Screening Computed Tomography Colonography (CTC) for Colorectal Cancer

I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients.

The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

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With no doubt there is overwhelming evidence that Virtual Colonoscopy (VC) works and has dramatically improved since 2001 when VC had already been proven equal to Optical Colonoscopy (OC) for >10mm polyps. The question now is will CMS now do the right thing and take a courageous stand to SAVE LIVES in large numbers or capitulate to upholding the status quo? When a qualified(>7mm) polyp is found/removed, a life is potentially saved. No one disputes that. If "effective" CRC screening compliance is 20%, give or take, that defines a monumental national failure by the cumulative impact of the 4 approved CRC screening options PRECEDING VC. No one disputes that.

So with 153 needless, preventable CRC deaths/day x 365, we are all collectively negligent (perhaps criminally so) by not doing whatever it takes to find all qualified polyps possible, thus saving millions of lives globally. It’s a numbers game to SAVE LIVES as opposed to preserving OC screening revenues, albeit in totally inadequate non-scalable quantities to achieve population level screening. The face that 8500 Multi-Detector CT''s doing 4 VCs/hour x 365 could provide nearly an 80% compliance bump. That''s a population screening option, which is literally at our fingertips. If those CT’s work 5 days/week, its a 57% compliance bump, still effectively tripling the compliance of the prior four approved CRC screening options, three of which are known to be essentially useless. No one disputes that.

OC screening cannot be rubber banded into a population screening tool, because of expense, risk, and manpower issues. No one disputes that. But internet linked CT''s can accommodate population level screening challenge, which is the only way CRC can be cured within our lifetimes. Only the endoscopy lobby disputes that. But if they would step back (or be pushed back) and support VC they will be clipping qualified polyps in very large numbers and saving many more lives in the process. Again, the first three institutional studies comparing OC vs. VC documented by 2001 that VC finds qualified polyps just as well as OC. No one disputes that, especially 8 years later, given the tremendous technical and software advances since 2001. Only VC can be scaled to the task those 153 daily, preventable deaths require. CMS should ask CRC victims’ families for prospective advice. Those families will tell CMS it’s a no brainer. And those victims’ families might suggest that if there is further capitulation to the endo lobby, CMS should join the endo''s in millions of wrongful death lawsuits by permitting the endo inspired disinformation and delay tactics regarding VC.
That’s a pretty sobering thought.

I''ve read all the literature, know most of the leading VC academics, have been involved in CT leading edge software advancements since Day #1 (1973)….so now you have to prove me wrong with regard to the numbers game we are playing. CRC can be cured within our lives, if the right people make the right choices. No one with the same facts that I have can dispute that. The desperate issues of irrelevant 3-5mm polyps and CT dose are just that: desperate stalling maneuvers, cloaked in scare tactics and exaggeration. CMS should table the first item for one decade and demand more action on the low dose CT data acquisition protocols that are so promising. CMS must summon the serious courage needed to SAVE LIVES….in massive numbers, because the same 7mm nodule in the lung or breast of a loved one is already a much more,virulent problem. CRC is a freak of nature, given that 93% arise from slow growing polyps that only need to be found on a very large scale. BTW half of those 8500 CT’s working half a shift (4 hrs) on Sat’s & Sun’s, provides a compliance bump of nearly 80%. What’s the point? We already have all the tools necessary to cure CRC. CMS must not waffle. CMS must make the binary choice to SAVE LIVES. Then what to do becomes crystal clear. Only massive VC, with internet leveraging and CAD has a prayer of curing CRC within our lifetimes. Let’s Get’R Done and leave CRC in the roadside ditch of medical history next to smallpox and polio. That''s what CMS must ponder and act on forcefully.

One last thought: not once in all the recent media coverage of "healthcare reform" or the HHS nominees has there been one mention of our government stepping up to the 153 needless, preventable CRC deaths/day x 365. That''s the equivalent of one 9/11 event every 3 weeks, which can be prevented. CMS should point that out to our new government leaders. Hopefully they will listen and invoke real, tangible “change”.

A few observations about the VC "literature". Remember that when VC was proven equivalent to OC for polyp detection 10mm and greater, those first three academic studies utilized single slice (!) spiral CT systems [1,2,3]. Today multi-channel CT''s provide VC major new advantages in terms of speed, dose, resolution, etc. That must count for something.

In radiology, the Caldwell Lecture is a big annual event. The expert for 2001 was The Father of the modern barium enema, having done them, taught them for over 40 years….more than anyone east of the Mississippi River. His lecture [4] was noteworthy for many reasons, but the two most impressive items were (a) his flat statement that DCBE''s had no future role for CRC screening, because they were too innaccurate and (b) his careful documentation of just how far the endoscopy lobby was prepared to go to ban the approval of BE''s at an earlier juncture, i.e. threatening a lawsuit if needed. Read it a weep. VC is déjà vu All Over Again. DCBE''s should have been removed from the approved CRC options list 8 years ago, but there DCBE still sits today, and for most of those years helpful to keep VC off the prime time list of options. With no deletion, who wants a new addition? Logical, but incredibly short sighted or perhaps clairvoyant.

Then we have the American College Of Gastroenterology board approved article [5], replete with red banners, and no stunning endorsement of VC. It speaks to dose concerns, tiny irrelevent 3-5mm polyps, but never once notes that massive expansion of VC would save millions of the lives that OC cannot. The "board approval" (1st paragraph) and the red banners telegraph this piece was never intended as a literature contribution, but as a future anti-VC handout to thousands of local referring physicians as part of a deliberate delay/disinformation campaign against VC. It''s how the medical "literature" can be prostituted for a purpose.

We all waited eagerly for the ACRIN study to validate that Pickhardt''s break through study (lead article NEJM 12/4/03) was not a fluke[6]. ACRIN was published by NEJM 9/08 [7], but only after an 18 month publication delay inspired by the anti-VC lobby. Dr. Carl Jaffe was the NIH branch chief who played a pivotal role in getting ACRIN funding approved and the results published. The 18 month delay was real, and he will tell you so.

Recently Dr. David Vining opined from his very special historical perspective of having done the very first VC exam in 1994[8]. Because of his computer background, many radioliogists laughed at his VC concept. But history will show that David was not from the lunatic software fringe, and more importantly had described something of immense future life saving potential….if only rational people would honestly listen. A segment of David''s recent article [8] follows:

“Dispelling Popular Myths - Gastroenterologists frequently try to discredit VC with the following…

1. Colonoscopy is the "gold standard." There are no published studies to validate this claim. In fact, studies comparing back- to-back colonoscopies on the same patients have reported OC miss rates of 22% for polyps, even in the hands of expert endoscopists.[9] Studies such as Pickhardt''s[6] landmark VC study have shown VC to outperform OC. Finally, the accuracy of screening colonoscopy has been shown to be dependent on how much time a gastroenterologist spends performing the examination.[10]

2. If VC finds a polyp, then colonoscopy is needed for polyp removal, so why not undergo colonoscopy in the first place? The vast majority of polyps are benign, hyperplastic polyps, and <5% <br="<br" />of the asymptomatic screening population has a significant adenomatous polyp.[11] Hence, if OC is the primary screening method, then >95% of the asymptomatic population would under go OC unnecessarily with its inherent risks of bowel perforation and anesthesia.

3. The radiation dose associated with VC is prohibitive. Radiation dose is a valid concern, but researchers are striving to mitigate this risk by using low-dose techniques, even as low as 10 mAs (compared with a conventional CT scan that might use a dose of 200 mAs).[12] Hence, the radiation risk from VC with low-dose techniques can be on the order of 1 to 2 mSv, which is far below the range that has been associated with potential cancer and multidetector CT use [13]. Alternatively, VC can be performed using MRI, but the availability of MRI scanners is a temporary hurdle, at least for today…”

SUMMARY: I''m Prof. & Chairman of Absolutely Nothing. But when you call Prof. J. Ferrucci, Prof. P. Pickhardt, Prof. C. Jaffe, Prof. D. Rex and Prof. D. Vining to testify, I want to be sitting at the same witness table speaking as a private practice voice with something serious to contribute to SAVING LIVES with VC. I have more VC software/digital networking credentials than all of them combined, in spite of my lack of academic credentials.

Refs:

1. Fenlon HM, Nunes DP, Schroy PC, Barish MA, Clarke PD, Ferrucci JT. A comparison of virtual colonoscopy and conventional colonoscopy for the detection of colorectal polyps. N Engl J Med 1999;341:1496-1503
2. Fletcher JG, Johnson CD, Welch TJ, et al. Optimization of CT colonography technique: prospective trial in 180 patients. Radiology 2000;216:704-711
3. Yee J, Akerbar GA, Hung FK, et all. Characteristics of CT colonography for the detection of colorectal neoplasia in 300 patients. Radiology 2001;219:685-692
4. Ferrucci, JT, 2001 Eugene W. Caldwell Lecture, Colon Cancer Screening with Virtual Colonoscopy: Promise, Polyps, Politics, AJR: 177, 975-988, November 2001
5. Rex DK and Lieberman D. ACG Colorectal Cancer Prevention Action Plan: Update On CT-Colonography, Amer J Gastroenterology, 2006, pg. 1410-1413
6. Pickhardt, PJ, Choi R, Hwang I, Butler JA, Puckett MJ. Hildebrandt HA, Wong RK, Nugent PA, Mysiliweic PA, and Schindler WR; Computerd Tomographic Virtual Colonscopy to Screen for Colorectal Neoplasia in Asymptomatic Adults, N Engl J Med 349;23 2191-2200, 12/4/03
7. Johnson CD et al, Accuracy of CT Colonography for Detection of Large Adenomas and Cancers, N Engl J Med 359;12 1207-1217, 9/18/08
8. Vining DJ, Virtual Colonoscopy: A Storm Is Brewing, Appl Radiol. 2008;37(11):12-16.
9. van Rijn JC, Reitsma JB, Stoker J, et al. Polyp miss rate determined by tandem colonoscopy: A systematic eview. Am J Gastroenterol. 2006;101: 343-350.
10. Barclay RL, Vicari JJ, Doughty AS, et al. Colonoscopic withdrawal times and adenoma detection during screening colonoscopy. N Engl J Med. 2006;355;2533-2541.
11. Kim DH, Pickhardt PJ, Taylor AJ, et al. CT colonography versus colonoscopy for the detection of advanced neoplasia. NEJM. 2007;357:1403-1412.
12. Iannaccone R, Catalano C, Mangiapane F, et. al. Colorectal polyps: Detection with low-dose multidetector row helical CT colonography versus two sequential colonoscopies. Radiology. 2005;237: 927-937.
13. Brenner DJ, Hall EJ. Computed tomography—An increasing source of radiation exposure. N Engl J Med. 2007;357:2277- 2284.

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March 13, 2009

Charlene Frizzera, Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Blvd, Room 314G
Baltimore, MD 21244-1850

Re: Proposed Decision Memo for Screening Computed Tomography Colongraphy (CTC) for Colorectal Cancer (CAG-00396N)

Dear Ms. Frizzera:

GE Healthcare appreciates the opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) February 11, 2009 proposed coverage decision memo for screening CT Colonography (CTC) for colorectal cancer (CRC).

GE Healthcare, a $17 billion unit of General Electric Company with headquarters in the United Kingdom, has expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceuticals manufacturing technologies. GE Healthcare’s broad range of products and services enables healthcare providers to offer patients earlier and better diagnosis and treatment of cancer, heart disease, neurological diseases, and other conditions to improve the quality and length of life. Worldwide, GE Healthcare employs more than 50,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

It is significant to recognize that we are advocating that CMS reconsider its non-coverage recommendation for CTC during National Colorectal Cancer Awareness Month. Colorectal cancer is the third most diagnosed cancer in the United States and the second leading cause of death from cancer. The disease kills as many as breast cancer and AIDS combined and 1 in every 18 Americans will be diagnosed with colorectal cancer in their lifetime with an increasing incidence correlated with older age. This loss of life is tragic considering that the disease is almost always preventable through routine screening and is highly treatable.

GE Healthcare recognizes and supports the initiation of this national coverage analysis and we fully support a Medicare CRC screening program that includes a range of alternatives that maximizes patient compliance. Specifically, GE Healthcare strongly supports national Medicare coverage of CTC as a clinically effective, more patient acceptable alternative for CRC screening. GE Healthcare believes there are five critical topics regarding the CMS proposed decision of non-coverage for CRC screening with CTC that require elaboration:

• Adding CTC as an alternative will support increased CRC screening compliance
• CTC is a clinically effective CRC screening alternative
• CMS does not have the legal authority to incorporate cost effectiveness as an assessment criteria in its screening coverage decision making
• MedCAC inappropriately considered cost-effectiveness information
• There are several concerns regarding the Agency for Healthcare Research and Quality (AHRQ) cost-effectiveness analysis that must be remedied

Adding CTC as alternative will support increased CRC screening compliance

We all share the common goal to increase CRC screening compliance rates beyond the 50% level, a participation plateau that has not improved in many years. Since the issuance of this proposed decision, President Obama and the Office of Management and Budget in its overview of the 2010 federal budget specifically mention increased funding for disease prevention, specifically highlighting the low CRC screening rates.¹ As a department of the Executive Branch, CMS is responsible for helping to achieve these objectives of increased prevention and screening and can do so by adding CTC as an alternative for CRC screening.

Several key stakeholder groups advocate CTC as a CRC screening alternative. Clinical guidelines issued jointly by the American Cancer Society (ACS), the US Multi Society Task Force on Colorectal Cancer, and the American College of Radiology (ACR) which support CTC screening for colorectal cancer, and was a catalyst for CMS initiating its coverage analysis. Importantly, these guidelines whose primary goal is colon cancer prevention, include CTC as an acceptable option for the early detection of CRC and adenomatous polyps for asymptomatic adults aged 50 years and older.² These guidelines were influenced by the preliminary results of the American College of Radiology Imaging Network (ACRIN) prospective, multi-center national CTC trial. The preliminary findings demonstrated the clinical efficacy of CTC compared to optical colonoscopy (OC) and its potential to enhance colon cancer screening compliance. ACS guidelines for the early detection of colorectal cancer have emphasized options, and will continue to do so to enhance access to and uptake of screening, according to the ACS. Specifically the guidelines state, “it is our hope that these new recommendations will facilitate increased rates of CRC screening and that referring clinicians find these new guidelines ease some of the challenges they have experienced in promoting CRC screening to their patients.” 2 Also, twenty-six states plus the District of Columbia legislate CRC coverage in accordance with these ACS guidelines that include CTC³. With a Medicare non-coverage decision, Medicare patients, whom may have chosen CTC prior to entering the Medicare program, would be forced to choose a more invasive or less accurate screening procedure or forgo screening.

The American College of Gastroenterology believes CTC provides an acceptable screening option for patients, particularly for those who may not seek a screening procedure due to some aversion to existing options. They recently updated their screening guidelines and endorse CT Colonography for patients who decline colonoscopy⁴. In addition, new data has recently emerged that suggests that among U.S. patients, there is evidence of a willingness to pay for CRC screening that could translate to improved screening compliance that is necessary to save more lives from colorectal cancer.⁵ This data and the multiple sets of guidelines support the premise that adding CTC to the list of available screening tools would increase compliance.

CTC is a clinically effective CRC screening alternative

We believe there are sufficient data and clinical evidence to support CTC screening coverage under Medicare as evidenced by the ACRIN trial. In September 2008, The New England Journal of Medicine published the final results of the clinical data collected from 2,531 asymptomatic participants enrolled in 15 centers across the U.S., making it the largest and most comprehensive CTC screening trial to date. The results found that CTC screening identified 90% of patients with adenomas and cancers measuring 10 mm or more in diameter, supporting and extending previously published data regarding the role of CTC in screening patients with an average risk of colorectal cancer.⁶

Two respected U.S. Heath Technology Assessment organizations also recognize the clinical value of CTC as a CRC screening alternative. The February 2009 ECRI Institute Evidence report indicates that CT Colonography “… has a sensitivity of 91%…” for screening asymptomatic, average-risk individuals⁷ and has been shown to be more sensitive than other screening methods already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema^8,9. The rigorous health technology assessment organization, Blue Cross Blue Shield Technology Evaluation Center (TEC), also recently concluded that CTC meets all five TEC criteria for the purpose of colon cancer screening which address regulatory approval, health outcomes, procedure alternatives, and provider settings¹⁰.

With respect to CMS’ concerns regarding the ‘generalizability’ to the Medicare population GE Healthcare feels this concern is less significant as CRC screening is a benefit for patients 50 years and older and Medicare coverage may also include younger disabled populations. In addition, screening only Medicare subjects is not practical for comprehensive study within a prospective clinical trial, as demonstrated by the government sponsored ACRIN 6664 trial. Although not specifically studied in the ACRIN trial, CTC may actually be more appropriate and successful in the older Medicare population, given the potential for poor tolerance of the OC procedure secondary to an increased incidence of colonic outpouching (diverticulosis) and colonic redundancy, which can be associated with painful coiling of the colonoscope and potential perforation.¹¹

Relative to CMS questions regarding radiation harms, GE Healthcare recognizes concerns about potential risk associated with ionizing radiation in medical imaging and remains committed to developing safe and effective devices that improve net health outcomes for patients. The benefit to patients from diagnostic information delivered with CT imaging systems need to be balanced against associated radiation doses. When prescribing a CT scan, the trained physician must make this determination. In their analysis of mass screening for colorectal cancer using CT colonography, Brenner and Georgsson¹² found a favorable clinical balance: “in terms of radiation exposure, the benefit-risk ratio potentially is large for CTC”. Recent information communicated to MedCAC on patient dose from the multi-centric, multi-vendor ACRIN 6664 screening that utilized current CT imaging technologies and clinical protocols indicated that effective dose range was between 5-8 mSv¹³. The potential risk is even lower for the Medicare population due to the decreasing radiosensitivity of abdominal organs that occurs with increasing age. With over 60 million annual CT exams in the US, CT has demonstrated itself as a safe and effective tool that delivers the high detail images needed for accurate diagnosis and medical care.

We believe CMS’ concerns related to site patient dose variance will be addressed through facility accreditation processes that will be mandated for advanced imaging modalities via the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). Operator and physician training as well as formal accreditation programs play the key role in minimizing dose, reducing variance and assuring quality.

In response to stakeholder questions about long-term effects of low-level excess radiation, GE Healthcare’s products and many other CT scanners record examination parameters to facilitate both patient examination reporting and broad, long-term longitudinal studies to assess population trending. GE Healthcare actively collaborates with other industry partners and professional societies who are committed to responsible, safe, and effective use of imaging technology to reduce colorectal cancer mortality. An example of this collaboration is the creation of a new DICOM standards-based dose report being incorporated on CT image systems that enables exam dose information to be recorded, networked, and available for future reference, trending, and analyses.

CMS does not have the legal authority to use cost-effectiveness in evaluating CTC

Contrary to the view of CMS in the proposed decision memorandum, there is simply no authority in the Social Security Act or other applicable law (and CMS cites none) that allows consideration of cost-effectiveness when determining that a procedure or service is covered by Medicare for colorectal cancer screening. This lack of authority is confirmed by applicable CMS guidance and by a review of Medicare statutory provisions:

• CMS Guidance

  The agency has issued a final guidance document that states “[c]ost effectiveness is not a factor CMS considers in making NCDs . . .the cost of a particular technology is not relevant in the determination of whether the technology improves health outcomes or should be covered for the Medicare population through an NCD.”¹⁴ This CMS guidance makes no exception for colorectal cancer screening technology or any other type of health care intervention.

• Medicare Statutory Provisions

  Social Security Act §1861(ddd), as added by MIPPA §101(a)(1)(B), provides for Medicare coverage of certain “additional preventive services” that are “not otherwise described” in title XVIII of the Social Security Act. Colorectal cancer screening services are among the services that title XVIII describes. Thus, we agree with the CMS assumption in the proposed decision memorandum that coverage of colorectal cancer screening tests must be considered under a different statutory provision Social Security Act §1861(pp)(1)–- that is dedicated exclusively to coverage of colorectal cancer screening.

  That said, the method by which §1861(ddd) provides for the coverage of “additional preventive services” bears on the question of CMS authority to use cost-effectiveness in a coverage decision. Specifically, in the case of the specified class of technologies to which it applies, §1861(ddd) provides that the HHS Secretary must use Medicare’s national coverage process, and, in using this process, “may conduct an assessment of the relation between predicted outcomes and the expenditures for such service and may take into account the results of such assessment in making such determination.” Whatever the precise implications of this §1861(ddd) passage, it makes clear that Congress employs explicit language when it means to confer authority for the Secretary to inject economic considerations into Medicare coverage decisions. Such explicit language is lacking in the authorities applicable to colorectal cancer screening tests, and, indeed, as noted above, would be directly inconsistent with CMS’ own guidance document.

We note, in the interest of completeness, that §1861(pp) –- the provision dedicated exclusively to coverage of colorectal cancer screening tests – recognizes authority of the Secretary to apply appropriate “payment limits.” These limits, as the statute elsewhere makes clear,¹⁵ are pertinent only to the methodology for calculating payment amounts for services and have no relation to CMS authority to cover services. As a federal court recently held, the HHS Secretary lacks authority to use purported coverage limits to supersede otherwise applicable Medicare payment methodologies.¹⁶

MedCAC inappropriately considered cost-effectiveness information

At the MedCAC meeting, the panel received some background from the CMS representative on the relevance of MIPPA section 101 – the provision that enables coverage of “additional preventive services” under Social Security Act §1861(ddd). The MedCAC transcript reads as follows: “… Congress in passing the legislation that authorized coverage for colorectal cancer screening authorized us to look at the cost of these particular technologies in the assessment of coverage of these different technologies”.¹³ This explanation, while well intentioned, may have created some confusion among panel members about the relevance of the new law, and it might possibly have led them to conclude (incorrectly) that this provision impacted how CT colonography was to be considered. As noted above, and as the CMS proposed decision memorandum acknowledges, the statutory authority for this NCD derives from Section 1861(pp) of the Social Security Act, not the MIPPA-enacted provision. Because the MIPPA provision restricts CMS from covering preventive or screening services that are not supported by an evidence grade of “A” or “B” by the USPSTF, we are concerned that MedCAC panel members may have mistakenly concluded that the evidence bearing on CT colonography could not be considered to be adequate for coverage. We believe that a careful and full explanation of the law bearing on this issue was in order at the meeting, and we trust that this matter will be made clear in the final coverage determination. In any event, any CMS decision that relies on the MedCAC findings is suspect.

Finally, during the MedCAC meeting the panel heard testimony from the AHRQ regarding cost-effectiveness that was passed on a draft analysis that contained several analytical errors, including the misrepresentation of costs that overstated CTC procedure costs and understated optical colonoscopy procedure costs. We believe that based on the errors in the AHRQ report and the incorrect guidance that panel members received from CMS regarding the evaluation of cost-effectiveness, the MedCAC panel findings should not be used during the final coverage determination process.

There are concerns regarding the AHRQ cost effectiveness analysis that must be remedied

Although GE Healthcare believes that the Secretary does not have authority to consider cost effectiveness in this coverage decision, we have concerns regarding the AHRQ cost effectiveness analysis. The CMS proposed decision relies in part on an AHRQ cost effectiveness analysis that is improperly designed and based on outdated cost information, which leads AHRQ and CMS to conclude erroneously that CTC is not cost effective. We are concerned that AHRQ’s false conclusion about cost effectiveness may have also biased CMS’ interpretation of the clinical literature.

AHRQ’s study design characterizes CTC as a substitute for currently covered screening technologies (FOBT, flexible sigmoidoscopy, colonoscopy or barium enema). In fact, CTC is intended to augment existing screening technologies, not replace them. A properly designed cost-effectiveness analysis should compare costs and benefits of the current Medicare screening program to the costs and benefits of a screening program that includes CTC as an alternative screening technology to augment the overall strategy to CRC screening.

AHRQ gave passing and incomplete attention to this fundamental issue in a sensitivity analysis that evaluated how changes in compliance would affect the cost effectiveness of CTC. Not surprising, this analysis clearly demonstrated that the cost-effectiveness ratio of CTC increases dramatically when it results in more patients being screened. A more robust evaluation of CTC on the Medicare’s screening program can be constructed from results provided in Table 9 of AHRQ’s report; the incremental cost-effectiveness ratio for CTC vs. no screening ranges from $1,800 to $9,500 across the two CTC options and three models considered in AHRQ’s analysis.

CMS and AHRQ’s inconsistent characterization of screening technologies as being substitutes for new technologies on the one hand, and being additive to the screening benefit on the other, is apparent when comparing the current benefit design to AHRQ’s analysis. The Medicare screening benefit includes a wide range of choices for Medicare beneficiaries. However, many of these options are not on the “efficient frontier”¹⁷ estimated by AHRQ and should, if logic holds, not be covered on pure cost effectiveness grounds. The fact that Medicare currently covers colorectal cancer screening options that are not efficient proves that factors other than clinical evidence and cost effectiveness - such as patient choice - are critical elements of coverage decisions.

In addition to being incorrectly designed, AHRQ’s analysis also relies on outdated and understated costs for screening colonoscopy.¹⁸ AHRQ estimated the cost of a screening colonoscopy to be $522.47 based on 2007 data.¹⁹ However, the comparable cost of a screening colonoscopy is $569.79 based on 2009 data.²⁰

We urge CMS to review the AHRQ analysis based on the additional beneficiaries that can be screened as part of a comprehensive program that includes CTC as an alternative.

In conclusion, GE Healthcare reiterates its support for CTC as a CRC screening alternative to provide a more patient acceptable, clinically effective test to help policymakers increase the low screening compliance rates to prevent CRC. We believe there is sufficient clinical evidence, and there are the necessary clinical guidelines and process infrastructure in place to ensure the safe and effective use of CTC in clinical settings.

We appreciate the opportunity to comment on this proposed decision memorandum, and look forward to providing CMS with any additional information that would be of value for the final decision on screening CTC for colorectal cancer.

Sincerely,

cc:
Carolyn Clancy, MD
Director, Agency for Healthcare Research and Quality

1 Office of Management and Budget. Jumpstarting the Economy and Investing for the Future. Available at: http://www.whitehouse.gov/omb/assets/fy2010_new_era/Jumpstarting_The_Economy.pdf. Accessed March 5, 2009.

2 Levin B, Lieberman DA, McFarland B et al. Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008: A Joint Guideline from the American Cancer Society, the US Multi- Society Task Force on Colorectal Cancer, and the American College of Radiology. CA Cancer J Clin 2008 March 5.

3 American Cancer Society. Colorectal Cancer Facts & Figures 2008-2010. Available at: http://www.cancer.org/downloads/STT/F861708_finalforweb.pdf. Accessed March 11, 2009.

4.Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM. American college of gastroenterology guidelines for colorectal cancer screening 2008. Am J Gastroenterol. 2009;104:739-50.

5 Marshall DA, Johnson FR, Kulin NA et al. How do physician assessments of patient preferences for colorectal cancer screening tests differ from actual preferences? A comparison in Canada and the United States using a stated-choice survey. Health Econ. 2009.

6 Johnson, CD, M.D., M.M.M., Chen, MH, Ph.D., et al, Accuracy of CT Colonography for Detection of Large Adenomas and Cancers, New England Journal of Medicine, 2008; 359:1207-1217.

7 ECRI Institute. Computed Tomographic (CT) Colonography for Colorectal Cancer Screening and Diagnosis. Available at: https://members2.ecri.org/Components/EvidenceReports/Documents/IssueFiles/TX1990.pdf. Accessed March 5, 2009.

8 Winawer, Sidney J., M.D., et al. A Comparison of Colonoscopy and Double-Contrast Barium Enema for Surveillance after Polypectomy. New England Journal of Medicine, 2000; 342:1766-72.

9 Imperiale TF, Wagner DR, Lin CY, Larkin GN, Rogge JD, Ransohoff DF. Risk of advanced proximal neoplasms in asymptomatic adults according to the distal colorectal findings. N Engl J Med 2000 July 20;343(3):169-74.

10 Blue Cross Blue Shield Association. CTC Colonography (“Virtual Colonoscopy”) for Colon Cancer Screening. Available at: http://www.bcbs.com/blueresources/tec/press/ct-colonography-virtual.html. Accessed March 5, 2009.

111 Ko CW, Sonnenberg A. Comparing risks and benefits of colorectal cancer screening in elderly patients. Gastroenterology 2005 October;129(4):1163-70.

12 Brenner DJ, Georgsson MA. Mass screening with CT colonography: should the radiation exposure be of concern? Gastroenterology 2005 July;129(1):328-37.

13 CMS: Centers for Medicare and Medicaid Services Medicare Evidence Development and Coverage Advisory Committee RE: Screening Computed Tomography Colonography (CTC). Available at: http://www.cms.hhs.gov/FACA/downloaads/id45c.pdf. Accessed: March 5, 2009.

14 Guidance for the Public, Industry and CMS Staff, “Factors CMS Considers in Opening a National Coverage Determination” (April 11, 2006).

15 See, e.g., Social Security Act 1834(d) (“Frequency Limits and Payment for Colorectal Cancer Screening Tests”).

16 See, Hays and Dey, L.P. v. Leavitt, 583 F. Supp. 2d 62 (D.D. 2008) (HHS Secretary could not apply a purported coverage limit based on “least costly alternative” to override Medicare Part B drug payment methodology).

17 For example, the only two efficient strategies from the CRC-SPIN model are hemoccult SENSA and colonoscopy.

18 We appreciate AHRQ responding to our previous comment by correctly including anesthesia costs in the cost of a screening colonoscopy in their final report.

19 $497.59 inflated by 5% to account for repeat colonoscopies.

20 Outpatient facility payments for optical colonoscopy increased substantially after 2007.

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March 13, 2009

Marcel E. Salive, M.D., M.P.H.
Director, Division of Medical and Surgical
Services
Centers for Medicare and Medicaid Services
Coverage and Analysis Group
7500 Security Blvd
Mail Stop C1-09-06
Baltimore, MD 21244

Re: Proposed Decision Memo for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N)

Dear Dr. Salive:

The American College of Radiology (ACR), representing over 32,000 diagnostic radiologists, interventional radiologists, radiation oncologists, nuclear medicine physicians and medical physicists, the Society of Gastrointestinal Radiology (SGR), and the Society of Computed Body Tomography and Magnetic Resonance (SCBT) are pleased to submit comments in response to the Proposed Decision Memo for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N). Briefly stated, we disagree with the Centers for Medicare and Medicaid Services (CMS) proposal that: “The evidence is inadequate to conclude that CT colonography is an appropriate colorectal cancer screening test under §1861(pp)(1) of the Social Security Act. CT colonography for colorectal cancer screening remains noncovered.” We urge CMS to reverse this proposal and provide coverage of screening CTC to increase the number of Medicare beneficiaries who could receive potentially life-saving screening for colorectal cancer. Our comments are organized into three main sections. In the first section, we summarize the key points that we made in response to the National Coverage Analysis (NCA) for Screening CTC for Colorectal Cancer (CAG-00396N). A copy of the June 16, 2008 ACR, SGR, and SCBT comment letter is attached.

In the second section, we address CMS concerns related to:

March 13, 2009

Charlene Frizzera, Acting Administrator
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard, Room 314G
Baltimore, MD 21244-1850

Dear Ms. Frizzera:

On behalf of Philips Healthcare (Philips), I am delighted to have this opportunity to comment on the Proposed Decision Memo for Screening Computed Tomography Colonography (“CTC”) for Colorectal Cancer (“CRC”) (CAG-00396N) (Proposed Decision). 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 computed tomography, as well as X-ray, ultrasound, magnetic resonance, nuclear medicine, PET, radiation oncology systems, patient monitoring, information management, personal emergency response systems, and resuscitation products.

Philips has significant concerns about the Proposed Decision and strongly urges CMS to extend Medicare coverage to CTC under the CRC benefit without awaiting any additional data. We do not believe that additional clinical or other information is necessary for CMS to determine that CTC is a clinically effective and appropriate screening test for CRC.

We are concerned that the Proposed Decision, if finalized in its present form, will deny to Medicare patients a benefit that is increasingly available to younger individuals covered by non-governmental payers. Twenty-six states currently mandate coverage for those colorectal cancer screening tests (including CTC) that are recognized by the American Cancer Society (ACS). Commercial payers, including Cigna and United Healthcare, have begun covering CTC as one method for conducting CRC screening, and more payers are likely to follow suit. Yet the Proposed Decision would deny coverage of CTC to Medicare patients precisely that patient population most at risk for CRC, and precisely that patient population for whom optical colonoscopy presents the greatest risk of complications.

CMS indicates that its proposal to deny Medicare coverage of CTC for CRC screening is based on its conclusions with respect to two issues:

March 13, 2009

Charlene Frizzera, Acting Administrator
Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services
7500 Security Boulevard, Room 314G
Baltimore, MD 21244-1850

Dear Ms. Frizzera:

We, the undersigned organizations, write to request that the Centers for Medicare and Medicaid Services (CMS) cover computed tomography colonography (CTC) under a national coverage determination. We fully support national Medicare coverage of CTC as an acceptable minimally invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer. The proposed CMS decision not to cover CTC is clearly contrary to the Administration’s public policy goals of expanding access to healthcare and enhancing prevention.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC and provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the second leading cause of death from cancer. The disease kills as many as breast cancer and AIDS combined, and one in every eighteen Americans will be diagnosed with colorectal cancer in their lifetime.

The American Cancer Society estimates that in 2008 about 148,810 people were diagnosed with colorectal cancer, and 49,960 people died from the disease. Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Additionally, cancer is a disease that disproportionately affects the elderly, more than 70 percent of all new cancer diagnoses occur in the elderly population.

Currently, many Americans are reluctant to undergo traditional colonoscopies due to various perceptions. These perceptions have a particularly adverse affect on the Hispanic and African American populations and their obtaining a colorectal cancer screening. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations by providing another vital screening option.

When comparing the value of CTC to no screening at all, the benefit is clear. For patients who are not properly screened and learn they have late-stage cancer the costs are devastating. It is estimated that for every one dollar spent on colorectal screening, three dollars in treatment costs are saved.

We appreciate your consideration in this important matter. Medicare coverage of CTC would provide a critical opportunity to save lives from cancer, end unbearable suffering, as well as save taxpayer dollars. We look forward to working with you to provide America’s seniors with access to CTC as another important tool to be considered in the fight against colon cancer.

Sincerely,
American College of Radiology
Colon Cancer Alliance
Colorectal Cancer Coalition
Medical Imaging & Technology Alliance

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March 13, 2009

Charlene Frizzera
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Room 445-G, Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

RE: CAG-00396N; Medicare Program; Proposed Decision Memo for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer

Dear Ms. Frizzera,

The American Cancer Society (the Society) respectfully submits the following comments for your consideration regarding the Centers for Medicare & Medicaid Services' (CMS') proposed national coverage decision for screening Computed Tomography Colonography (CTC) for colorectal cancer.

More than 70 percent of all new cancer diagnoses occur in the elderly population.¹ The Society is dedicated to ensuring that our nation's seniors have access to evidence-based screening tests that can help prevent the development of cancer, improve survival, and decrease mortality by detecting cancer at an early stage, when treatment is more effective. Promoting access to prevention and early detection of cancer is a top priority for the Society, and we look forward to working with CMS to promote cancer awareness and increase cancer screening rates among our nation's seniors.

The Society's Concerns Regarding CMS's Proposal to Not Cover Computed Tomography Colonography (CTC) Screening for Colorectal Cancer:

Colorectal cancer screening is already underutilized among Medicare beneficiaries. The Society is extremely concerned that CMS' proposed decision to deny coverage for screening CT Colonography has the potential to affect millions of Medicare beneficiaries who may need this option to have access to life saving colorectal cancer screening test or may prefer this option compared with other covered tests. Due to variability in access, patient preferences, and physician options, CMS should cover all recommended colorectal cancer screening options as acceptable choices. CTC should not be considered or evaluated as a replacement for other existing colorectal cancer screening strategies; rather it should be included as an additional effective option to increase overall adherence with screening guidelines.

Adding CT Colonography Would Help Increase Screening Rates:

Despite the known benefits of colorectal cancer screening in preventing or detecting cancer early, only about half of adults over age 50 currently report receiving a regular colorectal screening test. As a result, only 39% of cases are diagnosed when the disease is still localized. Diagnosis at later disease stages results in significantly lower survival.¹ Given clear evidence that adults vary in their preferences for various colorectal cancer screening options, providing a full range of evidence based screening options, including CTC, is vitally important to increase uptake of appropriate colorectal cancer screening to combat this deadly, yet preventable and treatable disease.

There is a growing literature that shows that some adults prefer CTC to other options. White and colleagues evaluated screening in a high risk cohort in the United Kingdom and reported that CTC was preferred by adults in this study compared with other screening options.² A recent conjoint analysis comparing attributes of the different options for colorectal cancer screening in a multi-ethnic sample of U.S. adults showed that virtual colonoscopy was ranked highest in preference compared with other screening tests.³ Rajapaska and colleagues also observed a non-significant preference for CTC over optical colonoscopy overall, but a significant preference for CTC among whites compared with blacks.⁴ In a recent University of Wisconsin Hospital and Clinics study, researchers found that colorectal screening rates increased with the introduction of CTC and did not cause a corresponding drop in number of endoscopic colonoscopy rates.⁵ They found that introducing the CTC actually generated a surplus of patients seeking colorectal cancer screening and also helped eliminate the 12-month backlog of people on the waiting list for screening colonoscopy. Further, initiation of the CTC program appeared to draw in patients that otherwise would not have been screened.

Although numerous screening options complicate the shared decision making process, it is clear that a growing proportion of adults and referring physicians prefer full structural exams compared with stool tests. The growing preference and rate of referral for colonoscopy has been viewed with concern because while colonoscopy is an option for screening, it is the appropriate test for following up a positive colorectal cancer screening test. Seeff and colleagues have shown that current colonoscopy capacity is probably adequate to meet current demands, but it is not adequate to meet current needs.⁶ Thus, while it is not certain that coverage for CTC will increase screening rates overall, the fact that some adults prefer CTC to other screening tests, and that coverage would increase availability of CTC and thus overall capacity to perform full structural exams, it is reasonable to expect that coverage for CTC will increase screening rates in the Medicare population.

Generalizing the Evidence for the Medicare Population:

The proposed decision memo expressed concern about the generalizability of the study results to the Medicare population because 'the mean age of participants in these studies was considerably younger than the Medicare aged population' and noted that 'estimates of test parameters for older participants ≥ 65 years of age are needed.'

To address this concern about sufficiency of data, the Society urges CMS to apply a national coverage with evidence development (CED) approach that includes development and use of a registry to obtain and evaluate data that will help the medical community better understand colorectal cancer screening patterns in the Medicare population.

The Society believes CTC screening would be appropriate for CED and the language in section 1861(pp)(1)(D) of the Social Security Act [42 U.S.C. 1395x] allows it:

(pp)(1) The term 'colorectal cancer screening test' means any of the following procedures furnished to an individual for the purpose of early detection of colorectal cancer:

(A) Screening fecal-occult blood test.

(B) Screening flexible sigmoidoscopy.

(C) Screening colonoscopy.

(D) Such other tests or procedures, and modifications to tests and procedures under this subsection, with such frequency and payment limits, as the Secretary determines appropriate, in consultation with appropriate organizations.

CTC qualifies under CED policy as an 'appropriate' test or procedure under (D) and evidence has established it is a reasonable and medically necessary test. Under section 1862(a)(1)(E) of the Social Security Act, the national coverage determination process may result in coverage with special conditions, where an item or service is covered only when provided within a setting in which there is a pre-specified process for gathering additional data. This type of CED would allow CMS to collect the data noted as lacking in the proposed coverage decision.

The American College of Radiology (ACR) developed a CTC Registry to collect information on how CTC is currently practiced and to provide quality and performance measures. By requiring the adequate reporting of CTC findings as part of coverage with appropriateness determination requirement using the CTC registry, CMS would be able to develop and evaluate the evidence for the appropriate use of CTC in the Medicare population and help further our progress toward achieving the ultimate goal of increased prevention and early detection of colorectal cancer.

The decision memo was not specific about possible reasons why CTC would perform more poorly in Medicare beneficiaries compared with other currently approved screening options, specifically colonoscopy. The relevant issues would be acceptance, operating performance (sensitivity, specificity, diagnostic yield, positive predictive value, etc.), and harms. As noted above, the current literature indicates that there is good acceptance of CTC, and in some studies it is preferred over other screening tests. We can not think of any reason why the comparative accuracy of CTC vs. colonoscopy for advanced lesions and cancer would be different in the Medicare population compared with populations (typically younger) that have participated in studies to date. One recently published study by Yucel, et al. of CTC in older patients (range 60-87 years) who had either incomplete colonoscopy or contraindications for colonoscopy found that CTC was well tolerated by the majority of patients, and was successful in imaging the entire colon.⁷

Cooper, et al. reviewed 1999 Medicare claims data for all fee-for-service Medicare beneficiaries who were over the age of sixty-five and underwent colonoscopy (~ 1.8 million colonoscopy exams) to estimate the proportion of procedures with polypectomy. Using several definitions of polyp detection based on current procedural terminology (CPT) codes, Cooper and colleagues identified a rate of polyp detection or colonoscopic yield ranging from 23.9% to 35.7%.⁸ These findings are consistent with observations by Lin, et al.⁹ Their study was not able to classify procedures by polyp size, so it is likely that this number includes a significant number of polyps < 6 mm in size. Both these studies indicate that the proportion of adults sixty-five and over that would be referred to therapeutic colonoscopy after CTC would be considerably lower than current practice since many of the polyps detected would be less than 6 mm in size.

With respect to harms, there is a growing literature on procedure related harms associated with CTC, and an extensive literature on colonoscopy related harms. In general, procedural related harms are lower with CTC compared with colonoscopy, and post examination complications are higher in older adults that that have undergone biopsy or polypectomy.^{10, 11} To the degree that some post-colonoscopy complications occur as a result of biopsy and removal of small polyps (< 6 mm) with limited malignant potential, the use of CTC in the Medicare population may be uniquely advantageous due to the likely lower rate of procedural or post examination adverse events.

Cost-effectiveness of CT Colonography:

CTC provides a time-efficient procedure with good accuracy and minimal invasiveness. No sedation or recovery time is required, nor is a chaperone needed to provide transportation after the procedure.

Similar to colonoscopy, recent studies have shown that CTC is a cost-effective test. Pickhardt, et al. found CTC with non-reporting of diminutive lesions was found to be the most cost-effective and safest screening option evaluated. These results provide further support for the practice of a ≥ 6-mm polyp size reporting threshold at CTC screening. In general, diminutive colorectal polyps appear to cause an unjustified cost burden and increase the complication rate for colorectal cancer screening, without a substantial concomitant improvement in clinical efficacy. Moreover, their removal results in patients entering an on-going protocol of short-term follow-up, resulting in significant excess costs to a screening program with little benefit.¹² The use of primary CTC screening as a selective filter for OC polypectomy for lesions measuring 6 mm or greater represents a potentially powerful new approach to colorectal cancer screening.¹³

The research cited in the proposed memo indicating diminished cost effectiveness of CTC has notable limitations. As noted in the Zauber, et al. analysis, costs for colorectal cancer treatment were for the period 1998 to 2003 when use of the expensive biological therapies cetuximab and bevacizumab was limited.¹⁴ Zauber, et al. concluded that:

'Inclusion of these costs as later data become available would make the cost-effectiveness more favorable overall. Colorectal cancer screening offers two potentially beneficial effects:

1) Primary prevention of colorectal cancer through detection and removal of adenomas that might have eventually become cancer, and2) Early detection of colorectal cancer, when it is in an earlier stage that is more amenable to treatment.

In general, those strategies that are associated with a higher reduction in cancer incidence (i.e., act largely through primary prevention rather than early detection,) will deliver a greater net savings.'

Furthermore, the indirect costs and costs borne by patients are not accounted in the Zauber, et al. study. For example, the analysis does not include cost of anesthesia for colonoscopy, which may impose a significant burden on patients in both time and expense. The Zauber analysis also modeled a best practice model of colonoscopy and follow-up, rather than the true, higher rate of non-recommended patterns of short-term follow-up that have been observed for individuals with diminutive, hyperplastic polyps, or even individuals with normal exams who are screened more frequently than every 10 years.

Zauber's study also did not look at the costs that can be saved in the screening and follow-up process if a positive CTC is immediately followed by an optical colonoscopy on the same day. Where such access is available, and anecdotal evidence suggests that institutions where CTC is available are attempting to accommodate same day colonoscopy for patients with a lesions identified on CTC, this may increase adherence to follow-up after diagnosis and increase the cost-effectiveness of CTC.

Extracolonic Findings:

The identification of extracolonic findings also has been an issue of concern, and the decision memo expressed apprehension about the magnitude of these findings and possible harms associated with further evaluation. Although the overall rates of extracolonic findings have been highly variable, the incidence of clinically significant extracolonic findings at CTC has ranged from 4.5-11% in various patient cohorts, and actual workup rates tend to be lower based on known diagnoses or clinical circumstances.^15-18 In an asymptomatic screening population, the incidence of unsuspected but potentially important extracolonic findings seems to be less than 5 %, and workup rates appear to be lower.¹⁹ While this rate is considerably lower than the broad baseline rates for all findings, it still represents an important added cost for which there are both potential benefits (i.e., aneurysms, other solid tumors, etc.) and harms (false positives). In the American Cancer Society, American College of Radiology and U.S. Multi-Society Task Force on Colorectal Cancer guidelines update, we noted that implementation of structured reporting of extracolonic findings and trends of subsequent diagnostic work-up will warrant careful review with ongoing quality metrics through the National Radiology Data Register (NRDR), ACR's national data warehouse.²⁰ Rather than question the wisdom of screening with CTC due to the occurrence of extra-colonic findings, we believe it is important to gather data and develop protocols that provide for the use of CTC to screen for colorectal cancer and advanced lesions while minimizing costs and harms false positive extracolonic findings.

Radiation Risk:

The possibility of harms associated with radiation exposure has been a source of on-going dispute, and it is a debate that is entirely based on inferential data. Most of the concerns in the literature about CT exposures are applicable to early life exposures, multiple examinations done on individuals with persistent chronic conditions and over utilization in emergency rooms. These concerns are less applicable to a screening examination that would take place only once every 5 years in individuals over the age of 50, and potentially, only once every 10 years if the screening interval is lengthened. In a critique of over-utilization of CT in everyday imaging, Brenner, et al. addressed the issue of radiation dose for screening CTC and concluded the benefit-risk ratio for colorectal cancer screening is high.²¹ Most estimates of the potential cancer risk related to low-dose radiation exposures during medical procedures derive from linear non-threshold models based on the long-term outcomes in survivors of acute radiation doses from atomic weapons, but there is controversy over whether this model is applicable to low-dose medical exposures.²² In addition, such statistical data are theoretical and are not based on an observed cause-effect relationship from cumulative low-dose medical exposures. In a recent position statement issued by the Health Physics Society, the health effects of low-dose radiation exposure (defined as below 50-100 mSv - a threshold many times higher than typical CTC levels) were considered to be 'either too small to be observed or are nonexistent'.²³ It also is important that we not confuse exposures and effective dose from daily CT protocols vs. screening, or to compare older protocols with newer ones. In one recent study, the median effective dose from CTC screening exams conducted at multiple sites was 5.7 mSv compared with 9.1 mSv for daily protocols.²⁴ Furthermore, these exposures have been going down over time. Current ACR guidelines for CTC stress that use of low dose techniques for CTC will be essential to minimize radiation dose in screening and surveillance patients.²⁵ Modern techniques are using doses that are roughly half of what is commonly cited as an average dose for a CTC exam.²⁴ Given that susceptibility to the effects of ionizing radiation decrease with increasing age, the low effective organ dose associated with CTC screening means the theoretical risk of radiation induced cancers is very, very low, and that the true benefit from screening significantly outweighs any theoretical risk of radiation induced harm.

Conclusion:

The Society urges CMS to reconsider its proposed decision on CTC, or at the very least, apply a CED approach. The evidence shows that CTC has similar operating characteristics to colonoscopy for lesions of important size and, in analyses that have considered relevant parameters, is cost-effective. Presently there is room for improvement in the quality of all the current screening options for colorectal cancer and, over time, it is likely that guidelines will evolve to tailor the technology to age and risk. In this respect, more remains to be learned about best practices with each of the screening tests. Unless we gain more experience with the use of CTC in settings with effective surveillance systems, and unless there is reimbursement to fuel an increase in utilization, capacity, and experience in delivering this test, we will not likely have answers to the questions posed by CMS in the decision memo.

The Society appreciates the hard work CMS has invested in evaluating the evidence supporting the CTC test, and we stand ready to work with you to improve colorectal cancer screening rates and reduce the cancer burden among Medicare beneficiaries.

Respectfully,
Otis W. Brawley, M.D.
Chief Medical Officer

1.American Cancer Society. American Cancer Society Facts and Figures. Atlanta: American Cancer Society; 2008.
2.White TJ, Avery GR, Kennan N, Syed AM, Hartley JE, Monson JR. Virtual colonoscopy vs conventional colonoscopy in patients at high risk of colorectal cancer a prospective trial of 150 patients. Colorectal Dis. 2009;11:138-145.
3.Hawley ST, Volk RJ, Krishnamurthy P, Jibaja-Weiss M, Vernon SW, Kneuper S. Preferences for colorectal cancer screening among racially/ethnically diverse primary care patients. Med Care. 2008;46:S10-16.
4.Rajapaksa RC, Macari M, Bini EJ. Racial/ethnic differences in patient experiences with and preferences for computed tomography colonography and optical colonoscopy. Clin Gastroenterol Hepatol. 2007;5:1306-1312.
5.Schwartz DC, Dasher KJ, Said A, et al. Impact of a CT colonography screening program on endoscopic colonoscopy in clinical practice. Am J Gastroenterol. 2008;103:346-351.
6.Seeff LC, Manninen DL, Dong FB, et al. Is there endoscopic capacity to provide colorectal cancer screening to the unscreened population in the United States? Gastroenterology. 2004;127:1661-1669.
7.Yucel C, Lev-Toaff AS, Moussa N, Durrani H. CT colonography for incomplete or contraindicated optical colonoscopy in older patients. AJR Am J Roentgenol. 2008;190:145-150.
8.Cooper GS, Chak A, Koroukian S. The polyp detection rate of colonoscopy: a national study of Medicare beneficiaries. Am J Med. 2005;118:1413.
9.Lin OS, Kozarek RA, Schembre DB, et al. Screening colonoscopy in very elderly patients: prevalence of neoplasia and estimated impact on life expectancy. Jama. 2006;295:2357-2365.
10.Levin TR, Zhao W, Conell C, et al. Complications of colonoscopy in an integrated health care delivery system. Ann Intern Med. 2006;145:880-886.
11.Rabeneck L, Paszat LF, Hilsden RJ, et al. Bleeding and perforation after outpatient colonoscopy and their risk factors in usual clinical practice. Gastroenterology. 2008;135:1899-1906, 1906 e1891.
12.Mysliwiec PA, Brown ML, Klabunde CN, Ransohoff DF. Are physicians doing too much colonoscopy? A national survey of colorectal surveillance after polypectomy. Ann Intern Med. 2004;141:264-271.
13.Pickhardt PJ, Hassan C, Laghi A, Zullo A, Kim DH, Morini S. Cost-effectiveness of colorectal cancer screening with computed tomography colonography: the impact of not reporting diminutive lesions. Cancer. 2007;109:2213-2221.
14.Zauber AG, Lansdorp-Vogelaar I, Wilschut J, Knudsen AB, van Ballegooijen M, Kuntz K. Cost-Effectiveness of DNA Stool Testing to Screen for Colorectal Cancer: Report to AHRQ and CMS from the Cancer Intervention and Surveillance Modeling Network (CISNET) for MISCAN and SimCRC Models Rockville: Agency for Health Care Quality and Research; 2007:1-84.
15.Hara AK, Johnson CD, MacCarty RL, Welch TJ. Incidental extracolonic findings at CT colonography. Radiology. 2000;215:353-357.
16.Gluecker TM, Johnson CD, Wilson LA, et al. Extracolonic findings at CT colonography: evaluation of prevalence and cost in a screening population. Gastroenterology. 2003;124:911-916.
17.Pickhardt PJ, Choi JR, Hwang I, et al. Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. N Engl J Med. 2003;349:2191-2200.
18.Yee J, Kumar NN, Godara S, et al. Extracolonic abnormalities discovered incidentally at CT colonography in a male population. Radiology. 2005;236:519-526.
19.Pickhardt PJ, Taylor AJ. Extracolonic findings identified in asymptomatic adults at screening CT colonography. AJR Am J Roentgenol. 2006;186:718-728.
20.Levin B, Lieberman DA, McFarland B, et al. Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008: A Joint Guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. CA Cancer J Clin. 2008;58:130-160.
21.Brenner DJ, Georgsson MA. Mass screening with CT colonography: should the radiation exposure be of concern? Gastroenterology. 2005;129:328-337.
22.Ron E. Ionizing radiation and cancer risk: evidence from epidemiology. Radiat Res. 1998;150:S30-41.
23.Radiation Risk in Perspective: Health Physics Society; 2004.
24.Liedenbaum MH, Venema HW, Stoker J. Radiation dose in CT colonography trends in time and differences between daily practice and screening protocols. Eur Radiol. 2008;18:2222-2230.
25.American College of Radiology. ACR Practice Guideline for the Performance of Computed Tomography (CT) Colonography in Adults: American College of Radiology; 2006.

