unstable angina in the acute setting: meta-analysis of diagnostic performance of multi- detector computed tomographic angiography. BMC Cardiovasc Disord. 2007 Dec 19;7(1):39 [Epub ahead of print] PMID: 18093295 [PubMed - as supplied by publisher]

2: Vanhoenacker PK, Heijenbrok-Kal MH, Van Heste R, Decramer I, Van Hoe LR, Wijns W, Hunink MG. Diagnostic performance of multidetector CT angiography for assessment of coronary artery disease: meta-analysis. Radiology. 2007 Aug;244(2):419-28. PMID: 17641365 [PubMed - indexed for MEDLINE]

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Coronary artery CTA can save patient morbidity and mortality by replacing invasive ,riskier, cardiac catheterization with a non-invasive technique. The negative predictive value is unequalled by any other test.Meaning: if your Coronary CTA is normal, you do not have coronary artery disease, and you do not need a cardiac catherization. Recent 64 slice CAT scans and recent medical literature confims this and supports outstanding positive predictive value as well. Radiologists have replaced invasive diagnostic carotid, abdominal, and peripheral angiograms with less expensive and safer CTA and MRA, and coronary artery CTA can do the same for cardiac catheterization. In low to moderate risk patients a negative coronary artery CTA precludes any further workup. Traditional stress testing has neither the negative predictive value of coronary artery CTA and is fraught with false positive exams resulting in needless cardiac catheterizations, a procedure that places a patient at risk for arterial injury and stroke.

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CCTA can save patient morbidity and mortality by replacing cath with a non-invasive technique. The NPV of CCTA is unequalled by any other test. Recent 64 slice and better literature confims this and supports outstanding PPV as well. Radiologists have replaced invasive diagnostic carotid, abdominal, and peripheral angiograms with less expensive and risky CTA and MRA, and CCTA can do the same for cardiac cath. In low to moderate risk patients a negative CCTA precludes any further workup. Traditional stress testing has neither the NPV of CCTA and is fraught with false positive exams resulting in needless caths

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Cardiovascular Management of Illinois which provides Cardiology services to the greater Chicagoland area. We have 29 physicians and serve approximately 26,000 patients annually. Illinois Heart & Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart & Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart & Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart & Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart & Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart & Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart & Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Illinois Heart & Vascular respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer- reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long- term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life- saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

CCTA can save patient morbidity and mortality by replacing cath with a non-invasive technique. The NPV of CCTA is unequalled by any other test. Recent 64 slice and better literature confims this and supports outstanding PPV as well. Radiologists have replaced invasive diagnostic carotid, abdominal, and peripheral angiograms with less expensive and risky CTA and MRA, and CCTA can do the same for cardiac cath. In low to moderate risk patients a negative CCTA precludes any further workup. Traditional stress testing has neither the NPV of CCTA and is fraught with false positive exams resulting in needless caths

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS’ final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare’s proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS’ proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment).
CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS’ memo, the conclusions made by CMS are disparate from the authors’.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians’ ability to gather the very data needed to prove CCTA’s additional efficacy.

2. CMS should rely on its local carriers’ judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient’s CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA’s application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS’ two clinical diagnoses being proposed as the basis for reimbursement and study are “chronic stable angina at intermediate risk for CAD” and “unstable angina at low risk for death and with intermediate risk of CAD.” These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by “risk of CAD.” Rather, guidelines for “acute chest pain” use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

“Unstable angina” or more commonly now “possible Acute Coronary Syndrome” likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the “risk of CAD” in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

§ Allow local Medicare contractors to continue coverage of CCTA for the diagnosis of CAD under their existing LCDs to enable Medicare beneficiaries the benefits of this clinically proven, lower-cost and lower-risk technology.

§ Eliminate implementation of its proposed CED. CARDIOVASCULAR ASSOCIATES, SC recommends that CMS work with the specialty multidisciplinary societies (SCCT, ACC and ACR) to develop criteria for a CCTA registry to minimize the impact on the delivery of appropriate care to beneficiaries. There are several excellent CCTA registries already in existence that may be used as models for a CMS-approved registry to gather clinical data for longitudinal studies.

§ Adopt accreditation guidelines, physician credentialing requirements and clinical appropriateness protocols to promote appropriate utilization of CTA for the diagnosis of CAD. The medical specialty societies are at the forefront in the development of these important quality endeavors, and (CARDIOVASCULAR ASSOCIATES, SC) fully supports their efforts and encourages Medicare to work with them in developing similar guidelines.

(CARDIOVASCULAR ASSOCIATES, SC) appreciates this opportunity to comment on Medicare’s Proposed Decision Memo regarding Cardiac CTA. Please contact me at 847-981-3680 if you have any questions.

Sincerely,Jennifer Cherry R.N.

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS’ final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare’s proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS’ proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS’ memo, the conclusions made by CMS are disparate from the authors’.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians’ ability to gather the very data needed to prove CCTA’s additional efficacy.

2. CMS should rely on its local carriers’ judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient’s CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA’s application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS’ two clinical diagnoses being proposed as the basis for reimbursement and study are “chronic stable angina at intermediate risk for CAD” and “unstable angina at low risk for death and with intermediate risk of CAD.” These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by “risk of CAD.” Rather, guidelines for “acute chest pain” use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

“Unstable angina” or more commonly now “possible Acute Coronary Syndrome” likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the “risk of CAD” in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

§ Allow local Medicare contractors to continue coverage of CCTA for the diagnosis of CAD under their existing LCDs to enable Medicare beneficiaries the benefits of this clinically proven, lower-cost and lower-risk technology.

§ Eliminate implementation of its proposed CED. CARDIOVASCULAR ASSOCIATES, SC recommends that CMS work with the specialty multidisciplinary societies (SCCT, ACC and ACR) to develop criteria for a CCTA registry to minimize the impact on the delivery of appropriate care to beneficiaries. There are several excellent CCTA registries already in existence that may be used as models for a CMS-approved registry to gather clinical data for longitudinal studies.

§ Adopt accreditation guidelines, physician credentialing requirements and clinical appropriateness protocols to promote appropriate utilization of CTA for the diagnosis of CAD. The medical specialty societies are at the forefront in the development of these important quality endeavors, and (CARDIOVASCULAR ASSOCIATES, SC) fully supports their efforts and encourages Medicare to work with them in developing similar guidelines.

(CARDIOVASCULAR ASSOCIATES, SC) appreciates this opportunity to comment on Medicare’s Proposed Decision Memo regarding Cardiac CTA. Please contact me at 847-981-3680 if you have any questions.

Sincerely,

David Cherry
Radiology Technologist (R)

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The proposed NCD should be withdrawn. If it is not withdrawn, substantial modifications should be made to provide coverage for appropriate indications and populations. The proposed NCD does not adequately reflect the current state of evidence in support of CCTA in regard tosymptomatic patients with chronic stable angina at intermediate risk of CAD. Data is rapidly accumulating for 64-slice CCTA and there are many additional studies in the peer-reviewed, publishedliterature to cite. CMS has failed to recognize many of these critically important studies. It is therefore premature to propose a new set of coverage criteria without a more thorough review of the available published evidence. I request that CMS conduct a more complete and up-to-date assessment of this vital imaging technology before the NCD is finalized.

The requirements CMS has established to obtain coverage for CCTA will have a severe negative impact on Medicare beneficiaries’ access to the service across the country given the uncertain approval process and timeline for futureclinical trial development. I believe CMS has not properly examined the full impact the NCD with CED will have on the Medicare beneficiary population.

The specialty societies have been working together for more than two years to define the appropriate indications for CCTA and I urge CMS to work with the relevant societies, specifically, the Society of Cardiovascular Computed Tomography (SCCT), to better develop criteria for the types of clinical research that is appropriate for CED to minimize the negative impact on quality patient care.

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

We represent Illinois Heart and Vascular which provides Cardiology services to the greater Chicago land area. We have 27 physicians, 92 employees and serve approximately 24,000 patients annually. Illinois Heart and Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart and Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart and Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart and Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart and Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart and Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart and Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing Illinois Heart and Vascular respectfully requests that CMS:

Failure to provide coverage for coronary CT arteriography (CCTA) is a disservice to patients and a potential failure of CMS to control spending on far more expensive and potentially risky diagnostic catheter angiography.

CCTA can save patient morbidity and mortality by replacing diagnostic catheter angiography with a non-invasive technique. The ability of CCTA to rule out significant coronary artery stenosis (high negative predictive value)is unequalled by any other nonivasive test. Recent imaging literature confims this and suggests CCTA is accurate when detecting coronary artery stenosis as well. Radiologists have replaced invasive diagnostic carotid, abdominal, and peripheral angiograms with less expensive and lower risk CTA and MRA, and CCTA can do the same for patients with atypical chest pain as well.

In low to moderate risk patients a negative CCTA precludes any further workup. Traditional stress testing relatively poor sensitivity and specificity compared to CCTA and cannot be similarly used to exclude coronary artery disease.

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CCTA can save patient morbidity and mortality by replacing cath with a non-invasive technique. The NPV of CCTA is unequalled by any other test. Recent 64 slice and better literature confims this and supports outstanding PPV as well. Radiologists have replaced invasive diagnostic carotid, abdominal, and peripheral angiograms with less expensive and risky CTA and MRA, and CCTA can do the same for cardiac cath. In low to moderate risk patients a negative CCTA precludes any further workup. Traditional stress testing has neither the NPV of CCTA and is fraught with false positive exams resulting in needless caths,

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CCTA is a diagnostic tool that aids in the determination of CAD. Patients that are at risk and who are having undiagnosed Chest Pain or other complications can be safely and conveniently scanned to determine if a more invasive and expensive procedure (cardiac catheterization) is necessary. The number of CCTA patients that do not need to have the more demanding procedure done are outweighing the cost to the government. Please do not deny such a wonderful test. We are a 49 bed hospital that has the been offering this exam to our patients for 4 months now. By removing reimbursement you are creating a burden on the people of underserved communities. Please reconsider.

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I guess I just don''t understand why you wouldn''t cover the cost of CTA''s. For the patients sake, all they need to endure is a needle placed into the arm, relax for an hour so the heartrate can be lowered to an appropriate rate and lay flat on their back for 25-30 minutes. after that they are free to go home. Where the alterantive is to stay the better portion of the day in the hospital after getting a long wire snaked thru their artery. Not only would it be better suited for the patient physically but financially if one cardiac CTA can give the information that would avoid the cost and time of a heart cath. Wouldn''t it be worth it? Again I may be all wrong in my thinking, but why put the patient thru the extra discomfort both physically and financially.

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I am appalled at the attempt to limit any patient''s access to Computed Tomographic Angiography! A vast number of patients, either due to ignorance, denial, fear or complicating health conditions, will never agree to undergo cardiac catheterization, which they perceive as "surgery". The ability to use a non-invasive medium to diagnose their heart disease is beyond important! The individuals making this decision should stop to consider how they''d feel if a member of their family or close friend died unnecessarily from undiagnosed heart disease before inflicting this restriction on other human beings.

Please continue to pay for testing that the citizens of the United States are incredibly fortunate to have!

Thank you

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Canceling all payments for CTA of the coronaries is not appropriate and would reflect poorly on CMS and other governmental institutions.

The CTA technology is in its infancy and multiple researchs studies are underway to try to understand what indications are best for this technology. Expert committee has already published their criteria for appropriate use of CTA but a small committee of non-experts does not appear to agree with their conclusions?

Improvement in the technology is expected but it is unlikely that it will ever replace invasive coronary angiography. A requirement from the CMS of such kind reflects poor understanding of clinical practice and importance of improving safety in patient care.

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As a radiologist and director of a large cardiac CTA program that has been active for more than five years, I cannot agree with the proposed coverage determination as outlined last month by CMS. In our experience, the ability for a select group of patients to undergo this noninvasive test has frequently obviated the need for further studies, particularly stress testing and cardiac catheterization.

More generally, in making the determination, it seems evident that certain considerations were overlooked. First, the proposed national coverage determination overlooks the fact that local carriers in every state and the District of Columbia have previously evaluated and determined that local coverage is appropriate for specific indications. While it is certainly the prerogative of CMS to supersede these decisions, I believe that to do so in such a draconian fashion is overstepping the mark. Second, the national coverage determination fails to consider all the evidence. Based on the supporting evidence in the NCD proposal, it appears that many if not most studies involving 64-slice CT, the current standard, were not considered. I would request that CMS consider these studies and the fact that improved CT technology of 256-slices and more has recently become commercially available.

I believe that if this proposal is implemented as presented, the overly restrictive limitations on access to coronary CTA would be highly detrimental to Medicare beneficiaries and have a crippling effect on further development of this technology.

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CTA is an exceptional diagnotic means to determine CAD. It is imparative that reimbursement for this procedure not be overturned. CTA is now a more acceptable diagnostic procedure that would eliminate other diagnostic procedures that are done presently. CTA can reduce CMS costs for other procedures that are now being order only because CTA is not fully reimbursed. CTA is the current state of the art diagnostic means of finding CAD early and doing so not only would save lives but would reduce CMS costs in the long term.

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Dear Sir/Madam;
As a physician who sees patients daily for cardiovascular testing, I see that cardiac CTA has demonstrated advantages beyond most of our current non-invasive exams. We can now characterize arterioslerotic plaque types within the arteries which helps us select medications. It defines anatomy/function of the entire heart beyond the coronary arteries also.It helps us to plan by-pass surgery and optimally place pacemaker leads into the myocardium. It simultaneously excludes other life threatening disoders such as pulmonary embolism, collapsed lungs, and lung cancers. Cardiac CTA -especially with the newer scanners -is so accurate, fast and inexpensive relative to the amount of information provided that I hope CMS does not restrict it''''s use.

