Cardiac Rehabilitation Programs

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The Centers for Medicare and Medicaid Services (CMS) determines: The evidence is adequate to conclude that cardiac rehabilitation is reasonable and necessary following acute myocardial infarction (AMI), coronary artery bypass graft (CABG), stable angina pectoris, heart valve repair or replacement, percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting, and heart or heart lung transplant. CMS has determined that the evidence is not adequate to conclude that cardiac rehabilitation is reasonable and necessary for congestive heart failure, and therefore we will not cover this indication. CMS revises the language in Manual 100-3 § 20.10 to read as follows: A. General Phase II cardiac rehabilitation, as described by the U.S. Public Health Service, is a comprehensive, long-term program including medical evaluation, prescribed exercise, cardiac risk factor modification, education, and counseling. Phase II refers to outpatient, medically supervised programs that are typically initiated 1-3 weeks after hospital discharge and provide appropriate electrocardiographic monitoring. B. Nationally Covered Indications Effective for services performed on or after March 22, 2006, Medicare coverage of cardiac rehabilitation programs are considered reasonable and necessary only for patients who: (1) have a documented diagnosis of acute myocardial infarction within the preceding 12 months; or (2) have had coronary bypass surgery; or (3) have stable angina pectoris; or (4) have had heart valve repair/replacement; or (5) have had percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; or (6) have had a heart or heart-lung transplant. 1. Program Requirements a. Duration Services provided in connection with a cardiac rehabilitation exercise program may be considered reasonable and necessary for up to 36 sessions. Patients generally receive 2 to 3 sessions per week for 12 to 18 weeks. Coverage of additional sessions is discussed in section D below. b. 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. c. Facility The facility must have available for immediate use the necessary cardio-pulmonary, emergency, diagnostic, and therapeutic life-saving equipment accepted by the medical community as medically necessary, e.g., oxygen, cardiopulmonary resuscitation equipment, or defibrillator. d. Staff The program must be staffed by personnel necessary to conduct the program safely and effectively, who are trained in both basic and advanced life support techniques and in exercise therapy for coronary disease. The program must be under the direct supervision of a physician, as defined in 42 CFR § 410.26(a)(2) (defined through cross reference to 42 CFR § 410.32(b)(3)(ii), or 42 CFR § 410.27(f)). C. Nationally Non-Covered Indications All other indications are non-covered. D. Other The contractor has the discretion to cover cardiac rehabilitation services beyond 18 weeks. Coverage must not exceed a total of 72 sessions for 36 weeks.

Decision Memo: To: Administrative File: CAG 00089R From: Steve E. Phurrough, MD, MPA Director, Coverage and Analysis Group Marcel Salive, MD, MPH Director, Division of Medical and Surgical Services JoAnna Baldwin, MS Lead Analyst, Division of Medical and Surgical Services Sarah McClain Analyst, Division of Medical and Surgical Services Lawrence Schott, MD, MS Lead Medical Officer, Division of Medical and Surgical Services Joseph Chin, MD, MS Medical Officer, Division of Medical and Surgical Services Subject: Coverage Decision Memorandum for Cardiac Rehabilitation Programs Date: March 22, 2006 I. Decision The Centers for Medicare and Medicaid Services (CMS) determines: The evidence is adequate to conclude that cardiac rehabilitation is reasonable and necessary following acute myocardial infarction (AMI), coronary artery bypass graft (CABG), stable angina pectoris, heart valve repair or replacement, percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting, and heart or heart lung transplant. CMS has determined that the evidence is not adequate to conclude that cardiac rehabilitation is reasonable and necessary for congestive heart failure, and therefore we will not cover this indication. CMS revises the language in Manual 100-3 § 20.10 to read as follows: A. General Phase II cardiac rehabilitation, as described by the U.S. Public Health Service, is a comprehensive, long-term program including medical evaluation, prescribed exercise, cardiac risk factor modification, education, and counseling. Phase II refers to outpatient, medically supervised programs that are typically initiated 1-3 weeks after hospital discharge and provide appropriate electrocardiographic monitoring. B. Nationally Covered Indications Effective for services performed on or after March 22, 2006, Medicare coverage of cardiac rehabilitation programs are considered reasonable and necessary only for patients who: (1) have a documented diagnosis of acute myocardial infarction within the preceding 12 months; or (2) have had coronary bypass surgery; or (3) have stable angina pectoris; or (4) have had heart valve repair/replacement; or (5) have had percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; or (6) have had a heart or heart-lung transplant. 1. Program Requirements a. Duration Services provided in connection with a cardiac rehabilitation exercise program may be considered reasonable and necessary for up to 36 sessions. Patients generally receive 2 to 3 sessions per week for 12 to 18 weeks. Coverage of additional sessions is discussed in section D below. b. 