Cardiac Catheterization Performed In Other Than A Hospital Setting

I am writing on behalf of a freestanding cath lab that we have operated for a number of years. We feel that repealing this NCD and leaving the decision to our local carrier’s discretion puts us at an unfair disadvantage. Our patients have had a lot of satisfaction with our facility because we have provided a high quality of care at a lower cost. We feel it is unfair to repeal this decision and would like to work towards a new national decision rather than leaving it up to our local carrier. We feel it is important to be accountable to quality standards and because of this our facility is Joint Commission Accredited. JCAHO has accredited us based on the same standards as hospital labs. Perhaps requiring labs to be accredited is the way to go. We strive to provide the highest quality of care to our patients and this repeal could thwart our initiatives in this area. We urge you not to repeal this NCD until there is a new NCD to take its place given the fact that there is little to no difference in complication rates of diagnostic catheterization procedures among freestanding labs versus hospital outpatient labs. Repealing this decision would have a harmful effect on our practice and our ability to deliver high quality and cost efficient services to our patients. Thank you for your consideration in this matter and an opportunity to comment on the proposed repeal of NCD Manual §20.25

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The Society for Cardiovascular Angiography and Interventions (SCAI) is a professional association representing 3,400 invasive and interventional cardiologists nationwide. SCAI promotes excellence in cardiac catheterization and angiography through physician education and representation, clinical guidelines and quality assurance to enhance patient care.

SCAI supports CMS's proposal to withdraw this national coverage policy. The proposed change reduces unnecessary oversight and regulations and is not an elimination of coverage. The AHRQ funded study found no reason to question the quality or safety of freestanding diagnostic cardiac catheterization laboratories. SCAI sees no reason for a unique, location specific, coverage policy for diagnostic cardiac catheterization.

If any local carriers or quality improvement organizations wish to develop local coverage policy for diagnostic cardiac catheterizations in freestanding facilities, we would like to work with them in those efforts. Please contact SCAI's Senior Director for Advocacy and Guidelines, Wayne Powell @ 301.493.2341 or wpowell@scai.org

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Specifically regarding the use of outpatient out-of-hospital diagnostic cath labs:I see the following advantages of out-of-hospital labs

1. Prevents the use of "ad hoc" PCI, where $3000 stents are placed without trial of reasonable medical therapy.

2. Allows patients true informed consent, where risks and benefits of PCI, medical therapy, or bypass can be discussed with patients and families.

3. Allows adequate loading of pre-procedural medications such as clopidogrel, which make PCI safer and less expensive, as well as avoiding its use and risks in patients who will ultimately go to bypass surgery.

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I have submitted a formal comment letter by mail on behalf our practice and its physicians and we have joined with 40 other cardiology practices to provide a more formal comment letter. I wanted to make sure received our comment urging repeal of CAG-00166N until a new ANCD can be put in place.

Our comments are as follows:

Clearwater Cardiovascular and Interventional Consultants is a 19-physician private medical practice in Clearwater, Florida. We have operated a freestanding cardiac catheterization laboratory in one of our three offices since 2001. Since inception, we have performed more than 6,000 diagnostic cath lab procedures in our lab and we have averaged about 1,500 cases per year each of the last four (4) calendar years. We are writing today to ask you to suspend repeal of National Coverage Determination (NCD) Manual §20.25 until a new NCD is issued.

We pride ourselves in providing excellent quality to our patients throughout our practice which includes the cath lab. Towards that end, we continually review our results and track our complication rates. We are proud to report that the complication rate in our practice cath lab is lower than that of the hospital labs in which we practice. Of course, we are very careful to follow the inclusion / exclusion criteria established by the American College of Cardiology / American Heart Association.

Our practice cath lab is located on the campus of a major community hospital which has interventional cardiology and cardiac surgery programs. We have a transfer agreement in place with the hospital.

We track patient satisfaction on a continuous basis in all areas of our practice, including the cardiac catheterization laboratory. We take pride in the fact that our patient satisfaction results in all areas, including the cardiac catheterization laboratory, compare favorably to national benchmarks.

Finally, we find our office cardiac catheterization laboratory is very efficient for the patients, the practice and the payors. We are aware that the cost to the payors is lower in our office-based cardiac cath lab than a comparable hospital-based lab for the same procedure.

We believe there are a number of reasons for CMS to suspend its consideration of repealing the NDC related to freestanding cardiac catheterization laboratories. Among the most important are the following:

1. Repeal of the NCD will not lead to an improvement in patient care.
2. Repeal of the NCD would result in significant and possibly life threatening hospital delays as our hospitals could not handle the increase in cath lab volume if the area freestanding cardiac cath labs were not able to treat Medicare patients.
3. CMS should not repeal the NCD Manual until a new NCD is ready.

With regard to the last reason, we understand the importance of having our facilities accredited as one way to help ensure quality. Our outpatient echocardiography and nuclear medicine laboratories are accredited by the Intersocietal Commission For Accreditation of Echocardiography Laboratories and the Intersocietal Commission For the Accreditation of Nuclear Medicine Laboratories, respectively. If CMS approved accrediting agencies for cardiac catheterization laboratories, we would be happy to undergo the accreditation process.

Thank you for this opportunity to comment on the proposed repeal of NCD Manual §20.25. We believe it is in the best interest of the patients, the public and the providers to take a thoughtful approach and to consider our suggestions.