Sincerely,
Steven Bujenovic, mD
Director, Nuclear Medicine
Our Lady of the Lake RMC
5000 Hennessy Blvd.
Baton Rouge, LA 70808

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Proposed National Coverage Determination for Coronary CT Angiography (CAG-00385N)

I am writing in response to the proposed national coverage determination (NCD) for coronary CT angiography (CCTA) recently publicized by Medicare.

Rapid advancements in CT technology have made non-invasive coronary artery imaging a reality. For the first time, physicians may directly and non-invasively assess patients for the presence and type of coronary artery disease (CAD). Prior to the development of CCTA, methods to assess patients for CAD either relied on perfusion, which detects CAD at a relatively late stage and cannot assess the type of CAD (calcified vs. vulnerable plaque), or required invasive methods which incur increased costs as well as patient morbidity and mortality. Furthermore, as our understanding of coronary artery disease has grown, it is now well understood that coronary artery angiography does not directly assess the vessel wall (the site of CAD), and negative coronary artery angiography results do not exclude the presence of CAD. Finally, none of these established methods for the assessment of CAD provide a simple, repeatable measure for response to treatment for CAD. The latter point is extremely important given the effectiveness of statin therapy.

The recently published NCD is flawed in a number of ways, and the proposal threatens to restrict access to CCTA and thereby deny patients and providers a valuable tool for the diagnosis of CAD and assessment of CAD therapy. A number of medical organizations, including the American College of Cardiology, American College of Radiology, North American Society for Cardiovascular Imaging, Society for Cardiovascular Computed Tomography, American Society of Nuclear Medicine, and the Society of Cardiovascular Angiography and Interventions, have drafted detailed responses to the proposed NCD. The comments that follow will be brief in comparison, but tis issue is critically important for the future of cardiovascular medicine, and therefore individual physician responses, in addition to the drafted statements issued by medical societies, are important for Medicare to acknowledge.

The proposed NCD by Medicare suffers from a number of drawbacks:

The data cited by Medicare primarily focuses on older technology, particularly 16-slice CT scanners. A number of papers have detailed the fact that newer technology, including 64-detector row scanners (and beyond) provide superior image quality and improve diagnostic efficacy compared to older scanners. It is very likely that rapid advancements in technology will continue to provide even further refinement in diagnostic quality and efficacy. Dual-source CT scanners, 320-row scanners, and high-definition scanners are currently being introduced into the market and preliminary data suggest that these technologies will further improve the quality and reliability of CCTA.The proposed strict NCD criteria for CCTA do not acknowledge the numerous indications for CCTA considered appropriate by experts in the field of cardiovascular medicine. Many such indications are currently reimbursed according to local coverage determination (LCD), and the proposed NCD will reverse LCDs and severely limit Medicare beneficiary access to CCTA technology. In fact, the current NCD proposes reimbursement for two situations only:

Symptomatic patients with chronic stable angina at intermediate risk for CADSymptomatic patients with unstable angina at low risk for short-term death and intermediate risk for CAD These two indications are situations when CCTA is probably not likely to be used. In fact, CCTA may even be considered a poor test choice for patients with unstable angina- such patients are often best evaluated with coronary artery angiography. The diagnosis of unstable angina implies that CAD is already known, and should be differentiated from patients with chest pain syndromes in whom CAD has not been diagnosed- these patients, particularly if at intermediate risk for CAD based on Framingham Risk Factor (FRS) assessment, are appropriate patients for CCTA testing. Additionally, using terminology such as “intermediate risk” is not appropriate for symptomatic patients. Risk categories are applied to asymptomatic patients suspected of, or at risk for, CAD, not for patients with chest pain syndromes characteristic of CAD. Symptomatic patients are evaluated into risk categories based on their likelihood of obstructive CAD at coronary artery angiography, not based on the mere presence or absence of CAD.

Other indications for which CCTA is clearly appropriate are not acknowledged by the proposed NDC, particularly assessment for suspected coronary anomalies (for which CCTA is the test of choice) and patients undergoing other non-invasive CAD evaluation with indeterminate test results (i.e., equivocal exercise treadmill testing, borderline abnormal nuclear perfusion stress tests, or equivocal results on stress echocardiography). This latter set of patients is often subjected to unnecessary coronary artery angiography, with resultant increased costs and potential morbidity and even mortality. This patient population comprises a substantial number of patients with negative coronary artery catheterizations, and CCTA could provide a lower cost and safer modality, with a high sensitivity and specificity, for the diagnosis of CAD. A number of other appropriate indications for CCTA have been enumerated by various societies and are also denied by the proposed NCD.

The proposed NCD does not acknowledge the ability of CCTA to actually reduce costs and patient morbidity by reducing the need coronary artery catheterization. Unnecessary coronary artery catheterization commonly occurs in patients with indeterminate non-invasive CAD testing (including asymptomatic patients at risk for CAD), and patients who undergo coronary artery catheterization but in whom the likelihood of a coronary artery intervention is low. Not only can CCTA potentially reduce healthcare costs in this setting, CCTA will also be associated with improved patient satisfaction and reduced patient morbidity.The proposed NCD does not acknowledge the ability of CCTA to provide information beyond mere vascular stenosis, such as plaque type, morphology, remodeling, and non-cardiac causes of chest pain or anginal-equivalents. I encourage CMS to re-evaluate the proposed NCD in light of the above information and revise its recommendations. The current NCD is flawed and restrictive, and reverses current LCDs in all 50 states and therefore risks denying Medicare beneficiary access to this important technology.

Regards,

Sunil K. Ram, MD

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We believe that the proposed NCD should be withdrawn or substancial modifications should be made to provide coverage for appropriate indications and populations. Data is rapidly accumulating for 64-slice CCTA and there are many additional studies that CMS has failed to recognize. It is premature to propose a new set of coverage criteria without more review of the available published evidence. The requirements CMS has established to obtain coverage for CCTA will have a severe negative impact on Medicare beneficiaries access to service across the country given the uncertain approval process and timeline for future clinical trial development. The specialty societies have been working together for more than two years to define the appropriate indications for CCTA and we urge CMS to work with the relevant societies to better develop criteria for the types of clinical research that is appropriate for CED to minimize the negative impact on quality patient care.

Bryan W McGwier, MD
G. Bruce Head III, MD
Lewis P Walker III, MD
Peter M Szeto, MD
Cindy R Hill

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To Whom It May Concern:
I am very disappointed in CMS for considering a NCD which would further limit patient access to noninvasive coronary imaging, specifically CCTA (Coronary Computed Tomography Angiography). It is premature to propose a set of coverage criteria without a more thorough review of the available published evidence. Data is rapidly accumulating for 64-slice CCTA and there are more complete studies in the peer-reviewed, published literature to cite. CMS has failed to include many of the critically important studies. Therefore, I request that CMS conduct a more complete and up-to-date assessment of this imaging technology before any NCD is implemented.
Noninvasive imaging is imperative in numerous noncoronary arterial beds before invasive imaging and treatment. Examples include: cerebral, carotid, aorta, visceral, iliac and lower extremity arteries. Now the proven technology has arrived to allow CCTA to limit the risks and cost of invasive coronary angiograms it should be welcomed, not limited to those with private medical coverage.
I would like to share the following experience: My Interventional Radiology Lab is next door the Coronary Catheterization Lab. I recall the flurry of activity as the cardiologist and his team attempted to resuscitate a patient who was undergoing a diagnostic coronary catheterization. She developed an arrhythmia which was fatal as soon as a catheter was placed in her right coronary artery. My colleague was forced to tell the eagerly waiting family that there was a complication and their mother was not expected to survive. The currently considered noninvasive testing, if used, may have prevented this scenario. Those of us treating patients should not be unnecessarily forced into these situations because of premature decisions based on incomplete review of the available literature.

Please do not implement a NCD without reviewing the following table of studies not previously considered which show the excellent negative predictive power and other data of CCTA in the evaluation of coronary artery disease.

Table 1 – 40 and 64 slice studies with angiographic correlation that were not referenced in the NCD. Invasive angiography used as the reference standard.
Author
(reference) Year Number Sensitivity (%) Specificity (%) Negative predictive power (%)
Raff (4) 2005 70 86 95 98
Meijboom (5) 2007 402 99 85 99
Leber (6) † 2007 90 95 90 98
Pundziute (7) 2007 103 97 91 98
Herzog (8) 2007 55 100 83 100
Meijboom (9) 2007 254 98 86 98
Cademartir (10) 2007 72 100 98 100
Scheffel (11) 2007 50 100 95 100
Leschka (12) 2005 67 94 97 99
Ghostine (13) 2006 66 95 97 97
Shabestari (14) 2007 143 94 94 97
Hausleiter (15) 2007 243 99 75 99
Muhlenbruch (16) 2007 51 98 50 75
Andreini (17)* 2007 200 99 96 100
Pugliese (18) 2006 35 99 96 99
Watkins (19)** 2007 85 86 97 97
Mollet (20) 2005 52 99 95 99
Busch (21) 2007 25 89 100 100
Johnson (22) † 2007 35 100 89 100
Weustink (23)† 2007 100 99 87 95
Leschka (24) † 2007 74 98 87 97
Brodoefel (25) 2007 102 91 99 98
Meijboom (26) 2007 104 100 75 100
Cademartiri (27) 2007 170 96 98 98
Pontone (28) 2007 120 86 91 100
Ropers (29) † 2007 100 96 86 89
* Found to be significantly safer than Invasive angiography (P<0.001)
** 40-slice system
† Dual Source CT

Indications CCTA should include the evaluation of chest pain (without a long list of qualifiers). Providing coverage for CCTA will decrease morbidity, mortality, and costs associated with the evaluation of coronary artery disease.

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I have recently learned that Medicare is considering reducing coverage for Cardiac CTA based on the information or lack of information currently available.

As information, Cardiac CTA is one of the biggest medical advances in years and has the ability to benefit millions of people around the world. Reducing coverage for Cardiac would be an incrediblly short sited medical atrocity. Whomever is responsible for this travisty clearly has not done their homework and is apparently mixing politics and medicine at the detriment of the entire population of the US.

Please reconsider this action as it will cost many individual not only their lives but will prevent many people from receiving timely care that will extend lives and reduce costs.

Cardiac CTA is an amazing technology that saves lives and reduces costs. How can you possibly think of reducing coverage when in reality you should be doing all you can to expand and facilitate this life saving technology

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The 2 acceptable categories for use of coronary CTA are inappropriate. Unstable angina should be evaluated by coronary angiography. We will never use CCTA for this due to the additional contrast and radiation needed for coronary angiography and potential stenting. Patients with stable angina would be best suited for nuclear stress testing, not CCTA, as nuclear imaging is better at risk stratification.

The specialty societies have been working together for more than two years to define the appropriate indications for CCTA and I urge CMS to work with the relevant societies, specifically, the Society of Cardiovascular Computed Tomography (SCCT), to better develop criteria for the types of clinical research that is appropriate for CED to minimize the negative impact on quality patient care.

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I disagree with your recent proposal for NCD. CCTA is a good and valid test, that effectively replaces the more expensive and invasive diagnostic coronary catherization. Studies are even showing the potential to replacement expensive nuclear medicine cardiac studies. Is your goal to have patients cared for in a fiscally responsible manner. Simply dropping payment denies a very valuable study to our patients. Why not deny payment for self referred patients to allow those who need it to get it and at the same time appropriately restrict utilization. Patients whose physicians felt that they would benefit from the exam would get it, but the physician''s judgement would not be tainted by personal gain. Further savings could be realized if payment for diagnostic coronary angiography within 6 months of CCTA were refused, thus causing CCTA to truly be used to replace coronary angiography. A savings of 3,5,6 thousand dollars per case.

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EIGHT specialty societies have outlined the appropriateness criteria for CCTA published in the July 2006 issue of the Journal of the American College of Cardiology.It is well known that published reports lag one to two years behind real time factual data.Therefore,it is intellectually dishonest in my view for CMS to propose its NCD at this time and without modifications.

The American Heart Association 2007 Heart Disease and Stroke Statistics Update in the Feb 2007 journal Circulation estimated the cost for coronary artery disease alone at 152 billion dollars.If we believe that early diagnosis and prevention stratagies work then perhaps we can preclude the high costs of catheter intervention and bypass surgery.

When will our society truely get serious about PREVENTION ?

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Reniging on the Medicare reimbursement of CCTA would greatly penalize a large portion of the US population by blocking their access to a less invasive means of diagnosis; of particular note is the impact on the elderly and those of frail health.

Recent data presented at the American Heart Association Sessions indicates that 64 slice CT scans are an effective modality to diagnose heart blockage. Almost 300 patients over the age of 40 participated in the trial. Data suggests that CT scans were able to accurately diagnose 91 percent of patients with blockage and 83 percent of patients who did not have blockage. In 90 percent of the cases, data gathered from CT scans was akin to that found with angioplasty. This level of detection allows clinicians to predict which patients will require future bypass or angioplasty. In fact, it can pinpoint those who do not require cardiac catheterization, which is significantly more invasive. National studies rate the level of negative heart caths in the 25% to 30% range.

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I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS’ final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare’s proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS’ proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS’ memo, the conclusions made by CMS are disparate from the authors’.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians’ ability to gather the very data needed to prove CCTA’s additional efficacy.

