Cardiac Rehabilitation Programs

My colleagues and I at the non-profit Preventive Medicine Research Institute are writing in response to the December 22, 2005, Proposed Decision Memo for Cardiac Rehabilitation Programs (CAG-00089R).

On September 14, 2004, I sent a letter to CMS Administrator Dr. Mark McClellan entitled, “Formal Request for a National Coverage Determination for an Intensive LifestyleModification Program for Reversing Coronary Heart Disease.” In this letter, I wrote, “We are requesting a national coverage determination only for programs that have been scientifically proven to reverse the progression of CHD. Such programs are distinguished from traditional cardiac rehabilitation, which is much less comprehensive and intensive and, as a result, has not been proven to reverse CHD. The core components of the lifestyle modification program for reversing coronaryheart disease are as follows: (1) a very low-fat, whole foods diet, (2)moderate aerobic exercise, (3) stress management techniques, and (4) support groups. Each component is discussed in detail in the supporting documentation.”

This NCD request resulted in the Medicare Coverage Advisory Commission hearing on January 25, 2005 referenced in CAG-00089R. As I reaffirmed in my presentations there and, at the end of that day, the Medicare Coverage Advisory Commission peer reviewers voted that there was sufficient scientific evidence for CMS to cover intensive lifestylemodification programs that have proven to reverse the progression of coronary heart disease.

I also wrote in this letter to Dr. McClellan, “We would like to make it clear at the beginning that we are not asking for coverage of a branded, proprietary program. Rather, if approved, Medicare coverage would be available to any program that meets the CMS coverage criteria for patient eligibility and program content and delivery for this Lifestyle Modification Program,” i.e., that has been proven to stop or reverse the progression of coronary heart disease in studies published in peer-reviewed journals.

My colleagues and I are glad that CMS has undertaken a review of its coverage policies regarding cardiac rehabilitation. However, we believe that the coverage criteria outlined in the Proposed Decision Memo for Cardiac Rehabilitation Programs do not adequately recognize the critical differences between cardiac rehabilitation and programs that have been scientifically proven to stop or reverse the progression of coronary heart disease. The latter programs include a more intensive diet, a larger number and longer duration of sessions, and support groups and stress management components.

Therefore, we strongly believe that the best approach is to issue a separate NCD covering only intensive lifestylemodification programs for reversing coronary heart disease.

Should CMS decide to include intensive lifestyle modification programs within the same NCD as cardiac rehabilitation programs, we respectfully request that CMS should modify its recent NCD decision memo to clearly distinguish between cardiac rehabilitation and programs that have been scientifically proven to stop or reverse the progression of coronary heart disease. Whatever approach CMS adopts, the criteria should be adequate to provide coverage for scientifically proven programs to stop or reverse coronary heart disease progression using coverage criteria that closely mirror the components of the Medicare Lifestyle Modification Program Demonstration.

This distinction is important to make for several reasons. First, whereas cardiac rehabilitation is primarily palliative and offered for secondary prevention following a myocardial infarction or revascularization, intensive lifestylemodification programs for reversing coronary heart disease can be an alternative treatment to coronary artery bypass surgery and percutaneous coronary interventions. Mutual of Omaha found that almost 80% of patients eligible for revascularization were able to safely avoid it by making intensive lifestylemodifications instead, saving almost $30,000/patient in the first year compared with a matched control group. In a second demonstration project, Highmark Blue Cross Blue Shield reduced costs by 50% in the first year when compared with a matched control group and by an additional 20-30% in years two and three. These findings were published in peer reviewed medical journals. (Ornish, American Journal of Cardiology. 1998;82:72T-76T. Koertge, Am J Cardiol. 2003;91:1316-1322. Perelson, Circulation, 2005; 111(20), e311).

Second, the substantial cost savings clearly demonstrated to be associated with such programs make it cost effective and justifiable to reimburse intensive lifestylemodification programs for reversing coronary heart disease for a larger number of sessions, a higher cost/session, and to include components not found in cardiac rehabilitation programs such as stress management techniques and support groups. Also, the policy outlined in the decision memo would not allow sufficient duration, intensity, or specificity of program components to provide intensive lifestylemodification programs for reversing coronary heart disease as a covered Medicare service as cardiac rehabilitation. The intensive lifestylemodification programs for reversing coronary heart disease require up to twelve months of services with an intensity of two four-hour sessions per week for the first three months, and then one four hour session per week for the remaining months of service.

Third, the effects of intensive lifestylemodification programs on modifying risk factors are much greater than those found in cardiac rehabilitation programs. For example, LDL-cholesterol decreased by an average of 40% (without lipid-lowering drugs in one year in patients making intensive lifestylemodifications compared with an average of only 3-5% in programs which are based on exercise and an AHA/NCEP diet (Ornish, TheLancet. 1990; 336:129-133. Gould, JAMA. 1995; 274:894-901. Ornish, JAMA. 1998; 280:2001-2007). All three demonstration projects—the Mutual of Omaha demonstration project, the Highmark Blue Cross Blue Shield demonstration project, and the Medicare Lifestyle Modification Program Demonstration—showed bigger changes in diet and lifestyle, better clinical outcomes, and larger cost savings than have ever been reported in any cardiac rehabilitation study. For example, patients participating in an intensive lifestylemodification program for reversing coronary heart disease lost an average of 24 pounds in the first year (almost 12%) after one year whereas cardiac rehabilitation weight loss averages less than 2%.

In summary, intensive lifestylemodification programs for reversing coronary heart disease are more effective than cardiac rehabilitation when offered for patients post-myocardial infarction and post-revascularization. Also, in contrast to cardiac rehabilitation, intensive lifestylemodification programs for reversing coronary heart disease can be offered as an alternative treatment to revascularization.

Therefore, we respectfully request that an additional NCD be issued that would cover intensive lifestylemodification programs for reversing coronary heart disease as an alternative treatment to revascularization and as a more effective approach than cardiac rehabilitation for secondary prevention in patients post-myocardial infarction and post-revascularization. Should CMS decide to include intensive lifestyle modification programs within its cardiac rehabilitation decision memo, we strongly recommend that the current memo be modified to adequately and appropriately provide coverage for intensive lifestylemodification programs. Again, the Medicare Lifestyle Modification Program Demonstration should be used as a model for this coverage.

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Highmark is a health plan headquartered in Pittsburgh and Camp Hill, Pennsylvania, that serves more than 3.5 million members, with the mission of helping people live longer and healthier lives. The Dr. Dean Ornish Program for Reversing Heart Disease is one of the most effective ways the mission is experienced by Highmark members.

I recommend that the Dr. Dean Ornish Program for Reversing Heart Disease not be included in the National Coverage Decision for cardiac rehabilitation. Highmark covers both cardiac rehab and the Dr. Dean Ornish Program, two very different programs, because it is our goal to provide all evidence-based options and services for Highmark members, including those who are ready and prefer to make significant lifestyle improvements. The Program has generated such remarkable biometric and psychosocial outcomes that we have expanded the defined benefit coverage, making members eligible who have diagnosed heart disease, have had a previous cardiac event, diabetes and to those at risk for heart disease.

Since 1997 Highmark members have experienced consistent and often stronger clinical results than the original research. Highmark is proud to offer this intensive, multi-component lifestyle program to help our members slow, stop, and even reverse heart disease.

For these reasons, I suggest that an additional NCD is created for intensive lifestyle modification programs, such as the Dr. Dean Ornish Program, to accommodate individual choice and the future of preventive medicine. This is clearly a clinically and cost-effective option for Medicare beneficiaries, as well as the commercial population.

Sincerely,

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First, let me commend CMS for seeking to expand the availability of cardiac rehabilitation services to the Medicare population and also for seeking to provide coverage for intensive lifestyle/risk factor modification programs like the Dr. Dean Ornish Program for Reversing Heart Disease.

I am concerned, however, that putting intensive programs together with more traditionally limited services like cardiac rehab will not result in adequate coverage (in terms of intensity and duration of services) and reimbursement for the intensive programs. The intensive programs should be covered and reimbursed at an adequate level so they can become widely available to the Medicare population. Based on our plan’s experience with the Ornish program in West Virginia, these programs can be extremely successful clinically and very cost-effective. Most importantly, they can significantly improve the health and quality of life of seniors covered by Medicare.

West Virginia, which our plan serves, is the oldest state in the U.S. It also has the highest rate of mortality from cardiovascular disease. West Virginians rank at or near the bottom nationally for all preventable risk factors.

Mountain State Blue Cross Blue Shield and the West Virginia Public Employees Insurance Agency began covering the Ornish program three years ago. Over 400 individuals have participated in the program. Collectively, these individuals have reduced their risk of a cardiac event by 50% (using the ATP III Framingham Risk Tool). Think of what this reduced risk means to the individuals and their families, in terms of extended and enhanced quality of life.

If intensive lifestyle modification programs can achieve these results in West Virginia, they undoubtedly have tremendous potential to benefit Medicare-covered senior Americans across the country.

The average per participant cost of the Ornish program for our members is $5,700. In West Virginia, the average cost of a stent or bypass surgery is $57,000 to $67,000. Thus, if just one procedure is avoided by participation in an intensive lifestyle modification program, this individual pays for 10 others to participate and reap the benefits.

Intensive risk factor modification programs like Ornish should be covered not just for people who have recently experienced a heart attack or surgery, but as a treatment option for individuals with diagnosed heart disease or at documented high risk. The average age for a first heart attack is 66 for men and 70 for women (American Heart Association statistics). This is the Medicare population. 335,000 people die from a heart attack in the emergency room or on the way. The average years of life lost due to heart attack is 11 ½ years.

Surgery and stents can be life-saving procedures for many individuals. Cardiac rehab, with its traditional exercise focus and some attention to risk factor modification, can help individuals who have suffered an event return to activities of daily living. Intensive lifestyle modification programs can help people avoid surgery or a repeat procedure. It can also enable motivated individuals to significantly improve their physical health, emotional well-being and quality of life.

I have witnessed individuals crippled by angina and shortness of breath, reduced to use of a walker and wheelchair, and in daily fear of dying, return to an active, pain-free life after making needed comprehensive lifestyle changes supported by a multi-disciplined clinical team under the supervision of a physician. This type of clinically effective, low-cost opportunity should be made available to all seniors with heart disease.

I encourage you to craft a coverage decision for intensive, comprehensive lifestyle/risk factor modification programs that will enable seniors and CMS to obtain the full health and financial benefit of such programs. In the Ornish program offered to our members, participants are risk-stratified, and stay in the program for 12 weeks up to one year, depending on the severity of their condition and the speed of improvement. Clinical measures and outcomes (e.g., cholesterol, blood pressure, dietary intake of fat, exercise hours, functional capacity, depression) are measured at baseline and regular intervals.

The success of intensive programs is due to their comprehensive, clinically-based approach. A multi-disciplined clinical team addresses diet, exercise, stress management and social support. As noted earlier, such programs are much more intensive than cardiac rehab, but are also very low-cost and cost-effective when compared to the traditional surgical interventions.

In conclusion, I again commend CMS for seeking to expand the availability of risk factor modification programs for Medicare beneficiaries with heart disease. I had the privilege of testifying before the Medicare Coverage Advisory Committee and was extremely pleased that the Committee expressed a high degree of confidence in the effectiveness and likely net health benefits of comprehensive, intensive, multi-disciplined programs. I have seen firsthand the tremendous good these programs can do in restoring individuals with heart disease to good health and full lives. I strongly encourage you to draft a coverage decision that will specifically address the necessary components and duration of comprehensive lifestyle modification programs, and make these programs covered not just for individuals who have suffered an event or undergone a procedure, but for all individuals with symptomatic heart disease. This coverage decision should be followed by establishment of a reimbursement rate that will enable physicians and health care entities to establish multi-disciplinary clinical teams and at least recover the costs of serving seniors.

The greatest challenge to the highly-successful Ornish program in West Virginia is the lack of reimbursement for many participants who could benefit from the program. This lack of coverage threatens the viability of the clinical sites that offer the program. Medicare has always been a leader to whom commercial payers look. Please take this important opportunity for leadership, and craft a coverage decision for intensive lifestyle modification programs that will benefit thousands of senior Americans and their loved ones, likely save money for the Medicare program, and begin the important and necessary shift in both public and private health coverage toward effective means of supporting people to change their lifestyles and reduce the preventable risks that are responsible for such a huge proportion of health care costs and services in this country.

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Having oversight responsibility for a traditional cardiac rehabilitation program and being director of the Hamot Medical Center's Dr. Dean Ornish Program for Reversing Heart Disease, I strongly urge CMS to reconsider the revision of the Cardiac Rehabilitation NCD that currently includes intensive Lifestyle Modification Programs as part of the NCD. AS currently written, the NCD does not include the Ornish Program as a treatment option. Moreover, the NCD does not provide the program duration, intensity or clearly define the key program components of a viable Intensive Lifestyle Modification Program. It is my experience that the current NCD does not meet the program standards necessary to achieve results that have been scientifically evidenced. I urge CMS to revise the NCD so that the duration, intensity and program components of intensive lifestyle modification programs are adequately represented. Further, CMS needs to issue a second NCD that provides coverage for intensive lifestyle modification programs as a treatment option.Thank you for the opportunity to share my perspective on this important issue.

