CAM 80308

Cardiac Rehabilitation in the Outpatient Setting

Category:Therapy   Last Reviewed:August 2019
Department(s):Medical Affairs   Next Review:August 2020
Original Date:August 2013    

Description
Cardiac rehabilitation refers to comprehensive medically supervised programs in the outpatient setting that aim to improve the function of patients with heart disease and prevent future cardiac events. National organizations have specified core components to be included in cardiac rehabilitation programs.

For individuals who have diagnosed heart disease who receive outpatient cardiac rehabilitation, the evidence includes multiple randomized controlled trials (RCTs) and systematic reviews of these trials. Relevant outcomes are overall survival, disease-specific survival, symptoms, and morbid events. Meta-analyses of the available trials have found that cardiac rehabilitation improves health outcomes for select patients, particularly those with coronary heart disease. The available evidence has limitations, including lack of blinded outcome assessment, but, for the survival-related outcomes of interest, this limitation is less critical. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have diagnosed heart disease without a second event who receive repeat outpatient cardiac rehabilitation, the evidence includes no trials. Relevant outcomes are overall survival, disease-specific survival, symptoms, and morbid events. No studies were identified evaluating the effectiveness of repeat participation in a cardiac rehabilitation program. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have diagnosed heart disease who receive intensive cardiac rehabilitation with the Ornish Program for Reversing Heart Disease, the evidence includes 1 RCT and uncontrolled studies. Relevant outcomes are overall survival, disease-specific survival, symptoms, and morbid events. No RCTs have compared the Ornish Program to a “standard” cardiac rehabilitation program; 1 RCT compared it with usual care. The trial included patients with coronary artery disease and no recent cardiac events, and had mixed findings at 1 and 5 years. The trial had a small sample size for a cardiac trial (N=48), and only 35 patients were available for the 5-year follow-up. The Ornish Program is considered by the Centers for Medicare & Medicaid Services as an intensive cardiac rehabilitation program, but the program described in the RCT might meet criteria for standard cardiac rehabilitation. No studies were identified comparing the Ornish Program with any other cardiac rehabilitation program. The evidence is insufficient to determine the effects of the technology on health outcomes. 

For individuals who have diagnosed heart disease who receive intensive cardiac rehabilitation with the Pritikin Program, the evidence includes 1 case series. Relevant outcomes are overall survival, disease-specific survival, symptoms, and morbid events. Studies are needed that compare the impact of intensive cardiac rehabilitation between the Pritikin Program and standard outpatient cardiac rehabilitation programs. The evidence is insufficient to determine the effects of the technology on health outcomes.

Background 
HEART DISEASE
Heart disease is the leading cause of mortality in the United States, accounting for more than half of all deaths. Coronary artery disease (CAD) is the most common cause of heart disease. In a 2015 update on heart disease and stroke statistics from the American Heart Association, it was estimated that 635,000 Americans have a new coronary attack (first hospitalized myocardial infarction or coronary heart disease death) and 300,000 have a recurrent attack annually.1 Both CAD and various other disorders -- structural heart disease and other genetic, metabolic, endocrine, toxic, inflammatory, and infectious causes -- can lead to the clinical syndrome of heart failure, of which there are about 650,000 new cases in the U.S. annually.2 Given the burden of heart disease, preventing secondary cardiac events and treating the symptoms of heart disease and heart failure have received much attention from national organizations. 

In 1995, the U.S. Public Health Service (USPHS) defined cardiac rehabilitation services as, in part, “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 for sudden death or reinfarction, control cardiac symptoms, stabilize or reverse the atherosclerotic process, and enhance the psychosocial and vocational status of selected patients.” This USPHS guideline recommended cardiac rehabilitation services for patients with coronary heart disease and with heart failure, including those awaiting or following cardiac transplantation. A 2010 definition of cardiac rehabilitation from the European Association of Cardiovascular Prevention and Rehabilitation stated: “Cardiac rehabilitation can be viewed as the clinical application of preventive care by means of a professional multi-disciplinary integrated approach for comprehensive risk reduction and global long-term care of cardiac patients.”3 Since release of the USPHS guideline, other societies, including the American Heart Association (2005)4 and the Heart Failure Society of America (2010)5 have developed guidelines on the role of cardiac rehabilitation in patient care.

Regulatory Status
Not applicable.