2. CMS should rely on its local carriers’ judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient’s CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA’s application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS’ two clinical diagnoses being proposed as the basis for reimbursement and study are “chronic stable angina at intermediate risk for CAD” and “unstable angina at low risk for death and with intermediate risk of CAD.” These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by “risk of CAD.” Rather, guidelines for “acute chest pain” use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

“Unstable angina” or more commonly now “possible Acute Coronary Syndrome” likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the “risk of CAD” in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

§ Allow local Medicare contractors to continue coverage of CCTA for the diagnosis of CAD under their existing LCDs to enable Medicare beneficiaries the benefits of this clinically proven, lower-cost and lower-risk technology.

§ Eliminate implementation of its proposed CED. CARDIOVASCULAR ASSOCIATES, SC recommends that CMS work with the specialty multidisciplinary societies (SCCT, ACC and ACR) to develop criteria for a CCTA registry to minimize the impact on the delivery of appropriate care to beneficiaries. There are several excellent CCTA registries already in existence that may be used as models for a CMS-approved registry to gather clinical data for longitudinal studies.

§ Adopt accreditation guidelines, physician credentialing requirements and clinical appropriateness protocols to promote appropriate utilization of CTA for the diagnosis of CAD. The medical specialty societies are at the forefront in the development of these important quality endeavors, and (CARDIOVASCULAR ASSOCIATES, SC) fully supports their efforts and encourages Medicare to work with them in developing similar guidelines.

(CARDIOVASCULAR ASSOCIATES, SC) appreciates this opportunity to comment on Medicare’s Proposed Decision Memo regarding Cardiac CTA. Please contact me at 847-981-3680 if you have any questions.

Sincerely,

Mohammed Khan, MD

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When I first heard about the CMS proposal, I honestly thought it was a joke. I just can''t believe that one of the most important imaging advancements in the last 20 years, one that radiologists have been striving for over years, is going to potentially be irresponsibly disregarded. CCTA is noninvasive, sees soft plaque that caths can''t see so that medical management can begin which will result in less heart disease and less money spent. CCTA at our practice has detected moderate and high grade stenoses which followed completely negative Nuclear Stress tests which are more expensive and often lead to caths anyway which are even more expensive. CCTA will save money in the evaluation of heart disease and will save lives, it already has at our practice. All 50 states have done their due diligence, come to the same conclusion and pay for this exciting new technology. Please think of the patients and the future of medicine before enacting unsubstantiated measures aimed only at saving money. This has already been done with the ridiculous Deficit Reduction Act. It is this very sort of illogical action passed by people who are not even knowledgable in the field of medicine that has led the brightest and best new students away from the medical field, in addition to more and more paperwork, less autonomy, less reimbursement and increased cost of business every year and out of control malpractice costs and lawsuits. Hell, can you blame them?

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Proposed National Coverage Determination for Coronary CT Angiography (CAG-00385N)

I am writing in response to the proposed national coverage determination (NCD) for coronary CT angiography (CCTA) recently publicized by Medicare.

Rapid advancements in CT technology have made non-invasive coronary artery imaging a reality. For the first time, physicians may directly and non-invasively assess patients for the presence and type of coronary artery disease (CAD). Prior to the development of CCTA, methods to assess patients for CAD either relied on perfusion, which detects CAD at a relatively late stage and cannot assess the type of CAD (calcified vs. vulnerable plaque), or required invasive methods which incur increased costs as well as patient morbidity and mortality. Furthermore, as our understanding of coronary artery disease has grown, it is now well understood that coronary artery angiography does not directly assess the vessel wall (the site of CAD), and negative coronary artery angiography results do not exclude the presence of CAD. Finally, none of these established methods for the assessment of CAD provide a simple, repeatable measure for response to treatment for CAD. The latter point is extremely important given the effectiveness of statin therapy.

The recently published NCD is flawed in a number of ways, and the proposal threatens to restrict access to CCTA and thereby deny patients and providers a valuable tool for the diagnosis of CAD and assessment of CAD therapy. A number of medical organizations, including the American College of Cardiology, American College of Radiology, North American Society for Cardiovascular Imaging, Society for Cardiovascular Computed Tomography, American Society of Nuclear Medicine, and the Society of Cardiovascular Angiography and Interventions, have drafted detailed responses to the proposed NCD. The comments that follow will be brief in comparison, but tis issue is critically important for the future of cardiovascular medicine, and therefore individual physician responses, in addition to the drafted statements issued by medical societies, are important for Medicare to acknowledge.

The proposed NCD by Medicare suffers from a number of drawbacks:

1. The data cited by Medicare primarily focuses on older technology, particularly 16-slice CT scanners. A number of papers have detailed the fact that newer technology, including 64-detector row scanners (and beyond) provide superior image quality and improve diagnostic efficacy compared to older scanners. It is very likely that rapid advancements in technology will continue to provide even further refinement in diagnostic quality and efficacy. Dual-source CT scanners, 320-row scanners, and high-definition scanners are currently being introduced into the market and preliminary data suggest that these technologies will further improve the quality and reliability of CCTA.

2. The proposed strict NCD criteria for CCTA do not acknowledge the numerous indications for CCTA considered appropriate by experts in the field of cardiovascular medicine. Many such indications are currently reimbursed according to local coverage determination (LCD), and the proposed NCD will reverse LCDs and severely limit Medicare beneficiary access to CCTA technology. In fact, the current NCD proposes reimbursement for two situations only:
a. Symptomatic patients with chronic stable angina at intermediate risk for CAD
b. Symptomatic patients with unstable angina at low risk for short-term death and intermediate risk for CAD These two indications are situations when CCTA is probably not likely to be used. In fact, CCTA may even be considered a poor test choice for patients with unstable angina- such patients are often best evaluated with coronary artery angiography. The diagnosis of unstable angina implies that CAD is already known, and should be differentiated from patients with chest pain syndromes in whom CAD has not been diagnosed- these patients, particularly if at intermediate risk for CAD based on Framingham Risk Factor (FRS) assessment, are appropriate patients for CCTA testing. Additionally, using terminology such as “intermediate risk” is not appropriate for symptomatic patients. Risk categories are applied to asymptomatic patients suspected of, or at risk for, CAD, not for patients with chest pain syndromes characteristic of CAD. Symptomatic patients are evaluated into risk categories based on their likelihood of obstructive CAD at coronary artery angiography, not based on the mere presence or absence of CAD.

Other indications for which CCTA is clearly appropriate are not acknowledged by the proposed NDC, particularly assessment for suspected coronary anomalies (for which CCTA is the test of choice) and patients undergoing other non-invasive CAD evaluation with indeterminate test results (i.e., equivocal exercise treadmill testing, borderline abnormal nuclear perfusion stress tests, or equivocal results on stress echocardiography). This latter set of patients is often subjected to unnecessary coronary artery angiography, with resultant increased costs and potential morbidity and even mortality. This patient population comprises a substantial number of patients with negative coronary artery catheterizations, and CCTA could provide a lower cost and safer modality, with a high sensitivity and specificity, for the diagnosis of CAD. A number of other appropriate indications for CCTA have been enumerated by various societies and are also denied by the proposed NCD.

3. The proposed NCD does not acknowledge the ability of CCTA to actually reduce costs and patient morbidity by reducing the need coronary artery catheterization. Unnecessary coronary artery catheterization commonly occurs in patients with indeterminate non-invasive CAD testing (including asymptomatic patients at risk for CAD), and patients who undergo coronary artery catheterization but in whom the likelihood of a coronary artery intervention is low. Not only can CCTA potentially reduce healthcare costs in this setting, CCTA will also be associated with improved patient satisfaction and reduced patient morbidity.

4. The proposed NCD does not acknowledge the ability of CCTA to provide information beyond mere vascular stenosis, such as plaque type, morphology, remodeling, and non-cardiac causes of chest pain or anginal-equivalents.

I encourage CMS to re-evaluate the proposed NCD in light of the above information and revise its recommendations. The current NCD is flawed and restrictive, and reverses current LCDs in all 50 states and therefore risks denying Medicare beneficiary access to this important technology.

Regards,

Michael B. Gotway, MD

Michael B. Gotway, MD
Scottsdale Medical Imaging, an Affiliate of Southwest Diagnostic Imaging, Ltd
Clinical Associate Professor, Department of Radiology, and Pulmonary / Critical Care Medicine
University of California, San Francisco
3501 North Scottsdale Ave, Suite 130 Box 1573
Scottsdale, AZ 85251
Office: (480) 425-5000
Cell: (480) 321-6394
Fax: (480) 425-5010
mgotway@esmil.net

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In regards to CCTA: I found it useful in selected population. This SINGLE test allowed to diagnose extensive CAD of moderate severity in a patient with dyslipidemia as single risk factor, atypical CP and reluctancy to primary prevention. He then agreed for primary prevention which was aggressively pursued leading to an excellent outcome. Other patient with CAD s/p prior CABG and s/p recent PV isolation due to severely symptomatic PAF presented with exertional RSCP and severe dyspnea; once again, this single study allowed evaluate pericardial effusion, pericarditis, PV stenosis, dissection and progression of CAD and treat the cause after a single intervention.In many cases, I am able NOT only to tell the patient whether the CP is due or nor due to ''cardiac reasons'' but more importantly identify other easily treatable causes of CP with resolution of symptoms [GERD/HH, contact pericarditis, pulmonary embolism, etc] without further OV and tests. Recently, a patient with advanced COPD and newly diagnosed dilated cardiomyopathy was admitted with pneumonia and then suffered VF arrest; after some improvement in his condition, he remained on ventilatory support. The local hospital did not have a cath lab; during a follow CT scan requested for presumed infected bronchiectasis, CCTA protocol [simple addition of cardiac gating] allowed to study his coronaries which did not demonstrated significant CAD. It saved time, money and transport to another facility for further testing while answered many questions that facilitated local management.Although we recently started scanning [after a prolongued preparation, training and protocol development] in selected population, it is of great help. This are just cases that I recolect made a major difference in treatment without additional testing.

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For many patients, the decision not to cover coronary CTA will turn out to be quite literally "dead wrong." The use of coronary CTA is one piece of a sweeping change of the scientific understanding of coronary disease. The scientific literature contributed by established leaders in the field of cardiology including Erling Falk, Peter Libby, Stephen Nissen, WJ Roberts has made the new science of cardiovascular disease irrefutable. Only 14% of heart attacks occur at the site of a stenosis of 70% or greater. 70% of heart attacks occur where the stenosis is 50% or less. Since the 50% stenosis causes no symptoms and does not cause a positive stress test, 70% of heart attacks come as the first symptom and half of them are fatal. Furthermore, even in the case of symptomatic patients in the COURAGE trial, most of whom had 2 and three vessel disease, optimal medical therapy was just as effective as optimal medical therapy plus appropriate stenting in preventing heart attack, sudden death and admission for unstable angina-all for a third of the cost. 70% of the medically treated patients had complete relief of their pain-most in the first year.

The case in women is even worse. The WISE study showed that women with recurrent chest pain with totally normal cardiac cath studies still have a 20% six year risk of dying, having a heart attack or stroke, or developing congestive heart failure. These women are treated as if they have no artery problem and one year after the cath only about 10% of them were on anything for their blood pressure or cholesterol. Only a small minority were on optimal medical therapy-the only intervention that would help them. I have seen a number of women like this in the last few months. They have had normal stress tests but these women with recurrent chest pain virtually all have high-risk calcium scores and/or non-obstructive soft plaque. Even better, they have been relieved of their pain by aggressive risk factor modification as in the COURAGE trial. The women with chest pain are not well served by the current system of stress tests and caths, they tend to form plaque that is symmetrical and concentric.with less focal obstruction. The best single image to direct their care is coronary CTA with a calcium score.

Virtually all heart attacks are clotting events and are the result of plaque rupture or erosion. Coronary CTA is so valuable because it is non-invasive and it gives us an indication of the presence of soft, non-obstructive plaque and calcium in the coronary arteries. Calcium in the coronary arteries is the result of healed plaque rupture. The coronary calcium score reflects that patient''s history of healed plaque rupture.

The Institute of Medicine says that our system is not designed to care for chronic conditions and no where is this more true than in coronary disease. In some states in our region, fully half of the population dies of cardiovascular conditions-many of them needlessly at at too young an age with the CV event being their first symptom. We desperately need to identify the patient that ruptures plaque with an increased frequency. That technology is very necessary to identify those patients who need the most aggressive medical treatment. When patients understand that heart attack occurs as a result of plaque rupture, and they know that they have plaque that ruptures at an increased rate, they are more adherent to their medical and lifestyle regimen. The best care of the patient requires access to technology that tells us that patient is one with increased plaque and rates of plaque rupture. That is what coronary CT angiography with calcium scoring tells us. There are limited funds available to care for patients. We know that cath, stents and bypass add nothing to the care of stable patients except pain relief and even pain relief can be achieved medically in the majority of patients. We should stop paying for caths and stents in stable patients and use that money for care that is more in keeping with the new science of vascular disease.

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The proposed NCD should be withdrawn. If it is not withdrawn, substantial modifications should be made to providecoverage for appropriate indications and populations.

Myocardial Infarction remains the #1 cause of death in this country. The population is aging and heart disease will continue killing Americans unless an effective non-invasive test can accurately evaluate patients at risk prior to MI. That tool has arrived- coronary CT imaging with 64-slice helical imaging. This tool will also be able to improve critical bed shortages in hospitals around the country by eliminating CAD as the etiology of chest pain in patients presenting to the ER. Please consider reversing your current decision on reimbursement policy for this absolutely critical test.

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The proposed NCD is totally unreasonable. During one year of use, many of my patients have avoided invasive cardiac catheterization because of CTA.There are many situations where CTA gives information otherwise unobtainable eg. Congenital Coronary anomalies and there course, Post CABG patients, intracardiac masses and thrombi, and patients going for EP procedures. I have found aortic dissections and lung cancers that would have been missed if patients had stress tests or cardiac catherization.CTA is a very helpful procedure in properly selected patients. Please stop this unjustified NCD.