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. c. Facility The facility must have available for immediate use the necessary cardio-pulmonary, emergency, diagnostic, and therapeutic life-saving equipment accepted by the medical community as medically necessary, e.g., oxygen, cardiopulmonary resuscitation equipment, or defibrillator. d. Staff The program must be staffed by personnel necessary to conduct the program safely and effectively, who are trained in both basic and advanced life support techniques and in exercise therapy for coronary disease. The program must be under the direct supervision of a physician, as defined in 42 CFR § 410.26(a)(2) (defined through cross reference to 42 CFR § 410.32(b)(3)(ii), or 42 CFR § 410.27(f)). C. Nationally Non-Covered Indications All other indications are non-covered. D. Other The contractor has the discretion to cover cardiac rehabilitation services beyond 18 weeks. Coverage must not exceed a total of 72 sessions for 36 weeks. II. Background On February 20, 2001, CMS internally generated a formal national coverage request for supervised cardiac rehabilitation to determine if literature supports the clinical effectiveness of four additional indications; (1) heart valve repair or replacement; (2) coronary angioplasty; (3) heart or heart/lung transplant; and (4) congestive heart failure. CMS then requested, on November 5, 2001, that the Office of the Inspector General assist CMS in determining whether outpatient cardiac rehabilitation programs meet the existing physician supervision requirement. Upon receipt of the OIG’s report, CMS intended to announce a new completion date for the NCD. The report resulted in a recommendation to CMS from the OIG to revise the NCD to provide needed clarification. CMS had separately received similar recommendations from providers that the policy be more straightforward in addition to their requesting that the policy be revised to reduce the burden required to be compliant with the current policy. In January 2005, CMS held a meeting of the Medicare Coverage Advisory Committee (MCAC) entitled Physician-supervised behavioral interventions for patients with symptomatic coronary artery disease. Information regarding this meeting is provided under the MCAC subheading in section VII(B)(4) of this document. On June 29, 2005, CMS closed the existing reconsideration and reopened a new national coverage determination process in order to review clinical indications and additional policy concerns using current evidence. The current NCD does not provide a definition of cardiac rehabilitation aside from describing the service as an exercise program for cardiac patients. To provide clarification, CMS has sought to adopt a well-accepted definition of cardiac rehabilitation. Cardiac rehabilitation is described by the U.S. Public Health Service as consisting of “comprehensive, long-term programs involving medical evaluation, prescribed exercise, cardiac risk factor modification, education, and counseling.” These programs “are designed to limit the physiologic and psychological effects of cardiac illness, reduce the risk of sudden death or reinfarction, control cardiac symptoms, stabilize or reverse the atherosclerotic process, and enhance the psychosocial and vocational status of selected patients.” Additionally, cardiac rehabilitation programs aim to reduce subsequent cardiovascular-related morbidity and mortality. 1 CMS has been evaluating, under demonstration authority, lifestyle modification programs for the treatment of coronary artery disease including Dr. Ornish’s Program for Reversing Heart Disease® and the Cardiac Wellness Program of the Mind/Body Institute in Boston, Massachusetts. These programs currently fall under the purview of this NCD. Completion of the demonstrations will allow further evaluation of the programs. Cardiac rehabilitation developed in the 1950s from the concept of early mobilization after acute myocardial infarction. 2 The standard of care prior to cardiac rehabilitation was bedrest and inactivity after acute myocardial infarction. 3 In the 1970s, cardiac rehabilitation developed into highly structured, physician supervised, electrocardiographically-monitored exercise programs. However, the programs consisted almost solely of exercise alone. 4 Foreman et al (2000) states that “over subsequent years, cardiac rehabilitation broadened beyond exercise into a composite of cardiac risk modification. Lipid, blood pressure and stress reductions, smoking cessation, diet change, and weight loss were coupled to goals of exercise training.” Cardiac rehabilitation programs are often divided into phases. Phase I refers to inpatient cardiac rehabilitation services. Phase II refers to outpatient medically supervised programs that are typically initiated 1-3 weeks after hospital discharge and provide appropriate ECG monitoring. Phase III refers to maintenance programs without physician supervision and monitoring. 5 This coverage decision pertains only to phase II cardiac rehabilitation. III. History of Medicare Coverage History of Medicare Coverage of Cardiac Rehabilitation Since 1982, Medicare’s national coverage decision has provided for phase II cardiac rehabilitation for patients who experience stable angina, have had coronary artery bypass grafts, or have had an acute myocardial infarction within the past twelve months. There have been two modifications to the policy since 1982. The first change, issued in December 1985, clarified the payment limitation applying to freestanding clinics and the policy regarding physical therapy and occupational therapy services. The second modification, issued in August 1989, was in response to CMS’s Technology Advisory Group’s (TAG) clarification of physician supervision. In 1988, the TAG defined the necessary level of supervision to be that the physician must be present on the immediate premises, but not necessarily in the room. Current Medicare National Coverage Decision Regarding Cardiac Rehabilitation The National Coverage Determination Manual (manual 100-3) addresses Medicare’s national coverage decision for cardiac rehabilitation in § 20.10. The current Medicare national coverage decision limits coverage to only phase II cardiac rehabilitation for patients who (1) have a documented diagnosis of acute myocardial infarction within the preceding 12 months; or (2) have had coronary bypass surgery; and/or (3) have stable angina pectoris. Under the current policy, no other diagnostic categories may be covered. Contractors do not currently have the discretion to extend coverage beyond these indications. Under the current policy, phase II cardiac rehabilitation programs may be provided under physician supervision either by the outpatient department of a hospital or in a physician-directed clinic. Benefit Category For an item or service to be covered by the Medicare program, it must meet one of the statutorily defined benefit categories outlined in the Social Security Act. Cardiac rehabilitation falls under the benefit category set forth in section 1861(s)(2)(A) of the Social Security Act (services incident to a physician’s professional service). Other citations related to the requirements of this benefit category include 42 CFR § 410.26(b)(2), 42 CFR § 410.27(a), Medicare Benefit Policy Manual Chapter 6 § 20.4.1, and Medicare Benefit Policy Manual Chapter 15 § 60.1. IV. Timeline of Recent Activities Date Action February 20, 2001 CMS internally generates a formal national