Sincerely,

Clearwater Cardiovascular and Interventional Consultants

Michael D. Williamson, M.D.
Jorge P. Navas, M.D.
Federico E. Lenz, M.D.
Paul L. Phillips, M.D.
Aland R. Fernandez, M.D.
Jay K. Amin, M.D.
Richard Sola, M.D.
H. Andrew Hazlitt, M.D.
Jason T. Zelenka, M.D.
Jose L. Gallastegui, M.D.
Mark J. Hepp, M.D.
Paul E. Kudelko, Sr., D.O.
Douglas J. Spriggs, M.D.
David D. Dieterich, D.O.
Marilyn Y. Kuo, M.D.
Vanessa J. Lucarella, M.D.
Paul E. Kudelko II, D.O.
Bernardo Stein, M.D.
Kenneth C. Sabatino, M.D.
Frederic R. Simmons, Jr. CPA
Chief Executive Officer

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The decision to repeal payment for freestanding outpatient catheterization is being made with no data nor documentation to support such a move. As a member of a 23 member group which has operated two labs, on hospital campuses, for more than 5 years, I see no medical reason to justify such a decision. Furthermore, under current Medicare reimbursement, it is more cost effective for the government and patients to have catheterization performed in a nonhospital setting. I would submit that data to support such a decision should be obtained before being implemented.

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I am writing to urge you to suspend the proposed repeal of National Coverage Determination (NCD) Manual §20.25 until a new NCD is issued.

Our non-hospital cardiac catheterization laboratory provides services that are more cost-effective and result in better patient satisfaction than hospital-based labs. We are committed to evidence-based practices, comply with American College of Cardiology/Society for Cardiac Angiography and Interventions guidelines for freestanding cath labs, and participate in established accreditation programs (AAAHC and JCAHO). We have had no major complications in our lab and and have emergency transfer procedures in place. I believe the repeal of national coverage for our services would be punitive. With National Health Care in Canada and England, is it surprising that there are no free standing cath labs ?? I would certainly not let their model of health care delivery become ours !!! And are the American Hospital Association's (ASA)views surprising ?? As they struggle to hang on to every possible procedure/operation that they can, they are threatened by the prospects of even coronary interventions leaving their purview. Hospitals and their administrators have squandered millions of dollars over the years through inefficiencies and incompetence. Our freestanding cath lab not only operates as safely as the hospitals' labs, but we even do it more cost effectively. We are willing to work with CMS to define appropriate quality indicators for outpatient cardiac catheterization procedures. This evidence-based, data-driven evaluation of clinical and financial performance of non-hospital laboratories will not only allow CMS to make an informed decision regarding national coverage, but it will facilitate continuous quality improvement on an ongoing basis.

I urge CMS to suspend its proposed repeal of NCD Manual §20.25.

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Sir or Madam,
Our large cardiology practice performs diagnostic cardiac catheterization in two freestanding laboratories and have done so for several years. Data regarding complication rates and outcomes are meticulously kept. I can assure you that the complications are comparable to or fewer than those of outpatient catheterizations performed in hospital laboratories, which are in very close proximity. In addition, the procedures can be performed at lower cost in the freestanding labs. Furthermore, patient satisfaction and convenience is greater, in that therapeutic procedures (coronary interventions) are not done in the freestanding labs, thus allowing the schedule to run on time (hospital labs are notoriously late due to ad hoc PTCI). If sufficient data are not available to document safety, CMS should require that such data be submitted. In my opinion, however, reversal of the current policy with no data to justify reversal is not only Draconian, unfair and unprecedented, but will have a devastating effect on the financial stability of our practice and our ability to deliver high quality, cost-efficient, convenient services to our patients.
W. Daniel Doty, MD, FACC, FAHA
Chairman, Quality of Patient Care Task Force
Florida Chapter, American College of Cardiology
and Past President, Florida and Puerto Rico
Affiliate, American Heart Association

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I am requesting that you consider the following comments regarding the proposed repeal of the National Coverage Determinations (NCD) Manual 20.25.

The Cardiac Center at Harris is a freestanding out patient catheterization lab that opened in May of 1998. Our facility from the beginning has followed the ACC/SCA&I clinical guidelines and standards for performing procedures and overall operations. We voluntarily sought accreditation from JCAHO upon opening and currently have AAAHC accreditation. The facility has maintained accreditiation since that time and continues to meet and/or exceed the standards for JCAHO/AAAHC and ACC/SCA&I without ever having any violations or concerns.

We have an extensive quality improvement program that includes tracking outcomes, patient satisfaction, normal rates, physician peer review, patient safety and numerous other indicators that have been implemented by ACC/SCA&I, JCAHO and AAAHC. To date our complication rate is lower than the national average (in-hospital and out-patient) for diagnostic procedures. Patient satisfaction surveys continue to be high with numerous comments on the exceptional care and education that was provided. The facility normal rates continue to fall within the Emory guidelines.

It is apparent to physicians who care for patients at the bedside, that the drive to repeal the NCD is brought about by Radiologists and others who only have financial gain in mind. Diagnostic procedures are best left in the hands of the physicians who care for the patients, not an outside physician who never sees the patient for whom he or she is interpreting their study. Freestanding facilities such as ours provide the highest quality of patient care and diagnostics administered by the patient's physician who knows them best and who is the most qualified to administer their care.

Thank you for your considerations.

Respectfully,

David L. Parrish, MD, FACC

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The conclusions that the national policy should be to deny coverage seems unreasonable particularily since the literature does not support a safety or cost consideration that would drive this decision. The choice could just as easily be to support the trend to do catheterizations as an outpatient since the lack of data suggests this is a safe and effective way to handle Cardiac diagnostic services. The question of oversite could be directly addressed through certification, instead of universal denial. The inovative and cost effective approaches taken in the outpatient labs are rarely encouraged in the hospital.I strongly support a national policy that encourages an outpatient cardiac catheterization policy.

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I am requesting that you consider the following comments regarding the proposed repeal of the National Coverage Determinations (NCD) Manual 20.25.