Related Policies
None

Policy
Outpatient cardiac rehabilitation programs are considered MEDICALLY NECESSARY for patients with a history of the following conditions and procedures: 

  • acute myocardial infarction (heart attack) within the preceding 12 months; 
  • coronary artery bypass graft surgery; 
  • percutaneous transluminal coronary angioplasty or coronary stenting; 
  • heart valve surgery; 
  • heart or heart-lung transplantation; 
  • current stable angina pectoris; and 
  • compensated heart failure.

Repeat participation in an outpatient cardiac rehabilitation program in the absence of another qualifying cardiac event is considered INVESTIGATIONAL.

Intensive cardiac rehabilitation with the Ornish Program for Reversing Heart Disease or Pritikin Program is considered INVESTIGATIONAL.

Policy Guidelines
The following components must be included in cardiac rehabilitation programs:

  • Physician-prescribed exercise each day cardiac rehabilitation services are provided
  • Cardiac risk factor modification
  • Psychosocial assessment
  • Outcomes assessment
  • Individualized treatment plan detailing how each of the above components are utilized

A cardiac rehabilitation exercise program is eligible for coverage for three sessions per week up to a 12-week period (36 sessions). Programs should start within 90 days of the cardiac event and be completed within six months of the cardiac event.

A comprehensive evaluation may be performed prior to initiation of cardiac rehabilitation to evaluate the patient and determine an appropriate exercise program. In addition to a medical examination, an electrocardiogram (EKG) stress test may be performed. An additional stress test may be performed at the completion of the program.

Physical and/or occupational therapy are not medically necessary in conjunction with cardiac rehabilitation unless performed for an unrelated diagnosis.

Rationale
Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function—including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical uses of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice. The following is a summary of the key literature to date.

Outpatient Cardiac Rehabilitation for Heart Disease
Systematic Reviews
Oldridge (2012) identified 6 independent meta-analyses published since 2000 that reported outcomes from 71 RCTs (total N=13824 patients) following cardiac rehabilitation interventions.5, The RCTs included in the meta-analyses enrolled patients with myocardial infarction (MI), coronary heart disease (CHD), angina, percutaneous coronary intervention, and/or coronary artery bypass graft (CABG). RCTs compared cardiac rehabilitation programs (exercise-only and/or comprehensive rehabilitation) with usual care. Cardiac rehabilitation was associated with a statistically significant (p<0.05) reduction in all-cause mortality in 4 of the 5 meta-analyses that reported this outcome. In the pooled analysis, cardiac rehabilitation was associated with an 18.5% mean reduction in all-cause mortality. Also, cardiac rehabilitation was associated with a statistically significant reduction in cardiac mortality in 3 of the 4 meta-analyses that reported disease-specific mortality as an outcome.

Two of the meta-analyses on cardiac rehabilitation was conducted by Cochrane. One included patients with CHD6, and the other focused on patients with systolic heart failure.7, Both addressed exercise-based cardiac rehabilitation programs (exercise alone or as part of a comprehensive program). Anderson et al (2016) updated a 2011 Cochrane review addressing exercise-based cardiac rehabilitation for individuals with CHD.6,8, Reviewers included RCTs of exercise-based interventions with at least 6 months of follow-up compared with no-exercise controls in patients with MI, CABG, or percutaneous coronary intervention, or with angina pectoris or coronary artery disease. The updated review included 63 RCTs (total N=14,486 individuals), of which 16 trials had been published since the 2011 update. Reviewers reported that the overall risk of bias was unclear, although the quality of reporting improved with more recent trials. Due to the nature of the intervention, patients were not blinded to treatment group in any of the studies, but 16 (25%) of 62 studies reported details of blinded assessment of study outcomes. In the pooled analysis, cardiac rehabilitation was not significantly associated with overall mortality. However, among 27 studies, cardiac rehabilitation was significantly associated with reduced cardiovascular mortality (292/3850 for cardiac rehabilitation subjects vs 375/3619 for control subjects; relative risk [RR], 0.74; 95% confidence interval [CI], 0.64 to 0.86). Rates of MI, CABG, and percutaneous coronary interventionwere not significantly associated with receiving cardiac rehabilitation.