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The faculty of UT M.D. Anderson Cancer Center whose research and clinical expertise relate specifically to colorectal cancer screening and prevention, would like to register our strong opposition to the recent proposed decision by CMS to deny coverage for CT colonography (CTC) as an appropriate colorectal screening test under Section 1861(pp)(1) of the Social Security Act. We find the scientific data as summarized in the proposed decision memo to be clinically compelling and entirely sufficient to justify reimbursement for this screening in the Medicare population. We encourage CMS to reconsider its decision and have submitted a letter signed by the aforementioned faculty to CMS detailing the rationale underlying our opposition. Thank you for this opportunity to provide comments on the draft decision. We strongly urge CMS to reconsider its position and firmly believe that together we can make colorectal cancer a preventable disease. Thank you.

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I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients. The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

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I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients.

The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

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March 12, 2009

Steve E. Phurrough, MD, MPH
Center for Medicare & Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244-1850

Re: Proposed Decision Memo for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N)

Dear Dr. Phurrough:

As representatives of the faculty of the Memorial Sloan-Kettering Cancer Center we wish to voice our strong opposition to CMS’ recent proposed decision to deny coverage for CT colonography (CTC) as an appropriate colorectal cancer (CRC) screening test under Section 1861(pp) (1) of the Social Security Act. Members of MSKCC’s faculty have spent the last three decades pressing the case for colorectal cancer prevention, screening and polyp detection and developing innovative combined modality treatments for localized and advanced colorectal cancer.We find the evidence-based data reviewed in the proposed decision memo scientifically robust and sufficient to support reimbursement for CTC in the Medicare population. The basis of our opposition to the draft decision is as follows:

1. Current screening for the #2 cancer killer in the USA is inadequate. An estimated 1/3 to 1/2 of patients who are eligible for CRC screening fail to undergo screening. A percentage of these will instead present with CRC at a later stage of disease with higher morbidity and mortality due to a missed opportunity to screen for this essentially preventable disease. Many of the reimbursed methods of screening do not directly detect pre-cancerous lesions with great accuracy (FOB, sigmoidoscopy, barium enema) and are incomplete surveys of the polyp-bearing colonic mucosa. CTC is a total colon examination that succeeds even where other tests fail. As such, this additional screening method, proven to perform at least as well as colonoscopy for advanced adenomas in large multicenter trials, is needed to address the current deficiency.

2. The aging US population at greater risk for colorectal cancer. Persons 65 and older and those in an ever-increasing lower socioeconomic bracket in this country are at greater risk for polyps and CRC. CMS has courageously reached out to this population in the past by supporting screening for other at-risk cancers by reimbursing the Pap smear and mammogram. Fortunately, CMS supports a number of CRC screening methods in recognition of the importance and potential burden of lost lives and dollars from CRC. As the number of elderly and poor increase, resources for screening this growing population will fall short. Reimbursing CTC, will provide another screening method and will also bring imaging specialists into the fold - a good start toward increasing resources.

3. An economic imperative and bold initiative in our evolving public health strategy. Prevention of disease has not been a strong enough initiative worldwide, but especially in the US. The growing cost of healthcare in this country, though partly due to a technological revolution, primarily addresses diseases at more advanced stages. Even in the best of economic times cutting unnecessary costs makes good sense. In these extraordinary times however, bold new initiatives and a departure from failed strategies is imperative. We must aim to prevent CRC and others. The cost of a screening test such as CTC or colonsocopy and a subsequent polypectomy pale in comparison to a 3-day hospital admission and a laparoscopic colectomy for the same polyp 5-10 years in the future when it has become an invasive cancer. On a larger scale, in addition to lives saved, vast dollar-savings could realized through the use of screening and prevention, resources of which could then be used for further research into yet other methods to screen for disease. It is in CMS’ interest to pioneer this trend and set the stage for ultimate cost-cutting and lives-saving.

4. Cost and risk benefit. Although cost estimates vary, and may be higher for colonoscopy when performed in-hospital and to non-Medicare patients than the $500 charged to Medicare, CTC could potentially reduce the cost and risk of screening for the majority of patients who will be proven not to have polyps compared with colonoscopy. The total cost of colonoscopy must include anesthesia, recovery room space and personnel and lost work-hours. The risks are rare when no polypectomy is performed. CTC costs less and does not incur the risk of sedation. The radiation used in a screening CTC is far less than for a diagnostic CT examination.

We appreciate this opportunity to offer comments on the draft decision and strongly urge CMS to reconsider its decision to deny CTC reimbursement. We look forward to a constructive joint effort in working with CMS to help make CRC a more preventable disease!

Sincerely,

Robert C. Kurtz, MD
Chief, Gastroenterology and Nutrition Service
Department of Medicine
Member, Memorial Sloan-Kettering Cancer Center

Sidney J. Winawer, MD
Former Chair of the U.S. Multisociety Task Force on Colorectal Cancer
Member and former Chair, Gastroenterology and Nutrition Service,Department of Medicine
Member, Memorial Sloan-Kettering Cancer Center

Marc J. Gollub, MD
Director CT,Department of Radiology
Associate Member, Memorial Sloan-Kettering Cancer Center

Hedvig Hricak MD, PhD, h.c
Chairman, Department of Radiology
Member, Memorial Sloan-Kettering Cancer Center

W. Douglas Wong, MD
Chief, Colorectal Surgery Service
Department of Surgery
Member, Memorial Sloan-Kettering Cancer Center

David P. Kelsen, MD
Chief, Gastrointestinal Oncology
Member, Memorial Sloan-Kettering Cancer Center

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March 13, 2009

Ms. Charlene Frizzera
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health & Human Services
Baltimore, MD 21244-8016

Dear Ms. Frizzera:

The Medical Imaging and Technology Alliance (MITA), a division of the National Electrical Manufacturer's Association (NEMA), appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS) Proposed Decision Memorandum for Screening Computed Tomography Colonography (CTC) for colorectal cancer (the "Proposed Decision").¹ As the leading trade association representing companies whose sales comprise over ninety five percent of the global market for medical imaging and radiotherapy, we have an in-depth understanding of the significant benefits to the health of Medicare beneficiaries that medical imaging, radiotherapy and proton therapy provides. MITA looks forward to working with you to continue to improve the healthcare of Medicare beneficiaries through appropriate use of these technologies for the early detection, diagnosis, staging, therapy monitoring, and surveillance of many diseases.

Medical imaging encompasses X-ray imaging, computed tomography (CT) scans, radiation therapy, related image acquisitions, diagnostic ultrasound, and nuclear medical imaging (including positron emission tomography (PET)), and magnetic resonance imaging (MRI). Medical imaging is used to diagnose patients with disease, often reducing the need for costly medical services and invasive surgical procedures.² In addition, medical imaging equipment often is used to select, guide and facilitate effective treatment, for example, by using image guidance for surgical or radiotherapeutic interventions.³ MITA's members also develop and manufacture innovative radiotherapy equipment used in cancer treatment.

We are pleased to offer these comments on the Proposed Decision, although we are greatly disappointed that CMS proposes not to cover screening CTC under the colorectal cancer screening benefit. Currently, only one out of four senior citizens receives a Medicare-covered screening test for colorectal cancer.⁴ According to the American Cancer Society (ACS), more than 147,000 new cases were diagnosed and more than 57,000 people died from colorectal cancer in 2007.⁵ The ACS further states that many of the deaths caused by colorectal cancer can be prevented if detected in early stages.⁶ Noting that fewer than 50 percent of Americans receive any type of colon cancer screening, President Obama identified expanding use of screening as a priority in his budget for fiscal year 2010.⁷ The ACS also reports that African Americans are likely to be diagnosed with colon cancer at a later stage and have lower five year survival rates than white Americans.⁸ Despite improvements in rates of screening with optical colonoscopy since 1995, testing rates for minority (African American, Asian/Pacific Islander, and Hispanic) Medicare beneficiaries continue to lag behind those for white beneficiaries.⁹ President Obama has made the reduction of health disparities, such as this one, as an important goal of his administration,¹⁰ Medicare coverage of CTC as an additional screening option could help to facilitate this early detection, prevent the development of colorectal cancer, reduce health disparities, and save lives.

We believe that sufficient clinical evidence currently exists to support coverage of screening CTC and give Medicare beneficiaries the option of an effective, minimally invasive colorectal cancer screening option. We urge CMS to reconsider this evidence, including the American College of Radiology Imaging Network (ACRIN) 6664 trial results and additional data provided during this comment period. If CMS concludes again that the evidence is not sufficient, we ask the agency to announced no change in policy at this time and state that it will reopen consideration of coverage when additional analyses of the ACRIN data are published in the coming months. We believe that CMS has the authority to apply coverage with evidence development (CED) to screening CTC, but we believe that CED is not appropriate because the necessary data are available now, and more data on screening CTC will be available in the near future.

The Evidence is Sufficient to Add CTC to the Colorectal Cancer Screening Benefit Now

We believe sufficient evidence is available for full coverage of screening CTC now. Screening CTC is supported by the major professional societies and organizations. As CMS acknowledges in the Proposed Decision,¹¹ the guidelines issued jointly by the American Cancer Society (ACS), the US Multi Society Task Force on Colorectal Cancer, and the American College of Radiology (ACR) recommend CTC as a screening test for colorectal cancer and conclude "that there are sufficient data to include CTC as an acceptable option for [colorectal cancer] CRC screening:¹² Since the Proposed Decision was released, the American College of Gastroenterology (ACG) released its revised Guidelines for Colorectal Cancer Screening. In these guidelines, the ACG recommends that patients who decline colonoscopy, or for whom colonoscopy is unavailable or not feasible, should be offered CTC every five years.¹³

Not only do these organizations see the value of screening CTC, but state governments also have recognized the importance of making this service available. Based on the ACS's guidelines, 26 states plus the District of Columbia mandate coverage of screening CTC, along with all other tests recommended by the ACS.¹⁴ If CMS finalizes its Proposed Decision, patients in these states will lose access to CTC when they enroll in Medicare. We urge CMS to follow the lead of these governments and ensure that Medicare beneficiaries have the option to use screening CTC.

Moreover, when the evidence is analyzed using the Cochrane and Holland framework described in the Proposed Decision, it is clear that the evidence supports coverage. These factors are as follows:

• Simplicity . We agree with CMS's conclusion that screening CTC is a "relatively simple test that can be performed on commercially available CT scanners" and does not require sedation.¹⁵ Screening CTC involves a straightforward testing process, and physicians can obtain competency in interpreting the images if they receive appropriate training.¹⁶
• Acceptability . As noted in the Proposed Decision, "in published studies, CT colonography was acceptable to the participants."¹⁷ We believe that CTC will be preferred by patients who might not be able to, or are reluctant to, undergo a colonoscopy. A study of patient preferences among colorectal cancer screening tests indicates that patients prefer screening CTC enough to be willing to pay for it.¹⁸ As Brooks Cash, MD testified at the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) meeting for this national coverage analysis, the National Navel Medical Center has seen at 70 percent increase in compliance with colon cancer screening since it adopted CTC.¹⁹ During the initial comment period on this NCD, CMS received several comments from patients and practitioners that explained that patients prefer CTC because it can be performed quickly, without sedation, and without fear of complications from sedation or risk of perforation.²⁰
• Accuracy . We agree with CMS's conclusion that, "with current technology and recommended scan settings, CT colonography provides an accurate image of the colon when preparation is adequate compared to optical colonoscopy."²¹ The scan protocol has been well defined and confirmed by the ACRIN 6664 study.
• Precision . As CMS notes, "a number of studies have shown that CT colonography can detect large polyps . 10 mm consistently."²² Mark Klein, MD presented data MedCAC meeting from a study by Pickhardt and Kim that indicates that CTC performed better than optical colonoscopy at finding invasive cancers, with CTC finding 14 compared to 4 for optical colonoscopy.²³
• Sensitivity/Specificity . The sensitivity and specificity of CTC is equivalent to optical colonoscopy for lesions ≥ 10 mm and is superior to other screening options that a patient might choose instead of colonoscopy. We note that the Proposed Decision compares CTC optical colonoscopy, but we believe it is appropriate to compare CTC to no screening because many patients who receive CTC would not have been screened at all.

In addition to its analysis of the above factors, CMS questions the sufficiency of the available evidence with regard to several specific points. First, it questions the generalizability of the study results to the Medicare population.²⁴ Although patients over age 65 were included in the ACRIN study, data on those patients had not been analyzed separately in the published results. Analyses of these data are being performed now, but unfortunately will not be available during the comment period. In general, we see no reason to believe that the results for these patients would be significantly different than for younger patients. If additional data on this population are submitted during the comment period, and we encourage you to give careful consideration to this information.

Second, CMS notes that no published data are available on the rate of referral for optical colonoscopy after screening CTC in the Medicare population.²⁵ This information could be extracted from the ACRIN data, but it will not be available during this comment period. Although the incidence of polyps may be higher in older patients, raising questions about the rate of referral for an optical colonoscopy following a screening CTC, these questions should not be seen as an impediment to coverage. For many patients, CTC would be a welcome alternative to a screening optical colonoscopy. If CTC is used to screen patients who refuse to undergo an optical colonoscopy, there is likely to be an overall health benefit compared to not being screened at all, even if the patient requires a follow-up procedure to remove any polyps found. Furthermore, CMS could develop policies to encourage providers to offer CTC and follow-up therapeutic optical colonoscopy in an efficient manner, with minimal burden for patients.

Third, CMS states, "since individuals undergoing screening are asymptomatic by definition, the potential impact of extracolonic findings on net health outcomes needs to be determined prior to general use of this modality."²⁶ We believe the potential value from extracolonic findings in treating patients outweighs any risk that the patient will undergo unnecessary procedures. The CT Colonography Reporting and Data System (C-RADS) offers a method to "identify and communicate the presence of clinically important abnormalities."²⁷ It can be used to help physicians systematically characterize extracolonic findings and make appropriate treatment decisions based on those findings.

Fourth, CMS questions the risk association with radiation exposure, citing Brenner, 2005, as estimating a radiation dose for 2 scans of 13 mSv.²⁸ This conclusion misinterprets Brenner, which found, "in terms of radiation exposure, the benefit-risk ratio potentially is large for CTC" when considered for mass colorectal cancer screening using modern CT imaging systems.²⁹ The Proposed Decision also does not mention the data presented at the MedCAC meeting regarding lower levels of radiation exposure. Dr. Cash reported exposure in the range of three to six mSv at the National Naval Medical Center, and Dr. Johnson, the principal investigator for the ACRIN trial, reported exposure in the range of five to eight mSv in that study.³⁰ Any concerns about radiation exposure risk can be addressed through implementation of accreditation standards or coverage standards that require the use of appropriate CT scanners.

When all of this evidence is considered, we believe that there is ample support for covering screening CTC for all Medicare beneficiaries. Alternatively, if CMS determines that the evidence regarding patients over age 65 is not sufficient for a positive coverage decision, we urge the agency to consider the strong evidence on patients under age 65 and cover screening CTC for those patients. This decision would allow younger beneficiaries who are eligible for Medicare based on disabilities or end-stage renal disease and may have comorbidities that prevent them from undergoing optical colonoscopy to have an alternate, effective screening option.

The Final Decision Should Not Consider Cost-Effectiveness

MITA believes that CMS inappropriately has considered cost-effectiveness in its analysis of screening CTC for colorectal cancer. Not only did CMS include the cost factor along with the otherwise appropriate Cochrane and Holland factors, but the technology assessment it requested from the Agency for Healthcare Research and Quality (AHRQ) was focused on cost-effectiveness. The longstanding provisions covering colorectal cancer screening tests do not provide authority for the Secretary to consider cost-effectiveness when deciding whether to cover these tests. In addition, colorectal cancer screening tests are not subject to the recently enacted provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) that allow CMS to consider cost-effectiveness for new screening benefits. We ask the agency to ensure that its coverage analysis for CTC does not consider cost.

The Federal Register notice regarding the November 19, 2008 meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) indicated that the panel would discuss available evidence on CTC as a screening test for colorectal cancer, including cost effectiveness.³¹ Subsequently, AHRQ published a draft technology assessment entitled "Cost-Effectiveness of CT Colonography to Screen for Colorectal Cancer." That draft's cost-effectiveness analysis suggested that CTC did provide a benefit in terms of life-years gained compared with no screening, but the cost, relative to the benefit derived and to the availability and costs of other colorectal cancer tests, would need to be in range of $108 to $205 to be a non-dominated strategy, and to be "cost effective" would have be paid in the range of $179-$237 in order to provide a benefit over other screening tests such as colonoscopy.³²

MITA submitted comments to AHRQ on this draft technology assessment that explained several problems with the analysis, including the tests being compared, the assumptions regarding use of screening, the costs of various screening tests, and the benefits of extracolonic findings achieved through the use of CTC.³³ We explained that the AHRQ draft report inappropriately focuses on comparing CT colonography to current methods of screening for colorectal cancer rather than to no screening at all. Because the analysis assumes that CTC would be used only by patients who currently use an existing screening test, rather than by patients who receive no screening, it underestimates the potential for coverage of this technology to increase adherence with colorectal cancer screening guidelines. AHRQ's analysis assumes an unrealistic best case scenario of 100 percent compliance with screening, follow-up, and surveillance procedures, which greatly overestimates adherence with guidelines for existing tests and underestimates the potential improvement in adherence due to CT colonography. The models also use incomplete estimates of the cost of other screening tests, including a significant underestimate of the cost of colonoscopy, and do not account for the benefits of extracolonic findings achieved through the use of CT colonography. As a result of these issues, the analyses produce incorrect estimates of the cost efficiency frontier for colorectal cancer screening.

This flawed analysis was presented at the MedCAC meeting, where the panel voted on the cost per life year saved of CTC compared to optical colonoscopy.³⁴ This improper consideration of cost-effectiveness tainted the MedCAC meeting, and as a result, neither the AHRQ report nor the MedCAC meeting's conclusions should be considered in the final decision.

As described in CMS's guidance on national coverage determinations (NCD), Medicare coverage decisions are based on the item's clinical characteristics, not its cost.³⁵ "The cost of an item or service is not relevant in the determination of whether [a] technology . . . should be covered for the Medicare program."³⁶ Although a recent amendment to the Social Security Act (SSA) permits consideration of the "relation between predicted outcomes and the expenditures" for certain preventive services,³⁷ it does not apply to colorectal cancer screening tests. By its express terms, the amendment applies only to "additional preventive services" that are "not otherwise described" in the statute.³⁸ As CMS acknowledged in the Federal Register notice regarding the MedCAC meeting,³⁹ colorectal cancer screening services are described in section 1861(pp) of the Act.⁴⁰ Because colorectal cancer screening services are "otherwise described" in the statute, the cost-effectiveness analysis permitted by section 1861(ddd) may not be used for them.

Section 1861(pp) requires only that the Secretary consult with appropriate organizations to identify other "tests and procedures, and modifications to tests and procedures" listed in the statute for Medicare coverage. CMS should use the same process for analyzing coverage of these tests as it would use for any other benefit. That process does not contemplate using cost-effectiveness analysis in determining coverage and payment, which MITA acknowledges might be appropriate under the MIPPA amendment authority with respect to "additional preventive services," but not with respect to services already described in the SSA.

Additionally, although section 1861(pp) allows the Secretary to consider" frequency and payment limits" when adding additional tests or procedures to the definition of "colorectal cancer screening tests,"⁴¹ this authority does not allow the consideration of cost in the coverage decision. As illustrated by the "frequency limits and payment limits" for the colorectal cancer screening tests listed in the statute, Congress intended for any "payment limit" to apply to the reimbursement rate for the service. For example, the "payment limit" for screening colonoscopy requires payment to "not exceed such amount as the Secretary specifies, based upon the rates recognized for diagnostic colonoscopy services."⁴² After CMS determines that a colorectal cancer screening test is covered, it may apply a payment limit for that test, but it may not consider cost in making the coverage decision. We realize that CMS considered cost in its coverage decision for screening immunoassay fecal occult blood tests,⁴³ but this decision was made before CMS implemented the current, more transparent procedures for NCDs and before the agency issued guidance on NCDs, and therefore should not be relied upon to justify any consideration of cost in this NCD.

If CMS Determines that the Evidence Is Not Sufficient to Grant Coverage Now, We Urge the Agency to Announce that It Will Reconsider This NCD Immediately Upon the Availability of Additional Data

We believe that sufficient evidence is available now to cover screening CTC. More data will be published in the coming months, however, and if CMS has any remaining questions after it reviews of all of the comments on the Proposed Decision, these data are likely to answer those questions. If CMS decides not to cover CTC now, we urge it to conclude this review by issuing an NCD that says that a reconsideration will be reopened immediately upon the availability of additional data. This announcement would be similar to the July 2007 decision memorandum on the clinical trial policy that announced that CMS would immediately reopen a reconsideration of the NCD,⁴⁴ or the reopening of the implantable cardioverter defibrillator decision on December 29, 2004, one day following the announcement of a final decision that retained current coverage policy, in anticipation of publication of additional data.⁴⁵ Both of these decisions allowed CMS to meet its statutory deadlines for completion of a national coverage analysis while making clear its intent to continue to review the data.

In addition, if CMS decides that the evidence is not sufficient to cover screening CTC now, we recommend that CMS state that it is not making a national coverage determination. A statement such as, "We have decided that no national coverage determination on the use of screening CTC is appropriate at this time," would indicate that CMS was refraining from making a new coverage policy rather than announcing a negative coverage decision. If CMS determines that the evidence is not sufficient to make a decision for screening CTC now, the inclusion of this language in the decision memorandum could be helpful for encouraging private payers to cover screening CTC until CMS reconsiders its decision.

CMS Has Authority to Apply CED to this Service, But It Should Not Do So Because the Evidence Is Sufficient for Coverage and More Evidence Will Be Published Soon

Finally, although we believe that CED is not appropriate because the substantial evidence currently available and the additional data to be available in the near future support coverage of screening CTC, we also believe that CMS has the authority to cover screening CTC through application of CED. We understand that the agency has indicated to some stakeholders that it is not certain that it has authority to apply CED to CTC because CTC would be covered as a screening benefit under sections 1862(a)(1)(H),⁴⁶ 1861(s)(2)(R),⁴⁷ and 1861(pp)(1)⁴⁸ of the Social Security Act (SSA), rather than a benefit under the "reasonable and necessary" provisions at section 1862(a)(1)(A) of the SSA.⁴⁹ This conclusion is not required by the statute, CMS's guidance document on CED, or by CMS's prior review of other colorectal cancer screening services.

As explained in its guidance document on CED,⁵⁰ there are two types of CED. Coverage with Appropriateness Determination (CAD) and Coverage with Study Participation (CSP). Coverage conditioned on specific additional data collection is referred to as CAD. CAD is used when CMS decides that "there is adequate evidence to determine that an item or service is reasonable and necessary under section 1862(a)(1)(A), but that additional clinical data is needed that is not routinely available on claims forms to ensure that the item or service is being provided to appropriate patients in the manner described in the NCD."⁵¹

Coverage conditioned on care being delivered in a setting with a pre-specified data collection process and additional protections in place such as are present in some research studies is referred to as CSP. CSP allows Medicare to cover items and services that do not meet the "reasonable and necessary" requirements for Medicare coverage under section 1862(a)(1)(A) by considering "whether coverage of the item or service is reasonable and necessary for Medicare coverage under section 1862(a)(1)(E) of the Act." Section 1862(a)(1)(E) allows coverage of items and services that are "reasonable and necessary" to carry out the purposes of "research conducted pursuant to Section 1142" of the SSA. Section 1142 permits AHRQ to "conduct and support research with respect to the outcomes, effectiveness, and appropriateness of health care services and procedures in order to identify the manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically." CMS describes the link between 1862(a)(1)(E) and 1142 as "allow[ing] CMS to work jointly with the Agency for Healthcare Research and Quality (AHRQ) to evaluate and empower CMS to pay for the clinical costs of this research."

Following on this guidance and CMS's prior consideration of the colorectal cancer screening benefit, CMS could cover screening CTC under either type of CED. Under CMS's guidance document on CED, if CMS believes that screening CTC is not covered under section 1862(a)(1)(A), it could cover this service under section 1862(a)(1)(E) using CSP. As described above, section 1862(a)(1)(E) allows Medicare to cover items and services that are "reasonable and necessary" to carry out research on the prevention, diagnosis, treatment, and clinical management of diseases, disorders, and other health conditions. The scope of research included under section 1862(a)(1)(E) is broad enough to encompass all treatment, diagnostic, and preventive services that are or could be covered by Medicare. As a result, a study of screening CTC could be included in this type of research, and therefore could be covered under CSP.

Alternatively, consistent with CMS's prior review of coverage of colorectal cancer screening benefits, CMS could evaluate screening CTC under the "reasonable and necessary" standard of section 1862(a)(1)(A). When CMS first set forth its policies for colorectal cancer screening, it cited its "authority under the 'reasonable and necessary' clause of the Act, section 1862(a)(1)(A)," when it established "conditions under which [it] would cover colorectal screening services."⁵² As it did when it set the coverage criteria for other colorectal cancer screening tests, CMS could use this authority now to establish coverage for screening CTC. If the evidence is sufficient for coverage of screening CTC for a specific population, CMS could apply CAD, or if the evidence is insufficient for coverage, CMS could apply CSP under section 1862(a)(1)(E).

If CMS chooses not to take either of the approaches discussed above, it could expand application of CED to address benefits covered under provisions other than section 1862(a)(1)(A), such as colorectal cancer screening services. As the CED guidance document notes, "This guidance represents the Centers for Medicare & Medicaid Services' (CMS') current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind CMS or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations."⁵³ With this statement, CMS retains the option to create and consider other approaches to coverage and acknowledges that the agency's thinking on CED may change. CMS has allowed itself the flexibility to develop alternative approaches, including an expansion of CED, to provide coverage of items and services of benefit to the Medicare population. Certainly, use of this flexibility would be warranted to provide beneficiaries with an important screening option for colorectal cancer, particularly when only 25 percent of senior citizens receives a Medicare-covered screening test for colorectal cancer.⁵⁴

We greatly appreciate the time you spent with us on March 10 discussing this proposed decision for screening CTC. As we expressed during our meeting, we believe that sufficient evidence is available to support coverage of screening CTC for Medicare beneficiaries. We firmly believe that adding CTC as a Medicare covered screening test for colorectal cancer will lead to the screening of more beneficiaries, detecting colorectal cancer earlier and saving lives. This decision would help CMS achieve President Obama's goals of increasing screening and reducing health disparities among minorities. If you have any questions or would like to discuss these matters further, please contact me at 703-841-3279. Thank you for consideration of these comments.

Sincerely,

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VC for CRC screening

I am asking that you reconsider coverage for VC as an option for colorectal cancer screening.

VC has a place for screening for those patients who don't want to undergo an invasive test. It also provides a method to screen patients who are on anti-coagulant therapy as well as those who have several co-morbidities and would have to alter their plan of care to undergo a colonoscopy.

I was the study coordinator for the initial VC stucy comparing VC to colonoscopy in the detection of polyps that was conducted at Naval facilities. Patient satisfaction was high and many patients stated they would prefer that method for screening.

Colorectal cancer is preventable, treatable, and beatable!

We should offer as many viable and tested options for screening as well possibly can to our citizens. Another modality could make more people get screened and polyps and cancer detected early so as to avoid the costly treatment.

Please reconsider your decision on behalf of all the American people who have not yet been screened due to costand/or fear. We all have many choices in other avenues of our life - colorectal cancer screening should be another.

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March 13, 2009

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

Dear Dr. Phurrough:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services' (CMS's) call for a national coverage analysis on Screening Computer Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N). America's Health Insurance Plans (AHIP) is the national association representing nearly 1,300 member companies providing health insurance coverage to more than 200 million Americans. We are pleased to submit these comments on behalf of our members.

General Comments
We support CMS's efforts to review all current, available, and robust clinical evidence to determine appropriate coverage for procedures and treatments that are best shown to be safe, effective, and improve the health outcomes of Medicare beneficiaries. AHIP is aware that screening rates for colorectal cancer are lower than other cancers, such as breast and cervical, and that current approaches to colorectal cancer screening (fecal occult blood testing, sigmoidoscopy, or colonoscopy) detects early-stage cancer, adenomatous polyps and reduces colorectal cancer mortality in adults age 50 to 75 years.

Computer tomography colonography (CTC) may provide an alternative to current modalities, and holds the potential for new populations, who may have previously resisted testing, to be screened. Although CTC requires the same bowel preparation as optical colonoscopy, it can usually be done without anesthesia or moderate sedation, and is less invasive than colonoscopy. Therefore, many experts believe that its adoption of CTC will contribute to higher screening rates and consequently earlier detection and treatment. We acknowledge that to date no studies have addressed this hypothesis directly.

The evidence reviews performed by the Unites States Preventive Services Task Force (USPSTF) are considered the gold standard for clinical preventive services and our member organizations look to their recommendations as a key resource. The USPSTF concluded that the evidence is insufficient to assess the benefits and harms of computed tomographic colonography (CTC) [and fecal DNA testing] as screening modalities for colorectal cancer. They further stated "the USPSTF concludes that, for CT colonography, evidence to assess the harms related to extracolonic findings is insufficient, and the balance of benefits and harms cannot be determined."

Given the absence of a recommendation from USPSTF of grade A or B for this modality, AHIP concurs with CMS that coverage of colorectal cancer screening modalities for Medicare beneficiaries should not be expanded to CTC, at this time. AHIP does consistently encourage USPSTF to re-review topics as evidence develops, and will do so if new studies indicate that CTC use improves detection with consequent improvement in health outcomes and reduced mortality with minimal risk.

Additionally, some concerns have been raised that there is a potential for inappropriate attempts to circumvent non-coverage of preventive screenings by submitting a claim, or resubmitting a denied claim, for CTC as a diagnostic tool to rule out disease, using symptomatic coding. Therefore, AHIP encourages CMS to monitor the utilization of this procedure across the system, for all uses, in order to identify potential inappropriate patterns of care.

Thank you for the opportunity to comment on this important issue.

Sincerely,

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Dear Medicare Official/Representative______:

I am writing to voice my strong disagreement with Medicare's recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American's age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy? Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness? Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test. Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

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Dear Medicare Official

I am writing to voice my strong disagreement with Medicare's recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American's age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy? Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness? Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test. Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

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[PHI Redacted] I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). I fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it's the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients.

The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

I appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

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I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it's the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients.

The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

Sincerely,

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Dear Medicare Official/Dear Senator______/Dear Representative______:

I am writing to voice my strong disagreement with Medicare's recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American's age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

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I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it's the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients.

The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

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Mr. William Larson, MA
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244-1850
USA

March 13, 2009

Re:  Comments on Proposed Denial of Coverage for Screening with Computed Tomographic
Colonography (CTC) for Colorectal Cancer (CAG-00396N)

Dear Mr. Larson,

On behalf of Medicsight, I would like to take this opportunity to give comment concerning the potential ruling by CMS not to approve reimbursement for Computed Tomographic Colonography (CTC) as a screening modality. Medicsight is a software developer of Computer Aided Detection (CAD) devices for CTC, with an interest in this area.

I believe it is in everyone’s best interest to remove all potential barriers to the adoption of CTC as a viable and accessible alternative for Colorectal Cancer (CRC) screening. There are a number of currently accepted methods of screening, but no single test offers the complete solution. Industry and healthcare providers need to work together to offer effective alternatives to the currently reimbursed options. Recent publications have shown that there is a considerable opportunity to extend the reach of screening programmes with the inclusion of CTC.

Optical Colonoscopy (OC) is a widely accepted, standard screening test, but has the limitations of relatively low levels of compliance and limited procedural capacity. Other screening tests such as FOBT, flexible sigmoidoscopy and double contrast barium enema (DCBE) also have drawbacks. Recent studies have shown CTC to demonstrate comparable sensitivity to OC for the detection of clinically significant colorectal polyps*. Any widely acceptable screening programme must assess both the risk and benefit to asymptomatic patients when considering the best available option. CTC is less invasive, less traumatic, and has fewer risks associated with perforations or effects of anaesthesia.

When considering the cost-effectiveness of any new screening method, it is imperative that the true costs are taken into account. The majority of OC procedures are required to be performed in hospital-based endoscopy units and therefore the cost per procedure is considerably higher than quoted in the recent CMS draft memo. In addition, and equally importantly, the burden of anaesthesia costs incurred during such procedures must be included in the assessment of costs.

In addition to the efficacy and cost efficiency points mentioned above, CTC scanning using a low dose protocol exposes patients to a lower total radiation dose than DCBE, and as such, radiation exposure should not be a barrier when considering the use of the technology in the CMS covered population.

There is significant evidence that CTC provides a cost effective, valuable addition to any screening programme for colorectal cancer, and as such the at-risk population can only benefit from CMS coverage of this examination.

We strongly urge you to reconsider your draft conclusions.

Yours sincerely

Allan J. Rowley
CEO Medicsight PLC

* CT Colonography versus Colonoscopy for the Detection of Advanced Neoplasia. Kim et al: N Engl J Med 2007;357:1403-12.
Accuracy of CT Colonography for Detection of Large Adenomas and Cancers. Johnson et al: N Engl J Med 2008;359:1207-17. (Clinical Trials.gov number, NCT00084929; American College of Radiology Imaging Network [ACRIN] number, 6664.)

Medicsight PLC is a UK-headquartered, research driven, leading developer of computer-aided detection (CAD) and image analysis software for the medical imaging market. The CAD software automatically highlights suspicious areas on computerised tomography (CT) scans of the colon and lung, helping radiologists to identify, measure and analyse potential disease and early indicators of disease.

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March 13, 2009

Via Electronic Mail

Ms. Charlene Frizzera
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health & Human Services
Baltimore, MD 21244-8016

RE: Administrative File CAG-00396N
Screening Computed Tomographic Colonography (CTC) for Colorectal Cancer

Dear Ms. Frizzera,

On behalf of Siemens Healthcare USA, I would like to comment on CMS’s proposed national coverage analysis (NCA) for CT colonography for colorectal cancer screening (CAG – 00396N). Siemens Healthcare, headquartered in Malvern, Pennsylvania and Erlangen, Germany, is a manufacturer of advanced imaging technology including the hardware and software that make modern cross-sectional imaging possible.

We believe that CMS should cover use of CT colonography as a screening test for colon cancer based on the following additional considerations.

1) Currently the only screening test that Medicare covers, which is invasive, is optical colonoscopy. While participation rates for Medicare’s optical colonoscopy screening program are difficult to obtain, evidence throughout clinical practice suggests that patients and Medicare participants prefer less-invasive to more-invasive medical care. We request that Medicare publish the optical colonoscopy screening rates under current policies. Given the likelihood that many Medicare beneficiaries do not and will not participate in an invasive screening program, we feel that the proper current care to compare CT colonography to is not just that of optical colonoscopy but also that of no screening. We request that CMS provide coverage of CT colonography until evidence can be provided that Medicare beneficiary participation rates do not differ between invasive and non-invasive colon cancer screening, since this is a central assumption in the proposed non-coverage decision.

2) In comparing CT colonography to optical colonoscopy, the decision memo makes the assumption that optical colonoscopy is the gold standard and does not include a symmetrical comparison of risks and benefits. Rather, the memo emphasizes risks of CT colonography without considering risks of optical colonoscopy. We request that a balanced comparison between the modalities be performed where risks of optical colonoscopy are fully considered. There is a considerable literature on the significant complications of optical colonoscopy which should be formally assessed [including Rabeneck, L et al, Gastroenterology Vol. 135(6), 1845-7, 2008; Iqbal CW et al, Arch Surg, Vol. 143(7), 701-6, 2008; Teoh AY, Arch Surg, Vol. 144(1), 9-13, 2009].

3) Looking at the accuracy of optical colonoscopy, while surface inspection is helpful, evidence suggests that optical colonoscopy actually misses a potentially significant number of lesions when compared to full volume imaging [Kim, DH et al, NEJM, Vol. 357, 1403-1412, 2007]. We think missed lesions and redo procedures with optical colonoscopy should be as rigorously modeled as are the misses with CT colonography.

4) The decision memo cites as a major risk of CT colonography concerns about radiation. Ongoing FDA review supports the safety and effectiveness of CT technology, including for radiation safety. Manufacturers continue to invest in software and hardware that increases image quality while decreasing dose. Additionally, accreditation programs improve the education and competency of providers which also assists in decreasing dose. While the precise biologic effects of low doses of radiation are unknown, what is clear with the experience of hundreds of millions of CT scans having been performed worldwide is that radiation risk to Medicare beneficiaries is at least two orders of magnitude less than their risk of death from preventable colon cancer. This is particularly the case since most Medicare beneficiaries are over 65 years of age and are therefore at materially lower baseline radiation-induced cancer risk.

5) The decision memo cites as a major risk of CT colonography coverage concern about incidental findings. Language in the decision memo posits this as an unknown potentially massive incremental cost. Physicians have successfully handled incidental findings on examination from modern diagnostic tests for the past several decades. If Medicare claims data suggests fundamental inability by physicians to adequately address incidental imaging findings, we would request that this data be made public. We feel that any incremental costs of incidental finding evaluation will be comparatively minor and urge the costs related to incidental findings be modeled on the assumption that those costs are minor absent national Medicare claims data to the contrary.

6) The largest mathematical driver of the relative cost-effectiveness of optical colonoscopy versus CTC appears to be the difference in the assumed frequency of testing. While we understand the source of the 5 year CTC retest interval vs. the 10 year optical colonoscopy interval, we believe that the reality of current clinical practice is that colonoscopy is actually performed more frequently for a wide variety of screening reasons. We request that AHRQ obtain the Medicare data on actual use patterns of screening optical colonoscopy and incorporate this data into the model.

Based on these additional considerations, we request that CMS provide coverage for CT colonography screening for colon cancer.

Additionally, we believe that CMS should consider methods to ensure timely ongoing re-evaluations when considering advanced imaging as these computer science based technologies improve with great speed. For example the recently released ACRIN study cited in the CMS decision memo largely used 16 slice CT scanner technology, a technology two product generations ago in terms of resolution and reductions in radiation dose. Some of the meta-analyses cited in the decision document rely on even older low resolution and now obsolete technology.

Please feel free to contact me if we can be of any assistance in providing more information.

Sincerely,

Donald W. Rucker, MD
Vice President and Chief Medical Officer
Siemens Healthcare USA

Cc: Steve Phurrough, MD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Mailstop C1-09-06
Baltimore, MD 21244

Cc: Mr. William Larson, MA
Lead Analyst
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Mailstop C1-09-06
7500 Security Boulevard
Baltimore, MD 21244-1850

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Thank you for giving the American College of Preventive Medicine the opportunity to comment on this National Coverage Decision. For this proposed National Coverage Decision, CMS refers to the recommendations of and evidence compiled by the USPSTF to reach its conclusions. ACPM strongly supports the work of the United States Preventive Services Task Force (USPSTF) because of the quality of its analysis and scientific rigor, and, as such, supports the proposed National Coverage Decision.

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Dear Medicare Official:

I am writing to voice my strong disagreement with Medicare's recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American's age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy? Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness? Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test. Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

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Do NOT deny reimbrusement for Virtual Colonoscopies (VCs) to doctors who prescribe these for persons at risk of colorecal cancer who also receive health care through CMS.

Screening RELUCTANT people early for colon and rectal cancer is important. The VC can catch the fearful with their fake bravado, who avoid other colorectal screening measures. [PHI Redacted]

March has been dubbed National Cancer Awareness Month in the US. Well, let’s give all folks a viable means to stay aware of colon cancer risks and means to ensure they don’t GET it. Don''t deny reimbursement for virtual colonoscopies to medical professionals who treat Medicare/Medicaid patients.

Respectfully,

Patricia Chambers Porter

cc: Virginia legislators

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I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients.

The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

Less

I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients. The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

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After being diagnosed with Stage IV colon cancer in July of 2008, [PHI Redacted] lost his courageous battle on February 19, 2009. We have been left devastate, sad, and empty.

I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients.

The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally- invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

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[PHI Redacted] I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). I fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients.

The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally- invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

I appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

Less

I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients. The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

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Having participated in the various aspects of this proceeding as well as the MedCAC meeting on this topic in November, 2008, the American College of Gastroenterology (ACG) is pleased to have the opportunity to provide these additional comments with respect to CMS’ national coverage analysis (NCA) of computed tomography colonography (CT colonography). The College supports the draft decision to deny coverage for CT colonography at this time. The College will not repeat all of the arguments and evidence provided in previous comments but will instead focus on those issues that have been discussed since the earlier filing deadlines passed.

Evidence demonstrates that colonoscopy is the gold standard for colorectal cancer screening. As previously stated, the ACG takes an evidence-based approach to new CRC screening technologies, and supports any colorectal cancer screening technology that is in the best interest of patients. New technologies must have well defined efficacy and safety, adequate cost-effectiveness, be accompanied by a full understanding of ancillary findings and pursuant testing and risks and be acceptable to patients. It is our opinion, based on a review of the available evidence, that CTC clearly does not yet meet this threshold.

The ACG is a physician organization representing gastroenterologists and other gastrointestinal specialists. Founded in 1932, the ACG currently numbers nearly 11,000 physicians among its membership and also includes other affiliate health care providers of gastroenterology specialty care. Although the vast majority of these physicians are gastroenterologists, the College’s membership also includes surgeons, pathologists, hepatologists, and other specialists in various aspects of the overall treatment of digestive diseases and conditions. The College has chosen to focus its activities on clinical gastroenterology – the issues confronting the gastrointestinal specialist in the treatment of patients. With this perspective we offer the following recommendations to supplement our prior public comments on this issue.

1) The specificity of CT colonography for patients with polyps 1 cm and larger in the recently published ACRIN trial was 86% (1). This number is considerably lower than the best number in the literature, published by Pickhardt et al, in 2003 (2). This finding has multiple implications specific to the Medicare population. First, the actual specificity in the elderly population has not been studied but might be even lower. This is because sensitivities and specificities of imaging tests that require human interpretation can actually be affected by disease prevalence. Thus, when the degree of suspicion is high on the part of the interpreter, sensitivity may increase, and specificity may fall. Whether this effect actually occurs in the elderly is uncertain but the low specificity observed in the ACRIN trial clearly was associated with low positive predictive values. Since the prevalence of disease in the elderly is quite high, we can expect substantial percentages of patients with lesions detected on CT colonography to have no lesion found at optical colonoscopy. Currently, CMS has no mechanism in place to handle this situation and its management is left to clinicians. Many of these patients will be subjected either to a repeat CT colonography to prove the presence or absence of the lesion or to a repeat colonoscopy. Either test would be associated with significant costs as well as risks to patients. It should also be noted that the nature of CTC, like all radiological exams, makes its effectiveness for identifying flat and depressed lesions, which recent studies have shown to be more deadly and far more common than previously believed, highly suspect. (3) Finally, the ACRIN trial involved only the most well trained and highest quality examiners. At the institutions involved in the study each of the potential participating physicians received a pre-test and the clinicians who scored in the lowest 25% on the pre-test were excluded from the trial. This will have important implications in terms of the ability to even replicate the ACRIN results more widely.

2) The Medicare population, because of their age, is a poor population in which to initiate the widespread use of large scale CT colonography. A recent study from the Clinical Outcomes Research Initiative of the American Society of Gastrointestinal Endoscopy estimated using the database established by colonoscopy performed in the community, that at least 15-20% of patients undergoing colonoscopy would be referred for colonoscopy and polypectomy. However, the prevalence of both adenomas and advanced adenomas approximately doubles between age 50 and 65. Therefore, in the Medicare population the percentage of patients referred for colonoscopy and polypectomy would be substantially greater, subjecting patients and society to increased costs and dramatically reducing the cost-effectiveness of CT colonography screening. The analysis presented to CMS by AHRQ from its draft report “Cost-Effectiveness of CT Colonography to Screen for Colorectal Cancer Technology Assessment Report” in November 2008 found that CT colonography was less cost-effective than colonoscopy, considering a screening population age 50 and older. These differences in cost-effectiveness would be amplified by confining the analysis to patients age 65 and older. Furthermore, this study did not look at the impact of removing lesions 5 mm or smaller on life-years gained or cost-effectiveness which would almost certainly reduce the cost effectiveness further of using CT colonography as a screening tool for colorectal cancer.

3) The benefits of colorectal cancer screening are achieved only through polypectomy. Imaging alone has no impact on the incidence of colorectal cancer. For that reason, an understanding of the impact of CT colonography on adherence rates for screening is critical to predicting its effect on colorectal cancer prevention. If CT colonography increases adherence rates, then patients who currently are not being screened by other methods, including colonoscopy, would have their large polyps detected and removed by referral for colonoscopy and polypectomy. An increase in adherence would be expected to reduce colorectal cancer incidence. Conversely, if CT colonography does not improve adherence, then it could compete with colonoscopy for patients already willing to undergo colorectal cancer screening. In this scenario, polypectomy rates would decline and the incidence of colorectal cancer could increase. Unfortunately, there is virtually no evidence that CT colonography will significantly impact adherence either in the general population or in the Medicare population. In the only randomized controlled trial, performed in Australia, there was no difference in the percentage of patients who underwent a screening test when patients were offered either colonoscopy alone, CT colonography alone, or their choice of CT colonography or colonoscopy (4). In fact, there is essentially no evidence in the literature that offering patients multiple options increases adherence rates.

4) Another concern is that there is no understanding in clinical practice of the percentage of patients who have lesions that should be removed by colonoscopy and polypectomy who will actually undergo colonoscopy and polypectomy. While failing to undergo colonoscopy and appropriate polypectomy may be due to numerous issues such as fear, lack of patient follow-through, diversion to other screening modalities, false negatives using other screening modalities, etc., policymakers must be especially careful not to adopt policies that inadvertently decrease the number of polypectomies in the Medicare population. Recent evidence from the German national screening trial that shows that advanced adenomas convert to cancer at a faster rate in the elderly than in younger individuals (5). This observation makes biologic sense, since the conversion rate of adenomas to cancer is a function of the number of mutations in adenoma cells and would be expected to increase with age and reach thresholds that allow cancer growth. Indeed, the observation that the prevalence of advanced adenomas increases in a linear fashion with age, while the incidence of colorectal cancer increases in a nonlinear fashion, supports the more rapid conversion of advanced adenomas to cancer in the elderly. For that reason, high rates of polypectomy are essential to cancer prevention in the elderly.

5) The recent inclusion of CT colonography as a screening option by the American Cancer Society, U.S. Multisociety Task Force, and American College of Radiology Task Force should not be construed as a clear rationale for CMS to approve CT colonography (6). That guideline group did not specifically address whether CT colonography would be an appropriate screening test to initiate in the Medicare population. Further, guideline groups use highly variable thresholds for inclusion of tests. The guideline group mentioned above now has six different types of tests and uses a threshold of 50% detection of cancer for inclusion in its menu of options for screening (6). This menu of options includes the seldom used double contrast barium enema. It was inevitable that CT colonography be included in that guideline, considering that CT colonography appears definitely superior to double contrast barium enema for detection of large polyps and from the perspective of patient acceptability. However, that threshold for inclusion of screening tests in the menu of options is relatively low and should not be construed as clear evidence that the Medicare population is a good population in which to begin an experiment with utilization of screening CT colonography. The U.S. Preventive Services Task Force, which has been the traditional guideline body relied on by CMS for recommendations, determined that there were insufficient data available to recommend CT colonography for screening.

6) The U.S Preventive Services Task Force cited potential net harms of CT colonography in its explanation for not recommending CT colonography for colorectal cancer screening. One of these net harms, that of extracolonic findings, is particularly relevant to the elderly population, because the prevalence of incidental findings at CT colonography increases with age. Incidental findings lead to increased costs through additional physician visits, repeat or additional imaging tests, and invasive tests to perform biopsy or surgery. The true cost of these interventions is unknown but will certainly be amplified in the elderly. Further, the morbidity and mortality associated with invasive procedures to diagnose and treat incidental lesions will be amplified in the elderly.

Conclusion

All of the above arguments constitute a strong basis against payment for CT colonography by CMS at this time.

1. For the Medicare population, which as a group is more likely to have polyps and faster conversion to advanced adenomas, payment for CT colonography should only be instituted after additional study has been completed, including studies specific to the elderly.
2. Given the current state of knowledge, it is possible that payment for CT colonography could displace patients from polypectomy and long term dangers from radiation that are not well understood would lead to increased costs to taxpayers and society, increase incidence rates for colorectal cancer, and increase costs, morbidity, and mortality associated with followup, diagnosis, and treatment of incidental extracolonic findings.
3. All of this must lead CMS to find that coverage of CT colonography for colorectal cancer screening is not appropriate at this time.

References:

1. Johnson C, Chen MH, Toledano AY, Heiken JP, Dachman A, Kuo MD, Menias CO, Siewert B, Cheema JO, Obregon RG, Fidler JL, Zimmerman P, Horton KM, Coakley K, Lyer RB, Hara AK, Halvorsen RA Jr, Casola G, Yee J, Herman BA, Burgart LJ, Limburg PJ. Accuracy of CT colonography for detection of large adenomas and cancers. N Engl J Med 2008;359:1207-17.
2. Pickhardt P, Choi J, Hwang I. Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. N Engl J Med 2003;349:2191-2200.
3. Soetikno, RM et al. “Prevalence of Nonpolypoid (Flat and Depressed) Colorectal Neoplasms in Asymptomatic and Symptomatic Adults,” JAMA, March 5, 2008; 299: 1027 - 1035
4. Scott RG, Edwards JT, Fritschi L, Foster NM, Mendelson RM, Forbes GM. Community-based screening by colonoscopy or computed tomographic colonography in asymptomatic average-risk subjects. Am J Gastroenterol 2004;99:1145-51.
5. Brenner H, Hoffmeister M, Stegmaier C, Brenner G, Altenhofen L, Haug U. Risk of progression of advanced adenomas to colorectal cancer by age and sex: estimates based on 840,149 screening colonoscopies. Gut 2007;56:1585-9.
6. Levin B, Lieberman DA, McFarland B, Andrews KS, Brooks D, Bond J, Dash C, Giardiello FM, Glick S, Johnson D, Johnson CD, Levin TR, Pickhardt PJ, Rex DK, Smith RA, Thorson A, Winawer SJ. Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. Gastroenterology 2008;134:1570-95.