The Cardiac Center at Harris is a freestanding out patient catheterization lab that opened in May of 1998. Our facility from the beginning has followed the ACC/SCA&I clinical guidelines and standards for performing procedures and overall operations. We voluntarily sought accreditation from JCAHO upon opening and currently have AAAHC accreditation. The facility has maintained accreditiation since that time and continues to meet and/or exceed the standards for JCAHO/AAAHC and ACC/SCA&I without ever having any violations or concerns.

We have an extensive quality improvement program that includes tracking outcomes, patient satisfaction, normal rates, physician peer review, patient safety and numerous other indicators that have been implemented by ACC/SCA&I, JCAHO and AAAHC. To date our complication rate is lower than the national average (in-hospital and out-patient) for diagnostic procedures. Patient satisfaction surveys continue to be high with numerous comments on the exceptional care and education that was provided. The facility normal rates continue to fall within the Emory guidelines.

Free standing diagnostic catheterization labs take the burden off the hospital catherization labs for diagnostic procedures enabling them to better utilize their staff and lab time for planned interventional and emergency procedures. The repeal of the NCD will not lead to an improvement in patient care, but will create a strain with the increased case loads in the hospital setting, which will ultimately lead to increased complications, patient dissatisfaction/inconvenience and continued loss of nursing staff due to burn out.

Sincerely,

Allison Elrod, RN

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Dear Sir or Madam,

I have been a cardiologist in Spokane Wa. for nearly 18 years and have worked in both the hospital setting as well as the outpatient arena.

Spokane Cardiology has a outpatient cath lab that opened in November 20003.

This has provided a high level of service to the patient in a very efficient and pleasant environment.

The costs to the payor system whether it be private or medicare, is less in this efficient environment.

Importantly our safety record is outstanding.
1) No deaths in approximately 2500 caths in 2 years including standard heart caths, carotid angigrams, and runoffs.
2) No strokes
3) 1 hematoma on average per month-rarely requiring admission to the hospital

This record and level of efficiency would warrant the continued operation of this outpatient cath lab, as well as others if they meet these high standards.

Sincerely,

Harold Goldberg, M.D.

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I am writing on behalf of a freestanding imaging center that performs diagnostic heart catherizations in a community in South Texas that has 4 hospital inpatient facilities for cardiac catherization. The JCAHO certified facility has been performing procedures since 2001. JCAHO certifies the freestanding facility utilizing the same standards as for catherization labs in the hospital setting. We utilize quality thresholds from nationally recognized organizations such as American Heart Association and American College of Cardiology. These thresholds are monitored on a quarterly basis by the governing committee. Very specific exclusion criteria are utilized, so that careful patient selection enhances our ability to provide safe testing. Our patient satisfaction surveys are outstanding. Because of our patient centered focus, preprocedure and post procedure education and caring staff, patients are more relaxed and comfortable than what our physicians have noted in a hospital environment.The physicians of this facility respectfully suggest that CMS suspend its consideration of repealing NCD Manual 20.25 and modify the coverage decision to include only accredited facilties. CMS currently relies on external reviews in relation to other health care providers such as hospitals, long-term care facilites and home health agencies. Our experience has shown that these procedures can be done safely in a nonhospital setting with high satisfaction rates by patients and providers and at a substantially lower cost compared to a hospital setting.

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The repeal of the (NDC)may create more regulatory confusion, significant financial loss, and force waiting periods due to a shift in patient volumes to other settings not staffed or equipped to handle the shift. This in itself would lead to a decrease in safety, patient outcomes and patient satisfaction. We believe that outside review along with a commitment to provide the highest standard of care is fundamental to long term success and that it is essential to establish a nationally recognized quality threshold for all freestanding catheterization laboratories under the quidance of the CMS. The repeal would not serve the best interests of this patient population.

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Dear Dr. Phurrough,
I am the Executive Director for Virginia Cardiovascular Specialists in Richmond, Va. We are 35 cardiologists with 8 offices covering Central Virginia. Our group is joining with 39 other practices to provide a more formal comment on the proposed repeal of the NCD for Cardiac Catheterizations performed in Other Than Hospital Setting. (CAG:# 00166N)Our group strongly believes that you should not repeal the current NCD until a new one has been drafted and approved. We support a new NCD that would allow for accreditation by an independent review organization for Free Standing Cardiac Catheterization Labs. Our group would also be happy to work with CMS on to identify appropriate data requirements.Thank you for the opportunity to respond.
Sincerely,
Ann Honeycutt

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First, Cardiovascular Associates of Kingsport, P.C. has joined 39 other cardiology groups that operate outpatient cath labs to suggest that CMS temporarily suspend its consideration of repealing NCD Manual §20.25. For reasons more fully discussed below, such a decision will prevent the potential disruption of diagnostic catheterization services in the Tri-cities service area.

Second, the Cardiovascular Associates of Kingsport, P.C. has filed a NCD request related to cardiac catheterizations performed outside a hospital setting no later than December 31, 2005. The focus of this Request was a proposal that freestanding cardiac catheterization laboratories be accredited by an independent review organization. The use of external reviewers is a practice currently utilized by CMS in relation to other health care providers (e.g., hospitals, long-term care facilities, home health agencies, etc.) and is appropriate to establish a quality threshold that will be nationally recognized.

There are a number of reasons for CMS to temporarily suspend its consideration of repealing its NCD relating to freestanding cardiac catheterization laboratories. Among the most important are the following:

1. Repeal of the NCD will not lead to an improvement in patient care.

There is no evidence that patients receive better quality care in hospital-based cardiac catheterization laboratories compared to freestanding cath labs. In fact, the 2005 AHRQ Report prepared by ECRI expressly stated:

The available evidence did not reveal substantial differences in complication rates of diagnostic catheterization procedures among freestanding clinics and hospital outpatient settings.