Walter Horner, MS
Director, Hamot Center for Healthy Living
Program Director, Dr. Dean Ornish Program
for Reversing Heart Disease
Hamot Medical Center
Erie, Pa.

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On behalf of our approximately 200 member hospitals and health care systems, the Illinois Hospital Association (IHA) is taking this opportunity to formally comment on the proposed decision memo for Medicare coverage of outpatient cardiac rehabilitation programs. This has been a very important issue for Illinois hospitals over the past five years and IHA is pleased to work with the Centers for Medicare and Medicaid Services (CMS) to ensure continued beneficiary access to this important and highly effective service. Following are the Association’s specific comments:

Physician Supervision: IHA supports the physician supervision revisions made to the coverage policy; however, the policy could be improved even more by a minor adjustment. The proposed policy states that cardiac rehabilitation services must be provided under the “directsupervision” of a physician. It then references several sections in the Medicare regulations that define “direct supervision” for services performed “incident to” a physician service in a hospital outpatient department and in a physician office. The CMS analysis section under “Physician Supervision” states: “The physician supervision requirement is generally assumed to be met where the services are performed on hospital premises; the hospital medical staff that supervises the services need not be in the same department as the ordering physician.” IHA recommends that the previous sentence, which is derived from Section 3112.4A of the Medicare Intermediary Manual, be placed directly in the coverage policy. This would clarify that for cardiac rehabilitation services provided on hospital premises, physician supervision can be provided as it is for other hospital outpatient department services; by relying on the hospital’s emergency department medical staff, through the hospital’s regular “code” team, or through another approach that assures the immediate availability of a physician for consultation or treatment in the event of a patient emergency.

Secondly, as “hospital premises” is not defined in the regulation, the Association recommends that CMS clarify that a hospital’s premises are not limited to the main building of the hospital but extend to the hospital’s “campus” as defined in 42 CFR 413.65 (a)(2) (“the physical area immediately adjacent to the provider’s main buildings, other areas, and structures that are not strictly contiguous to the main buildings but are located within 250 yards of the main buildings, and any other areas determined on an individual case basis, by the CMS regional office, to be part of the provider’s campus”). While some cardiac rehabilitation programs are located in the hospital’s main building, others can be found close to, but not physically within, the main building. In emergencies, these programs have immediate access to physicians through the same approaches described above.

Finally, the “direct supervision” requirement for cardiac rehabilitation programs is not feasible for many rural hospitals. Requiring a physician to be “immediately available to furnish assistance and on the premises” for a cardiac rehabilitation patient in a rural setting is not reasonable or practical. Highly skilled and trained staff monitor patients who participate in outpatient cardiac rehabilitation programs. Requiring an outpatient cardiac rehabilitation program to adhere to a higher standard than, for example, an emergency department is unreasonable and will force more rural hospitals to close their programs.

Therefore, the IHA recommends that the physician availability standards in the final coverage policy for cardiac rehabilitation in rural hospitals mirror those currently applied to emergency department services for the same facilities.

“Incident to” Physician: The CMS analysis section, under “Incident to,” states that the ordering physician is the “incident to” physician. The Illinois Hospital Association strongly opposes this decision. The concern is that the physician who orders the cardiac rehabilitation is often neither accessible nor appropriate to meet the on-going physician involvement requirements for “incident to” services. Such services require the ordering physician to “personally see the patient periodically and sufficiently often to assess the course of treatment and the patient's progress and, where necessary, to change the treatment regimen.”

Limiting this designation to the ordering physician would be a particular problem, again, in rural communities. Beneficiaries in rural areas often travel long distances to undergo surgery in a large urban hospital or regional referral center, and it is often this hospital’s surgeon who writes the order for the patient’s cardiac rehabilitation services. The patient then returns to their local community hospital for the ordered cardiac rehabilitation services. In this very common scenario, the patient’s on-going care is provided by the patient’s own cardiologist or primary care physician, not by the surgeon. It would be unreasonable to expect the patient to travelpotentially hundreds of miles to their surgeon for these services.

Rural or small hospitals also often use cardiology consultants, who travel from nearby cities to help manage the care of the hospital’s patients. In these cases, it is likely that the cardiology consultant is the ordering physician, and the patient’s primary care physician or the hospital’s cardiac rehabilitation program medical director then follows and manages the patient’s on-going care. This level of flexibility should be preserved for patients who receive cardiac rehabilitation services in small or rural hospitals. IHA recommends that CMS adopt a previous recommendation to broaden the definition. That is, there are three appropriate options for determining the physician to whom services are “incident to”:
1. the ordering/referring physician,
2. the patient’s own primary care physician or cardiologist, or
3. the cardiac rehabilitation program’s medical director or program-affiliated physician.

During the course of cardiac rehabilitation treatment, this physician would be responsible for assessing the course of treatment and the patient’s progress and, where necessary, changing the treatment regimen. It should also be appropriate for the designated “incident to” physician to change through the course of cardiac rehabilitation treatment, as long as the change is noted in the patient’s medical record.

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On behalf of the Iowa Hospital Association’s (IHA) 116 member hospitals, we appreciate this opportunity to comment on the Centers for Medicare & Medicaid’s (CMS) proposed decision memo (PDM) for cardiac rehabilitation programs. The following are IHA’s comments.

Indications and Limitations of Coverage
The IHA supports the decision to expand the diagnoses covered under Medicare to include acute myocardial infarction, coronary artery bypass graft, stable angina pectoris, heart valve repair/replacement, percutaneous transluminal coronary angioplasty, and heart or heart-lung transplant. The research summarized in the PDM demonstrates that beneficiaries with these diagnoses will benefit from cardiac rehabilitation services, and the expansion of covered diagnostic categories will ensure that more beneficiaries have access to these important services.

Physician Supervision
While the IHA supports the physician supervision revisions made to the coverage policy, we believe the policy can be improved by a minor adjustment. The proposed policy states that cardiac rehabilitation services must be provided under the “direct supervision” of a physician. It then references several sections in the Medicare regulations that define “direct supervision” for services performed “incident to” a physician service in a hospital outpatient department and in a physician office. The CMS analysis section under “Physician Supervision” (but not in the proposed coverage policy) states: “The physician supervision requirement is generally assumed to be met where the services are performed on hospital premises; the hospital medical staff that supervises the services need not be in the same department as the ordering physician.”

The IHA recommends that this sentence, which is derived from Section 3112.4 A (Outpatient Therapeutic Services) of the Medicare Intermediary Manual, be placed directly in the coverage policy. This would clarify that for cardiac rehabilitation services provided on hospital premises, physician supervision can be provided as it is for other hospital outpatient department services; by relying on the hospital’s emergency department medical staff, through the hospital’s regular “code” team, or through another approach that assures the immediate availability of a physician for consultation or treatment in the event of a patient emergency.

“Incident to” Physician
The CMS analysis section, under “Incident to,” states that the ordering physician is the “incident to” physician. The IHA strongly opposes this short-sighted and inflexible decision. Our concern is that the physician who orders the cardiac rehabilitation is often neither accessible nor appropriate to meet the on-going physician involvement requirements for “incident to” services. Such services require the ordering physician to “personally see the patient periodically and sufficiently often to assess the course of treatment and the patient's progress and, where necessary, to change the treatment regimen.”

Limiting this designation to the ordering physician would be a particular problem in rural communities. Beneficiaries in rural areas often travel long distances to undergo surgery in a large urban hospital or regional referral center, and it is often this hospital’s surgeon who writes the order for the patient’s cardiac rehabilitation services. The patient then returns to their local community hospital for the ordered cardiac rehabilitation services. In this very common scenario, the patient’s on- going care is provided by the patient’s own cardiologist or primary care physician, not by the surgeon. It would be unreasonable to expect the patient to travel potentially hundreds of miles to their surgeon for these services.

Rural or small hospitals also often use cardiology consultants, who travel from nearby cities to help manage the care of the hospital’s patients. In these cases, it is likely that the cardiology consultant is the ordering physician, and the patient’s primary care physician or the hospital’s cardiac rehabilitation program medical director then follows and manages the patient’s on-going care. This level of flexibility should be preserved for patients who receive cardiac rehabilitation services in small or rural hospitals.

The IHA recommends that, instead of a narrow policy defining the “incident to” physician as the ordering physician, CMS adopt a previous recommendation to broaden the definition. That is, there are three appropriate options for determining the physician to whom services are “incident to” – the ordering/referring physician; the patient’s own primary care physician or cardiologist; or the cardiac rehabilitation program’s medical director or program-affiliated physician. During the course of cardiac rehabilitation treatment, this physician would be responsible for assessing the course of treatment and the patient’s progress and, where necessary, changing the treatment regimen. It should also be appropriate for the designated “incident to” physician to change through the course of cardiac rehabilitation treatment, as long as the change is noted in the patient’s medical record.

Components of Cardiac Rehabilitation Services
The IHA supports CMS’ revised definition of cardiac rehabilitation as a comprehensive long- term program including a medical evaluation, cardiac risk factor modification (e.g. nutritional counseling), prescribed exercise, education and counseling. However, as several of these components are covered separately under Medicare, we request that CMS clarify proper billing procedure. For instance, may the hospital separately bill an evaluation and management code for the medical evaluation that is performed in the facility? If a beneficiary receives medically necessary services within the facility, such as individual psychosocial services or nutritional counseling, in conjunction with their course of cardiac rehabilitation, would these services be separately billable?

If these services are not separately billable by the facility, then the IHA recommends that upon finalization of the cardiac rehabilitation coverage requirements, the payment rate for the service be reconsidered. Each of these newly identified comprehensive program components result in additional direct and indirect costs to the facility, and the payment rate for the service should be commensurate with the additional costs the facility will bear. The IHA recommends that the service be referred to the Advisory Panel on Ambulatory Payment Classification (APCs) Groups for reconsideration of the Healthcare Common Procedure Coding System (HCPCS) codes packaged within APC 0095, Cardiac Rehabilitation and that the APC payment rate be recalculated.

Duration
The IHA supports CMS’ decision to lengthen the time over which a course of cardiac rehabilitation therapy may be provided and increase the number of sessions that may be provided over the allowed period. The PDM would allow a course of up to 36 cardiac rehabilitation sessions over 12 to 18 weeks without individual review by a Medicare contractor and up to 72 sessions of cardiac rehabilitation over 36 weeks with Medicare contractor review. This change will allow greater flexibility for beneficiaries, particularly those living in rural areas who may have difficulty traveling long distances several times a week to receive services.

However, we request that CMS clarify that the maximum time period to conduct cardiac rehabilitation with contractor review is 36 weeks, as included in the proposed policy, and not 24 weeks, as was stated in the CMS analysis section under “Number of Sessions and Frequency.”

In conclusion, the IHA again thanks CMS for proposing changes that mark a significant improvement over existing policy.
Sincerely,

Heather Hulscher
Director, Finance Policy
Iowa Hospital Association

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I strongly support the expansion of covered diagnoses for cardiac rehab to include PTCA and valvular heart procedures. In my experience as a Medical Director for a hospital-based cardiac rehab program I see patients on a daily basis who have these diagnoses. I believe the opportunity to educate patients following an acute coronary intervention is extremely valuable and the cardiac rehab experience reinforces compliance regarding modifiable coronary risk factors. In addition, valvular heart patients often struggle with a delayed surgical recovery, and demonstrate improved activity levels in the setting of a medically supervised program. I strongly encourage the re-evaluation of CHF and peripheral vascular disease patients who would also benefit from cardiac rehab services. These patients have significant disease-related lifestyle impediments which could be improved by intensive risk factor modification and supervised exercise offered by a comprehensive cardiac rehab program.

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First, I would like to thank you for your proposed expansion of coverage to also include patients who have undergone heart valve repair/replacement; have had percutaneous transluminal coronary angioplasty; or have had heart or heart lung transplant. This change, along with the others noted within the document support the provision of evidenced-based practice in the cardiac rehabilitation setting.

However, I would recommend a change related to the proposed language designating the “incident to” physician. The proposed decision memo currently states:

“In the case of the cardiac rehabilitation, the ordering physician is the “incident to” physician.”

As a primary care physician, I am not comfortable being assigned the ‘incident to’ responsibility. When a primary care physician refers a patient to an outpatient cardiac rehabilitation program, they are often relying on the clinical expertise of the program Medical Director and would expect this physician to assume “incident to” responsibility. If the referring physician is a specialist (cardiologist, cardiac surgeon), I expect that they might feel comfortable with this responsibility.

Given that the referring physician can either be a specialist or a primary care physician, and each physician may have a different comfort level in taking on this responsibility, I recommend the language be amended to state:

“In the case of cardiac rehabilitation, the“ incident to” requirement can be met by any physician who is supervising or monitoring the program including the referring physician or the Medical Director.

An unintended outcome of requiring that only the referring physician can assume the responsibility of ‘incident to’ may be that a primary care physician will not refer an appropriate patient to Cardiac Rehab. This will prevent appropriate and timely access to services for the patient. Medicare and the patient will incur additional expenses if the patient needs have an appointment with the specialist in order to receive a referral for Cardiac Rehabilitation.