coverage request for supervised cardiac rehabilitation to evaluate whether literature supports the clinical effectiveness of physician supervised cardiac rehabilitation for the following additional indications: (1) heart valve repair or replacement; (2) coronary angioplasty; (3) heart or heart/lung transplant; and (4) congestive heart failure. November 5, 2001 CMS requests that the Office of the Inspector General assist CMS in determining whether outpatient cardiac rehabilitation programs meet the current physician supervision requirements as outlined in the existing coverage policy. A new due date will be announced after CMS has received the OIG's report. January 25, 2005 Medicare Coverage Advisory Committee meeting is held to discuss the evidence for Supervised Behavioral Interventions for Patients with Symptomatic Coronary Artery Disease. June 15, 2005 CMS requests that the Agency for Healthcare Research and Quality (AHRQ) expand a previous technology assessment (available at http://www.cms.hhs.gov/mcac/id144a.pdf ) to examine the components of cardiac rehabilitation programs. June 29, 2005 Due to the length of time this reconsideration was pending, CMS closes the analysis without changing coverage for cardiac rehabilitation programs and opens a new reconsideration to review clinical indications and additional policy concerns using current evidence. At this time CMS requests public comment. August 18, 2005 OIG issues final report. December 12, 2005 AHRQ issues final report. December 22, 2005 Proposed decision memorandum is posted for 30 days of public comment. January 22, 2006 Public comment period closes. V. FDA Status Cardiac rehabilitation is comprised of services that do not require FDA approval. VI. General Methodological Principles When making national coverage decisions, CMS evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a finding of whether an item or service is reasonable and necessary for the diagnosis and treatment of illness or injury. The evidence may consist of external technology assessments, internal review of published and unpublished studies, recommendations from the Medicare Coverage Advisory Committee, evidence-based guidelines, professional society position statements, expert opinion, and public comments. The overall objective for the critical appraisal of the evidence is to determine to what degree we are confident that: (1) specific clinical questions relevant to the coverage request can be answered conclusively; and (2) the extent to which we are confident that the intervention will improve net health outcomes for patients. A fully detailed account of “General Methodological Principles of Study Design” that CMS staff utilizes to assess the relevant literature on the therapeutic or diagnostic item or service for specific conditions is available in Appendix A. VII. Evidence A. Introduction This summary represents the body of evidence for cardiac rehabilitation following AMI, CABG, stable angina pectoris, heart valve repair or replacement, PTCA or coronary stenting, heart or heart lung transplant, and congestive heart failure (CHF). Health outcomes of interest to CMS for these indications include changes in mortality, re-infarction or restenosis rates, modifiable risk factors, quality-of-life measures, and intermediate physiological outcomes. This National Coverage Analysis (NCA) focuses on the following question: “In persons age 65 years and older, what is the clinical evidence for a net health benefit from cardiac rehabilitation for the seven indications?” B. Discussion of evidence reviewed 1. Literature Search CMS searched the Cochrane Library, National Health Service (NHS) Centre and International Network of Agencies for Health Technology Assessments databases for systematic reviews and technology assessments of cardiac rehabilitation. CMS similarly searched PubMed (1995 to present) for randomized clinical trials (RCTs) and observational studies evaluating cardiac rehabilitation for persons 65 years of age and older. General keywords included cardiac rehabilitation, core components, and secondary prevention. Studies must have presented original data, included ≥ 10 patients, examined primary health outcomes or intermediate physiological outcomes, and been published in peer-reviewed English language journals. Abstracts were excluded. 2. External technology assessments OHTA Report on Cardiac Rehabilitation Programs (1991) The Agency for Healthcare Policy and Research (AHCPR) Office of Health Technology Assessment (OHTA) performed a technology assessment assessing the benefits of cardiac rehabilitation programs for patients following heart transplantation, PTCA or heart valve surgery. The report concluded that cardiac rehabilitation programs were safe and effective in improving functional activities of patients with cardiac disease, and that transplant, PTCA, or heart valve surgery patients had no unique characteristics differentiating them from AMI, CABG, or stable angina patients regarding necessity for cardiac rehabilitation. NHS Centre for Revi e ws and Dissemination (1998) The NHS bulletin identified over 200 reviews of cardiac rehabilitation. Evaluation was acknowledged to have been difficult “due to the variability of interventions and patient populations studied.” The bulletin stated “exercise improves physical aspects of recovery at no additional risk, but as a sole intervention it is not sufficient to reduce risk factors, morbidity or mortality.” Also noted was that “a combination of exercise, psychological, and educational interventions is the most effective form of cardiac rehabilitation.” 6 Cochrane Collaboration Re vi ew of Exercise-Based Rehabilitation (2001) The Cochrane meta-analysis of exercise-based rehabilitation for coronary artery disease (CAD) was based on 8,440 patients in hospital and community settings following AMI (majority of participants), CABG or PTCA, or angina or CAD defined by angiography. Primary conclusions included that: (1) exercise-only intervention reduced total cardiac mortality by 31%; (2) comprehensive cardiac rehabilitation reduced total cardiac mortality by 26%; (3) neither intervention had any effect on the occurrence of non-fatal myocardial infarction; and (4) total cholesterol of patients participating in comprehensive programs was reduced significantly. 