The truth is that the statistical evidence cited in the AHRQ Report showed that both the mortality and complication rates were lower in the freestanding cath labs than those in a fixed outpatient hospital setting. I am not suggesting that the hospitals are providing lower quality care since the same physicians perform the cardiac catheterization procedures in both settings. What I do suggest is that the cardiologists associated with the freestanding cath labs utilize appropriate inclusion/exclusion criteria for patients assigned to the freestanding cath labs. Consequently, repeal of the NCD will not improve the quality of patient care and, depending on decisions made by regional carriers, the data suggests the quality of patient care could decline if LCDs are issued denying Medicare reimbursement for freestanding catheterization labs.

2. The NCD’s Repeal Could Lead to Substantial Financial Losses

Cardiovascular Associates has invested substantial sums in facilities, equipment and staff to establish their freestanding cardiac catheterization laboratories. The millions of dollars invested in this freestanding cath lab would be put at risk by a decision to repeal the NCD. While I do not suggest that Kingport's investment decisions should be determinative of the CMS decision in this matter, the financial impact of that decision is due consideration, especially where there is no evidence that the quality of patient care will be improved by the proposed repeal.

The financial impact of the repeal of NCD Manual §20.25 could result from decisions made by regional carriers to deny reimbursement for freestanding cardiac catheterization laboratories. The result could be devastating. The typical cardiology practice has a patient population with an average age in the mid-60s and roughly half of a typical cardiologist’s patients are Medicare beneficiaries. There are few cardiology practices that could sustain the financial losses resulting from the lost eligibility of half their patients to use the freestanding cath lab in which we have invested more than $2.0 million.

It cannot be fairly assumed that the carriers will not act if the NCD is repealed. It can be fairly assumed that the carriers who consider whether to approve Medicare reimbursement for freestanding cardiac catheterization laboratories will use a variety of factors in making that decision that are not within an evidence-based approach. I believe that CMS (i) should and can appropriately inquire concerning the quality of care provided to Medicare beneficiaries by freestanding cath labs and (ii) should develop evidence-based approach that will inform its future decisionmaking in this area. Neither of these goals are achieved by repeal of NCD Manual §20.25.

3. CMS Should Not Repeal NCD Manual §20.25 Until A New NCD is Ready.

Cardiovascular Associates recognizes that, in performing its regulatory oversight responsibilities, CMS must have some assurance concerning the quality of care provided to Medicare beneficiaries. However, it cannot be assumed that such assurance will result from repeal of §20.25. Cardiovascular Associates will commit to provide CMS with a NCD application no later than December 31, 2005, that proposes that all freestanding cardiac catheterization laboratories must, within 24 months of issuing the NCD, be accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or Accreditation Association for Ambulatory Health Care (AAAHC).

While a new NCD requiring accreditation by a nationally-recognized organization would provide an appropriate threshold of quality assurance, it does not answer the questions posed in the AHRQ Report. For example, as part of an evidence-based coverage process, it is appropriate to determine the risk-adjusted mortality and complication rates in freestanding cardiac catheterization laboratories versus those labs that are hospital-based. In a study that differs from the one being conduct by Dr. Aversano, it is appropriate to determine the risk-adjusted mortality and complication rates related to performing PCI in freestanding versus hospital-based labs and what the appropriate inclusion/exclusion criteria should be.

As such, Cardiovascular Associates is willing to participate with CMS in this review through providing appropriate data. Physician representatives from Cardiovascular Associates would agree to work with CMS to identify and describe the appropriate data elements and assist the appropriate persons in collecting and analyzing this data over a specified period. I believe that such a process is consistent with the belief that evidence-based decisionmaking is a superior process and would improve the ability of CMS to make coverage decisions related to cardiac catheterizations.

Thank you for this opportunity to comment on the proposed repeal of NCD Manual §20.25. I believe that the interests of the patient, those who must provide regulatory oversight and the provider community will be best served by my proposal. I am happy to discuss any of these matters and answer any questions you might have. The best telephone number at which you can reach me is **********.

With regards,
Douglas Malie
Chief Executive Officer
Cardiovascular Associates of Kingsport, PC

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I am writing to you as a participant and practicing cardiologist in the Columbia Cardiology Diagnostic Center, which is a free- standing cardiac catheterization laboratory which began serving patients in September of this year. We are an 11 physician group who began our outpatient catheterization center (Columbia Cardiology Diagnostic Center) partially in response to a lack of hospital capacity at our regional hospitals for outpatient diagnostic angiograms. The provision of our services has resulted in a palpable improvement in patient care as evidenced by the enclosed patient satisfaction survey results. We are utilizing state-of-the-art imaging, nursing and technical facilities and, at the present time, only board-certified cardiologists are delivering service at our diagnostic center.

Given the fact that available evidence does not reveal any substantial differences in complication rates of diagnostic catheterization procedures among free-standing clinics versus hospital outpatient settings, we strongly urge you to SUSPEND REPEAL of the National Coverage Determination (NCD) Manual Number 20.25 until a new NCD is issued. This will allow us time to organize national standardization of independent outpatient catheterization facilities such that they can be clearly documented to be of equal efficacy and safety as hospital-based centers. Repealing the NCD at this time would be premature and ill advised.

In behalf of Columbia Cardiology Associates, I would like to thank you for your careful consideration of this matter and, again, urge you to read the patient satisfaction survey which is enclosed with this communication.

Please do not hesitate to call me at any time should you have questions about any aspect of this extremely important issue.