Sincerely,

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First, I would like to thank you for your proposed expansion of coverage to also include patients who have undergone heart valve repair/replacement; have had percutaneous transluminal coronary angioplasty; or have had heart or heart lung transplant. This change, along with the others noted within the document support the provision of evidenced-based practice in the cardiac rehabilitation setting.

However, I would recommend a change related to the proposed language designating the “incident to” physician. The proposed decision memo currently states:

“In the case of the cardiac rehabilitation, the ordering physician is the “incident to” physician.”

As a primary care physician, I am not comfortable being assigned the ‘incident to’ responsibility. When primary care physicians refer patients to an outpatient cardiac rehabilitation program, they are often relying on the clinical expertise of the program Medical Director and would expect this physician to assume “incident to” responsibility. If the referring physician is a specialist (cardiologist, cardiac surgeon), I expect that they will feel comfortable with this responsibility.

Given that the referring physician can either be a specialist or a primary care physician, and each physician may have a different comfort level in taking on this responsibility, I recommend the language be amended to state:

“In the case of cardiac rehabilitation, the“ incident to” requirement can be met by any physician who is supervising or monitoring the program including the referring physician or the Medical Director.

An unintended outcome of requiring that only the referring physician can assume the responsibility of ‘incident to’ may be that a primary care physician will not refer an appropriate patient to Cardiac Rehab. This will prevent appropriate and timely access to services for the patient. Medicare and the patient will incur additional expenses if the patient needs have an appointment with the specialist in order to receive a referral for Cardiac Rehabilitation.

Thank you for your consideration in this important matter.

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The American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) and the American College of Cardiology (ACC) welcome the opportunity to comment on the proposed decision memo outlining changes to the national coverage policy for cardiac rehabilitation. AACVPR is the leading professional health care association focusing on cardiac and pulmonary rehabilitation, and its members include physicians, nurses, respiratory therapists, physical therapists, exercise physiologists and other allied health professionals. ACC is a 30,000 member non-profit professional medical society and teaching institution whose mission is to advocate for quality cardiovascular care—through education, research promotion, development and application of standards and guidelines—and to influence health care policy. The College represents more than 90 percent of the cardiologists practicing in the United States.

We commend the Centers for Medicare and Medicaid Services for promulgating the proposed revisions to its current cardiac rehabilitation policy and we believe that, overall, the revisions reflect thoughtful consideration of comments previously submitted by the AACVPR, the American College of Cardiology (ACC) and the American Hospital Association (AHA). We also believe that the new policy reflects the current state-of-the-art and clinical evidence supporting the efficacy of cardiac rehabilitation.

PRIMARY ISSUES:

Triggering Diagnoses: We commend CMS for expanding its coverage criteria for cardiac rehabilitation and support adoption of the proposed expanded diagnoses. We do strongly recommend, however, a slight change in wording to ensure that Medicare beneficiaries who have received stents and related procedures are not unintentionally excluded from coverage. To address that, we recommend using the term percutaneous coronary intervention (PCI) rather than percutaneous transluminal coronary angioplasty (PTCA).

We appreciate the diligent and comprehensive review of the heart failure literature and look forward to timely future discussions with CMS regarding the benefits of cardiac rehabilitation for patients with heart failure when pending studies are completed and formally reported.

Physician Supervision: We also support CMS’ revisions to the physician supervision components of the policy. We regard this proposal as a major step forward and we commend the Agency for its acceptance of recommendations from AACVPR, ACC, and the American Hospital Association. We support the current Medicare policy that generally focuses on a 250 yard parameter for separate buildings on the hospital campus. We do recommend, however, inclusion in the actual policy a specific reference that appears throughout various Medicare manuals – physician supervision is presumed to be met when provided on the hospital premises.

Additionally, it is our understanding that CMS does recognize that it has inadvertently used a confusing term regarding physician supervision when it stated, “ …if the services are furnished outside the hospital, they must be rendered under the direct personal supervision (emphasis added) of a physician who is treating the patient.” We recommend that CMS clarify its use of direct supervision in the final decision memorandum to ensure that providers and contractors are not inadvertently confused by this phrasing.

“Incident to” Physician: CMS has stated that the “incident to” physician is the ordering physician. We do not support this singular approach for clinical as well as practical management reasons. If the ordering physician is also the physician who must meet the ongoing physician involvement requirements spelled out as part of CMS’ definition of what constitutes “incident to” services, there are common and frequent scenarios where it is not clinically coherent to require the ordering physician to “personally see the patient periodically and sufficiently often to assess the course of treatment and the patient's progress and, where necessary, to change the treatment regimen.” While we agree with the appropriateness of this level of physician involvement, the ordering physician might be the cardiac surgeon or other physician who is not the clinically appropriate physician to provide oversight of the patient’s progress through the CR program.

We also concur with the American Hospital Association’s statement that limiting this designation to the ordering physician would be a particular problem in rural communities. According to the AHA, beneficiaries in rural areas often travel long distances to undergo surgery in a large urban hospital or regional referral center, and it is often this hospital’s surgeon or interventional cardiologist who writes the order for the patient’s cardiac rehabilitation services. The patient then returns to their local community hospital for the ordered cardiac rehabilitation services. In this very common scenario, the patient’s on-going care is provided by the patient’s own cardiologist or primary care physician, not by the surgeon. It would be unreasonable to expect the patient to travel potentially hundreds of miles to their surgeon for these services.

Rural or small hospitals also may use cardiology consultants, who travel from nearby cities to help manage the care of the hospital’s patients. In these cases, it is likely that the cardiology consultant is the ordering physician, and the patient’s primary care physician or the hospital’s cardiac rehabilitation program medical director then follows and manages the patient’s on-going care. This level of flexibility should be preserved for patients who receive cardiac rehabilitation services in small or rural hospitals.

Finally, in some cardiac rehabilitation programs, the program medical director facilitates coordination of care related to exercise and secondary prevention issues, communicating closely with the patient’s other physicians. In this scenario, the program medical director assumes the responsibility to assess the course of cardiac rehabilitation treatment and the patient’s progress, facilitating change of the treatment regiment as appropriate.

As an alternative, we recommend that CMS adopt a position that, for the purposes of cardiac rehabilitation, defines the “incident to” physician as the physician most clinically appropriate to manage issues which arise during the course of cardiac rehabilitation. This definition affords important flexibility to the cardiac rehabilitation program but nevertheless requires identification of a specific physician at the commencement of cardiac rehabilitation. It is this physician who accepts clinical responsibility to assess the course of treatment and the patient’s progress, changing the treatment regimen as appropriate.

Definition of Cardiac Rehabilitation: We strongly supports CMS’ revised definition of cardiac rehabilitation as a comprehensive long term program including a medical evaluation, cardiac risk factor modification prescribed exercise, education and counseling. This is important recognition of the true core components of cardiac rehabilitation as it has evolved over the past two decades.

However, we do believe the CMS statement that cardiac rehabilitation services are “typically initiated 1-3 weeks after hospital discharge and provide appropriate ECG monitoring” could be misinterpreted by contractors. There are many legitimate clinical scenarios where the beneficiary might not start cardiac rehabilitation within that time frame and contractors might infer from the CMS statement that rehabilitation that begins several months after discharge from the hospital does not meet the new entrance criteria. We recommend that CMS instruct its contractors to provide reasonable flexibility for the commencement of cardiac rehabilitation. Alternatively, specific reference to a 1-3 week time frame could be deleted from policy.

Rhythm Strips: We support CMS’ revision regarding rhythm strips, but again we seek clarification regarding two aspects of the new policy. As proposed, a “clinician” is permitted to determine the appropriateness of the need for ECG monitoring, and we request that the definition of this clinician be clarified. Because the need for ECG monitoring for a specific patient is based on medical criteria, we suggest that the physician who is performing the medical evaluation for cardiac rehabilitation determine the need for ECG monitoring for that particular patient.

Secondly, we recognize that CMS wants to provide a certain level of latitude to its contractors to implement coverage decisions, but we must state our concerns with this specific instruction because it appears to give the contractor incredibly broad latitude. For example, the current policy gives the contractor latitude regarding physician supervision: It does not require that a physician be physically present in the exercise room itself, provided the contractor does not determine that the physician is too remote from the patients' exercise area to be considered immediately available and accessible. A limited number of contractors unilaterally determined that every cardiac rehabilitation program, without exception, had the physician too remote, thereby requiring physician presence at all times. We are simply fearful that well intentioned contractors impose rules that are not clinically sound and inhibit true risk stratification.

We recommend that CMS modify its proposed policy to require the physician who performs the medical evaluation for cardiac rehabilitation to specify the appropriateness and need for ECG monitoring.

Duration: AACVPR also supports the CMS recommendation to expand the duration of cardiac rehabilitation to 18 weeks. This provides important flexibility, particularly to rural hospitals, where it is often difficult for cardiac rehabilitation patients to travel far distances 3 times a week for rehabilitation services.

SECONDARY ISSUES:

Stress testing: We support the removal of specific references to stress testing from this policy and assume that stress testing related to cardiac rehabilitation participation will be covered when reasonable and necessary, based upon CMS policy specific to stress testing.

Other Diagnostic and Therapeutic Services: As mentioned above, we support the revised definition of cardiac rehabilitation as a comprehensive service and support the appropriate deletion of related references to varied health services.

Staffing: We support the revised language regarding appropriate staffing for cardiac rehabilitation services, but we do seek clarification of an important component of staffing issues. First, as indicated above, on occasion a beneficiary may be referred by the program for specific nutritional counseling, psychosocial services, etc. We would find it useful for CMS to clarify which professionals on the cardiac rehabilitation team are authorized to make such referrals.

Secondly, although the proposed physician supervision requirements reflect a vast improvement over current policy, we would like additional clarification of the circumstances under which CMS will accept physician assistants, nurse practitioners and other recognized health professionals to provide certain services traditionally provided by physicians.

Facility: We support the revised language regarding facility requirements.

In conclusion, we believe that CMS has done an excellent job in revising its national coverage policy for cardiac rehabilitation and this new policy clearly reflects the current comprehensive nature of the services our members provide. With slight adjustment to certain aspects of the proposed policy, we heartily endorse and support this new approach.

Sincerely,

Marjorie King, MD, FACC, FAACVPR
President, American Association of Cardiovascular and Pulmonary Rehabilitation

Pamela S. Douglas, MD, FACC
President, American College of Cardiology

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I wish to take this opportunity to applaud your decision to expand the diagnoses that will be covered by this new ruling. It will truly serve to benefit those patients who in the past would have been told that Cardiac Rehab was not an option for them. This in spite of the personal knowledge and experience of the rehab staff and referring physicians that such a program would have been an invaluable source of knowledge, social support, physical conditioning, and lifestyle modification so necessary to the attenuation of their disease process. In light of this I would strongly encourage you to reconsider your decision not to include CHF as a valid diagnosis. The number of patients we see referred to our program by their physicians with a diagnosis of CHF continues to grow annually. These are physicians who are attuned to the benefits, listed earlier, that a Cardiac Rehab program offers all heart patients and are seeking every available avenue in the treatment/management of this debilitating disease process. While the statistical evidence may not yet be available to support what we in the field see on a daily basis I can speak, from first hand experience, to the profound life changing difference that the Cardiac Rehab experience has made to those CHF patients who have made the decision to participate in a rehab program at their own expense. While the cost up front may appear to be staggering by adding this diagnosis to those already included it pales in comparison to the costs incurred by not doing so. These patients are the very ones who would benefit most from the ongoing close supervision afforded by regular attendance in a Cardiac Rehab program. Thank you for this opportunity and for your consideration in this matter. Respectfully,

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I have been the Nurse Case Manager for the Dean Ornish Program for the past 3 1/2 years. Prior to that, I worked as a cardiac rehab nurse for 15 years. Cardic rehab's main focus is on increasing exercise tolerance and endurance. An attempt is made to educate patients regarding heart healthy diet and stress management. Patients come in 3 time a week for 36 session to exercise. Educational sessions are worked in if possible.The Ornish Program is much more intense. The Ornish Program not only focuses on exercise but also on stress management (yoga), group support and a vegetarian diet. Participants come in twice a week, 4 hours a day for 12 weeks (Stage 1)They then come into Stage 2 which meets for 2 hours a week for possibly 3-6 months. Participants are monitored more intensely regarding lipids, weight loss, B/P response, blood sugar and HgA1c. As a result of the intensity of this program,there are drastic changes in all values measured. A large percentages of our participants are able to decrease their B/P medications and diabetic meds as well. The descison CMS has made to include such an intensive program that actually treats heart disease with cardiac rehab shoud be reconsidered.

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As a cardiac rehab nurse, I see so much improvement in those that come through our rehab program. Life-changing habits are encouraged and formed. This cannot help but lower costs down the road for those patients choosing to exercise/eat right/maintain tighter blood sugar control etc. PTCA's have documented heart disease, so prevention would certainly be more cost effective than treatment the second/third time around. Also valves would benefit so much from the opportunity of rehab! I hope Medicare expands coverage for these 3 additional groups.