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I write as the CEO of the Colon Cancer Alliance, the nation''s largest patient advocacy organization dedicated to colorectal cancer. We speak on behalf of the 1.2 people who currently have CRC as well as our more than 50,000 active members.

The Colon cancer alliance supports medicare coverage of CTC for CRC and respectfully requests a reversal of its preliminary decision against coverage.

The recent CMS proposed denial of coverage for CT Colonography (CTC) is based upon a questionable comparative premise and data input flaws that invalidate the cost-effectiveness analysis, and several misconceptions related to purported “potential harms” of CTC that have also confounded the USPSTF in its analyses.

The proposed denial, if finalized, would deal a major blow to America’s effort to eradicate the most preventable of the deadly cancers, Colorectal Cancer (CRC), and would do a major disservice not only to America’s seniors, but to all Americans eligible for CRC screening.

The questionable flawed comparative premise relates to the question: “how does CTC compare with the current best screening option: optical colonoscopy (OC)”? The more appropriate comparison would have been: “how does CTC compare with the best alternatives to OC?” This more appropriate comparison would have clearly yielded an approval for CTC on all counts. There was no reason for Medicare to compare one test against another. It clearly did not make that comparison between OC and the Flexible sigmoidoscopy which Medicare covers and which is far less effective than OC.

The goal of introducing CTC for CRC screening is not to replace or to challenge OC as the dominant screening test, but rather to provide an acceptable option for those patients who cannot undergo—or refuse to undergo—OC screening. The more appropriate technology assessment would have been to evaluate how CTC compares to the four alternatives to OC, namely FOBT, Flex Sig, and DCBE, and no screening at all.

Comparing CTC only to OC fails to recognize the well-established fact that more than 50% of Americans have not, cannot, or will not receive OC screening. While Medicare may not be overly concerned with screening rates, it ought to be given that treatment costs are rising significantly. As Medicare is aware, the costs of the newer chemotherapies are tremendous and it is likely the costs of treating CRC patients will be in the hundreds of thousands per patient very soon.

Because of the long-standing low screening compliance with OC, OC can never be the complete answer to CRC screening. Since CTC (Sensitivity 85-90%) is an overwhelmingly better screening test than FOBT (10-20%), Flex Sig (45-55%), DCBE (50-60%), or No Screening (0%), this more appropriate technology comparison would have clearly yielded a strong endorsement for CTC.

Data Inputs:

The cost-effectiveness analysis of CTC by Zauber, et. al. was flawed and biased by a major data input error: the cost input for OC. When CMS provided the OC cost inputs for OC, it provided the 80% cost of in-office endoscopy: $497.59. In providing this number, CMS failed to recognize—or chose to ignore—the fact that the majority of Medicare screening OCs are done in more costly places of service, namely licensed ASCs and—even more costly—hospital-based endoscopy units. Furthermore, it failed to recognize that a significant number of these cases are done with the assistance of propofol anesthesia, adding an additional cost to the screening.

One example of this major oversight: The State of Virginia does not allow Medicare cases to be performed in the in-office setting, rather only in licensed ASCs and hospitals. The state also has strict CON requirements for approval of ASCs and subsequently, few ASCs exist in the state. Therefore, the overwhelming majority of screening OC performed on Medicare patients in the state of Virginia is done in the hospital setting, dramatically increasing the cost of screening OC in that state.

Other Concerns

Further concerns over three issues—1) radiation exposure, 2) cost and untoward effects resulting from extracolonic findings, and 3) whether the investigational results be replicated in non-investigational situations—appeared to negatively impact the CMS proposal not to cover CTC. Allow me to address these concerns in turn.

Radiation Concerns

While the concern over radiation exposure with CT scanning, including CTC, remains unproven, theoretical, and likely “unprovable”, the USPSTF had no such concern when recommending DCBE as an acceptable screening test as recently as the previous update in 2002. DCBE has been shown to have a higher total radiation dose than the current low-dose CTC protocols[i] [ii]. While DCBE was quietly dropped from the 2008 USPSTF recommendations, it remains an approved and reimbursed screening test with Medicare.

If CMS were truly concerned about the radiation risk of CTC and its role in the “I” rating from USPSTF, then the logical extension of that concern would be to drop DCBE from its list of approved CRC screening tests.

Further, the concern surrounding excessive radiation exposure is primarily voiced in relation to children and young adults who have many decades for this radiation to cause problems. Even the most vociferous of the “radiation damage” advocates concede that 2-4 CT colonographys after age 50 has no discernable impact. The less than 5 mSv per exam is an amount the Health Physics Society considers a risk that is either nonexistent or "too small to be measured".[iii]

Extracolonic Findings

The cost of extracolonic findings on CTC has been shown to add $20-30[iv] [v] to the overall cost of each study. A CTC is not the same as an abdominal CT. Its lower radiation dose does not allow small abnormalities to be found and therefore be misdiagnosed in the abdomen. When found, these extracolonic findings are not uncommonly shown to be important serendipitous findings. In our center, approximately 1% of our patients have been found to have resectable abdominal cancers, aneurysms, and other curable life-threatening abnormalities that have potentially saved the patient’s life, not to mention the healthcare dollars saved by early diagnosis and prevention. Further, CTC has now been shown to be an effective screening test to assess bone mineral density (BMD) to diagnosis osteoporosis,[vi] and to screen for aortic aneurysms.

CTC is not only a highly sensitive test for CRC/polyps, but can simultaneously screen for BMD, aortic aneurysms, and early abdominal cancers. With experienced CTC readers, the extracolonic findings are a benefit, not a detriment.

Over 45% of the patients that have been screened with Integrated Virtual Colonoscopy report that they would not have been screened without its availability.[vii] CTC is not replacing OC; it is augmenting OC, and getting many more Americans off the screening sidelines.

Conclusion:

The result of the NDA process by CMS—if finalized—would deal a major blow to the preventive health not only to America’s seniors, but to all Americans of CRC screening age. Despite the best efforts of America’s healthcare professionals, more than 50% of eligible Americans have not, will not, or cannot be screened by OC. This proposed denial, if finalized, sends the message that CMS is unmoved by the tragically low CRC screening rate in this country, and is inconsistant with President Obama’s call for a move towards prevention-based, rather than illness-based healthcare.

Conversely, in multiple clinical programs providing VC services, patients are demonstrating that the availability of VC has drawn them “off the screening sidelines” and into a highly-sensitive and patient-friendly modality of screening.

A final denial of coverage for CTC would not restrict only the access for America’s seniors to this patient-friendly screening test, but may also impact the coverage decisions made by commercial and other governmental insurance programs.

In a healthcare world full of tough decisions and needed reform, the decision to cover CTC for CRC screening should have been an easy one. Please do the right thing for America’s seniors and all Americans of CRC screening age: reverse the NCA decision and cover seniors for life-saving CTC, a test that will allow millions of additional Americans to be screened.

Respectfully submitted

Andrew R. Spiegel, Esquire
Chief Executive Officer
Colon Cancer Alliance
1200 G Street, NW Suite 800
Washington, DC 20005
DC Office (202) 434-8996
PA Office (610) 668-8600
Fax: (202) 434-8707
aspiegel@ccalliance.org
www.ccalliance.org

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It is with great conviction that I urge the committee to reconsider the initial decision to deny coverage for CT Colonography.

As a practicing primary care physician of nearly 30 years, it is my ethical duty to utilize the most appropriate clinical tools that will best serve the well-being of my patients. One of these tools is CTC.

It is no secret that Colorectal cancer screening saves lives, and Medicare coverage of CTC will result in the screening of patients who are resistant to Optical Colonoscopy. Pier reviewed medical literature has helped validate that CTC is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. Knowing that over 50% of eligible Americans won’t undergo Optical Colonoscopy (OC) as a screening test, CTC is the clinically best test for the 50% of Americans that would otherwise go unscreened for the most preventable of the deadly cancers. We also know CTC to be more cost effective than OC given the number of OC procedures that are performed in either an outpatient surgery center or hospital – both of which are much more costly than an in-office charge for an endoscopic procedure. Include the cost of anesthesia which is used on the majority of OC cases and the per unit cost easily exceeds that of CTC.

The assumption that OC is the default “gold standard” purely by its tenure in clinical medicine is not a safe assumption to make. Data on screening OC reveals numerous sensitivity/specificity issues and cancer miss rates. In the ACRIN trail, both tests found polyps missed by the other. But only one missed an actual colon cancer, and that test was OC. In another published study (Kim et al, NEJM 2007; 350:1403-1412), CTC found almost 3 times the number of cancers as OC (14 to 4), while finding almost the exact same number of advanced adenomas. This is a very compelling fact that can not be ignored.

Any concern over radiation exposure with CT scanning, including CTC remains unproven. CTC subjects patients to less radiation than a standard CT scan of the abdomen and pelvis, and if this were a risk we should have seen a profound increase in mortality from these CT derived cancers in these areas over the past 30 years – which clearly has NOT occurred. CTC is a test directed at those over 50 years of age, so the radiation risk is even less. The risk is further diminished considering the average age of a Medicare beneficiary. However, the USPSTF expressed radiation exposure as a key factor in it’s “insufficient data” rating of CTC. Double contrast barium enema (DCBE) has been shown to have a higher total radiation dose than existing low-dose CTC protocols and remains an approved and reimbursed screening test with Medicare. Another USPSTF concern was the cost of extra-colonic findings on CTC yet the study referenced should have used a more realistic and higher average cost for screening OC. Doing so would demonstrate that the overall cost of CTC would be negligible (if any) and still prove to be more cost-effective than OC.

Denial of coverage for CTC would restrict access for America’s seniors to a very safe and lifestyle friendly screening test, and will greatly influence the coverage decisions made by other health programs. With over 50,000 Americans dieing from Colorectal cancer each year, something must be done to encourage the 50% of Americans that go unscreened. The ramifications of a non-coverage decision would expose Medicare beneficiaries to a variety of risks such as the following: A.) Those who avoid OC will only have one other complete colon-screening test, DCBE, which is inferior to CTC. Therefore, this population will at best be suboptimally screened without the benefit of having access to a well known and clinically superior test (CTC), B.) Many cancers will be missed by OC that could be found on CTC, 3.) Complications derived from OC, including perforation, are low but NOT zero. By not covering CTC, Medicare will subject a number of their beneficiaries to unnecessary physical harm.

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March 13, 2009

Mr. William Larson
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Re: Proposed decision memo for screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N)

Dear Mr. Larson:

The American Society for Gastrointestinal Endoscopy (ASGE) appreciates the opportunity to comment on the Proposed decision memo for screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N). ASGE is a professional organization representing over 10,000 gastroenterologists across the United States practicing in a wide variety of medical, surgical, and pediatric specialties. The Society agrees with the Agency''s proposed decision not to extend coverage of the Medicare screening benefit to CTC, and we urge CMS to finalize this proposed decision.

As noted in the proposed decision memo, while colorectal cancer remains a leading cancer among men and women, the recent declines in US incidence and mortality are encouraging. Evidence indicates that in recent years colorectal cancer screening has increased among US adults 50 years and older. As an association representing physicians specializing in the diagnosis and treatment of disorders of the digestive system, ASGE is very supportive of efforts to expand the coverage of colorectal cancer (CRC) screening that would encourage an even greater number of Medicare beneficiaries to get screened and we would support expansion of approved screening methods that are supported by clinical evidence. However, as we have stated in previous comments to the Agency we believe it is premature to recommend CTC for routine colorectal cancer screening at this time.

In recent years as the coverage determination process has become increasingly transparent, CMS has been developing an evidence-based framework for coverage decisions. In establishing these decisions the Agency uses published and non-published studies, expert opinions, technical assessments, and recommendations from professional societies. Based on the principles of this methodology, coverage of CTC falls short of the minimum threshold for coverage and that the Agency''s proposed decision to not extend coverage to CTC is appropriate.

The Agency’s proposed decision is based on two main conclusions: 1) the evidence was not sufficient to determine that CTC is a valuable screening test for colorectal cancer for average risk Medicare beneficiaries compared to screening colonoscopy and 2) the evidence was not sufficient to conclude that the use of CTC for CRC screening for average risk Medicare beneficiaries improves net health outcomes compared to screening colonoscopy. These conclusions were reached principally because the current available evidence is not generalizable to the Medicare population. ASGE concurs that these are fair and reasonable conclusions. We strongly recommend that any consideration of CTC as a routine CRC screening test in average risk individuals be postponed until more information that support the use of CTC for this purpose has been published in peer-reviewed journals.

The importance of the generalizability of evidence to the Medicare population has been an important criterion in CMS’s coverage decision process. The proposed decision memo pointed out that a number of the seminal studies on CTC examined the results of CTC among a population younger than Medicare beneficiaries. Younger individuals have a lower prevalence of polyps, lower test positive rates and lower rates of referral for optical colonoscopy with polypectomy. The results of these studies lack external validity and generalizability to an older Medicare population and are therefore less suitable as a basis for a Medicare coverage decision. We believe that this lack of evidence based on an age-appropriate population speaks to our position that the decision must be postponed until more information has been published in peer-reviewed journals.

As CMS transforms from a passive payor of services into an active purchaser of higher quality, more affordable healthcare, the cost effectiveness of services becomes an important consideration. As reviewed, the cost effectiveness of CTC does not compare favorably with other available CRC screening tests.

In addition, as enumerated in the proposed decision memorandum, multiple questions remain about the sensitivity, specificity, reproducibility, and safety of the procedure in community settings. These unresolved issues include:

Optical colonoscopy is not working. A recent study published in 2008 has shown that the procedure remains under utilized in Medicare recipients. 'Underuse of colorectal cancer screening in a cohort of medicare beneficiaries', Gregory S. Cooper, Tzuyung Doug Kou, Cancer, Volume 112, Issue 2, Date: 15 January 2008, Pages: 293-299

In another study published in 2008 as well, it was shown that optical colonoscopy can miss polyps. 'Effect of Institution-Wide Policy of Colonoscopy Withdrawal Time ¡Ý7 Minutes on Polyp Detection' , 28 August 2008, Mandeep S. Sawhney, Marcelo S. Cury, Naama Neeman, Long H. Ngo, Janet M. Lewis, Ram Chuttani, Douglas K. Pleskow, Mark D. Aronson, Gastroenterology,December 2008 (Vol. 135, Issue 6, Pages 1892-1898)

Optical colonoscopy for screening is not perfect and may have its draw backs when it comes to screening but more importantly it is not being utilized as a screening tool by Medicare recipients. As a result 50,000 people are dying each year from a cancer that is 90% preventable. The healthcare system is paying an enormous cost of treating these patients.

CT Colonography (CTC) offers a viable proven alternative. When used as a screening tool in two different cities in the US ¨C Madison, Wisconsin and Bethesda Maryland during the past 5+ years it has consistently shown a 70% increase in screening by the local screening age populations in those areas.

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March 12, 2009

Centers for Medicare and Medicaid Services
Coverage and Analysis Group
Attn: Mr. William Larson
7500 Security Blvd
Mail Stop C-1-09-06
Baltimore, MD 21244

Re: Proposed Decision Memo for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N)

Dear Mr. Larson:

The American Gastroenterological Association (AGA) is dedicated to the mission of advancing the science and practice of gastroenterology. Founded in 1897, the AGA is the oldest medical-specialty society in the United States. Comprised of two non-profit organizations — the AGA and the AGA Institute — our 16,500 members include physicians and scientists who research, diagnose and treat disorders of the gastrointestinal tract and liver. We are pleased to submit comments in response to the Proposed Decision Memo for Screening Computed Tomography Colonography (CTC for Colorectal Cancer (CAG-00396N). The AGA has reviewed the proposed decision memo and respectfully requests that the Agency reconsider its position and consider how CTC might be effectively covered under a Coverage with Evidence Development (CED) Process.

The realities of colorectal cancer (CRC) are devastating, and the statistics are well documented with more than 140,000 newly diagnosed Americans every year, and nearly 50,000 deaths due to late detection. Colorectal Cancer is the third most common cancer diagnosed among men and women in the United States and the second leading cause of cancer death. But if detected early, colorectal cancer has a 90% cure rate. We note that compliance with colorectal cancer screening varies by racial background, with lower screening rates seen in non-Caucasian populations. By providing Medicare beneficiaries with an effective and less invasive screening alternative for CRC, the Agency might encourage more people to undergo screening, resulting in early detection and improved survival rates.

The AGA appreciated the opportunity to meet with Agency representatives, in conjunction with the American College of Radiology (ACR) and American Cancer Society (ACS), on March 3, 2009 as we sought to better understand the proposed decision memo and the additional information necessary for the Agency to implement a positive coverage determination. While colonoscopy remains the gold standard for the detection and prevention of CRC, as it is the only test that can both detect and remove cancerous lesions, it is possible that CTC, if performed properly, can be a valuable technology that can advance the goal of increasing CRC screening rates, and thus reduce the incidence of mortality from CRC. We agree with the Agency that the limitations of CTC cannot be ignored and must be taken under advisement in the development of a coverage policy. Concerns related to test sensitivity, specificity, reporting, training and technology requirements, radiation exposure, extra-colonic findings and appropriate surveillance intervals are well documented. As previously stated in our June 18, 2008 letter to CMS, the AGA supports coverage for screening CTC if CMS requires, as a “condition of coverage" (1) adherence to CTC training standards as developed by the AGA and ACR, (2) participation in a CTC certification program that meets the necessary standards related to technology, training, and reporting of all polyps and (3) the development of an "episode-based" period of CTC screening to increase the appropriate follow up care based on an evaluation of the CTC results, patient history and an assessment of the CRC risk factors, all of which can be implemented through the Coverage with Evidence Development (CED) process.

The AGA believes that the concerns related to the reporting of findings, training and technology can be effectively mitigated through the development of certification program(s) for CTC. Such program(s) would ensure physicians have achieved and maintained competency in reading and interpreting CTC scans, and that any facility that offers CTC employs appropriate technology and safety measures for doing so. Requiring participation in a CTC Certification program can be implemented through CMS’ policy regarding Coverage with Evidence Development (CED), specifically Coverage with Appropriateness Determination (CAD), which is coverage conditioned on specific additional data collection.

Based on comments made during the March 3rd meeting, it appears that CMS has concluded that they do not have the authority to permit coverage of CTC for colorectal cancer under their CED process based on an interpretation by CMS staff that CED is only appropriate for national coverage determinations based on the “reasonable and necessary” provisions in §1862(a)(1)(A) of the Social Security Act. Further, CMS staff believes that coverage for CTC for colorectal cancer is based on §1861(pp)(1), not §1862(a)(1)(A) and so the CED process cannot be used.

Respectfully, the AGA disagrees with the Agency’s interpretation. We believe that the CED process can be used, and that Section 1862(a)(1)(A) does apply to CTC for colorectal cancer. The intention of Congress, at the time the Medicare law was enacted in 1965, was that Medicare would provide health insurance to protect the elderly or disabled from the substantial costs of acute health care services, principally hospital care. The law was designed generally to cover services ordinarily furnished by hospitals, SNFs, and physicians licensed to practice medicine. Congress understood that questions as to coverage of specific services would invariably arise and would require a specific decision of coverage by those administering the program. Thus, it vested in the Secretary the authority to make those decisions.

Section 1862(a)(1)(A) of the Act states: "Notwithstanding any other provisions of this title, no payment may be made under Part A or Part B for any expenses incurred for items or services which… are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member." This is a key provision since the words "notwithstanding any other provision of this title…" make this an overriding exclusion that may be applicable in a given situation despite the existence of provisions that would otherwise permit coverage. Thus, while Congress provided for the coverage of services such as inpatient hospital care and physicians'' services, coverage for those services is prohibited unless they are "reasonable" and "necessary".

The proposed decision memo demonstrates that section 1862(a)(1)(A) does apply to the proposed decision on CTC for colorectal cancer screening. Appendix A, “General Methodological Principles of Study Design”, states:

“When making national coverage determinations, CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding that an item or service is reasonable and necessary [emphasis added].” In the guidance document, CMS states:“In most instances, CMS, through the NCD process determines whether the item or service is “reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.” In making NCDs under section 1862(a)(1)(A), CMS considers medical and scientific evidence and provides an opportunity for public comments on our proposed decisions. Because an NCD must be supported by a record, we attempt to gather and discuss all relevant medical and scientific information about a given topic and present our analysis for public scrutiny to ensure transparency. An aggrieved person can challenge an NCD pursuant to the procedure established by statute and regulation. In this guidance document, we describe a second statutory provision that may permit Medicare payment in some circumstances. If the evidence is not adequate for coverage under section 1862(a)(1)(A), an item or service may be considered for coverage under the CMS Coverage with Evidence Development (CED) policy in which “reasonable and necessary” is established under 1862(a)(1)(E) of the Act. Section 1862(a)(1)(E) is linked to Section 1142 of the Social Security Act, which allows CMS to work jointly with the Agency for Healthcare Research and Quality (AHRQ) to evaluate and empower CMS to pay for the clinical costs of this research.

In fact, the text of the proposed decision memo is consistent with the intent of the guidance to use CED when "evidence is not adequate to support coverage under section 1862(a)(1)(A) and where additional data gathered in the context of clinical care would further clarify the impact of these items and services on the health of Medicare beneficiaries". This statutory link to Section 1142 is important because this section of the statute includes specific reference to prevention, thereby making the use of CED for CTC for colorectal cancer appropriate since screening is a form of prevention. As noted in the guidance, "In the past, this level of evidence would have prompted non-coverage decisions", exactly the conclusion of the proposed decision memo on CT Colonography. The statutory language is as follows:

(1) IN GENERAL.—The Secretary, acting through the Administrator for Health Care Policy and Research, shall—(A) conduct and support research with respect to the outcomes, effectiveness, and appropriateness of health care services and procedures in order to identify the manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically; (2) EVALUATIONS OF ALTERNATIVE SERVICES AND PROCEDURES.—In carrying out paragraph (1), the Secretary shall conduct or support evaluations of the comparative effects, on health and functional capacity, of alternative services and procedures utilized in preventing, diagnosing, treating, and clinically managing diseases, disorders, and other health conditions. Even if CMS believes that they can only work within the context of 1861(pp), then they should consider the possibility that it would be “appropriate” to collect additional data on CTC while limiting coverage to qualified physicians who submit data. After all, 1861(pp)(1)(D) confers coverage on

“(D) Such other tests or procedures, and modifications to tests and procedures under this subsection, with such frequency and payment limits, as the Secretary determines appropriate, in consultation with appropriate organizations.”

In the final rule implementing the new colorectal cancer screening benefit (Federal Register Vol. 62, No. 211. October 31, 1997. page 59078), the Agency acknowledged the importance of prevention, stating “It is our expectation that implementation of the recently enacted new Medicare benefit provisions should help to overcome at least some of the barriers to the use of preventive services, and may lead to substantial reductions in morbidity and mortality.” Based on this, the AGA believes that CED for screening CT Colonography is an appropriate means for meeting the expectations of CMS and the Congress. Addressing the CTC Sensitivity Issues through Appropriate Training

In 2007, the AGA issued minimum training standards that addresses many of the factors related to training and technology requirements that can impact test performance issues (as has the American College of Radiology (ACR))[1][2]. The AGA has convened a multi-disciplinary workgroup that is updating this document to reflect the current standards of practice for performing CTC, including an in-depth definition of the scope, duration and options for completing a CTC preceptorship/mentorship and standards for assuring competency. In addition, the AGA and ACR are working to develop a standardized preceptorship curriculum that can be implemented across all institutions and practice settings.

As indicated in our January 30, 2009 letter to the Agency, the AGA will further its efforts by working collaboratively with the ACR to ensure recommendations are in-line with the current practice standards, and further, to establish quality training programs that will provide gastroenterologists and radiologists with the tools necessary to meet the required standards, and ultimately to perform a quality exam.

The AGA anticipates that, if appropriately trained, both gastroenterologists and radiologists will perform CTC in a manner that will further the public health benefit of reliable CRC screening. Incorporating standards that would establish minimum competency thresholds for providing physicians performing CTC as a condition of coverage will help to ensure a quality CTC exam. Rigorous training and proper technique are essential to ensuring that CTC achieves appropriate sensitivity, specificity and performance. The AGA recommends the adherence or compliance with training standards for physicians who will administer CTC (such as the AGA and ACR standards), including one that requires a process where the interpreter demonstrates ongoing maintenance of competency.

Addressing Sensitivity Issues through Mandated Technology Standards The AGA recommends that any CTC coverage policy incorporate standards which would require the appropriate technology as a condition of coverage. There is a need to establish minimum standards for the technology used in performing CTC. The literature shows that multi-detector-row (multi-slice) helical CT scanners that facilitate faster image acquisition and thinner sections, with collimation < 5 mm, and a scan acquired within a single breath hold of < 30 seconds, are important in assuring appropriate performance. Reconstructed axial or multiplanar 2-dimensional images for detection of an abnormality should be used with 3-dimensional reformatting software cleared by the U.S. Food and Drug Administration for use as a screening tool in detecting colon cancer and confirmation of an abnormality.

The Need for Mandated Reporting of All Polyps

It is the position of the AGA that all polyps identified by CTC be documented and reported. As noted above, there is a concern that CTC has low sensitivity for polyps of < 6 mm as well as significant concerns with the identification of flat and depressed lesions and the risk that they may pose. Early detection of CRC is a significant benefit of CTC, but only when the test reliably identifies polyps. CTC screening that fails to reliably identify polyps for removal presents potential public health risks.

While reports suggest that polyps smaller than 5 mm need not be reported, there is no large scale study or evidence to support such a position. In fact, the natural history of small polyps is unknown. Non reporting and ignoring small polyps could potentially place the patient at risk for CRC, contrary to the ultimate purpose of CTC for screening. While more frequent CTC screening may help address those concerns, the impact of small polyps has not been fully studied. For that reason, the AGA is working to promote that the National Institutes of Health institutes a study of the natural history of small polyps. Until the history of polyps is determined, the AGA along with ACG and ASGE believe that all small and diminutive polyps identified on CTC must be documented and reported. Patients must be informed of the results, and patients in consultation with their physician should determine whether or not to remove the polyps.

There is a clear need to determine what threshold of size constitutes a clinically relevant lesion for reporting. The AGA encourages efforts to study and obtain data to help the medical community better understand the natural evolution of polyps/lesions, which could be accomplished through the CED process. The AGA supports and will collaborate in the development of a registry that will assist in obtaining this important information.

The AGA is aware that the ACR has established a CT Colonography Registry which may represent an opportunity for the radiology and gastroenterology community to work together towards a common goal. Subsequent to our June 18, 2008 comments to CMS, the AGA has entered into a Memorandum of Understanding with the ACR to allow reporting by all physicians into this registry. By requiring the adequate reporting of CTC findings as part of coverage with appropriateness determination requirements, CMS will be able to develop the evidence for the appropriate use of CTC, for referrals from CTC to colonoscopy and polypectomy, and to achieve the ultimate goal of increased early detection of CRC.

CTC Certification Programs Can Address Issues with Training, Technology and Reporting

The AGA is working with the ACR to facilitate the development of a CTC certification program that includes training, technology and reporting as requirements as a means of enabling individual physicians and practices to become certified CTC providers, thereby allowing CMS to include CTC certification as a condition of coverage. Development of a certification program will allow CMS to ensure that coverage of CTC screening only takes place where the manner of screening is consistent with the 2008 consensus recommendations of the US Multi-Society Task Force on Colorectal Cancer and is consistent with CMS’ long-standing policy that a service is reasonable and necessary when it improves health outcomes. The basic elements of a CTC Certification Program have been developed. For example, physician training programs have been developed by the AGA and the ACR. A standard reporting model for CTC findings comparable to the Breast Imaging Reporting and Data System (BI-RADS®) has been developed by the ACR , and the ACR is in the process of issuing updated standards regarding CT technology. The AGA supports facility accreditation by entities such as the American College of Radiology or the Intersocietal Commission for the Accreditation of Computed Tomography Laboratories (ICACTL).

The AGA understands that enforcing certification requirements on single physicians may be difficult. However, coverage through a CED will facilitate the CTC Certification process. By submitting a claim for CTC screening services, the physician will, in effect, certify his or her CTC training. In addition, as a requirement of coverage with appropriateness determination, the physician will be required to report all polyps identified on the CTC examination, using an appropriate data registry as has already been developed by the ACR.

The Coverage Policy Can Mitigate the Likelihood of Unnecessary Tests

The current level of CRC screening which, by definition, is only performed in the absence of signs and symptoms, is too low. Because CTC requires patient compliance (through adequate cathartic preparation) it is possible that the ability of a physician to “over” perform CTCs is remote. Nevertheless, the coverage policy can mitigate the likelihood that physicians will perform unnecessary tests. For example, the coverage policy could limit the frequency of covered CTCs that are provided as a screening test, and by mandating the adoption of the CT Colonography Reporting and Data System(C-RADs) structure, the performance of unnecessary testing resulting from extra-colonic findings.

The State of Washington Health Technology Assessment Report found only one CTC screening strategy to be marginally more effective than colonoscopy every ten years, and that strategy is to perform CTC every five years with colonoscopy referral for polyps ≥ 6mm. CTC every ten years is more expensive and less effective in preventing cases of cancer (47 vs. 52 in a lifetime cohort of 1,000 individuals) and cancer deaths (24 vs. 26). Thus, CMS could limit coverage for CTC, in the absence of polyps, to every 5 years. While this is not as cost effective as the 10 year screening interval for colonoscopy, a 5 year screening interval for CTC would be consistent with the data available at this time. Once polyps are detected on CTC, the appropriate follow-up examination from a patient care and resource consumption perspective is colonoscopy.

Defining an "Episode-Based" Period of CTC Screening

The AGA recommends a coverage policy that encourages rapid follow up procedures and which correspondingly would not create a disincentive for physicians who refer those procedures. The above discussion provides a plan for addressing issues related to the sensitivity and reliability of CTC for effective CRC screening. However, even if CTC increases the number of individuals screened for CRC, and screening is appropriately performed, that increase will only be effective in decreasing CRC mortality if those individuals receive the appropriate follow up care when necessary. Although there is some discussion about the amount of follow up care that would be required, the State of Washington Health Technology Assessment Report indicates that follow up colonoscopy would occur in roughly 10.3% of all cases if the cut-off point were > 6 mm. However, other studies have reported the rates may be significantly higher, with referral rates ranging from 30 to 51%. , Higher referral rates make CTC much less cost-effective than colonoscopy. Thus, the CMS coverage policy should take into consideration what follow up procedures are covered if polyps < 9 mm are discovered during CTC. The coverage policy should recognize that a significant advantage of colonoscopy is that detection and removal of polyps can occur during the same procedure. The AGA recommends that the coverage policy should include coverage for follow-up procedures during the CTC screening episode, including colonoscopies performed if polyps, regardless of size, are discovered during the CTC examination. The inclusion of colonoscopy as a screening benefit during the CTC screening episode will allow for the consultation by the physician with the patient as to the management of the CTC findings.

By using an episode-based period of CTC screening, the coverage policy would recognize the significant advantage of colonoscopy—i.e. the detection and removal of polyps during the same procedure. With CTC, removal of identified polyps must take place through a second procedure. Proper bowel preparation is an important factor in the success of colonoscopy. Because patient adherence to appropriate follow up care may be improved if colonoscopy and polypectomy can take place on the same day of, and in rapid succession to, the CTC, an episode-based CTC screening benefit would ensure rapid succession of colonoscopy and polypectomies, when appropriate. Further, the policy should allow for colonoscopy as a screening benefit if the physician and patient want to follow up on polyps < 10 mm.

Summary

In sum, the AGA believes that CMS has the authority to cover CTC under the CED process, and recommends that CTC be covered as a colorectal cancer screening benefit for Medicare beneficiaries as long as the enumerated conditions are satisfied. The coverage policy should mandate the training, technology, quality standards and reporting prerequisites necessary to increase the likelihood that screening CTC will improve detection and that the CRC burden will not increase as a result of the false negative results associated with inadequate training or inappropriate technology. In addition, the AGA recommends standard reporting of all polyps in order to develop the evidence as to the appropriate use of referrals from CTC to colonoscopy and polypectomy, and the screening interval for CTC should be based on an analysis of the implications of the published literature.

The AGA’s endorsement of coverage for CTC under the circumstances described herein should not be interpreted as suggesting that CTC should replace colonoscopy. Colonoscopy remains the gold standard for the detection of CRC and the removal of lesions. However, given the gap in patient compliance with current screening guidelines, CTC could be an acceptable screening test if the coverage policy addresses those factors that impact test performance.

Provided that the key issues are addressed in the coverage policy, the AGA would endorse a decision to provide coverage for screening CTC for Medicare beneficiaries.

Respectfully submitted,
Robert S. Sandler, MD, AGAF
President, AGA Institute

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I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients. The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

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I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients.

The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

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Dear Sirs:

As one of the few gastroenterologists in the US with an integrated capacity to perform virtual colonoscopy [CTC] in my medical practice, I am uniquely positioned to comment on Medicare coverage for this procedure. I am writing you as I believe your recent proposed decision [CAG-00396N], not to cover virtual colonoscopy as a benefit for Medicare beneficiaries is in error. I recommend that Medicare: 1. cover virtual colonoscopy as a benefit for their beneficiaries, on the basis of proven efficacy, safety, convenience of patients, cost considerations and access considerations;2. Medicare and Congress should also consider easing the regulatory burden on gastroenterologists, to allow those best positioned to provide colon cancer screening services to do so.

You have requested additional evidence of clinical and cost effectiveness. I would also take a moment to comment on proposed decision.

Your summary of the background of the problem [section II] correctly points out that current screening efforts to date have been associated with declining rates of colon cancer in the population as a whole. Most authorities attribute that decrease to increasing screening and polypectomies when appropriate. Unfortunately, this declining rate of colon cancer has not been shared with some minority populations, particularly the black population. There are many conjectures as to why this might be so, including lack of access to screening, higher colon cancer risk than the white population, cultural barriers to screening. The Medicare program, by including coverage of virtual colonoscopy, has the opportunity to improve access to care of this disadvantaged population.

Your review comments on the ethical requirement to avoid harm to patients who are being screened. Virtual colonoscopy has a very low rate of complications, particularly as compared to optical colonoscopy. This is particularly important in the Medicare population, who members often have co-morbidities that increase the risk of screening optical colonoscopy. In your analysis, there is no discussion of the costs of optical colonoscopy complications. These costs include direct medical costs as well as indirect costs to patients, as lost wages, lost consortium. These costs are substantial to those who have suffered complications. The use of virtual colonoscopy to screen patients has the potential to dramatically reduce those costs by reducing complication rates.

In section V, where you discuss the status of whole body CT scanning, most authorities agree with your determination that this procedure does not pass muster for routine screening purposes. However, it is a very common clinical circumstance that unsuspected disease entities are uncovered during the evaluation of a patient’s presenting clinical problem. It is a clinical judgment to determine how important these incidental findings may be to the patient, and whether they are worthy of evaluation. For virtual colonoscopy, the most common incidental findings are abdominal aortic aneurism, renal neoplasia and lung lesions. Most authorities would agree that these lesions would be worthy of investigation if discovered through mechanisms other than a screening virtual colonoscopy. The ability to find such important asymptomatic findings actually increases the value of the virtual colonoscopy to the patient. If it were possible to improve a stool test or optical colonoscopy to discover such lesions, the medical profession would certainly do so.

In section VII B 2, under external evidence reviewed, there is a comment about the management of small polyps, and uncertainties about the management of small polyps. There are, of course, many uncertainties in all areas of clinical medicine. These are daily problems for clinicians. However, even in the setting of ambiguity and incomplete information, most authorities believe that small polyps are not an immediate risk to health. Many authorities are advocating monitoring of small polyps rather than immediate optical colonoscopy. This is a subject worthy of formal study. In the mean time, the availability of virtual colonoscopy, allowing monitoring of small polyps, may decrease the need for optical colonoscopy, along with the costs and complications of optical colonoscopy. Dangers for radiation are likely to be less important for older Medicare patients than for younger patients, as any proposed radiation complications are thought to have very long lag times.

There is concern about the sensitivity and specificity of virtual colonoscopy as opposed to optical colonoscopy, particular for polyps in the 6-9 mm size range. Virtual colonoscopy fares well when the sensitivity of optical colonoscopy is compared to itself, as in tandem colonoscopy studies. In such tandem studies, optical colonoscopy may miss as many as 25% of small polyps. Also, in some published studies, virtual colonoscopy is more accurate than optical. Optical colonoscopy is not the gold standard it was once thought to be.

Using pooled data to assess virtual colonoscopy may not be the best way to evaluate its sensitivity or specificity. Most authorities believe that a primary 3 D read is superior to a primary 2 D read of the virtual colonoscopy data. Also, the accuracy of reading is in part related to the training of the reader. The best 3 D data is what we should be aiming for in our training and ongoing clinical monitoring.

For VII. 4., the MEDAC voting was curious. If you had asked question 2 and substituted optical colonoscopy for virtual colonoscopy, the response would likely have been similar. The health benefits of removal of small polyps is uncertain. The responses to your question 3 support my assertion.

For section VII, 7 Radiation concerns, the perception of risk of a low dose CT scan by most medical professionals is low. The risks always have to be balanced against benefits. The risks of complications of CT radiation are certainly lower than the risk of optical colonoscopy complications, which are seen with unfortunate frequency. As a rough average, only 10% of patients undergoing virtual colonoscopy will require optical colonoscopy. Virtual colonoscopy has the potential to decrease optical colonoscopy complications by 90%!

For section VII. 7 Extra colonic findings are clearly a benefit to patients and to the Medicare program. If important findings can be diagnosed before they become clinically symptomatic, it is more likely that we can apply effective treatments to them. If it were possible to improve any screening test to find other diseases, that would be considered an improvement, not a liability.

For section VIII A. cost, the CMS cost analysis is seriously flawed, as it does not consider the cost of the facility fee in which the optical colonoscopy is performed, the cost of anesthesia and sedation commonly used with optical colonoscopy, the cost to the patient of copayments and deductibles, and the cost of lost productivity for the day of the patient and for the person required to accompany the patient for a procedure requiring sedation. Cost analysis strongly favors virtual colonoscopy, even if 10% of them will require follow up optical colonoscopy.

For section VIII B2, referral rate, in my own personal practice, I have felt it reasonable, in selected patients, to not refer some patients with small polyps for optical colonoscopy, based on an analysis of risk vs. benefit. Particularly in a Medicare patient population, patients have a high rate of co-morbidities making optical colonoscopy less desirable. Knowing that a patient had a low risk of colon cancer over the next few years, as evidenced by a small polyp seen on virtual colonoscopy, can be acceptable for selected patients. It would be my presumption that patients over the age of 75 would not be referred for routine screening virtual colonoscopies, just as we are not referring these patients for optical colonoscopies, mooting the argument that patients would be more likely to referred as they get older, given the increasing rate of polyps in the elderly.

I have reviewed my own unpublished evaluations of my Medicare patients who underwent both optical colonoscopy and virtual colonoscopy. While obviously not a random collection of patients, this group already indicates how Medicare patients can be triaged into groups requiring action, as newly diagnosed colon cancer patients, and how most of the patients can be reassured and simply monitored clinically.

As a gastroenterologist, I have been able to expedite the care of patients undergoing virtual colonoscopy who have already had incomplete optical colonoscopy or who require optical colonoscopy based on virtual colonoscopy findings. It is my belief that a gastroenterologist-led unit offers patients significant advantages over the typical radiologist-led unit. Gastroenterologists actually know and examine patients, interpret clinical ambiguity, can accurately assess risk and benefit, and control access to the endoscopy suite when needed. Medicare regulations should take these considerations and minimize the regulatory obstacles to gastroenterologist-led virtual colonoscopy units. Medicare should also consider regulatory relief to facilitate cooperation between gastroenterologists and radiologists interested in colon cancer screening.

In summary, I recommend that Medicare cover virtual colonoscopy as a benefit for their beneficiaries, limited only by appropriate medical considerations, for the safety and convenience of patients, for cost considerations, for access considerations. Medicare and Congress should also consider easing the regulatory burden on gastroenterologists, to allow those best positioned to provide colon cancer screening services to do so.

Brian C. Weiner, MD, MS, FACP
Clinical Assistant Professor, Medicine
Robert Wood Johnson Medical School

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I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients. The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

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[PHI Redacted] is a colon cancer survivor. She has sufferred one recurrence. All told, she has had four colon surgeries. As the CTC procudure is non- invasive, it is an important and on-going tool in insuring recurrences are detected early. The invasive colonoscopy poses risks of perforation and other damage to an already damaged colon.

I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients.

The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally- invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

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As a former principal investigator for the Department of Defense Army Navy CT Virtual Colonoscopy Trial (Pickhardt 2003) and director for the Center for Virtual Colonoscopy at the Walter Reed Army Medical Center, and current director of Virtual Colonoscopy for the Fairfax Radiological Consultants, I am surprised and disappointed with the Centers for Medicare and Medicaid Services (CMS) decision to not cover CT colonography for colorectal cancer screening despite overwhelming evidence that CT colonography (virtual colonoscopy) is both sensitive and cost effective. The decision is even more troubling when we are committed in both the Department of Defense and the Department of Veteran's Affairs to incorporating CT colonography to colorectal cancer screening.

I would like to respond to specific comments made in section VIII., the CMS Analysis portion of the proposed decision memo.

A. Is the evidence sufficient to determine that CT colonography is a valuable test as described above for colorectal cancer for average risk Medicare individuals compared to optical colonoscopy?

As stated in CMS's proposed decision memo, CT colonography is a relatively simple test that is acceptable, accurate, sensitive, and specific for the detection of colonic polyps in a screening population. However, a point was raised concerning the cost-effectiveness of CT colonography. As stated in Vijan (2007), of which I am a coauthor, we studied the cost effectiveness of CT colonography compared to conventional optical colonoscopy and no screening. The primary determining factor in whether CT colonography was cost-effective was its overall sensitivity and specificity. Using modern 3D technique, as was used in both the DOD clinical trial (Pickhardt 2003) and ACRIN trial (Johnson 2008), CT colonography every 5 or 10 years was both effective and cost effective compared to no screening. More importantly CT colonography every 5 years was more cost effective than optical colonoscopy every 10 years if optical colonoscopy costs 1.6 times more than CT colonography. Our conclusion stating that CT colonography technology will need to improve its accuracy and reliability to be a cost-effective screening option was to warn against antiquated legacy 2D methods of CT colonography advocated by some at that time.

Another pivotal, overarching concern raised in the proposed decision memo was the generalizability of the results of the published studies (mean age of 57.8 years, 57 years, and 58.3 years in the Pickhardt, Kim, and Johnson studies respectively) to the Medicare population (mean age 75.5 in 2007). As was stated in the proposed decision memo, there are no published studies focused on a population more representative of the Medicare population. However, Lin (2006) evaluated the estimated impact on screening colonoscopy in elderly population and concluded that with longer polyp lag times, the mean extension in life expectancy decreased more in the elderly than in the younger patients, and screening colonoscopy in very elderly persons (aged > or =80 years) results in only 15% of the expected gain in life expectancy in younger patients.

B. Is the evidence sufficient to conclude that the use of CT colonography for colorectal cancer screening for average risk Medicare individuals improves net health outcomes compared to optical colonoscopy?

1. Size and Type of Polyp

CT colonography cannot reliably detect polyps <6mm, and the proposed decision memo raises some important concerns regarding the importance of these small polyps. However the largest study to date to examine the natural progression of these small polyps is the National Polyp Study. The study concludes that most small polyps are non-adenomas, and there must be high incidence of regression of adenomas (Loeve 2004). Furthermore, current practice of removal of all polyps at conventional colonoscopy regardless of size increases the risk of colonic perforation and cost of examination without any clinical proof of efficacy. We have shown previously (Pickhardt 2004) that with current 3D technique, flat adenomas measuring 6 mm or greater are uncommon in a typical Western screening population. Moreover, advanced flat neoplasms are rare, and the sensitivity of virtual colonoscopy for detecting flat lesions was similar to that of polypoid lesions. These results indicate that the detection of flat lesions is not a significant drawback for virtual colonoscopy screening.

2. Referral to Optical colonoscopy and Prevalence of Polyps

The referral rate for conventional colonoscopy for individuals with polyps > 6mm would be 29.7% in the 2003 Pickhardt study (mean age = 57.8 years), 12.9% in the 2007 Kim study (mean age = 57.0 years), and 12% in the 2008 Johnson study (mean age = 58.3 years). However, if a higher size threshold is used for referral, such as > 10mm, the rate decreases to 7.5% in the 2003 Pickhardt study and 5.3% in the 2007 Kim study.

Although incidence of polyps increases with increasing age, the proportion of patients that will require conventional colonoscopy following CT colonography is still very low. Our current clinical practice offers the patients the option of same-day colonoscopy in the event that significant colonic polyp is found on CT colonography, negating the need for multiple bowel preparations.

3. Extracolonic finding

Extracolonic findings on CT colonography are indeed very common. However, great majority of the findings are a benign part of aging, such as cysts and stones. This was recognized early on. CT Colonography Reporting and Data System (C-RADS) was developed by the Working Group on Virtual Colonoscopy to categorize those extracolonic findings that require workup and those that are simply incidental findings (Zalis 2005). Using the C-RADS system, we studied 2,277 asymptomatic patients who underwent CT colonography from June 2003 to June 2006 at the Walter Reed Army Medical Center (Veerappan ¨C submitted for publication). Of these patients, 44% were found to have extracolonic findings. Patients were stratified into the following categories: normal (E1), benign (E2), needing additional workup (E3), or needing expedited workup (E4). In our study, E1 (54%) and E2 (34.5%) classifications accounted for majority of the patient, and E3 (7.4%) and E4 (1.7%) were in the minority. However, among the patients in categories E3 and E4, 1.8% (4/212) of E3 patients and 27.5% (11/40) of E4 patients had findings that required surgical evaluations, which resulted in discovery of 6 extracolonic cancers and 1 life-threatening aortic aneurysm. In addition, 5 out of 6 extracolonic cancers were detected early enough to be cured with resection. The total cost of extracolonic findings workups came to $45 per CT colonography.

4. U.S. Preventive Services Task Force

The proposed decision memo states that 'For colorectal cancer screening with CT colonography, the USPSTF concluded that 'the evidence is insufficient to assess the benefits and harms of computed tomographic colonography and fecal DNA testing as screening modalities for colorectal cancer.' The memo adds that 'Other appropriate organizations also share this view.' However, the American Cancer Society and the U.S. Multi-Society Task Force on Colorectal Cancer recently released the first-ever joint consensus guidelines for colorectal cancer screening, which added CT colonography to the recommended list of screening modality. The consensus guidelines note that 'CT colonography is a time-efficient procedure that produces good accuracy with minimal invasiveness. CT colonography does not require sedation or recovery time, and patients can return to work on the same day as the examination' (Smith 2009).

5. Radiation

As stated in the proposed decision memo, radiation exposure from CT colonography for colorectal cancer screening is a potential concern. However with the increasing use of low dose CT colonography technique, radiation exposure in an average individual is estimated to be around 5mSv, which is less than the exposure associated with routine CT scan of abdomen and pelvis and lower than in double contrast barium enema examinations.

6. Health Outcomes

The proposed decision memo states that no published study has evaluated survival following participation in colorectal cancer screening with CT colonography. However, the same statement can be made about conventional optical colonoscopy and double contrast barium enema examinations that are currently reimbursed by Medicare for colon cancer screening. It is medically accepted that vast majority of colorectal cancer are completely preventable since we screen for adenomas which are precursors to cancer, unlike other forms of cancer screening such as breast cancer screening or lung cancer screening. The Centers for Disease Control and Prevention estimates that the number of US individuals who require colorectal cancer screening is 70.1 million (Seeff 2004). Of this number, approximately 40% (28.2 million) are currently being screened using a combination of colonoscopy (22% or 15.7 million), fecal occult blood testing and sigmoidoscopy (8.4% or 5.9 million), and fecal occult blood testing alone (9.6% or 6.7 million). There are approximately 41.8 million people who receive no form of colorectal screening. There are not enough gastroenterologists to screen everyone who needs screening for colorectal cancer. Before CT colonography was instituted for routine colorectal screening at the Walter Reed Army Medical Center, the waiting list for conventional screening colonoscopy was in excess of 6 months, and less than 50% of eligible patients were being screened for colorectal cancer. The Center for Virtual Colonoscopy was established at the Walter Reed Army Medical Center in 2004 by a joint effort between the Departments of Radiology and Gastroenterology to remedy this situation. To date, over 7,000 patients have been screened and the results have been dramatic. The waiting time for conventional screening colonoscopy now is 2 weeks and over 70% of eligible patients are now being screened for colorectal cancer.

7. Overall Consideration

Overall, the clinical and scientific evidence is overwhelmingly in support of CT colonography as a viable and economically-sound means of colorectal cancer screening. Coverage of CT colonography by private insurers is variable and, in many cases, under consideration. However, CMS's decision on Medicare coverage will play a major role in whether private insurers will cover this essential new modality. CMS can play a leading role in increasing screening compliance for this completely preventable cancer.

C. Other Considerations

1. Colonoscopy as Reference Standard

Prior to the advent of CT colonography, it has been difficult to assess colonoscopy as a gold standard since no other examination had similar sensitivity or specificity for detection of polyps. However with segmental unblinding, we have shown that even in the best hands, conventional colonoscopy has a sensitivity of approximately 90% for detection of polyps ≥10mm (Pickhardt 2003). This number is easily matched by current CT colonography techniques.

2. CT Colonography Training and Experience

As with any clinical examination, meticulous technique and adequate training are necessary to achieve excellent results. In recognition of this, the American College of Radiology (ACR) has published ACR Practice Guidelines for the Performance of Computed Tomography (CT) Colonography in Adults, which lists recommendation for minimum equipment, technique, and training.

3. Health Disparities

As noted in the proposed decision memo, given the increased incidence of polyps and colorectal cancer with age, we must use all the clinical tools in our arsenal to combat colorectal cancer. Elderly patients often suffer from multiple medical conditions, which make sedation required for conventional colonoscopy risky. CT colonography does not require sedation and has almost no risk of colonic perforation.

* * *

In conclusion, we respectfully ask CMS to reconsider its decision not to cover CT colonography for colorectal cancer screening. There are very few instances in our lives where we can truly effect the life and welfare of our fellow citizens. This is one instance where CMS's decision can save thousands of lives and benefit millions of others.