Sincerely,

Columbia Cardiology Diagnostic Center
9701 S.W. Barnes Road, Suite LL10
Portland, Oregon 97225
503-972-4343 - Fax 972-4345

WHAT OUR PATIENTS ARE SAYING ABOUT US:

• The staff humor was greatly appreciated by both of us.
• A good job explaining in detail what to expect.
• Good soup
• Great food
• The entire procedure was more than excellent and made it a pleasure
• Everything absolutely perfect
• The staff here is excellent! Keep up the great job.
• Keep on doing as you did today
• Glad I came here (And I agree!! Good job. Husband – Stan)
• Maybe should have call buttons for nurses
• Nursing staff is very friendly and professional
• If patients are scheduled in before the front desk receptionist “just let them know”. This environment is much nicer than being over in the hospital. It is great that everyone seems to be enjoying their work.
• Everyone was helpful and courteous. Thanks for not making me sick.
• Staff very polite.
• Our experience was extremely good. Great staff! Thank you.
• Everyone was great.
• Staff very courteous and professional. Had a very comfortable, painless experience. The pen wasn’t so good.
• Everyone was professional, friendly and great. The best hospital procedure/experience I have ever had. Keep up the great service! 
• A friendly, relaxed attitude is nice. Directions on how to locate the building was desirable and good. Good information by staff emphasized the doctor’s instructions – a good supplement to what he said.
• Excellent care – attentive, caring, thorough, kind, competent & patient (from CeCe through each nurse and technologist ad both doctors….) Thanks (daughter)
• Thanks – the best experience I’ve had – and I’ve had plenty experience to compare. Very friendly staff.
• CeCe was wonderful and has the same birthday that I have.”
• The positive attitude of the staff made it a comfortable and relaxing experience.
• I was most grateful.
• All my needs were met the entire time.
• Very caring professionals.
• Everyone was very nice and extremely helpful.
• I conclude that your people were very supportive, answered questions in a respectful way, and were most helpful in their guidance. Thank you.
• Everyone was great!
• Kathy was very cheerful and everyone was very nice!
• Treated very well. All staff was very friendly and helpful. We appreciate you!
• For something that had to be done, it was a comfortable experience.
• I love the gentle, peaceful, professional, helpful, kind, and fun-loving atmosphere! God bless you all! You are in my prayers.
• Everything was great. Staff was very supportive, helpful, and pleasant. Kept us well informed on what was going to happen and what did happen.
• Some music would be nice. Large windows with serene forest view was nice. Might also add a picture or painting to the holding room. Staff was exceptionally personable and friendly. Thanks, [Illegible].
• I enjoy a sense of humor and both Charlene and Kathy made for a relaxed atmosphere. Thank you.
• I think this is one of the nicest places I have been.
• Treated very well.
• The whole experience from beginning to end went well and was pleasant. Staff all professional and caring. Thank you,
• Thank you.
• Thank you so much!
• Excellent.
• Thanks for being so friendly and knowledgeable and making us feel so comfortable!
• Thank you.
• You have a great crew.
• Every effort was made to make this as reassuring and “enjoyable” as possible.
• We appreciate your very human and caring workplace. It was a very pleasant experience. Thank you.
• Make this a checklist and room for comments.
• Very personable staff; upbeat attitude appreciated.
• Outside building doorway could have been better marked with something like, “Entry – Peterkort Centre Building.” Everyone was wonderful. The entire procedure was a good experience.
• Great Staff!
• The nurses and doctors were outstanding. Made my wife and I at home. All were very professional. Thank you for everything.
• Totally professional and caring. Thanks.
• I really appreciate service given to me. I was set at ease because I was very apprehensive. Valium worked great.
• Awesome. Thank you.
• Thank you for a comfortable experience and totally professional manner in which I was treated.

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I write specifically to urge you to suspend repeal of National Coverage Determination (NCD) Manual §20.25 until a new NCD is issued.

Background

The freestanding cardiac catheterization laboratories were created for reasons unique to their community. These rationale range from lack of hospital capacity to insufficient hospital capital resources to meet demand to a difference of opinion whether additional catheterization laboratories were needed. The result has been vastly improved patient satisfaction and accessibility, lower costs for catheterization procedures than is otherwise possible in hospitals, and outcomes that are virtually indistinguishable between freestanding and hospital-based labs.

The achievement of comparable outcomes at a lower cost to payors is achievable due to adherence to quality clinical practices, the most important of which is utilization of the inclusion/exclusion criteria established by the American College of Cardiology/American Heart Association. In addition, we have transfer agreements that permit the emergency transfer of patients, and are able to perform intubations as well as insert an intra-aortic balloon pump where required.

The following are our group's Requests and comments:

First, we suggest that CMS temporarily suspend its consideration of repealing NCD Manual §20.25. For reasons more fully discussed below, such a decision will prevent the potential disruption of diagnostic catheterization services in our community.

Second, file a NCD request (“Request”) related to cardiac catheterizations performed outside a hospital setting no later than December 31, 2005. The focus of this Request will be a proposal that freestanding cardiac catheterization laboratories be accredited by an independent review organization. The use of external reviewers is a practice currently utilized by CMS in relation to other health care providers (e.g., hospitals, long-term care facilities, home health agencies, etc.) and is appropriate to establish a quality threshold that will be nationally recognized.

Rationale in Support of our Request

There are a number of reasons for CMS to temporarily suspend its consideration of repealing its NCD relating to freestanding cardiac catheterization laboratories. Among the most important are the following:

1. Repeal of the NCD will not lead to an improvement in patient care.

There is no evidence that patients receive better quality care in hospital-based cardiac catheterization laboratories compared to freestanding cath labs. In fact, the 2005 AHRQ Report prepared by ECRI expressly stated

The available evidence did not reveal substantial differences in complication rates of diagnostic catheterization procedures among freestanding clinics and hospital outpatient settings.