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Heart Failure patients show a much improved quality of life, physical tolerance, energy level, and control of there disease/device when they have cardiac rehab. They and their family/signifcant-others are afraid of their disease and exacerbation of symptoms from exercise. Cardiac Rehab allows structure and monitor progression in ability to a high quality of life and functioning and should be covered for Heart Failure and VAD patients so they will get moving and decrease comorbidity from immobility.

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I would like to encourage you to consider cardiac rehab for patients with ventricular assist devices. Currently the majority of my patients with a ventricular assist device are sent home to wait for their heart transplant. During this period, cardiac rehabilitation is paramount to improve their clinical condition prior to transplant. In addition, a number of patients now receive a ventricular assist device as destination therapy. They are also severely deconditioned because of their preoperative heart failure and their assist device implantation. I feel that both groups of patients would benefit from cardiac rehabilitation and this therepy should be covered by CMS

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1. In response to the Centers for Medicare and Medicaid Services (CMS) proposed coverage memo regarding cardiac rehabilitation services being covered by Medicare as an “incident to” physician service, Portage Health System (PHS) of Hancock, MI does not support this proposed coverage. Located in a rural setting, PHS and the community would be in jeopardy of losing their program since the majority(>95%) of our referrals are received from the Cardiologists at our regional Medical Center, Marquette General Hospital (MGH). We are approximately 100 miles from MGH and due to our above average snowfall each year, this equates to approximately 2 hours and/or 4 hours round trip. It would be very unrealistic to expect Cardiologists and/or patients to travel 3 times a week for approximately 1.5 hours of exercise time. Due to the demanding schedules of the Cardiologists and the interventional practices which are revenue- producing for the institution, Cardiac Rehabilitation (CR) would not be a high priority. It is also unrealistic to expect primary physicians or ordering physicians to be present during the course of the cardiac rehabilitation treatment due to their conflicting schedules and lack of expertise in this specialty area.

2. On the other hand, PHS supports “direct supervision” of a physician in the hospital outpatient department and/or in the physician’s office setting and is in compliance with this regulation.

3. The expansion of diagnosis under medical to include acute myocardial infarction, coronary artery bypass graft, stable angina pectoris, heart valve repair/replacement, percutaneous transluminal coronary angioplasty, and heart or heart-lung transplant receive PHS’s support. Many patients are currently “falling through the cracks” and are being turned away from our Phase II CR program because their diagnosis does not fit the current criteria for medical coverage/reimbursement. By expanding the diagnoses PHS will be able to better serve the community.

4. PHS supports the components of cardiac rehabilitation to include patient education, counseling regarding risk factor management, social and psychological support, nutritional counseling, and aerobic exercise. PHS’s CR program is tailored to the “holistic approach” which incorporates the psychological, social, and physical components. PHS’s CR program is currently fulfilling the above components and has observed and documented positive outcomes.

5. Lengthening the time span allowed for beneficiaries to receive 36 cardiac rehabilitation sessions from 12 to 18 weeks receives support from PHS CR program. Due to our changing weather conditions, it is difficult for many patients to attend consistently 3 times a week. This is advantageous in several respects. It provides more flexibility and adherence to the program for the working population who can not commit to three days a week. It is more manageable for patients who have to rely on the transportation of others because they are not allowed to drive for approximately six to eight weeks after surgery. The aged population will respond more favorably to one less day per week. Due to our variable weather conditions, it will allow for fewer cancellations. If patients become ill during their CR period, they will have ample time to return and progress in their program. Behavior changes do not occur overnight and this time span increases the likelihood of long-term positive outcomes.

6. PHS supports the specific use of electrocardiogram rhythm strips in the CR setting. For moderate to high risk patients, this provides an important additional tool for detecting potential life-threatening arrhythmias and noting changes with patient’s resting EKGs. Patients also feel a sense of security with close monitoring after a life-changing event. Electrocardiogram monitoring has proven itself to be a vital interventional tool at PHS CR.

Sincerely,

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While I applaude the decision to include patients who have undergone valve/PTCA/heart/lung transplantation for cardiac rehabiliation coverage, I feel that those suffering from congestive heart failure should also be covered. This population would include those patients who due to the severity of their heart failure end up requiring a Ventricular Assist Device,whether it be as a bridge to cardiac transplantation or as a destination therapy. Patients that are post VAD implant especially benefit from cardiac rehab. As we are all aware, congestive heart failure is a chronic, debilitating illness. By the time patients reach class IV heart failure, they are often extremely debilitated. Should these patients undergo a major heart operation for VAD placement, recovery time is prolonged when rehab is not available. It would not only be a benefit to the patients health but a monetary benefit to society to include these patients for rehab coverage. Patients participating in rehab, are discharged sooner, avoid readmissions, and would become functioning members of society in a more timely manner (improved quality of life). Many of these VAD patients are still awaiting another major surgery-heart transplantation and to be able to participate in rehab prior can only aid in making the the final outcome a better one.

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The application of continued cardiac rehabilitation after hospitalization warrents consideration by CMS for inclusion in the indications for reimbursable therapies. This patient population evolves from groups of patients who have the requisit etioloigies that qualify for reimbursement under the traditional and anticipated reimbursement schemes. Definitive empiric studies have not been performed as of yet that are directed soley toward the interrelationship between cardiac assist devices and cardiac rehabilitation programs on patient outcomes. The benefits of cardiac rehabilitation on the outcomes of patients with the underlying disease sequalae that leads to most of the uses of this therapy does, however, have a documented relationship. I strongly urge the panel to include cardiac rehabilitation reimbursement for this patient population.

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I have been involved with cardiac transplant and now mechanical assist devices since early 80's. Pt who are S/P LVAD need cardiac rehabilitation as much as a patient who has had a cardiac transplant. Since mechanical assist devices are relatively new one can understand why it has been excluded from the list of pts who NEED cardiac rehab. The data that supports cardiac rehab for cardiac transplant pts is pertinent to this group as well as we know from experience that a pt who has enrolled and completed a cardiac rehab program is a much better candidate post transplant and can avoid the ravages of muscle myopathy. Please consider cardiac rehab for this group of patients.

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We feel Cardiac Rehab reimbursement for patients with a diagnosis of congestive heart failure should be included.

Congestive heart failure is an ominous disease and the prognosis is poor. Data from the Framingham Heart Study show that 60% of men and 40% of women are dead within four years of the initial diagnosis of congestive heart failure. According to the American Heart Association 2005 update of heart disease and stroke statistics, of the 13,000,000 Americans with coronary heart disease, 4,900,000 have congestive heart failure. The annual cost for heart failure in America exceeds $100 billion. Heart failure is a major cause of morbidity and mortality and is the single most frequent reason for hospitalizations of people age 64 and older. According to research, the prevalence of congestive heart failure is increasing and rises with increasing age. The U.S. Census estimates that there will be 40 million Americans age 65 and older in 2010. This aging of the population will undoubtedly result in an increased incidence of heart failure. Heart failure is, and will continue to be, a major public health problem in the United States.

Research has shown that exercise training in patients with heart failure is associated with improvements in shortness of breath, the ability to perform activities of daily living, anxiety, depression, and general well-being. Rehabilitation of patients with congestive heart failure has gone from an overly cautious avoidance of this important parameter of therapy to a carefully administered use of exercise training in this high-risk patient group. Many valid studies have brought about increasing information to help guide cardiac rehabilitation professionals in the optimum management of patients with congestive heart failure. Because these patients are at increased risk due to left ventricular dysfunction and an overactive sympathetic nervous system, safety is of utmost importance.

To enhance safety, these patients should undergo a period of supervised exercise to evaluate for potential heart failure related complications. Supervision and monitoring in cardiac rehabilitation helps to reveal signs and symptoms. Research has shown that patients with congestive heart failure can safely benefit from cardiac rehabilitation and the implementation of such a program will help to improve their quality of life and may also allow these patients to lead a more independent and active life.

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In my experience as a Ventricular Assist Device (VAD) Coordinator at our facility, I have found cardiac rehabilitation to be an invaluable tool in the post operative outpatient treatment plan of a ventricular assist device recipient. As is often the case, this patient population often suffers the ill-effects of profound congestive heart failure for an extended duration of time. Resulting from poor heart pump performance, deficits include inadequate nutritional intake, inactivity and general effects from poor organ perfusion. In summary, the patient is cachextic. An already decompensated patient who has elected to undergo surgical implantation of a ventricular assist device must then make a substantial recovery one in which will allow him to live outside of the facility as an outpatient.

The inpatient phase, both pre-device implantation and postoperatively, can amount to a significant duration of time. A cardiac rehabilitation program can provide the following:

1) Provide additional rehabilitation in an outpatient setting under sufficiently trained, supervised and monitored care.

a) A patient may be relatively stable, from a hemodynamic standpoint, for discharge yet still require rehabilitory efforts. This may, in fact, decrease hospital inpatient stays (and corresponding costs and associated complications such as hospital aquired infections) when the knowledge is available that monitored rehab care will be provided.
b) Patients who have undergone ventricular assist device placement (along with their support systems)often are very tentative about venturing out into the community and participating in activities despite encouragement and extensive training regarding physical limitations from hospital staff. Cardiac rehabilitation encourages safe participation in physical activity. Patients feel required to participate as part of their treatment plan. Increases in physical stamina and endurance in a monitored program decrease the chances of potential complications resulting from inactivity and seemingly improve a patient's confidence and ability of a patient to care for their device and themselves post implant. This improvement also helps to prepare a patient who has had their device implanted for the indication of bridge to transplantation for enduring a grueling heart transplantation surgery. Evidence suggests that patients who have maximized their nutritional and physical status will have improved surgical outcomes.

2) Have a causative effect on a patient's well-being and improve quality of life (QOL). This patient population is prone to depression (eg. end of life issues, living with a "mechanical heart", unknown of when transplant may occur if even if that will be an option, etc...). Promoting a return to normal activities of daily living in an expiditious fashion provides for distractions that may discourage depressive tendancies.

3) Phase II Cardiac Rehabilitation allows for supervised monitoring that may not be available through a traditional in-home physical therapy program. Patients who have undergone device placement are often having their medications adjusted and may be prone to effects such as hypo-or hypertension, arrythmias, etc.. In addition, a program such as cardiac rehab provides that extra set of eyes and ears that may not be traditionally available to patients not seen at implanting centers on a regular basis. As rehab staff routinely assess these patients, they can evaluate fluid retention, blood pressure issues, etc... that a patient may not necessarily report to the coordinator. In this very difficult to manage patient population, this information is can be critical in managing a LVAD patient in an outpatient setting. Most LVAD patients, in my experience, are not candidates for home health care and the services provided by a rehab center are a benefit.

In summary, cardiac rehabilitation should be a covered service for the post implanted ventricular assist device patient.

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We applaud CMS’ recognition that Percutaneous Transluminary Coronary Angioplasty should be included as an indication for coverage, as it is a treatment and not a cure for Coronary Artery Disease, along with Valve Repairs and Replacement and Heart and Heart-Lung transplants. We applaud CMS’ recognition that secondary prevention programs, such as Cardiac Rehabilitation Programs have “improved the processes of care, enhanced quality of life/functional status, reduced hospitalizations, reduced recurrent myocardial infarctions and reduced ling-term mortality in patients with established CAD” (AHRQ Technology Assessment of Secondary Prevention Programs in CAD (2005) as taken from CMS’ proposed decision memo.

It is also important to recognize that a Cardiac Rehabilitation Program is more than just exercise as evidenced by the updated definition of Cardiac Rehabilitation you have adopted. This provides the patient with the physical rehabilitation they need as well as the education and psychological support to combat the depression and anxiety that inevitably follows a change in someone’s health status. Thank you.

Even after the OIG published their findings and recommendation to CMS regarding a clearer definition of “incident to” and “direct supervision”, the language in the draft still leaves much to be interpreted, probably by the Fiscal Intermediary. It appeared to be the lack of communication between CMS and the FI regarding these issues that may have prompted the OIG investigation.

The proposed memo reiterates that Cardiac Rehabilitation is covered as an “incident to” physician service and clarifies that the “incident to” physician is the ordering physician. This is restrictive because this requires a face-to-face encounter with the referring physician during the course of treatment. The ordering physician evaluates the patient prior to beginning Cardiac Rehabilitation to verify that the patient is stable enough to participate. Unless a problem arises during the course of treatment, the ordering physician does not evaluate the patient until the end of their rehabilitation in most cases. The proposed decision memo also reiterates that the cardiac rehabilitation must be provided under the direct supervision of a physician. According to 42 CFR 410.27, in for outpatient hospital services incident to a physician service, direct supervision means “the physician must be present and on the premises of the location and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed.” In your own literature review, the OHTA “…concluded that cardiac rehabilitation programs were safe and effective…” All of the other sources used by CMS came up with similar conclusions. However, nowhere within those conclusions did any of them state that the reason cardiac rehabilitation was deemed safe and effective was because of the presence of direct physician supervision. No attention was paid to the low incidence of emergencies requiring a physician in Cardiac Rehabilitation programs.