7 Taylor, et al.’s (2004) Review and Meta-Analysis of Exercise-Based Rehabilitation Taylor and colleagues included 48 trials and a total of 8,940 patients in their systematic review and meta-analysis of RCTs of exercise-based cardiac rehabilitation for patients with coronary heart disease (CHD). Most of the trials evaluated (67%) recruited patients with AMI alone. Compared to usual care, patients who participated in rehabilitation exhibited reduced all-cause mortality (odds ratio [OR] = 0.80; 95% confidence interval [CI]: 0.68 to 0.93) and reduced cardiac mortality (OR = 0.74; 95% CI: 0.61 to 0.96); greater reductions in total cholesterol level, triglyceride level, and systolic blood pressure; as well as lower rates of self-reported smoking. There were no significant differences in rates of nonfatal myocardial infarction, CABG, and percutaneous coronary intervention (PCI), or in changes in high- and low-density lipoprotein cholesterol levels and diastolic pressure. The authors reported that cardiac rehabilitation’s effect on all-cause mortality was independent of CHD diagnosis, type of cardiac rehabilitation, dose of exercise intervention, length of follow-up, trial quality, and trial publication date. 8 AHRQ Techn ology Assessment of Secondary Prevention Programs in CAD (2005) A meta-analysis of coronary heart diseasemanagement programs was provided by Clark and colleagues at the University of Alberta Evidence-based Practice Center for the AHRQ Technology Assessment Program. This review of 46 RCTs of secondary prevention in 18,821 patients with CAD concluded that secondary prevention programs (for patients who are already diagnosed with cardiac disease) improved 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. The summary risk ratio (RR) equaled 0.87 (95% CI 0.79-0.97) for all-cause mortality in the 29 trials (13,857 patients) reporting that outcome. 9 The document describes that this systematic review, “…demonstrates that a wide variety of secondary prevention programs delivered by health care providers, in addition to having beneficial effects on patient risk factor profiles and quality of life/functional status, provide tangible reductions in clinically relevant endpoints such as hospitalization and death.” Studies reviewed in the report and considered to provide comprehensive cardiac rehabilitation included a range of services in addition to exercise. Many included patient education, social and psychological support, nutritional counseling, stress management, and smoking cessation. Although many studies provided services beyond exercise, studies by Ornish, et al. (1990, 1998) describe a program of lifestyle modification and provided some of the most comprehensive and most intense programs to include most of the above listed components. In addition to varying components, the studies varied greatly in program duration. Programs ranged from less than one month to over twelve months of services. The study by Ornish, et al. provides perhaps the most comprehensive follow up with some patients continuing cardiac rehabilitation for 60 months. 3. Internal technology assessments Acute Myocardial Infarction CMS independently searched PubMed for cardiac rehabilitation and AMI. Two additional relevant studies were identified. Witt, et al. (2004) reported on a cohort of 1,821 AMI survivors discharged from hospitals in Olmsted County, Minnesota between 1982 and 1998. The subjects were 58% male, and 46% of patients were ≥ 70 years of age. Results showed that study participants were more likely to be male, younger, and with fewer co-morbidities (p < 0.01 for all comparisons). Participants also had lower risk of death (p < 0.001) and recurrent AMI (p < 0.049) at 3 years, and the survival benefit associated with cardiac rehabilitation participation was stronger in more recent years (RR for 1998 versus 1982 = 0.28, 95% CI 0.18-0.43, as well as RR for 1990 versus 1982 = 0.41, 95% CI 0.33-0.52). 10 Blumenthal, et al. (2005) reported an RCT of 134 patients with stable ischemic heart disease (92 men and 42 women, mean age = 63 ± 10 years) that evaluated the impact of two behavioral intervention programs on psychosocial functioning and cardiovascular risk markers. Results showed that patients in both exercise and stress management groups showed significantly greater reductions (p = 0.02) in general distress and depressive symptoms than usual medical care alone, but there were no between-group treatment differences in either hostility or anxiety measures. Bloomberg and colleagues concluded that 16 weeks of exercise and stress management training reduced emotional distress and improved markers of cardiovascular risk more than usual medical care alone. 11 Coronary Artery Bypass Graft CMS independently searched PubMed for cardiac rehabilitation and CABG. One additional relevant study was identified. Hedback, et al. (2001) reported a 10 year post-op observational study of 49 consecutive Swedish patients (39 men and 10 women, mean age = 57 ± 7.4 years) who underwent elective CABG and were offered a rehabilitation program consisting of education in risk-factor control, a physical training program, and regular post-CABG clinic follow-up. The control group (78 men and 20 women, mean age = 57.3 ± 7.3 years) consisted of two well-matched CABG patients for each study patient, who were offered usual care but no access to a cardiac rehabilitation program. Results showed that, after 10 years, patients in the study group experienced longer mean time to a first adverse cardiac event compared to controls (82 months versus 66 months, p < 0.05), and the percent of patients who developed a cardiac event (cardiovascular death, nonfatal MI, CABG or PTCA) was significantly less in the study group compared to controls (18.4% versus 34.7%, p < 0.05). Additionally, the number of hospital readmissions (2.1 versus 3.5 per patient) and length of admissions (11 versus 26 days per patient) was significantly lower in the study group (p < 0.01). Hedback and colleagues concluded that comprehensive cardiac rehabilitation post-CABG improved long-term prognosis and reduced the need for hospital care. 12 Stable Angina Pectoris CMS independently searched PubMed for cardiac rehabilitation and angina. One additional technology assessment on coronary artery disease (CAD) was identified. CAD is the most common cause of angina pectoris. In 2005, the AHRQ published a technology assessment (prepared by the University of Alberta Evidence-based Practice Center) on patients with established coronary artery disease. The objectives of the assessment were “to determine whether secondary prevention programs for patients with established coronary artery disease (CAD) improve health outcomes and to characterize secondary prevention programs which have been evaluated in the literature and to identify any program-related factors which influence effectiveness for patients with established coronary artery disease (CAD).” 