The truth is that the statistical evidence cited in the AHRQ Report showed that both the mortality and complication rates were lower in the freestanding cath labs than those in a fixed outpatient hospital setting. We do not suggest that the hospitals are providing lower quality care since the same physicians perform the cardiac catheterization procedures in both settings. What we do suggest is that the cardiologists associated with the freestanding cath labs utilize appropriate inclusion/exclusion criteria for patients assigned to the freestanding cath labs. Consequently, repeal of the NCD will not improve the quality of patient care and, depending on decisions made by regional carriers, the data suggests the quality of patient care could decline if LCDs are issued denying Medicare reimbursement for freestanding catheterization labs.

2. The NCD’s Repeal Could Lead to Substantial Financial Losses.

Practices who own or have joint ownership in outpatient cath labe have invested substantial sums in facilities, equipment and staff, sometimes in coordination with their local hospital, to establish their freestanding cardiac catheterization laboratories. The tens of millions of dollars invested in these freestanding cath labs would be put at risk by a decision to repeal the NCD. While I do not suggest that the provider community’s investment decisions should be determinative of the CMS decision in this matter, the financial impact of that decision is due consideration, especially where there is no evidence that the quality of patient care will be improved by the proposed repeal.

The financial impact of the repeal of NCD Manual §20.25 could result from decisions made by regional carriers to deny reimbursement for freestanding cardiac catheterization laboratories. The result could be devastating. The typical cardiology practice has a patient population with an average age in the mid-60s and roughly half of a typical cardiologist’s patients are Medicare beneficiaries. There are few cardiology practices that could sustain the financial losses resulting from the lost eligibility of half their patients to use the freestanding cath lab in which they have invested almost $2.0 million.

It cannot be fairly assumed that the carriers will not act if the NCD is repealed. It can be fairly assumed that the carriers who consider whether to approve Medicare reimbursement for freestanding cardiac catheterization laboratories will use a variety of factors in making that decision that are not within an evidence-based approach. We believe that CMS (i) should and can appropriately inquire concerning the quality of care provided to Medicare beneficiaries by freestanding cath labs and (ii) should develop evidence-based approach that will inform its future decisionmaking in this area. Neither of these goals are achieved by repeal of NCD Manual §20.25.

3. CMS Should Not Repeal NCD Manual §20.25 Until A New NCD is Ready.

In performing its regulatory oversight responsibilities, CMS must have some assurance concerning the quality of care provided to Medicare beneficiaries. However, it cannot be assumed that such assurance will result from repeal of §20.25. It is suggested that owners of will commit to provide CMS with a NCD application no later than December 31, 2005, that proposes that all freestanding cardiac catheterization laboratories must, within 24 months of issuing the NCD, be accredited by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or Accreditation Association for Ambulatory Health Care (AAAHC).

Thank you for this opportunity to comment on the proposed repeal of NCD Manual §20.25. We believe that the interests of the patient, those who must provide regulatory oversight and the provider community will be best served by our proposals.

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I have been associated with freestanding cardiac cath labs since they were first approved for payment by Medicare in 1988. When I was with the Heart Institute of the Desrt in Rancho Mirage, we had one of the 3 cath lab pilot projects for the State of California. It has been proven over the last 17 years that diagnostic catheterization in settings outside of a hosptial (with a transfer agreement in place for emergencies) is performed equally as safe as those in hosptials but at a lower cost to payers and more pleasant experinece for patients.

The group that am currently with has 2 cath labs that are each joined to hosptials under the same roof. Cardiology Consultants has joined with 39 other cardiology practices to provide a more formal comment, but as the Administrator here, I am urging CMS to suspend the proposed repeal until a new NCD can be put into place.

Thanks you for your consideration,

Andrew Radoszewski
Pensacola, Florida

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I would respectively request that you suspend the repeal of the NCD for cardiac catheterization in other than a hospital setting. We have joined with 39 other cardiology practices to provide a more formal comment in letter format, but we would like to sumbit these brief comments via the CMS website. We strongly believe that a repeal of the NCD would be have a negative impact for CMS recipients regarding quality care, patient choice and financially. We urge CMS to suspend the proposed repeal until a new NCD can be put into place.

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I am Administrator Of CardioVascular Associates of North Alabama, PC, a 29 physician Cardiology practice located in Birmingham Alabama. We have owned and operated an OutPatient Cardiac Catheterization Lab since 1996 and have done approximately 12,000 procedures. We have also joined 39 other cardiology practices asking that CMS suspend the proposed repeal of the free standing cath lab policy currently in effect until a new NCD can be put into place. Thanks you for your consideration of this request.

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We are writing to urge you to suspend the proposed repeal of National Coverage Determination (NCD) Manual §20.25 until a new NCD is issued.

Our non-hospital cardiac catheterization laboratories provide services that are more cost-effective and result in better patient satisfaction than hospital-based labs. We are committed to evidence-based practices, comply with American College of Cardiology/Society for Cardiac Angiography and Interventions guidelines for freestanding cath labs, and participate in established accreditation programs (AAAHC and JCAHO). Our laboratories have transfer agreements that secure the emergency transfer of patients if required. Over the previous 12 months, 4023 procedures have been performed in our facilities and 7 major complications have been documented: no deaths, no myocardial infarctions, 1 stroke, 3 pseudoaneurysms, 2 hematomas requiring transfusion, and 1 arteriovenous fistula, yielding a major complication rate of 0.17%. According to the 2001 ACC/SCA&I expert consensus document, the expected rate of major complications from hospital-based diagnostic catheterization is 1%-2%. In light of our compliance with guidelines and excellent outcomes, we view repeal of national coverage for our services as unfairly punitive. In addition, denial of reimbursement by local carriers will result in higher costs to CMS and reduced access to patients.