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I am writing in regards to the limitations that are being proposed on cardiac CTA.

In the last decade, there have been significant advances in noninvasive vascular imaging using CTA and MRA. These advances have greatly enhanced patient care, allowing noninvasive diagnosis of vascular disease with significant reduction in complications related to diagnostic angiography.

Recent advances in CT technology have also made possible accurate noninvasive imaging of the coronary arteries. Multiple studies over the last several years have shown that cardiac CTA is essentially equal to invasive coronary angiography in excluding coronary artery disease, with a negative predictive value of 99%.

Noninvasive diagnosis of CAD would be a huge benefit to patients, likely even greater than that of noninvasive vascular imaging in other areas of the body. There would be a significant decrease in overall costs, due to the significant reduction in unnecessary coronary angiograms and hospitalizations for complications associated with the procedure.

Denying or strictly limiting payment for cardiac CTA is absurd. The accuracy and benefits of the test are clear. The elimination of physician self-referral for imaging studies would be much more effective way to reduce health care costs.

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Thank you for the opportunity to add my personal comments to those of others in cardiology regarding the upcoming decision on covered diagnoses for Coronary CTA. I am confident you are attempting to make recommendations which take into account available data, risks, and the national purse and public good. This is undoubtedly difficult, and I appreciate your efforts.

My position is as a general cardiologist working with a large multispecialty group which will not own the MSCT equipment available to me, but which would provide significant economic potential only to the hospital in which I practice. The minimal reimbursement allowed for interpretation in our area would require years to even repay my education costs to learn proper utilization of this technology, but I felt these expenses would be worthwhile in the care of my patients. Studies from groups in Nashville and elsewhere have demonstrated that use of the technique in truly intermediate risk groups (as defined by symptoms and other clinical criteria) results in high value actionable data and small, if any, net income to the physicians involved. It seems to me that management of concern about overutilization can best be dealt with by clear delineation of the criteria which must be met for reimbursement to occur. Unfortunately, the two groups included by CMS for initial coverage would not likely be studied in laboratories following guidelines already made stringent voluntarily by the ACC and AHA. Patients with "chronic stable angina" should not have angiography by any technique, whether CT or invasive without clear symptom change. Symptomatic patients with unstable angina are, based on abundant data, not at "low risk of short-term death" but are at high risk and require invasive angiography with the expectation of intervention. I believe the information from clinical studies using the proposed allowable coverage diagnoses will not further support or deny the results of excellent data amassed by reputable laboratories which led to the ACC/AHA recommendations.

Radiation risk is real, but will rapidly decrease as computer engineering techniques improve the procedure protocols limiting exposure.

Extensive experience in laboratories such as that of Dr. Matthew Budoff at Harbor-UCLA in Torrance, California indicates the risk to renal function from use of radiographic contrast in these studies can be miniscule by use of already available guidelines.

Concerns about accuracy and benefit of new technology will always be difficult and I appreciate the effort made by CMS personnel to do this well. I''m very concerned, however, that the proposed limitations deal with questions already answered. Surely, a better use of resources would involve collaborative efforts of recognized experts among both providers and public overseers to avoid stifling implementation of a technique with great potential for the public good.

Thank you again for the opportunity to express my concerns.

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Dear Sirs, I have authored the DVD set "Practical Interpretation of Computed Coronary Tomography on the Workstation" and have had a great deal of experience in cardiac ct. I have performed more than 14,000 cardiac catheterizations in my career. I am very impressed with the power of coronary CT which has been so robust in defining the present, absence and extent of coronary artery disease that I have given up cardiac catheterization as a procedure to use this cost saving and less risky technology instead. The new regulations would severely limit this application.

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The proposed NCD will limit access to CCTA, which is a very useful, non-invasive, safe method of coronary interrogation, in favor of more costly, more invasive, and more risky invasive coronary artery catheterization. CCTA is fast and effective in excluding significant coronary artery stenosis in elderly patients suffering chest pain or other symptoms of coronary artery disease, with a negative predictive value of 99%. Using CCTA leads to a significant decrease in the number of coronary artery catheterizations that show no abnormality and the normal or equivocal nuclear cardiology (e.g. cardiolite) exams.

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My Imaging Center has been performing CTA exam of the neck, head, abdomen and lower extremities for over three years. We have performed well over 500 exams. Over the past year we have also performed CCTA on over 100 patients. We have correlation with angiogaphy or surgery in a large number of cases.

The correlation is greater than 95% and on several cases the CTA study was more accurate because of the ability to look at a lesion or stenosis in an infinite number of projections. Our experience in non coronary CTA is being reproduced with CCTA. The ability to characterize plaque adds significantly to the information the surgeon or interventional physician needs to obtain the best outcome for our patients.

The meticulous approach we use throughout each case including the radiologist protocoling and performing the 3D reconstructions ourselves has allowed us to achieve these results. CTA of the carotids, brain, abdomen and lower extremities have significantly reduced the number of diagnostic angiograms being performed. This also contributes to the decrease in angiographic complications.

If CCTA is allowed to mature as CTA has, there will be the same results. I urge you to expand the indications for the procedure and reimburse qualified physician for the procedure.

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CTA of the coronary arteries is a huge advance for the public. Rather than getting an arterial puncture for a catheter case requiring paperwork admissions through same day surgery and waiting for several hours post procedure or having a device in the groin, the test can be done through an IV as an outpatient. The doctor can see the vessels. Measure the ones that need to be stented so they can have stent stock on hand before the patient gets there, have a rough idea how many vessels need to be stented through a catheter or wheter the patient needs surgery. It''s cheaper, less morbidity and mortality than a diagnositic angiogram. It''s safer and cost effective. Why wouldn''t you want this? In the brain we do CTA all the time over diagnostic angiography, it''s cheaper with less morbidity for patients. Patients love it. Doctors love it. The surgeons have accepted CTA over carotid angiograms. Why wouldn''t heart patients want the same benefit? Why are we going backwards rather than forward? What is the cost to society of early death for a breadwinner whose dependent family will be impoverished because a fatal heart attack could have been prevented by a CTA leading to an intervention, stent or surgery, which could have extended the life and productivity of a functional taxpayer supporting his family, making earnings, growing the economy and paying taxes. We''re not yet England or Canada where you write off health care at 55. Would you write off a presidential hopeful McCain because he''s over age? My dad had coronary bypass surgery in his early 60''s. He''s lived about 15 more years, bought and sold houmes, invested in the stock market, helped raise his grandchildren, and I bet for every dollar spent on his health, over triple has been pumped back into the economy by him alone. Let''s keep this country great! let''s pay for healthcare for our US citizens who in turn contribute to the economy and growth of this nation. Our people are our nation. American business used to pay to educate it''s workforce. Now they don''t care, they just want to import foreign workers and dumb down america. American businees used to pay for health care. Medical advances requires money. The US drove advances in health care the world over and our people benefited. We''ve given our markets to the chinese putting americans out of work. Our economic leaders would rather import foreign labor or send jobs abroad to worker they don''t have to pay benefits for. Americans don''t have jobs, don''t have money to buy goods. And now we don''t want to pay for healthcare. Why not just give the communists the keys to this country and let them drive it into the ground. Why not spit on everything the founding fathers stood for who wrested our future greatness from under the tyrany of England, millions of American boys who gave their lives for our freedoms so we could have a free, productive, educated and healthy society able to lead the free world. Health care is not free. It costs money. But Americans are worth it. The alternative is disease, death, loss, contraction. Is that what American government stands for now, disease, death, loss?

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As a group of 17 cardiologist who practice in the state (MS) with the highest mortality rate from cardiovascular disease in the nation, and who also serve a large Medicare population, we are distressed to see CMS decision not to cover cardiac cta. Cardiac cta (with a 64 slice scanner)has been an integral part of our practice since February, 2006. We have enjoyed a collegial working relationship with our local Medicare medical directorship and worked closely with them in 2006 to develop and implement a reasonable program for coverage of cardiac cta. 99+% of our cardiac ctas are performed on patients that have had a full cardiac consultation by a member of our group prior to undergoing the study. We have found that rather than adding another layer of cardiac testing, cardiac cta more often results in "one and done" testing. We have also found that we have been able to reduce the number of normal cardiac catheterizations, especially in patients with equivocal or mildly abnormal nuclear perfusion studies.

Appropriate use of cardiac cta is vital to the care of our patients. Guidelines for the appropriateness of cardiac cta have been published, as have credentialling criteria for physicians and cardiac cta lab accreditation guidelines.It would seem reasonable for CMS to utilize this information as a framework for providing coverage for cardiac cta. We would strongly urge CMS to carefully review the available data, as well as the comments already given by respected physicians and societies and reverse the NCD for cardiac cta.

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Steve E. Phurrough, MD, MPA
Director, Coverage and Analysis Group, CMS
Re: CTA
Mailstop C1-09-06
7500 Security Blvd.
Baltimore, MD 21244-1850

Dear Dr. Phurrough:

With interest we read your Proposed Decision Memo for Computed Tomographic Angiography (CAG- 00385N). As physicians at a major academic center, we share many of your concerns about the potential unjustified and even harmful use of medical interventions to the public. The recent review by Brenner in the NEJM correctly outlined the hazard for thousands of children and young adults as the result of unjustified prescription of imaging tools such as computed tomography. We strongly agree that before a new imaging tool can be endorsed, a benefit for the individual and public health should be evident.

In the case of computed tomographic angiography (CTA) for the detection of coronary artery disease (CAD), our institution has been on the forefront of investigation. We presented the results of the CORE-64 trial, for which we served as core lab and coordinating center, at the Annual Scientific Sessions of the American Heart Association two months ago. This trial for showed for the first time using a multi-center study design, that high accuracy for the detection of obstructive CAD in patients can be achieved with 64-slice CT in an intermediate- high risk population. Importantly, our trial showed the ability to predict the need for revascularization in patients was essentially identical for invasive angiography and CTA.

In support of our findings, results from the ACCURACY trial were presented a few weeks ago at the RSNA meeting. This second multi-center study using 64 slice technology confirmed high accuracy for CTA to detect obstructive CAD in a low-intermediate risk population. Therefore, we believe that the first question posed by CMS:” Does cardiac CTA have the ability to diagnose or exclude CAD as well as invasive coronary angiography?” is sufficiently addressed by the available evidence from single and multi-center studies to warrant the use for CTA in the appropriate clinical context. In fact, there may now be ethical issues involved in repeating these two studies, which required that all patients undergo both catheterization and CTA.

The second question posed by CMS:” Does coronary CTA reduce the need for invasive coronary angiography?”, is to some extent addressed by the accuracy of CTA to detect CAD. An imaging tool with high sensitivity and specificity for the detection of obstructive CAD in patients in whom invasive coronary angiography is considered but for whom the pretest probability is not high, consequently must lower the need for invasive angiography. The results from the numerous single-center studies and the results from the mentioned multi-center studies provide substantial evidence for the accuracy of CTA to detect CAD in comparison with invasive angiography. Evidence that invasive angiography can safely be omitted by the use of CTA even in unselected patients referred for invasive coronary angiography has been published (Gilard et al, Arch Int Med 2007). Furthermore, evidence is accumulating that prediction of all-cause mortality using CAD indexes derived from CTA is comparable to those derived by invasive angiography (Min et al, JACC 2007).

Based on the evidence available, we are very concerned that restriction of CTA for the clinical use in selected patients will result in harm to patients in whom CTA can safely rule out the presence of obstructive CAD and who will otherwise be subjected to invasive coronary angiography. The risks associated with invasive angiography include vascular injury, stroke, MI, and death, and are documented to be 0.2 – 0.7 %. We all have seen patients who suffered a coronary dissection during a diagnostic invasive angiogram resulting in emergency CABG or death. Even considering higher radiation exposure to the patient (which is no longer valid for new generation scanners as outlined below), the benefit-risk ratio is favorable for CTA when compared to invasive angiography (Zanzonico et al, JACC 2006).

Radiation exposure is a valid concern and should be taken very seriously. It is particularly concerning that every year approximately 7 million nuclear scans are being obtained in the US, which are associated with radiation exposure far exceeding that of CTA in many instances (Einstein et al Circulation 2007) and for which alternative imaging tools such as echocardiography or MRI are widely available. In contrast, CTA is currently the only non-invasive imaging tool which can reliably image the coronary arteries. Thus, the benefit in omitting an invasive procedure with the associated risks must be weighed against the risks associated with radiation exposure. Fortunately, the risks from radiation exposure resulting from 64-slice CTA are less concerning in the population typically encountered for the detection of CAD: male, age greater than 50 years (Einstein et al, JAMA 2007). On the other hand, younger female patients should not be scanned with 64-slice CT unless a pertinent indication exists or unless radiation dose can be substantially lowered.

The ongoing rapid evolution of CTA technology allows the use of prospective gating with many scanners now, reducing the radiation exposure to the patient dramatically. Published experience with prospective gating using commercially available scanners suggests CTA imaging with radiation exposure of 1-3 mSv is feasible (Husmann et al, Eur Heart J, 2007). Our experience here at Johns Hopkins with prospective gating has been similar. We have been able to obtain high quality coronary angiograms with estimated total body radiation exposure between 3-4 mSv, which is less than the currently estimated average annual dose for an American adult, less than the exposure derived from an invasive angiogram, and far less than that of a nuclear imaging test. We are able to omit invasive coronary angiograms in many patients in whom cardiac catheterization is considered but in whom suspicion for obstructive CAD is not high. It is well documented, that at least 20-30% of the more than one million diagnostic cardiac catheterizations performed annually in the US reveal no obstructive coronary artery disease (Johnson LW et al, Cath Cardiovasc Diag 1993). Accordingly, hundreds of patients die and thousands suffer complications from cardiac catheterization every year in the US, in whom the knowledge of the absence of obstructive CAD would have saved them harm.