13 A total of 46 randomized trials with 18,821 patients were reviewed. The assessment concluded: “Secondary prevention programs improve processes of care, enhance quality of life/functional status, reduce hospitalizations, reduce recurrent myocardial infarctions, and reduce long-term mortality in patients with established CAD. Although these clinical benefits are likely to reduce health care costs, there is inadequate data to conclusively comment on the cost-effectiveness of these programs and specific components contained therein. Though most programs are likely to involve specialist health professionals, physicians adopt an active coordinating role in only a small minority of programs. Programs with more individualization are more effective at reducing hospitalizations.” 14 Heart Valve Repair or Replacement CMS independently searched PubMed for cardiac rehabilitation and heart valve surgery. One additional relevant review was identified. Stewart, et al. (2003) reviewed the evidence for comprehensive exercise-based cardiac rehabilitation and reported that “the exercise component of cardiac rehabilitation is useful for reversing the symptoms associated with deconditioning. Women with mitral valve prostheses improved their peak metabolic equivalent capacity by 19% and their physical working capacity by 25% after undergoing an 8-week program, whereas control subjects did not improve. After aortic valve replacement, exercise training increased peak aerobic capacity and decreased rate pressure product and the rating of perceived exertion at a fixed workload. The increase in aerobic capacity in the exercise group was 38% higher than that in the control group at 6 months and was 37% higher after 12 months [Sire 1987]. In a randomized controlled study, patients who had aortic/mitral valve surgery were assigned to supervised exercise or a control group. Nevertheless, more than half of the control subjects routinely exercised on their own or joined community exercise programs. After the 3-month intervention period, peak VO 2 was improved by 25% with no group differences [Jairath, et al. 1995].” The review further noted that “for most patients, enhanced functional capacity leads to a greater ability to perform the activities of daily living and to tolerate activity for a longer duration with less perceived exertion. Older patients who undergo heart valve surgery have longer hospital stays and more complications, and they require more follow-up care after hospital discharge. Cardiac rehabilitation is also an opportunity to evaluate medical management and to educate patients about the safety of increasing physical activity and monitoring symptoms.” 15 Percutaneous Transluminal Coronary Angioplasty CMS independently searched PubMed for cardiac rehabilitation, PTCA, PCI and revascularization. One review and two additional relevant studies were identified. Stewart, et al. (2003) reviewed the evidence for comprehensive exercise-based cardiac rehabilitation programs following percutaneous revascularization and reported that “percutaneous interventions are effective for interrupting the process of acute coronary stenosis. Although it is fortunate that myocardial tissue damage can be avoided or minimized if the patient is treated in a timely manner, the need to treat the underlying disease that precipitated the stenosis is not changed after a revascularization procedure.” The review further noted that “despite the expanded use of percutaneous revascularization, there are few controlled studies of cardiac rehabilitation after these procedures. In one study, 93 patients who had been treated with percutaneous transluminal coronary angioplasty were randomly assigned to receive a behaviorally oriented intervention or to a control group [Lisspers, et al. 1999]. After 12 months, the intervention patients, compared with the control subjects, improved significantly on self-rated measures of smoking, exercise, and diet habits. Patients also lost weight, improved their exercise capacity, and experienced less chest pain during exertion. Although the mechanisms for decreased mortality with exercise have not been fully explained, exercise training improves the lipid profile, reduces blood pressure, lowers the fasting glucose level, and reduces body fat and increases lean body mass….” Therefore, “risk factor management is no less critical for these [PTCA] patients than for those with other manifestations of atherosclerosis, even in the absence of myocardial damage, and may lead to a slowing of coronary disease progression. ” 16 Belardinelli, et al. (2001) reported a randomized controlled trial (RCT) of 118 consecutive patients with CAD (mean age = 57 ± 10 years) who underwent PTCA or stenting on one (69%) or two (31%) coronary arteries. Patients were randomized into either a training group (49 men and 10 women, mean age = 53 ± 11 years) who exercised 3 times a week for 6 months at 60% of peak VO 2 , or a control group (50 men and 9 women, mean age = 59 ± 10 years) who were recommended to perform daily mild physical activities but to avoid physical training. Results showed that only trained patients had significant improvements in peak VO 2 (26% increase, p < 0.001) and quality-of-life (26.8% increase, p = 0.001) versus controls. The angiographic restenosis rate was unaffected by exercise training and was not significantly different after either PTCA or stenting. During the follow-up (33 ± 7 months), trained patients had a significantly lower event rate (e.g., new AMI, angioplasty or CABG) than controls (11.9 vs. 32.2%, RR 0.71, 95% CI: 0.60-0.91, p = 0.008) and a lower rate of hospital readmission (18.6 vs. 46%, RR 0.69, 95% CI: 0.55-0.93, p < 0.001). 17 Dendale, et al. (2005) retrospectively reported a cohort of 223 Dutch post-PCI patients “none of whom had experienced a cardiac event in the 3 years before PCI was performed.” The training group (107 men and 33 women, mean age = 62 ± 7 years) consisted of those patients who participated in the entire 3 month multidisciplinary cardiac rehabilitation program offered by one hospital’s cardiologists, and the control group (54 men and 29 women, mean age = 68 ± 8 years) were patients referred to the hospital’s cath lab from an outside institution where no structured rehabilitation was offered. Results showed that the incidence of total major adverse cardiac events in the rehabilitation group was lower (24% versus 42%, p = 0.005) than in the controls. There was no significant between-group difference in myocardial infarction (3% versus 2%), but the incidences of documented restenosis (14% versus 23%, p <0.005), recurrent angina (7% versus 20%, p < 0.005), need for revascularization (17% versus 30%, p < 0.005) and death (1% versus 6%, p < 0.05) were all significantly lower in the rehabilitation group compared to controls. The only risk factor significantly different between groups was hypercholesterolemia, which was present in 61% of rehabilitation patients and 85% of controls (p < 0.005). 