The American Association of Cardiovascular and Pulmonary Rehabilitation has certified our Cardiac Rehabilitation Program since 2001. What that means is that policies and procedures are in place for all emergencies from a hypoglycemic event to a blue alert, the appropriate staff is treating our cardiac patients (Registered Nurses, bachelor or masters level Exercise Physiologists, Registered Dietician and stress management specialists) who are certified in Healthcare Provider CPR and the Nurses and Physiologists are certified in Advanced Cardiac Life Support. WE have the appropriate equipment, crash cart, oxygen and sublingual nitroglycerine and should a patient have a true emergency or an event that requires observation, that patient must be transported to the Emergency Department for appropriate care whether a physician is present in the rehab or not. Our healthcare system did hire a Cardiac Rehabilitation Physician in January 2003. The presence of a physician has not affected how we handle our emergencies in that the physician is limited to ACLS protocols as much as the rest of the staff. If patient safety requires that if the patient need anything beyond what we can reasonably provide in an outpatient setting, we must transport them.

In conclusion, we ask that CMS continue to re- evaluate coronary artery disease to expand coverage to be more inclusive of other cardiac diagnoses which will bring about a healthier community. We also urge CMS to strongly consider the language they use when putting forth the requirements for the “incident to” physician and that they clearly define what “direct physician supervision” means for outpatient cardiac rehab programs within the hospital, on hospital grounds and off-site. The less that is left for the Fiscal Intermediary to interpret, the more compliant programs will be with what is intended by CMS and the OIG. Thank you for your time and attention in this matter.

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I am a respiratory therapist in a very cardia program.We are truly concerned for those patients that we cannot admit due to their diagnosis. These patients probably need our help just as much as those who have had cardiac surgery or an MI. The intent is to keep them healthy so they don't require major surgery. The exercise and education that comes from these programs are often a life changing intervention that can make a differnce in their well being and lives. Cardiac Rehab impacts patients so much that once they complete the program most of the time they continue that life style that they have learned from our programs. It would be amazing to see the intervention process begin earlier instead of later and hopefully do prevention and not always recovery. We need to reach out to these patients and give them the help and assistance they need now to change the way they view their health in all aspects from eating right to exercising the correct way. We need the chance to help these people. Please allow us to do so and let us make a huge differnce in more patient's lives. We turn away too many patients that need our help just because of their diagnosis. Thank you. Helen Thomure

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What about heart failure, congestive heart failure, systolic dysfunction, diastolic dysfunction, right heart failure? You know the AHA facts: 5 million patients, 50% mortality at 5 years; millions in hospital costs. Who needs rehab more: a patient with single vessel coronary disease and a normal EF or a patient with chf who is deconditioned and can walk only a block or two? Who stands to gain more from a cardiac rehab program? The decision to exclude heart failure is dumb and NOT cost effective.

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The post-VAD implant patient is not included in your list of rehab patient coverage. These patients are sorely in need for several reasons. First, may patients are deconditioned due to their heart failure and secondly they have just undergone major open heart surgery to have a ventricular assist device placed as bridge to transplant. If they were to be covered for this their outcome from transplant would be much improved; their recovery from a second open heart procedure could potentially be MUCH shorter if they have had the opportunity to recover and be in shape for transplant. We've seen patients who got VADs then go on to transplant who get out of the hospital in 7-10 days after their transplant! Please consider this unique patient population for coverage.Thank you for your time. Sincerely, Shauna Andrus, RN

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I take care of many patients who have left ventricular assist device for the treatment of end-stage heart failure. The need of devices are rapidly increasing and more patients are having such device. Because of the deconditioned status from preoperative heart failure, almost all such patients require cardiac rehabilitation. I believe the needs are more than routine cardiac surgery patients. Therefore, I would like to request cardiac rehabilitation is covered for patients who received ventricular assist devices.

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Please consider the population of patients who have undergone artificial heart surgeries ( i.e left ventricular assist device) as a category for medical coverage.This population of patients are recieving assistive implant devices which support the cardiac function. In most cases, patients are discharged from the hospital and recieve mechanical support at home. Without cardiac rehabilitation and in rare cases,occupational therapy options, they maybe require expensive and extensive length of stay in an acute care setting for their rehab verses going home and attending outpt rehab .

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Section: C – Program Requirements

Proposed: Duration
Services provided in connection with a cardiac rehabilitation exercise program may be considered reasonable and necessary for up to 36 sessions without individual review by a contractor’s medical consultant. Patients generally receive 2 to 3 sessions per week for 12 to 18 weeks. Claims for cardiac rehabilitation services beyond 18 weeks should be reviewed by the contractors’ medical consultants to determine if coverage should be extended but not exceed a total of 72 sessions for 36 weeks.

Issue: First, a requirement for Medical Staff review creates a large unfunded workload requirement for CMS contractors. An alternative to individual review (LCD) would be helpful. Second, it is unclear whether the limitation of sessions is a lifetime limitation or per event or per diagnosis. If "per event", an increase to 72 sessions creates a very large lifetime benefit for a service that is primarily educational and lifestyle changing. Note that since the rationale for the value of CR is based on the lifestyle change (educational intervention), this argues in favor of a "lifetime" benefit.

Recommendation: Claims for cardiac rehabilitation services beyond 36 sessions should either be individually reviewed by the contractors’ medical consultants or determined by a Local Coverage Decision. Coverage may be extended but not exceed a total of 72 sessions per beneficiary as a lifetime benefit.

Proposed: Components
Cardiac rehabilitation programs must be comprehensive and to be comprehensive they must include a medical evaluation, a program to modify cardiac risk factors (e.g., nutritional counseling), prescribed exercise, education and counseling.

Issue: The issue is unresolved relating to the billing of ancillary testing, which is integral to CR but can be billed separately. Different patterns of billing create widely disparate reimbursement rates. This is outside a pure coverage decision but should be addressed within the manual system, either within the NCD, within the Payment section, or within a MedLearn article.

Recommendation: Add the following: A stress test is reasonable and necessary and separately billable as part of the entry criteria to the program. All additional testing (stress testing, oxygen saturation, etc) is bundled as part of the 36 rehabilitation sessions and is not medically necessary as a separate service except in the instance of a complication requiring the immediate intervention of the supervising physician.

Proposed: Staff
The program must be under the direct supervision of a physician, as defined in 42 C.F.R. §410.26(a)(2) (defined through cross reference to 42 C.F.R. §410.32(b)(3)(ii), or 42 C.F.R. §410.27(f)).

Issue: The basic definitions of direct supervision still is unclear. It is unclear whether hospital means only one building or all buildings on the hospital campus, no matter how spread out. It is also unclear whether physician extenders are considered "physicians" for this purpose. (We would argue that this is beyond the usual scope of physician extenders.)

Recommendation: Add: In an inpatient hospital building, direct supervision is considered to be met as long as there is a physical presence of physicians in the building. In the outpatient setting, or in ancillary buildings on a hospital campus, direct supervision requires the presence of a physician in the office suite. For the purposes of cardiac rehabilitation supervision, "physician" is intended to mean MDs and DOs and does not include physician assistants, nurse practitioners or other physician extenders.

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We applaud CMS’ recognition that Percutaneous Transluminary Coronary Angioplasty should be included as an indication for coverage, as it is a treatment and not a cure for Coronary Artery Disease, along with Valve Repairs and Replacement and Heart and Heart-Lung transplants. We applaud CMS’ recognition that secondary prevention programs, such as Cardiac Rehabilitation Programs have “improved the processes of care, enhanced quality of life/functional status, reduced hospitalizations, reduced recurrent myocardial infarctions and reduced ling-term mortality in patients with established CAD” (AHRQ Technology Assessment of Secondary Prevention Programs in CAD (2005) as taken from CMS’ proposed decision memo.

It is also important to recognize that a Cardiac Rehabilitation Program is more than just exercise as evidenced by the updated definition of Cardiac Rehabilitation you have adopted. This provides the patient with the physical rehabilitation they need as well as the education and psychological support to combat the depression and anxiety that inevitably follows a change in someone’s health status. Thank you.

Even after the OIG published their findings and recommendation to CMS regarding a clearer definition of “incident to” and “direct supervision”, the language in the draft still leaves much to be interpreted, probably by the Fiscal Intermediary. It appeared to be the lack of communication between CMS and the FI regarding these issues that may have prompted the OIG investigation.

The proposed memo reiterates that Cardiac Rehabilitation is covered as an “incident to” physician service and clarifies that the “incident to” physician is the ordering physician. This is restrictive because this requires a face-to-face encounter with the referring physician during the course of treatment. The ordering physician evaluates the patient prior to beginning Cardiac Rehabilitation to verify that the patient is stable enough to participate. Unless a problem arises during the course of treatment, the ordering physician does not evaluate the patient until the end of their rehabilitation in most cases. The proposed decision memo also reiterates that the cardiac rehabilitation must be provided under the direct supervision of a physician. According to 42 CFR 410.27, in for outpatient hospital services incident to a physician service, direct supervision means “the physician must be present and on the premises of the location and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed.” In your own literature review, the OHTA “…concluded that cardiac rehabilitation programs were safe and effective…” All of the other sources used by CMS came up with similar conclusions. However, nowhere within those conclusions did any of them state that the reason cardiac rehabilitation was deemed safe and effective was because of the presence of direct physician supervision. No attention was paid to the low incidence of emergencies requiring a physician in Cardiac Rehabilitation programs.

The American Association of Cardiovascular and Pulmonary Rehabilitation has certified our Cardiac Rehabilitation Program since 2001. What that means is that policies and procedures are in place for all emergencies from a hypoglycemic event to a blue alert, the appropriate staff is treating our cardiac patients (Registered Nurses, bachelor or masters level Exercise Physiologists, Registered Dietician and stress management specialists) who are certified in Healthcare Provider CPR and the Nurses and Physiologists are certified in Advanced Cardiac Life Support. WE have the appropriate equipment, crash cart, oxygen and sublingual nitroglycerine and should a patient have a true emergency or an event that requires observation, that patient must be transported to the Emergency Department for appropriate care whether a physician is present in the rehab or not. Our healthcare system did hire a Cardiac Rehabilitation Physician in January 2003. The presence of a physician has not affected how we handle our emergencies in that the physician is limited to ACLS protocols as much as the rest of the staff. If patient safety requires that if the patient need anything beyond what we can reasonably provide in an outpatient setting, we must transport them.

In conclusion, we ask that CMS continue to re- evaluate coronary artery disease to expand coverage to be more inclusive of other cardiac diagnoses which will bring about a healthier community. We also urge CMS to strongly consider the language they use when putting forth the requirements for the “incident to” physician and that they clearly define what “direct physician supervision” means for outpatient cardiac rehab programs within the hospital, on hospital grounds and off-site. The less that is left for the Fiscal Intermediary to interpret, the more compliant programs will be with what is intended by CMS and the OIG. Thank you for your time and attention in this matter.

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Dear Madam and Sirs,I work with heart failure, heart transplant and ventricular assist device patients. There are resources available to this population on a very limited basis. Inpatient and in-home physical therapy are available but this isn't not enough. A patient's rehabilitation and reintigration into society is stunted by lack of financial coverage for outpatient rehab. I believe it is important for CMS to consider covering. I don't know why there is coverage for patients who are doing well one day and have a heart attack and or CABG but there is no coverage for the population that deconditions waiting months for a transplant or VAD and comes out weaker than before. The care and rehab have not kept up with the technology we provide patients with heart failure

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As a former director of our cardiac rehab, a heart failure cardiologist, and a site-PI for the HF-ACTION study, I am biased about cardiac rehab in HF, transplant, and VAD patients. I'm am very pleased that you are extending coverage to post-valve surgery, post-transplant, and post-PCI patients. I am hopeful that you will extend coverage to the HF population. I have personally seen great results from cardiac rehab in HF patients (patients covered by commercial insurers, those given scholarships to attend rehab, and those that have self-payed).

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We applaud CMS’ recognition that Percutaneous Transluminary Coronary Angioplasty should be included as an indication for coverage, as it is a treatment and not a cure for Coronary Artery Disease, along with Valve Repairs and Replacement and Heart and Heart-Lung transplants. We applaud CMS’ recognition that secondary prevention programs, such as Cardiac Rehabilitation Programs have “improved the processes of care, enhanced quality of life/functional status, reduced hospitalizations, reduced recurrent myocardial infarctions and reduced ling-term mortality in patients with established CAD” (AHRQ Technology Assessment of Secondary Prevention Programs in CAD (2005) as taken from CMS’ proposed decision memo.

It is also important to recognize that a Cardiac Rehabilitation Program is more than just exercise as evidenced by the updated definition of Cardiac Rehabilitation you have adopted. This provides the patient with the physical rehabilitation they need as well as the education and psychological support to combat the depression and anxiety that inevitably follows a change in someone’s health status. Thank you.

Even after the OIG published their findings and recommendation to CMS regarding a clearer definition of “incident to” and “direct supervision”, the language in the draft still leaves much to be interpreted, probably by the Fiscal Intermediary. It appeared to be the lack of communication between CMS and the FI regarding these issues that may have prompted the OIG investigation.