There can be no doubt, that ruling out CAD in selected patients using a CTA protocol as described, results in reduction of stroke, MI, and death by avoiding the associated risks from cardiac catheterization. There can be no doubt, that by restricting the use of CTA for such clinical indication, patients will suffer complications and will be harmed or die during invasive procedures which could have been avoided. Thus, we are very concerned that further validation of this indication will result in unnecessary harm to many patients.

Dr. Phurrhough, we cordially invite you to visit of our CT laboratory here in your neighborhood. We would be pleased to show you our operation and the invaluable use of CTA in daily clinical practice. We hope to convince you that the appropriate use of current CT technology results in benefit to our patients and the reduction of risk. While we agree with you that more research is needed to document various other promising aspects of CTA, such as estimation of plaque burden, tissue characterization etc., we believe the evidence is sufficient to endorse the use of CTA for the assessment of CAD in patients with low-intermediate Framingham risk, in whom cardiac catheterization can be omitted with a normal CTA. We do believe that adequate expertise with CTA is required to read studies with the accuracy reported in clinical studies. We too share your concern of widespread use of CTA in the community by operators without adequate training. As opposed to restricting reimbursement to research subjects, which undoubtedly would exclude many patients who will benefit from CTA, we propose to restrict the reimbursement for CTA to centers/readers with level III (academic CT laboratory, Budoff et al, Circulation 2005) qualification until more data about quality assurance can be obtained.

We look forward to seeing you here Johns Hopkins Hospital soon to continue our discussion.

Sincerely,

Joao A. C. Lima MD
Professor of Medicine
Johns Hopkins University

Armin Arbab-Zadeh MD
Assistant Professor of Medicine
Johns Hopkins University

David Bush MD
Associate Professor of Medicine
Johns Hopkins University

Jeffrey Brinker MD
Professor of Medicine
Johns Hopkins University

Richard George MD
Assistant Professor of Medicine
Johns Hopkins University

Albert C. Lardo PhD
Assistant Professor of Medicine
Johns Hopkins University

Mahadevappa Mahesh PhD
Assistant Professor of Medicine
Johns Hopkins University

Julie M. Miller MD
Assistant Professor of Medicine
Johns Hopkins University

Edward P. Shapiro
Professor of Medicine
Johns Hopkins University

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Cardiovascular Management of Illinois which provides Cardiology services to the greater Chicagoland area. We have 29 physicians and serve approximately 26,000 patients annually. Illinois Heart & Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart & Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart & Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart & Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart & Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart & Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart & Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Illinois Heart & Vascular respectfully requests that CMS:

The proposed NCD for cardiac CT angiography is too restrictive and would negatively impact the care of many patients with atypical angina and indeterminate stress test results. These patients would be forced to undergo higher risk invasive testing instead of a simple CT angiogram. Any one of us would prefer to have a safer noninvasive test if that option is available. I also feel that there is a definite role for the use of combined cardiac, pulmonary and vascular (aortic) CT angiography in the Emergency Department for evaluation of acute chest pain.

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While it makes sense for CMS to scrutinize what it pays for, it does not make sense to withold reimbursement for coronary CTA which is one of the greatest breakthroughs in imaging in the last 20 years. The issue of overutilization should really be applied to stress testing which is most often done in asymptomatic individuals. Many cardiologists do stress testing as often as once per year. There is no scientific evidence that this testing decreases cardiac events or prevents deaths. Coronary CTA has a negative predictive value for coronary artery disease approaching 99% while stress testing is only about 75%. Before doing anything, CMS should really analyze why so much money is being spent and where the cuts really need to be made. There is no doubt that if performed well coronary CTA can obviate many cardiac catheterizations triggered by false positive stress tests.

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(electronic submission)

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment).
CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)
I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above. CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS’ final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare’s proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS’ proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS’ memo, the conclusions made by CMS are disparate from the authors’.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians’ ability to gather the very data needed to prove CCTA’s additional efficacy.

2. CMS should rely on its local carriers’ judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient’s CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA’s application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS’ two clinical diagnoses being proposed as the basis for reimbursement and study are “chronic stable angina at intermediate risk for CAD” and “unstable angina at low risk for death and with intermediate risk of CAD.” These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by “risk of CAD.” Rather, guidelines for “acute chest pain” use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

“Unstable angina” or more commonly now “possible Acute Coronary Syndrome” likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the “risk of CAD” in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

§ Allow local Medicare contractors to continue coverage of CCTA for the diagnosis of CAD under their existing LCDs to enable Medicare beneficiaries the benefits of this clinically proven, lower-cost and lower-risk technology.

§ Eliminate implementation of its proposed CED. CARDIOVASCULAR ASSOCIATES, SC recommends that CMS work with the specialty multidisciplinary societies (SCCT, ACC and ACR) to develop criteria for a CCTA registry to minimize the impact on the delivery of appropriate care to beneficiaries. There are several excellent CCTA registries already in existence that may be used as models for a CMS-approved registry to gather clinical data for longitudinal studies.

§ Adopt accreditation guidelines, physician credentialing requirements and clinical appropriateness protocols to promote appropriate utilization of CTA for the diagnosis of CAD. The medical specialty societies are at the forefront in the development of these important quality endeavors, and (CARDIOVASCULAR ASSOCIATES, SC) fully supports their efforts and encourages Medicare to work with them in developing similar guidelines.

(CARDIOVASCULAR ASSOCIATES, SC) appreciates this opportunity to comment on Medicare’s Proposed Decision Memo regarding Cardiac CTA. Please contact me at 847-981-3680 if you have any questions. Sincerely,

Nephtali Kogan MD, FACC.

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The decision by CMS is extremely unfortunate and does not accurately reflect an accurate scientific assessment of the state of this technology. The data used to generate this decision was not complete and did not reflect extremely relevant peer reviewed published studies demonstrating the accuracy of Cardiac CTA in comparison to cardiac catheterization as well as the cost efficacy when used appropriately under proper guidelines.

Moreover, to require that an imaging study show outcomes data is breathtaking in its ramifications for the development of any imaging technology in the U.S. in the future if this is going to be the standard.

The rigid standards put forward will essentially deny access to Medicare patients of a technology that is safer than invasive catheterization but also cheaper by far which is ironic given the current concerns for cost.

I would strongly recommend that more fair guidelines for CTA use be developed in conjuction with returning the control of coverage decisions to local carriers until CMS has had an opportunity to more thoroughly review ALL of the relevant data and make a more informed and rational decision than this one made in haste.

Thank you for your consideration.

Less

The medicare proposal is groundless and has little evidence to support its claims. It also ignores enormous work of the American College of Cardiology and other professional society''s tremendous efforts to comb through the literature to come up the the appropriateness criteria for CTA.

CTA of the coronaries have multiple uses, and I have found that some of my patients truly can avoid the invasiveness of a diagnostic catheterization. Until you are you family experiences a complication from such a procedure, you cannot fanthom how important having a reliable noninvasive test such as this in assessing the number one cause of death in the US.

Needless to say, the tremendous excitement and efforts being poured into CTA coronary research will be completely diffused- and what a shame as CTA is the truly first noninvasive procedure to define coronary anatomy reliably.

I encourage the committee to postpone its recommendations and reassess the enormous amount of data that support CTA use and to set up studies or sponsor studies to get data that the committee thinks is not yet out there instead of blindly halting one of the most exciting and important break throughs in cardiovascular care.

Sincerely,

Howard Dinh, MD

Less

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

We represent Illinois Heart and Vascular which provides Cardiology services to the greater Chicago land area. We have 27 physicians, 92 employees and serve approximately 24,000 patients annually. Illinois Heart and Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart and Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart and Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart and Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart and Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart and Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart and Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing Illinois Heart and Vascular respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

We represent Illinois Heart and Vascular which provides Cardiology services to the greater Chicago land area. We have 27 physicians, 92 employees and serve approximately 24,000 patients annually. Illinois Heart and Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart and Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart and Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart and Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart and Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart and Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart and Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing Illinois Heart and Vascular respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

We represent Illinois Heart and Vascular which provides Cardiology services to the greater Chicago land area. We have 27 physicians, 92 employees and serve approximately 24,000 patients annually. Illinois Heart and Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart and Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart and Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart and Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart and Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart and Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart and Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing Illinois Heart and Vascular respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I am a physician partner representing CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent Cardiovascular Management of Illinois which provides Cardiology services to the greater Chicagoland area. We have 19 physicians and serve approximately 16,000 patients annually. Cardiovascular Associates appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Cardiovascular Associates believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Cardiovascular Associates strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Cardiovascular Associates defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Cardiovascular Associates appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Cardiovascular Associates is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Cardiovascular Associates, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, Cardiovascular Associates respectfully requests that CMS:

Re: Medicare Program; Proposed National Coverage Determination (NCD) Memo for Cardiac Computed Tomography Angiography (CCTA), CAG-00385N

I am writing to express my concerns regarding the inpatient payment proposed rule and its recommendations to deny or reduce coverage for Cardiac Computed Tomography Angiography (CCTA).

After reviewing the proposed changes, I respectfully ask that CMS consider:

1) CCTA has substantial clinical utility in ruling out coronary disease in both acute care and non-acute care settings.

(2) The proposed NCD does not fully reflect the current state of evidence in support of CCTA in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD.

(3) Denying coverage for CCTA for the diagnosis of CAD will limit Medicare patients’ access to this valuable technology, resulting in the performance of more costly and invasive diagnostic tests.

(4) It is entirely inappropriate for CMS to demand evidence that proves that "coronary CTA improves health outcomes for patients with acute chest pain who present in the emergency room or other setting." Health outcomes depend on numerous factors, including, for example, the efficacy of treatment, patient compliance with medication protocols, the severity of disease, and other factors. For this reason, it is entirely inappropriate to demand that a diagnostic technology, such as CCTA, demonstrate an impact on health outcomes in order to be covered.

(5) In light of the difficulties involved in structuring randomized clinical trials to address the specific clinical issues identified in the proposed NCD, CMS should consider a registry approach instead of, or in addition to, the clinical trial approach.

(6) Rather than cutting off coverage precipitously, CMS should consider allowing local carrier decisions to remain in place, at least pending enrollment of the first clinical trial or establishment of an approved registry.

I respectfully request that CMS delay implementing the Proposed National Coverage Determination (NCD) Memo for Cardiac Computed Tomography Angiography (CCTA), CAG-00385N, and reconsider allowing local carrier determinations of coverage until the above are considered and incorporated into coverage determination recommendations.

Thank you for your consideration.

Sincerely,
Jeffrey N. Reed, RN
Clinical Manager
Cardiology and Neurovascular Services
Exempla Lutheran Medical Center
Jeffrey Reed, RN - Clinical Manager - Invasive Cardiology & Neurovascular
Exempla - Lutheran Medical Center - 8300 West 38th Ave - Wheat Ridge, Colorado 80031
Voice 303-425-2652 - Fax-303-467-8826 - Page 303-897-0125

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This decision is terribly short sighted. There is a large group of patients, particularly female, who have slghtly atypical acut or chronic pain syndromes, a modicum of risk factors, and abnormal stress tests in whom CCTA is incredibly helpful. If they have little calcium and no evidence of significant disease in a good quality study they can avoid the riskier and more expensive diagnostic cardiac cathetrization. We would estimate as many as 30-40% of dianostic catheterizations might be avoided selectively and effectively utlizing this approach. And patients with recurrent admissions to the ER and CPC with atypical CP and non-diagnostic RNST''s is another group in whom a CTA of the coronaries would prevent the need for cathetrizations. Yet another group would be the middle-aged patient with valvular heart disease particularly of the mitral valve needing valve replacement or repair in whom a negative CCTA would preclude the need for preoperative cardiac catheterization.

This is an incredibly helpful tool whose role can be expected to enlarge as the equipment is further developed and refined and our experience grows which should not only enhance our diagnostic abilities but also do so at a lower cost both financially as well as patient morbidity and mortality. That is particularly true now with the emergence of newer gating technology that may well decrease the radiation exposure for a complete study to perhaps as low as 3 millisieverts.

Another extremely helpful role of CTA is in the patient with AF prior to ablation to document the pulmonary vein anatomy and subsequent to ablation to diagnose pulmonary vein stenosis as a complication of that procedure. And the patient in need of a biventricular pacemaker or AICD can have there coronary venous anatomy determined in advance to know whether they have a coronary vein in the distribution of the myocardium that requires pacing to restore synchrony to the contractile pattern. If no vein is there then the generator and atrial and ventricular leads can be placed percutaneously with planned thoracoscopy placed LV lead implantation, avoiding a potentially long and unuccessful attempt at transvenous implantation.

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(electronic submission)

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

I am deeply disturbed with the proposed NCD. It does not adequately reflect the current state of evidence in support of coronary computed tomographic angiogrpahy (CCTA) in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD. Approximately one half of the available evidence with 64 slice CT scanners has not been considered in the draft proposal. As the standard of practice in 2007 is to perform CCTA with MDCT scanners of 64-slices, we encourage CMS to consider the large numbers of 64-slice CCTA studies omitted from the proposed NCD in lieu of other studies involving outmoded 4-, 8-, and 16-slice MDCT scanners. While 8 manuscripts employing 40 or greater slice CT scanners were evaluated, 25 full manuscripts using this contemporary level of CT scanner were not considered. Data has rapidly accumulated for 64-slice CCTA and there are many additional studies in the peer-reviewed, published literature to cite. CMS has failed to recognize many of these critically important studies.