A Cochrane review by Taylor et al (2014) reported on studies assessing cardiac rehabilitation in patients with heart failure.9, Reviewers included 33 trials (total N=4740 individuals), with 14 studies added with the latest update. One large trial (HF-ACTION) contributed 50% of patients; most other studies were small and single center. The population was predominantly patients with heart failure with reduced ejection fraction and New York Heart Association functional class II and III heart failure. The trials had a moderate risk of bias; many earlier studies (particularly pre-2000) had insufficient detail to permit assessment of the risk of bias. In the 25 studies that reported all-cause mortality up to 12-month follow-up, there was no difference in pooled mortality between groups (RR=0.93; 95% CI, 0.69 to 1.27; p=0.59). For health-related quality of life, most studies reported disease-specific quality of life with the Minnesota Living With Heart Failure questionnaire. Although there was statistical heterogeneity in the differences in Minnesota Living With Heart Failure scores between exercise and control groups, there was a significant improvement in Minnesota Living With Heart Failure scores with exercise in the pooled analysis (mean difference, -5.8; 95% CI, -9.2 to -2.4, p=0.001). Most studies selected for the Cochrane review, including the HF-ACTION trial, were exercise-only interventions; thus, conclusions cannot be drawn from this review about the impact of comprehensive cardiac rehabilitation programs on mortality or hospital admissions in patients with heart failure. Reviewers did not require that studies only include patients with compensated heart failure.

Table 1. SR & MA Characteristics

Study Dates Trials Participants N..Range. Design
Davies (2010)7, 1990-2002 29 All adults with chronic HF 1126 RCT
Oldridge (2012)5,   71 Patients with MI, CHD, angina, PCI, and/or CABG 13,824 RCT
Taylor (2014)9, 1995-2012 33 Patients with HF 4740 RCT
Anderson (2016)6, 1975-2014 63 Patients with MI, angina pectoris, CAD, or who underwent CABG or PCI 14,486 RCT

HF: heart failure; NR: not reported; MI: myocardial infarction; CHD: coronary heart disease; PCI: percutaneous coronary intervention CABG: coronary artery bypass graft; CAD: coronary artery disease; PCI: percutaneous coronary intervention.

Table 2. SR & MA Results 

Study IncreaseinVO2Max ReductioninAllCauseMortality CardiovascularMortality
Davies (2010)7, 2.16 ml/kg/min    
95% CI 2.82-1.49    
Oldridge (2012)5,   18.50%  
P-value   <0.05  
Taylor (2014)9,      
RR   0.93  
95% CI   0.69-1.27  
P-value   0.59  
Anderson (2016)6,      
RR   0.96 0.74
95% CI   0.88-1.04 0.64-0.86

RR: risk ratio; CI: confidence interval.

Randomized Controlled Trials
Findings of a large, multicenter RCT from the U.K., which evaluated the effectiveness of cardiac rehabilitation in a “real-life” setting, were published by West et al (2012).10, Called the Rehabilitation After Myocardial Infarction Trial (RAMIT), the study included patients from 14 centers with established multifactorial cardiac rehabilitation programs (including exercise, education, and counseling), involved more than 1 discipline, and provided an intervention lasting a minimum of 10 hours. A total of 1813 patients were randomized¾903 to cardiac rehabilitation and 910 to a control condition. Vital status was obtained at 2 years for 99.9% (all but 1 patient) and at 7 to 9 years for 99.4% of patients. By 2 years, 166 patients had died, 82 in the cardiac rehabilitation group and 84 in the control group. The between-group difference in mortality at 2 years (the primary study outcome) was not statistically significant (RR=0.98; 95% CI, 0.74 to 1.30). After 7 to 9 years, 488 patients had died, 245 in the cardiac rehabilitation group and 243 in the control group (RR=0.99; 95% CI, 0.85 to 1.15). In addition, at 1 year, cardiovascular morbidity did not differ significantly between groups. For a combined end point including death, nonfatal MI, stroke, or revascularization, the RR was 0.96 (95% CI, 0.88 to 1.07). In discussing the study’s negative findings, trialists noted that medical management of heart disease had improved over time, and patients in the control group might have had better outcomes than in earlier RCTs on this topic. Moreover, an editorial accompanying the publication of the trial’s findings emphasized that RAMIT was not an efficacy trial, but rather, a trial evaluating the effectiveness of actual cardiac rehabilitation programs in the U.K.11, Finally, these results might in part reflect the degree to which clinically based cardiac rehabilitation programs in the U.K. differ from the treatment protocols used in RCTs based in research settings.

A concern raised by the negative findings in the RAMIT trial is that most of the RCTs evaluating cardiac rehabilitation were conducted in an earlier era of heart disease management and might not be relevant to current care. However, RAMIT’s results, along with 15 additional RCTs reported since a 2011 Cochrane review, were included in the updated 2016 Cochrane review, which found improvements in cardiovascular mortality associated with exercise-based cardiac rehabilitation.