The proposed memo reiterates that Cardiac Rehabilitation is covered as an “incident to” physician service and clarifies that the “incident to” physician is the ordering physician. This is restrictive because this requires a face-to-face encounter with the referring physician during the course of treatment. The ordering physician evaluates the patient prior to beginning Cardiac Rehabilitation to verify that the patient is stable enough to participate. Unless a problem arises during the course of treatment, the ordering physician does not evaluate the patient until the end of their rehabilitation in most cases. The proposed decision memo also reiterates that the cardiac rehabilitation must be provided under the direct supervision of a physician. According to 42 CFR 410.27, in for outpatient hospital services incident to a physician service, direct supervision means “the physician must be present and on the premises of the location and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed.” In your own literature review, the OHTA “…concluded that cardiac rehabilitation programs were safe and effective…” All of the other sources used by CMS came up with similar conclusions. However, nowhere within those conclusions did any of them state that the reason cardiac rehabilitation was deemed safe and effective was because of the presence of direct physician supervision. No attention was paid to the low incidence of emergencies requiring a physician in Cardiac Rehabilitation programs.

The American Association of Cardiovascular and Pulmonary Rehabilitation has certified our Cardiac Rehabilitation Program since 2001. What that means is that policies and procedures are in place for all emergencies from a hypoglycemic event to a blue alert, the appropriate staff is treating our cardiac patients (Registered Nurses, bachelor or masters level Exercise Physiologists, Registered Dietician and stress management specialists) who are certified in Healthcare Provider CPR and the Nurses and Physiologists are certified in Advanced Cardiac Life Support. WE have the appropriate equipment, crash cart, oxygen and sublingual nitroglycerine and should a patient have a true emergency or an event that requires observation, that patient must be transported to the Emergency Department for appropriate care whether a physician is present in the rehab or not. Our healthcare system did hire a Cardiac Rehabilitation Physician in January 2003. The presence of a physician has not affected how we handle our emergencies in that the physician is limited to ACLS protocols as much as the rest of the staff. If patient safety requires that if the patient need anything beyond what we can reasonably provide in an outpatient setting, we must transport them.

In conclusion, we ask that CMS continue to re-evaluate coronary artery disease to expand coverage to be more inclusive of other cardiac diagnoses which will bring about a healthier community. We also urge CMS to strongly consider the language they use when putting forth the requirements for the “incident to” physician and that they clearly define what “direct physician supervision” means for outpatient cardiac rehab programs within the hospital, on hospital grounds and off-site. The less that is left for the Fiscal Intermediary to interpret, the more compliant programs will be with what is intended by CMS and the OIG. Thank you for your time and attention in this matter.

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CMS is to be congratulated for the efforts to revamp the requirements and coverage regarding cardiac rehabilitation programs. These updates truly reflect the US Public Health Service definition of cardiac rehabiltation:

"comprehensive, long-term programs involving medical evaluation, prescribed exercise, cardiac risk factor modification, education and counseling." These programs are "designed to limit the physiological and psychological effects of cardiac illness, reduce the risk of sudden death or reinfarction, control cardiac symptons, stablize or reverse the atheroclerotic process, and enhance the psychosocial and vocational status of selected patients."

The outcomes that programs have demonstrated in the state of North Carolina (Verill, et. al) and across the country (as outlined in the CMS report) now may have the opportunity to have an even further reach and impact more lives perhaps even the lives of sicker patients. The population of our country is increasing in age and decreasing in health. These potential changes in the guidelines may help slow this trend.

I look forward to the committee continuing to research the findings related to supporting Cardiac Rehabilitation for CHF patients. The preliminary results from the HF-ACTION study look promising, and I hope CMS will review soon for additional coverage consideration.

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The Florida Hospital Association appreciates the work that CMS has put into the development of this proposed coverage decision related to outpatient cardiac rehabilitation. We are concerned, however, with the clarification that the "incident to" physician is the ordering physician. The "incident to" regulations require a face-to-face encounter with the "incident to" physician during the course of the cardiac rehab treatment. This proposed clarification would limit this interaction with only the ordering physician and would disallow other physicians, such as a primary care physician or the hospital's medical director of the rehab service. It is possible that the ordering physician is not in the vicinity of the hospital - perhaps referring a patient from a rural area to a cardiac rehab center many miles away - it is even possible that the ordering/referring physician would not have staff privileges at the hospital sponsoring the cardiac rehab service.

We support the expansion of covered diagnoses for cardiac rehabilitation, but urge CMS to continue to explore the inclusion of congestive heart failure (CHF) among the covered diagnoses.

Other changes, including the expanded time frame allowed for patients to receive the 36 cardiac rehab sessions, providing physician discretion on the use of ECG rhythm strips, and clarification that the direct supervision is generally assumed to be met when the services are provided in a hospital setting, are positive changes and will do much to clarify the coverage of outpatient cardiac rehabilitation.

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As someone who has been involved in cardiac rehab type programs for years and also directing the Dr Dean Ornish Program, I find it irresponsible for Medicare to consider lumping the Ornish Program in with standard cardiac rehab and similar reimbursement.

Having seen first hand the incredible outcomes from patients in the Ornish Program and how much better they do than in typical cardiac rehab, it is like comparing apples to oranges. Cardiac rehab is a program for people who have suffered an event and want to get back to activities of daily living. The Ornish Program is about learning how to embrace a new and healthier life that encompases exercise, nutrition, stress management, and social connections. This is just not something cardiac rehab is equiped to deal with. Plus the Ornish Program has the research and science to back it up.

Sincerely,
Dave Harshbarger, MS
Ornish Program Director
West Virginia University Hospitals

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We applaud CMS’ recognition that Percutaneous Transluminary Coronary Angioplasty should be included as an indication for coverage, as it is a treatment and not a cure for Coronary Artery Disease, along with Valve Repairs and Replacement and Heart and Heart-Lung transplants. We applaud CMS’ recognition that secondary prevention programs, such as Cardiac Rehabilitation Programs have “improved the processes of care, enhanced quality of life/functional status, reduced hospitalizations, reduced recurrent myocardial infarctions and reduced long-term mortality in patients with established CAD” (AHRQ Technology Assessment of Secondary Prevention Programs in CAD (2005) as taken from CMS’ proposed decision memo.

It is also important to recognize that a Cardiac Rehabilitation Program is more than just exercise as evidenced by the updated definition of Cardiac Rehabilitation you have adopted. This provides the patient with the physical rehabilitation they need as well as the education and psychological support to combat the depression and anxiety that inevitably follows a change in someone’s health status. Thank you.

Even after the OIG published their findings and recommendation to CMS regarding a clearer definition of “incident to” and “direct supervision”, the language in the draft still leaves much to be interpreted, probably by the Fiscal Intermediary. It appeared to be the lack of communication between CMS and the FI regarding these issues that may have prompted the OIG investigation.

The proposed memo reiterates that Cardiac Rehabilitation is covered as an “incident to” physician service and clarifies that the “incident to” physician is the ordering physician. This is restrictive because this requires a face-to-face encounter with the referring physician during the course of treatment. The ordering physician evaluates the patient prior to beginning Cardiac Rehabilitation to verify that the patient is stable enough to participate. Unless a problem arises during the course of treatment, the ordering physician does not evaluate the patient until the end of their rehabilitation in most cases. The proposed decision memo also reiterates that the cardiac rehabilitation must be provided under the direct supervision of a physician. According to 42 CFR 410.27, in for outpatient hospital services incident to a physician service, direct supervision means “the physician must be present and on the premises of the location and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician must be present in the room when the procedure is performed.” In your own literature review, the OHTA “…concluded that cardiac rehabilitation programs were safe and effective…” All of the other sources used by CMS came up with similar conclusions. However, nowhere within those conclusions did any of them state that the reason cardiac rehabilitation was deemed safe and effective was because of the presence of direct physician supervision. No attention was paid to the low incidence of emergencies requiring a physician in Cardiac Rehabilitation programs.

The American Association of Cardiovascular and Pulmonary Rehabilitation has certified our Cardiac Rehabilitation Program since 2001. What that means is that policies and procedures are in place for all emergencies from a hypoglycemic event to a blue alert, the appropriate staff is treating our cardiac patients (Registered Nurses, bachelor or masters level Exercise Physiologists, Registered Dietician and stress management specialists) who are certified in Healthcare Provider CPR and the Nurses and Physiologists are certified in Advanced Cardiac Life Support. WE have the appropriate equipment, crash cart, oxygen and sublingual nitroglycerine and should a patient have a true emergency or an event that requires observation, that patient must be transported to the Emergency Department for appropriate care whether a physician is present in the rehab or not. Our healthcare system did hire a Cardiac Rehabilitation Physician in January 2003. The presence of a physician has not affected how we handle our emergencies in that the physician is limited to ACLS protocols as much as the rest of the staff. If patient safety requires that if the patient need anything beyond what we can reasonably provide in an outpatient setting, we must transport them.

In conclusion, we ask that CMS continue to re-evaluate coronary artery disease to expand coverage to be more inclusive of other cardiac diagnoses which will bring about a healthier community. We also urge CMS to strongly consider the language they use when putting forth the requirements for the “incident to” physician and that they clearly define what “direct physician supervision” means for outpatient cardiac rehab programs within the hospital, on hospital grounds and off-site. The less that is left for the Fiscal Intermediary to interpret, the more compliant programs will be with what is intended by CMS and the OIG. Thank you for your time and attention in this matter.

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I have worked with cardiac patients for over 15 years in a variety of settings from inpatient hospital, private cardiac surgery and cardiology practices. It is my firm belief that Phase II Cardiac Rehab is not only beneficial to post-angioplasty/stent patients as well as patients recovering from valve repair/replacement surgery it is essential for a speedy and complete recovery. It also increases the long term compliance with risk factor reduction and healthy living. By participating in Phase II Cardiac Rehab the patients are more aware of early signs and symptoms of future cardiac problems which will thereby decrease future high cost interventions. The patient's increased knowledge also has an effect on their family's compliance with risk factor identification and reduction.

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Medicare reimbursement should reflect the best of science. It is only fair that we provide people with the exercise and monitoring they need to cope with their coronary artery disease and valve disease independent of their course of treatment. A bypass patient has a scar on their chest to remind them everyday that they need to modify thier risk factors. A person who has been to the cath lab for a stent may be left with the impression that they have been "fixed" in the lab and that they need to do nothing more to halt the progression of their cardiac disease. This is a disservice to all those Medicare participants who opt not to have surgery. Patients recovering from valve surgery deserve the same care and attention that their counterparts who received a valve repair with perhaps a single bypass. I have been a cardiac rehab nurse for 15 years. I have supported access to Medicare consumers. It is my hope that this inequality will be corrected so that I may assist more people to recover from their cardiac events.

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As director of three cardiac rehab facilities and a cardiac nurse with 17 years of rehab experience, I am extremely pleased at the proposal of expanding the covered diagnoses and time frame for cardiac rehab. I have witnessed countless number of patients denied the clinically proven benefits of cardiac rehab due to lack of coverage based on their diagnosis. I would, however like to see clarification of direct supervision for rehab in a free standing facility or physician’s office. Especially if the rehab is on hospital premises(professional building attached to the hospital by a walkway) and the physician response time is less than three minutes (as documented by emergency drills). The proposal states rehab must be under direct physician supervision, but references the same manuals and language that was a controversy among rehab programs and the OIG auditors themselves. I would hope the final policy includes language that clearly defines supervision expectations for an outpatient cardiac rehabilitation center that is located on a hospital campus, not in the hospital itself.

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As program coordinator for cardiac rehab, I am extremely pleased that the CMS is considering expanding it's coverage to include PTCA, valve replacement, and transplants. CAD is enveloping a younger and younger population with devastating effects. The expanded coverage being proposed would allow us to reach a much broader population and help stress the importance of lifestyle modification. I have to agree with an earlier comment, it is very difficult to inform a patient that is desperate for information that may improve his health, that he does not qualify for cardiac rehab because he "only" had a heart valve replaced or "3 stents" placed in his coronary arteries. Thank you again for considering the proposed expanded diagnosis for cardiac rehab.

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Expanding the coverage criteria for cardiac patients to receive a service that does more for them than most medication is to be applauded. The duration of time for 36 sessions should also be mandated to all HMO's and insurance companies. It takes time for patients to make life changes. The staff at cardiac rehabilitation facilities are able to provide the knowledge and support that patients need to achieve the necessary changes. The requirement for direct physician presence on the exercise floor would probably put such a financial strain on rehab programs that many would close. Having a cardiologist or experienced emergency physician immediately available should be ample coverage. Physician review of the medical records, oversight of the staff, and review of the exercise prescription ensures that the therapy is appropriate for the patient.