It is premature to propose a new set of coverage criteria without a more thorough review of the available published evidence. Therefore, we request that CMS conduct a more complete and up-to-date assessment of this vital imaging technology before the NCD is finalized. Ultimately, the proposed NCD will limit access to a very useful, non-invasive method of coronary evaluation in favor of the more costly and more invasive, reimbursed methods (e.g., invasive catheterization). Certainly exposing patients to greater risk and expense does not provide better patient care or outcomes. If the proposed NCD is not withdrawn, substantial modifications should be made to provide coverage for appropriate indications and populations.

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer- reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non- invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well- trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

• Allow local Medicare contractors to continue coverage of CCTA for the diagnosis of CAD under their existing LCDs to enable Medicare beneficiaries the benefits of this clinically proven, lower-cost and lower-risk technology.
• Eliminate implementation of its proposed CED. CARDIOVASCULAR ASSOCIATES, SC recommends that CMS work with the specialty multidisciplinary societies (SCCT, ACC and ACR) to develop criteria for a CCTA registry to minimize the impact on the delivery of appropriate care to beneficiaries. There are several excellent CCTA registries already in existence that may be used as models for a CMS- approved registry to gather clinical data for longitudinal studies.
• Adopt accreditation guidelines, physician credentialing requirements and clinical appropriateness protocols to promote appropriate utilization of CTA for the diagnosis of CAD. The medical specialty societies are at the forefront in the development of these important quality endeavors, and (CARDIOVASCULAR ASSOCIATES, SC) fully supports their efforts and encourages Medicare to work with them in developing similar guidelines.

(CARDIOVASCULAR ASSOCIATES, SC) appreciates this opportunity to comment on Medicare's Proposed Decision Memo regarding Cardiac CTA. Please contact me at 847-981-3680 if you have any questions.

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We disagree with CMS’ conclusions in the proposed Coronary Artery CTA (“CCTA”) coverage determination and believe that if implemented, the policy will be profoundly negative for Medicare beneficiaries by limiting their access to CCTA for clinically appropriate indications. The proposed national coverage determination ("NCD") is contrary to current local coverage determinations in place in all fifty states and the District of Columbia. The local coverage determination (“LCD”) process already evaluated CCTA in all 50 states and the District of Columbia, and deemed CCTA reimbursable for CMS beneficiaries for a set of well-defined indications.

Approximately half of the available evidence relating to CCTA on 64 slice CT scanners is not taken into consideration in the analysis in the draft proposal. Since the current standard of practice in 2007 is to perform CCTA with multidetector CT ("MDCT") scanners of 64-slices, we encourage CMS to consider the large number of 64-slice CCTA studies omitted from the proposed NCD in lieu of older studies involving outmoded 4-, 8-, and 16-slice MDCT scanners. Only 8 of the 25 published studies employing 40 or greater slice CT scanners were evaluated for the NCD. The remaining 17 manuscripts using 64 slice contemporary CT scanners were not considered, which largely invalidates the conclusions of the NCD.

The proposed NCD will limit access to CCTA, which is a very useful, non-invasive, safe method of coronary interrogation, in favor of more costly, more invasive, and more risky invasive coronary artery catheterization. CCTA is fast and effective in excluding significant coronary artery stenosis in elderly patients suffering chest pain or other symptoms of coronary artery disease, with a negative predictive value of 99%. Using CCTA leads to a significant decrease in the number of coronary artery catheterizations that show no abnormality and the normal or equivocal nuclear cardiology (e.g. cardiolite) exams.

We urge CMS to allow the LCDs to remain in force in lieu of implementing a NCD that requires coverage with evidence development ("CED").

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We disagree with CMS’ conclusions in the proposed Coronary Artery CTA (“CCTA”) coverage determination and believe that if implemented, the policy will be profoundly negative for Medicare beneficiaries by limiting their access to CCTA for clinically appropriate indications. The proposed national coverage determination ("NCD") is contrary to current local coverage determinations in place in all fifty states and the District of Columbia.

The local coverage determination (“LCD”) process already evaluated CCTA in all 50 states and the District of Columbia, and deemed CCTA reimbursable for CMS beneficiaries for a set of well-defined indications.

Approximately half of the available evidence relating to CCTA on 64 slice CT scanners is not taken into consideration in the analysis in the draft proposal. Since the current standard of practice in 2007 is to perform CCTA with multidetector CT ("MDCT") scanners of 64-slices, we encourage CMS to consider the large number of 64-slice CCTA studies omitted from the proposed NCD in lieu of older studies involving outmoded 4-, 8-, and 16-slice MDCT scanners. Only 8 of the 25 published studies employing 40 or greater slice CT scanners were evaluated for the NCD. The remaining 17 manuscripts using 64 slice contemporary CT scanners were not considered, which largely invalidates the conclusions of the NCD.

The proposed NCD will limit access to CCTA, which is a very useful, non-invasive, safe method of coronary interrogation, in favor of more costly, more invasive, and more risky invasive coronary artery catheterization. CCTA is fast and effective in excluding significant coronary artery stenosis in elderly patients suffering chest pain or other symptoms of coronary artery disease, with a negative predictive value of 99%. Using CCTA leads to a significant decrease in the number of coronary artery catheterizations that show no abnormality and the normal or equivocal nuclear cardiology (e.g. cardiolite) exams.

We urge CMS to allow the LCDs to remain in force in lieu of implementing a NCD that requires coverage with evidence development ("CED").

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer- reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long- term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life- saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

• Allow local Medicare contractors to continue coverage of CCTA for the diagnosis of CAD under their existing LCDs to enable Medicare beneficiaries the benefits of this clinically proven, lower-cost and lower-risk technology.
• Eliminate implementation of its proposed CED. CARDIOVASCULAR ASSOCIATES, SC recommends that CMS work with the specialty multidisciplinary societies (SCCT, ACC and ACR) to develop criteria for a CCTA registry to minimize the impact on the delivery of appropriate care to beneficiaries. There are several excellent CCTA registries already in existence that may be used as models for a CMS- approved registry to gather clinical data for longitudinal studies.
• Adopt accreditation guidelines, physician credentialing requirements and clinical appropriateness protocols to promote appropriate utilization of CTA for the diagnosis of CAD. The medical specialty societies are at the forefront in the development of these important quality endeavors, and (CARDIOVASCULAR ASSOCIATES, SC) fully supports their efforts and encourages Medicare to work with them in developing similar guidelines.

(CARDIOVASCULAR ASSOCIATES, SC) appreciates this opportunity to comment on Medicare's Proposed Decision Memo regarding Cardiac CTA. Please contact me at 847-981-3680 if you have any questions.

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To whom it may concern,
I want to express my sincere disappointment with the recent CMS proposal regarding CCTA. This policy will affect the availablity of this extremely valuable technology for our patients. I am a practicing cardiologist and am convinced CCTA will change diagnosis and treatment of CAD as it becomes mainstream to improve outcome if it is allowed to progress. Your proposed NCD will stifle this progress. This proposed NCD does not take into consideration all of the current clinical studies, especially involving 64 slice CT technology. Multiple specialty societies have published Appropriateness Criteria in JACC 2006 that should be reflected in your policy. I personally have saved several patient lives or avoided catastrophic life altering events, soley based on findings on CCTA that were not identified be traditional noninvasive evaluation. Please reconsider this proposed NCD. This policy is not all inclusive of current data and will be a step backwards for the medical community and for our patients at a time where coronary artery disease is becoming a crisis as the number one killer in the US.
Sincerely,
Michael Langer

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This proposal is unreasonable and should be withdrawn. It doesn''t reflect the importance of this technology to the medicare population. In our initial exposure to this technology, it is clear that many patients have made significant adjustments in their treatment protocols and lifestyle. Cardiac CT should be embraced for it''s role in cardiac care. CMS should work with professional societies to determine appropriateness criteria for this testing. At this time there continue to be further innovations that make Cardiac CTA a more viable imaging technology.

I would respectfully request that the proposal should be dropped.

John L. Joliff, M.D., FACC

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

We represent Illinois Heart and Vascular which provides Cardiology services to the greater Chicago land area. We have 27 physicians, 92 employees and serve approximately 24,000 patients annually. Illinois Heart and Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart and Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart and Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart and Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart and Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart and Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart and Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing Illinois Heart and Vascular respectfully requests that CMS:

I oppose the proposed national coverage policy for coronary CTA for the following reasons:

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TALKING POINTS FOR LETTER TO CMS

(electronic submission)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for

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I oppose the proposed national coverage policy for coronary CTA for the following reasons:

I oppose the proposed national coverage policy for coronary CTA for the following reasons:

I am writing to express my concern over a National Coverage Decision (NCD) proposal that CMS is making that will limit an important and potentially lifesaving test to Medicare beneficiaries. The procedure that they want to stop paying for is Cardiac CT angiography, one of the most promising technologies in decades for the diagnosis and evaluation of heart disease. It is a non-invasive, less expensive way to look at all the structures in your heart including your coronary arteries.

CT Scanning defines the presence or absence of disease. This information is not available to nuclear perfusion imaging. Disease modification strategies can be tailored to be more aggressive if CT imaging is available and this will impact millions in a positive preventative way. If the CMS limitation to coverage takes hold, it could impact the commercial insurance industry and so too limit this imaging advantage to younger aged people at ri sk. Al though some 3rd party payors have decided the available data is adequate to cover CT, this decisions has not been universally embraced. The negative impact on the ability of our cardiology community to modify disease and major adverse outcomes could be crippling.

The Medicare carriers in all 50 states have already reviewed all the evidence for Cardiac CTA and unanimously approved this study and it is currently being paid for (Local Coverage Determination Policies). The new proposed NCD would overrule the policies present in all 50 states. CMS has failed to consider data in many critically important studies in peer-reviewed, published literature that addresses the current state of evidence in support of CT in our patient population at risk. They are using this as a test case to limit future technological developments which will directly impact many, many Americans.

CMS is asking for studies that prove that this technology changes patient outcomes. This does not make s ense since this is an imaging technology that takes the pictures that we need to make treatment decisions. It is not a treatment which is what outcome studies are for. The studies they are proposing would take years and cost tens if not hundreds of millions of dollars.

There is a commentary period in which physicians are letting Medicare know how they feel about this ruling. Many physicians and societies are joining together to fight this decision, but we only have until January, 12th 2008. After that there is 60 days and then CMS will make its final decision.

I am respectfully asking that you call for an investigation into how CMS has arrived at their decision and consider the impact that this will have on Medicare beneficiaries and even younger patients and constituents we are both responsible for. If this passes, Medicare beneficiaries first , and then maybe commercially enrolled beneficiaries second, would lose access to a procedure to diagnose coronary a rtery di sease which is non-invasive, rapid, less expensive and safer than other technology currently available.

Thank you for taking time to read this. Your action will have far reaching consequences.

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I oppose the proposed national coverage policy for coronary CTA for the following reasons:

I oppose the proposed national coverage policy for coronary CTA for the following reasons:

I oppose the proposed national coverage policy for coronary CTA for the following reasons:

We disagree with CMS’ conclusions in the proposed Coronary Artery CTA (CCTA) coverage determination and believe that if implemented, the policy will be profoundly negative for Medicare beneficiaries by limiting their access to CCTA for clinically appropriate indications.

The proposed national coverage determination is contrary to current local coverage determinations (LCDs) in place in all fifty states and the District of Columbia.

The local coverage determination (LCD) process already evaluated CCTA in all 50 states and the District of Columbia, and deemed CCTA reimbursable for CMS beneficiaries for a set of well-defined indications.

Approximately half of the available evidence relating to CCTA on 64 slice CT scanners is not taken into consideration in the analysis in the draft proposal. Since the current standard of practice in 2007 is to perform CCTA with MDCT scanners of 64-slices, we encourage CMS to consider the large number of 64-slice CCTA studies omitted from the proposed NCD in lieu of older studies involving outmoded 4-, 8-, and 16-slice MDCT scanners. Only 8 of the 25 published studies employing 40 or greater slice CT scanners were evaluated for the NCD. The remaining 17 manuscripts using 64 slice contemporary CT scanners were not considered, which largely invalidates the conclusions of the NCD.

The proposed NCD will limit access to CCTA, which is a very useful, non-invasive, safe method of coronary interrogation, in favor of more costly, more invasive, and more risky invasive coronary artery catheterization. CCTA is fast and effective in excluding significant coronary artery stenosis in elderly patients suffering chest pain or other symptoms of coronary artery disease, with a negative predictive value of 99%. Using CCTA leads to a significant decrease in the number of coronary artery catheterizations that show no abnormality and the normal or equivocal nuclear cardiology (e.g. cardiolite) exams.

We urge CMS to allow the LCDs to remain in force in lieu of implementing a NCD that requires coverage with evidence development (CED).

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I oppose the proposed national coverage policy for coronary CTA for the following reasons:

I oppose the proposed national coverage policy for coronary CTA for the following reasons:

We disagree with CMS’ conclusions in the proposed Coronary Artery CTA (CCTA) coverage determination and believe that if implemented, the policy will be profoundly negative for Medicare beneficiaries by limiting their access to CCTA for clinically appropriate indications.

The proposed national coverage determination is contrary to current local coverage determinations (LCDs) in place in all fifty states and the District of Columbia.

The local coverage determination (LCD) process already evaluated CCTA in all 50 states and the District of Columbia, and deemed CCTA reimbursable for CMS beneficiaries for a set of well-defined indications.