Pandey et al (2017) evaluated endurance exercise training as part of a cardiac rehabilitation program in a population of heart failure patients stratified by ejection fraction.12,Participants had heart failure with preserved ejection fraction (HFpEF) or reduced ejection fraction, were 65 years of age or older, and had participated in a 16-week exercise program that intensified from 40% to 50% of heart rate reserve in the first 2 weeks to 60% to 70% over the ensuing weeks as part of a previously published RCT (Kitzman et al [2010]).13, The primary outcome for assessing change in exercise capacity was percentage change in peak oxygen uptake (Vo2peak) (mL/kg per minute) from baseline to end of exercise training (16-week follow-up). Data on testing from 48 patients (24 reduced ejection fraction, 24 HFpEF) were assessed. HFpEF patients experienced greater improvement in exercise training patients (18.7%) than reduced ejection faction patients (-0.3%; p<0.001) as measured by Vo2peak. There was no information on subsequent hospitalizations rates or clinical outcomes such as heart failure progression or mortality. This secondary analysis was used to assert the appropriateness of cardiac rehabilitation in HFpEF patients.

Table 3. Summary of Key RCT Characteristics

StudyTrial Countries Sites Dates Participants Interventions X
          Active Comparator
West (2012); RAMIT10, UK 14 1997-2000 Patients diagnosed with acute MI Cardiac rehabilitation (n=903) Control (n=910)
Pandey (2017)12, US 1 NR Patients age 65 with either HFrEF (n=24) or HFpEF (n=24) 16-week supervised moderate endurance exercise training  

RCT: randomized controlled trial; MI: myocardial infarction; NR: not reported; HF: heart failure; HFrEF: HF with reduced ejection fraction; HFpEF: HF with preserved ejection fraction.

Table 4. Summary of Key RCT Results 

Study X2yrMortality ReadmissionstoHospitalforanyCardioConditionat1yr TrainingRelatedImprovementinVO2peak change
West (2012)10,      
CR 82 patients 222 (25%)  
Control 84 patients 239 (26%)  
95% CI 0.74-1.30    
Pandey (2017)12,      
HFrEF     18.7+/-17.6
HFpEF     -0.3+/-15.4
P-value     <0.001

RCT: randomized controlled trial; Yr.: year; CR: cardiac rehabilitation; Cardio.: cardiovascular; VO2peak: peak oxygen uptake.

Table 5. Relevance Gaps

Study

Populationa

Interventionb

Comparatorc

Outcomesd

FollowUpe

West (2012)10,

 

 

 

 

1,2. Trial was closed prematurely

Pandey (2017)12,

 

 

2. No comparator used

 

1,2. Only 16 weeks follow-up

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3.  Delivery not similar intensity as intervention; 4. Not delivered effectively.
d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 6. Study Design and Conduct Gaps 

Study

Allocationa

Blindingb

SelectiveReportingc

Follow.Upd

Powere

Statisticalf

West (2012)10, 3. Allocation concealment unclear 1,2. Not blinded        
Pandey (2017)12, 1. Participants not randomly allocated 1,2. Not blinded        

The evidence gaps stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3.  Evidence of selective publication.
d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Observational Studies
Sumner et al (2017) published a systematic review of controlled observational studies evaluating cardiac rehabilitation in patients diagnosed with acute MI.14, Cardiac rehabilitation interventions consisted of structured multicomponent programs that included exercise and at least one of the following: education, information, health behavior change, and psychological or social support. Usual care interventions generally supervised medical interventions, were the control conditions. Ten studies met reviewers’ eligibility criteria. In a meta-analysis of 5 studies reporting all-cause mortality (an unadjusted outcome), there was a significantly lower risk of death in the group that received cardiac rehabilitation (odds ratio, 0.25; 95% CI, 0.16 to 0.40). Three studies that reported an adjusted analysis of all-cause mortality also found a significant benefit from cardiac rehabilitation (odds ratio, 0.47; 95% CI, 0.38 to 0.59). Similarly, a meta-analysis of 3 studies reporting cardiac-related mortality (an unadjusted analysis) found a significant benefit from cardiac rehabilitation (odds ratio, 0.21; 95% CI, 0.12 to 0.37). Only 1 study reported an adjusted analysis of cardiac-related mortality, so data could not be pooled.