Sincerely,

J. Richard Choi, ScD, MD
Principal Investigator Department of Defense Army Navy Virtual Colonoscopy Clinical Trial
Assistant Professor of Radiology Uniformed Services University of Health Sciences
Instructor and Former Director Center for Virtual Colonoscopy at Walter Reed Army Medical Center
Director of Virtual Colonoscopy Fairfax Radiological Consultants

Bibliography

Johnson CD, Chen MH, Toledano AY, et al., Accuracy of CT colonography for detection of large adenomas and cancers, N Engl J Med. 2008 Sep 18;359(12):1207-17

Kim DH, Pickhardt PJ, Taylor AJ, et al., CT colonography versus colonoscopy for the detection of advanced neoplasia, N Engl J Med. 2007 Oct 4;357(14):1403-12 Lin OS, Kozarek RA, Schembre DB, et al., Screening colonoscopy in very elderly patients: prevalence of neoplasia and estimated impact on life expectancy, JAMA 2006 May 24; 295 (20):2411-2

Loeve F, Boer R, Zauber A, et al., National Polyp Study data: Evidence for regression of adenomas, Int J Cancer 2004 Sep; 111(4):633-9

O'Brien MJ, Winawer SJ, Zauber AG, et al., The National Polyp Study: Patient and polyp characteristics associated with high-grade dysplasia in colorectal adenomas, Gatroenterology 1990 Feb; 98(2):371-9

Pickhardt PJ, Choi JR, Hwang I, et al., Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults, N Engl J Med. 2003 Dec 4;349(23):2191-200Pickhardt PJ, Nigent PA, Choi JR, et al., Flat colorectal lesions in asymptomatic adults: implications for screening with CT virtual colonoscopy, Am J Roentgenol. 2004 Nov;183(5):1343-7

Seeff LC, Manninen DL, Dong FB, et al., Is there endoscopic capacity to provide colorectal cancer screening to the unscreened population in the United States?, Gastroenterology 2004 Dec;127(6):1661-9

Vijan S, Hwang I, Inadomi J, et al., The cost-effectiveness of CT colonography in screening for colorectal neoplasia, Am J Gastroenterol. 2007 Feb;102(2):380-90

Zalis ME, Barish MA, Choi JR, et al., CT Colonography Reporting and Data System: A Concensus Proposal, Radiology 2005 July;236(1):3-9

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I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients. The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

Thank you,Dionne Rivera

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I am in support of the vc being covered. [PHI Redacted] has just recently been diagnosed with colon cancer. By the time he noticed symptoms, it was in stage 4. He starts his chemo monday, and has a very long fight ahead of him. I did not no much like many other people about colon cancer, and how it begins. From the moment I found out about [PHI Redacted] I have been consumed in finding out all I can. Before a tumor becomes cancer it starts off as tiny little pollups. They can grow for years and years before any symptoms show. So a person would not know they had colon cancer until it is advanced unless they could be checked for it. The doctors told [PHI Redacted] his cancer could have been growing for 10 to 15 years before it turned into the tumor. I think a colon screening should be something you get as part of a regular healthcheck when you get to a certain age. I would say that age is 50, but more and more people are finding out their stage 4 in their 30''s, and even 20''s. This is a horrible PREVENTABLE disease. Anything we can do to save people from it, I believe strongly we should do. Some cancers show no warning signs until you actually have it, this one has warning signs for years, it is almost screaming HERE I COME YOU BETTER GET ME OUT. Please do whatever you can to help those who are fighting the fight against this beast, and maybe you or someone you love can be saved from ever having to join the fight.

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Last week, [PHI Redacted] passed away from a rough 8 month battle with colorectal cancer. The fight that she put up to keep her life was one in which no individual or family should have to go through. Therefore, I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). A virtual colonoscapy should be available to everyone to curb the outcome of this horrible disease.

I fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients.

The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month. Thank you very much.

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I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients.

The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

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I respectfully request that the Center for Medicare and Medicaid Services (CMS) propose Medicare coverage under a national coverage determination for computed tomography colonography (CTC). We fully support national Medicare coverage of CTC as an acceptable minimally-invasive screening test and an additional valuable tool in our arsenal for detecting and preventing colorectal cancer.

March is National Colorectal Cancer Awareness Month. There has never been a better time to implement coverage of CTC to provide millions of Medicare beneficiaries and their physicians with another effective screening option. Colorectal cancer is the third most diagnosed cancer in the United States, and the second leading cause of death from cancer.

Only 39 percent of colorectal cancer patients have their cancers detected at an early stage. The lack of early screening and detection results in a much higher mortality rate for this disease than there ought to be. Colorectal cancer can be prevented through the early identification and removal of pre-cancerous polyps, detectable only through colorectal cancer screenings.

Colorectal cancer is almost always curable when caught early enough through colorectal cancer screening, and Medicare coverage of CTC could prevent unnecessary deaths. Many Americans forgo the colorectal screening process, whether it''s the invasive nature of traditional colonoscopy or sigmoidoscopy, or the sample collection issues associated with fecal occult blood stool testing, so an alternative such as CTC should be covered by Medicare.

CTC is a less-invasive screening procedure than colonoscopy, offering the promise of increasing initial colorectal cancer screening rates. The National Naval Medical Center in Bethesda, MD, a leading institution in CTC research, has increased colorectal screening rates by 70% since it added CTC as an option to patients. The Department of Defense has large volume screening programs using CTC at Walter Reed Army Medical Center and the National Naval Medical Center. Walter Reed has determined their program to be a success and is working with the Department of Veterans Administration to deploy CTC screening throughout the VA Health System. Medicare patients deserve the same access to colorectal cancer screening.

Sufficient data and clinical evidence exist to support CTC screening coverage under Medicare. In September 2008, the American College of Radiology Imaging Network released the results of its multi-site national CTC trial, sponsored by the National Cancer Institute to compare the accuracy of CTC to the gold standard of conventional colonoscopy. The New England Journal of Medicine published study results found that CTC is comparable to standard colonoscopy in its ability to accurately detect cancer and precancerous polyps, and it could serve as an initial screening exam for colorectal cancer.

National Medicare coverage of CTC as a minimally-invasive screening test for colorectal cancer would not just encourage more patients to undergo screening, but it would potentially close or eliminate the gap in colorectal cancer screening between whites and minority populations. This year, the Journal of the American Geriatrics Society, released a study demonstrating that the disparity between white and nonwhite Medicare enrollees receiving a colonoscopy screening actually increased between 1995 and 2003. For populations not receiving a traditional colonoscopy, CTC can provide another vital option for detecting cancer in its early stages - especially in underserved populations.

We appreciate your consideration in this important matter and the critical opportunity to save lives from cancer during Colorectal Cancer Awareness Month.

Diana Velez-Griffen

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History is replete with examples of governments, politicians, philosophers and businessmen making colossal blunders while clinging to mistaken ideals even in the face of significant evidence to the contrary. Further, many scientists who were once leaders in their field are, when illuminated by the cold light of history, considered jesters for rejecting and even suppressing revolutionary or paradigm-shifting scientific breakthroughs to protect their own careers and further their own theories.

Any failure to approve reimbursement of CT Colonography (“CTC”) for colon cancer screening would promptly take its place as among the biggest, costliest and deadliest gaffes in the history of public health. The effect of such a decision will be that (a) more Medicare patients will die from colon cancer, and (b) the costs of Medicare will continue to escalate because Medicare will be paying for treatment and care of colon cancer patients, rather than preventative care for an extremely curable disease. If not literally a crime, this is a figurative crime against both Medicare recipients and the American taxpayers. It is mind-boggling to even attempt to understand how the committee could consider denying potentially life-saving screening alternatives for a disease that is 90% curable, when almost as many Americans die each year from colon cancer (50,000) as were killed during the entire Vietnam war. In addition, there are between 100,000 – 150,000 new cases of colon cancer diagnosed each year. The good news is that this long-standing error can be reversed. The advantages associated with CTC are many:CTC has been proven to be as effective as optical colonscopy. The scientific evidence is clear. According to the seminal peer-reviewed study in the New England Journal of Medicine, CTC accurately detected medically-significant polyps over 90% of the time. This is a significantly higher success rate than other life-saving technologies that are currently reimbursed, including mammography, technology which is only 80% effective and yet is reimbursed by Medicare, is widely used, and is saving lives.

There are fewer health risks than screening conducted via optical colonscopy. CTC is not accompanied by any of the risks of bowel perforation, infection or other surgical complications faced by patients undergoing optical colonoscopies.

CTC can also detect other undiagnosed medical issues. Because the entire abdomen is scanned in connection with CTC, radiologists have the ability to review extra-colonic areas in the abdomen and detect anomalies. In several cases, including anecdotal reports from other people submitting comments in support of reimbursement for CTC, this has led to early detection and treatment of cancer in other organs such as the kidneys and liver.

Screening by CTC is faster and easier. Because a CTC requires no anesthesia, has very few side effects and requires only a very short CT scan, patients being screened can be quickly processed and return to work or their family shortly after the procedure. Rudimentary economic analysis tells us that because the cost of colon cancer screening is lower with CTC than with optical colonscopy (both in terms of the opportunity cost of people’s time, and the costs associated with risks of complication), the quantity of people seek screening will increase. As a direct result of this, more cancerous and pre-cancerous polyps would be detected, more people would be treated, and more cancer deaths would be prevented.

CTC creates a digital record. Another obvious advantage of colon cancer screening by CTC is that a digital image of each patient’s colon is created and stored electronically. In addition to easily being attached to digital medical records of the patient, this technology allows the patient’s physician to quickly and accurately track the patient’s medical history and electronically compare the results of prior CTCs. Among other applications, this could permit the physician to track and compare non-medically significant polyps over time with precision.

In summary, colon cancer screening by CTC is a scientifically-proven alternative to optical colonoscopy, that is more cost-effective, less intrusive and less risky. As a result, CTC increases the likelihood that patients will be screened, cancer will be detected and lives will be saved. In long run, money will be saved as less will be required to be spent caring for those that were not fortunate enough to have received screening in time to prevent their death from this horrible disease. In these troubled economic times, with rising costs of health care, and pending social security crisis, I implore you to do the right thing and reverse your tentative decision to deny reimbursement for CTC.

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Dear Mr. Larson:

I am writing as a consumer representative to the MedCAC and a panel member of the California Technology Assessment Forum, re. the Medicare NCA for Screening CTC for colorectal cancer. I was a member of the MedCAC panel that reviewed this issue in November 2008. (Although I had to decline attendance at the last minute, I did read the materials and filled out the decision form) Just this week I was the discussant for CTAF's review of CTC.

The CTAF panel concurred with CMS and the USPSTF that there is insufficient evidence to indicate that CTC is an appropriate screening mechanism for colorectal cancer, particularly in a population that is of average risk. The accuracy of CTC in comparison to conventional colonoscopy is still in question; the impact of the radiation risks of repeated CTCs is not yet known; the need for highly trained radiologists to conduct these screens is not in dispute. We also do not know with any degree of uncertainty whether or not compliance would be enhanced if CTCs were routinely available to the Medicare population. Most elderly patients are not fully informed of the fact that bowel preparation is still required for CTCs as it is for conventional colonoscopy and that sedation is not administered with CTC, resulting in acute discomfort for some patients. The appeal of a non-invasive procedure is not well explained, particularly when polyps are identified and then a conventional colonscopy must be done in addition to the CTC. There are many unresolved issues regarding this technology, not to mention the fact that if this screening technique is made available to part of the Medicare population, it will spread broadly and rapidly and perhaps be used inappropriately and inaccurately in the community setting.

I therefore recommend that Medicare deny a NCD for CTC at this time, or cover it only within a Coverage with Evidence Development framework until the research answers the questions noted above.

Thank you for your consideration.

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Ladies and Gentlemen, Below you will find several well written reasons that CTC must be supported as a critical colorectal cancer screening tool. At Walter Reed Army Medical Center, where I am the Chief of Diagnostic Radiology, even the gastroenterologists support its use as it expands the population able to be screened, increases the yield of optical colonoscopy, and is a PREVENTIVE modality by identifying polyps before they become symptomatic and malignant. Thnak you for your attention to this critical matter.Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]Colorectal cancer screening saves livesCoverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical ColonoscopyVirtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

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To Whom It May Concern:

I am writing to ask Medicare to reconsider its proposal not to reimburse screening CT colonography (CTC). You discuss several reasons for this decision in your proposal. However, the scientific literature clearly supports the accuracy and cost effectiveness of CTC, and I would like to address a few of your key points.

1. RADIATION EXPOSURE

You express a concern about excess radiation exposure. You cite a 2005 study by Brenner (Brenner and Georgsson 2005) which estimates the radiation dose for CTC with prone and supine images at around 13 mSv. However, this 2005 data is outdated. It was performed on older generation 8 and 16 row scanners. The ACRIN trial used newer multi row scanners with low dose technique and was able to limit radiation dose to approximately 5 mSv per exam (Johnson, Chen et al. 2008). This is very close to the 4.5 mSv annual background exposure at high altitude (Yee 2009). A 2008 by Liedenbaum surveyed CTC providers about their equipment and dose parameters. He found that 62% of his questionnaire respondents were using 64 row scanners and 50% used dose modulation. The average dose of his respondents was 5.7 mSv. (Liedenbaum, Venema et al. 2008) Ultra low dose scans have been shown to be able to deliver an effective radiation dose of 1.8 mSv for males and 2.4 mSv for females while preserving excellent sensitivity (100% for polyps greater than 10mm and 100% for cancers)(Iannaccone, Laghi et al. 2003).

Dose efficiency will continue to improve as more modern equipment and dose modulation are increasingly prevalent. In comparison, barium enema (BE), a radiographic examination which Medicare covers for colon cancer screening, has a dose of approximately 4-5 mSv (Yee 2009), essentially equal to CTC. Barium enema however has a sensitivity of only 45% for polyps greater than 10 mm (Rockey, Paulson et al. 2005). This is much less than the approximately 90% sensitivity of CTC. Moreover, while the sensitivity of CTC continues to improve, that of BE will certainly decline as current trainees are becoming less competent and comfortable with the procedure.

2. HEALTH OUTCOMES

You state that there is “insufficient evidence to conclude that the use of CT colonography improves health outcomes in Medicare beneficiaries.” The main goal of screening is to prevent colon cancer. Removing polyps has been shown to prevent colon cancer. However, although optical colonoscopy (OC) is considered the gold standard for colon evaluation, there is only indirect evidence that it reduces CRC mortality. In fact, the evidence of its efficacy has been extrapolated from fecal occult blood test (FOBT) and sigmoidoscopy studies. This extrapolation could easily hold true for CTC, and I would argue that the evidence for CTC is as strong as that for OC. One might even question the convention of considering OC the gold standard for polyp detection. The most recent data using state-of-the-art machinery and protocols demonstrate excellent test characteristics, sometimes better than OC. For example, in Pickhardt’s 2003 NEJM study(Pickhardt, Choi et al. 2003) which used segmental unblinding, sensitivity for polyps greater than or equal to 8 millimeters was better for CTC (94%) than OC (90%). In Kim’s 2007 study in NEJM (Kim, Pickhardt et al. 2007), CTC and OC had similar rates of detection for advanced neoplasia. However, the number of polypectomies and perforations were significantly higher in the OC group.

CTC, as with all studies, has its limitations. However, OC also has drawbacks, including variable compliance, the requirement for IV sedation, cost, and inability to complete the exam in 5-10% of patients (Yee 2009). Complications also occur. In fact the death rate from OC in patients 50-54 years old is 1-3/10,000, compared with a death rate of 1.8/10,000 from colon cancer (Winawer, Fletcher et al. 1997).

3. EXTRACOLONIC FINDINGS

You express concern that the discovery of extra colonic findings will lead to higher health care costs. You cite an article by Fletcher and Pignone (Fletcher and Pignone 2008) which questioned: “What is the responsible use of information that nobody asked for but once found is difficult to ignore?” As a general rule, “incidentalomas” are commonly found in all imaging studies and are not something unique to CTC. The discovery of incidental lesions is part and parcel of imaging. Even though up to 60% of CTC examinations have extracolonic findings, many of these are unimportant and do not require follow-up. However, fortuitous discoveries also occur. In one study by Kim et al (Kim, Pickhardt et al. 2007), 241 out of 3120 patients (7.7%) had findings which either required further imaging or intervention. They discovered eight extracolonic cancers in this group, a prevalence of 0.3%. In Pickhardt’s 2003 study in the New England Journal, 4.5% of patients had extracolonic findings of a high importance. Unexpected cancers were found in 0.4% and two patients went on to AAA repair (Pickhardt, Choi et al. 2003). One could argue that the discovery of these finds is of questionable clinical utility, and drives up cost. However, Hara et al evaluated the cost associated with the discovery of extracolonic findings in 264 patients, and that working up these findings added a mean cost of only $28 per examination (Hara, Johnson et al. 2000). As you can see, the criticism that we need further study to determine the prevalence of extra-colonic findings and their clinical impact and cost is unwarranted. These studies have already been performed.

4. SMALL LESIONS

You state that “Further research on the natural history of polyps < 6mm and nonpolypoid lesions and their health outcomes is needed.” While it is true that more information is needed, this statement holds true for optical colonoscopy as much as for CTC. These lesions are difficult to diagnose using both modalities. When seen on colonoscopy, they are uniformly removed. This increases cost, as well as the risk of complications. Not only is the removal of polyps 6-9mm of low clinical utility, it is not cost effective. A cost effectiveness analysis performed by Pickhardt in 2008 found “The high costs, additional complications, and relatively low incremental yield associated with immediate polypectomy of 6- to 9-mm polyps support the practice of 3-year CTC surveillance, which allows for selective noninvasive identification of small polyps at risk.”(Pickhardt, Hassan et al. 2008)

With regard to flat lesions, these may account for up to 30% of all CRC and have greater malignant potential (Yee 2009). These are difficult to detect on both CTC and OC. However, CTC has a sensitivity for flat lesions which is similar to that of OC. In a 2004 study by Pickhardt (Pickhardt, Nugent et al. 2004), CTC found 80% of flat lesions prospectively. OC missed 8.5% of the flat lesions. This argument that CTC cannot detect flat lesions is simply not true. No studies have compared CTC with high magnification chromoscopic colonoscopy, but this technique is not yet common in the US.

5. COST EFFECTIVENESS

You state, “With the higher prevalence of polyps in the older Medicare population, the rate of referral to optical colonoscopy is extremely important and also unknown at this point. If there is a relatively high referral rate, the utility of an intermediate test such as CT colonography is limited.” You cite an article by Lieberman et al. (Lieberman, Moravec et al. 2008) which states “Further study is needed to examine the cost-effectiveness of CTC if 20% of patients will require colonoscopy.” This estimate of a referral from CTC to colonoscopy is much higher than stated in the literature. For example, the 2003 Pickhardt study from NEJM (Pickhardt, Choi et al. 2003) demonstrated a referral rate to colonoscopy of 7.5% (all patients with a polyp greater than 10 mm). The mean age of patients in the study was 57.8 years, not far off from the Medicare population.Lieberman also states “If large proportions of patients will require colonoscopy after CTC, patients will need to understand the likelihood of requiring colonoscopy and the possible need for 2 bowel preparations.” However, many institutions, including our own, have designed their CTC programs such that patients with positive findings can proceed immediately to optical colonoscopy, negating the need for duplicate bowel prep. In a cost-effectiveness analysis you cite, performed by Zauber and colleagues for Medicare, Zauber states “the cost of CT colonography relative to the benefit derived and to the availability and costs of other CRC screening tests, would need to be in the range of… $179 to $237 to be cost-effective compared to colonoscopy screening with CMS payment of approximately $500 for colonoscopy without polypectomy and $650 for colonoscopy with polypectomy.” This amounts to a threshold cost of approximately 36-47%. A different study coauthored by Zauber (Lansdorp-Vogelaar, van Ballegooijen et al. 2009) cites a threshold cost of 43% of colonoscopy to be cost-effective. These estimates are outliers amongst cost-effectiveness analyses, lower than has been calculated by other authors. Although the modeling was not exactly the same, 3 other studies performed from 2004 to 2007 demonstrate threshold costs from 60 to 75% of colonoscopy to be cost-effective. If one models Zauber’s data using the modeling method used in a 2007 Pickhardt study (Perry J. Pickhardt 2007), the threshold cost would be 62% (compared with Pickhardt’s own result of 70%). (Lansdorp-Vogelaar, van Ballegooijen et al. 2009)

7. SCREENING RATES

You cite an Australian article by Scott and colleagues which states that adding CTC to the possible choice of screening tests “did not increase participation.”(Scott, Edwards et al. 2004) However, the methodology of enrolling patients was not similar to actual clinical situations. The patients in this study were simply sent a letter in the mail offering them the choice of CTC or colonoscopy. They did not have the opportunity to discuss the choice with their physician. Also, the overall participation rate in screening (less than 20%) is much lower than current participation rates in the US. It is unclear that the results of this study can be extrapolated to a different country, culture, and healthcare setting.

The choice of CTC may be preferable to many patients. In a 2003 study comparing CTC with OC, 50% of the patients preferred VC compared with 41% who preferred OC (Pickhardt, Choi et al. 2003). In a 1993 study by Rex et al, only 15% of physicians and nurses who were invited for a free screening colonoscopy accepted (Yee 2009).

I hope that you will take all the evidence into account and reconsider your decision. CTC is an effective screening modality and should be reimbursed.

R. Brooke Jeffrey, M.D.
Professor of Radiology
Body Imaging
Section Chief Department of Radiology
Stanford University

Peter D. Poullos M.D.
Body Imaging Fellow
Department of Radiology
Stanford University

References

Brenner, D. J. and M. A. Georgsson (2005). "Mass screening with CT colonography: should the radiation exposure be of concern?" Gastroenterology 129(1): 328-37.
Fletcher, R. H. and M. Pignone (2008). "Extracolonic findings with computed tomographic colonography: asset or liability?" Arch Intern Med 168(7): 685-6.
Hara, A. K., C. D. Johnson, et al. (2000). "Incidental extracolonic findings at CT colonography." Radiology 215(2): 353-7.
Iannaccone, R., A. Laghi, et al. (2003). "Detection of colorectal lesions: lower-dose multi-detector row helical CT colonography compared with conventional colonoscopy." Radiology 229(3): 775-81.
Johnson, C. D., M.-H. Chen, et al. (2008). "Accuracy of CT Colonography for Detection of Large Adenomas and Cancers." N Engl J Med 359(12): 1207-1217.
Kim, D. H., P. J. Pickhardt, et al. (2007). "CT Colonography versus Colonoscopy for the Detection of Advanced Neoplasia." N Engl J Med 357(14): 1403-1412.
Lansdorp-Vogelaar, I., M. van Ballegooijen, et al. (2009). "At what costs will screening with CT colonography be competitive? A cost-effectiveness approach." Int J Cancer 124(5): 1161-8.
Lieberman, D., M. Moravec, et al. (2008). "Polyp Size and Advanced Histology in Patients Undergoing Colonoscopy Screening: Implications for CT Colonography." Gastroenterology 135(4): 1100-1105.
Liedenbaum, M. H., H. W. Venema, et al. (2008). "Radiation dose in CT colonography trends in time and differences between daily practice and screening protocols." Eur Radiol 18(10): 2222-30.
Perry J. Pickhardt, C. H. A. L. A. Z. D. H. K. S. M. (2007). "Cost-effectiveness of colorectal cancer screening with computed tomography colonography." Cancer 109(11): 2213-2221.
Pickhardt, P. J., J. R. Choi, et al. (2003). "Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults." N Engl J Med 349(23): 2191-200.
Pickhardt, P. J., C. Hassan, et al. (2008). "Clinical management of small (6- to 9-mm) polyps detected at screening CT colonography: a cost-effectiveness analysis." AJR Am J Roentgenol 191(5): 1509-16.
Pickhardt, P. J., P. A. Nugent, et al. (2004). "Flat Colorectal Lesions in Asymptomatic Adults: Implications for Screening with CT Virtual Colonoscopy." Am. J. Roentgenol. 183(5): 1343-1347.
Rockey, D. C., E. Paulson, et al. (2005). "Analysis of air contrast barium enema, computed tomographic colonography, and colonoscopy: prospective comparison." Lancet 365(9456): 305-11.
Scott, R. G., J. T. Edwards, et al. (2004). "Community-based screening by colonoscopy or computed tomographic colonography in asymptomatic average-risk subjects." Am J Gastroenterol 99(6): 1145-51.
Winawer, S. J., R. H. Fletcher, et al. (1997). "Colorectal cancer screening: clinical guidelines and rationale." Gastroenterology 112(2): 594-642.Yee, J. (2009). Virtual Colonoscopy Workshop. San Francisco, CA.

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These comments replace previously submitted comments on Tuesday, March 10. They contain an addition to the original comments.

March 11, 2009

The Prevent Cancer Foundation is a national non-profit organization whose mission is educing mortality from cancer through prevention and early detection. The organization funds research, provides direct screening and early intervention programs to the public, and educates men and women across the country about prevention and screening strategies. We are writing today to express our disagreement with the decision not to provide coverage for Computed Tomography Colonography (CTC) as outlined in Proposed Decision Memo (CAG-00396N.)

Colorectal cancer has been a major focus of our Foundation’s mission, because there are effective tools available to screen for the disease and prevent colorectal cancer from developing. Yet despite these validated screening tools and coverage under Medicare and many private insurance plans, we know that many insured men and women are still not being screened for what is a highly preventable cancer.

The Centers for Disease Control and Prevention (CDC) estimates that up to 60 percent of deaths could be prevented if everyone age 50 and older were screened regularly according to guidelines. One of the barriers to screening is patient concern about invasive procedures such as colonoscopy and flexible sigmoidoscopy.

In March 2008, the American Cancer Society, the Multi-Society Task Force guidelines panel (comprised of representatives of the American College of Gastroenterology, American Gastroenterological Association, American Society for Gastrointestinal Endoscopy, American College of Physician, American Academy of Family Practice, American College of Radiology, and the American College of Colorectal Surgeons) and the American College of Radiology issued revised guidelines for colorectal cancer screening. Their rigorous, evidence-based evaluation of the various screening methods resulted in the addition of CTC to the previous screening guidelines.

The Prevent Cancer Foundation believes that all Americans should have full access to validated colorectal cancer screening and access to as many screening options as recommended, and fully supports the coverage of CTC by Medicare. Giving men and women access to additional rigorously-reviewed screening technology can be critical in dramatically increasing screening rates for colorectal cancer, and can result in both prevention and earlier detection of the disease, when chances of a cure are vastly improved.

Colorectal cancer is the third most commonly diagnosed cancer and the second most common cause of cancer death in the United States. This disease claims the lives of more than 50,000 men and women annually. When it is diagnosed at an early stage, the five year survival rate is nearly 90 percent. However, when cancer is not diagnosed until it has spread to distant organs, the five year survival rate is only five percent.

In addition, when precancerous polyps are discovered and removed, colorectal cancer can not only be detected early, it can be prevented.Since 90 percent of colorectal cancer diagnosis occurs after the age of 50 and the risk of developing colorectal cancer increases with each decade of life, routine screening for colorectal cancer is critical for Medicare beneficiaries.CTC uses x-rays to produce two- and three-dimensional images of the colon. The exam takes around ten minutes, does not require a sedative, and is less expensive than optical colonoscopy. CTC is not invasive, and its sensitivity and specificity are acceptably high. From a patient’s perspective, these characteristics make CTC an attractive option. As such, we feel that reimbursement of screening CTC by Medicare will very likely increase screening rates by Medicare consumers.

The Prevent Cancer Foundation urges you to reconsider the Proposed Decision Memo for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N) and make Medicare coverage of CTC consistent with all colorectal cancer screening tests recommended by the American Cancer Society, the Multi-Society Task Force and the American College of Radiology.
Sincerely,

Carolyn R. Aldige
President and Founder

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C3: Colorectal Cancer Coalition Comments Regarding the Centers for Medicare and Medicaid Services National Coverage Analysis on Computed Tomography Colonography and the Proposed Decision Memo for Screening Computed Tomography Colonography for Colorectal Cancer (CAG-00396N)
March 9, 2009

These comments are submitted by C3: Colorectal Cancer Coalition (C3), a non-profit, nonpartisan advocacy organization committed to the fight against colon and rectal cancer. We appreciate the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) National Coverage Analysis (NCA) on Computed Tomography Colonography (CTC) and the Proposed Decision Memo for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N).

After careful review of the Proposed Decision Memo for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N) , our past comment on this issue , and the many references available, C3 believes that there is sufficient evidence to recommend CTC to screen for colorectal cancer in the Medicare population. While we agree with CMS that there is limited data in the Medicare population, we believe that the existing data supports coverage of CTC by CMS. No one disputes that colorectal cancer screening saves lives and saves money. At the same time, almost every article about screening acknowledges that it is under-utilized. CTC provides the unique option of a whole-bowel, non-invasive visualization of the colon and rectum. This option is important for people who will not or cannot undergo optical colonoscopy .

C3 recognizes that CMS and the US Preventive Services Task Force (USPSTF) disagree with our conclusion. Both CMS and USPSTF want to see additional supportive data prior to adopting CTC for screening.

C3 Recommendation:

Therefore, C3 strongly urges CMS to gather the evidence by approving coverage of CTC, and implement the new coverage through a Coverage with Evidence Development (CED) process. A CED will generate additional safety and efficacy data in people over the age of 65, a population that is typically under-represented in clinical research. CED can also generate information that will help to identify patients who can benefit from CTC as opposed to optical colonoscopy.

A complete denial of coverage is akin to “throwing the baby out with the bathwater.” Thus, we urge CMS to use its unique ability to generate data from its consumer base, and determine whether CTC is appropriate for people over age 65. Background for C3 Recommendation:

Evidence that CTC is an Effective Colorectal Cancer Screening Tool

In March 2008, the American Cancer Society in collaboration with the Multi-Society Task Force on Colorectal

Cancer and the American College of Radiology consensus guidelines (ACS-MSTFCC-ACR consensus ) found that “Based on the accumulation of evidence . . . the expert panel concludes that there are sufficient data to include CTC as an acceptable option for [colorectal cancer] screening.” CTC is included in their recommendations as one of the “tests that are effective at detecting cancer and premalignant adenomatous polyps.”

Since the release of the ACS-MSTFCC-ACR consensus guidelines, results from the American College of Radiology Imaging Network (ACRIN) National CT Colonography Trial have been published . These results found similar sensitivity between CTC and optical colonoscopy to find polyps over 1 cm. CTC in the National CT Colonography trial found 90 percent of larger polyps over 1 cm and 78 percent of those 6 to 9 mm. The nationwide, 15-site study supported earlier research with similar results.

In October 2008, we believe that the USPSTF confused the screening issue for patients and advocates by dissenting from the ACS-MSTFCC-ACR consensus. They concluded, “The evidence is insufficient to assess the benefits and harms of computed tomographic colonography and fecal DNA testing as screening modalities for colorectal cancer. (I statement)”. As a result, their recommendations for screening methods include only fecal occult blood testing, sigmoidoscopy and colonoscopy.

However, neither FOBT nor sigmoidoscopy has the single-test sensitivity of CTC, and false positives from FOBT lead to unnecessary colonoscopy in about one-third of cases . Furthermore, sigmoidoscopy alone offers only partial bowel screening, and misses proximal polyps and tumors. Women are significantly more likely to have proximal polyps (42.2% vs 31.5%, P < 0.001) , further limiting the usefulness of sigmoidoscopy.

As C3 reviewed the material supporting the CMS national coverage decision, we found that the USPSTF recommendations and the computer simulations that supported it were strongly influential at the MEDCAC meeting. We urge fuller reconsideration of the supporting evidence for the ACS-MSTFCC-ACR guidelines and the results of the ACRIN trial.

Reaching Screening Candidates Who Refuse Optical Colonoscopy

We regularly hear from people who adamantly refuse colonoscopy screening. They relate personal stories of family or friends who experienced excessive pain or perforation of the colon. Some worry that surgery or heart conditions might make them more vulnerable to colonoscopy complications. While bowel preparation is the most frequently given reason for avoiding colonoscopy, patients also are concerned about the invasiveness of the procedure, the size and length of the scope, being sedated, having to miss work, and needing a ride home.

While anecdotal information has limited usefulness, we believe that the relatively low uptake of colorectal cancer screening illustrates public concern with existing methods of screening.

The ACS-MSTFCC-ACR consensus guidelines point out that, “CTC surveillance could be offered to those patients who would benefit from screening but either decline CSPY (colonoscopy) or are not good candidates for CSPY for one or more reasons."

The American Society for Gastrointestinal Endoscopy, a member of the US Multi-Society Task Force on Colorectal Cancer, does not recommend CTC for “widespread screening” but points out in their 2008 Screening Recommendations, “However, it may be useful for patients who refuse colonoscopy or who have had an incomplete colonoscopic examination.”

Patients Need Clear Guidance:

C3 is concerned that there is an important difference in the screening recommendations between ACS in collaboration with the Multi-Society Task Force on Colorectal Cancer and the American College of Radiology and the guidelines from the US Preventive Services Task Force. While the ACS-MSTFCC-ACR consensus includes CTC as a screening option to prevent colorectal cancer, the USPSTF does not. In an environment where several different screening options are available, choices with varying benefits, risks, and payment coverage can confuse patients and physicians.

CMS coverage with evidence development of CTC will generate data that can resolve this confusion and provide significant public benefit.

Conclusion:

C3 urges reconsideration of the non-coverage decision by CMS, and strongly urges CMS to gather the evidence by approving coverage of CTC, and implementing the new coverage through a Coverage with Evidence Development (CED) process.

About C3:

C3 pushes for research to improve screening, diagnosis, and treatment of colorectal cancer; for policy decisions that make the most effective colorectal cancer prevention and treatment available to all; and for increased awareness that colorectal cancer is preventable, treatable, and beatable. More information can be found at www.FightColorectalCancer.org.

C3 believes in fully disclosing sources of financial support, per our disclosure policy which can be viewed at www.FightColorectalCancer.org/sponsors. C3 has received no financial or in-kind support from manufacturers of CTCs. None of our other corporate supporters have influenced our comments on this issue.

References:

Available at https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=220& Available at http://www.cms.hhs.gov/mcd/publiccomment_popup.asp?comment_id=18470 Levin B, Lieberman DA, McFarland, et al. Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008: A Joint Guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. Published online March 5, 2008. CA Cancer J Clin. 2008;58: “CTC surveillance could be offered to those patients who would benefit from screening but either decline CSPY (colonoscopy) or are not good candidates for CSPY for one or more reasons.”

The American Society for Gastrointestinal Endoscopy, a member of the US Multi-Society Task Force on Colorectal Cancer does not recommend CTC for “widespread screening” but points out in their 2008 Screening Recommendations, “However, it may be useful for patients who refuse colonoscopy or who have had an incomplete colonoscopic examination.”

U.S. Preventive Services Task Force (USPSTF). Screening for colorectal cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2008;149:627-637. Available at http://www.ahrq.gov/clinic/uspstf08/colocancer/coloartwhit.htm
Levin B, Lieberman DA, McFarland, et al. Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008: A Joint Guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. Published online March 5, 2008. CA Cancer J Clin. 2008;58
Johnson CD, Chen MH, Toledano AY, Heiken JP, Dachman A, Kuo MD, et al. Accuracy of CT colonography for detection of large adenomas and cancers. N Engl J Med 2008;359:1207-17.
Johnson CD, MacCarty RL, Welch TJ, Wilson LA, Harmsen WS, Ilstrup DM, Ahlquist DA. Comparison of the relative sensitivity of CT colonography and double-contrast barium enema for screen detection of colorectal polyps. Clin Gastroenterol Hepatol 2004;4:314-321.
Kim DH, Pickhardt PJ, Taylor AJ, Leung WK, Winter TC, Hinshaw JL, et al. CT Colonography versus colonoscopy for the detection of advanced neoplasia. N Engl J Med 2007;357:1403-12.
Pickhardt PJ, ChoiRJ, Hwang I, Butler JA, Puckett ML, Hildebrandt HA, et al. Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. N Engl J Med. 2003;349:2191-200.
Ronsohoff DF, Lang CA. Screening for colorectal cancer with the fecal occult blood test: a background paper. Ann Intern Med. 1997;126:811-22. Koo et al. Improved Survival in Young Women With Colorectal Cancer. The American Journal of Gastroenterology (2008) 103, 1488–1495

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Date: March 6, 2009

To: CMS
From: Mayo Clinic
Re: Proposed Decision for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAD00396M)

Dear Center for Medicare and Medicaid Services (CMS):

We are writing to petition CMS to reconsider their decision relating to computed tomographic colonography (CTC) for colorectal cancer screening. It is in the public interest to provide screening reimbursement for the Medicare population under a coverage with evidence development (CED) at institutions with interdisciplinary collaboration on screening, management and quality relating to this new technology. Below we outline important considerations that support our contention.

1. Poor compliance of the Medicare population at colorectal cancer screening.
It is estimated that only 57% of adults older than 50 years of age are compliant with current colorectal cancer screening guidelines (1) and reports of even more dismal compliance (of 25%) in some Medicare cohorts (2). The addition of CTC to colorectal structural screening evaluation represents an important option, particularly for those with barriers to routine endoscopic screening (prior incomplete endoscopy, anti-coagulation therapy, severe cardiopulmonary disease, sedation risk, or excessive anxiety or scheduling problems). We have found that when CTC is employed in an interdisciplinary and complementary fashion in an integrated medical practice, it can be an appealing test for many patients and their providers. Without reimbursement for CTC, at least in a limited fashion, it will be impossible to estimate the potential impact of CTC for improved CRC screening compliance, as has been demonstrated in some practices (3). The ability of CTC to improve CRC screening compliance, particularly in patients with barriers to optical colonoscopy, increases the cost-effectiveness of the exam itself. This past year, we have been participating in the American College of Radiology (ACR) CTC Registry (4), during which we have performed 914 CTC exams. 449 (49%) of these were in patients 65 or older, with 199 screening CTC exams performed in screening patients of Medicare age. Most significantly, the majority of screening CTC exams in patients of Medicare age (51%; 102/199) were in patients with barriers to endoscopic screening (17% on anti-coagulation; 28% with recent or remote incomplete endoscopy; 6 % other). For these patients and their primary care providers, CTC provides an indispensable full structural alternative to endoscopy. Because CTC has been proven to be a more accurate screening test than non-colonoscopic alternatives (i.e., barium enema or flexible sigmoidoscopy) in large prospective studies (5, 6), CTC provides an important full structural alternative to endoscopy.

2. Performance of CTC at expert sites with quality methods.
Multiple studies using multidetector CT and modern computer workstations demonstrate that CTC is comparable to optical colonoscopy for polyps ≥ 10 mm in size, and similar or slightly less sensitive for polyps 6-9 mm in size (7-11). At our own institution, we have found that the sensitivity for large polyps using primary 2D and 3D search methods, which we employ in our daily practice, is 95%, comparable with optical colonoscopy (9). Moreover, in our daily practice, we employ a double reading paradigm, which improves sensitivity for the detection of autonomous lesions (5), using radiologic technologists, who have been taught to perform primary 2D and 3D interpretations (12). These technologists also employ computer-aided detection (CAD) in their reads.

In our integrated practice, we are able to translate positive CTC exams immediately to polypectomy in our routine or complex endoscopy suite (for patients who are not anti-coagulated). We have established common criteria for management of polyps between the Division of Gastroenterology and the Department of Radiology, jointly participating in a CTC quality database, a portion of which data are also recorded the ACR CTC Registry. Monthly collaboration meetings occur between Radiology, Gastroenterology and Colorectal Surgery to facilitate prompt and appropriate referral and management of patients.

3. Cost/burden and benefit of extracolonic findings.
The average cost associated with the workup of extracolonic findings at CTC has been described in two large published series from our own institution. These studies estimate this extra expense to be between $28-34/patient (13, 14). In these studies, 1-2% of patients went on to receive surgical treatment for life-threatening findings as a result. Hassan et al. demonstrated that extracolonic findings can be beneficial by improving the cost effectiveness of CTC by the detection of abdominal aortic aneurysms (AAA) (15). In an effort to mitigate the burden and maximize the benefit of extracolonic findings, we divide extracolonic findings according to the C-RADS criteria (16) and input this data into the ACR CTC Registry. As an integrated practice, we have established standard, low-cost recommendations for frequent extracolonic findings that minimize both downstream risks and costs. In the 199 Medicare patients undergoing screening CTC over the last year, 6.5 % (13/199) had significant extracolonic findings of potential medical significance, which were not previously known, including 2 renal cell carcinomas (successfully resected) and 3 AAA. Our integrated practice provides a mechanism for tracking extracolonic findings in a CT workup, but more data are needed to fully understand the cost:benefit profile among Medicare patients.

4. CT colonography reduces the number of patients going to polypectomy.
While criticized for not being a randomized trial, the large retrospective study by Kim et al. at the University of Wisconsin demonstrated a four-fold reduction in patients undergoing polypectomy in over 3000 patients screened by CTC compared to a similar number of patients being screened by optical colonoscopy (17). The risks for developing colorectal cancer in these patient cohorts were actually slightly higher in the optical colonoscopy arm, which detected a similar number of patients with advanced neoplasia but resulted in more complications, largely owing to the four-fold increase in number of polypectomies. In the 449 patients 65 or older undergoing CTC at our institution over the last year, 10% (47/449) had at least one polyp 6 ¨C 9 mm in size and 4%(19/449) had a polyp or cancer ≥ 10 mm in size, with the remaining large majority cleared of the need for subsequent polypectomy.

5. Complementarity of CT colonography and optical colonoscopy.
There is a growing body of evidence that CTC and optical colonoscopy are complementary tests, each with its own strengths and weaknesses. CTC performs slightly less favorably in the detection of subcentimeter polyps. However, the benefit of detecting diminutive polyps (5 mm in size and smaller) is a matter of great debate. Given the low (1.7%) incidence of advanced neoplasia in polyps of this size and the large numbers of patients with only diminutive polyps ≤ 5 mm in size (18), the CORI investigators concluded that 'in these patients, the risk of invasive colonoscopy and polypectomy may exceed the risk of progression to cancer (18).' Recently, the miss rate of optical colonoscopy for the detection of some adenomas and cancers has been recognized (9, 19, 20). We believe the complimentarity and use of both full structural exams at institutions is likely to result in better performance of both tests over time. We are installing CT colonography workstations in our complex endoscopy room, to maximize the use of both CTC and colonoscopy images to improve overall patient care.

6. Individualized and mixed scanning strategies.
Most cost-effective studies to date have compared only CTC at 5 years or 10 years or optical colonoscopy at 10 year screening mechanisms for patients as they age. In practicality, it would make intuitive sense for average-risk individuals to undergo optical colonoscopy at younger ages (to aid in the detection of smaller polyps) and CTC at older ages (as medical conditions associated with increased endoscopic risk may increase). The ideal structural screening exam can vary not only from individual to individual (based on their risk or colorectal cancer), but within an individual over time (e.g., depending on co-morbidities, ability to undergo bowel preparation, ability to obtain transportation, etc). Collection of additional data, ideally through the proposed CED mechanism, would greatly facilitate the definition of new, more integrated and patient-centered CRC screening algorithms.

7. Radiation dose.
We respectfully disagree with the U.S. Preventative Services Task Force evaluation of the radiation risk at CTC. CTC is a low-dose radiation exam, which has been shown to have a high benefit/risk ratio, even by proponents of a linear, non-threshold model of radiation effects (21). These estimates were based on whole-body exposures of all ages of people to atomic radiation, not targeted medical exams of only the abdomen and pelvis. Importantly for the Medicare population, the risk of radiation-induced malignancy drops dramatically after the age of 35 (22), with theoretical models estimating that it takes 20 years for a radiation-induced malignancy to develop. Brenner estimated the radiation-induced malignancy risk of CTC in a 70-year-old male to be 0.07%, compared to the overall 20% risk of developing a fatal cancer, and stated that this risk could be lowered by a factor of five to ten based on acquisition technique(21).

8. Overall public health benefits.
Extracolonic findings have potential for net health benefit, which is not currently being utilized or analyzed. CTC could serve as a consolidation of several preventative services (CRC screening, AAA screening, bone mineral density), but more data relating to the potentially large positive health impact of this approach is needed, underscoring this petition for CED.

Recommendations

We believe that CTC can serve as an important option to improve CRC screening compliance and, ultimately, reduce the public health burden associated with this common disease. As with any medical test, appropriate safeguards and quality standards must be rigorously defined and uniformly applied. Interdisciplinary collaboration is critical for addressing the outstanding issues cited above, which we believe would be ideally accomplished through a CED mechanism at centers with demonstrated excellence, integration and collaboration between Radiology, Gastroenterology, Colorectal Surgery and other relevant expertise.
Sincerely,

Bernard F. King, MD, Chair, Dept. of Radiology
Gregory J. Gores, MD, Chair, Div.of Gastroenterology
Bruce D. Wolff, MD, Chair, Dept.of Radiology

Mayo Clinic Arizona

C. Daniel Johnson, MD, Chair, Dept. of Radiology
Jonathan A. Leighton,MD Chair Div. of Gastroenterology
Tonia Young-Fadok, MD, Chair, Colorectal Surgery

Mayo Clinic Jacksonville

Hugh Williams, MD, Chair, Dept. of Radiology
Kenneth R. DeVault, MD, Chair, Div. of Gastroenterology
C. Daniel Smith, MD, Chair, Surgery

REFERENCES

1. Increased use of colorectal cancer tests United States, 2002 and 2004. MMWR 2006; 55:308 - 311.
2. Cooper GS KT. Underuse of colorectal cancer screening in a cohort of medicare beneficiaries. Cancer 2008; 112:293 - 299.
3. Schwartz DC, Dasher KJ, Said A, et al. Impact of a CT colonography screening program on endoscopic colonoscopy in clinical practice. Am J Gastroenterol 2008; 103:346-351.
4. https://nrdr.acr.org/portal/CTC/Main/page.aspx.
5. Johnson CD, Harmsen WS, Wilson LA, et al. Prospective blinded evaluation of computed tomographic colonography for screen detection of colorectal polyps. Gastroenterology 2003; 125:311-319.
6. Rockey DC PE, Niedzwiecki D, Davis W, Bosworth HB, Sanders L, Yee J, Henderson J, Hatten P, Burdick S, Sanyal A, Rubin DT, Sterling M, Akerkar G, Bhutani MS, Binmoeller K, Garvie J, Bini EJ, McQuaid K, Foster WL, Thompson WM, Dachman A, Halvorsen R. Analysis of air contrast barium enema, computed tomographic colonography, and colonoscopy: prospective comparison. Lancet 2005; 365:305 - 311.
7. Johnson CD, Chen M-H, Toledano AY, al. e. Accuracy of CT colonography for detection of large adenomas and cancers. N Engl J Med 2008; 359:1207 - 1217.
8. Pickhardt PJ, Choi JR, Hwang I, et al. Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. N Engl J Med 2003; 349:2191-2200.
9. Johnson CD, Fletcher JG, MacCarty RL, et al. Effect of slice thickness and primary 2D versus 3D virtual dissection on colorectal lesion detection at CT colonography in 452 asymptomatic adults. AJR Am J Roentgenol 2007; 189:672-680.
10. Graser A, Stieber P, Nagel D, et al. Comparison of CT colonography, colonoscopy, sigmoidoscopy and faecal occult blood tests for the detection of advanced adenoma in an average risk population. Gut 2009; 58:241-248.
11. Yee J, Akerkar GA, Hung RK, Steinauer-Gebauer AM, Wall SD, McQuaid KR. Colorectal neoplasia: performance characteristics of CT colonography for detection in 300 patients. Radiology 2001; 219:685-692.
12. Bodily KD, Fletcher JG, Engelby T, et al. Nonradiologists as second readers for intraluminal findings at CT colonography. Acad Radiol 2005; 12:67-73.
13. Gluecker TM, Johnson CD, Wilson LA, et al. Extracolonic findings at CT colonography: evaluation of prevalence and cost in a screening population. Gastroenterology 2003; 124:911-916.
14. Hara AK, Johnson CD, MacCarty RL, Welch TJ. Incidental extracolonic findings at CT colonography. Radiology 2000; 215:353-357.
15. Hassan C, Pickhardt PJ, Laghi A, et al. Computed tomographic colonography to screen for colorectal cancer, extracolonic cancer, and aortic aneurysm: model simulation with cost-effectiveness analysis. Arch Intern Med 2008; 168:696-705.
16. Zalis ME, Barish MA, Choi JR, et al. CT colonography reporting and data system: a consensus proposal. Radiology 2005; 236:3-9.
17. Kim DH, Pickhardt PJ, Taylor AJ, et al. CT colonography versus colonoscopy for the detection of advanced neoplasia. N Engl J Med 2007; 357:1403-1412.
18. Lieberman D, Moravec M, Holub J, Michaels L, Eisen G. Polyp Size and Advanced Histology in Patients Undergoing Colonoscopy Screening: Implications for CT Colonography. Gastroenterology 2008; 135:1100-1105.
19. Baxter NN, Goldwasser MA, Paszat LF, Saskin R, Urbach DR, Rabeneck L. Association of colonoscopy and death from colorectal cancer. Ann Intern Med 2009; 150:1-8.
20. Barclay RL, Vicari JJ, Doughty AS, Johanson JF, Greenlaw RL. Colonoscopic withdrawal times and adenoma detection during screening colonoscopy. N Engl J Med 2006; 355:2533-2541.
21. Brenner DJ, Georgsson MA. Mass screening with CT colonography: should the radiation exposure be of concern? Gastroenterology 2005; 129:328-337.
22. Brenner DJ, Hall EJ. Computed tomography an increasing source of radiation exposure. N Engl J Med 2007; 357:2277-2284.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

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March 10, 2009

Mr. William Larson, MA
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244-1850

Re: NCA for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG- 00396N); Comments on Proposed Denial of Coverage

Dear Mr. Larson:

With its proposal to deny coverage for virtual colonoscopy for screening colon cancer in seniors on February 11, 2009, the Center for Medicare and Medicaid Services (CMS) missed the point: colon cancer screening is about saving lives, not dollars. What do we know? First, colon cancer kills 50,000 Americans every year and is the second most common cancer in the United States. Second, Afro Americans have the highest incidence of colon cancer, 15.5% to 23% higher, and their death rate from the cancer is up to 43% higher than in the white population. And lastly, colon cancer is preventable.

Screening Tests Fail to Attract Half of those in Need

That’s right. If Americans over the age of 50 get screened for colon cancer, this deadly disease is curable before it consumes its victim. Since 1998, the gold standard of screening has been the optical colonoscopy (OC). But OC is not perfect. The procedure itself takes up to 30 minutes and the outpatient visit may take most of a day. In fact, it misses some polyps and many of the so called “flat lesions”, requires an invasive approach, needs anesthesia, makes missing work necessary, risks bowel perforation with complications, requires that someone drive the individual to and from the procedure, and offends the modesty of many. Had CMS put OC through the same analysis and critique that virtual colonoscopy has faced, it is not at all certain that CMS would have recommended coverage. Yet OC is the best CMS approved test available to date for colon cancer screening and it saves live. But only 39% of those undergoing testing choose it. Indeed, only 50% of Americans over 50 choose to get any screening. Thus many Americans are dying unnecessarily from a curable disease because their colon cancer is caught too late in its evolution. And that is where virtual colonoscopy comes in: it offers a new screening test almost as accurate as OC without the complication profile, the need for anesthesia, the missed day of work, the need for a second person to transport, or the embarrassment. And virtual colonoscopy is performed at a lower cost.