Approximately half of the available evidence relating to CCTA on 64 slice CT scanners is not taken into consideration in the analysis in the draft proposal. Since the current standard of practice in 2007 is to perform CCTA with MDCT scanners of 64-slices, we encourage CMS to consider the large number of 64-slice CCTA studies omitted from the proposed NCD in lieu of older studies involving outmoded 4-, 8-, and 16-slice MDCT scanners. Only 8 of the 25 published studies employing 40 or greater slice CT scanners were evaluated for the NCD. The remaining 17 manuscripts using 64 slice contemporary CT scanners were not considered, which largely invalidates the conclusions of the NCD.

The proposed NCD will limit access to CCTA, which is a very useful, non-invasive, safe method of coronary interrogation, in favor of more costly, more invasive, and more risky invasive coronary artery catheterization. CCTA is fast and effective in excluding significant coronary artery stenosis in elderly patients suffering chest pain or other symptoms of coronary artery disease, with a negative predictive value of 99%. Using CCTA leads to a significant decrease in the number of coronary artery catheterizations that show no abnormality and the normal or equivocal nuclear cardiology (e.g. cardiolite) exams.

We urge CMS to allow the LCDs to remain in force in lieu of implementing a NCD that requires coverage with evidence development (CED).

Less

I oppose the proposed national coverage policy for coronary CTA for the following reasons:

I oppose the proposed national coverage policy for coronary CTA for the following reasons:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare's proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors'.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

I oppose the proposed national coverage policy for coronary CTA for the following reasons:

The proposed NCD should be withdrawn. If it is not withdrawn, substantial modifications should be made to provide coverage for appropriate indications and populations.

The proposed NCD does not adequately reflect the current state of evidence in support of CCTA in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD.

Data is rapidly accumulating for 64-slice CCTA and there are many additional studies in the peer-reviewed, published literature to cite. CMS has failed to recognize many of these critically important studies. It is premature to propose a new set of coverage criteria without a more thorough review of the available published evidence. Therefore, we request that CMS conduct a more complete and up-to-date assessment of this vital imaging technology before the NCD is finalized.

The requirements CMS has established to obtain coverage for CCTA will have a severe negative impact on Medicare beneficiaries’ access to the service across the country given the uncertain approval process and timeline for future clinical trial development. We believe CMS has not properly examined the full impact the NCD with CED will have on the Medicare beneficiary population.

The specialty societies have been working together for more than two years to define the appropriate indications for CCTA and we urge CMS to work with the relevant societies, specifically, the Society of Cardiovascular Computed Tomography (SCCT), to better develop criteria for the types of clinical research that is appropriate for CED to minimize the negative impact on quality patient care.

Less

I oppose the proposed national coverage policy for coronary CTA for the following reasons:

RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

I represent CARDIOVASCULAR ASSOCIATES, SC, which provides Cardiology services to the greater Elk Grove Village/Hoffman Estates, IL area. We have 19 physicians, 85 employees and serve approximately 16,000 patients annually. CARDIOVASCULAR ASSOCIATES, SC appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS’ final decision. CARDIOVASCULAR ASSOCIATES, SC believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. CARDIOVASCULAR ASSOCIATES, SC strongly opposes Medicare’s proposed decision for numerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS’ proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). CARDIOVASCULAR ASSOCIATES, SC defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS’ memo, the conclusions made by CMS are disparate from the authors’.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians’ ability to gather the very data needed to prove CCTA’s additional efficacy.

2. CMS should rely on its local carriers’ judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

CARDIOVASCULAR ASSOCIATES, SC appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient’s CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA’s application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS’ two clinical diagnoses being proposed as the basis for reimbursement and study are “chronic stable angina at intermediate risk for CAD” and “unstable angina at low risk for death and with intermediate risk of CAD.” These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by “risk of CAD.” Rather, guidelines for “acute chest pain” use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

“Unstable angina” or more commonly now “possible Acute Coronary Syndrome” likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, CARDIOVASCULAR ASSOCIATES, SC is unaware of guidelines that use the “risk of CAD” in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from CARDIOVASCULAR ASSOCIATES, SC, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing, CARDIOVASCULAR ASSOCIATES, SC respectfully requests that CMS:

§ Allow local Medicare contractors to continue coverage of CCTA for the diagnosis of CAD under their existing LCDs to enable Medicare beneficiaries the benefits of this clinically proven, lower-cost and lower-risk technology.

§ Eliminate implementation of its proposed CED. CARDIOVASCULAR ASSOCIATES, SC recommends that CMS work with the specialty multidisciplinary societies (SCCT, ACC and ACR) to develop criteria for a CCTA registry to minimize the impact on the delivery of appropriate care to beneficiaries. There are several excellent CCTA registries already in existence that may be used as models for a CMS-approved registry to gather clinical data for longitudinal studies.

§ Adopt accreditation guidelines, physician credentialing requirements and clinical appropriateness protocols to promote appropriate utilization of CTA for the diagnosis of CAD. The medical specialty societies are at the forefront in the development of these important quality endeavors, and (CARDIOVASCULAR ASSOCIATES, SC) fully supports their efforts and encourages Medicare to work with them in developing similar guidelines.

(CARDIOVASCULAR ASSOCIATES, SC) appreciates this opportunity to comment on Medicare’s Proposed Decision Memo regarding Cardiac CTA. Please contact me at 847-981-3680 if you have any questions.

Sincerely,

Holli HabibCardiovascular Technician

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I oppose the proposed national coverage policy for coronary CTA for the following reasons:

I oppose the proposed national coverage policy for coronary CTA for the following reasons:

The proposed NCD should be withdrawn. If it is not withdrawn, substantial modifications should be made to provide coverage for appropriate indications and populations.

The proposed NCD does not adequately reflect the current state of evidence in support of CCTA in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD.

Data is rapidly accumulating for 64-slice CCTA and there are many additional studies in the peer-reviewed, published literature to cite. CMS has failed to recognize many of these critically important studies. It is premature to propose a new set of coverage criteria without a more thorough review of the available published evidence. Therefore, we request that CMS conduct a more complete and up-to-date assessment of this vital imaging technology before the NCD is finalized.

The requirements CMS has established to obtain coverage for CCTA will have a severe negative impact on Medicare beneficiaries’ access to the service across the country given the uncertain approval process and timeline for future clinical trial development. We believe CMS has not properly examined the full impact the NCD with CED will have on the Medicare beneficiary population.

The specialty societies have been working together for more than two years to define the appropriate indications for CCTA and we urge CMS to work with the relevant societies, specifically, the Society of Cardiovascular Computed Tomography (SCCT), to better develop criteria for the types of clinical research that is appropriate for CED to minimize the negative impact on quality patient care.

Less

The proposed NCD should be withdrawn. If it is not withdrawn, substantial modifications should be made to provide coverage for appropriate indications and populations.

The proposed NCD does not adequately reflect the current state of evidence in support of CCTA in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD.

Data is rapidly accumulating for 64-slice CCTA and there are many additional studies in the peer-reviewed, published literature to cite. CMS has failed to recognize many of these critically important studies. It is premature to propose a new set of coverage criteria without a more thorough review of the available published evidence. Therefore, we request that CMS conduct a more complete and up-to-date assessment of this vital imaging technology before the NCD is finalized.

The requirements CMS has established to obtain coverage for CCTA will have a severe negative impact on Medicare beneficiaries’ access to the service across the country given the uncertain approval process and timeline for future clinical trial development. We believe CMS has not properly examined the full impact the NCD with CED will have on the Medicare beneficiary population.

The specialty societies have been working together for more than two years to define the appropriate indications for CCTA and we urge CMS to work with the relevant societies, specifically, the Society of Cardiovascular Computed Tomography (SCCT), to better develop criteria for the types of clinical research that is appropriate for CED to minimize the negative impact on quality patient care.

Less

The proposed NCD should be withdrawn. If it is not withdrawn, substantial modifications should be made to provide coverage for appropriate indications and populations.

The proposed NCD does not adequately reflect the current state of evidence in support of CCTA in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD.

Data is rapidly accumulating for 64-slice CCTA and there are many additional studies in the peer-reviewed, published literature to cite. CMS has failed to recognize many of these critically important studies. It is premature to propose a new set of coverage criteria without a more thorough review of the available published evidence. Therefore, we request that CMS conduct a more complete and up-to-date assessment of this vital imaging technology before the NCD is finalized.

The requirements CMS has established to obtain coverage for CCTA will have a severe negative impact on Medicare beneficiaries’ access to the service across the country given the uncertain approval process and timeline for future clinical trial development. We believe CMS has not properly examined the full impact the NCD with CED will have on the Medicare beneficiary population.

The specialty societies have been working together for more than two years to define the appropriate indications for CCTA and we urge CMS to work with the relevant societies, specifically, the Society of Cardiovascular Computed Tomography (SCCT), to better develop criteria for the types of clinical research that is appropriate for CED to minimize the negative impact on quality patient care.

Less

I oppose the proposed national coverage policy for coronary CTA for the following reasons:

The proposed NCD should be withdrawn. If it is not withdrawn, substantial modifications should be made to provide coverage for appropriate indications and populations.

The proposed NCD does not adequately reflect the current state of evidence in support of CCTA in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD.

Data is rapidly accumulating for 64-slice CCTA and there are many additional studies in the peer-reviewed, published literature to cite. CMS has failed to recognize many of these critically important studies. It is premature to propose a new set of coverage criteria without a more thorough review of the available published evidence. Therefore, we request that CMS conduct a more complete and up-to-date assessment of this vital imaging technology before the NCD is finalized.

The requirements CMS has established to obtain coverage for CCTA will have a severe negative impact on Medicare beneficiaries’ access to the service across the country given the uncertain approval process and timeline for future clinical trial development. We believe CMS has not properly examined the full impact the NCD with CED will have on the Medicare beneficiary population.

The specialty societies have been working together for more than two years to define the appropriate indications for CCTA and we urge CMS to work with the relevant societies, specifically, the Society of Cardiovascular Computed Tomography (SCCT), to better develop criteria for the types of clinical research that is appropriate for CED to minimize the negative impact on quality patient care.

Less

The proposed NCD should be withdrawn. If it is not withdrawn, substantial modifications should be made to provide coverage for appropriate indications and populations.

The proposed NCD does not adequately reflect the current state of evidence in support of CCTA in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD.

Data is rapidly accumulating for 64-slice CCTA and there are many additional studies in the peer-reviewed, published literature to cite. CMS has failed to recognize many of these critically important studies. It is premature to propose a new set of coverage criteria without a more thorough review of the available published evidence. Therefore, we request that CMS conduct a more complete and up-to-date assessment of this vital imaging technology before the NCD is finalized.

The requirements CMS has established to obtain coverage for CCTA will have a severe negative impact on Medicare beneficiaries’ access to the service across the country given the uncertain approval process and timeline for future clinical trial development. We believe CMS has not properly examined the full impact the NCD with CED will have on the Medicare beneficiary population.

The specialty societies have been working together for more than two years to define the appropriate indications for CCTA and we urge CMS to work with the relevant societies, specifically, the Society of Cardiovascular Computed Tomography (SCCT), to better develop criteria for the types of clinical research that is appropriate for CED to minimize the negative impact on quality patient care.

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

We represent Illinois Heart and Vascular whichprovides Cardiology services to the greater Chicago land area. We have 27 physicians, 92 employees and serve approximately 24,000 patients annually. Illinois Heart and Vascular appreciates he opportunity to comment on the Centers forMedicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to asCCTA) for the diagnosis of Coronary Artery Disease(CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CED) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS’ final decision. Illinois Heart and Vascular believes the proposed CED not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart and Vascular strongly opposes Medicare’s proposed decision fornumerous reasons:

1. CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less expensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS’ proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart and Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS’ memo, the conclusions made by CMS are disparate from the authors’.

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated inpatients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress test indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as well as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians’ ability to gather the very data needed to prove CCTA’s additional efficacy.

2. CMS should rely on its local carriers’ judgment and expertise put forth via Local Coverage Determinations (LCDs) in effect in all 50 states and keep the LCDs in place during its data-gathering phase. CMS has granted its local Medicare contractors the authority to utilize clinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Excellus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart and Vascular appreciates the concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient’s CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of long-term data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA’s application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS’ two clinical diagnoses being proposed as the basis for reimbursement and study are “chronic stable angina at intermediate risk for CAD” and “unstable angina at low risk for death and with intermediate risk of CAD.” These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CCTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by “risk of CAD.” Rather, guidelines for “acute chest pain” use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

“Unstable angina” or more commonly now “possible Acute Coronary Syndrome” likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart and Vascular is unaware of guidelines that use the “risk of CAD” in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. CCTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-of-the-art, life-saving technology earlierin the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart and Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient riskand discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations performed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

In closing Illinois Heart and Vascular respectfully requests that CMS:
ß Allow local Medicare contractors to continue coverage of CCTA for the diagnosis of CAD under their existing LCDs to enable Medicare beneficiaries the benefits of this clinically proven, lower-cost and lower-risk technology.
ß Eliminate implementation of its proposed CED. Illinois Heart and Vascular recommends that CMS work with the specialty multidisciplinary societies (SCCT, ACC and ACR) to develop criteria for a CCTA registry to minimize the impact on the delivery of appropriate care to beneficiaries.There are several excellent CCTA registries already in existence that may be used as models for a CMS-approved registry to gather clinical data for longitudinal studies.
ß Adopt accreditation guidelines, physician credentialing requirements and clinical appropriateness protocols to promote appropriate utilization of CTA for the diagnosis of CAD. The medical specialty societies are at the forefront in the development of these important quality endeavors, and Illinois Heart and Vascular fully supports their efforts and encourages Medicare to work with them in developing similar guidelines.
Illinois Heart and Vascular appreciates this opportunity to comment on Medicare’s Proposed Decision Memo regarding Cardiac CTA. Please contact me at 708-952-7444 or via email attomlevin@mac.com if you have any questions.