We recognize the possibility that not all freestanding cath labs comply with national guidelines or participate in accepted accreditation programs, and we agree with CMS that regulatory oversight is necessary. To this end, we are joining a coalition of affected parties to draft a request to CMS, which we intend to submit no later than December 31, 2005, proposing that freestanding cardiac catheterization laboratories be accredited by AAAHC or JCAHO, both of which currently accredit freestanding cath labs. We urge CMS to suspend its proposed repeal of NCD Manual §20.25 until it reviews this request. We wish to work in cooperation with CMS to define appropriate clinical and financial quality indicators for outpatient cardiac catheterization procedures, to collect the necessary data, and to submit this data to the designated organizations for analysis. This evidence-based, data-driven evaluation of clinical and financial performance of non-hospital laboratories will not only allow CMS to make an informed decision regarding national coverage, but it will facilitate continuous quality improvement on an ongoing basis.

We agree wholeheartedly that CMS should oversee the quality of care provided to Medicare beneficiaries by freestanding cath labs. Rather than delegate this responsibility to local carriers, we advocate the position that CMS should develop an evidence-based approach that will lead to a uniform national level of quality. Repeal of NCD Manual §20.25 will not accomplish this objective.

Sincerely,

Harry R. Jacobson, M.D.
Chairman
Cardiovascular Services of America, Inc.

David J. Maron, M.D., F.A.C.C.
Chief Medical Officer
Cardiovascular Services of America, Inc.

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We are writing to urge you to suspend the proposed repeal of National Coverage Determination (NCD) Manual §20.25 until a new NCD is issued.

Our non-hospital cardiac catheterization laboratories provide services that are more cost-effective and result in better patient satisfaction than hospital-based labs. We are committed to evidence-based practices, comply with American College of Cardiology/Society for Cardiac Angiography and Interventions guidelines for freestanding cath labs, and participate in established accreditation programs (AAAHC and JCAHO). Our laboratories have transfer agreements that secure the emergency transfer of patients if required. Over the previous 12 months, 4023 procedures have been performed in our facilities and 7 major complications have been documented: no deaths, no myocardial infarctions, 1 stroke, 3 pseudoaneurysms, 2 hematomas requiring transfusion, and 1 arteriovenous fistula, yielding a major complication rate of 0.17%. According to the 2001 ACC/SCA&I expert consensus document, the expected rate of major complications from hospital-based diagnostic catheterization is 1%-2%. In light of our compliance with guidelines and excellent outcomes, we view repeal of national coverage for our services as unfairly punitive. In addition, denial of reimbursement by local carriers will result in higher costs to CMS and reduced access to patients.

We recognize the possibility that not all freestanding cath labs comply with national guidelines or participate in accepted accreditation programs, and we agree with CMS that regulatory oversight is necessary. To this end, we are joining a coalition of affected parties to draft a request to CMS, which we intend to submit no later than December 31, 2005, proposing that freestanding cardiac catheterization laboratories be accredited by AAAHC or JCAHO, both of which currently accredit freestanding cath labs. We urge CMS to suspend its proposed repeal of NCD Manual §20.25 until it reviews this request. We wish to work in cooperation with CMS to define appropriate clinical and financial quality indicators for outpatient cardiac catheterization procedures, to collect the necessary data, and to submit this data to the designated organizations for analysis. This evidence-based, data-driven evaluation of clinical and financial performance of non-hospital laboratories will not only allow CMS to make an informed decision regarding national coverage, but it will facilitate continuous quality improvement on an ongoing basis.

We agree wholeheartedly that CMS should oversee the quality of care provided to Medicare beneficiaries by freestanding cath labs. Rather than delegate this responsibility to local carriers, we advocate the position that CMS should develop an evidence-based approach that will lead to a uniform national level of quality. Repeal of NCD Manual §20.25 will not accomplish this objective.

Sincerely,

Harry R. Jacobson, M.D.
Chairman
Cardiovascular Services of America, Inc.

David J. Maron, M.D., F.A.C.C.
Chief Medical Officer
Cardiovascular Services of America, Inc.

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I am writing on behalf of all the Cardiologists that own and operate a free standing cardiac catheterization laboratory. Atlantic Cardiolink was established and structured in December of 1997. Since then over a thousand procedures a year have been done at Atlantic Cardiolink. We write this letter to specifically urge to suspend repeal of National Coverage Determination (NCD) Manual 20.25 until a new NCD is issued.

Background:

Atlantic Cardiolink was established in 1997 with the idea to provide patients with a more convenient, cost effective alternative to hospitalization. The result is a state of the art facility that allows Cardiologists to provide superb services to their cardiac patients. Atlantic Cardiolink was Joint Commission accredited with commendation in 1998 and AAAHC in December 2001. We currently hold AAAHC accreditation. Atlantic Cardiolink is located 1,000 feet away from a major hospital. Atlantic Cardiolink’s Quality Assurance medical staff members are also part of a nearby hospital’s Quality Assurance program. Per Joint Commission JCAHO and AAAHC, we have certain requirements in place at Atlantic Cardiolink such as 911 transfer agreement, fire and hazard protocols, emergency protocols, and Code blue protocols. Emergency equipment such as an intra-aortic balloon pump, intubation trays, IV pumps and IV medication therapy are also available on site. Service agreements such as pharmacy consultant and biohazard collection materials are also in place. The above requirements are a small portion of the criteria needed in order to pass both JCAHO and AAAHC accreditation.

One of the key factors that makes Atlantic Cardiolink such a great outpatient cardiac catheterization lab is the fact that we are able to provide service to the physician and to the patients due to the close proximity of the facility. An example, the cath lab suite is only a few steps away from the patient’s recovery room allowing nurses and staff to discuss with physicians direct and appropriate care to the patient, whereas if we were to do this in a hospital setting, there would be separation of staff in different departments and floors that would be taking care of the patient, therefore allowing for a greater amount of margin for error.