Virtual Colonoscopy Offers an Alternative

By adding virtual colonoscopy (also called CT colonography or CTC) to the approved colon cancer screening test list, CMS would open up an important alternative to senior Americans. The goal must be to get first time participants into the screening program. Virtual colonoscopy is performed in the CT room in less than two minutes with minimal discomfort, and the patient is back to normal as soon as they get off of the CT table. Perhaps that is why in April of 2008 the American Cancer Society, in an unusual decision, not only added virtual colonoscopy to its screening test list but also elevated it to a preferred status. Perhaps that is why the BlueCross BlueShield Technology Evaluation Committee (TEC) recognized the recent ACRIN study, which showed that virtual colonoscopy found 90% of large polyps and 80% of medium sized polyps, and approved virtual colonoscopy. And perhaps those unscreened seniors, whether they are black, white, Asian or Hispanic, would be willing to undergo virtual colonoscopy and enter the screening program with all of its positive implications. In a recent multicenter study of over 85,000 patients that got screened by OC, only 6.4% of the patients were Afro American, telling us that if we do not change the attractiveness of screening tests, many preventable deaths will continue unabated, particularly in the black population.

Not Seeing the Forest for the Trees

But CMS, unmoved by the simple opportunity to save lives, rather looks to their statistics and consultants. Their economists tell them that virtual colonoscopy may not be cost effective at the moment. Using perhaps flawed data, CMS says that an OC costs on average of $497.59 when other observers estimate costs in the $1500 to $2000 range. With the average cost of virtual colonoscopy at $488, it is difficult to imagine a scenario where virtual colonoscopy is not cost effective, despite adding in expected costs for necessary follow on OC and extra colonic findings. Even Medicare’s own consultants using deflated OC costs acknowledge that if only 12% of the currently unscreened group of Americans change and get screened, virtual colonoscopy will be cost effective. Instead of trying virtual colonoscopy in a five to ten year temporary trial as an approved screening procedure to see how the targeted population responds, CMS defers coverage until someone can prove to them that Americans will change their behavior. Their own denial of coverage will act as a self fulfilling prophecy because the elderly do not have the resources to pay out of their own pockets to get virtual colonoscopy. Unnecessary deaths will occur. But there is more to this story. CMS questions whether the good results for virtual colonoscopy in the 50 to 65 year old population, as shown by ACRIN and other large, multicenter studies, will have meaning in the older Medicare population. In fact, other than cost concerns, this issue appeared to trouble CMS more than any other. Yet this concern makes no sense. First, you would have to suspend common sense not to realize that for patients that have never been screened in the first place, any polyps found by virtual colonoscopy in seniors would be larger, and thus more easily detected, than these same polyps would have been when the individual was 10 years younger. The polyps would grow over time, making them ever more easily seen. Second, the 50% of Americans refusing screening today will all fall into that first group. Third, the Afro Americans who currently are avoiding colon cancer screening but have a higher incidence of cancer and higher death rate will automatically benefit from a broadened screening program which removes economics as a barrier. Lives will be saved. And costs avoided.

Virtual Colonoscopy costs $488. Saving a Life is Priceless.

In all candor, virtual colonoscopy is not perfect. The individual must still take the bowel prep before the study. Carbon dioxide must be insufflated to distend the colon and there is a very small but finite risk of perforation. And there may be a very small risk of cancer from the CT itself, although speculative and inconsequential for seniors. Virtual colonoscopy may miss the smallest polyps and likely will not find the so called “flat lesions”, fortunately fairly uncommon and difficult to find on OC as well. But computer assisted diagnosis (CAD) is likely to change those shortcomings in virtual colonoscopy, much as it did for breast mammography. And eight to twelve percent of patients will need to have an OC because polyps will be found. But of all of the colon cancer screening tests, it is unquestionably a close second to OC today and will only improve with the refinement of CAD programs. And for many patients, it probably will be the preferred screening method and the only reason they are willing to undergo the testing. Unfortunately, unless something or someone changes CMS’s opinion, millions of senior Americans, of all races, will be denied the opportunity to choose the virtual colonoscopy, a less invasive, more dignified colon cancer screening test. While CMS mandates new multiyear studies trying to answer questions that our common sense has long ago answered, more than 50,000 Americans a year will die of colon cancer. Many of those victims may have been saved by virtual colonoscopy screening, and a disproportionately large share of them will have been Afro American. An American tragedy indeed. And preventable, at that.

Joseph Jenkins MD
Chief Medical Officer
March 10, 2009
Neuisys LLC
Chapel Hill, NC

References:
Accuracy of CT colonography for detection of large adenomas and cancers, Johnson CD, Chen MH, Toledano AY, et al. New England Journal of Medicine 2008 Sep 18; 359(12):1207-17.

Colonoscopic withdrawal times and adenoma detection during screening colonoscopy, Barclay RI et al. New England Journal of Medicine 2006 Dec 14; 355(24): 2533-41.

Black Americans are at higher risk for colon polyps. Lieberman DA et al. JAMA 2008 Sep 24.

Racial gap in rate of cancer deaths remains wide, researchers say. US Today 2/18/09

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I must respectfully disagree with the decision to not cover CTC. With the overwhelming evidence that CTC, when performed by properly trained physician, is an effective screening test [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] and is MORE sensitive than other already covered screening tests [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]. It is unfortunate that a few poorly designed and run studies and some politically-powered professional organizations playing turf-war''s become more important than health of patients.

Thanks you for your time. Please reconsider [PHI Redacted]

-Kevin

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I thank the committee for performing the evidentiary review of screening computed tomography colonography (CTC) for colorectal cancer. I respectfully disagree with the conclusion that CT colonography is not clinically effective for Medicare beneficiaries.

Utilization of CTC for Medicare beneficiaries by gastroenterologists and colorectal surgeons in our metropolitan subspecialty radiology practice has steadily risen over the last seven years. Medicare beneficiaries who have a contraindication to colonoscopy or sedation or who have undergone incomplete screening or diagnostic colonoscopy are now referred exclusively for CTC. Completion fluoroscopic barium enema is no longer utilized. This same CTC utilization pattern is also observed in our non-Medicare population. Our radiology practice has performed nearly 2000 CTC since 2003 of which the vast majority are for incomplete screening colonoscopy.

It is a personal observation that the Medicare population has a higher rate of incomplete screening colonoscopy due to colonic redundancy and tortuosity, colonic diverticulosis, colonic fixation and angulation due to prior abdominopelvic surgery and inability to fully cooperate with the demands of colonoscopy and sedation. The patients are difficult to screen with colonoscopy or sigmoidoscopy and barium enema. If the Medicare beneficiary is of average risk for colorectal cancer, their physician should have the choice to recommend CTC

Multiple studies have shown that screening CT colonography is an effective screening strategy for patients who are at average risk for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] It is also well established that CTC is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

It is well established that colorectal cancer screening saves lives. I am confident that coverage of screening CTC will result in the screening of patients who would otherwise be resistant to colonoscopy.

Medicare coverage of screening CTC will be clinically effective in screening for colorectal cancer in average risk Medicare beneficiaries.

Sincerely,

Robert Butler, M.D., Ph.D.
Saint Paul Radiology, P.A.
Saint Paul, Minnesota

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How many more Americans must die just because the US is more concerned with looking further into issues of "cost-effectiveness"? In the analysis for "cost effectiveness" - I am curious - were the burial costs of 50,000+ lost lives a year (due to preventable colon cancer) being factored into the equation? How about the cost of prolonging the lives of those who are agonizingly and needlessly suffering? Know what the big problem is? We are pumping taxpayer dollars into treating cancer AFTER diagnosis! Why are we so barbaric? Why not pour some of our distressed tax dollars into PREVENTION rather than expensive, largely futile treatment? According to the World Health Organization, our health system ranks 37th in the world, just above Slovenia and below Kosovo. I think it''s time that we all made some use out of virtual colonoscopy and empower the public with prevention/awareness. Let''s cross the bridge into the 21st century already.

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Dear Medicare,

I am a registered nurse who works in the home health field. I have just been informed that you have denied coverage for the Virtual Colonoscopy screening. I am extremey disappointed and hope you will seriously re-consider. Colon cancer kills more people each year than AIDS or breast cancer combined. We have a [PHI Redacted] right now who is only 50 who is dying of this horrid cancer and she would have been caught sooner with this exam. I have taken care of many patients struggling with the horrific effects of this killer.

I had the opportunity to see first hand Viatronix Inc.''s virtual colonoscopy and was very impressed. I am confident this could save millions of people''s lives and would be more cost effective than the invasive colonoscopy cirrently used. Over 50% of Americans do not even have access to this costly exam and go without and die each year becasue they were not able to be screened.

This is a very preventable cancer and this non- invasive procedure is the answer. All of us who work in the health care industry know that prevention and not having to treat illness'' is far more cost effective.

PLEASE cover the virtual colonoscopy for all eligible Medicare beneficiaries. Many lives will be saved.

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Dear CMS,

Please reconsider your position regarding Virtual Colonoscopy for the following reasons:

• Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]
• Colorectal cancer screening saves lives
• Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy
• Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]
• With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

Thank you for your consideration.

Sincerely,

Robb LaChappelle

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I thank the committee for performing the evidentiary review of screening computed tomography colonography (CTC) for colorectal cancer. I respectfully disagree with the conclusion that CT colonography is not clinically effective for Medicare beneficiaries.

Utilization of CTC for Medicare beneficiaries by gastroenterologists and colorectal surgeons in our metropolitan subspecialty radiology practice has steadily risen over the last seven years. Medicare beneficiaries who have a contraindication to colonoscopy or sedation or who have undergone incomplete screening or diagnostic colonoscopy are now referred exclusively for CTC. Completion fluoroscopic barium enema is no longer utilized. This same CTC utilization pattern is also observed in our non-Medicare population. Our radiology practice has performed nearly 2000 CTC since 2003 of which the vast majority are for incomplete screening colonoscopy. I have personally interpreted over 500 exams myself for this indication.

It is a personal observation that the Medicare population has a higher rate of incomplete screening colonoscopy due to colonic redundancy and tortuosity, colonic diverticulosis, colonic fixation and angulation due to prior abdominopelvic surgery and inability to fully cooperate with the demands of colonoscopy and sedation. The patients are difficult to screen with colonoscopy or sigmoidoscopy and barium enema. If the Medicare beneficiary is of average risk for colorectal cancer, their physician should have the choice to recommend CTC

Multiple studies have shown that screening CT colonography is an effective screening strategy for patients who are at average risk for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] It is also well established that CTC is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

It is well established that colorectal cancer screening saves lives. I am confident that coverage of screening CTC will result in the screening of patients who would otherwise be resistant to colonoscopy.

Medicare coverage of screening CTC will be clinically effective in screening for colorectal cancer in average risk Medicare beneficiaries.

Sincerely,

John M. Caspers, M.D.
Saint Paul Radiology, P.A.
Saint Paul, Minnesota

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As a radiologist that monitors and interprets these exams I have firsthand experience with CT colonography studies and believe they provide a necessary alternative to other screening tests including colonoscopy. I believe the test is currently sufficiently accurate for screening and no doubt will continue to improve. There is potential for cost savings as well as CT screening is less costly than colonoscopy and carries fewer complications. Many of our patients have been pleased to have CT as an alternative to colonoscopy. I hope this decision will be reconsidered after additional information is gathered.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

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I thank the committee for performing the evidentiary review of screening computed tomography colonography (CTC) for colorectal cancer. I respectfully disagree with the conclusion that CT colonography is not clinically effective for Medicare beneficiaries. An important component of President Obama''s Health initiative is increased utilization of effective screening exams to improve patient health and control cost. CTC is such an exam.

Utilization of CTC for Medicare beneficiaries by gastroenterologists and colorectal surgeons in our metropolitan subspecialty radiology practice has steadily risen over the last seven years. Medicare beneficiaries who have a contraindication to colonoscopy or sedation or who have undergone incomplete screening or diagnostic colonoscopy are now referred exclusively for CTC. Completion fluoroscopic barium enema is no longer utilized. This same CTC utilization pattern is also observed in our non-Medicare population. Our radiology practice has performed nearly 2000 CTC since 2003 of which the vast majority are for incomplete screening colonoscopy.

It is a personal observation that the Medicare population has a higher rate of incomplete screening colonoscopy due to colonic redundancy and tortuosity, colonic diverticulosis, colonic fixation and angulation due to prior abdominopelvic surgery and inability to fully cooperate with the demands of colonoscopy and sedation. The patients are difficult to screen with colonoscopy or sigmoidoscopy and barium enema. If the Medicare beneficiary is of average risk for colorectal cancer, their physician should have the choice to recommend CTC

Multiple studies have shown that screening CT colonography is an effective screening strategy for patients who are at average risk for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] It is also well established that CTC is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72] It is well established that colorectal cancer screening saves lives. I am confident that coverage of screening CTC will result in the screening of patients who would otherwise be resistant to colonoscopy. Medicare coverage of screening CTC will be clinically effective in screening for colorectal cancer in average risk Medicare beneficiaries.

Sincerely,

James H Sullivan M.D. St. Paul Radiology St. Paul Minnesota

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I thank the committee for performing the evidentiary review of screening computed tomography colonography (CTC) for colorectal cancer. I respectfully disagree with the conclusion that CT colonography is not clinically effective for Medicare beneficiaries.

Utilization of CTC for Medicare beneficiaries by gastroenterologists and colorectal surgeons in our metropolitan subspecialty radiology practice has steadily risen over the last seven years. Medicare beneficiaries who have a contraindication to colonoscopy or sedation or who have undergone incomplete screening or diagnostic colonoscopy are now referred exclusively for CTC. Completion fluoroscopic barium enema is no longer utilized. This same CTC utilization pattern is also observed in our non-Medicare population. Our radiology practice has performed nearly 2000 CTC since 2003 of which the vast majority are for incomplete screening colonoscopy.

Multiple studies have shown that screening CT colonography is an effective screening strategy for patients who are at average risk for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] It is also well established that CTC is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72] It is well established that colorectal cancer screening saves lives. I am confident that coverage of screening CTC will result in the screening of patients who would otherwise be resistant to colonoscopy. Medicare coverage of screening CTC will be clinically effective in screening for colorectal cancer in average risk Medicare beneficiaries.

Sincerely,

Mark Veldman, M.D.

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I thank the committee for performing the evidentiary review of screening computed tomography colonography (CTC) for colorectal cancer. I respectfully disagree with the conclusion that CT colonography is not clinically effective for Medicare beneficiaries.

Utilization of CTC for Medicare beneficiaries by gastroenterologists and colorectal surgeons in our metropolitan subspecialty radiology practice has steadily risen over the last seven years. Medicare beneficiaries who have a contraindication to colonoscopy or sedation or who have undergone incomplete screening or diagnostic colonoscopy are now referred exclusively for CTC. Completion fluoroscopic barium enema is no longer utilized. This same CTC utilization pattern is also observed in our non-Medicare population. Our radiology practice has performed nearly 2000 CTC since 2003 of which the vast majority are for incomplete screening colonoscopy.

It is a personal observation that the Medicare population has a higher rate of incomplete screening colonoscopy due to colonic redundancy and tortuosity, colonic diverticulosis, colonic fixation and angulation due to prior abdominopelvic surgery and inability to fully cooperate with the demands of colonoscopy and sedation. Up to 10-15% of these exams are incomplete, even in the best of hands. These patients are difficult to screen with colonoscopy or sigmoidoscopy and barium enema. If the Medicare beneficiary is of average risk for colorectal cancer, their physician should have the choice to recommend CTC

Multiple studies have shown that screening CT colonography is an effective screening strategy for patients who are at average risk for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] It is also well established that CTC is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72] It is well established that colorectal cancer screening saves lives. I am confident that coverage of screening CTC will result in the screening of patients who would otherwise be resistant to colonoscopy. Our experience and the literature has shown that CTC is a viable, and likely better alternative to other existing CMS approved screening exams, when colonoscopy fails. Medicare coverage of screening CTC will be clinically effective in screening for colorectal cancer in average risk Medicare beneficiaries.

Sincerely,

Jeffrey Barkmeier, M.D.
Saint Paul Radiology, P.A.
Saint Paul, Minnesota

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I thank the committee for performing the evidentiary review of screening computed tomography colonography (CTC) for colorectal cancer. I respectfully disagree with the conclusion that CT colonography is not clinically effective for Medicare beneficiaries.

Utilization of CTC for Medicare beneficiaries by gastroenterologists and colorectal surgeons in our metropolitan subspecialty radiology practice has steadily risen over the last seven years. Medicare beneficiaries who have a contraindication to colonoscopy or sedation or who have undergone incomplete screening or diagnostic colonoscopy are now referred exclusively for CTC. Completion fluoroscopic barium enema is no longer utilized. This same CTC utilization pattern is also observed in our non-Medicare population. Our radiology practice has performed nearly 2000 CTC since 2003 of which the vast majority are for incomplete screening colonoscopy.

It is a personal observation that the Medicare population has a higher rate of incomplete screening colonoscopy due to colonic redundancy and tortuosity, colonic diverticulosis, colonic fixation and angulation due to prior abdominopelvic surgery and inability to fully cooperate with the demands of colonoscopy and sedation. The patients are difficult to screen with colonoscopy or sigmoidoscopy and barium enema. If the Medicare beneficiary is of average risk for colorectal cancer, their physician should have the choice to recommend CTC

Multiple studies have shown that screening CT colonography is an effective screening strategy for patients who are at average risk for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] It is also well established that CTC is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

It is well established that colorectal cancer screening saves lives. I am confident that coverage of screening CTC will result in the screening of patients who would otherwise be resistant to colonoscopy.

Medicare coverage of screening CTC will be clinically effective in screening for colorectal cancer in average risk Medicare beneficiaries.

Sincerely,

Keith H. Wittenberg, MD Saint Paul Radiology, P.A. Saint Paul, Minnesota

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I thank the committee for performing the evidentiary review of screening computed tomography colonography (CTC) for colorectal cancer. I respectfully disagree with the conclusion that CT colonography is not clinically effective for Medicare beneficiaries.

Utilization of CTC for Medicare beneficiaries by gastroenterologists and colorectal surgeons in our metropolitan subspecialty radiology practice has steadily risen over the last seven years. Medicare beneficiaries who have a contraindication to colonoscopy or sedation or who have undergone incomplete screening or diagnostic colonoscopy are now referred exclusively for CTC. Completion fluoroscopic barium enema is no longer utilized. This same CTC utilization pattern is also observed in our non-Medicare population. Our radiology practice has performed nearly 2000 CTC since 2003 of which the vast majority are for incomplete screening colonoscopy.

It is a personal observation that the Medicare population has a higher rate of incomplete screening colonoscopy due to colonic redundancy and tortuosity, colonic diverticulosis, colonic fixation and angulation due to prior abdominopelvic surgery and inability to fully cooperate with the demands of colonoscopy and sedation. The patients are difficult to screen with colonoscopy or sigmoidoscopy and barium enema. If the Medicare beneficiary is of average risk for colorectal cancer, their physician should have the choice to recommend CTC

Multiple studies have shown that screening CT colonography is an effective screening strategy for patients who are at average risk for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] It is also well established that CTC is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72] It is well established that colorectal cancer screening saves lives. I am confident that coverage of screening CTC will result in the screening of patients who would otherwise be resistant to colonoscopy. Medicare coverage of screening CTC will be clinically effective in screening for colorectal cancer in average risk Medicare beneficiaries.

Sincerely,

T. David Cox, M.D.
Saint Paul Radiology, P.A.
Saint Paul, Minnesota

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I thank the committee for performing the evidentiary review of screening computed tomography colonography (CTC) for colorectal cancer. I respectfully disagree with the conclusion that CT colonography is not clinically effective for Medicare beneficiaries.

Utilization of CTC for Medicare beneficiaries by gastroenterologists and colorectal surgeons in our metropolitan subspecialty radiology practice has steadily risen over the last seven years. Medicare beneficiaries who have a contraindication to colonoscopy or sedation or who have undergone incomplete screening or diagnostic colonoscopy are now referred exclusively for CTC. Completion fluoroscopic barium enema is no longer utilized. This same CTC utilization pattern is also observed in our non-Medicare population. Our radiology practice has performed nearly 2000 CTC since 2003 of which the vast majority are for incomplete screening colonoscopy.

It is a personal observation that the Medicare population has a higher rate of incomplete screening colonoscopy due to colonic redundancy and tortuosity, colonic diverticulosis, colonic fixation and angulation due to prior abdominopelvic surgery and inability to fully cooperate with the demands of colonoscopy and sedation. The patients are difficult to screen with colonoscopy or sigmoidoscopy and barium enema. If the Medicare beneficiary is of average risk for colorectal cancer, their physician should have the choice to recommend CTC

Multiple studies have shown that screening CT colonography is an effective screening strategy for patients who are at average risk for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] It is also well established that CTC is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

It is well established that colorectal cancer screening saves lives. I am confident that coverage of screening CTC will result in the screening of patients who would otherwise be resistant to colonoscopy.

Medicare coverage of screening CTC will be clinically effective in screening for colorectal cancer in average risk Medicare beneficiaries.

Sincerely,

Peter Wold, M.D. Saint Paul Radiology, P.A. Saint Paul, Minnesota

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I thank the committee for performing the evidentiary review of screening computed tomography colonography (CTC) for colorectal cancer. I respectfully disagree with the conclusion that CT colonography is not clinically effective for Medicare beneficiaries.

Utilization of CTC for Medicare beneficiaries by gastroenterologists and colorectal surgeons in our metropolitan subspecialty radiology practice has steadily risen over the last seven years. Medicare beneficiaries who have a contraindication to colonoscopy or sedation or who have undergone incomplete screening or diagnostic colonoscopy are now referred exclusively for CTC. Completion fluoroscopic barium enema is no longer utilized. This same CTC utilization pattern is also observed in our non-Medicare population. Our radiology practice has performed nearly 2000 CTC since 2003 of which the vast majority are for incomplete screening colonoscopy.

It is a personal observation that the Medicare population has a higher rate of incomplete screening colonoscopy due to colonic redundancy and tortuosity, colonic diverticulosis, colonic fixation and angulation due to prior abdominopelvic surgery and inability to fully cooperate with the demands of colonoscopy and sedation. The patients are difficult to screen with colonoscopy or sigmoidoscopy and barium enema. If the Medicare beneficiary is of average risk for colorectal cancer, their physician should have the choice to recommend CTC

Multiple studies have shown that screening CT colonography is an effective screening strategy for patients who are at average risk for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] It is also well established that CTC is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

It is well established that colorectal cancer screening saves lives. I am confident that coverage of screening CTC will result in the screening of patients who would otherwise be resistant to colonoscopy.

Medicare coverage of screening CTC will be clinically effective in screening for colorectal cancer in average risk Medicare beneficiaries.

Sincerely,

Matthew T. Baldwin, M.D.
Saint Paul Radiology, P.A.
Saint Paul, Minnesota

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First I would like to thank the committee for performing the evidentiary review of screening computed tomography colonography (CTC) for colorectal cancer. I however respectfully disagree with the conclusion that CT colonography is not clinically effective for Medicare beneficiaries.

Utilization of CTC for Medicare beneficiaries by gastroenterologists and colorectal surgeons in our metropolitan subspecialty radiology practice has steadily risen since its introduction. Medicare beneficiaries who have a contraindication to colonoscopy or sedation or who have undergone incomplete screening or diagnostic colonoscopy are now referred exclusively for CTC. Completion fluoroscopic barium enema is no longer utilized. This same CTC utilization pattern is also observed in our non-Medicare population. Our radiology practice has performed nearly 2000 CTC since 2003 of which the vast majority are for incomplete screening colonoscopy.

It is a personal observation shared by my colleagues that the Medicare population has a higher rate of incomplete screening colonoscopy due to colonic redundancy and tortuosity, colonic diverticulosis, colonic fixation and angulation due to prior abdominopelvic surgery and inability to fully cooperate with the demands of colonoscopy and sedation. The patients are difficult to screen with colonoscopy or sigmoidoscopy and barium enema.

If the Medicare beneficiary is of average risk for colorectal cancer, their physician should have the choice to recommend CTC.

Multiple studies have shown that screening CT colonography is an effective screening strategy for patients who are at average risk for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] It is also well established that CTC is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

It is well established that colorectal cancer screening saves lives. I am confident that coverage of screening CTC will result in the screening of patients who would otherwise be resistant to colonoscopy and therefore to real lives saved.

Medicare coverage of screening CTC will be clinically effective in screening for colorectal cancer in average risk Medicare beneficiaries.

Sincerely,

Rob Weinmann IV, M.D.
Saint Paul Radiology, P.A.
Saint Paul, Minnesota

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Dear Sirs:

We respectfully disagree with the conclusion that CT colonography is not clinically effective for Medicare beneficiaries.

Utilization of CTC for Medicare beneficiaries by gastroenterologists and colorectal surgeons in Saint Paul, MN has steadily risen over the last seven years. Medicare and non-Medicare beneficiaries who have a contraindication to colonoscopy or sedation or who have undergone incomplete screening or diagnostic colonoscopy are now referred exclusively for CTC. The conventional barium enema is no longer utilized. Our radiology practice has performed nearly 2000 CTC since 2003 of which the vast majority is for incomplete screening colonoscopy.

We believe the Medicare population has a higher rate of incomplete screening colonoscopy due to colonic redundancy and tortuosity, colonic diverticulosis, colonic fixation and angulation due to prior abdominopelvic surgery and inability to fully cooperate with the demands of colonoscopy and sedation. The patients are difficult to screen with colonoscopy or sigmoidoscopy and barium enema. If the Medicare beneficiary is of average risk for colorectal cancer, their physician should have the choice to recommend CTC. It is well established that colorectal cancer screening saves lives. We believe screening CTC will be of significant benefit to these patients.

Multiple studies have shown that screening CT colonography is an effective screening strategy for patients who are at average risk for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] It is also well established that CTC is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

We do wish you will reconsider your position. Sincerely,

Joseph Tashjian, MD
Saint Paul Radiology, P.A.
Saint Paul, Minnesota

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March 6, 2009

Dr. Steve E. Phurrough
Coverage & Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Blvd. 21244-1850

Re: Proposed Decision Memorandum for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N)

Dear Dr. Phurrough:

Since 1996, the National Patient Advocate Foundation ("NPAF") has represented patients battling cancer and other life-threatening diseases, in concert with our companion organization, Patient Assistance Foundation, which provides counseling and mediation to individuals who have been diagnosed with a chronic, debilitating or life-threatening disease. On behalf of those patients, we welcome the opportunity to comment on the Proposed Coverage Decision for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N.)

Colorectal cancer is the second leading cause of cancer death in the United States, and early detection is critical to increase one’s chances for survival. The early diagnosis of colorectal cancer depends on a number of available screening methods – including the flexible sigmoidoscopy, colonoscopy, CTC, and double contrast barium enema. Of course, screening is only successful as a diagnostic tool if patients are engaged with their physicians and agree to undertake recommended screening procedures at appropriate intervals. NPAF remains concerned that some beneficiaries will not present for the screening tests ordered by their physician if they find the only available options to be too invasive, too uncomfortable, or associated with too many risks. Test avoidance is a particular concern with colorectal cancer screening because of the invasive nature of optical colonoscopy and the requirement for sedation during the procedure. It should be less of a concern with CTC since it is less invasive and can be performed without sedation.

NPAF strongly supports evidence-based medicine and consistently has supported CMS’ use of clinical evidence as a decision making tool. In this instance, we do not agree that the clinical evidence justifies a non-coverage decision with regard to the extension of coverage to CTC under Social Security Act § 1861(pp)(1). Rather, we note that the Agency for Healthcare Research and Quality (“AHRQ”) found that screening CTC provides a benefit in life-years gained compared to no screening at all. That is enough for us.

While we wish there were data showing whether adherence for screening CTC is differentially higher than that for other colon cancer screening procedures, NPAF is not prepared to leave those patients who will forego screening using the currently covered tests at continued risk until such studies become available. Neither were the majority of those who commented during the initial public comment period in May 2008,

We recognize that AHRQ concluded screening CTC is less cost effective than the colorectal cancer screening methods that are currently covered under Medicare. Nonetheless, we have consistently expressed the view that cost-effectiveness should not be determinative of coverage decisions. We certainly are not prepared to condone using cost-effectiveness data to justify, even in part, a non-coverage decision for a less invasive, more patient-friendly screening test proven to improve outcomes compared with no screening. We are particularly unpersuaded by the cost-effectiveness data presented by AHRQ and relied upon by CMS because that data does not appear to take into account the higher costs that are typically associated with treating colorectal cancer patients who are diagnosed with later stage disease. We concur with CMS’ conclusion that more research is needed to see whether CTC leads to better overall cancer detection. However, we submit the easiest way to collect that data in light of the proven effectiveness of CTC as a screening tool would be to add CTC to the list of Medicare-covered colorectal cancer screening tests at Social Security Act § 1861(pp)(1) and then analyze Medicare claims data for all of the various covered screening procedures over the subsequent two to three year period.

Sincerely,

Nancy Davenport-Ennis
President and CEO

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We disagree with the decision not to recommend CTC for Medicare reimbursement. We have been doing fairly large volume screening CTC at two remote rural locations where fecal occult blood testing is not practical for most patients and screening optical colonoscopy is not readily available. Our data (not as yet published) can address the committee’s radiation concern and the extracolonic findings concern, and supplement the literature as to efficacy. We would also like to comment on the comparison to DCBE, FOBT and flexible sigmoidoscopy.

Radiation: we use a low dose technique so that the estimated dose of < 3 mSv is < one year’s background radiation at sea level, so that we do not think radiation is a real concern for the Medicare patient population.

Extracolonic findings: out of 197 patients examined between 7/1/08 and 1/26/09 68 were > 65 years old. We uncovered extracolonic findings with the potential for unnecessary additional testing in only 3 patients- one 7 mm lung nodule for which followup CT is recommended to exclude malignancy, one calcified contracted gallbladder versus cholecystectomy clips (which could be resolved by history rather than additional testing) and one patient with a right pleural effusion and right middle and lower lobe atelectasis for which chest CT was recommended (probably lung cancer but conceivably unnecessary additional testing). The percentage of unnecessary testing is 4.5% of patients maximum and probably only 1.4% (patient with lung nodule only). The quoted incidence of 8% is far to high, both in these data and our personal experience.

Efficacy: we cannot say whether or not we have false negative CTC’s. We have reported six C-RADS C3 lesions (>1 cm). Four were true positive and one was false positive and one has not had optical follow-up yet. We reported C2 lesions (1-2 polyps between 6 and 9 mm) in 8 patients all of whom have elected CTC surveillance. Small numbers but quite good results so far.

Comparison to FOBT, DCBE, flexible sigmoidoscopy: all of these are paid for by Medicare. There is no doubt that CTC is a better test than FOBT. Flexible sigmoidoscopy for screening is like doing mammography of only one breast- only half of the potentially affected mucosa is examined. Most of the radiologists who developed CTC are old enough to be skilled in performing and interpreting DCBE. We can tell you that CTC is far less unpleasant for the patient and a much more sensitive exam. The technical aspects of DCBE are much m ore operator dependent than CTC. Every day there are fewer radiologists available who are skilled in the performance and interpretation of DCBE because volume during residency has been insufficient for training for the past 15 years. Although the charges for DCBE exceed those for CTC DCBE is not a viable alternative.

Comparison to optical colonoscopy: there are data suggesting CTC is at least equally sensitive for significant adenomas compared to CTC. From a public health point of view, we have millions in the US who are not being adequately screened for colorectal cancer either because they do not wish to undergo optical colonoscopy or because it is not available. If CTC were reimbursed, many more people would get screened, lives would be saved, and overall health care costs reduced.

Sincerely,

Arnold C. Friedman, M.D. FACr=R
Professor of Radiology
Chief, Body Imaging
Department of Radiology, University of Arizona Med Ctr
1501 N. Campbell
Tucson, AZ 85724

Peter Lance, M.D.
Professor of Medicine, Molecular & Cellular
Biology, and Public Health
Chief Cancer Control Officer
Arizona Cancer Center
Director, Health Research Alliance Arizona, Tucson Program
Arizona Cancer Center
1515 N. Campbell Avenue
Tucson, AZ 85724-5024

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Dear Members of CMS:

Thank you for accepting my comments in reference to the upcoming decision regarding CTC screening reimbursement approval for Medicare partcipants.

I have been working over the past six years with several physicians, cancer prevention charities, and commercial organizations to see that CTC becomes a viable CRC screening alternative for the tens of millions of Americans who currently do not seek screening due to their objection to the alternatives.

It is a shame that in a progressive country such as ours, that 53,000 people of the 150,000 diagnosed with Colon Rectal Cancer (CRC), died. Unlike breast findings, where positive results can potentially lead to lumpectomies, mastectomies, radiation treatments, chemotherapy, and a high incidence of death, a positive CTC finding of a polyp 10mm or greater requires a polypectomy-a simple outpatient procedure that does not require radiation or chemo.

Other than Optical Colonoscopy (OC), there are no other reimbursed preventive and viable alternatives for screening. It is sad that millions of Americans will not get screened because of their fears of OC. The American Cancer Society has recommended that Fecal Occult Blood Tests and Barium Enemas (which provides the same radiation dose as a CTC) be removed as accepted screening procedures.

If CMS decides to update their accepted CRC screening procedures, they will find economically that as more people get screened, the savings from FOBT,BE,and cancer treatments for 90% of the 150,000 people disagnosed will offset much of the costs of this approval. Also, as we as a nation become more aware to be screened, the cost of CTC screening is less than half of the cost of an OC.

If CRC screening becomes as popular as breast screening during the previous decade, it will be noted that there are not enough endoscopy labs nor Gastroenterologists in the nation to meet this demand for screening nor the removal of the less than 10% of screened patients who are positive with sizeable polyps.

As I have reviewed all the data, studies, and comments over the years, it has become apparent that there are several groups associated with the Gastro-intestinal world that are the lead influencers in trying to prevent the approval of this important technology. I ask myself-WHY? Are they being short sighted in thinking that they will lose revenues to this form of screening? Do they think they will lose control of the patient''s colon health? Has American greed crept into healthcare from Wall Street? I truly hope that these are not the cases.

In reality, as the promotion and adoption of CRC screening gains momentum, patients will be directed by their referring physicians for either OC (if they have history or symptoms)or CTC (pure screening candidates). This end result will be that OC procedures will increase due to the new demand for folks seeking screening who have history and symptoms and the small percentage of CTC screened patients that require polypectomies. It is estimated that this will cause a backlog to the current available endoscopy labs in the USA if CRC screening is as successful as breast was.

In reality, the Radiology community is not trying to steal away the patients from the Gastroenterologists, they are trying to bring more patients into the system by providing a less invasive, more accepting technology to the patient. Everyone needs to get real here and understand that this is about reducing the number of needless deaths from CRC, not who is infringing on who''s turf. I have yet to meet a Radiologist who wants to "Virtually" remove a polyp.

I implore you to think long and hard about this decision. Please remove the politics of the situation. Please do the right thing and save tens of thousands of lives.

Respectfully

John J. DeBiase

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Charlene Frizzera, Acting Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Mail Stop C5-11-24
Baltimore, Maryland 21244-1850

Re: Coverage of Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N)

Dear Ms. Frizzera:

The Advanced Medical Technology Association (AdvaMed) welcomes the opportunity to comment on the proposed decision memorandum that the Centers for Medicare and Medicaid Services (CMS) has posted regarding coverage of computed tomography (CT) colonography for colorectal cancer screening.

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies.

AdvaMed believes that efforts to prevent disease are key to achieving an efficient and affordable health care system that delivers the highest quality care and fosters medical progress and innovation. Including prevention in primary health care and ensuring insurance coverage for effective preventive services are critical goals in the effort to improve the state of the U.S. health care system. Improving the delivery of preventive services is also important as we try to narrow gaps in the provision of preventive care among different populations. In this vein, the colorectal cancer screening benefit, and CMS’s consideration of coverage for CT colonography in the context of that benefit, is of interest to AdvaMed members because of the great potential this technology holds in pursuing the public health goal of preventing colorectal cancer through early detection, diagnosis and treatment. CT colonography used to screen for colorectal cancer is a means to significantly expand the options available for effective screening.

Concerns with the Proposed National Coverage Decision

The proposed national coverage decision presumes that CMS has the authority to make its coverage decision on screening CT Colonography based at least in part on cost effectiveness considerations. In the proposed national coverage decision memorandum for screening CT colonography, CMS states that:

[If] we determine that CT colonography is clinically effective, then we would need to determine, using current or additional cost information, if CT colonography is cost effective. We are asking for public comment on the cost effectiveness of screening CT colonography for the Medicare population if we were to alter our clinical decision.

CMS also commissioned AHRQ to conduct a study of the cost effectiveness of screening CT colonography. For the following reasons, we do not believe that CMS’s decision should be based on cost effectiveness considerations.

First, CMS does not have the statutory authority to use cost effectiveness in its coverage determination for CT colonography. Congress mandated creation of a colorectal cancer screening benefit in 1997 under the Balanced Budget Act, P.L. 105-33, Section 4104. Colorectal cancer screening is covered by Medicare pursuant to section 1862(a)(1)(H) of the Social Security Act (the “Act”). This screening benefit allows for expansion of procedures covered for colorectal cancer screening:

Such other tests or procedures, and modifications to tests and procedures under this subsection, with such frequency and payment limits, as the Secretary determines appropriate, in consultation with appropriate organizations.

This provision does not contain any express or implied language authorizing the Secretary to consider cost effectiveness when determining whether a procedure or service is appropriately covered for colorectal cancer screening.

Second, the statutory language providing for coverage under the colorectal cancer screening benefit differs significantly from the statutory language describing the method to determine coverage of additional categories of preventive services under section 101 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA, P.L. 110-275) (see sections 1861(s)(2), (ddd), and 1862(a)(1)(A) of the Act). In contrast to language in the colorectal cancer screening provision, the MIPPA provision states that:

(1) The term ‘additional preventive services’ means services not otherwise described in this title that identify medical conditions or risk factors and that the Secretary determines are—(A) reasonable and necessary for the prevention or early detection of an illness or disability(B) recommended with a grade of A or B by the United States Preventive Services Task Force; and(C) appropriate for individuals entitled to benefits under [P]art A or enrolled under [P]art B.(2) In making determinations under paragraph (1) regarding the coverage of a new service, the Secretary shall use the process for making national coverage determinations…As part of the use of such process, the Secretary may conduct an assessment of the relation between predicted outcomes and the expenditures for such service and may take into account the results of such assessment in making such determination.

This MIPPA provision clearly states that it applies only to categories of services not already described in the title, which would preclude application to colorectal cancer screening tests. The MIPPA language does not specifically reference “cost effectiveness analysis” but instead gives the Secretary authority to assess the relation between predicted outcomes and expenditures when determining coverage of new preventive benefits. Clearly, the MIPPA preventive benefits language is significantly different from the language used in the colorectal cancer screening provision (at § 1861(pp) of the Act).

For these reasons, AdvaMed believes that section 101 of MIPPA does not apply to national coverage analysis of CT colonography, and that operating under § 1861(pp) of the Act, the Secretary lacks authority to consider cost effectiveness in the context of the coverage determination for this cancer screening procedure.

Third, CMS stated in its own guidance document on “Factors CMS Considers in Opening a National Coverage Determination” (Document Issued: April 11, 2006) that:

Cost effectiveness is not a factor CMS considers in making NCDs. In other words, the cost of a particular technology is not relevant in the determination of whether the technology improves health outcomes or should be covered for the Medicare population through an NCD.

Moreover, cost effectiveness estimates are speculative with respect to future costs and benefits and could prevent the diffusion of technologies that will improve patient care. It would be inappropriate to universally preempt coverage of an item or service on the basis of estimates of average costs and benefits when for some patients that item or service may well be the most appropriate (or perhaps the only) option.

AdvaMed urges the CMS to determine coverage of CT colonography without consideration of cost effectiveness.

Recommendations Involving Payment

With respect to CMS’s determination of payment for CT colonography, AdvaMed believes that the Secretary should use the same process to determine payment for all benefits, unless otherwise directed by Congress. Thus, the Secretary should determine payment limits for a covered colorectal cancer screening test using the same method she uses to determine payment rates for all Medicare covered services. If a CT colonography is performed in a physician’s office or independent testing facility, payment should be determined in the same manner as other procedures and services paid under the Physician Fee Schedule. Likewise, if performed in the hospital outpatient department, payment should be determined under the Hospital Outpatient Prospective Payment System, and if in an ambulatory surgery center (ASC) under the ASC Payment System.

This conclusion is supported by a recent federal court decision holding that the Secretary of Health and Human Services does not have the discretion to determine the amount paid for every item and service covered by Medicare, without reference to the detailed formulas set by Congress. The court blocked the Administration''s effort to pay for only the least expensive treatments for particular conditions. The court concluded that Congress never intended to give government officials broad discretion to alter Medicare payment rates, irrespective of the Medicare payment systems that are set forth in legislation.

Relevance of MIPPA, Section 101 to MedCAC Proceedings

CMS convened the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) on November 19, 2008. The stated purpose of this meeting was to review the available evidence on the use of CT colonography as a screening test for colorectal cancer for average risk individuals, including test characteristics, screening frequency, cost effectiveness, safety and training requirements.

At the meeting, the MedCAC panel received some background from the CMS representative on the relevance of section 101 of MIPPA and its bearing on the MedCAC proceedings. This explanation, while well-intentioned, may have created some confusion among panel members about the relevance of the new law, and it might possibly have led them to conclude (incorrectly) that this provision impacted how CT colonography was to be considered.

As you are aware, the statutory authority for this NCD derives from Section 1861(pp) of the Social Security Act, not the MIPPA provision. Because the MIPPA provision, where applicable, will restrict CMS from covering new preventive or screening services that are not supported by an evidence grade of “A” or “B” by the USPSTF, we are concerned that MedCAC panel members may have mistakenly concluded that the evidence bearing on CT colonography could not be considered to be adequate for coverage based entirely on a misinterpretation of the law.

Moreover, the presentation of the AHRQ analysis of the “Cost-Effectiveness of CT Colonography to Screen for Colorectal Cancer” at the MedCAC meeting also led the panel members to believe that consideration of cost effectiveness was appropriate. As stated above, CMS should not be considering cost effectiveness to determine coverage of screening CT colonography, and likewise the MedCAC should not have considered cost effectiveness in its recommendations.

* * *

AdvaMed greatly appreciates the opportunity to comment. We urge CMS to cover screening CT colonography without considering cost effectiveness, and to determine payment using the detailed payment formulas included in the law.

We would be pleased to answer any questions regarding these comments. Please contact Madeleine Smith at (202) 434-7207 or msmith@advamed.org if we can be of further assistance.

Sincerely,

Ann-Marie Lynch
Executive Vice President,
Payment and Health Care Delivery

Cc: Barry Straube
Steve Phurrough
Tamara Syrek Jensen

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March 6, 2009

Mr. William Larson, MA
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244-1850

Re: NCA for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG- 00396N); Comments on Proposed Denial of Coverage

Dear Mr. Larson:
I am writing on behalf of iCAD, Inc. to submit comments regarding your proposed decision to deny coverage for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CRC). iCAD submitted comments in June 2008 in support of covering CTC as an added option for colorectal cancer screening during the initial public comment period. As CMS is aware, colon cancer remains the second leading cause of death from cancer in the United States, despite being highly preventable with the early identification and removal of polyps. iCAD, like many in the community, commends CMS for recognizing the need to take action toward reducing death rates from colorectal cancer and initiating an NCA process for covering CTC as an additional screening option. However, we disagree with the proposed non-coverage decision by CMS in light of the evidence that strongly supports the use of CTC for screening, particularly in comparison to the other options currently covered by Medicare. Importantly, CTC holds substantially higher sensitivities and specificities for polyps and cancers than barium enema, flexible sigmoidoscopy, and FOBT.^1-3 In making the proposed decision, CMS appears to have discounted the views of the U.S. Multi Society Task Force on Colorectal Cancer, the American College of Radiology, and the American Cancer Society, who jointly issued guidelines recommending the use of CTC for colorectal cancer screening. The guidelines recommend many screening alternatives, in recognition that alternative testing supports the goal of increasing the number of people undergoing some form of screening to assist in the prevention of CRC. Medicare’s screening benefit for CRC supports that position as well. Without expanding the screening benefit to include CTC, Medicare beneficiaries will not have access to a clinically effective test that has the potential to increase the current screening rate of only approximately half of the eligible population. It is clear that the options available to the public have not been effective in improving screening rates and curbing death rates from what is largely a preventable disease. As many as 60 percent of deaths from colorectal cancer could be prevented if everyone age 50 and older were screened regularly.⁴ We note the concern of CMS for quality patient care, and iCAD supports incorporating quality control measures such as qualification of personnel, equipment, and image quality into the coverage decision. While the current economic conditions warrant concern about cost containment, the more pertinent question is the cost of CTC screening compared to that of no screening. It is estimated that more than 40 million individuals who are eligible for screening do not undergo any screening at all. In the case of screening and prevention of a leading cause of cancer death in the United States such as colorectal cancer, it is important to consider the costs associated with treatment for advanced disease and lost productivity if screening rates remain unchanged. The overall five year survival rate for colon cancer is 64%. The five year survival for early localized colon cancer is over 90%, but only 39% of these cancers are diagnosed early and localized due to inadequate screening.^5,6 Compliance with screening in the U.S. is nowhere near acceptable levels with the currently available options; particularly for the Medicare population.⁷ It is vital that we maintain focus on the current reality.

CMS acknowledges that CTC is an effective screening methodology, but questions the applicability of available evidence to the Medicare population. Numerous presentations, peer reviewed published data, and public comments by clinicians with years of experience implementing and running CTC screening programs for the entire eligible population, including Medicare patients, should not be dismissed. It is important to note that the Medicare population is more susceptible to the risks of perforation and adverse effects of sedation associated with the currently established colonoscopy procedure,^8,9 which is not the case with CTC. It does not seem reasonable to deny this population an alternative that is known to be effective, known to carry less tangible risks, and known to be extremely cost effective relative to no screening at all until all hypothetical concerns surrounding CTC and its cost effectiveness relative to a higher risk procedure are resolved.

On behalf of iCAD, and as a member of the healthcare community, I urge CMS to reconsider its proposed decision of non-coverage and to provide Medicare beneficiaries’ access to CTC for colorectal cancer screening, a proven low risk high benefit procedure.

Thank you for your consideration. Yours truly,

Jeff Hoffmeister, MD, MSEE
Vice President, Medical Director iCAD, Inc.

References

1. Pickhardt PJ, Choi JR, Hwang I, et al. Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. N Engl J Med 2003; 349:2191-2200.

2. Johnson CD, Chen MH, Toledano AY, et al. Accuracy of CT colonography for detection of large adenomas and cancers. New England Journal of Medicine. 2008;359(12):1207-1217.

3. Kim DH, Pickhardt PJ, Taylor, AJ, et al. CT Colonography versus Colonoscopy for the Detection of Advanced Neoplasia. N Engl J Med 2007; 357:1403-1412.

4. http://www.cdc.gov/cancer/colorectal/statistics/s creening_rates.htm Page last updated: February 15, 2008

5. American Cancer Society. Cancer Facts and Figures 2007, page 12.

6. Seeff LC, Manninen DL, Dong FB, et al. Is there endoscopic capacity to provide colorectal cancer screening to the unscreened population in the United States? Gastroenterology. 2004;127 (6):1661-1669.

7. Cooper GS, Kou TD. Underuse of colorectal cancer screening in a cohort of Medicare beneficiaries. 2008:293-299.

8. Linda Rabeneck, Lawrence F. Paszat, Robert J. Hilsden, Refik Saskin, Des Leddin, Eva Grunfeld, Elaine Wai, Meredith Goldwasser, Rinku Sutradhar, Therese A. Stukel, Bleeding and Perforation After Outpatient Colonoscopy and Their Risk Factors in Usual Clinical Practice, Gastroenterology - December 2008 (Vol. 135), Issue 6, Pages 1899-1906.

9. Nicolle M. Gatto , Harold Frucht , Vijaya Sundararajan , Judith S. Jacobson , Victor R. Grann , and Alfred I. Neugut, Risk of Perforation After Colonoscopy and Sigmoidoscopy: A Population-Based Study, J. Natl. Cancer Inst. 95: 230-236.

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As a retired surgeon, I am well aware of the benefits of cancer screening. I am also aware of the potential risks and complications of a screening colonoscopy. As you know they include bleeding, perforation, need for unexpected hospitalization, emergency surgery, temporary or permanent colostomy, sepsis and even death. If I told a female patient that there is a 0.5 - 1 in a thousand chance that here breasts might be temporarily or permanently injured by a screening mammogram, or a male patient that there is a similar chance to become impotent from a PSA blood test, how many patients would have this test still done or look for a less dangerous alternative? A screening test in my opinion should carry virtually 0% risk, whereas in a diagnostic test one may have to accept the inherent risk of the diagnostic procedure. I therefore argue that the day has come for CTC to be approved as an appropriate screening procedure for colorectal neoplasms as a less dangerous alternative to screening colonoscopy.

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Dear CMS

We are writing in response to CMS’ decision not to assign a CPT code to computerized tomographic colonography (CTC), also known as “virtual colonoscopy”.

While we appreciate CMS' use of the USPSTF evaluation (which gave CTC a category “I” recommendation overall because of insufficient evidence that CTC improved net outcomes for average risk Medicare individuals undergoing colorectal cancer screening when compared to optical colonoscopy), we suggest that certain important subgroups might merit special consideration. The main concern is that not everyone is willing or able to undergo colonoscopy. Another concern is that the risk-to-benefit of colonoscopy may be unfavorable for certain subgroups. CTC has a very high sensitivity for polyps 1 cm or larger, compared to other (supported) CRC screening tests, such as FOBT, ACBE, or sigmoidoscopy; in a recent cross-sectional, population-based, screening study, the sensitivity and specificity of CTC for advanced colorectal neoplasia was second only to colonoscopy.(1) While there is no published evidence establishing CTC as having a clear screening benefit for the Medicare population - a very high bar - we suggest that, in the spirit of "evidence-based medicine," which is the integration of best research evidence with clinical expertise and patient values (2), it might make common sense to allow CTC to be reimbursed for certain indications within well-defined patient subgroups, and at the same time collect and analyze data on patient and provider uptake, acceptability, yield, subsequent testing, outcomes, and satisfaction of the patient and primary care provider.

Specifically we believe that CTC deserves serious consideration by CMS for the following patient subgroups:

1. Persons receiving abdominal CT for diagnostic purposes: For patients who have been scheduled to undergo abdominal CT for a diagnostic indication and who are not current with their CRC screening, adding the CTC component to conventional CT would seem to make sense, as it has a higher than average benefit:risk ratio than for the screening setting alone. The benefits include achieving compliance with CRC screening; with less concern about “incidental” findings (as there is no “added” risk of such findings compared to the conventional CT already scheduled); and in an age group where the long-term radiation risk is less of an issue.

2. Persons who have had a colorectal cancer resected with curative intent: Patients who have undergone surgery for a CRC with curative intent are at high-risk for recurrent disease, particularly extraluminal, intrabdominal disease. These patients are supposed to be followed with surveillance testing, including periodic history and physical examination; laboratory tests including carcinoembryonic antigen level; abdominal CT; and colonoscopy. Among the several randomized trials comparing various degrees of post-operative surveillance (minimal, moderate, intense), two studies have demonstrated a mortality difference in favor of more intense surveillance. (3, 4) In both trials, abdominal CT was used in the intense surveillance group but not in the less-intense group. However, colonoscopy was not differentially used in either trial: in one trial both groups had periodic colonoscopy, while in the other trial, neither group did, suggesting that abdominal CT is useful in detecting resectable recurrent disease and that colonoscopy is not. (5) Similar to the previous group of patients undergoing abdominal CT for diagnostic indications, adding the CTC component to this group of patients undergoing post-cancer surveillance to look for metachronous neoplasia might make more sense than periodic colonoscopy on everyone in this group.