Sincerely,

Thomas Levin, MD, FACC, FSCAI

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The proposed NCD should be withdrawn. If it is not withdrawn, substantial modifications should be made to provide coverage for appropriate indications and populations.

The proposed NCD does not adequately reflect the current state of evidence in support of CCTA in regard to symptomatic patients with chronic stable angina at intermediate risk of CAD.

Data is rapidly accumulating for 64-slice CCTA and there are many additional studies in the peer-reviewed, published literature to cite. CMS has failed to recognize many of these critically important studies. It is premature to propose a new set of coverage criteria without a more thorough review of the available published evidence. Therefore, we request that CMS conduct a more complete and up-to-date assessment of this vital imaging technology before the NCD is finalized.

The requirements CMS has established to obtain coverage for CCTA will have a severe negative impact on Medicare beneficiaries’ access to the service across the country given the uncertain approval process and timeline for future clinical trial development. We believe CMS has not properly examined the full impact the NCD with CED will have on the Medicare beneficiary population.

The specialty societies have been working together for more than two years to define the appropriate indications for CCTA and we urge CMS to work with the relevant societies, specifically, the Society of Cardiovascular Computed Tomography (SCCT), to better develop criteria for the types of clinical research that is appropriate for CED to minimize the negative impact on quality patient care.

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I disagree with CMS’conclusions in the proposed Coronary Artery CTA (CCTA) coverage determination and believe that if implemented, the policy will be profoundly negative for Medicare beneficiaries by limiting their access to CCTA for clinically appropriate indications.

The proposed national coverage determination is contrary to current local coverage determinations (LCDs) in place in all fifty states and the District of Columbia.

The local coverage determination (LCD) process already evaluated CCTA in all 50 states and the District of Columbia, and deemed CCTA reimbursable for CMS beneficiaries for a set of well-defined indications.

Approximately half of the available evidence relating to CCTA on 64 slice CT scanners is not taken into consideration in the analysis in the draft proposal. Since the current standard of practice in 2007 is to perform CCTA with MDCT scanners of 64-slices, we encourage CMS to consider the large number of 64-slice CCTA studies omitted from the proposed NCD in lieu of older studies involving outmoded 4-, 8-, and 16-slice MDCT scanners. Only 8 of the 25 published studies employing 40 or greater slice CT scanners were evaluated for the NCD. The remaining 17 manuscripts using 64 slice contemporary CT scanners were not considered, which largely invalidates the conclusions of the NCD.

The proposed NCD will limit access to CCTA, which is a very useful, non-invasive, safe method of coronary interrogation, in favor of more costly, more invasive, and more risky invasive coronary artery catheterization. CCTA is fast and effective in excluding significant coronary artery stenosis in elderly patients suffering chest pain or other symptoms of coronary artery disease, with a negative predictive value of 99%. Using CCTA leads to a significant decrease in the number of coronary artery catheterizations that show no abnormality and the normal or equivocal nuclear cardiology (e.g. cardiolite) exams.

I urge CMS to allow the LCDs to remain in force in lieu of implementing a NCD that requires coverage with evidence development (CED).

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RE: Proposed Decision Memo for Computed Tomographic Angiography (CAG-00385N)

We represent Illinois Heart and Vascular which provides Cardiology services to the greater Chicago land area. We have 27 physicians, 92 employees and serve approximately 24,000 patients annually. Illinois Heart and Vascular appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services (CMS) Proposed Decision Memo for CTA (hereafter referred to as CCTA) for the diagnosis of Coronary Artery Disease (CAD) referenced above.

CMS, in its memo, proposes a narrowly defined Coverage with Evidence Development (CEO) for CCTA for limited, inappropriately restrictive indications and strict research study protocols that must be submitted, reviewed and approved within 60 days of CMS' final decision. Illinois Heart and Vascular believes the proposed CEO not only is extremely poor public policy but is precedent-setting in its attempt to utilize a reimbursement strategy for a diagnostic modality that mandates an assessment of its impact on health outcomes. Illinois Heart and Vascular strongly opposes Medicare's proposed decision for numerous reasons:

1.CMS has failed to take into account a considerable body of current clinical, peer-reviewed evidence that demonstrates CCTA is a valuable technology to diagnose CAD that is less lexpensive and poses less risk to the patient than invasive cardiac catheterization. A significant number of studies cited in CMS' proposed memo are based on older data that, not only do not reflect current clinical literature, but many of the cited studies used older technology (16-slice equipment). Illinois Heart and Vascular defers to the responses of the specialty clinical societies, namely the American College of Cardiology (ACC), Society of Cardiovascular Computed Tomography (SCCT) and the American College of Radiology (ACR), which cite in detail the numerous clinical studies CMS did not consider in issuing the Proposed Decision Memo. Though the AHA Scientific Statement on the topic and the CCTA Appropriateness Criteria Document with input from all the involved societies (both published in 2006) are referenced in CMS' memo, the conclusions made by CMS are disparate from the authors' .

These currently available studies and data demonstrate that CCTA, in specific patient populations, has a high sensitivity and specificity when compared to myocardial perfusion studies, treadmill stress testing and invasive cardiac catheterization in diagnosing the presence and extent of CAD. It has been evaluated in patients with symptomatic coronary disease, patients with coronary anomalies, and is particularly valuable in evaluating patients with indeterminate stress tests or with stress tests whose findings are discrepant with the clinical impression. When appropriately performed, CCTA often obviates the need for more invasive studies. This latter group is important as stress tlest indications include a number of presenting conditions other than chest discomfort (sudden death, atrial fibrillation, heart failure, etc).

Clinical trials currently underway also hold great potential for continuing to affirm these conclusions as welt as to assess the economic benefit of CCTA when compared to cardiac catheterization. To make a decision that drastically limits CCTA will inhibit clinicians' ability to gather the very data needed to prove CCTA's additional efficacy.

2. CMS should rely on its local carriers' judgment and expertise put forth via Local Coverage Determinations (LCOs) in effect in all 50 states and keep the LCOs in place during its dlatagathering phase. CMS has granted its local Medicare contractors the authority to utilize dinical experts and specialty organizations in determining the appropriateness of local coverage decisions. The vast majority of coverage decisions with regard to imaging procedures are made by local Medicare carriers, which work with specialty societies and their own advisory committees to develop LCDs that support the use of CCTA to diagnose CAD.

The LCDs include appropriate clinical indications, diagnoses, and technical requirements for the performance of CCTA based on peer-reviewed clinical evidence and a comprehensive model LCD created jointly by the ACC and the ACR. Numerous third party payers, including Aetna, United Healthcare, Humana, Cigna, Wellpoint (14 states) and many Blue Cross Blue Shield carriers, most notably Highmark, HCSC, Wellmark and Exceltus also provide coverage for CCTA for their beneficiaries based on clinical data, appropriateness criteria and accreditation guidelines.

The Model LCD for CCTA upon which many LCDs were based includes clinical indications such as the evaluation of acute chest pain, equivocal stress tests, suspected congenital coronary anomalies, and for the detection of coronary artery disease in patients anticipating valve surgery, amongst others.

3. In the covered clinical trial requirements outlined in the Proposed Decision Memo, CMS takes the unprecedented step of requiring that a technology used solely for diagnosis should demonstrate improved patient health outcomes.

Illinois Heart and Vascular appreciates the .concept that positive clinical outcomes (both short term and long term) always should be the goal for the introduction of new therapeutic modalities. The difference between how we assess the impact of therapeutic vs. diagnostic modalities is beyond the scope of this response. However, an X-ray does not heal a broken bone; it merely reveals the break. Likewise, CCTA cannot treat a patient's CAD, it merely can diagnose it. CMS did not require clinical trials to demonstrate improved outcomes for a multitude of other technologies in use today. Therefore, CMS should not set an unrealistic precedent with regard to CCTA.

The proposed requirement to demonstrate that the use of a diagnostic imaging test will improve health outcomes will be impossible to achieve unless CCTA is applied in the community clinical setting with a realistic breadth of clinical presentations so a statistically relevant amount of longterm data can be collected and analyzed. Moreover, CMS effectively is eliminating that possibility by closing the door at the outset, limiting CCTA's application to an inappropriately narrow patient population and by so doing precluding the collection of long-term outcome data.

4. There are errors in the way CMS defined populations in its proposed indications for CT research protocols. CMS' two clinical diagnoses being proposed as the basis for reimbursement and study are "chronic stable angina at intermediate risk for CAD" and "unstable angina at low risk for death and with intermediate risk of CAD." These categories do not accurately reflect the defined patient populations upon which guidelines are currently based.

Chronic stable angina pectoris implies the presence of CAD. A patient with chronic stable angina usually will have had some diagnostic test to support its presence (including potentially CeTA). For a patient with chronic stable angina whose symptoms are refractory to medicines, invasive cardiac catheterization usually is indicated. We are unaware of any guideline for chronic stable angina that stratifies that patient by "risk of CAD." Rather, guidelines for "acute chest pain" use risk of CAD for triage to certain tests or strategies. Indeed, it is the patient with acute chest pain of uncertain etiology where the presumed risk of CAD is used in decision-making and where CCTA has a potential role.

"Unstable angina" or more commonly now "possible Acute Coronary Syndrome" likewise implies the presence of CAD as the assessment of its likelihood precedes the diagnosis. Most cardiologists refer patients with definite or presumed unstable angina for diagnostic catheterization, in part because of the ability to perform, when appropriate, percutaneous revascularization without the duplication, expense, added contrast and added risk of two or three separate procedures. As was the case with chronic stable angina, Illinois Heart and Vascular is unaware of guidelines that use the "risk of CAD" in their algorithms. Risk of short-term death and non-fatal MI is indeed assessed in these patients and when deemed low, a non-invasive risk stratification arm is provided as a possible alternative in current guidelines.

While the use of CCTA in acute coronary syndrome may merit further research, the study referenced in NSTEMI revealed only 15 percent who were shown to be CCTA negative, therefore subjecting the rest to both CCTA and invasive catheterization.

5. The narrowly defined research parameters CMS proposes will greatly inhibit participation by community cardiologists, who currently perform a majority of CCTA studies for the indications provided in current LCDs. Many groups with well-trained CCTA physicians will not be able to muster the resources to apply and follow their patients in the ways described in the CMS memo.

The severe restrictions under which CMS would cover CCTA in clinical research trials would also significantly reduce the amount of long-term, statistically significant data that can be analyzed to demonstrate the effectiveness of CTA. In contrast, a national registry would promote far greater physician participation and result in a more comprehensive set of data that more accurately reflect the current and appropriate uses of CCTA in the diagnosis of cardiac disease.

There are registries already active in some regions that were carefully derived with appropriateness guidelines embedded and from which data will be forthcoming.

6. Non-coverage of CCTA for the diagnosis of CAD will result in many Medicare patients having to undergo invasive, higher-risk, more expensive procedures to diagnose CAD, especially those patients who have symptoms suggestive of coronary disease but have equivocal results on stress echo or stress nuclear perfusion scans. eeTA has allowed many of these patients to avoid invasive cardiac catheterization and the risks inherent in that procedure. Denial of coverage for CCTA places Medicare recipients at greater risk, with higher out-of-pocket costs, and restricts access to state-ofthe- art, life-saving technology earlier in the disease process.

7. Several recent studies, as well as empirical data from Illinois Heart and Vascular, demonstrate that CCTA reduces overall costs to Medicare and third-party insurers while providing excellent diagnostic capabilities and reduced patient risk and discomfort. Practices nationwide, as well as hospitals, saw cardiac catheterization rates fall in 2006. Although some of the reduction can be linked to the use of statins and other medical advances, there is no question that CCTA is a factor in the decreased number of invasive catheterizations perf()rmed. This indicates that CCTA is not only a good clinical choice for many patients in terms of risk and comfort, but also is a fiscally responsible choice for both the Medicare program and its beneficiaries.

• Allow local Medicare contractors to continue coverage of CCTA for the diagnosis of CAD under their existing LCDs to enable Medicare beneficiaries the benefits of this clinically proven, lower-cost and lower-risk technology.
• Eliminate implementation of its proposed CEO. Illinois Heart and Vascular recommends that CMS work with the specialty multidisciplinary societies (SCCT, ACC and ACR) to develop criteria for a CCTA registry to minimize the impact on the delivery of appropriate care to beneficiaries. There are several excellent CCTA registries already in existence that may be used as models for a CMSapproved registry to gather clinical data for longitudinal studies.
• Adopt accreditation guidelines, physician credentialing requirements and clinical appropriateness protocols to promote appropriate utilization of CTA for the diagnosis of CAD. The medical specialty societies are at the forefront in the development of these important quality endeavors, and Illinois Heart and Vascular fully supports their efforts and encourages Medicare to work with them in developing similar guidelines.

Illinois Heart and Vascular appreciates this opportunity to comment on Medicare's Proposed Decision Memo regarding Cardiac CTA. Please contact me at 630-528-4370 or via email at mjborg@illinoisheart.com if you have any questions.

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I oppose the proposed national coverage policy for coronary CTA for the following reasons:

CCTA is a safe, proven diagnostic technology that is as effective at diagnosing CAD as a tradition cath procedure (white costs more, has greater risk to the pt. and possibly more radiation dose*)

***The new CT technology from Toshiba (320CT)and other vendors will offer greater dose reduction, less time to diagnose and better economics to the patient and hospital.

Please do not limit the patients or physicians choice on diagnostic technology. Do not make the fatal flaw of basing your health upon finances, either. The best technology needs to be available to the patient; and that decision needs to be between the pt. and their primary care giver.

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