Although we write to specifically repeal the NCD Manual 20.25, we do agree that new NCD rules or regulations should be in place. We agree that outpatient free standing cardiac catheterization laboratories should be accredited under JCAHO or AAAHC as done for hospitals and outpatient surgical centers.

By repealing the Medicare rule, you are in fact allowing a monopolistic hospital based idea to flourish. Our safety record speaks for itself. Until now we have done more than 7,000 patients with major and minor complication rates as compared to any national and regional standards. We would be happy to attend any further hearings to explain and render opinion of outpatient cardiac catheterization labs.

In conclusion, Atlantic Cardiolink is willing to participate with CMS in a new program that will allow other free standing cardiac catheterization labs as well as Atlantic Cardiolink to identify key elements for a benchmark process.

We respectfully request your attention to our petition.

Sincerely yours,
Erick Villalobos, Director

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While you are looking at the safety of performing cardiac cathterizations in freestanding labs, why not look at the added cost of performing these. I work in a hospital based lab that has 2 freestanding , physician owned labs ajoining. We often see patients that have known cardiac disease scheduled in the private labs then sent to the hospital for an intervention. As I understand it Medicare will pay the physicians for the diagnostic cath and the hospital for the intervention. If the diagnostic study and intervention are performed by the hospital the only patient would be charged for the intervention. Seems to me this would save the medicare system a lot of money.I think they should also be held to a standard of the number od "normal" studies that are done. Thanks you. Tim Ugaldea

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I wish to express my oposition to the removal of the national coverage decision on cardiac catherization. The establishment or change in program policy should be made based upon factual, medical evidence. The fact that the review authority for the QIO was eliminated, should not be the decidng factor to change a national policy. The review of the literature is clearly inconclusive in that no evidence was cited to indicate that the office setting is a safe and effective location for such a procedure. Additionally, to return the authority to each carrier, is contradictory to all of the recent efforts of CMS to achieve uniformity and consistency within the Medicare program. We should not have a hodge podge of coverage for such a procedure, given the fact that its volume is so significant, over 400,000 procedures in 2004, let alone the program expenditure of a few billion dollars a year since the procedure is performed in conjunction with a number of other CPT codes at the same time. It is also contradictory to the CMS transition to the MAC's, which will include a number of states within their jurisdiction. It will become extremely difficult to administer different policies in different states when all the claims are processed by the same entitity. As an alternative, I would recommend that CMS consider entering into demonstration projects, whereby CMS would waive the existing requirement that CC's be performed in hospital facitilities. As part of the demonstration, the agency can also have an evaluation of the safety and effectiveness of the procedure in such a setting.

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Given the current environment of national payors using all sorts of questionable coverage techniques to lower cost as is evidenced by the rash of out of court settlements on physician fee schedules, CMS' proposal makes little or no sense as it would allow the payors to determine whether or not to cover cardiac catherizations performed in free-standing centers. Such an approach will lead to further conflict between payors and physicians.

One significant variable left out of the equation is CMS' lack of consideration of the cost of cardiac catherization's in free-standing versus hospital settings. The technical component fees charged by hospitals are by far higher than those charged by free-standing centers. Curious that CMS staff doesn't consider this to be as big a problem as the growth in physician services leading it to implement the 4.4% reduction in Part B reimbursement due to the Sustainable Growth rate. The proposed rule will lead to further rate inflation on cardiac catherization services if carriers determine only those procedures performed in hospital settings will be covered and is fiscally unwise policy.

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As you consider this proposed change, please differniate between freestanding labs which do not have hospitals as partners vs those that are partnerships between physicians and hospitals.When hospitals are partners, the freestanding lab is often a strategy to assist hospitals to address the increasing interventioanl cath volume without having to modify their campus. In these cases, hospitals are an integral part of the quality oversight process and protocols are mirror images of those used in the hospital. Thank you

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As a lawyer who represents physician groups who have such freestanding cath labs as part of their practice, I note that your proposed decision fails to take two factors into account.

1. Some freestanding cath labs are joint ventures with hospitals and, as such, there are quality controls in place, including review by JCAHO.

2. There is no grandfathering provision and, as such, you place great financial risk on those practices who have made the significant financial commitment to include cath services as part of their office practice due to increased patient satisifaction and comparable quality of care.

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I believe there are two additional issues with free standing diagnostic cath centers that should have been addressed in your analysis:

1. What portion of diagnostic caths go on to have to have a therepuetic cath procedure? In full service centers these can be done in the same session, alleviating the need for an additional separate procedure.

2. What is the outcome of patients in both full service cardiac programs and free standing centers who have an unexpected event during a diagnostic cath. In other words, does the need for an emergency transfer from a free standing center result in poorer outcomes, for these patients.

By definition, a free standing dx cath center treats low risk (elective) patients. Since these patients are non-emergent, wouldn't they be better off traveling to a full service cardiac program, which is able to handle an emergency if it occurs?

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The effect of repealing the old policy is to defer the decision to local carriers and to state regulatory agencies (CON, Dept of Health, etc). Such action is only appropriate if the local carriers and state agencies then take positive action to determine if caths in non- hospital settings are safe or properly regulated. If the local carriers or state agencies take no action, there is the real possibility that unsafe and unregulated cath facilities could be set up. Medicare would then pay for caths in these facilities, in essence supporting possibly unsafe practices.

When CMS defers to local carriers or state agenices there should be a strong link to ensure that these agencies follow through with the responsibilities that have been delegated to them.

Thomas Reinke
Wallingford, PA

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