18 Heart or Heart Lung Transplant CMS independently searched PubMed for cardiac rehabilitation and heart and heart lung transplant. Two studies and two additional reviews were identified. In 2005, Kavanagh published a review of exercise rehabilitation for cardiac transplant patients. 19 The author noted: “The routine use of a comprehensive exercise rehabilitation program following heart transplantation improves exercise capacity, permits bouts of submaximal effort for longer periods and with less fatigue, improves muscle mass and function, and ameliorates steroid-induced osteoporosis. While maximizing the benefits of surgery, it is unlikely that it can completely restore physiological function. The prescription of exercise must take into account the denervated heart’s peculiar response to effort and must place heavy reliance on perceived exertion and metabolic measurements rather than on target heart rates for defining the intensity of training.” 20 In 2003, Stewart and colleagues discussed the scientific and clinical evidence for cardiac rehabilitation in patients who underwent heart transplant. 21 The authors noted: “Although the studies reviewed are small, there is sufficient evidence that cardiac rehabilitation improves physiologic hemodynamic responses and helps to preserve or reverse bone and muscle loss (Table 1). Dealing with the continued medical consequences of cardiac transplantation is challenging, and the multidisciplinary nature of cardiac rehabilitation, including exercise, education, nutrition, and behavioral interventions, is ideally suited to these patients. One study reported that heart transplantation in selected patients who were ≥ 70 years of age could be performed with similar morbidity, mortality, and intermediate-term survival as found in younger persons. Although the efficacy of cardiac rehabilitation for elderly heart transplant patients has not been studied, it would be expected that the same benefits as demonstrated in younger persons would result in these patients.” 22 In 2003, Kavanagh and colleagues published the results of a case control study on exercise capacity following heart transplant. Thirty six cases were enrolled and received 16 months of outpatient exercise training which involved walking, progressing to jogging if tolerated, initially a distance of 1.6 km 5 times weekly. All patients completed the program. The final assessment was performed an average of 12 years after the program. Of the 36 men, 20 were evaluated. Mean age was 48 years. Thirteen patients had died and 3 were lost to follow up. At 16 months of outpatient exercise training, there was a significant increase of 26% on average in peak oxygen intake, as measured by progressive cycle ergometry test. Over the follow-up period, “gains in exercise capacity are lost over 12 years at a rate commensurate with normal aging.” 23 In this study, univariate and multivariate analyses were used. Controls were age matched men who were not regularly exercising and used to establish changes with aging. In 2001, Hummel and colleagues published the results of a case series study on quality of life after heart and heart-lung transplant. Of the 369 cases, 350 had heart transplantations and 19 had heart-lung transplants. Patients were entered into a phase-II rehabilitation program. Mean age of heart transplant patients was 48 years. Mean age of heart-lung transplant patients was 31 years. Physical condition was evaluated by maximum possible workload during 15 minute bicycle exercise. Quality of life was assessed with the SF-36 questionnaire. All patients completed the program. Of the 369 patients, 250 (62%) were able to exercise 25-50 watts. Most patients (90% of a subgroup of 61 patients tested) reported good or very good physical condition. The authors concluded that: “Shortly after transplantation most of the transplanted patients estimated their personal status positively, even though their physical capabilities were largely impaired at that time.” 24 In this study, the composition of the rehabilitation program was not reported. Statistical methods were not fully described. Congestive Heart Failure CMS independently searched PubMed for cardiac rehabilitation and heart failure. Four additional studies and 5 reviews were identified. In 2005 (in press), Jonsdottir and colleagues reported the results of a randomized trial on supervised training in patients with chronic heart failure. Chronic heart failure was defined as New York Heart Association class II or III 25 and having a hospitalization due to CHF. Primary outcomes included 6-minute walk distance, muscle strength, and quality of life. Forty three patients were randomly assigned to exercise (n=21) or a control group (n=22). The program included supervised aerobic and resistance training twice a week for 5 weeks. Mean age was 68 years. About 80% were men. At the end of the program, the authors found significant improvements in 6-minute walk distance, muscle strength, and quality of life. 26 In this study, left ventricular ejection fraction was not reported as an inclusion criterion. In 2005, Witham and colleagues reported the results of a trial on exercise in older patients with heart failure. Heart failure was defined according to the European Society of Cardiology guidelines, New York Heart Association class II or III, and evidence of left ventricular systolic dysfunction. The primary outcome was 6-minute walk distance. Eighty-two patients were randomly assigned to exercise (n=41) or usual care. The exercise program lasted about 20 minutes and was offered twice a week for 3 months. After the initial 3 months, patients in the exercise group were asked to continue exercises at home 2-3 times per week. Mean age was about 80 years. There were more men (63%) in the exercise group than the control group (46%). At the 6 month follow-up, there were no significant differences between groups on 6-minute walk distance and quality of life. 27 In this study, the level of left ventricular systolic dysfunction used as an inclusion criterion was not reported. The program included aerobic and strengthening exercises. A physiotherapist delivered the exercise intervention. In 2004, Austin and colleagues reported the results of a trial “to determine whether a cardiac rehabilitation programme improved on the outcomes of an outpatient heart failure clinic (standard care) for patients, over 60 years of age, with chronic heart failure.” 