3. Persons on anticoagulation: Patients receiving anticoagulation may experience adverse events when anticoagulation is stopped to perform colonoscopy or when it is restarted. Those who are anticoagulated with warfarin, for high-risk indications such as a mechanical heart valve, are at increased risk for both thromboembolic disease and bleeding as they transition from warfarin to bridge therapy with heparin, during the time when there is no anticoagulation effect, and during the time when they reverse transition from heparin back to warfarin. The yield of this process is low and ends up being “unnecessary” in most persons who will not have large adenomas or cancer. However, not “reversing” patients prior to colonoscopy is wasteful if a large polyp is found because the risk of post-polypectomy bleeding is too high to remove the polyp prior to reversing anticoagulation, resulting in the need for another colonoscopy with bridge therapy and its risks of thromboembolism and hemorrhage. It would clinically sensible to use CTC to “screen” patients for large polyps who have high-risk indications for anticoagulation, or at least to offer it to this patient subgroup to optimize the need to reverse anticoagulation; patients with a large polyp seen on CTC would stop warfarin prior to colonoscopy while those with no or only small polyps on CTC would continue it, at either the usual dose or a lower dose.

4. Persons who require adenoma surveillance: Nearly 25% of colonoscopies are performed for periodic re-examination (i.e., surveillance) of persons who have had 1 or more adenomas removed. Sensible management of surveillance is particularly important to Medicare beneficiaries, for whom the benefits of surveillance and removal of small adenomas in particular may be much smaller because of less remaining life to prolong. The principle of "age to stop" or "age to become less aggressive" for cancer detection is well-established: For prostate cancer screening, the U.S. Preventive Services Task Force has recommended against doing it for men age 75 or older, based on consideration that the harms of screening outweigh the benefits. (6) Since the yield (and thus, benefit) of surveillance colonoscopy is generally lower than screening colonoscopy and since the risk of major complications from colonoscopy increases with age (7), the risk-to- benefit ratio, especially for elder patients, becomes questionable. As in prostate cancer screening, a case can be made for an older age at which to stop screening altogether and, in fact, was made by the U.S. Preventive Services Task Force, which recommended that screening not be offered to persons aged 85 years or older. (8) Similarly, a case could be made that finding small polyps is less important in older persons, so that, even if found by CTC, they might be left alone. While it is widely assumed that finding and removing small polyps in younger persons is important, the benefit has not been quantitatively assessed. In this setting, use of CTC in surveillance among elderly persons - to look mainly for large polyps or early cancer - might be appropriate. Using CTC to select persons with large polyps for subsequent colonoscopy seems to make sense, as it would decrease the number of elders for whom the risks may outweigh any benefit. Elders who have no polyps on a high-quality CTC could forego colonoscopy. Elders with 1-2 small polyps could be given an option of no further follow-up, CTC surveillance at some point, or colonoscopy, depending on age, comorbidity, and preferences. The goal here is to decrease the number of elders undergoing surveillance colonoscopy, who stand to gain very little or nothing from it, and who are at relatively high-risk for major complications and procedure-related morbidity. (7) One last word regarding this subgroup: the model that was used to inform the USPSTF (and thus, CMS) assumed that once a patient had a screening colonoscopy, they would continue to have either screening or surveillance colonoscopy until age 80. (9) We believe that a quantitative analysis that considers the benefits, risks, and costs of CTC and perhaps other subsequent tests following initial colonoscopy would be both very appropriate and potentially useful for informing policy, particularly for elder patients.

5. Persons who prefer CTC. While the USPSTF decided (and CMS concurred) that there was no clear evidence that adoption of CTC would increase the number of persons receiving screening, it seems clear that some persons may still prefer CTC to other tests. CMS should consider making CTC available for those persons who refuse to undergo CRC screening with any of the established tests and strategies. Nearly 40% of adults who require CRC screening are not current or have never had any screening. (10) This might be one indication where the cost to CMS could perhaps be defrayed by a higher copayment, reflective of patient preference.

6. Persons in whom colonoscopy cannot be done. For persons in whom total colonoscopy is not feasible, CTC might be useful; for example, the case where an obstructing lesion precludes safe passage of the colonoscope to the cecum. This is a scenario for which a barium enema has been used when total colonoscopy is intended but could not be achieved. Indirect evidence suggests that CTC is much better than barium enema for identifying large polyps (11), it would seem to make sense to approve CTC for this indication.

We suggest that, for these specific indications, it makes good clinical sense to consider use of CTC. In order to collect additional clinical data to quantify the value of CTC, we suggest that data might be collected in much the same way that post-marketing surveillance is done following approval of a new drug to look for rare but clinically important adverse drug effects.

Thomas F. Imperiale, MD
Indiana University, Indianapolis, IN

David F. Ransohoff, MD
University of North Carolina, Chapel Hill, NC

REFERENCES
1. Graser A, Stieber P, Nagel D, et al. Comparison of CT colonography, colonoscopy, sigmoidoscopy and faecal occult blood tests for the detection of advanced adenoma in an average risk population. Gut 2009; 58:241-48.
2. Sackett DL, Starus S, Richardson WS, et al. Evidence-based medicine. How to practice and teach EBM. San Diego: Harcourt-Brace, 2000.
3. Pietra N, Sarli L, Costi R, Ouchemi C, Grattarola M, Peracchia A. Role of follow-up in management of local recurrences of colorectal cancer. Dis Colon Rectum 1998; 41:1127-1133.
4. Secco GB, Fardelli R, Gianquinto D, Bonfante P, et al. Efficacy and cost of risk-adapted follow-up in patients after colorectal cancer surgery: a prospective, randomized and controlled trial. Eur J Surg Oncol 2002; 28(4):418-423.
5. Jeffery M, Hickey BE, Hider PN. Follow-up strategies for patients treated for non-metastatic colorectal cancer. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD002200. DOI: 10.1002/14651858.CD002200.pub2.
6. U.S. Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2008;149(3):185-91.
7. Warren JL, Klabunde CN, Mariotto AB, et al. Adverse events following outpatient colonoscopy in the Medicare population. Ann Intern Med 2009 (in press)
8. U.S. Preventive Services Task Force. Screening for colorectal cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med 2008;
9. Zauber AG, Lansdorp-Vogelaar I, Knudsen AB, Wilschut J, van Ballegooijen M, Kuntz KM. Evaluating test strategies for colorectal cancer screening: a decision analysis for the U.S. Preventive Services Task Force. Ann Intern Med 2008; 149: 659-669.
10. Smith RA, Cokkinides V, Brawley OW. Cancer screening in the United States, 2009: a review of current American Cancer Society guidelines and issues in cancer screening. CA Cancer J Clin. 2009 Jan-Feb;59(1):27-41.
11. Winawer SJ, Stuart ET, Zauber AG, Bond JH, et al. A comparison of colonoscopy and double-contrast barium enema for surveillance after polypectomy. National Polyp Study Work Group. N Engl J Med 2000; 342:1766-1772.

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Re: NCA for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N); Comments on Proposed Denial of Coverage

Dear Mr. Larson:

The recent CMS proposed denial of coverage for CT Colonography (CTC) is based upon a flawed comparative premise and demonstrates an incomplete understanding of the field of colorectal cancer (CRC) screening. In addition there are data input flaws that invalidate the cost-effectiveness analysis, and several misconceptions related to purported 'potential harms' of CTC that have also confounded the USPSTF in their analyses.

The proposed denial, if finalized, would deal a major blow to America's effort to eradicate the most preventable of the deadly cancers, Colorectal Cancer (CRC), and would do a major disservice not only to America's seniors, but to all Americans eligible for CRC screening.

A Flawed Comparison

The flawed comparative premise relates to the question: 'how does CTC compare with the current best screening option: optical colonoscopy (OC)'? The more appropriate comparison would have been: 'how does CTC compare with the best alternatives to OC?' This more appropriate comparison would have clearly yielded an approval for CTC on all counts.

The goal of introducing CTC for CRC screening is not to replace or to challenge OC as the dominant screening test, but rather to provide an acceptable option for those patients who cannot undergo or refuse to undergo OC screening. The more appropriate technology assessment would have been to evaluate how CTC compares to the four alternatives to OC, namely FOBT, Flex Sig, and DCBE, and no screening at all.

Consider: Comparing CTC only to OC fails to recognize the well-established fact that more than 50% of Americans have not, cannot, or will not receive OC screening. Therefore, 50% or more of individuals will be screened, not with OC, but with one of these alternatives to OC”and by most commonly the worst option: no screening at all. Because of the long-standing low screening compliance with OC, OC can never be the complete answer to CRC screening. Since CTC (Sensitivity 85-90%) is an overwhelmingly better screening test than FOBT (10-20%), Flex Sig (45-55%), DCBE (50-60%), or No Screening (0%), this more appropriate technology comparison would have clearly yielded a strong endorsement for CTC.

By failing to recognize this distinction, CMS is sending the message that it is satisfied with the 50% CRC screening rate accomplished by OC alone. The lack of recognition of this reality is a tragedy for all Americans.

Flawed Data Inputs:

The cost-effectiveness analysis of CTC by Zauber, et. al. was flawed and biased by a major data input error: the cost input for OC. When CMS provided the OC cost inputs for OC, it provided the 80% cost of in-office endoscopy: $497.59. In providing this number, CMS failed to recognize or chose to ignore the fact that the majority of Medicare screening OCs are done in more costly places of service, namely licensed ASCs and even more costly hospital-based endoscopy units. Furthermore, it failed to recognize that a small but significant significant number of these cases are done with the assistance of propofol anesthesia (requiring anesthesiologist services), adding an additional cost to the screening.

Other Concerns

Further concerns over three issues 1) radiation exposure, 2) cost and untoward effects resulting from extracolonic findings, and 3) whether the investigational results be replicated in non-investigational situations appeared to negatively impact the CMS proposal not to cover CTC. Allow me to address these concerns in turn.

Radiation Concerns

While the concern over radiation exposure with CT scanning, including CTC, remains unproven, theoretical, and likely 'unprovable', the USPSTF had no such concern when recommending DCBE as an acceptable screening test as recently as the previous update in 2002. DCBE has been shown to have a higher total radiation dose than the current low-dose CTC protocols[i] [ii]. While DCBE was quietly dropped from the 2008 USPSTF recommendations, it remains an approved and reimbursed screening test with Medicare.

If CMS were truly concerned about the radiation risk of CTC and its role in the 'I' rating from USPSTF, then the logical extension of that concern would be to drop DCBE from its list of approved CRC screening tests.

Further, the concern surrounding excessive radiation exposure is primarily voiced in relation to children and young adults who have many decades for this radiation to cause problems. Even the most vociferous of the 'radiation damage' advocates concede that 2-4 CT colonographys after age 50 has no discernable impact. The less than 5 mSv per exam is an amount the Health Physics Society considers a risk that is either nonexistent or "too small to be measured".[iii]

Extracolonic Findings

The cost of extracolonic findings on CTC has been shown to add $20-30[iv] [v] to the overall cost of each study. A CTC is not the same as an abdominal CT. Its lower radiation dose does not allow small abnormalities to be found and therefore be misdiagnosed in the abdomen. When found, these extracolonic findings are not uncommonly shown to be important serendipitous findings. In our center, approximately 1% of our patients have been found to have resectable abdominal cancers, aneurysms, and other curable life-threatening abnormalities that have potentially saved the patient's life, not to mention the healthcare dollars saved by early diagnosis and prevention. Further, CTC has now been shown to be an effective screening test to assess bone mineral density (BMD) to diagnosis osteoporosis,[vi] and to screen for aortic aneurysms.

CTC is not only a highly sensitive test for CRC/polyps, but can simultaneously screen for BMD, aortic aneurysms, and early abdominal cancers. With experienced CTC readers, the extracolonic findings are a benefit, not a detriment.

More than 80% of patients who chose CTC can be screened with the non-invasive, sedation-free test, without the need of the more expensive and invasive OC as CTC findings may be negative.

Over 45% of the patients that have been screened with Integrated Virtual Colonoscopy report that they would not have been screened without its availability.[vii] CTC is not replacing OC; it is augmenting OC, and getting many more Americans off the screening sidelines.

Conclusion:

The result of the flawed NDA process by CMS if finalized would deal a major blow to the preventive health not only to America's seniors, but to all Americans of CRC screening age. Despite the best efforts of America's healthcare professionals, more than 50% of eligible Americans have not, will not, or cannot be screened by OC. This NCA proposed denial, if finalized, sends the message that CMS is unmoved by the tragically low CRC screening rate in this country, and is willing to place the agenda of select interest groups over President Obama's call for a move towards prevention-based, rather than illness-based healthcare.

Conversely, in multiple clinical programs providing VC services, patients are demonstrating that the availability of VC has drawn them 'off the screening sidelines' and into a highly-sensitive and patient-friendly modality of screening.

A final denial of coverage for CTC would not restrict only the access for America's seniors to this patient-friendly screening test, but may also impact the coverage decisions made by commercial and other governmental insurance programs. How can CMS stand idly by while 50,000 Americans continue to die every year from CRC, while 50% of Americans continue to remain unscreened? If finalized, this decision would yield a tragic policy formulated from a flawed NDA process.

In a healthcare world full of tough decisions and needed reform, the decision to cover CTC for CRC screening should have been an easy one. Unfortunately, CMS got it wrong. Please do the right thing for America's seniors and all Americans of CRC screening age: reverse the NCA decision and cover seniors for life-saving CTC, a test that will allow millions of additional Americans to be screened.

Nikhil Inamdar, MD

[i] Computed Tomography Colonography: The Future of Colon Cancer Screening M Fraser-Hill, MDCM, C

Walsh, et. al. Vol 59, No 4, October 2008

[ii]Wall BF, Hart D. Revised radiation doses for typical x-ray examinations. Br J Radiol. 1997;70:437-439.

[iii] Radiation risk in perspective: position statement of the Health Physics Society. Adopted Jan. 1996. Revised August 2004. Mclean, VA. http://www.hps.org/documents/radiationrisk.pdf

[iv] Extracolonic findings at CT colonography: Evaluation of prevalence and cost in a screening populationGastroenterology 2003, Volume 124, Issue 4, Pages 911-916 T.GLUECKER

[v] Perry J. Pickhardt, Andrew J. Taylor. Extracolonic Findings Identified in Asymptomatic Adults at Screening CT Colonography. AJR 2006:186, 718-728

[vi] Abstract: http://rsna2008.rsna.org/event_display.cfm?em_id=6014550

[vii] Colon Health Center of Delaware: over 45% of the 500 patients screened with Integrated Virtual Colonoscopy report that they would have remained unscreened without the availability of VC. The other 55% simply preferred a non-invasive, sedation-free option. (unpublished data):

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March 5, 2009

Mr. William Larson, MA
Centers for Medicare and Medicaid Services
7500 Security Blvd.
Baltimore, MD 21244-1850

Re: NCA for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N); Comments on Proposed Denial of Coverage

Dear Mr. Larson:

The recent CMS proposed denial of coverage for CT Colonography (CTC) is based upon a flawed comparative premise and demonstrates an incomplete understanding of the field of colorectal cancer (CRC) screening. In addition there are data input flaws that invalidate the cost-effectiveness analysis, and several misconceptions related to purported “potential harms” of CTC that have also confounded the USPSTF in their analyses.

The proposed denial, if finalized, would deal a major blow to America’s effort to eradicate the most preventable of the deadly cancers, Colorectal Cancer (CRC), and would do a major disservice not only to America’s seniors, but to all Americans eligible for CRC screening.

A Flawed Comparison

The flawed comparative premise relates to the question: “how does CTC compare with the current best screening option: optical colonoscopy (OC)”? The more appropriate comparison would have been: “how does CTC compare with the best alternatives to OC?” This more appropriate comparison would have clearly yielded an approval for CTC on all counts.

The goal of introducing CTC for CRC screening is not to replace or to challenge OC as the dominant screening test, but rather to provide an acceptable option for those patients who cannot undergo—or refuse to undergo—OC screening. The more appropriate technology assessment would have been to evaluate how CTC compares to the four alternatives to OC, namely FOBT, Flex Sig, and DCBE, and no screening at all.

Consider: Comparing CTC only to OC fails to recognize the well-established fact that more than 50% of Americans have not, cannot, or will not receive OC screening. Therefore, 50% or more of individuals will be screened, not with OC, but with one of these alternatives to OC—and by most commonly the worst option: no screening at all. Because of the long-standing low screening compliance with OC, OC can never be the complete answer to CRC screening. Since CTC (Sensitivity 85-90%) is an overwhelmingly better screening test than FOBT (10-20%), Flex Sig (45-55%), DCBE (50-60%), or No Screening (0%), this more appropriate technology comparison would have clearly yielded a strong endorsement for CTC.

By failing to recognize this distinction, CMS is sending the message that it is satisfied with the 50% CRC screening rate accomplished by OC alone. The lack of recognition of this reality is a tragedy for all Americans.

Flawed Data Inputs:

The cost-effectiveness analysis of CTC by Zauber, et. al. was flawed and biased by a major data input error: the cost input for OC. When CMS provided the OC cost inputs for OC, it provided the 80% cost of in-office endoscopy: $497.59. In providing this number, CMS failed to recognize—or chose to ignore—the fact that the majority of Medicare screening OCs are done in more costly places of service, namely licensed ASCs and—even more costly—hospital-based endoscopy units. Furthermore, it failed to recognize that a significant number of these cases are done with the assistance of propofol anesthesia, adding an additional cost to the screening.

One example of this major oversight: The State of Virginia does not allow Medicare cases to be performed in the in-office setting, rather only in licensed ASCs and hospitals. The state also has strict CON requirements for approval of ASCs and subsequently, few ASCs exist in the state. Therefore, the overwhelming majority of screening OC performed on Medicare patients in the state of Virginia is done in the hospital setting, dramatically increasing the cost of screening OC in that state.

Other Concerns

Further concerns over three issues—1) radiation exposure, 2) cost and untoward effects resulting from extracolonic findings, and 3) whether the investigational results be replicated in non-investigational situations—appeared to negatively impact the CMS proposal not to cover CTC. Allow me to address these concerns in turn.

Radiation Concerns

While the concern over radiation exposure with CT scanning, including CTC, remains unproven, theoretical, and likely “unprovable”, the USPSTF had no such concern when recommending DCBE as an acceptable screening test as recently as the previous update in 2002. DCBE has been shown to have a higher total radiation dose than the current low-dose CTC protocols . While DCBE was quietly dropped from the 2008 USPSTF recommendations, it remains an approved and reimbursed screening test with Medicare.

If CMS were truly concerned about the radiation risk of CTC and its role in the “I” rating from USPSTF, then the logical extension of that concern would be to drop DCBE from its list of approved CRC screening tests.

Further, the concern surrounding excessive radiation exposure is primarily voiced in relation to children and young adults who have many decades for this radiation to cause problems. Even the most vociferous of the “radiation damage” advocates concede that 2-4 CT colonographys after age 50 has no discernable impact. The less than 5 mSv per exam is an amount the Health Physics Society considers a risk that is either nonexistent or "too small to be measured".

Extracolonic Findings

The cost of extracolonic findings on CTC has been shown to add $20-30 to the overall cost of each study. A CTC is not the same as an abdominal CT. Its lower radiation dose does not allow small abnormalities to be found and therefore be misdiagnosed in the abdomen. When found, these extracolonic findings are not uncommonly shown to be important serendipitous findings. In our center, approximately 1% of our patients have been found to have resectable abdominal cancers, aneurysms, and other curable life-threatening abnormalities that have potentially saved the patient’s life, not to mention the healthcare dollars saved by early diagnosis and prevention. Further, CTC has now been shown to be an effective screening test to assess bone mineral density (BMD) to diagnosis osteoporosis, and to screen for aortic aneurysms.

CTC is not only a highly sensitive test for CRC/polyps, but can simultaneously screen for BMD, aortic aneurysms, and early abdominal cancers. With experienced CTC readers, the extracolonic findings are a benefit, not a detriment.

Translation to Community Practice

Our company, Colon Health Centers of America, is dedicated to enabling major GI physician groups to replicate the investigational CTC model, and therefore incorporate “Integrated Virtual Colonoscopy” (IVC) into their existing suite of CRC screening services. IVC provides the patient the option for non-invasive, sedation-free CTC, followed immediately by same-day, same-prep OC for those patients with found polyps. Through this model, more than 80% of patients who chose CTC can be screened with the non-invasive, sedation-free test, without the need of the more expensive and invasive OC.

CHC America uses a hub and spoke CTC reading model, using teleradiology to send all the centers’ CTC studies into a centralized reading hub staffed by some of the most experienced CTC readers in the country. In this way, CHC America can create many community-based IVC centers while using only centralized, highly-experienced radiology readers. This model maximizes the sensitivity of the interpretations and minimizes the problem of over-called extracolonic findings.

Over 45% of the patients that have been screened with Integrated Virtual Colonoscopy report that they would not have been screened without its availability. CTC is not replacing OC; it is augmenting OC, and getting many more Americans off the screening sidelines.

Conclusion:

The result of the flawed NDA process by CMS—if finalized—would deal a major blow to the preventive health not only to America’s seniors, but to all Americans of CRC screening age. Despite the best efforts of America’s healthcare professionals, more than 50% of eligible Americans have not, will not, or cannot be screened by OC. This NCA proposed denial, if finalized, sends the message that CMS is unmoved by the tragically low CRC screening rate in this country, and is willing to place the agenda of select interest groups over President Obama’s call for a move towards prevention-based, rather than illness-based healthcare.

Conversely, in multiple clinical programs providing VC services, patients are demonstrating that the availability of VC has drawn them “off the screening sidelines” and into a highly-sensitive and patient-friendly modality of screening.

A final denial of coverage for CTC would not restrict only the access for America’s seniors to this patient-friendly screening test, but may also impact the coverage decisions made by commercial and other governmental insurance programs. How can CMS stand idly by while 50,000 Americans continue to die every year from CRC, while 50% of Americans continue to remain unscreened? If finalized, this decision would yield a tragic policy formulated from a flawed NDA process.

In a healthcare world full of tough decisions and needed reform, the decision to cover CTC for CRC screening should have been an easy one. Unfortunately, CMS got it wrong. Please do the right thing for America’s seniors and all Americans of CRC screening age: reverse the NCA decision and cover seniors for life-saving CTC, a test that will allow millions of additional Americans to be screened.

Respectfully submitted,
Mark J. Baumel, MD MS
President/CEO
Colon Health Centers of America, LLC
Box 854
Mendenhall, PA 19357

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CT Virtual colonoscopy fits the definition of a "screening" tool. In the setting of an asymptomatic patient of appropriate age, history, etc., it is a relatively low-cost non-invasive, proven effective method to exclude significant lesions of the colon - in addition to the fact that it can identify pathology outside the colon, within the region of examination.Several recent studies have attested to it''s effectiveness.There is certainly some "turf" concern within the colonoscopy community. There must, however, be some consideration for the additional costs, morbidity, recovery, etc., associated with the traditional endoscopic process.The biopsy issue is a minor one since the majority of screening exams are normal. With the cost savings, the addition of the minority of follow-up biopsy procedures can be justified.The CMS would do all involved a favor to reconsider a decision not to "cover" CT Virtual Colonoscopy.

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I have heard that Medicare just announced its intention to not cover virtual colonoscopies. I am [PHI Redacted] an advocate who believes this is a serious mistake.

Medicare coverage of traditional colonoscopy resulted in a tremendous increase in screening rates that has resulted in decreased incidence of and deaths from CRC. Far less effective screening methods are currently covered by Medicare. The virtual colonoscopy is an important tool in the menu of screening options and will prevent many cases of polyps developing into cancer.

Please re-consider your decision in this matter.

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I believe that CTC should be an alternative to colonoscopy. The following research indicates that it is an effective alternative:

Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]Colorectal cancer screening saves livesCoverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical ColonoscopyVirtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

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This seems an unfortunate decision for many patients who will benefit from Colorectal Cancer screening. There is published evidence that CTC is at least as good as Endoscopic Optical Colonography (EOC). NEJM articles have indicated CTC can be superior to EOC. There are clearly examinations that are currently covered such as Barium Studies and Sigmoidoscopy which are clearly inferior to CTC.

Some patients delay EOC out of fear and would welcome the opportunity for CTC screening. Our department receives multiple requests for this exam.

Difficult EOC exams often result in Barium enemas. I have performed many such BE exams under difficult circumstances where I knew the result would be less than perfect. What value is created when a quality exam is replaced by one that is inferior. CTC is superior to Barium Enema. We all know colorectal cancer screening saves lives. If the goal is to save lives CTC should be covered.

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I strongly oppose the proposed CMS plan to deny coverage for virtual colonoscopy. For the following reasons:

Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]

Colorectal cancer screening saves lives

Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy

Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

Thank you for your consideration

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Please consider coverage of CT virtual colonography as a method for screening for colon cancer. [PHI Redacted] I am aware of numerous studies on the internet verifying the effectiveness of this type of examination and its superiority over lesser tests which remain covered ( fecaoccult blood, flexible sigmoidoscopy and Barium enema ). Numerous friends of mine have also avoided screening up to this point for similar reasons. I believe coverage of this examination will lead to more people screened, more cancers prevented and more lives saved. Thank you for your consideration.

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I would strongly urge CMS to consider Medicare coverage for Virtual Colonography procedures. I am aware of numerous people who have continued to avoid optical colonoscopy due to the possible risks of perforation, the need for anesthesia and the loss of work time to have the procedure performed. [PHI Redacted] However, many individuals may not have that luxury. Increased screening will lead to more lives saved and possible lowered costs in treating colorectal cancer. I believe that more individuals will be screened and more concers discovered with use of this modality, which has shown proven effectiveness in the ACRIN trial and in numerous published studies ( Johnson, NEJM 2008, Kim, NEJM 2007, Pickhardt, NEJM 2003 ) as examples. It makes no sense to deny virtual colonography with its proven efficacy and yet still cover flexible sigmoidoscopy and Air contrast Barium enema,which are far inferior examinations. Please consider this test in the light of the lives it will potentially save.

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[PHI Redacted] was diagnosed with Stage IV colon cancer last year and is now struggling for his life and will probably not make it past the 5 year mark. One of the reasons he did not get screened for colon cancer is that the procedure was not covered by insurance. Although I do not know his current medical bill total, I''m sure it''s close to $100,000 or more. If he''d been able to cover the small cost of screening, his family would not be having to worry about covering his medical bills long after he dies. And he probably would have had a much better chance of survival had they caught this cancer earlier.

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I am a private physician in Internal Medicine and take care of about 3500 patients. Screening for colon cancer is stressed but completed at a low rate due to preparation, anesthesia, risk of perforation and day lost from work with a driver required. I have found CTC a more acceptable option [PHI Redacted]. With an experienced reader and trained technicians this test is easy to perform and all of the above bypassed except the prep. We do them in the AM and if something found we call the patients to come back before noon and have the polyp or lesion removed. THis may occur in 1 out of 19 patients. I am more satisfied with all the other information I get about the abdomen which in some cases have saved the patients life. I do not stress the test for the paracolonic findings but what a bonus. I can''t believe that medicare pays for sigmoid and occult blood which are far less sensative and not CTC. I also did the math and at a cost saving of about $1000/exam with one in 19 needing an optical analysis the government would save money and isn''t that refreshing.

I encourage the committee to consider these and the ease of acceptance to the patient for reducing colon cancer if CTC is approved. My patients will often pay for it knowing it is easier and lets them return to work the same day and no driver needed.

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Colorectal Cancer is one of the leading causes of death in the U.S. [PHI Redacted] CTC offers a low cost, now low dose and non-invasive method to screen for this disease compared to the alternatives.

Using our most advanced technology, CT, to help fight this disease only makes sense and we should open up this technology to all so that we can utilize all early detection methods possible.

Similar to the fight against Breast cancer, Colon cancer can be beat.

Please see other points below.

Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200].

Colorectal cancer screening saves lives.

Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy.

Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed.

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I am a Gastroenterologist, I believe in colonoscopy and I spend a lot of my time doing screening colonoscopy. I was disappointed to learn of the proposal to not include CT colonography as an acceptable and reimbursable option for colon cancer screening. I think this is a mistake. I would endorse Medicare reimbursement for CT Colonography for the following reasons.
1. It is now well established that CT colonography, if done by well trained radiologists with state of the art equipment, is a highly sensitive test for detection of both cancer and significant (>6mm in size) adenomas of the colon; studies have shown that it is as good as optical colonoscopy for detection of these lesions. The concern that CT colonography would be more likely to miss "flat" adenomas is not proven and none of the well done comparative studies have shown that CT colonography has a higher miss rate of any type of polyp (be it flat or not) 6mm in size or larger. Although CT colonography does not detect diminutive (< 6mm in size)adenomas as well as optical colonoscopy, the risk of advanced histology in these lesions is low and we know that optical colonoscopy is not very good for these lesions either. We don''t get too concerned about the fact that optical colonoscopy misses about 25% of dimnutive adenomas. Furthermore other screening tests such as stool tests or flexible sigmoidoscopy or barium enema that Medicare does pay for have much higher miss rates for diminutive polyps.
2. The concern about variable quality of CT colonography in the community is real but it is equally true or even moreso for colonoscopy. It is well established that colonoscopy quality as measured by cecal entubation rates, withdrawal times, adenoma detection rates and/or complication rates varies widely among endoscopists so that high quality screening is required for both CT colonography and optical colonoscopy.
3. The concern about the cancer risk of radiation exposure with CT colonograpny is appropriate but theoretical (back-extrapolated from exposure data to much higher doses or radiation) and is much less than the radiation exposure of a barium enema which is covered as a screening option by Medicare.
4. The concern about extraintestinal findings possibly leading to higher costs without better health care is also a legitimate concern but it is uncertain whether the overall balance of these effect is harmful or beneficial nor what the magnitude of the effect would be in practice. A similar argument is not made for the unintended consequences of other screening tests like false positive fecal occult blood tests that lead to negative colonoscopies which may be followed by upper endoscopy and/or capsule endoscopy to look for a source of the blood in the stool. I think that issue of extraintestinal findings could be minimized by guidelines about which lesions should be followed up and which workups Medicare will pay for.
5. The inablity to biopsy or remove lesions is a real disadvantage of CT colonography so it would not be a good choice in a population that would have a high pretest probability of having a polyp seen but there are populations that have a low risk such as those with a negative previous colonoscopy where CT colonography would be a good and cost effective alternative to colonoscopy.
6. CT colonography has some distinct advantages over optical colonoscopy in that it is less expensive, associated with less of a risk of both the procedure and the sedation and is much more convenient for the patient. These advantages should compensate for some of the concerns raised above.

Overall, it seems to me, that CT colonography is being held to a higher standard than other screening tests and I would urge you to reconsider your proposed ruling. Thanks very much for allowing comment and for taking this note into consideration.

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Dear Dr. Phurrough,

I am writing as a concerned citizen more so than experienced reader of ct colonographic exams. [PHI Redacted] both died in the last three years as a result of metastatic colon carcinoma. I strongly believe in screening and am convinced that the ct approach is valid and valuable to individuals over the age of 50 as a screening tool.

[PHI Redacted]

The article by Kim and Pickhardt in NEJM in 2007 with over 3000 patients in both the optical and ct groups was reviewed by your staff, but they left out the fact that there were no perforations in the ct group and 7 in the optical group. Your review did not comment on whether or not those 7 perforations were with or without biopsy. I realize there have been some studies with reports of perforation with ct colonography, but suspect with proper technique and C02 insufflation this should be significantly less than optical. It was 0/3163 ct studies in the University of Wisconsin group which does excellent work.

I have been reading these studies for about 7 years with the Viatronix software. When the exam is well prepared and distended, a true polyp is conspicuous. The number of cases going to optical is about 5% in my experience.

I realize we can miss a flat lesion, but so can optical. I can identify the back of the folds better than optical. The speed can be varied with both ct and optical and we know that an experienced and careful operator with optical will have a significantly higher rate of polyp detection than one who rushes or is inexperienced. Although the "gold standard", optical is operator dependent, has risk of perforation (particularly in inexperienced hands) and there is an economic incentive to remove the small (4-6mm) lesions that have a insignifcant incidence of atypia or neoplasia.

We should increase the number of patients undergoing screening. The ct approach is appropriate for a screening exam: similar sensitivity, specificity and accuracy for significant lesions to optical, safe (extremely low risk for perforation), and more tolerable than the standard optical prep with no need for conscious sedation. The call back rate and rate of referral to optical is acceptable in my experience. The risk of carcinoma from one to three of these ct exams beginning at the age of 50 is negilible.

The objections of the gastroenterologist''s and their societies seem self serving at best. We should try everything possible to get more people into screening and the incidental findings from the body ct interpretations do not result in signficant increase in costs and additional exams. I have discovered a number of carcinoma''s (particularly renal cell) over the years.

I stongly recommend screening ct colonography to be considered for apporval. I appreciate your group''s literature review and analysis, but suspect there may be underlying political and non-scientific pressure to undermine this process. I have no economic interest in Viatronix or other commercial companies and only get paid a fee for service for interpretation. Thank you for your time and consideration in this important matter.

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TO WHOM IT MAY CONCERN AT CMS:

For once, can decisions be made without the politics of enriching special interst groups ie. (GI DOCTORS), over the public''s well being!!!

1. The American Cancer Sosciety has endorsed the virtual colon fro colon screening in March 2008 after the studies confirming its efficacy was overwhelming.

2. 92% of all optical colonoscopies fail and this number becomes suspect when its now known that conventional colonoscopy was not associated with reduction in deaths from right sided colon disease as it is on left sided disease, as only 72% to 85% of the colon is seen.

3. The GI doctors are afraid that it will impact their income yet when less than 40% of the public ever have an optical colonoscopy perhaps from fear of having their colons perforated, and knowing that colon cancer is slow growing, that they might actually see their incomes go up by finding more disease inside and out of the colon that need to be addressed.

4. Finally perhaps, President Obama was just stroking the public about hsi intentions of having more preventive measures taken within healthcare. It shard to make good decisions based on facts, when your mind is already made up.
Tom Haley

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In “Proposed Decision Memo for Screening Computed Tomography Colonography (CTC) for Colorectal Cancer (CAG-00396N), the proposed decision memo states that the analytic framework for screening tests involves consideration of several different factors compared to diagnostic tests and therapeutic interventions. CMS states that “the evaluation of screening tests has been standardized and accepted” and utilizes as a framework the criteria set forth by Cochrane and Holland in 1971.

I will utilize the criteria set forth in CMS’ own decision memo to refute the decision that CMS has made regarding its decision not to cover Virtual Colonoscopy as a screening modality.

I. Simplicity: “In many screening programmes more than one test is used to detect one disease, and in a multiphasic programme the individual will be subjected to a number of tests within a short space of time. It is therefore essential that the tests used should be easy to administer and should be capable of use by para-medical and other personnel.”

Virtual colonoscopy is clearly no more difficult, and in many ways, simpler to perform than traditional, optical colonoscopy. Virtual colonoscopy is typically performed by a technologist “para-medical personnel”, and is much easier to administer than an optical colonoscopy, which requires, a gastroenterologist and anesthesiologist, as well as what essentially amounts to an operating room-type set-up.

II. Acceptability: “As screening is in most instances voluntary and a high rate of co-operation is necessary in an efficient screening programme, it is important that tests should be acceptable to the subjects.”

According to Svensson, et al “Patient Acceptance of CT Colonography and Conventional Colonoscopy: Prospective Comparative Study in Patients with or Suspected of Having Colorectal Disease”, Radiology 2002, 111 patients underwent virtual colonoscopy and optical colonoscopy and were administered a self-assessed questionnaire after both procedures. 82% who reported a preference preferred virtual colonoscopy. 69% considered optical colonoscopy more difficult. 57% reported virtual colonoscopy as not painful compared with 26% for colonoscopy. Laghi, et al in the American Journal of Surgery detailed similar findings, with far more (32% vs. 2 %) optical colonoscopy patients detailing a high amount of discomfort during their exam than a virtual colonoscopy. Clearly, patients have indicated their acceptance of Virtual colonoscopy.

III. Accuracy: “The test should give a true measurement of the attribute under investigation”The sensitivity of virtual colonoscopy has been demonstrated to exceed optical colonoscopy for polyps greater than or equal to 10 mm in size (94%-88%) and between 8-10 mm (94%-92%). Below 8 mm, virtual colonoscopy detects 89% of polyps as opposed to 92% for optical colonoscopy.

IV. Cost: “The expense of screening should be considered in relation to the benefits resulting from the early detection of disease, i.e., the severity of the disease, the advantages of treatment at an early stage and the probability of cure.”

The expense of screening with virtual colonoscopy is less than that of optical colonoscopy, which requires expenditure on an anesthesiologist in addition to a gastroenterologist, with the likelihood of unnecessary costly biopsies performed on small lesions less than 6 mm obviously greater for optical colonoscopy than that of virtual.

There is no disease that benefits more greatly from early detection than colon cancer, as colon cancer is one of the very few diseases where a benign lesion will in its life-cycle become malignant. Lung cancer is generally always malignant or benign, and therefore an argument can be raised against the efficacy of early screening; no such logical argument can be made in the setting of colon cancer since early, benign polyp detection may prevent a malignancy from ever occurring.

V. Precision: “The test should give consistent results in repeated trials.”

Numerous trials have been performed consistently detailing similar sensitivity and specificity results that have been published in esteemed gold-standard peer-reviewed publications such as the New England Journal of Medicine (Pickhardt, et al “Computed Tomographic Virtual Colonoscopy to Screen for Colorectal Neoplasia in Asymptomatic Adults”, 2003; Kim, et al “CT Colonography Versus Colonoscopy for the Detection of Advanced Neoplasia”, 2007.), with many additional research papers detailing similar consistency and precision.

VI. Sensitivity. “This may be defined as the ability of the test to give a negative finding when the individual screened does not have the disease or abnormality under investigation.”

As detailed above in item III, the sensitivity of Virtual Colonoscopy is comparable and may exceed that of optical colonoscopy. In comparison to the additional CMS-approved screening tests such as the Fecal Occult Blood Test, Flexible Sigmoidoscopy, and Barium Enema, the sensitivity of Virtual Colonoscopy is undeniably far, far in excess of these exams (75% for Barium Enema; virtually 0% for Flexible Sigmoidoscopy for an ascending colonic lesion).

VII. Specificity. “This may be defined as the ability of the test to give a negative finding when the individual screened does not have the disease or abnormality under investigation.”

The specificity of Virtual Colonoscopy at 10 mm has been documented as high as 96%, and remains above 90% for lesions greater than 6 mm. With the advent of contrast enhancement through Gastroview and Tagitol, the specificity continues to rise for smaller lesions.

Utilizing the framework set aside in CMS’ own decision memo, I find no logical reason for the recent decision of CMS to not reimburse Medicare beneficiaries for Virtual Colonoscopy screening. I could apply these seven stated items to argue why studies which are currently reimbursable for screening should NOT be reimbursed since they do not fulfill Cochrane and Holland’s screening criteria (flexible sigmoidoscopy, fecal occult blood test, barium enema). But by every measurable and unbiased criterion, Virtual Colonoscopy fulfills Cochrane and Holland’s screening test dictum which is utilized as the gold-standard measurement of choice in the Proposed Decision memo.

It is with great concern for the 60% of Americans who do not avail themselves of optical colonoscopy as a screening methodology that I respectfully ask CMS to reconsider the recent Proposed Decision Memo for Screening Computed Tomography Colonography for Colorectal Cancer during this commentary period.

Sincerely,

Dr. Eric S. Schnipper

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Based on multiple scientific articles, CTC has been shown to be a very accurate screening exam, with less cost and less risk than optical colonoscopy. It is the many millions of Americans, especially those who opt out of optical colonoscopy (half of the screening population) who would benefit from this exam. Here are some articles that state benefits of CTC.

Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]

Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

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Colorectal cancer screening saves lives Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy.

CMS should cover virtual colonoscopy because multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]. In addition,Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]. Finally with relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

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In the past year or so I have been speaking with people that have serious concerns with traditional colonoscopy protocol of receiving anesthesia. I was also surprised to hear patients are educated enough to understand the risks of bowel perforation. These concerns keep patients from having traditional colon screening. They instead would like to have a virtual colonoscopy but do not want to pay out of pocket which now has them avoiding colon screening totally. I was hoping that in 2009 this option would be available for these particular patients but it isn’t. After reading the reasons why reimbursement is being denied for screening I am a little confused. The first reason is that I was under the impression the anesthesiologist’s fee is more expensive than the actual reimbursement for VC exams. Wouldn’t a VC exam be cheaper? Is it only considered accurate when a GI doctor has an incomplete colonoscopy? Barium enemas were the alternative to incomplete colonoscopies. Now we have better technology. American Cancer Society feels that VC exams are accurate.I understand the concerns of possible polyp visualization on a VC exam but I have seen more GI doctors send their patients for VC exams because of incomplete colonoscopies than a radiology office sending their VC patients to GI doctors for polyp removal. What about VC’s ability to visualize the external walls of the colon as well as the internal walls? This to me is a tremendous benefit. I can only hope this is re-evaluated in the near future.

Thank you,

Dom

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The AGA has stated there are not enough GI specialist to perform all the needed colonoscopy screening exams in our aging population. Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] Colorectal cancer screening saves lives Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72] With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

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I should first disclose that I am a radiologist and am in charge of virtual CT colonography (CTC or VC) at the University of California, Los Angeles David Geffen School of Medicine. I also perform air-contrast (or double-contrast) barium enemas (ACBE or DCBE) for the screening of colon polyps and cancer. I do not advocate for CTC over conventional colonoscopy as the primary method of colon polyp and cancer screening. However, for a subset of the population it is the best choice, as it is safer for patients with bleeding disorders or who should not be sedated. Multiple studies have shown CTC to be equal in sensitivity to conventional colonoscopy, and have shown DCBE to be inferior to CTC (see Am J Roentgenol. 2008 Feb;190(2):374-85) yet we still reimburse DCBE, but not CTC, for colon cancer screening. We currently screen less than half of our target population, which likely results in colon cancer remaining the second leading cause of cancer death in this country. Please consider adding CTC for colon cancer screening with appropriate training and equipment requirements similar to mammography.

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I am writing to voice my strong disagreement with Medicare’s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American’s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the “screening sidelines”? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

Respectively submitted,

Rita Baumel

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To whom it may concern:

Although colon cancer screening is well documented to save lives, only a minority of eligible patients undergo regular colon screening. There is a significant need for a safe, accurate, and well tolerated test to supplement our current screening strategy.

Numerous studies have shown that CT colonography is an effective screening examination for colon cancer, similar in effectiveness to optical colonoscopy.(1,2,3) In addition, it is clearly more sensitive than air contrast barium enema or flexible sigmoidoscopy, both of which are already covered by Medicare.(4,5)

CT colonography is a safe, well tolerated procedure. The rate of colonic perforation with CT colonography is lower than with optical colonoscopy, and the rate of clinically significant perforation with bad outcome is even lower.(6) With the rates of colon cancer screening estimated from 15-40%, our number one priority should be to screen more eligible patients. CT colonography is a well tolerated, patient friendly test that will directly result in lives saved through expansion of the screened population. I urge you to reconsider your decision against coverage of CT colonography and to decide in favor of expanded screening options for Medicare patients.

Sincerely,

Todd Tibbetts, M.D., Ph.D.

1 Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200.
2 Johnson CD, et al. N Engl J Med 2008;359:1207-17.
3 Kim, DH, et al. N Engl J Med 2007;357:1403-12
4 Imperiale, TF, et al. N Engl J Med 2000;343:169-74.
5 Winawer SJ, et al. N Engl J Med 2000;342:1766-72.
6 Pickhardt, PJ. Radiology 2006; 239:313-316.

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Preventing or treating early colon cancer is good for the individual and Society.

Sceening as inexpensively and safely and least invassively is ideal.

Colonoscopies are expensive to the patient and society. Patients and families take time off for work. Many resources are utilized. There are complications.

CT Colonography solves many of these problems and costs and dangers.

However, it is disruptive technology. Many hospitals, outpatient colonoscopies centers, administrators, nurses, doctors make much money from colonoscopies. Therefore, there is undeserved opposition.

CT Colonography should be a procedure paid for by Medicare, however, it should be set up to avoid abuse for monetary gain.

Thank you.

David Marcus, MD
Board Certified Radiologist

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Kaiser Permanente Center for Health Research has just completed an evidence review and released findings that computed tomographic colonography (CTC) is just as effective as colonoscopy at detecting cancerous lesions, only it''s non-invasive. This method is simply a CAT scan so more people may be willing to be screened and therefore more cancers detected early on. In addition, the majority of healthcare costs come from treating chronic diseases including cancer, which is why preventive medicine is so important. Not only is it easier on our wallets as taxpayers, but also on our quality of life.

Please reconsider covering this type of screening for colorectal cancer that could help detect the cancer and ultimately save lives.

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I believe that the decision regarding screening colonography should be revisited in view of the following:

Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]

Colorectal cancer screening saves lives

Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

Please cover this important screening device. Sincerely, Dana Nelson

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CTC should be paid for by CMS for the following reasons:

1. The ability to find significant lesions isvirtually as good as colonoscopy.
2. The biopsy rate is significantly less.Therefore less cost to CMS.
3. Significant complications are significantlyless.
4. The number of significant lesions found elsewhere (cancers, aneuryisms, etc) is equal to the signicant complication rate of colonoscopy. Thus a significant side benefit.
5. Patients with countra-indications to colonoscopy need this as a viable alternative.
6. Some patients perfer CTC.
[PHI Redacted]

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Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] Colorectal cancer screening saves lives Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72] With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

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Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] Colorectal cancer screening saves lives Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72] With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

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HELLO, I AM A DIAGNOSTIC RADIOLOGY PHYSICIAN IN THE DC AREA. YOUR DECISION TO NOT COVER CTC IS WRONG AND WILL NEGATIVELY IMPACT ON THE ABILITY OF THE MEDICAL COMMUNITY TO PREVENT AMERICANS FROM DYING OF COLON CANCER. OF ALL THE CANCERS THAT EXIST, COLON CANCER IS ONE OF THE FEW GOLDEN OPPORTUNITIES THAT WE HAVE TO DETECT AND ELIMINATE THE DISEASE AT THE PRECANCEROUS STAGE, BEFORE IT EVEN BECOMES A MALIGNANCY. OPTICAL COLONOSCOPY (0C) IS OF COURSE EXCELLENT AS WELL, THOUGH NOT WITHOUT ITS OWN POTENTIAL ADVERSE COMPLICATIONS AND IMPERFECTIONS, WHICH HOPEFULLY YOU ARE AWARE OF. I WOULD IMPLORE YOU TO ALLOW COVERAGE FOR THE LIFESAVING TECHNOLOGY OF CTC WHICH SO MANY HARDWORKING RESEARCHERS HAVE SHOWN IN MAJOR PEER-REVIEWED MEDICAL JOURNALS TO BE HIGHLY EFFECTIVE IN DETECTING PREMALIGNANT AND MALIGNANT LESIONS IN THE COLON.

SINCERELY,
IAN PETERKIN M.D.
WORK 202 223-9723 option9

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As a radiologist, I have extensive experience in performing air contrast barium enema exams and CT colonography. There is no question that CT colonography is a much more sensitive and reliable exam for detecting polyps/colorectal cancer. I believe it is a mistake not be using CTC as a screening tool for colorectal cancer. There are many patients who would have CTC but are unwilling to undergo colonoscopy or barium enema. We need to focus on getting as many at risk people in the population to have effective colon cancer screening of some sort; CTC is a highly effective option.

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I lost a PHD-well educated [PHI Redacted] who feard having a colonscopy and she died before the age of 50 due to colon-rectal cancer. If a virtual colonoscopy had been availible I am sure she would have had herself screened and might be alive today. As you surely know, there are multiple studies that have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]

Colorectal cancer screening saves lives Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy

Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72] With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

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There is strong research showing that CTC is a minimally invasive and cost effective method of detecting and staging colon cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]. Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72].I believe that this effective, patient-friendly screening test will save lives and is desperately needed.

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[PHI Redacted] had the traditional colonography several years ago. He had to take off worrk and so did I in order to take him for this procedure. It''''s at least a half day and usually more depending on if your appointment time on time. This year he chose to have the virtual colonography and had a 7:30 a.m. appt. and was finished in 30 minutes and was able to go back to work. He did NOT have to be put to sleep and a recovery period. I didn''''t have to take off work for this "recommended" and repeated procedure. The Virtual colongraphy was much easier and quicker for both of us and we chose to pay for this because it was a lot cheaper than if we processed the traditional colonography through our insurance and our remainder payment. I think you should consider the patients ease, convenience and comfort. The pictures we received showed the colon and same pictures he had done a few years ago with the traditional procedure. We should be looking out for patient health and well being and not always the traditional way. Technology is and has changed.

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I believe that CTC would be a valuable technology for the screening of Colorectal cancer. It has been proven to provide a strong sensitivity and is less invasive that OC. Newer technologies such as CAD should also help in standardizing the performance of radiologist so that they would perform at the level of experts. I believe that, with future preparations that will not be cathartic, it will be possible for the patient not to loose a whole day to get receive OC rather, could follow an appropriate diet and then schedule a visit for 1 hr or so and head back to work. It would allow to perform much more screening and catch potential lesions early.

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Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]

Colorectal cancer screening saves lives

Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy

Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72] With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

Virtual colonoscopy also has the potential to demonstrate spread of disease with in the abdomen at the same time with out further testing.

Much less expensive than traditional colonoscopy as we are trying to lower the cost of health care.

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Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]

Colorectal cancer screening saves lives Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy

Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72] With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

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re: CMS Virtual Colonoscopy (CTC) coverage decision.

Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]

In addition, in research published by PJ Pickhardt in 2007, CTC and OC screening resulted in similar detection rates for advanced neoplasias while significantly less polypectomies were required in the CTC arm to achieve these results. In addition, there were no serious adverse events related to the CTC examination or subsequent therapeutic OC as opposed to the primary OC arm where there was 0.2% colonic perforation rate. (7 patients, 4 of which required surgical repair)[Pickhardt, PJ, et al. N Engl J Med 2007;357:1403-1412]

Colorectal cancer screening saves lives and coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy.

Virtual Colonoscopy also is much more sensitive than other screening methods which are already covered by Medicare, such as double contrast barium enema and flexible sigmoidoscopy. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72] This research absolutely parallels my own personal experience. If I or a relative needed to be screened, I would strongly recommend a CTC examination over these other less sensitive covered Medicare exams.

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As the Associate Medical Director for Quality and Informatics at Group Health Cooperative, I am heartened that CMS has set a reasonable bar for approval of a technology for use in screening. The "theory of possible benefit" is a poor substitute for properly designed trials to evaluate the impact of a screening intervention on disease specific mortality. This decision reflects a reasoned stance that puts the burden of proof on the intervention, an appropriate standard for a screening test.

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This is a critically important coverage decision that demonstrates important leadership. Aligning coverage decisions with USPSTF guidelines is an important step forward to coverage decisions that are aligned with the evidence. There should be increased investment from the government to bridge the evidence gaps for USPSTF "I" statements to move them towards a "A or B" recommendation or shift these to "D" recommendations. There is likely a tremendous amount of waste in health care delivery and harms to individuals by covering I statements. This is an important step forward to ensuring new technologies are required to demonstrate not just equivalence for performance, but also to demonstrate there are no increased harms from their use.

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I am very disappointed that CMS did not approve of payment for CTC as a screening exam.