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I am very pleased to see the consideration of expanded diagnosis to provide Cardiac Rehab services. My experience as Critical Care Nurse for 18 years showed me the frequent offenders were not the clients who were well educated about heart disease through cardiac rehab. As a cardiac rehab nurse, I see first hand the benefits of education and exercise and we frequently turn down clients for cardiac rehab services who were prudent in getting checked out and stented prior to having a heart attack because medicare will not cover. The valve replacement clients are just as weak as bypass surgery clients and would certainly recover quicker with cardiac rehab. They often exhibit cardiac dysrhythmias requiring close monitoring. Thank you for the positive consideration of this diagnosis expansion

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I applaud the proposal to include heart valve repair/replacement, percutaneous transluminal coronary angioplasty and heart or heart lung transplant as eligible conditions for cardiac rehabilitation. I am also happy to see additional weeks being added in order to complete the 36 sessions as I feel the longer programs can keep in contact with patients the better the outcomes will be. Ideally I would like to see the time period to achieve the 36 sessions extended to 26 weeks.

Further defining the program and staff requirements is also a positive improvement. However, I am not in agreement with the "incident to" billing classification. The incident rate in cardiac rehab is exceptionally low (frankly I am more worried about the "apparently healthy" unknown adult working out in our facility than the cardiac rehab patients). I feel the billing classification for this program should be similar to physical therapy requirements.

I was also dissapointed in the decision to not include CHF at this time and to await the results of the HF-Action trial that are 3-5 years away. There is a wealth of information supporting positive physiologic changes resulting from exercise training in this population that lower risk, reduce hospitalizations and cost, improve quality of life and most likely have a positive influence on mobidity and mortality (impacts on pro-inflammatory markers; antioxidative enzymes; sympathetic neural activation; oxygen utilization; ventilatory response; antiremodeling effects; etc). It took years to finally come up with a surgeon general's recommedation on physical inactivity (it was downplayed for far too long) and I am fearful that the same pattern exists for CHF. While we are waiting for more data many, many people who would benefit are left out of the programs.

I am also hopeful that coverage reimbursement will be increased as currently the per visit reimbursement is extremely low and many hospitals are looking closely at whether they should continue to provide this servce when it loses major dollars.

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I am a registered nurse currently working in the pulmonary rehab department in our hospital. I also work closely with the cardiac rehab team and have witnessed first hands it tremendous benefits both physically and mentally for our patients having under gone heart surgery. I strongly believe that adding addition covered diagnosis such as valve replacement, PTCA, and heart transplant is essential! The benefits of reducing hospitalizations and increased patient education and improved quality of life for these patient is inmeasurable!

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In regards to "incident to": I am the coordinator for a rural cardiac rehab program. It would create a burden for the rural facilities and cardiologist if our program would have to rely on the ordering physician as the one referred to as "incident to" Our cardiologist are 90-100 miles from us. It would also create a burden for them. Our referrals come from the cardilogists and then I contact their attending. From there, the patients are enrolled in our program. They are followed by the attending, however most do see the cardilogist durring their enrollment period. I would like to see the "incident to" remain as to the attending or medical director of the program with consultation as indicated by the cardilogist.

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I appreciate the proposed expanded diagnoses that will capture more patients needing the benefit of cardiac rehabilitation. It is possible that a patient is cared for by more than one physician:ie, a patient with diabetes that had an MI and needed CABG could possibly be cared for by a CV surgeon, a cardiologist, as well as a primary care physican, and overseen in the Cardiac Rehab by the Medical Director. Incident to should be covered by the MD supervising the patient's progress to improved cardiac health.What is important is that there is consistent and ongoing communication between the current supervising physician(s) and the cardiac rehabilitation staff.

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As program director for a small rural facility, I am both encourage to see the progress in the proposed NCD for cardiac rehab, yet dismayed at some of the continuing language seen the memo. The added diagnoses, the expanded time frame for session visits and the clarification of direct supervision are very positive revisions. However, the decision to keep coverage of services as "incident to" only the ordering physician is too narrow in its scope.

In our experience, routine progress and face-to-face interaction should also include, at the very minimum, the program's medical director. In rural communities, where referrals are often made from physicians 40+ miles away, it seems unreasonable and unnecessary to have patients make long commutes for routine follow-up office visits that can easily be performed on-site or nearby. Please consider the urgings of AHA and AACVPR to be flexible on this issue. We look forward to the final decision in March!

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As Director of Clinical Services for a health system serving more than a hundred patients each week in our cardiac rehab program, I am pleased with CMS' recommendation to expand coverage for valve surgery, transplants, and PTCA. Cardiac rehab has demonstrated its benefits in providing meaningful clinical improvement for patients with CV disease and this expansion will further benefit that population.

I have to add, however, that direct physician supervision is problemmatic and unrealistic. These are outpatients who spend the rest of their time in unsupervised activity at home or in the community. They are carefully supervised by trained, clinical staff while participating in cardiac rehab and physician supervision is unnecessary and costly. If you compare the cardiac rehab environment to other settings including outpatient PT, pulmonary rehab, sleep studies, etc - physician supervision isn't required in any of those places - when patient risk may be even higher. In cardiac rehab, due to extensive evaluation, screening, and monitoring patients' risks are well-known and carefully managed.

Expanding coverage for more patients is a positive step, however, if direct physician supervision is required, the net effect will be a decrease in cardiac rehab access and participation. Thank you.

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I am a cardiac rehab nurse. The benefits of cardiac rehabilitation are so profound. It is amazing to see how quickly people are feeling even better than they were before their surgery. Many say they feel better than they have for years. These patients really improve not only their physical endurance and quality of life but they make lifestyle changes. They quit smoking, start eating healthier and learn not to be as stressed. It helps with the post surgical depression that is often seen by giving these patients a support group. The physicians enjoy the benefits of having another pair of eyes watching over and monitering their patients on a regular basis. These patients are no longer ashamed of the lifestyle choices or perhaps just poor genetics that led to their heart trouble. They aren't ashamed because they are proud of the fact that they made changes, are exercising and learning to take great care of themself. They feel great about themselves and their recovery. What a misfortune that some of are older patients on medicare can't receive the same benefits as the younger patients who work due to coverage. I believe cardiac rehab changes lives. I know it sounds extreme but its true. I think anyone who has had a bypass, stent, heart transplant, valve replacement, MI, angina, ect. deserves and will no doubt benefit from the recovery and lifestyle change that cardiac rehab can bring about. Thanks for listening.

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The suggested changes to the medicare guidelines in reference to cardiac rehab would be a major improvement. If approved, it would greatly benefit medicare recipients who are not able to afford this service. I do not agree with the thoughts of having constant physician supervision. Currently at my facility all staff are acls certified and we have physicians who are readily available. I believe if this concept were to be implemented it would place many programs in jeopardy of closing. A lot of times programs are at a bare minimum concerning budgetary issues and this would place major constraints.

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I think clarification should be made for the "incident to"clause. Is it the Primary Care physician or the cardiologist that this order is "incident to" or can it be either?

I think physician supervision as long as it is in the same facility and is immediately available is more reasonable than a physician in the room or next door at the time the rehab sessions are being held. As long as an emergency reponse team that includes a physician is part of the process and a policy to that effect is in place the physician supervision is more than covered.

Including the educational counseling is important and in most programs already happens but being specific about it will make it happen more consistently.

I like the addition of the heart valve/replacement/PTCA (should include stent in the terminology however) and heart transplant and I really feel strongly that CHF patients would benefit from cardiac rehab significantly and that diagnosis should be added.

I like the time span extension. It is much more reasonable for long term outcome and the establishment of lifestyle changes and treatment plan compliance for the patient.

Thanks for the idea about ECG strips! It is an overused mechanism that often is not necessary.

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There are many proven benefits for individuals attending a cardiac rehab program. Regardless of age, we know that a structured program including education, exercise and behavioral management can be effective in decresing the cost and occurance of future intervention. There is much support for the efficacy and implementation of structured programs for PTCA, valve repair/ replacement, and heart/ lung transplantaion.

The measured outcomes for post-bypass surgery patients, stable angina, and myocardial infarction should be indicative of the necessity for programs designed to encourage behavioral changes and provide assistance for adaptation to the clients life. Following suit, programs for PTCA have been found to be equally beneficial to decrease the incidence to and price of future intervention. Cardiac rehab was shown to be highly cost effective in providing better QOL to patients with recent AMI or after elective PCI, and the improvement of QOL was quick and sustained for at least 2 years after CR (Yu et al 2004). The incidence of documented restenosis, angina pectoris with resulting reintervention, all revascularisations, and death is significantly lower in the group recieving rehabilitation after PTCA (Dendale et al. 2005). Other studies found that cardiac rehabilitation could be more effective than PTCA. Compared with PCI, a 12-month program of regular physical exercise in patients with stable coronary artery disease resulted in superior event-free survival and exercise capacity at lower costs, notably owing to reduced rehospitalizations and repeat revascularizations (Hambrecht et al. 2004). Many times it can be said that cardiac rehabilitation is the least utilized intervention.

While most of the documantation for cardiac rehab focuses on the quality of outcomes few report the need for longer participation times. As an exercise physiologist, I focus on the effect of strength, cardiovascular and flexibility training on the human body. In my experience it takes upwards of 6-8 months to get the full benefits of an exercise program, promting the necessity to extend the traditional cardiac rehab program beyond 12 weeks and 18 weeks should show an improvement in outcomes. The additional sessions would be beneficial for including additional educational materials and incorporating more advanced strength training modalities with the clients, especially post-surgery patients who may have severe weakness due to CABG or valve surgery. If we want to make an impact on the QOL for our Medicare recipients, it is vital to include more service options to prevent future complications.

The physician 'incident to' initiative should be reconsidered since in post-surgery patients the surgeon typically is the referring physician. In our system this usually takes place 3-5 weeks post-operative and then they are released by their surgeon after 6-8 weeks. The clients are then under the care of their cardiologist or primary care physician who is not the ordering physician. It is imperative for the cardiac rehab to be in communication with the physician providing care.

I envision great things on the horizon for cardiovascular patients that need intervention in their lives. Cardiac rehab needs to be more consistent in their treatment and increasing the number of visits and accepted diagnosis will allow us to have a greater impact on more lives and possibly be the difference in life and death. I hope to see Medicare lead the way for the future of behavioral and lifestyle programs that have profound effects on the participants.

Thank you, Terry Hinton, RCEP

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Thank you for considering expansion for patients with heart valve repair, PCI and heart transplant. Risk factor management is no less critical for these patients than those with Angina, CABG or MI. We have treated younger patients with valve/transplant/PCI covered by other insurances with outstanding outcomes. I have been working in a hosptial based rehabilitation for the past 13 years. Patients consistenty report their success stories to staff, administration, families, physicians as well reganing confidence and learning risk factor reduction for secondary prevention. Thank you for supporting Cardiac Rehabiliation programs to help manage patients with cardiovascular disease, in particular, after a coronary event or intervention.

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I wish to voice my support for the proposed changes to covered diagnoses for Cardiac Rehabilitation programs. I have worked in cardiac rehab for the past 8 years and have seen first hand how the service of cardiac rehab has benefitted those patients who undertook the rehabilitation. One of the determining factors in participation is insurance coverage. By expanding coverage to those disease conditions stated, it would benefit a large number of individuals in our region. Please consider the patient's quality of life when deciding what conditions are covered under the new proposal. I don't have statistics to support my contention (I'm sure someone has made them available to you), but my personal experience has shown me it is a cost savings in the long run to have heart disease patients undergo a comprehensive cardiac rehab program.

Sincerely,
Randy Kobienia, MS, CES, RCEP
Clinical Exercise Phsiologist

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Cardiovascular disease remains our number 1 health problem. Congestive Heart Failure specifically accounts for more hospitalizations than any other diagnosis. Cardiac rehab focuses on longterm behavior changes that reduce morbidity and mortality. Studies are very clear about the incidence of depression following a cardiac event. Data clearly show a reduction in depression in those individuals participating in cardiac rehab programs. Telling a patient to "Just go out and walk." or "Follow this diet." is not enough to insure longterm healthty lifestyle changes. Patients benefit from clear instruction, ongoing education and support. I have worked in cardiac rehab for 23 years. The comments from patients are always the same, "I could not have done this on my own." "You need someone to guide you through this difficult time."Omitting a certain diagnosis just because there was minimal disease or intervention seems ridiculous. It is time we become proactive in our fight against heart disease. I believe all coronary diagnoses should be covered. The evidence is there.

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By broadening the patient population, I believe that we will be able to help alot of patients and their families, that previously have been left out. Cardiac rehab is more than exercise and I believe anyone with a cardiac related diagnosis should be eligible to enter into a cardiac rehab program, as the education and positive re-inforcement of healthy lifestyle changes is valuable for all cardiac patients. Our goal in cardiac rehab is to help patients and their families modify their risk factors, everyone even those without current cardiac disease will benefit, this is a win win situation!!!!CAD is the number one killer of woman and our programs still have significantly less women than men. Not only do we need to expand on the target population of cardiac patients but we need to educate the doctors, nurses and the public about cardiac risk factors.

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The Valley Health System, Ridgewood, New Jersey would like to go on record in support of the CMS proposed changes to Cardiac Rehabilitation Program coverage.