28 Heart failure was defined as New York Heart Association class II or III, left ventricular systolic dysfunction (ejection fraction ≤ 40%), confirmed by echocardiography. The primary endpoints were functional status (NYHA class I–IV), functional performance (6-minute walk test), perceived exertion (Borg Rating of Perceived Exertion), and health-related quality of life in terms of disease specific (Minnesota Living with Heart Failure survey) and cost utility (EuroQol - European Qualify of Life index) questionnaires. Two hundred patients were randomly assigned to cardiac rehabilitation (N=100) or standard care (n=100). The program consisted of an 8 week rehabilitation program, educational sessions, and counseling. Patients had sessions two times per week for 2.5 hours. After the initial 8 weeks, patients had weekly 1 hour sessions for 16 weeks. At the 24 week follow-up, the authors noted “significant improvements in MLHF and EuroQol scores, NYHA classification and 6-minute walking distance (meters) at 24 weeks between the groups (p<0.001).” 29 In this study, the type of exercise was not specifically reported. A clinical nurse specialist coordinated the exercise. In 2004, van den Berg-Emons and colleagues reported the results of a clinical trial “to assess whether aerobic training leads to a more active lifestyle and improved quality of life (QoL) in patients with CHF.” 30 Patients with stable heart failure, NYHA class II or III, and ejection fraction < 40% were included. Thirty-four patients were randomly assigned to training (n=18) or control (n=16) groups. Training consisted of cycling, walking and aerobic games and was performed 2 times per week for 1 hour. Mean age was 59 years. Men comprised 74% of the study population. After 3 months, there were no significant changes in lifestyle and quality of life. The authors concluded that “at group level training did not result in a more active lifestyle or improved QoL.” 31 The Heart Failure – A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) is a large ongoing trial funded by NIH to examine the effects of exercise training on mortality and morbidity of patients with heart failure. 32 It aims to enroll 3,000 patients at 70 U.S., Canadian, and European sites. The primary hypothesis is that “exercise training in patients with LV systolic dysfunction will reduce the combined primary end point of all cause deaths and hospitalizations by 20% over 2 years vs. a usual-care group.” 33 Inclusion criteria included heart failure due to left ventricular systolic dysfunction, ejection fraction ≤ 35%, NYHA class II-IV, and stable optimal medical therapy. The exercise program consists of treadmill or bicycle exercise three times a week for the first 3 months at the participating site. 34 In 2005, Ko and McKelvie reported the findings of a systematic review of exercise training in patients with heart failure. The authors noted: “Heart failure (HF) is characterized by dyspnea and fatigue leading to exercise intolerance. HF patients have been advised to avoid exercise because of concerns about detrimental cardiac effects. However, in many studies on the effects of exercise training, HF patients have demonstrated beneficial outcomes. Furthermore, exercise training has been found to be safe. Recent studies have demonstrated that exercise training might reduce morbidity and mortality. Although these data are promising, confirmation is required from a large clinical trial powered to examine the effect of exercise training on morbidity and mortality.” 35 In 2005, Delagardelle and Feiereisen reported the findings of a systematic review of strength training for patients with chronic heart failure. The authors noted: “Due to the specific loss of muscular mass, function and strength in advanced CHF, application of strength training should be considered as a logical answer to address muscle wasting. Strength training has to be applied by well trained therapists in an adapted infrastructure and regular supervision of the patients has to be provided. Actual recommendations state that strength training should only be applied in hospital or rehabilitation centres and that careful, individually adapted programs are needed. Adequate training of therapists is required to promote strength training on a larger scale. Strength training can add to the quality of life of CHF patients as their daily life activities are often limited by the loss of muscular strength. It further improves balance, reducing falls and increases bone density in those (often old-aged) patients. For the moment, large trials are lacking, especially because training is not as largely funded as other therapeutic interventions in CHF like new drugs or resynchronization therapy. Thus it is difficult to compare the effects of training therapy to other proven therapeutic options. As CHF is a disease which is also very frequent in countries where expensive therapeutic options cannot be afforded, training therapy should be recommended and promoted by the world wide cardiology community.” 36 In 2004, Rees and colleagues presented the findings of a Cochrane review on exercise based rehabilitation for heart failure. They reported: “Exercise training improves exercise capacity and quality of life in patients with mild to moderate heart failure in the short term. One study found beneficial effects of exercise on cardiac mortality and hospital readmissions over 3 years of follow-up, the remaining included studies did not aim to measure clinical outcomes and were of short duration. The findings of the review are based on small-scale trials in patients who are unrepresentative of the total population of patients with heart failure. Other groups (more severe patients, the elderly, women) may also benefit. Large-scale pragmatic trials of exercise training of longer duration, recruiting a wider spectrum of patients are needed to address these issues.” 