CTC does not have to be better than traditional colonoscopy, it just has to be better than screening barium enema - which it is.

There is absolutely no reason that we consumers should have to settle for traditional optical colonoscopy. As a screening exam, it has potential for serious complications - including perforation and death, which is absurd. CTC has proven itself again and again to be, at the very least, comparable to traditional optical colonoscopy and far less expensive. There is no need for anesthesia.

Screening with traditional optical colonoscopy is a failed health policy because so few patients get screened. If the addition of CTC results in more patients screened, at a lesser cost than optical, and with more accuracy than barium enema and fecal occult blood, then more lives will be saved. American citizens deserve a choice

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I am disappointed to here the CMS is proposing to NOT cover virtual colonography! Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] Colorectal cancer screening saves lives!Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy. Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72] With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed!
Sincerely,
Debra Hale

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The use of CT for colonoscopy has provided a positive alternative to the long and uncomfortable process of a standard colonoscopy. It is my belief, based upon personal knowledge, that it has gotten many people to get a needed colonoscopy screening when they had not and would not have gotten one with the traditional methods due to fear and potential bad reactions. Additionally, there is the reduced cost to consider of the use of a full fledged ASC.I hope that CMS does not recommend ending payment for virtual colonoscopies. They are a valuable tool in providing prevention.

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I firmly believe that CT Colonography is equal or better as a screening device to actual colonoscopy for the detection of colorectal cancer. CT Colonography is technically better than actual colonoscopy because it does not require conscious sedation, takes less patient time, takes fewer healthcare man hours to perform, is not an invasive procedure, and can always examine the entire colon to the cecal tip and behind folds in the colon wall (which actual colonoscopy cannot). CT Colonography is free from potential side effects of the conscious sedation medications and does not risk bowel perforation from the instrumentation of actual colonscopy. Patients need to be offered the choice between these two screening procedures.

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I am a Radiologist in Boulder, Colorado and understand the difficulty of performing an air contrast barium enema. I feel like we are doing a disservice to the public when we have such a better test in CT virtual colonscopy to offer to individuals. Plus virtual colonoscopy is better tolerated and will be more accepted by patients as long as it is covered by insurance. To be honest, CTVC takes much more time for me to interpret than a routine BE, however, I feel it is a much better exam for the patient.

A screening study is only useful if it is performed and is sensitive enough to find disease. CT virtual colonoscopy is both.

Thank you,

Richard Finer, MD

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CTC has been shown in multiple trials to have excellent sensitivity and specificity for the detection of significant colon cancer/polyps. There is no question that it should be added as a reimbursed screening method for colon cancer. One argument against CTC is the fact that a biopsy can not be performed at the same time. That is as absurd as saying we should not do screening mammography because a biopsy can''t be performed at the same time. Another argument is that some patients will have to have a colonoscopy anyway. Since the majority of screening tests are negative, only a minority of screened patients will need to under go direct colonoscopy.

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* Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]

* Colorectal cancer screening saves lives

* Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy

* Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

* With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

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I can understand the difficulty in making the decision to fund screening CTC and I do understand that there are still questions. I would like to make two seperate points.

1. As a practicing radiologist who was recently finished my training and who was trained in performing CTC exams during fellowship and currentlty performs CTC I look at the currently reimbursed screening procedures and have to question why CTC is not included. Surely I understand that a case can be made optical colonoscopy is a superior test. But the idea that a Barium enema will be reimbursed instead of CTC is nonsensical to me. I can tell you that as a physician that interprets both I would be much more comfortable with CTC.

2. Thus, at the very least, I think that CMS should consider expanding the coverage to failed screening Colonoscopies as well - not just diagnostic studies. Especially since from the data we know that CTC performs best in an assymptomatic population.

Thank You

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- Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]

- Colorectal cancer screening saves lives

- Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy

- Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

- With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

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The following comes from Lewy Body Dementia Association''s (www.lbda.org) 2007 ''Facts about LBD'' pamphlet. Note: Lewy Body Dementia (or LBD) is the 2nd most common form of dementia in the United States.

“When considering any surgery, caregivers should meet with the anesthesiologist in advance. ''People with LBD often respond to certain anesthetics and surgery with acute confusional states (delirium) and/or may have a precipitous drop in functional abilities which may or may not be permanent.'' The pros and cons of stopping donepezil, rivastigmine, or galantamine should be carefully considered. If a spinal block or regional block can be used instead of general anesthesia, this would be preferred as those methods are less likely to result in postoperative confusion.”

Therefore, since a colonoscopy involves anesthesia, this should be avoided and a virtual colonoscopy is preferred. In addition, many people who do not have LBD, but who have a family history of Lewy Body Dementia also choose to avoid anesthesia whenever possible and hence may not get a colonoscopy if a virtual colonoscopy is not paid for by Medicare. Hence, a virtual colonoscopy is far less costly for this population than a traditional colonoscopy, especially if the outcome results in, or increases, dementia.

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I am in favor of the CMS approving screening CT Colonography for colorectal CA. The American Cancer Society has done it''s dilgence on the procedure and has approved it as an acceptable screening procedure for colon CA. The latest large scale study that was just published also concluded that it is just as accurate as screening colongraphy.

It is a much less invasive procedure then a screening colonography it is also a less costly procedure then a screening colonography. Proven to just as accurate, easier on the patinet, less costly then what you are currently paying for, why wouldn''t we want to approve it.

Let''s not over think things.

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In a recent, high quality systematic evidence review published by the US Preventive Services Task Force, CTC was shown to be equally effective in detecting cancerous lesions as colonoscopy. Due to the non-invasive nature of the test, people will be more likely to be screened, cancers detected early, and therefore have a more positive prognosis. In addition, as the majority of healthcare costs come from treating chronic illness including cancer, preventive medicine is so incredibly important. Not only on taxpayers'' wallets, but also on our quality of life. Not covering CTC would be a huge mistake.

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I am a radiologist who has been trained by the American College of Radiology to perform and interpret Virtual Colonoscopy exams. This exam could save countless lives every year and save the government a lot of money by finding polyps sooner so that they can be removed before becoming cancer. VC is better than flexible sigmoidoscopy and barium enema in detecting colon polyps and cancer and yet these are paid for by the CMS. Many peoples lives could be saved by VC, so PLEASE help us medical professionals help the people of our great country.

• Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]
• Colorectal cancer screening saves lives
• Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy
• Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]
• With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

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As a member of the Board of the Midwest Division of the American Cancer Society, I think that it is incredibly important to take a hard look at the long-term cost savings of preventing colon cancer by offering CTC as a colon cancer screening option; not the short-term savings. In fact, I think it''s embarrassing that so many people still die of a form of cancer that is nearly 100% preventable with proper screening. I see CTC as even more important than mammography in finding cancer early when it is nearly 100% preventable. (After all, breast cancer is actual cancer when detected, while polyps in the colon are pre-cancerous.) I could cite a litany of other reasons to reimburse CTC for colon cancer screening, but I will spare you the long note. Please keep this in mind, however: you can and will (eventually) set the bar for CTC reimbursement. Put a reasonable number out there and efficient imagers will find a way to make a profit (or breakeven) at that number while providing quality care. It works for mammography.

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I was Software Engineering & Project Manager responsible for one of the first integration of colon CAD into the premier radiological visualization software system used by thousands of radiologists throughout the world. This was in support of the first & second Pickardt et al sudy which conclusively proved the effectiveness of Virtual Colonoscopy compared to traditional methods. To deny reimbursement for colorectal cancer screening is absurd. Can we assume that next you will only reimburse for the use of leeches to treat brain tumors?

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I urge you to continue to reimburse physicians who through Medicare and Medicaid request and prescribe CTC screening as a way to try and detect colorectal cancer. Anything that can make earlier detection of cancer possible and more likely for a greater number of people should be supported. I would also urge standard screening to be moved back from 50 to 40 years of age. [PHI Redacted] was diagnosed with colorectal cancer (stage 3) at 42. He had no risk factors for the disease and if he had been checked at an earlier time, he would have a much better prognosis at this time. We have seem many other relatively young people, men and women in their 30s and early 40s, facing late stages of this disease because adequate screening is not available. Successful screening is much less costly to the public than cancer treatment and far more efficacious. Please help. Thank you. Anne Harrison.

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I am writing to strongly encourage CMS to approve screening CT colonography (CTC) coverage for CMS beneficiaries. Colorectal cancer (CRC) is one of the most preventable cnacers there is, yet is is the second leading cause of cancer related deaths in the U.S.as less than half of our population gets age appropriate screening. CTC provides a safe and effective method of screening that many people will be more inclined to undergo than traditional screening such as optical colonoscopy. methods. Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for CRC. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] CTC is also more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]I am requesting that CMS approve coverage for this important test that will result in saving many lives for patients who would otherwise not have screening for colon cancer.

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I think it is absolutely necessary for CTC to be APPROVED for colorectal cancer screening. The clincal data certainly supports its efficacy regarding the sensitivity and specificity. Other advantages and benefits include the fact that many people AVOID having a conventional colonoscopy due to the nature of the study, the cost involved, the anesthesia used, the time needed to prep and have procedure, a whole day or two of work missed. The minor disadvantages would include the inabilitly of an intervention to be performed at that time as well as a radiation exposure risk. The comparative risks to the invasive colonoscopy (IV''s anesthesia,perforated bowels, etc.)should be evaluated and used in the decision process. I understand that many Radiologists are eager to collaborate with the Gastroenterologists to facilitate a patient being seen the same day, should the VCTC be positive. The GI docs are simply concerned about losing the $$ they would make, assuming they would have seen the patient in the first place. They might even make more $$ by having the Radiologists refer their positive CTC patients to them.The public should be given the choice to decide which procedure to use for colorectal screening. The explanations for not approving this procedue appear weak,frivolous, unsupported and biased. How many of you have seen this technology first hand? How many of you have had both a conventional colonoscopy and a virtual CT colonoscopy? Perhaps your recommendations will be more acceptable and assuring if they were being totally objectively presented to the public. The majority of patients for screening would, in all liklihood, be negative. If not approved for screening, and not efficacious for the diagnostic patient - it seems a waste of time, research, money, and resources to have developed this amazing technology. What costs more and who makes the most money??? That''s what this is about. It certainly isn''t about the patient. Let''s hope the folks who are in the decision making roles are approaching their 50th birthday and will understand the frustration of not having a choice. Respectfully submitted for your serious consideration.

Merryl N. Fulmer

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Optical Colonoscopy(OC) has failed in reaching to the people at risk:about 20% compliance is a crime.Let''s put politics aside and let''s save lifes. Failure of OC should make Virtual Colonoscopy (VC)a must. All scientific datas and studies support VC.Even if VC misses few cases (and I doubt it), it is easier, less invasive, cost much less, and as accurate as OC if not more.VC will make compliance as high as Mammograpy (75%). [PHI Redacted] (VC by far is more accepted and more accurate, and not much room for interpretation. OC is dependent on ONE person only:Gastroenterologist!!)

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I would ask that this decision be seriously reconsidered. I teach CAT scanning and along with that, I teach Virtual Colonoscopy. I submit to you that I was involved at a site where a Radiologist requested to have a VC performed on her since her 2 prior colonoscopies both failed.It took 2 days of proper cleasing but we were able to successfully scan her.It was somewhat difficult to track through 2 narrowed areas. I was able to refer her images to a radiologists that has a great deal of experience reading the virtual colons and her impression came back as positive for colon cacer. Had she not had this performed she would not be alive and doing well today. I am asking that this decision be seriously reviewed. There have been so many clinical studies that have demonstrated how significant the sensitivity and specificity is for virtual colonoscopy. Please reconsider this. This could be you or a family member. Thank you for your time.

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I have performed over 200 CTC examinations over the past 4 years. These studies have been done on patients who were unable to undergo conventional colonoscopy for medical reason or for those patients who had incomplete colonscopies. The CTC has been an important part of patient care in these instances and literature supports an expanded role in screening for colorectal cancer.

I am a general surgeon in practice in a small community hospital for 20 years, and now in a Stanford-affilitated county (public) hospital and trauma center. At least 3-4 times a year I have been called emergently to the endoscopy suite to assume the care of a deteriorating patient who was undergoing a screening colonoscopy and who sustained colonic perforation. In several cases recently, death was the clinical outcome despite timely surgical exploration and repair. Discomfort during colonoscopy requiring administration of significant doses of IV narcotics and hypnotics, as well as vasovagal and other physiologic reactions have also resulted in significant morbidity for this screening procedure, and has led many patients to resist submitting to a test that has been shown to impact positively on disease treatment outcome. Many times, the colonoscopy procedure is incomplete, and the right colon may not be seen, due to patient discomfort and inability to advance the scope safely. Virtual colonoscopy (colonography), as a screening procedure instead of colonoscopy, avoids or greatly minimizes these life-threatening complications and may increase compliance with screening recommendations for those who refuse colonoscopy. The evidence in recent, peer-reviewed clinical studies performed at multiple centers worldwide confirms that colonography is effective as a screening modality and is more sensitive than other screning modalities that are already covered by CMS. These are all compelling arguments for covering colonograpy as a screening modality; I have not heard any compelling arguments as to why this screening modality should not be covered.

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There is strong research showing that CTC is a minimally invasive and cost effective method of detecting and staging colon cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]. Virtual Colonoscopy is more sensitive than other screening methods, which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72].I believe that this effective, patient-friendly screening test will save lives and is desperately needed. Screening tests such as Virtual Colonoscopy ultimately save money through early detection of potentially deadly diseases such as colorectal cancer that are easily treated if caught in time.

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No one should ever die from colon cancer. Colon cancer is 100% curable. 55,000 Americans die needlessly each year from colon cancer. We have a solid program in place for breast cancer screening. Only about 40% of Americans are screened annually for colon cancer; the other 60% are at risk for a curable disease. The scientific studies unequivocally demonstrate that CT colonography (Virtual Colonoscopy) is a robust, proven screening method for colon cancer; and is the preferred technique. By not endorsing CTC, CMS''s actions are beyond credibility. The position CMS has taken is NOT sustainable. I have devoted my career in medicine (over 30 years) to provide for my patients. I am saddened by CMS''s position on CTC. I STRONGLY encourage CMS to reverse their position on CTC ASAP.

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There is strong research showing that CTC is a minimally invasive and cost effective method of detecting and staging colon cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]. Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72].I believe that this effective, patient-friendly screening test will save lives and is desperately needed.

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Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] Colorectal cancer screening saves lives Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72] With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

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There is strong research showing that CTC is a minimally invasive and cost effective method of detecting and staging colon cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]. Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72].I believe that this effective, patient-friendly screening test will save lives and is desperately needed.

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There is strong research showing that CTC is a minimally invasive and cost effective method of detecting and staging colon cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]. Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72].I believe that this effective, patient-friendly screening test will save lives and is desperately needed.

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Dear Sirs:

I am a family physician and have always seen one of my responsibilities as screening for colon cancer. To be honest, I have not been happy with invasive colonoscopy, as now practiced and have looked forward to your approval of virtual colonoscopy. The invasive technique is expensive, includes a risk of peforation, an anesthesia risk, and the usual practice of numerous biopsies of small hyperplastic polyps. The reimbursement system for all of this has driven GI medicine to a primary interest in doing endoscopies, rather than taking care of patients with GI problems. I assumed VC would be an obvious choice for Medicare - cheaper, less risk to patients, more patients getting screened, etc. I can only conclude that the decision was a victory of medical specialty politics over medical science. This is a terrible decision!!!

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The FTC and FCC delays in approving the Sirius XM merger did significant damage to the viability of that combined business. Please don''t fall prey to the same type of thinking. I''m suspicious of the same "competition-fear" lobbying by the Gastroenterology community as satellite radio got from traditional radio. With the end result being far more harmful for US Citizens. [PHI Redacted] How many millions of Americans avoid the invasive screening because they wish to avoid the known hazards and discomfort? Your decision to continue to delay reimbursement for CTC screening is not helpful, it''s harmful. The small percentage of patients that also might need a follow-up invasive procedure to remove a polyp, etc., do not justify your position. Please do what''s best for the public, and not the special interests. Remember all the airlines in Dallas that fought hard to keep Southwest from flying out of Love Field. They failed at the anti-competitive posturing, and also failed at their own businesses shortly afterwards. Braniff, Eastern, and Texas Air. Sad, but true. I expect the government to do a better job of looking out for the good of the public.
Thank you,
Eric Shawger

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Please note the following statements and reconsider your stance on VC reimbursements.

I am almost speechless. It is my opinion that one of the greatest rip off''s of CMS is the double and triple dipping of gastroenterologists, who require a pre op consult, performed by an NP, which is a total waste of money given that I a board certified Internist have already performed and examination and have referred the patient for the procedure. Then they often find some reason to perform and endoscopy too, so 3 services are performed at GREAT COST compared to a single test which equivalent performance for lesions of a "size that matters". The 4th dip in the trough is the finding of a completely benigh hyperplastic polyp which sets of the repeat colonoscopy 3 years later.... It is a scam and should be stopped within the next 6 months.

The VC gives us much more useful information in the "screening" department. Period.

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Please reconsider your decision denying coverage for CT virtual colonoscopy.

Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]

Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy.

Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed.

Thank you.

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[PHI Redacted] was die last November due to the colon cancer.[PHI Redacted] I always follow the research publications on colon cancer screening. In recent years, the CT colonograph has gained a lot of improvement. Based on all the published clinical trial results, the CT colonography for detection of polyp is much more accurate than barium anema and sigmoidoscopy. It also bears great potential for patient friendly examination comparing to the harsh colon cleansing of conventional colonoscopy. [PHI Redacted] The CMS rejection to reimburse the CT colonograph was indeed a shock to me. I just could not understand what scientific evidence the CMS based on for thier decision. All the positive evedience to CT colonograph have been published for almost 10 years now.

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With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed NOW. There are now too few gastroenterologists to do the job, and we are losing lives and dollars.

It is well documented the VC is far more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]. If any NON-COVERAGE of exams should be considered, it would be to drop off reimbursement for LESS Sensitive procedures.

It is a position of denial to ignore multiple studies have shown that CTC is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200] To assume that the dollars and expertise of these steller studies is not enough evidence will only delay a decision that will be made based on the same evidence down the road.

Colorectal cancer screening saves lives,and CTC is safe and considerate. Optical procedures still carry greater risk to the patient and should be limited to therapeutic necessity.

Coverage of CTC will result in the screening of patients who are resistant to Optical Colonoscopy, reducing the incidence of colon cancer to record lows.

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There is strong research showing that CTC is a minimally invasive and cost effective method of detecting and staging colon cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]. Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72].I believe that this effective, patient-friendly screening test will save lives and is desperately needed.

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Screening CTC has been under development for several years and has been studied extensively as to sensitivity and specificity and cost effectiveness and patient acceptance. We have found it to be very useful as a screening tool for colon cancer. It has now been scientifically proved to be as accurate as traditional optical colonoscopy and better than sigmoidoscopy, air contrast barium enema and stool occult blood tests. Furthermore it costs 1/3 to 1/4 the price of optical colonoscopy.

We know of many patients who would have never had an optical colonoscopy because of fear of complications such as anesthesia death and bowel perforation. They are thrilled to discover that we perform CTC.

The one drawback compared to optical colonoscopy is that a visualized polyp cannot be immediately biopsied... however that is the same problem with barium enema and occult blood tests, both of which are approved by CMS. Is CMS holding CTS to a higher standard than other approved tests?

We also know that generally conservative medical groups such as the American College of Radiology and the American Cancer Society have embraced and recommend that CTC be accepted by all as a valid screening test.

I request that CMS reject its initial report and approve CTS as one of the screening tests for colon cancer.

Thanks very much for your consideration.

George W. Privett, Jr. MD

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Please reconsider your decision to not fund CT Colonography for colorectal cancer. It would save lives, is non-invasive and cost effective for not only colorectal cancer but for anomalous findings that may be visible outside the colon that may otherwise not be found. Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]

Please also consider that Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy

Also consider that Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

Lets improve screening rates for CRC, through this effective, patient-friendly screening test.

Thank you.

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Virtual colonoscopy provides a screening tool that is important to patients of all ages in that it is a known fact that it takes 10 optical colons to have a positive finding. Optical colons see only about 80% of the inside of the colon as the scope does not have the ability to rotate side to side and see behind the folds in the colon. In addition, the risk of perforation is greater than explained and becomes a huge issue if you or a loved one has experienced a perforation which can be life threatening. The optical colon does not see outside of the colon wherein the virtual colon provides imaging of the organs in the abdomen and pelvis which gives the patient and physician the knowledge of early abnormalities such as an aortic aneursym, renal or liver cancer or abnormalities and pancreatic abnormalties can be visualized using the 3D software that is part of the virtual colonography. The cost for a virtual colon as a screening tool is 1/3 to 1/2 less than the cost of a traditional colonoscopy. If on a virtual colon an abnormality such as a polyp is found it can be sized, and the location noted so that a GI doctor would be able to know exactly where to look no one tells the patient that the opticalcolon is a "blind search" or that gastroenterologists will remove any finding even if it is not within the guidelines one they are already in a clean site and 2 this allows them to then bill additional charges because it has become a surgical procedure. This seems to be a huge political issue between the groups of GI organizations as some of the GI doctors understand and support the virtual colon. There are only 39 out of 100 patients who willingly undergo an optical colon exam. They do not want the sedation, they do not like the prep, or the time that is needed away from a job for the prepation time and time after because of sedation. It has been shown by the American Cancer Society and others that the virtual colon provides better imaging of the RIGHT SIDE COLON disease which the optical does not. There are no failed virtual colon evaluations. Patients who are on anticoagulant medicaton are at increased risk because they must discontinue their medication in order to have an exam after age 50 to have the opportunity to know that there is no indication of colon cancer. DOES THIS SEEM FAIR TO ASK A PATIENT TO HAVE A SCREENING EXAM TO RULE OUT A DISEASE BUT TO RISK DEVELOPING BLOOD CLOTS WIT THE LUNG OR WORSE I THINK NOT. CMS needs to understand that the American Public are informed consumers and we understand that there are other advanced technologies that should be covered that would in essence save everyone, including insurance companies, MONEY!!!! VIRTUAL COLON is one of those procedures!!!!!The studies have been done the evidence has been shown virtual colons are needed to provide the opportunity for the public to receive medical care that would save money for everyone and Americans who are covered under Medicare should have the same options as those in the government who get medical care for free or greatly reducted pricing!!! We are in a crisis in this country and need to provide PREVENTIVE CARE to save huge amounts of money over the long term whether it is retired people on Medicare or the consumer who is at the recommended age for screening to determine early disease that can be cured i.e. COLON CANCER!!! I have worked in the medical world for many years and have watched many insurance companies refuse to advance from the reactive mode of operations to the PROACTICE APPROACH TO MEDICINE. WE NEED TO RETHINK HOW MEDICAL CARE IS PROVIDED AND if we educate the public about prevention and provide for them the tools that are needed in the end this country will spend considerably less money on medical crisis issues than we do today.THE DETERMINATION MADE BY CMS UNDER THE PRESSURE I AM SURE OF THE STRONGER GI ORGANIZATIONAL PHYSICIANS - NOT THE GI DOCS THAT UNDERSTAND THEY WILL NOT LOSE BUSINESS BUT WILL BE PART OF THE EVENT IN A PATIENT''S LIFE THAT SAVES MONEY AND GIVES GOOD CARE NEEDS TO BE OVERTURNED AND THE VIRTUAL COLON PREVENTIVE SCREENING NEEDS TO BE APPROVED!!!!!!!!!

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CMS'' coverage policies guide coverage policies for private insurance carriers also, so this policy decision will likely have tremendous impact on long term costs and health. CMS'' approval of CT Virtual Colonoscopy would likely increase screening at younger but appropriate ages thereby reducing cancer risk to patients and the long term treatment costs that could be the federal government''s obligation. President Obama states he wants to increase preventative healthcare as part of the healthcare system reform. Wouldn''t increasing compliance with colorectal cancer screening be a major factor in helping to save lives and lower long term costs. Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200].Colorectal cancer screening saves lives. Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy. Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72] With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed.

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I have heard from many neighbors, friends, and relatives that they would be willing to have a CTC, but have refused a colonoscopy. The state that the colonoscopy does not visualize the entire colon, but CTC does. It is a less invasive procedure and therefore, no possibility of perforating the colon. I strongly believe that the CTC will ensure that a greater percentage of the population has colorectal screening. This will reduce the incidence and associated costs of treating colon cancer. I strongly urge the CMS to reconsider and approve reimbursement for CTC. It WILL save lives.

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Now with CT Colonoscopy, patients have the availability of a great screening tool at a price that''s much lower for the government that optical colonoscopy. Moreover, there will be more people that can take advantage of this procedure and they will loose less time from work and not have the need for expensive sedation and associated monitoring. How in the world can this committee fail to see the benefit that has been so well documented by qualified researchers at world class institutions. There are far too many cases of colon cancer that are detected too late for cure and that costs us all too much in the long run. It''s time that you approve this technology.

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I find it hard to comprehend denying coverage for this safe and cost effective test that would save hundreds of thousands of lives. With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed. Colorectal cancer screening saves lives. Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy

Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]

Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

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I believe the available data is more than adequate to allow reimbursement for CT Colonography. The evidence is certainly suffucuent at least postpone such a strongly worded denial. Given the high prevalence of colorectal cancer, the notoriously poor screening rate and the inadequate numbers of trained optical colonoscopists to screen a significantly higher portion of the eligiblle population, such a denial will cost thousands of lives. I believe the motivation is based more on the current poor economic climate than upon the available medical evidence. Such a denial is counter to virtually all of the available recent literature and the opinions of every radiological expert in the field.

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Here are referenced reasons why ooverage for Virtual Colonoscopy screening should not be denied:

Although the convenience of virtual colonoscopy is extremely high, CMS should not cover it for routine procedures at this time. A routine screening, that is one without bowel obstruction or some other medically necessary reason for performing VC, should not enlist the option of a procedure which is financially desirable for health care professionals and also more desirable, e.g. less invasive, for the patient if it carries the known and definite risk of causing fatal cancer while a safer procedure is available. It is true that the dose is small, but dose-reduction protocols have historically not been followed and the fact that doctors can tell patients that the dose is nothing to worry about, coupled with the infinitely more comfortable nature of the procedure, would make patients that would otherwise decline from having their colon irradiated opt for VC out of respect for the doctor’s opinion.

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I think that not covering CTC is a short sighted policy. It would seem like a good idea to limit expenditures. However, CTC is less expensive than the invasive colonoscopy that patients would otherwise be getting. In addition, any measures that could cause more people to get screened should be encouraged as it has been shown that screening saves lives. The technique itself has been proven in trials and real world experience.

Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]

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As a radiologist who has been performing and reading barium enemas for over 15 years and CT colonography for over 4 years, I must emphatically state that it CT colonography is tolerated much better than a Barium Enema, and most people who have a barium enema refuse to have another while just about all patients who have had CT colonography seem very willing to repeat the study for screening purposes. Also, I am much more confident in my ability to detect as well as exclude the presence of polyps on CT Colonography than on Barium Enemas. In addition, I have had several patients who have had early cancers of other organs (lung, kidney) detected on CTcolonography and were able to have surgery before their tumor had spread. Had these patients had a barium enema instead or an optical colonoscopy, these early cancers would not have been detected! I so strongly feel that patients are not having their colons screened for colon cancer because currently available screening tools are not well tolerated, whereas if CTC were accepted as a screening tool, I am certain that more people would undergo screening and therefore colon cancer could be prevented if colon polyps are found when they are small! Ultimately, prevention of advanced cancers would certainly diminish that amount of money that the government would need to spend to treat cancers.

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I believe that the CTC is vital for this aging population. The potential is there for an increased number of people to actually go through cancer screening if they have an alternative to the optical colonoscopy. One advantage that the virtual colonscopy test carries is there is no need for the conscious sedation protocol that most centers use when performing the optical test. This is a definite advantage to older patients, not having to give them any drugs that carry risk in and of themselves. Virtual colonoscopy could be used to screen patients for the optical test, ultimately saving in dollars overall.

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I strongly urge CMS to approve screening CTC studies for the reasons outlined below:

Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]

Colorectal cancer screening saves lives

Coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy

Virtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]

With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

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Multiple studies have shown that Virtual Colonoscopy is an effective screening strategy for colorectal cancer. [Johnson CD, et al. N Engl J Med 2008;359:1207-17], [Kim, DH, et al. N Engl J Med 2007;357:1403-12], [Pickhardt, PJ, et al. N Engl J Med 2003;349:2191-200]Colorectal cancer screening saves livesCoverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical ColonoscopyVirtual Colonoscopy is more sensitive than other screening methods which are already covered by Medicare, such as flexible sigmoidoscopy and double contrast barium enema. [Imperiale, TF, et al. N Engl J Med2000;343:169-74], [Winawer SJ, et al. N Engl J Med 2000:;342:1766-72]With relatively low screening rates for CRC, this effective, patient-friendly screening test is desperately needed

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I''ve recently learned of Medicare''s decision to deny coverage of the use of CTC as a tool for pre-screening for colorectal cancer, and am writing to express my strong concern, and my hope that this decision will be re-considered and reversed. There is abundant evidence that CTC is effective in detecting colorectal polyp growth, and the procedure is much cheaper, less invasive, and more readily accessible than traditional colonoscopy. By denying CTC coverage, and requiring the single most expensive and difficult diagnostic option (colonoscopy), Medicare runs the likelihood of exposing more Americans to the ravages of this terrible disease.

PLEASE do the right thing and make all demonstrated therapeutic options available to those who need them!!!!!

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As an imaging center with a 64-slice CT, we do not perform Virtual Colonscopies at this time nor do we have the software. However, we are very surprised at the high number of inquiries we receive regularly regarding the Virtual Colonoscopy exam. The inquiries come mainly from middle to senior aged males, both walk-ins, but also patients and their families. We have received so many inquiries about the exam, particularly over the past few months, that we started to ask the reasons for the inquiry. The resounding message back has been that most of these individuals have been told by their doctor they must do a colonoscopy. Most of them refuse to do the optical colonoscopy. Once they hear about the patient-friendly virtual exam for which it seems they are aware has been shown to be an effective screening strategy (see Johnson CD, et al. New England Journal of Medicine 2008;359:1207-17], they are more inclined to complete this exam. In fact, quite a few are willing to pay out of pocket to do have this done. Given the high number of requests that we receive, we believe that insurance coverage of Virtual Colonoscopy will result in the screening of patients who are resistant to Optical Colonoscopy and as a result the test will save lives. Additionally, Virtual Colonoscopy is more sensitive than other screening methods such as double contrast barium enema and flexible sigmoidoscopy ( see Imperiale, TF, et al. New England Journal of Medicine 2000;343:169-74]. Since current screening rates for colorectal cancer are low, we are convinced that this test is necessary and that it will save lives.

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I am not quite sure how to address this email or even if I am sending it to the correct area within CMS,however, I feel it necessary to respond to the February decision that CMS made in regards to CT Colonography.

I am the coordinator of the virtual colonoscopy program here at Saint Joseph’s Hospital in Atlanta. We started our program a year ago and are rapidly approaching out 100th procedure. I have had numerous phone calls from Medicare patients who just do not understand why our government will not cover this exam. For starters, the exam costs $550. The amount reimbursed to facilities and physicians performing traditional colonoscopies is outrageous in comparison. This could amount to a phenomenal savings to the federal government.

Out of all of the studies that we have performed here at SJHA, only a few patients needed to be referred for traditional colonoscopies.

For patients who have had incomplete colonoscopies, you only cover a barium enema. A barium enema is outdated and is not specific for locating polyps. Why should we have to provide documentation for medical necessity with Medicare,when our main concern should be eradicating colon cancer.

The costs put out for surgery, radiation, and chemotherapy in no way compare to the fee for the CT Colonography. I am asking on behalf of the citizens, to please re-consider coverage of this test. The population of people that we would capture for colon screening would increase dramatically.

Thus, the costs that Medicare has to put out would, in fact, be reduced by millions. As we get older, we have other health issues to consider, we may not have family available to drive us to appointments and we start considering less invasive methods of treatment in regards to overall safety. The CT Colonography study does not require sedation, perforation is rare, and people like the fact that they do not have to rely on others for transportation. This exam is convenient to many and should be available to all. Our goal is prevention! CT Colonography is as reliable as a traditional colonoscopy when it comes to clinically significant findings. As with traditional screenings, there is a guideline to follow based on the findings. We need to give the people of the United States the right to choose which screening methods work best for them.

I strongly believe that we would see a decrease in spending when it comes to colon cancer prevention.

We need to start looking at things preventatively if we are going to save money in the long run. I am no where near Medicare age,however I would like to think that all of the money I am paying to Medicare will allow me the same benefits as what we have now.

If we continue on the way we are now, that money will not exist! Thank you for your time.Linda Byrd,ADN,RN,CGRN

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I am surprised that CMS would consider not covering CT colonography given the evidence that this is an effective screening tool. I think this test should be covered as it has been scientifically proven to be effective. Furthermore, it is much less invasive and provides much more information than other screening methods. All of these factors combined help to make this an excellent screening exam which is an important component of preventive medicine and early detection of disease which in the long term will save lives and ultimately reduce health care expenditures.

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Dear Medicare Official/Dear Senators Pryor and Lincoln/Dear Representatives Snyder and Ross:

I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer screening is the only way to prevent Colon Cancer. Many americans will not or cannot receive traditional colonoscopy as a screening test. Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest,highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

Respectfully submitted,

George Norton M.D.

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[PHI Redacted] I have also followed the development and growth of CTC for the past 10 years and firmly believe in the efficacy of this procedure. It is a cost effective procedure that has saved lives.

It was a shock when I read the recent decision by Medicare denying its recipients CTC for colon cancer screening. After reading the 21 page decision, I was surprised to note that several important points were not even taken into account when making the decision. I would like to highlight those below.

Over 50,000 Americans die each year from colon cancer. Another 150,000 to 155,000 new case are diagnosed each year and the astonishing fact is that colon cancer is more than 90% preventable. In looking at the number of cases each year, two things come to mind:

First, it is quite clear that the current screening methods are not working. The fact that everyone agrees is that more than 50% of the over 50 population choose to stay away from optical colonoscopy because they do not like this procedure for screening and as a consequence 150,000 to 155,000 new cases are being diagnosed each year.

Second, in reviewing the document put out by CMS denying the coverage for CT Colonography, no where did I see anyone from CMS taking into account the staggering amount of dollars being spent on diagnosing and treating so many cases of colon cancer each year when we all agree that more than 90% of colon cancer is preventable. I firmly believe all costs should be taken into account when doing a cost analysis.

The fact remains that the current ¡°gold standard¡± optical colonoscopy is not working. A recent study published in 2008 has shown that the procedure remains under utilized in Medicare recipients. ¡°Underuse of colorectal cancer screening in a cohort of medicare beneficiaries¡±, Gregory S. Cooper, Tzuyung Doug Kou, Cancer, Volume 112, Issue 2, Date: 15 January 2008, Pages: 293-299

In another study published in 2008 as well, it was shown that optical colonoscopy can miss polyps. ¡°Effect of Institution-Wide Policy of Colonoscopy Withdrawal Time ¡Ý7 Minutes on Polyp Detection¡± , 28 August 2008, Mandeep S. Sawhney, Marcelo S. Cury, Naama Neeman, Long H. Ngo, Janet M. Lewis, Ram Chuttani, Douglas K. Pleskow, Mark D. Aronson, Gastroenterology,December 2008 (Vol. 135, Issue 6, Pages 1892-1898)

The reality is that optical colonoscopy for screening is not perfect either and may have its draw backs when it comes to screening but more importantly it is not being utilized as a screening tool by Medicare recipients. As a result 50,000 people are dying each year from a cancer that is 90% preventable. The healthcare system is paying an enormous cost of treating these patients.

CT Colonography (CTC) does offer a viable proven alternative. When used as a screening tool in two different cities in the US ¨C Madison, Wisconsin and Bethesda Maryland during the past 5+ years it has consistently shown a 70% increase in screening by the local screening age populations in those areas.

To sum up the most important facts about CTC:

CTC has more than proven its efficacy in multiple clinical trials
CTC is widely accepted by the over 50years of age population for screening for colon cancer CTC is brining more people in for colon cancer screening. People who would have otherwise stayed away from the traditional optical screening CTC can be widely available because of the number of CT scanners in the US. Taking into account that there are millions of people in the over 50 age group who are not getting screened, everyone knows that if screening compliance jumped there is no capacity for the GI¡¯s in the entire world to screen such a large age group as the over 50 population in the US.

We all agree that colon cancer screening will lead to lower incidents of colon cancer which will lead to lowering healthcare costs on diagnosis and treatment. CT Colonography is one screening test that will show results in the near term because it will help bring people who are otherwise sitting on the sidelines.

I think by denying reimbursement for CT Colonography CMS is missing on a great opportunity to lead the way and be in the fore front of adopting new screening methods as a way to prevention of colon cancer.

I urge you to reconsider and approve CT Colonography for screening and make it available for all Medicare recipients. It will increase screening compliance. It will help prevent colon cancer. It will reduce the costs for treating colon cancer. It will save lives of Medicare constituents.

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A decision to deny coverage for CTC is a terrible medical as well as business decision. CTC is utterly risk-free, while colonoscopy carries the real risks of colon damage and anesthesia accident. CTC is offered at 1/2 to 1/5 the cost, and since all payors are obliged to pay for some form of diagnostic screening,if those people who are likely to need biopsies are directed away from CTC initially, the vast majority of CTC screens wiil be safe, cheap, and all that''s needed. The insinuation that physicians cannot tell the difference between someone who is bleeding or has a bowel disorder and one who is without symptoms and simply needs a simple, accurate screening is absurd.

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I protest the CMS decision. Colorectal cancer advances have been made through early detection. Especially poorf and minority patients do not access the present diagnostic system until late in their disease. They are more likely to be diagnosed and treated early if CTC is available, since no prep, anesthesia, or instrumentation is involved. The cost overall is less with early detection and treatment. This is an accurate method with less fuss and more information. To deny it to the population is unreasonable,

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I find it hard to believe that the decision is about to be made to deny this procedure as a covered benefit. The science behind this technology has been proven and the nature of the procedure can''t help but increase the number of people who have this important screening completed. This option will save lives that are currently being lost because of the fear that people have concerning the current singular screening method.

It begs the question of the possibility that the intent is to not save as many lives as possible, to help keep costs in check and as Scrooge said to "decrease the surplus population" Be mindful, that Scrooge was later warned to be sure he knew who made up "the surplus population".

I implore you, if not for your own sake or that of your loved ones, reconsider this decision for me and mine.

Roger Kittredge

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Colon cancer kills 56,000 people in the US every year. This is regrettable since over 90% arise from an adenomatous polyp the target for CTC . Only 30% of patients of average risk over 50 are screened by optical colonoscopy (OC). CTC ''s aim is to fill the gap by providing a more widely available, less invasive and cost effective alternative. In centers where CTC screening has been deployed double the amount of patients have been screened. CTC has been validated with a multicenter trial of 2600 patients with a sensitivity of 90% for polyps over 10mm NEJM Sept 2008, as well as a trial at Wisconsin in 2003 yielding a sensitivity of 93.8%. This means there is a 99% negative predictive value for this procedure. These trials resulted in The American Cancer Society including CTC in the guidelines for colorectal cancer screening. In addition this procedure carries no risk for perforation and does not require sedation. A study in cancer in 2007 concluded that CTC is the most cost effective screening test costing $4,400 per QALY, significantly less than OC and 1/10 that of screening mammography. CMS does pay for double contrast barium enema which is curious since this procedure has only a sensitivity of 50% for polyps greater than 10mm.

Based on this information one can only conclude that if CMS where not to approve CTC for colon cancer screening it would be because CMS is not interested in paying the costs of screening a potential preventable disease resulting in significant US fatalities.

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I am appalled at this decision in view of the support for this process by the professional organizations listed. At the very least, this should be considered for exceptions to coverage exclusions under the Americans with Disabilities Act for persons who have a history of extreme allergies and adverse reactions to chemicals, including the anesthetics and sedatives used normally for a colonoscopy (as well as the risks for such persons of general anesthesia when the milder forms are considered too risky, i.e. a possibility that the person could stop breathing. This would appear to be a decision to protect the incomes of those performing the usual colonoscopies rather than to protect the public from this common cancer. This exclusion makes no economic sense. If persons are moer likely to submit to this less invasive and less risky type of screening, then colon cancer is more likely to be identified and treated at an earlier stage at LESS cost to Medicare and Medicaid than if it progresses to need for more expensive and prolonged treatment. Further, for persons at high risk of adverse reactions for any reasons to the normal procedure, additional costs could result to Medicare for the necessary treatment for those conditions, which might have been totally avoided by using this method. I most strongly protest Medicare''s stubborn and antiquated decision to withhold coverage for this procedure.

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February 23, 2009

I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. Colon Cancer is a major concern to all Americans age 50 and older. Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined. Appropriate screening is the only way to prevent Colon Cancer. If detected at any early stage, it is easily correctable.

The discussion that was a part of the Decision Memo indicated that the screening rate for Colorectal Cancer for individuals 50 years of age or older had increased from 20 to 39% from 2000 to 2005. This is a truly abysmal screening rate. Did you consider that many individuals consider optical colonoscopy to be a test that is very unpleasant, and as a result, they will probably not undergo the test? These same individuals would consider virtual colonoscopy to be a much more pleasant and safer screening method.

Fifty thousand Americans are dying every year from a preventable cancer. Virtual Colonoscopy will encourage many more Americans to get a test that is accurate, safe, cost efficient, and pleasant.

A part of the Decision Memo included many studies. Conclusion from two of the studies are shown below.

“In this study of asymptomatic adults, CT colonographic screening identified 90% of subjects with adenomas or cancers measuring 10 mm or more in diameter. These findings augment published data on the role of CT colonography in screening patients with an average risk of colorectal cancer.”

“Primary CTC and OC screening strategies resulted in similar detection rates for advanced neoplasia, although the numbers of polypectomies and complications were considerably smaller in the CTC group. These findings support the use of CTC as a primary screening test before therapeutic OC.”

Note that the second conclusion stated that the CTC group had considerably fewer complications. This means safety.

I have personally been a member of the Health Physics Society for 40 years. The HPS concluded that the average patient dose from a virtual colonoscopy is approximately 5 mSv and that the risk from this dose is “too small to be measured” I personnel agree with this conclusion especially for patients receiving Medicare.

The Professional Society Position Statement that was a part of the Decision Memo concluded “the expert panel concludes that there are sufficient data to include CTC as an acceptable option for CRC screening. Screening of average-risk adults with CTC should commence at age 50 years“. This position should be heavily considered in your decision.

In conclusion, Medicare recipients should be given the option to receive a virtual colonoscopy every 5 years. It has been proven to be effective and safer than optical colonoscopies. And most important, they will consider receiving this screening test before an optical colonoscopy since the optical colonoscopy is so unpleasant. More tests mean more lives saved.

It is obvious that seniors are not getting screened using optical colonoscopies in large numbers. Give our seniors a break and give them access to something that they can readily accept.

Thank you for your consideration.

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[PHI Redacted] Therefore, I am saddened that there is resistance to a developed examination that cost considerably less, needs no sedation, has few if any complications, ie perforation and hemoraging, and allows a participant to get immediately back to work after a 20 minute exam. Colonoscopist are important and do a great job of looking and removing or biopsing lesions, but the expense, the miss rate due to limitations in their examination, and the complication that arise that require hospitalization or repeat examination should also raise a concern that there might be a better way to initially SCREEN a colon for polyps or masses.

Is it reasonable that it takes over 3-4 months to schedule a SCREENING colonoscopy? Is it fair that many who have a scope will not have another due to the pain, sedation, and cost? Should gastroenteroscopist be better used to go after suspected lesions than to be burdened with Screening examinations? Should the majority of those 50 years old and older wait until they are bleeding, obstructed, or suffering the complications of spreadig cancer because they did not have a screening examination when their colon cancer was just an adenomatous polyp or early cancer? Is the cost of caring for cancer victims until they hopefully get cured or die cost effective from the view point of a government paying for such care? Similar to mammography for early detectin of breast cancer, is that a mistake, not cost justified, not appropriate? The majoritiy of those that need inspection of their colons will not detect their cancer until it is too late. Colon cancer is a significant cancer in the USA meat eating population. Colon cancer is almost a preventable cancer when it is detected early. It would be a shame, during these economic times, polical fighting between radiologist and gastroenterologist, and the nation debt to set aside an opportunity at a significant cost reduction to Screen for this killer. If a scoping costs between $2-4,000 and a screening CTC cost $3-500, could many unnecessary scopes be eliminated at a significant cost to Medicare? Wouldnt it be nice to only have the government pay for a diagnostic but expensive exam to biopsy only those suspicious lesions found on CTC? Preventive care is the name of the game in saving the insurance or government payor money. Trying to catch up with disease after it is out of the barn is futile, unless you play the numbers and hope most will die before their disease appears or dies quickly from the cancerthat could have been detected early with a screening test. Does it seem logical having the patient back at work, paying taxes, and contributing longer by surviving their cancer? I am a radiologist who believes that many physicians milk the system and take advantage of who is paying for their condo, boat or plane. I come from the midwest with values that I want to do no more than is necessary, but no less than is required to care for those patients that look to me to help them find their disease early enough to have many more Christmases and birth days. I feel my contribution to the masses is in helping detect early, not too late where there is no hope. The CTC exam takes considerable time out of my day to safely interpret. The reimbursement for the exam far pales the time and liabilty in the performing the exam at a level that advantages patients. I want to offer this SCREENING exam as an opportunity. An abiltiy to eliminate UNNECESSARY EXPENSIVE colonoscopies, a major savings to the American Tax Payor. The discussed problem with finding unsuspected abnormalites in organs outside the CTC colon exam is feared by some because there will be additional cost in evaluating these masses. But should we ignore these findings and only concentrate on the colon? Would that not violate our obligation to protect the patient? You as government leaders have a significant burden of opening up opportunity, yet occuring more expense. These times are hard, and will only become more difficult as the economy waxes and wanes toward recovery. I know you have to cut cost,but I have witnessed so much abuse by greedy physicians in the past and present that better expectations for appropriateness starts with you folks policing better to eliminate the cheats so patients in the long run dont get denigned good care, because others have milked the cow dry, plucked the golden goose bare, or just simply stolen from Uncle Sam. I am an advocate for responsible medicine with a good return for you and my patients. I will only hope that wisdom rather than politics will win out in this small arena of medicine. If I can be of further help please do not hesitate to call. I would be honored to represent the patient at your meetings when you are deciding, because we can make a difference and save money with CTC.

Thanks for this opportunity,

Dr. John Bartow

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Screening CT colonography provided it is limited to 64 slice or above scanners is an effective took in discovering polyps and colon Carcinoma. Data is contaminated by the inclusion of lesser scanners.

The benefit to patients is that ct colonoagraphy does not require anesthesia, taking days off from work, an individual to accompany the patient. It''s accuracy when using 64 slice or better scanners is well documented,

It''s downside is the need for a theurapeutic colonoscopy is the small percent of patietns with a positive finding.

We find it particularly helpful in the patinet who has had a negative colonoscopy in provideing ongoing screening.

The efficacy is well established in patients who have incomplete colonoscopy for whatever reason. These are frequently the toughest cases.

The availability of other information is a byproduct of ct imaging.

Thank you for your consideration

Respectfully yours

Edward J Petrella MD

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I have been practicing diagnostic radiology for close to 20 years and am well aware of how rapidly the use of imaging has expanded and with it the associated costs. I understand the difficulty in approving new expensive techniques which will undoubtedly have initial increased costs.

However, I am struck by how different CT colonography or "virtual colonoscopy" is. The test is generally better tolerated and more acceptable to patients who often decline colonoscopy rather than submit to the percieved indignity of preparations and colonoscopy.

Optical (scope) and Virtual (CT) colonoscopy are screening techniques available which if widely performed would decrease the mortality from colon cancer in the U.S.

I agree that if everyone underwent appropriate scope procedures we would have great results. But the truth is that the U.S. does not have the capacity to perform so many procedures (neither physicians nor equipment)and the population does not follow guidelines for screening.

CT is now widely available and is considered more acceptable for many patients. In other words we can perform more screening procedures and get more cancer found at an early treatable stage.

I agree we should screen more patients for early colon cancer (look for polyps) but I believe we need CT to accomplish this on a large scale basis as an adjunct to scoping.

Please reconsider the decision to deny coverage and allow Virtual Colonoscopy to be part of an increase in the total amount of cancer screening performed.

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I am dismayed that CT Colonography (CTC) continues to be considered as a viable screening test for routine CRCA screening. It is precisely the medicare population that has a high polyp rate. Further, it is only after disregarding polyps smaller than around 5 mm - not even reporting them - that CTC becomes remotely appropriate from an economic perspective. However, assuming these polyps are not of clinical consequence is a critical error and clinically inappropriate. All adenomatous polyps begin smaller than 5mm, and have an important subsequent impact on screening intervals for individuals and family members. There is a small but real rate of adenocarcinoma and high-grade dysplasia within these lesions as well. Further, the CTC data is supposedly "state-of-the art", but the Optical Colonoscopic data are not - we await data from high-definition and narrow-band imaging. High-definition optical colonoscopy is becoming the standard and can, on sight, usually differentiate hyperplastic and adenomatous polyps, identify large flat polyps frequently missed by CTC and possibly by older generation optical colonoscopy, and likely provide for extended intervals between screenings that CTC''s inferior colonic exam can not justify. The CTC data are not likely to compare to the data emerging from these studies, and do not compare (now) to existing data when all polyps are included. This is an inappropriately promoted technology, and the image of its use promoted to the public has been misleading. The cart is ahead of the horse and judicious clinical care is being superseded by what I fear is $$$ shrouded in data tailored to make a misleading conclusion. There are other major problems with the key studies comparing CTC and Optical Colonoscopy, surely being addressed elsewhere in this space. I commend the CMS decision currently at hand.

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February 20, 2009

Re: Screening Computed Tomography Colonography (CTC) for Colorectal Cancer

From: Jennifer T. Plymale, Assistant Dean, Director, Robert C. Byrd Center for Rural Health
Joan C. Edwards School of Medicine, Marshall University

Colon cancer is the second leading cause of cancer death in men and the third leading cause of cancer death in women in West Virginia. Recent reports indicate that more than 1,300 new cases of colon and rectal cancer are diagnosed annually in West Virginia accounting for almost 500 deaths per year. On average, 27 people a day in West Virginia are diagnosed with invasive cancer, including four with invasive colorectal cancer. (Cancer Incidence in WV 1993-2004) The American Cancer Society (2007) estimates that 5-year survival rates of colorectal cancer is 93% when it is diagnosed at the local stage but 8% when diagnosed in the latter stage.. In West Virginia, nearly 44% of colorectal cancers are diagnosed at the in situ or local stage. It is estimated that if all Americans received guidelines-based screening, about 25,000 lives would be saved each year. (WV Cancer Plan)

The challenges in providing quality care to West Virginia’s citizens can be summarized as follows:

It is disappointing that CMS has decided not to approve payment for Virtual Colonoscopy as a cancer screening tool. The recent data demonstrates that CTC is as accurate as colonoscopy, if not more so, and the test has less complications. It is also less time-consuming, less uncomfortable, and less expensive.

It is time CMS stops regarding money as the overwhelming issue and consider the care of their clients, the people of the USA. Not approving CTC will lead to more colon cancers with resulting morbidity, mortality and expense.

Not to approve CTC is negligent and criminal, in my opinion.