Cardiac Rehabilitation/Secondary Prevention programs are well established programs that are important, efficient venues to which exercise therapy, education and other rehabilitative services can be delivered to an individual by competent professionals in a safe and well monitored environment. The proposed decision to include the expanded diagnosis coverage for heart valve/replacement, percutaneous transluminal coronary angioplasty (PTCA), and heart or heart/lung transplant in addition to the traditionally covered diagnoses of myocardial infarction (AMI), coronary artery bypass graft (CABG), and stable angina pectoris will improve the quality of patient care at the individual patient level. The obvious positive health outcomes will consist of decreases in:

Agree "whole heartily" with expanded diagnoses coverage. I also feel CHF should still be considered. I have seen from personal experience the difference it can make in people's lives.The removal of some problematic language regarding direct supervision is also a very positive change. As a hospital based facility with a Medical Director I see the importance of including other physicians as direct supervision. Our director is always available to assist when a patient is having problems, however the first place we send them is the ED. If a code is called, the code team including a physician, is the first to respond.

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I have supervised a hospital based Cardiopulmonary Rehab program for 23 years and have witnessed its benefits. I am totally opposed to the CMS proposal regarding the "incident to" physician language meaning the ordering physician. I manage a community hospital program and many of our patients are direct referals from an interventional center in a city 50 miles away. Those patients would never consider driving that far to participate in an outpatient program nor do they have a reason to be seen by that physician again. Even the patient's local primary physician would not order rehab if they personally had to see the patients. This patient population is better served by the Medical Director for Cardiac Rehab.

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Cardiac Rehab programs are vitally important to facilitate recovery and education toward maintaining health lifestyles following cardiac events. Adding PCTA and cardiac valve surgery and transplants will increase compliancein changing behaviors and through support may decrease reocclusion in CAD patients. I have been caring for Cardiovascular patients for over 25 years, cardiac events continue to occur in the ages between 30-50-and this population needs attention to educate and prevent further occurences.

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I wish to applaud the proposed changes which will allow us to return to providing supervised cardiac rehabilitation for Medicare patients. Many of the patients returning to our area either did not actively exercise or used our fitness center ( where we have an AED but do not have ACLS trained nurses ). Allowing our ACLS trained nurses to oversee the aerobic exercise portion with physician availability, as provided for in the proposed NCD, will permit our patients the opportunity for optimal recovery.

I would appreciate clarification in the langauge that the physician supervision is required only for the aerobic exercise and not the education/counseling/support activities when offered apart from the aerobic exercise.

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I am the medical director at a mod-large regional rural hospital in Middle Tennessee. Our cardiac rehab program has been active for several years. I disagree with the requirement of the need for constant physician supervision. This has proven costly to the organization with no benefit in patient care, safety, or outcomes. The nursing and rehab personnel are highly trained and have easy access to the referring physician who knows the patient best. Also with the availability of the Emergency Dept. or other house staff acute medical attention is not an issue. No other physical rehabilitation program requires this intensive supervision.

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Thank you very much for the opportunity to comment. As a Cardiac Rehab RN 15+ years, I have seen my patients benefit significantly from Cardiac Rehab- whether they have had bypass surgery, stents, or MI. I have yet to witness any untoward events that needed a physician present. In fact, I had less supervision of MD in the Critical Care unit, where I administered IV drug infusions! I am so happy to see this problem of physician involement being addressed, as well as coverage of PTCA and stents— I have had many Medicare patients who have been turned away from Cardiac rehab because of the limitations of diagnosis. Most of the patients I have cared for are Medicare patients, and they are scared and hungry for knowledge after recieving a stent—-Cardiac Rehab is the best place for them to getanswers to their questions, their medications monitered and their lifestyle changed to a more heart healthy one to prevent re-occurance. Studies have shown that Cardiac Rehab graduates see the doctor less often, have less ER visits and overall do better with their health issues than those who do not attend. That saves money in the long run! Thank you again for the opportunity to comment and for addressing these issues—- you have made my day as well as many other Cardiac Rehab nurses' days!!!

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I have seen first hand the difference CR has made in the lives of those patients with valve repair/replacement, heart transplant and angioplasty. These patients recover faster, have better outcomes physically, emotionally, and are able to return to work faster. CR provides patients with the educational components to assist patients in making lifestyle changes to improve overall health and prevent further heart disease. I believe that the proposed changes to Medicare coverage would be of great benefit to patients and will save money because secondary prevention education will help patients make changes that will prevent further heart disease and therefore cost money in the long run. Patients in CR are monitored closely and low cost interventions can be initiated early also saving money.

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Following AMI and/or CABG surgery, many patients are "too sick and debilitated" to attend an outpatient cardiac rehab program. Instead, they receive physical therapy at home. They also practice the exercises prescribed by the physical therapist on their own. There is no physician present or even in the area when this occurs. The patient may receive therapy for weeks before they are actually strong enough to benefit from a more structured exercise program in an outpatient setting. Yet, when they come to Cardiac Rehab, they can only exercise is a setting that requires a physician to be readily available. AACVPR has documented millions of hours of exercise in Outpatient Cardiac Rehab facilities over the past 20 years. The event rate during rehab is unbelievably low because of the safeguards, assessment, evaluation, and monitoring these patients routinely receive in Outpatient Cardiac Rehab programs. With the limited resources we now have in health care, including physician resources, it seems reasonable to look at the data and conclude that the safest environment a cardiac patient can be in is an Outpatient Cardiac Rehab program without the necessity of a physician in the immediate area. (You are already allowing this to occur in the home without any supervision for the sickest of the cardiac patients)

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As an master's prepared exercise physiologist with 17 years of clinical experience with cardiac rehab patients, I have seen over and over again the benefits a monitored, well designed exercise program can provide to patients with any heart ailment... from CABG, MI, PTCA, Cardiomyopathy, CHF, transplant, etc. I would hope that CMS would be proactive and pay for Cardiac Rehab to a greater variety of diagnosis allowing their subscribers to participate in a monitored secondary prevention program in any effort to reduce the disease process and therefore any future, very expensive, hospitalizations and procedures.

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I have responsibility for cardiac rehabilitation programs in a three hospital health system and about 20 years of first hand experience in seeing the benefits of Cardiac Rehabilitation for patient of all kinds. I am so pleased with the expanded coverage being proposed and believe that both the research and the testimonials of patients around the world support it. I wanted to comment on the need for a "face to face" encounter with the "incident to" physician. The programs I manage have patients whose length of stay in the program varies anywhere from 2 to 12 weeks. Every referring physicians gets a copy of the plan of treatment for which we request his approval prior to the patient beginning the program. The plan of treatment is written by trained prefessionals in our program and includes recommendation on the starting point and progression of exercise, risk factor management and if needed ways they will attempt to address psychosocial needs. The physician signs this form if in agreement with the plan and the program begins. I see no need unless the patient experiences an adverse response to the approved plan of treatment or the staff needs further professional input from the physicians concerning the patients care, why there should be any further "incident to" requirements placed on this service. It is my opinion that placing more requirements adds to the overall cost of care and adds little to the quality of care.

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I applaud and support the decision to include valve replacement, PTCA, heart transplant, and combined heart & lung transplant as covered diagnoses for cardiac rehablitation services. Having been involved in the delivery of cardiac rehabilitation services for over 18 years, I can attest to the significant impact this service has on the lives of participants. Cardiac rehab provides a safe and effective means by which individuals with a variety of cardiac conditions can improve their functional status, develop the skills to improve their cardiac risk profile ("secondary prevention"), decrease levels of anxiety and depression, and enjoy renewed levels of self-confidence. Cardiac rehab is so much more than a structured exercise class, it's about helping people take control of their health so that they can enjoy an enhanced quality and quantity of life. I only hope that in the future, individuals experiencing heart failure will be include.

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It has been my experience in 18 years of Cardiac Rehab nursing dealing with both inpatients and outpatients, as well as 14 years of critical care nursing prior, that patients who have congestive heart failure are frequently non compliant with guidelines regarding self care. For reasons that range from fear to misunderstanding to complacency and depression, they often fail to follow guidelines regarding medication, diet, daily wt checks and activity even though they are educated prior to leaving the hospital. Many become severely deconditioned due to lack of activity. We frequently see and re-educate the same people upon their readmission to the hospital. I would estimate that 50% of the admitted congestive heart failure patients that we educate are readmissions for heart failure. Conversely, we have a number of congestive heart failure patients in our cardiac rehab maintenance program who started with us because of an AMI or other covered diagnosis. These patients are constantly reminded about dietary guidelines, keeping track of their weight, limiting their fluids, adhering to their meds. Most of them really improve their cardiovascular fitness. Some of them do only a minimal amount of exercise, but they are doing something and they get out of the house and they socialize, hence an improved quality of life. We feel that we have helped these people avoid hospitalization by notifying their doctors when they have a change in their condition that we can sometimes ascertain before the patient can. Problems are often taken care of over the phone before they escalate into the need for hospital admission. The cost of hospitalization, far outweighs the cost of a rehab program. I feel that Cardiac Rehab is as needed for congestive heart failure patients as it is for AMI and CABG patients.

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As Director for Cardiac Rehab for over 26 years, I questioned why PTCA and valve surgery was not included as diagnosis for cardiac rehab. Those patients have had cardiac events and they would benefit from this service. Another group of patients that would do extremely well and need medical supervision are the Heart Failure patients.My experience having worked with heart failure patients that they do much better with compliance to medication diet and exercise when directed by staff in cardiac rehab. Hope that diagnosis will be considered in the near future.

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I am very excited to hear about the proposed expanded coverage for Cardiac Rehabilitation! There are so many individuals who have not been able to benefit from this therapy due to financial/reimbursement issues. One of the hardest things to hear from a patient is that they cannot participate in cardiac rehab because of lack of insurance coverage.

By increasing the applicable patient population for Cardiac Rehab, ultimately you should see a decline in readmission rates for patients with CAD. This, in turn, will reflect as a cost savings to all involved. Please make the decision to approve this proposal. Thank You.

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I am the CEO of a small rural hospital in central Iowa. We have a small cardiac rehabilitation department which has been in operation for 12 years. In those 12 years, we have had to turn down several referrals for patients who did not qualify for cardiac rehabilitation due to diagnoses or procedure performed. We also see those patients who have long term complications and have for many years felt that we could have affected more positive outcomes post valve replacement.

Since cardiac rehab is far more than just exercise, we have much to offer this population and feel that CMS would be well served to expand coverage in this area.

Thank you for your consideration.

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Clinical Criteria and time frame for "Stable Angina" must be clearly delineated. Patients on antianginal/ischemic medications whether the patient is symptomatic or not, regardless of the presence or absence of ischemia on a stress test (exercise or pharmacological) within 12 months of program entry should be should be approved for CR. A patient in need of treatment for angina/ischemia justifies the need for physician supervised exercise and a physician directed CR Phase II program.

Patients should be approved for CR within 12 mos of CABG, PTCA, or Valvular surgery.

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As a long-standing professional in the area of Rehabilitation medicine, working in Cardiac Rehabilitation now for > 16 years, I applaud the proposed changes to the CMS 35-25 guidelines for CR Therapy.

I would agree with the allowance of the additional time to 18 weeks to give flexibility for patients completing their CR therapy. I also would agree that the compendium of research data does show the wealth of benefits for individuals after having Valve Surgery, PTCA's and OHT's. I would also submit that the data on inclusion of CHF is also fairly compelling as well, and trust that this will be seen once the current trial is completed.

As for the proposed requirements for Nutrition Counseling and Education of patients, I would also agree that this should be a part of CR patients therapy, and actually has been in most CR circles for many years now.

But, I also believe that with these requirements for both physician supervision and these now required counseling and education being performed, that the current rate of reimbursement for these services does not come close to covering all that these proposed requirements shall now cost to these programs around the US.There should also be required a new review of the costs to provide these services with the added requirements for the salary expense for these professionals to provide these services during the course of CR therapy.

Again, I applaud the committe for their extensive review, and hope that a complete review will be performed on the reimbursement side of these proposed changes if they are approved.

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The proposed decision includes coronary artery bypass graft (CABG), heart valve repair/replacement, percutaneous transluminal coronary angioplasty (PTCA), and heart or heart lung transplant as conditions indicating medical necessity for cardiac rehabilitation. Although the description of the service in the proposed NCD states the service is typically provided 1-3 weeks after hospital discharge, it does not mandate a specific time period after each of these procedures during which the rehabiltation must be started. This is confounded by the criteria of acute myocardial infarction which has to have occurred within the previous 12 months.

After a certain point in time, the patient under going rehabilitation would be receiving it for his/her underlying debilitation or overall cardiac comorbidities rather than for the specified surgical procedure.

It would be most helpful to specifically state in the NCD that the rehabilitation must be started within a specified time period of discharge.

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1. Studies show cardiac rehabilitation is an important component for the care of people with coronary artery disease. PREVENTION of disease progression is less costly than medical treatment of disease and likely will have greater benefit for quality of life and societal productivity. I would like to see CHF added to the list of covered diagnoses for cardiac rehab.

2. Patients are clinically assessed by their physicians as well as rehab personnel prior to entering rehabn and throughout rehab. Decision-making related to continuous verses intermittent monitoring or any monitoring at all should be made by clinicians with intimate knowlege of patients' supervision/monitoring needs and overall risk stratification and not by mandated by law or local coverage decisions.

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