37 In 2004, the ExTraMATCH collaborative group reported the results of a meta-analysis to determine the effect of exercise training on survival in patients with heart failure. Randomized controlled trials of exercise training for at least eight weeks with individual patient data on survival for at least three months were included. Nine studies through 2002 with 801 patients (395 exercise training, 406 controls) were reviewed. The primary outcome studied in the trial was death from all causes. The authors found that “during a mean (SD) follow up of 705 (729) days there were 88 (22%) deaths in the exercise arm and 105 (26%) in the control arm” (hazard ratio 0.65, 95% confidence interval, 0.46 to 0.92). 38 They concluded: “Meta-analysis of randomised trials to date gives no evidence that properly supervised medical training programmes for patients with heart failure might be dangerous, and indeed there is clear evidence of an overall reduction in mortality. Further research should focus on optimising exercise programmes and identifying appropriate patient groups to target.” 39 In 2003, Stewart and colleagues discussed the scientific and clinical evidence for cardiac rehabilitation in patients with CHF. 40 They noted: “Patients with heart failure often experience fatigue and dyspnea with exertion. Although the primary pathology of heart failure results from abnormalities in cardiovascular function, abnormalities in peripheral blood flow, skeletal muscle morphology, metabolism, strength, and endurance all contribute to the heart failure syndrome. Several trials have shown that cardiac rehabilitation improves disease-related symptoms, quality of life, and clinical outcomes. Overall, prescribed exercise attenuates the fatigue and dyspnea that limit exercise intolerance. The improvements ranged from 15 to 30% in peak VO2, which is greater than or equal to the gains in exercise capacity observed in many clinical drug trials.” 41 4. MCAC A meeting of the Medicare Coverage Advisory Committee entitled Physician-supervised behavioral interventions for patients with symptomatic coronary artery disease (CAD) was held in January 2005. Meeting materials and detailed information are available at http://www.cms.hhs.gov/Regulations-and-Guidance/Guidance/FACA/MEDCAC.html#TopOfPage . The MCAC only reviewed evidence for symptomatic coronary artery disease and did not evaluate all of the requested indications in this NCA. In summary, a technology assessment provided evidence that secondary prevention programs (programs for patients that have already suffered a cardiac event and therefore not a primary intervention program) improve processes of care, enhance quality of life/functional status, reduce hospitalizations, and reduce long-term mortality in patients with established CAD. The weight of the published randomized trial evidence suggests that comprehensive secondary prevention programs positively impact on processes of care (risk factor profiles, use of proven efficacious therapies) which are closely linked to subsequent morbidity and mortality in patients with CAD. Pooling the data from those trials which reported subsequent rates of MI does reveal a trend towards reduction in recurrent MIs over a median follow-up of 12 months; the majority of these programs also demonstrate improved symptom scores, exercise tolerance, or quality of life in participants. The mortality benefit derived from participation in the secondary prevention programs was apparent with longer lengths of follow-up. There was a statistically significant 15% reduction in hospitalizations. The panel voted to inform CMS that for the purpose of the panel’s recommendations, physician-supervised behavioral interventions refer to interventions that are comprehensive, intensive and multidisciplinary. On the question of how well the evidence addresses the effectiveness of physician-supervised behavioral interventions for patients with symptomatic CAD as compared to usual medical/surgical management, the panel voted that the evidence reasonably demonstrated the effectiveness. On the question of how well the evidence addresses the effectiveness of physician-supervised behavioral interventions for patients with symptomatic CAD the panel voted that they were moderately to highly confident in cases of cardiac event including angina, long-term survival, short-term survival and quality of life. Concerning the likelihood that the therapy would produce a clinically important net health benefit in the treatment of patients with symptomatic CAD, the panel voted that they were moderately to highly confident that it would and that, based on the evidence, they were moderately confident that the results could be generalized to the Medicare population (aged 65+). 5. Evidence-based guidelines AHCPR Cardiac Rehabilitation Clinical Practice Guideline (1995) The AHCPR guideline’s specific recommendation was that “elderly coronary patients have exercise trainability comparable to that of younger patients participating in similar exercise rehabilitation. Elderly female and male patients show comparable improvement. Referral to and participation in exercise rehabilitation is less frequent at elderly age, especially for elderly females. No complications or adverse outcomes of exercise training at elderly age were described in any study. Elderly patients of both genders should be strongly encouraged to participate in exercise-based cardiac rehabilitation.” 42 6. Professional Society Position Statements Balady, et al. (2000) Core Components of Cardiac Rehabilitation/Secondary Prevention Program In 2000, the AHA and AACVPR issued a joint scientific statement outlining the core components, expected outcomes, and interventions of cardiac rehabilitation programs. 43 The purpose of this statement was to provide a foundation for and assistance to staff in design and development of cardiac rehabilitation programs, with emphasis on a comprehensive multifaceted approach. The stated core components of cardiac rehabilitation/secondary prevention programs included: Baseline patient assessment Nutritional counseling Risk factor management (lipids, hypertension, weight, diabetes, and smoking) Psychosocial management Physical activity counseling Exercise training AHA Statement: Secondary Prevention of Coronary Heart Disease in the Elderly (2002) With particular emphasis on patients ≥ 75 years of age, this AHA statement concluded that “secondary prevention interventions to impact and control riskfactors in older patients with CHD, including habitual cigarettesmoking, hypertension, abnormal blood lipids, elevated bloodglucose, obesity, various psychological