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Dear Medicare Official
I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

Respectfully submitted,
John Curtis

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Dear Medicare Official:

I am writing to voice my objection with Medicare''s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer touches all Americans and is a major concern for all Americans age 50 and older. Colon Cancer kills more Americans each year than Breast Cancer and Aids combined. Appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life saving Colon Cancer screening to seniors, why did it choose NOT to cover the best, most patient friendly, new colon screening test available, Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the “screening sidelines”? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your denial of coverage for the highly sensitive most patient friendly Colon Cancer screening test, Virtual Colonoscopy.

Please do the right thing for seniors and all Americans over the age of 50.

COVER VIRTUAL COLONOSCOPY FOR ALL ELIGIBLE MEDICARE BENEFICIARIES!

Sincerely,

Willis Smith, II

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SUBJECT: Pending Decision on Virtual Colonoscopies

TO: Center for Medicare and Medicaid Services

ATTN: Steve E. Phurrough, Director
Coverage and Analysis Group
7500 Security Blvd
Baltimore MD 21244-1850

20 Feb 2009

Reference Medicare's recently stated intent not to pay for Virtual Colonoscopies. I do not believe there are any federal government employees qualified to make medical decisions.

[PHI Redacted]

No, any idiot knows it is not going to change or improve the outcome to beneficiaries (as it is a test, not a cure), but it will make the procedure more tolerable for the patient.

Again, no one in the federal government has the right or the expertise to deny a medical procedure to any United States citizen, whether they are young or old. It is time for Medicare to be abolished and the government to get out of the health care business!

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I am writing to voice my objection to the recent denial of coverage for Virtual Colonoscopy. I am aware that colon cancer is a major concern to all Americans age 50 or older& that Colon cancer kills more Americans each year than breast cancer & AIDS combined & that appropriate screening is the only way to detect & prevent colon cancer. Why did Medicare not acknowledge that more than 50% of Americans have not, will not or cannot receive traditional colonoscopy as a screnning test? If Medicare is truly concerned about providing life saving colon cancer screening to seniors, why did it chose not to cover the best, most patient friendly, new colon screening teast available:Virtual colonoscopy?Is Medicare content with over 50,000 Americans dying each year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health & Wellness rather than just paying for illness? Please do the right thing for seniors & have all Americans age 50 & older. Reconsider your denial of coverage for the newest, highly sensitive, & patient friendly colon cancer screening test. I have talked with numerous people who are afraid to get the traditional colonoscopy because of the pain, anesthesia, etc. Please cover Virtual Colonoscopy for all eligible Medicare beneficiaries!!

Sincerely, Larry A. Sylva, DDS, MScD, APC

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.

As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.

As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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I am writing to voice my strong disagreement with Medicare''''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.

As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.

As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear...CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.

As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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To Whom It May Concern:

I am writing to voice my strong disagreement with Medicare''''s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American''''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? This screening practice is much more likely to get patient''''s screened than a colonoscopy. Patient''''s dread the current screening method. Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

Respectfully submitted, Shannon Malinosky

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer. The American Cancer Society, the American Gastroenterology Society, the American College of Radiology, the Society of GI Radiology, and the Society of computed Body Tomography and Magnetic Resonance, and many GI''''''''s who are already getting certified on reading the results of VC have all stated clearly that the data shows that VC identifies over 90% of asymptomatic neoplasias or equal to 10mm and is actually better than optical colonoscopy for right sided colon lesions. Can they all be wrong? This is especially important since more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy? Time has demonstrated the current screening methods are not getting the job done. Your decision is a disgrace and a slap in the face of all senior citizens. Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness? Please do the right thing for seniors, and all Americans age 50 and older. Please reconsider the denial of coverage for the newest, highly- sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

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[PHI Redacted] I beleive that virtual scanning technology should be used and if used and covered by insurance, [PHI Redacted] probably would have had the test and would not have died from colon cancer. too many people opt out of the test because of its invasiveness. I understand that procedure does not remove polyps if found, but most people would rather have an invasive procedure knowing it was actually needed to treat something. In the long run, I believe it would save money overall to allow payment of virtual colonoscopy.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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I am writing to voice my strong disagreement with Medicare''''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

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I''m commenting in FAVOR of CTC screening and reimbursement.

We have been doing CTC for almost 7 years. Our radiologist has read thousands of these studies. For the most part, patients have had to pay cash for these safe, accurate, fast CT Colonoscopies - and at the cash rate we have done them it has meant $1000''s of dollars in savings to patients compared to what they would have had to pay with optical colonoscopies.

We estimate fewer than 3% have need follow up optical procedures - and some of those went directly to surgical procedures - meaning that if they would have had an optical they would still have had to have a CT scan before surgery. So the savings as even great starting with a CTC.

We currently are seeing patients who are returning for their 5 year followup. Why? Because the cash price for TWO CTC was still less than one optical procedure - without the risk and trama.

North American studies in 2003 & 2008 have kept us on the cutting edge - and have demonstrated accuracy and effectiveness. European and Asian research has confirmed these results repeatedly.

Let''s step up to the plate and provide our patients with this option - without delay. There are no known injuries or death because of CTC - we can''t say the same about optical procedures. Both save lives. Only one risks lives. Stand behind the researchers and American Cancer Society in endorsing CTC progress.

CTC is more effective in its discipline than mammography - and we have rightly encouraged and reimbursed mammography for years. Let''s support the gastroenterolgy community in their efforts by complimenting them by screening, where they have NO CHANCE of keeping up with demand with their current numbers and an aging population.

Thank you for changing you decision - and making the intellegent decision for our times!

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A number of years ago, [PHI Redacted] died of colon cancer. She, like so many people, had refused, as she got older, to have further colonoscopies. She was not a weak person, but, like many persons, she found invasive tests to be harder to withstand. If she had had access to a non-invasive procedure, like virtual colonscopy, to screen her, the tumor would have been found much sooner, and she might have survived.

In addition, two years ago, [PHI Redacted] petitioned his insurance company to allow a colonoscopy and was told he was too young to have colo-rectal cancer. It was cancer, and he''s now gone through radiation, chemo, surgery and six more months of chemo with attendant liver toxicity and neuropathy.

My question is: why would medicare and medicaid reject a non-invasive, less expensive procedure which will draw in others in the 40% unscreened group? Colon cancer is a huge killer. Should we not work to cut down the havoc? Would better screening not actually save money?

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Dear Medicare:

I am writing to voice my strong disagreement with Medicare’s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American’s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the “screening sidelines”? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

Respectfully submitted,

Jonathan Baumel

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Dear Medicare Official:

I am writing to voice my strong disagreement with Medicare’s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American’s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the “screening sidelines”? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

Respectfully submitted,

Julia Baumel

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Please do not stop funding for the above named screening test. 1st, the invasive colonoscopy requires that someone escort you to and from the process, ride services and taxis are not allowed to avoid problems because the patient has to be heavily medicated. Not all of us have someone willing to do that. [PHI Redacted] 2nd, the virtual colonoscopy is noninvasive and that alone will be encouraging for more people to have it done resulting in greater prevention. 3rd, this procedure is usually less expensive than the invasive method and over the long run would save money if the invasive method were only used whenthis procedure indicates a problem. Funding this procedure, at least as an option, is much more sensible than doing the expensive, painful, inconvenient, discouraging, invasive procedure first when most people won''t have any problems. Please,, please, please fully fund this procedure for screening for colorectal cancer. Thank you.

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I disagree with the decision to not cover CT colonography. Ample research has been conducted over the past several years to demonstrate the effectiveness of the technique. It is better tolerated by patients, of lower cost and has fewer complications than traditional colonoscopy while having similar detection accuracy to current standards. The technique may cost more in the begninning as more people are able to get screened and biopsies are recommended, but I believe that the long term cost savings will be substantial as cancers are caught at earlier stages, similar to what has occurred with the widespread use of mammography.

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life- saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

Thank You,
Respectfully submitted,

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Dear Medicare Official:

I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. We are all aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized, and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients. In well-trained hands the chance of significant incidental findings is approximately 3%. This is a low price to pay for effectively eliminating the risks and costs associated with screening optical colonoscopy. There has not been a reported perforation or bleed related to CTC. Incidental findings can be managed with the described C-RADS system; A system modeled after the BI-RADS system to classify incidental findings and their significance.

As medicine evolves we as physicians and researchers continually look for safer, less invasive ways to care for our patient population. This applies to the development of CTC. This has been one of the more thoroughly researched and evaluated technologies in some time and the results have been validated many times over. To deny this advancement in technology to patients is dangerous. Not only to the patients, but to the very system that has been encouraged in the past to push the envelope for safer, more cost effective ways to detect and diagnose disease. In these economic times cost savings is essential. CTC provides a huge cost savings to Medicare and insured patients alike. The great majority of patients (>90%) will need only the CTC, obviating the cost and risks of conscious sedation and polypectomy. In all, we can screen patients quicker, safer and cheaper than the current model.

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please reconsider your decision. Re-review the literature that is available. This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal. CTC has the chance to change the face of colon cancer screening. With ongoing research the understanding and approach to colonic polyps will change.

Respectfully submitted,

dipak s shah md.

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I am writing to voice my strong disagreement with Medicare’s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American’s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

The American Cancer Society, the American Gastroenterology Society, the American College of Radiology, the Society of GI Radiology, and the Society of computed Body Tomography and Magnetic Resonance, and many GI''''s who are already getting certified on reading the results of VC have all stated clearly that the data shows that VC identifies over 90% of asymptomatic neoplasias > or equal to 10mm and is actually better than optical colonoscopy for right sided colon lesions. Can they all be wrong? This is especially important since more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test?

If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy? Time has demonstrated the current screening methods are not getting the job done.

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the “screening sidelines”? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for seniors, and all Americans age 50 and older. Please reconsider the denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

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I am writing to voice my very strong disappointment and disagreement with Medicare''s recent proposal to deny coverage for Virtual Colonoscopy. I am aware that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% OF AMERICANS HAVE NOT, WIIL NOT, OR CANNOT RECEIVE TRADITIONAL COLONOSCOPY AS A SCREENING TEST? If medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a highly preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for the seniors and all Americans age 50 and older. Reconsider your proposal to deny coverage for the newest, most highly sensative, and patient friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all elligible Medicare Beneficiaries !!!

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Dear Medicare Official/Dear Senator_Grassley:

A previous comment I sent on this topic mistakingly used the term MRI instead of CT as the source of the imaging for the virtual colonoscopy.

I am again writing to even more forcefully voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

I trust you are aware that the VAH has approved these procedures for use in all of their facilities. I also trust that you are aware that most of the objection to this procedure comes from those gastroenterologists who stand to loose most all of their diagnostic business if the non-invasive virtual colonscopy is approved.

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

Respectfully submitted,

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

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Colon cancer is the second leading cause of death in this country. If there are better prevention measures available - they should be made accessible!

Current statistics from the American Cancer Society places 1 out of 19 people will become diagnosed with colon cancer. [PHI Redacted] was one of those. He passed away from colon cancer. There were absolutely no symptoms whatsoever before his diagnosis. All of his past screenings were regular. They missed something on the last screening. By the time his next one rolled around it was too late. He only lasted four months after the diagnosis. Current technology is NOT up to par. If new technology is available, which it is, it should be equally accessible to everyone in this wonderful country that needs it.

http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statistics_for_colon_and_rectum_cancer.asp?sitearea=

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I am not certain about what bias the panel had when they made the decision to not fund virtual colonoscopy using 3D imaging of MRI''s. It is the only safe procedure and has been proven to be the most accurate diagnostic method even when compared to colonoscopy in a prospective randomized selection study. It''s use would encourage many more people to get the screening test who are frightened by the negative publicity that the accidental perforations from the invasive colonoscopy procedure. Safer? More accurate? Who in their right mind would withod the option from the deserving public?

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[PHI Redacted] I am disturbed that the Centers for Medicare and Medicare Services has proposed denying seniors the option of Colonography/Virtual Colonoscopy (CTC)as a Colorectal Cancer Screening test (CTC). Discussions with other seniors indicate that the non-evasive feature of CTC would greatly increase the number od seniors having a CRC Screening test. Therefore, it would decrease the number Colorectal Cancer cases. [PHI Redacted] Some health insurers have already approved CTC as a CRC screening test for non-Medicare receipents. Therefore, by denying the CTC procedure, Medicare has effectively made seniors second class citizens. I strongly urge you to reconsider your proposed denial of the CYC procedure as a CRC screening test! If you truely want to "improve the health, safety and well being of America," you should approve the use of CTC as a CRC screening procedure.

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To Whom it may concern,

I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy.

Colon cancer is one of the few known cancers that are preventable if caught early enough. It is a shame that there are people who will be injuried by this preventable disease that could have gotten screened if they were given access to a relatively simple and painless screening test.

Virtual CT seems to pass the test for this type of screening exam. It is available, quick, relatively painless and has proven in the liturature to be accurate.

Optical colonoscopy is not really a screening test. It is and should be considered the definative procedure. It is not as available, costs more, and is more involved and invasive.

In the same vein, mammography is a screening test and should be performed on all eligible people. However, Breast MR is a more accurate test, but cost more, is more involved and should only be performed on those who really need it.

The fact of the matter is that many US seniors will not get their colon screened for many reasons. Access to a good, cost effective test should not be one of them.

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

Respectfully submitted,

Jason M. Stoane, MD

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I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

I am a Diagnostic Radiologist who has read these studies since my fellowship training 6 years ago. Virtual Colonoscopy will not replace conventional colonoscopy, but will give the patient another option for screening. This is very important for the patient who is on blood thinning medication or if they have had a bad experience in the past. Patient compliance with screening is very poor, and we need to do everything we can to improve that. Additionally, CT Virtual Colonoscopy is much better tolerated and much more sensitive test than the Double Contrast Barium Enema, which is an approved test for screening.

Thanks for your attention to this matter.

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I am outraged that there is an easier screening available and that anyone would deny coverage for it. [PHI Redacted] I also have relatives that refuse to do the current screening because of the procedure. [PHI Redacted] Look at how many women refuse mamograms due to the discomfort. If an accurate test that was pain free became an option, would you deny coverage for that as well? Why spend money and do the research if we aren''t going to utilize what we find. We need to get this info out to the media and see what the whole of our country thinks about this decision. Our new President believes we need a lot of change and reform. The political *good-ole-boy* syndrome, needs to end. This is nothing more than the medical *good-ole- boy* syndrome....and yes, it too needs to end.

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Dear Medicare Official,

I thought we were trying to the win war on cancer not retreat. Government has a sworn duty to put the public''s health first. I think my opinion is shared by many Americans. Why don''t you approve reimbursement for Computed Tomography Colonography (virtual colonoscopy) before any more Americans die of this disease. I feel it would be criminal not to be responsible for the lives that could be lost. This is the best way to detect colon cancer! Please reconsider. Thank you.

Respectfully yours,

Richard Shaw

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I am extremely concerned that we will not be able to have colorectal screening through Virtual Colonoscopy. [PHI Redacted] I know too many people who received injuries from the endoscopic procedures and if this is not approved, thousands of people will not be screened for colon cancer because endoscopy is just not the right choice for them. It is extremely important that you allow Virtual Colonoscopy so people at least have a choice. Do the right thing and approve this procedure. By doing so, you will save lives!

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Dear Medicare Official:

I strongly disagree with Medicare''s recent denial of coverage for virtual colonoscopy. Virtual colonoscopy has been proven in very well-done clinical trials reported in the New England Journal of Medicine to be a safe, cost-effective and medically effective screening tool for colon cancer.

I have had personal experience with a [PHI Redacted] who was screened by the optical colonoscopy and given a clean bill of health and shortly after had a virtual colonoscopy. The virtual found a large polyp which was completely missed by the optical and the virtual saved his life!!

Americans over 50 are at high risk for colon cancer and few actually are screened due to the expense and difficult nature of the optical colonoscopy. The virtual colonoscopy would contribute to far more screening and far less colon cancer. Lives would be saved and the costs the the health care system would be minimized.

Please reconsider the denial decision and make this safe, highly-sensitive screening test for colon cancer available to seniors. You must cover Virtual Colonoscopy for all eligible Medicare beneficiaries to do otherwise just makes no sense!!!

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Dear Senators Kerry and Kennedy,

I am writing to voice my strong disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries!

Respectfully submitted,
Dr. Joseph T Ferrucci

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Dear Senator:

I am writing to voice my disagreement with Medicare''s recent denial of coverage for Virtual Colonoscopy. I am aware that Colon Cancer is a major concern to all American''s age 50 and older, that Colon Cancer kills more Americans each year than Breast Cancer and AIDS combined, and that appropriate screening is the only way to prevent Colon Cancer.

Why did Medicare not acknowledge that more than 50% of Americans have not, will not, or cannot receive traditional colonoscopy as a screening test? If Medicare is truly concerned about providing life-saving Colon Cancer screening to seniors, why did it chose not to cover the best, most patient-friendly, new colon screening test available: Virtual Colonoscopy?

Is Medicare content with over 50,000 Americans dying every year from a preventable cancer? Is Medicare aware that Virtual Colonoscopy will encourage many more Americans to get off the "screening sidelines"? Is Medicare not interested in promoting Health and Wellness rather than just paying for illness?

Please do the right thing for seniors, and all Americans age 50 and older. Reconsider your denial of coverage for the newest, highly-sensitive, cost-effective, and patient-friendly Colon Cancer screening test.

Please Cover Virtual Colonoscopy for all eligible Medicare Beneficiaries! Sincerely,

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If you believe in screening for colon cancer, then not including CTC in that armamentarium is in my view a major error. No one questions that CTC can find those polyps that matter most (>1cm.) at least as well, and as has been documented in several articles (Pickhardt NEJM 2003;349:23-30), better than optical colonoscopy (OC). In many series where good technique is utilized there is no appreciable difference in the detection of polyps 6-9 mm. As I have mentioned in previous communications and has now been documented in the literature, OC misses many colon cancers (Annals of Internal Medicine 2009; 150:1-8). While there is no prospective study that confirms that CTC will find those cancers missed by OC, at least one large study implies that it will. In the same number of patients, CTC found almost 3 times the number of cancers as OC (14 to 4), while finding almost the exact same number of advanced adenomas. (Kim et al, NEJM 2007; 350:1403-1412) This is impossible to ignore, and coincides with clinical experience. For those of us who perform these studies daily, it is crystal clear that CTC is excellent for identifying colorectal CA, and that is why I highly recommend to friends and family that they have at least one CTC at some point in their screening lifetime. The issues of radiation dosage and extracolonic findings for some reason remain an obstacle to your endorsement of CTC. Time will prove that these concerns are severely overblown and threaten missing the forest for the trees. CTC subjects patients to less radiation than a standard CT scan of the abdomen and pelvis, and if this were a risk we should have seen a huge increase in mortality from these cancers in these areas over the past 30 years. Clearly this has not occurred. CTC is a test primarily for those over 50 years of age, so the radiation risk is even less, especially in the Medicare age population where it is almost certainly of little to no significance. As for the extracolonic findings, the low dose utilized in CTC makes evaluation of the abdomen and pelvis quite limited, so much so that in my extensive experience the required workup for extracolonic findings is very low. Dr. Pickhardt’s 2008 article (Radiology 2008; 249: 151-159) identifying a 6% incidence of moderate to highly significant findings in my view is at the high end. Critics liken CTC to Whole Body Screening CT and the problems associated with extracolonic findings in this group. Comparing CTC to Whole Body Screening CT is an error, since the low dose utilized in CTC markedly minimizes the viewable anatomy. During this period of public commenting I hope that the committee will understand the ramifications of this non-coverage decision which exposes the Medicare population to the following risks:

1. Those who will not undergo OC for myriad reasons will have no other viable option for total colon screening (since barium enema is clearly inferior) and therefore will effectively go either unscreened or suboptimally screened.
2. Many cancers will be missed by OC that could be demonstrated on CTC.
3. The incidence of complications including perforation is small but not zero for OC; therefore this decision not to cover CTC guarantees that a significant number of Medicare beneficiaries will be unnecessarily harmed.

This committee, following the lead of the USPSTF, seems willing to accept these very real risks in lieu of the imaginary and highly improbable risks of CTC. If I were a Medicare beneficiary I would be disappointed in, if not angry about, a process that insists I accept real risks rather than imaginary ones. The American Cancer Society, The American College of Radiology, multiple GI societies, and theBCBS Association Technology Evaluation Center all have recognized the value of CTC and have endorsed it as a colon cancer screening modality. I urge the committee to join with these highly regarded organizations and provide Medicare beneficiaries access to CTC, a proven, low risk-high yield procedure.

Thank you.
Mark E. Klein, MD
Washington Radiology Associates
Washington, DC
Assistant Professorial Lecturer
The George Washington University Medical Center

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Appeal of denial of Virtual Colonoscopy.

Virtual Colonoscopy, (CT Colonography) is a test used to screen for colon neoplasms. Technically it involves a prep the day before, insufflation of the colon with air or preferably carbon dioxide, and a decreased radiation CAT scan through the abdomen and pelvis in the supine and prone positions. The images are then placed on a work station and evaluated for the presence of polyps or cancers.

This technology has been refined over the past 10 years. It is been determined to be more accurate at identifying clinically important neoplasms than conventional colonoscopy plus it is safer and less expensive than conventional colonoscopy. It is recommended by the American Cancer Society as a screening tool as well as by the American College of Radiology.

First, let’s review colon cancer and colon cancer screening options.

Colon cancer is the second leading cause of cancer death in this country. One out of sixteen Americans develop colon cancer and one out of forty Americans die from colon cancer. The overall five year survival for colon cancer is 64%. The five year survival for early localized colon cancer is over 90%. Unfortunately only 39% of cancers are diagnosed early and localized due to inadequate screening.

The US Preventive Services Task Force (USPSTF) recommends that all Americans over the age of 50 get some form of colon cancer screening. The options for screening include digital rectal exam, fecal occult blood testing, sigmoidoscopy, optical colonoscopy, double contrast barium enema, and virtual colonoscopy. Medicare and all major insurance companies cover all of these options with the exception of virtual colonoscopy. Let’s look at the DATA behind these options.

Fewer than 10% of cancers are close enough to the rectum to be detected by the examining finger. Missing 90% of cancers seems to make digital rectal examination inadequate as a screening tool.

Sensitivity of fecal occult blood testing is estimated to be about 40%. This is to say that 60% of colon cancers would have a negative fecal occult blood test. Furthermore, only 2% of positive fecal occult blood tests are associated with colon cancers and 6% are associated with advanced benign polyps. Although very inexpensive, this test seems to have an unacceptably low sensitivity and specificity to be a good screening test.

Sigmoidoscopy visualizes at best 50% of the colon, more likely around 30% in most cases. It is estimated to miss 25 to 50% of the polyps and cancers in the colon. The USPSTF criticizes sigmoidoscopy: “screening may lead to the removal of many polyps that are of low malignant potential or that would not have caused clinical disease.”

One may question the wisdom of not taking out small polyps before they become large. The problem stems from the fact that polypectomy of small polyps is associated with measurable risk while the potential for future malignancy is very low. Fewer than 1 percent of adenomatous polyps less than 1 cm will eventually develop into cancer. The lifetime risk for developing cancer anywhere in the colon is around 6%. Therefore it can be argued that to do a polypectomy on a tiny polyp is greater risk and less benefit to the patient that earlier repeat surveillance. Furthermore, removing the tiny, low risk polyps significantly increases the cost of screening.

In the National Polyp Study double contrast barium enema detected only 48 percent of polyps greater than 1 cm. You miss more clinically important polyps than you find! Despite these very poor results, DCBE is still reimbursed by Medicare and most major insurers.

Optical Colonoscopy has become the usual standard for colon cancer screening. It can visualize and remove polyps from the entire colon. Unfortunately, it is expensive, invasive, requires anesthesia and comes with a risk of bleeding and perforation. The USPSTF states: “It is unclear whether the increased accuracy of colonoscopy compared with alternative screening methods...offsets the procedure''s additional complications, inconvenience, and costs.”

Virtual colonoscopy as evaluated by the USPSTF: “Although CT colography can be relatively sensitive and specific in research settings (85 percent to 90 percent), recent reports have suggested lower accuracy when performed by less experienced examiners. Small and flat polyps are less well visualized on CT colography than are cancers and large polyps. Studies have not yet examined clinical outcomes with CT colography screening.” However the USPSTF goes further to state: “Estimates of cost-effectiveness, however, suggest that, from a societal perspective, compared with no screening, all methods of colorectal cancer screening are likely to be as cost-effective as many other clinical preventive services—less than $30,000 per additional year of life gained”

Before reviewing the current literature regarding virtual colonoscopy, let’s review the assumption that conventional colonoscopy is the most accurate way to detect clinically important polyps.

Tandem colonoscopy studies have revealed a miss rate of 0% to 6% for polyps 10mm or greater in size by conventional colonoscopy. As it turns out, tandem colonoscopy studies miss the same polyps with both procedures. With studies in which CT colonography served as the gold standard for conventional colonoscopy through the process of so-called segmental unblinding, conventional colonoscopy has been shown to miss 12 to 17% of 10mm and larger polyps. Be mindful of the fact that this is in the setting of a clinical study, how does conventional colonoscopy do in general practice outside of clinical study setting?

A study was performed in a practice of 12 experienced gastroenterologists each caring for a similar population of patients to determine if there was a difference in polyp detection rates based on the speed of the examination. The findings were startling! Those gastroenterologists who took over 6 minutes to withdraw the scope found 6.6 polyps of 10mm in size or larger per 100 patients examined. Those taking less than 6 minutes to withdraw the scope found 2 polyps 10mm in size or larger per 100 patients examined. In other words, the fast gastroenterologists missed almost 70% of the clinically important polyps! This is significantly worse than what we expect to find with the unacceptable results associated with double contrast barium enema. There was a 10 fold difference in total polyps of all size found between the most sensitive gastroenterologist and the least sensative.

A study published in JAMA in 2006 found that in a study of 35,975 patients with normal optical colonoscopies; found that 6 months after “normal” conventional colonoscopies, subjects still had 69% of the risk of being diagnosed with colon cancer compared to the general unscreened population. This result strongly suggests that conventional colonoscopy missed 69% of the very high grade adenomas and cancers in this study.

So what DATA do we have regarding the diagnostic accuracy and safety of virtual colonoscopy? The article most frequently quoted by detractors from virtual colonoscopy is the Cotton article from JAMA in 2004. In this study, multiple locations were utilized, many with minimal experience or training, utilizing an inadequate protocol without stool tagging and 2 dimensional reads from inexperienced radiologists. Not surprisingly their results were bad with only 55% of the polyps greater than 10 mm being identified. Although this is better than double contrast barium enema, and better than the gastroenterologists who took less than 6 minutes to withdraw the scope, it seems unacceptable as a screening tool. One would argue that any technology that misses 45% of clinically important polyps would not be a good screening tool, especially if it were an expensive test. However a review of the literature reveals that all other major studies have found a detection rate of clinically important 10mm and larger polyps to be in the 90 to 100% range by virtual colonoscopy.

A 2007 study in the NEJM: of 3,136 subjects undergoing conventional colonoscopy, 4 colon cancers were discovered; of 3,120 subjects undergoing virtual colonoscopy, 14 colon cancers were discovered. Is it possible that conventional colonoscopy missed 70% of the cancers in this study matching the results of the JAMA 2006 study?

The above DATA strongly suggests that conventional colonoscopy is not nearly as sensitive as is usually assumed in the detection of colon cancers.

There are two large studies that compare virtual colonoscopy with conventional colonoscopy. They are both published in the New England Journal of Medicine.

The first was published in 2003. 1,233 subjects had a virtual colonoscopy followed immediately by a conventional colonoscopy. They did segmental unblinding of the virtual colonoscopy to get a legitimate comparison between the technologies. In other words, the gastroenterologist advanced the scope to the cecum and then withdrew it to the hepatic flexure. At that time the endoscopist would announce the findings of the ascending colon. The ascending colon results from the virtual colonoscopy was then unblinded and compared. This was repeated for the transverse colon, descending colon and recto-sigmoid. The virtual colonoscopy identified 93.8% of the 10mm polyps and larger while the conventional colonoscopy identified 87.5% of the 10 mm polyps. The virtual found 2 colon cancers while the conventional found only 1 colon cancer until the virtual was unblinded. In addition, the virtual found 5 cancers outside of the colon, one ovarian, one renal, one lymphoma, and 2 lung cancers, all stage 1 potentially curable. In addition, 2 aortic aneurysms requiring surgery were identified.

In summary, virtual colonoscopy found more clinically important benign polyps, 7 cancers, and 2 significant aortic aneurysms; compared to conventional colonoscopy which found a smaller number of clinically important benign adenomas and only 1 cancer. Some question if these findings of virtual colonoscopy could be replicated in clinical practice, one should also question if the conventional colonoscopy results can be replicated in clinical practice.

A second study published in NEJM 2007 compared 3,120 subjects who chose virtual colonoscopy and 3,136 subjects who chose conventional colonoscopy. Those who chose conventional were on average one year older and had more family history of colon cancer so one might reasonably assume that the conventional colonoscopy set should demonstrate more pathology than the virtual colonoscopy set.

134 polyps 10mm and larger were found on conventional colonoscopy. 164 polyps 10mm and greater were detected by virtual colonoscopy. 4 colon cancers were found on conventional colonoscopy. 14 colon cancers and 8 cancers outside the colon were found on virtual colonoscopy.

Conventional colonoscopy perforated 7 patients’ colons, 4 of whom required open surgical repair. Virtual colonoscopy was associated with no perforations. 8% of the virtual colonoscopy subjects needed a conventional colonoscopy to remove polyps found on the virtual.

A third study was published in NEJM in 2008 of 2,600 asymptomatic subjects in 15 different centers. This study was flawed by the fact that conventional colonoscopy was assumed to be the gold standard, segmental unblinding was not used, and the number of polyps missed by conventional colonoscopy was not accounted for in the results. 15 subjects with 10 mm polyps on virtual colonoscopy but not detected on conventional colonoscopy underwent repeat virtual colonoscopy and 5 were found to have polyps missed by the initial conventional colonoscopy but found on the virtual. Indeed the false positive results ascribed to virtual colonoscopy could be largely explained by unallocated false negative results from conventional colonoscopy due to the lack of segmental unblinding. This study although flawed by design, demonstrated that in a multi-center study, virtual colonoscopy is able to identify 90% of the clinically important polyps found on conventional colonoscopy even though it did not investigate the true miss rate of conventional colonoscopy. Complications were comparable except for a 2 day hospitalization for rectal bleeding in the colonoscopy group.

It is an inescapable conclusion that virtual colonoscopy is at least equivalent if not superior to conventional colonoscopy in the detection of advanced adenomas and carcinomas. In addition virtual colonoscopy has been found to be safer than conventional colonoscopy. Finally virtual colonoscopy has the advantage of finding significant extracolonic findings such as cancers, kidney stones, gall stones, incarcerated hernias and aortic aneurysms.

Virtual colonoscopy is significantly less expensive than conventional colonoscopy. Studies have demonstrated that virtual colonoscopy is twice as cost effective as conventional colonoscopy based upon life year gained with virtual colonoscopy costing $4,361 per life year gained while conventional colonoscopy costs $9,180 per life year gained. In addition, no consideration is given to the cost of loosing on average 1.5 days work by the subjects undergoing conventional colonoscopy as a consequence of the need for sedation during the procedure. As virtual colonoscopy does not require sedation, the patient can immediately return to normal activities. This fact improves participation with screening as well as reducing the economic impact of lost productivity of the subjects undergoing screening.

Anti-coagulant and anti-platelet therapy increases the risk for bleeding with conventional colonoscopy. Discontinuing anti-coagulant and anti-platelet therapy in anticipation of colonoscopy has significant potential for complication. My own personal experience includes the unfortunate consequence of a patient on Coumadin having a life threatening retroperitoneal bleed due to residual anti-coagulant effects despite 5 days without Coumadin prior to the colonoscopy. Two other patients of mine had strokes as a consequence of discontinuation of Coumadin in anticipation of colonoscopy. A major advantage of virtual colonoscopy is the ability to do the procedure without discontinuing the anti-coagulant or anti-platelet therapy.

It is argued that the 10 year recommendation for repeat conventional colonoscopy following initial normal colonoscopy is an argument in favor of conventional colonoscopy over virtual colonoscopy where a 5 year follow up is recommended. The 10 year recommendation is an economic decision not based on clinical studies. Indeed the only study looking at the appropriateness of the 10 year follow up recommendation found that the likelihood of being diagnosed with colon cancer was twice as great at 5 years than at 10 years after the initial normal procedure. A study of 35,975 subjects with a normal colonoscopy found that at 5 years after the “normal colonoscopy”, subjects experienced 59% of the risk of being diagnosed with colon cancer compared to the general population. 10 years after “normal colonoscopy”, subjects experienced only 28% of the risk of the unscreened population of being diagnosed with colon cancer. Therefore the economically based recommendation for 10 year follow up seems foolish.

Virtual Colonoscopy is criticized because of the radiation associated with this procedure. As virtual colonoscopy looks at the interface between air and soft tissue, the radiation dose can be reduced to significantly less than a traditional abdominal and pelvic cat scan. The estimated radiation dose for a virtual colonoscopy is 5 msv. This is equivalent to the cosmic radiation we are exposed to every 30 months at sea level. It is estimated that 50 msv radiation would increase a 50 year old’s lifetime risk of cancer by 0.1%. Therefore, starting at age 50 and having a virtual colonoscopy every 5 years would increase the lifetime likelihood of developing cancer by less than one in a thousand. Considering that there is over 160 times the likelihood of finding cancer or significant extracolonic findings than there is of developing a radiation induced cancer, this concern seems unimportant.

In conclusion, virtual colonoscopy should be covered. It is shown to be equal or superior to conventional colonoscopy in the detection of clinically important colonic neoplasms plus it has the advantage of finding extracolonic pathology. It is significantly less expensive than conventional colonoscopy and a better value based on life years saved. It is safer in all patients but especially for patients on anti-coagulant or anti-platelet therapy. Virtual Colonoscopy is endorsed by the American Cancer Society, the America College of Radiology, and the US Multi-Society Task Force on Colorectal Cancer.

Considering the fact that fewer than 50% of Americans do any type of colon cancer screening, it is important to make this easier and safer alternative available.

Indeed, the clinical DATA supporting the use of virtual colonoscopy from a safety and accuracy prospective is overwhelming. Studies have shown it to be more accurate, safer, and more cost effective than conventional colonoscopy. Should the initial position of non-coverage not be revisited and changed to a position of coverage of this valuable procedure, I feel that a congressional inquiry should be undertaken to find out why.

William L. Blanchet, MD
Boulder Internal Medicine
2880 Folsom Suite 100
Boulder CO 80304

1. Winawer SJ, Fletcher RH, Miller L, Godlee F, Stolar MH, Mulrow CD et al. Colorectal cancer screening: clinical guidelines and rationale. Gastroenterology 1997;112:594-642

2. American Cancer Society. Cancer facts and figures 2007

3. USPSTF 2002 Guide to Clinical Preventive Services, Second Edition

4. Winawer SJ and Shike, M. Prevention and control of colorectal cancer. In: Greenwald P.; Kramer BS; Weed DL, eds. Cancer Prevention and Control. New York: Marcel-Dekker, 1995. pp. 537-60.

5. National Polyp Study. N Engl J Med 2000;342:393-97

6. Z. Lefkovitz et al. Med Clin N Am 89 (2005) 111-138

7. Cotton et al JAMA, 2004

8. Pickhardt PJ, Nugent PA, Mysliwiec PA, et al. Location of adenomas missed by optical colonoscopy. Ann Intern Med. 2004;141:352-359.

9. van Gelder RE, Nio CY, Florie J, et al. Computed tomographic colonography compared with colonoscopy in patients at increased risk for colorectal cancer. Gastroenterology. 2004;127:41-48.

10. Computed Tomographic Virtual Colonoscopy to Screen for Colorectal Neoplasia in Asymptomatic Adults N Engl J Med 2003;349:2191-200

11. Gastrointest Endosc. 2005;61:AB-107. [Sp752]

12. Singh H; Turner D; Xue L; Targownik LE; Bernstein CN JAMA. 2006; 295(20):2366-73 (ISSN: 1538-3598)

13. VC in symptomatic patients over age 70 Am J Roentgenol 2007;189:1104-1111

14. JAMA. 2006; 295(20):2357-65

15. CT Colonography versus Colonoscopy for the Detection of Advanced Neoplasia N Engl J Med Volume 357(14):1403-1412 October 4, 2007

16. Cost-Effectiveness of Colorectal Cancer Screening With Computed Tomography Colonography Pickhardt PJ, Hassan C, Laghi A, Zullo A, Kim DH, Morini S, CANCER: Published Online: April 23, 2007 (DOI: 10.1002/cncr. 22668); Print Issue Date: June 1, 2007.

17. A Joint Guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology CA Cancer J Clin 2008 doe: 10.3322/CA.2007.0018

18. C. Daniel Johnson, M.D., M.M.M., Mei-Hsiu Chen, Ph.D., Alicia Y. Toledano, Sc.D., Jay P. Heiken, M.D., Accuracy of CT Colonography for Detection of Large Adenomas and Cancers n engl j med 359;12 www.nejm.org september 18, 2008.

19. Gut. Published online May 9, 2008. Anticoagulant and Antiplatelet Therapy for Endoscopic Procedures Reviewed

20. Ann Intern Med. 2006; 145(12):880-6 Complications of colonoscopy in an integrated health care delivery system

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After reading yout article on CMS not validating the CTC as a standardized testing method for screening colonography, I would like to suggest that the MCS use CTC for screening colonography. Without going on and on I would just like to say even though there is an amount of radiation involved, I believe that the information far out weighs the effects from the radiation. The patient can have a CTC at a cheaper cost to the patient. There is no anesthesia used which has its own side effects and can cause its own problems. You can see inside and outside of the colon whereas you cannot with the standardized colonoscopy.

In your response about what to do with additional findings, I would think this is a plus. If I was to have a CTC and there were no findings in the colon, I would be very grateful that on the extra findings they had found a problem that could possibly have been detected at an early stage.

Overall I believe this is a tool that should be offered and reimbursed with CMS approval. It is a lot less invasive and I should be able to choose what test I have to help detect cancer and any other problem that could come about from this test.

Thank you for considering this e-mail.

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Customer - 02/16/2009 09:32 PM
Dear Sir or MS: I am writing in reference to the proposal by CMS to not cover Ct colonoscopy.CT colonoscopy is an effective modality to screen for colorectal cancer. This has been shown by Perry Pickhardt, M.D et al in a recent article in the NEJM (2-18-2008 vol 359 nn. 12)In addition to being effective, CT colonography is a needed tool for early detection/screening for colorectal cancer. It is relatively non-invasive, therefore an appropriate option for individuals who are not able to have a visual colonoscopy. Althought it does not provide a means of treating polyps, it reduces the number of negative visual colonoscopies possibly reducing overall cost of screening and providing a venue for treatment of detected tumors. Only a fraction of individuals eligible for screening actually get screened, in part because there are not enough trained gastroenterologis to perform the procedure on all those who need it. Virtual colonoscopy is certainly more effective and more complete than flexible simoidoscopy and barium enema, both of which are covered services.Please reconsider the proposal not to reimburse for CT colonoscopy.
Maged Khalil, M.D.
Radiology Department
Newton Wellesley Hospital
Newton, MA 02462

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February 17, 2009

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

Re: Proposed National Coverage Decision on computed tomography colonography (CTC)

Dear Dr. Phurrough:

UnitedHealthcare thanks the Centers for Medicare and Medicaid Services (CMS) for the opportunity to comment on the CMS proposed National Coverage Decision (NCO) on the use of computed tomography colonography to screen for colorectal cancer.

About UnitedHealth Group
UnitedHealth Group, of which UnitedHealthcare is one business segment, is a diversified health services delivery company offering health care benefits to approximately 26 million Americans. Through its additional specialty companies, we touch the lives of approximately 68 million Americans. Our enrollees and beneficiaries reside in commercial, Medicare and Medicaid benefit designs.

UnitedHealthcare recommendation
UnitedHealthcare believes that published clinical evidence is sufficient to warrant benefit coverage for computed tomography colonography (CTC) as an alternative to colonoscopy to screen low risk and high risk persons for colorectal cancer.

Benefit coverage for preventive services
We are aware that Centers for Medicare and Medicaid Services (CMS) benefit design covers preventive services only in specified circumstances, e.g. influenza immunizations, colonoscopy to screen for colorectal cancer. We acknowledge further that the US Preventive Services Task Force (USPSTF) is generally recognized as offering the gold standard for recommendations for preventive services. UnitedHealthcare is proud to support the efforts of the Agency for Healthcare Research and Quality (AHRQ), sponsor of the USPSTF, to advance the use of evidence-based medicine. Today, the USPSTF states that the evidence is insufficient to make a recommendation for the use of CTC for colorectal cancer screening. That said, UnitedHealthcare believes that the evidence is sufficient to recommend expansion of coverage for colorectal cancer screening to include CTC, as specified, below.

Professional society recommendations
In 2008, the American Cancer Society (ACS) worked jointly with the US Multi-Society Task Force and the American College of Radiology to publish colorectal cancer guidelines. Based upon their review of the evidence, the task force concluded that screening of average-risk adults with CTC should begin at age 50 years with repeat examinations every five years if the initial CTC is negative for significant polyps. However, if current studies detect polyps 6mm or greater, colonoscopy should be offered. Additionally, CTC surveillance could be offered to those patients who would benefit from screening but either decline colonoscopy or who are not good candidates for colonoscopy for one or more reasons.

Rationale for CTC as a screening test for colorectal cancer
While colonoscopy is the gold standard screening procedure for colorectal cancer, many eligible patients avoid it for a variety of reasons, including its invasiveness and the possible need for sedation or anesthesia.

While CTC requires the same colonic preparation as colonoscopy, many patients perceive it as less invasive and, therefore, more acceptable. Since the purpose of colorectal cancer screening is to improve early identification of adenomatous polyps and localized cancers, coverage of CTC as an alternative to colonoscopy is likely to improve the rate of such early identification.

Clinical evidence supports the conclusion that computed tomography colonography has sensitivity and specificity comparable to conventional colonoscopy in detecting larger polyps and malignancies. Clinical evidence also suggests that computed tomography colonography can detect lesions in sections of the bowel that cannot be evaluated by conventional colonoscopy for various reasons such as unsuitable bowel configuration, bowel obstruction, poor bowel preparation and limited patient tolerance.

Disadvantages of CTC
UnitedHealthcare acknowledges that CTC may miss very small, flat lesions that would otherwise be detected by colonoscopy-if the patient permitted colonoscopy to be performed. In addition, if lesions are found on CTC, follow up colonoscopy must be done to biopsy and excise them. However, w~ believe that these disadvantages are more than offset by the advantages of improved rates of surveillance for a disease that is readily curable when localized, and exceedingly difficult to treat when it has metastasized.

Summary and conclusions
For the reasons stated above, UnitedHealthcare believes that improved survival from colorectal cancer is dependent upon improved rates of early detection. We believe that CTC is a sufficiently effective technology to improve early detection, and we believe that clinical evidence supports its use.

If you wish to discuss our comments further, please feel free to call me at (952) 992-4202.

Thank you for your consideration of our comments.

Sincerely,

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CT Colonoscopy (CTC) should be an approved method of detecting Colorectal Cancer.
1. CTC finds as many polyps and Colorectal Cancers as does fiberoptic (Traditional) colonoscopy.
2. CTC demonstrates the entire colon, the thickness of the wall and the adjacent anatomy, not just the inside of the colon as with fiberoptic colonoscopy.
3. CTC displays the colon in multiple ways. It allows visualization of the colon in a "fly through" method simulating fiberoptic colonoscopy in addition to transaxial and other digitally reconstructed views for a more complete evaluation of the entire colon.
4. Significant unexpected abnormalities are found in other organs such as the lower lung, abdomen and pelvis. These are commonly found and could not possibly have been seen by fiberoptic colonoscopy.
5. Danger of perforation of the bowel during CTC is much less than with fiberoptic colonoscopy.
6. Patients do not have fiberoptic colonoscopy because of the danger of perforation, the discomfort and the use of sedation. CTC scores better on all of these counts, sedation is rarely used with CTC; the patient can drive home or back to work. Not so with fiberoptic (Traditional) colonoscopy.
7. The COST of CTC is less than fiberoptic colonoscopy.

And the list goes on.

CTC should be an option for the patient and the patient''s physician.

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Virtual Colonography Screening should be paid for by CMS. There is the value when a Virtual Colonoscopy is done, the results can be made available; on a CD for example, for many other GI physicians or other referring Physicians to see. If CMS is only going to reimburse for the traditional Colonoscopy then the ONLY one who saw what seen during the exam was the Doctor who was performing the procedure. Medicine is a "Team effort” and this technology contributes visual diagnostic information to the patient and his or her Physician.

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I applaud the decision that the evidence is inadequate to conclude that CT colonography is an appropriate colorectal cancer screening test under §1861(pp)(1) of the Social Security Act. Colonoscopy is the gold standard test, shown by years of studies to detect and reduce colon cancer in a high percentage of cases. To add another test, expensive and unproven, that will often lead to colonoscopy anyway is totally unneeded. This is especially true as we find ourselves with limited resources and needs that requires wise expenditure of health care dollars.

In addition colonoscopy is, despite other claims,is very inexpensive on a cost-benefit ratio; safe and widely available. The total cost of physician fee and facility (outpatient) to Medicare is less than $700; which will be much less than CT colonography in most center.

Thank you for your decision and not yielding to manufacturers of expensive equipment and costly but unproven technology.

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To Whom It May Concern:

My name is David Kim and I am a researcher in CT colonography (CTC) at the University of Wisconsin. Our group at UW directs a large scale CTC screening program, having enrolled over 5,000 patients since April of 2004. I was the lead author of the New England Journal article (October 2007) that compared the advanced neoplasia detection rates between CT colonography and optical colonoscopy.

I am disheartened by the proposed decision of non coverage by Medicare due to inadequate evidence. In my opinion, the evidence strongly supports the use of CTC in the screening setting, particularly in comparison to other options currently on the accepted list. CTC holds substantially higher sensitivities and specificities for polyps and cancers than barium enema, flexible sigmoidoscopy, and FOBT. It has shown polyp detection rates comparable to optical colonoscopy (OC), particularly for those that truly matter (1-3). At the very least, screening CTC performance is equivalent to OC and there is emerging evidence that this noninvasive modality may even be superior for the detection of unsuspected colorectal cancers (where the prevalence in the Medicare population is much higher than in the 50-64 year old cohort (4)). The recent large population-based study by Baxter et al. reported that the protective effects of colonoscopy against cancers were predominantly related to left-sided lesions and not so for right-sided cancers (5). One potential explanation is related to missed cancers and observations in the CTC research realm support this possibility. A large Mayo Clinic study primarily investigating the differences in CTC performance related to CTC viewing strategies raised an unanticipated result (6). The highly trained Mayo colonoscopists (who were blinded to the CTC results) initially missed 4 of the 5 cancers in this series (CTC detected all of the cancers). It was not until the CTC results were revealed where the cancers were detected on subsequent endoscopies.

A major concern cited in the memo involves cost effectiveness. The Zauber analysis reports that screening by colonoscopy represents a more favorable economic option over CTC (7). Certainly, however, there are studies in the peer-reviewed literature that demonstrate the opposite (8). Putting these differing results aside, I would argue that the more pertinent comparison is the one that compares CTC screening to the situation of no screening. Compared to the no screening option, CTC certainly leads a more cost effective outcome (8, 9). It is vital that we maintain focus on current reality. Compliance with screening in the US is nowhere near acceptable levels with the currently available options, particularly for the Medicare population (10). It is estimated that over 40 million individuals in the US who are eligible for screening choose not to do so (11). Furthermore, it is clear that optical colonoscopy capacity cannot support this volume. CTC can help fill this need and is a cost effective approach to the option of no screening. The University of Wisconsin experience and Colon Health Initiative at Bethesda Naval Hospital have demonstrated that the institution of CTC alongside OC can indeed increase compliance rates and significantly increase screening numbers (12, 13). Colorectal cancer is one of the few truly preventable cancers and I am positive that CTC would make a huge impact in decreasing the future incidence of this deadly disease. I would urge CMS to reconsider the proposed non coverage decision. Such a decision will likely have huge detrimental effects where it may end the development and implementation of a very effective screening test simply due to reimbursement reasons. Perhaps a measured approach to coverage of this validated modality could be undertaken. A Centers of Excellence approach for CTC coverage would allow this modality to be implemented in an orderly fashion to aid in the national screening effort while addressing the raised concerns in the proposed decision memo.

Thank you for your time and consideration of this letter.

Sincerely,

David H. Kim MDAssistant Professor of RadiologyUniversity of Wisconsin School of Medicine and Public Health

References:

1. Pickhardt PJ, Choi JR, Hwang I, et al. Computed tomographic virtual colonoscopy to screen for colorectal neoplasia in asymptomatic adults. New England Journal of Medicine. 2003;349(23):2191-2200.
2. Johnson CD, Chen MH, Toledano AY, et al. Accuracy of CT colonography for detection of large adenomas and cancers. New England Journal of Medicine. 2008;359(12):1207-1217.
3. Kim DH, Pickhardt PJ, Taylor AJ, et al. CT colonography versus colonoscopy for the detection of advanced neoplasia. New England Journal of Medicine. 2007;357(14):1403-1412.
4. Jemal A, Siegel R, Ward E, Murray T, Xu JQ, Thun MJ. Cancer statistics, 2007. Ca-a Cancer Journal for Clinicians. 2007;57(1):43-66.
5. Baxter NN, Goldwasser MA, Paszat LF, Saskin R, Urbach DR, Rabeneck L. Association of Colonoscopy and Death From Colorectal Cancer. Ann Intern Med. 2009;150(1):1-8.
6. Johnson CD, Fletcher JG, MacCarty RL, et al. Effect of slice thickness and primary 2D versus 3D virtual dissection on colorectal lesion detection at CT Colonography in 452 asymptomatic adults. American Journal of Roentgenology. 2007;189(3):672-680.
7. Zauber AG, Knudsen AM, Rutter CM, et al. Cost-effectiveness of CT colonography to screen for colorectal cancer. Report to AHRQ from the Cancer Intervention and Surveillance Modeling Network (CISNET) for MISCAN, SimCRC, and CRC-SPIN Models.
8. Pickhardt PJ, Hassan C, Laghi A, Zullo A, Kim DH, Morini S. Cost-effectiveness of colorectal cancer screening with computed tomography colonography - The impact of not reporting diminutive lesions. Cancer. 2007;109(11):2213-2221.
9. Sonnenberg A, Delco F, Bauerfeind P. Is virtual colonoscopy a cost-effective option to screen for colorectal cancer? American Journal of Gastroenterology. 1999;94(8):2268-2274.
10. Cooper GS, Kou TD. Underuse of colorectal cancer screening in a cohort of Medicare beneficiaries. 2008: 293-299.
11. Seeff LC, Manninen DL, Dong FB, et al. Is there endoscopic capacity to provide colorectal cancer screening to the unscreened population in the United States? Gastroenterology. 2004;127(6):1661-1669.
12. Cash BD, Barlow DS. Computed Tomographic Colonography: A model for gastroenterology and radiology collaboration. AGA Perspectives;August/September 2008.
13. Schwartz DC, Dasher KJ, Said A, et al. Impact of a CT colonography screening program on endoscopic colonoscopy in clinical practice. American Journal of Gastroenterology. 2008;103(2):346-351.

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