Nilsson et al (2018) investigated the effect of a 12-week cardiac rehabilitation program with a high-intensity interval exercise component using participant Vo2peak as a measure of improved exercise capacity.15, Increased exercise capacity has been shown to improve survival among persons with CHD. The objective of the study was to assess whether this addition to a cardiac rehabilitation program yielded improved long-term results. One hundred thirty-three coronary patients participated in this prospective cohort study and were evaluated at baseline, at the end of the 12-week program, and again at a 15-month follow-up. Additional test measurements included a cardiopulmonary exercise test, body mass index, blood pressure tests, and a quality of life questionnaire. Of the 133 patients, 86 patients had complete information for the 15-month follow-up. Mean Vo2peak improved from a baseline of 31.9 mL/kg/min to 35.9 mL/kg/min (p<0.001) at the end of the 12-week program, and to 36.8 mL/kg/min (CI not reported) at 15-month follow-up. Most of the 86 patients reported maintaining an exercise routine. Study limitations included the small sample size, a relatively low-risk male population at baseline, and lack of information on the qualifying event for cardiac rehabilitation. The authors concluded that the cardiac rehabilitation program intervention potentially fostered consistent and beneficial exercise habits as demonstrated by improved Vo2peak.

Section Summary: Outpatient Cardiac Rehabilitation for Heart Disease
Overall, the evidence from RCTs reviewed in well-structured systematic reviews suggests that cardiac rehabilitation is associated with reduced cardiovascular mortality in patients with CHD. Additional RCTs, systematic reviews, and observational studies have evaluated outpatient cardiac rehabilitation in patients with heart failure or in the postintervention setting. An overview of 6 meta-analyses found a statistically significant association between cardiac rehabilitation and all-cause mortality and/or cardiac mortality. The available evidence has limitations, including lack of blinded outcome assessment, but, for the survival-related outcomes of interest, this limitation is less critical.

Repeat Outpatient Cardiac Rehabilitation
No studies were identified that evaluated the effectiveness of repeat participation in a cardiac rehabilitation program.

Intensive Cardiac Rehabilitation for Heart Disease
There is no standard definition of an intensive cardiac rehabilitation program and, thus, specific programs are reviewed individually. Two programs have been evaluated by Centers for Medicare & Medicaid Services, and we describe the published evidence supporting these programs next. The ideal trial design would be an RCT comparing the impact of intensive cardiac rehabilitation with standard cardiac rehabilitation on health outcomes.

Ornish Program for Reversing Heart Disease
Ornish et al (1990) conducted an RCT, called the Lifestyle Heart Trial, comparing a version of the Ornish Program for Reversing Heart Disease with usual care. Initial results were reported in 1990, and 5-year results in 1998.16,17, Eligibility for the trial included diagnosed coronary artery disease, left ventricular ejection fraction greater than 25%, no MI during the previous 6 weeks, no scheduled for CABG, and not taking lipid-lowering medication. Ninety-four eligible patients were randomized to an intervention group (n=53) or a usual care control group (n=43). Final consenting was done after randomization; 28 (53%) of patients assigned to the intervention group and 20 (43%) assigned to the control group agreed to participate in the trial.

The Lifestyle intervention consisted of recommending a low-fat vegetarian diet and an individualized exercise regimen. Also, patients were taught stress management techniques and were taught to practice them at home for at least an hour a day. Also, twice-weekly group discussions were offered to provide social support. It is not clear how long patients attended these group discussion (ie, the number of weeks or months). As reported by Ornish et al (1990), the mean percentage diameter stenosis decreased from 40% at baseline to 37.8% at 1year in the intervention group and increased from 42.7% to 46.1% in the control group (p=0.001). The frequency and duration of chest pain did not differ between groups. However, during chest pain episodes, at 1 year, the intervention group reported mean chest pain severity of 1.7 (on a 7-point scale) whereas the mean score in the control group was 2.5 (p<0.001).

Twenty (71%) of 28 patients in the intervention group and 15 (75%) of 20 in the control group completed the 5-year follow-up. The intervention and control groups did not differ significantly in the number of MI events (2 vs 4), CABGs (2 vs 5), or deaths (2 vs 1). However, compared with the control group, the intervention group had significantly fewer percutaneous transluminal coronary angioplasties (8 vs 14, p<0.050) and cardiac hospitalizations (23 vs 44, p<0.001).

Section Summary: Ornish Program for Reversing Heart Disease
One RCT was identified that evaluated the Ornish Program in patients diagnosed with heart disease, and compared it with usual care. This RCT, which included patients with coronary artery disease but no recent cardiac event, had mixed findings at 1 and 5 years. The trial had a small sample size for a cardiac trial (N=48), and only 35 patients were available for the 5-year follow-up. The Ornish Program is considered by Centers for Medicare & Medicaid Services to be an intensive cardiac rehabilitation program, but the program described in this RCT might meet criteria for standard cardiac rehabilitation. No studies were identified that compared the Ornish Program with any other cardiac rehabilitation program.

Pritikin Program
No RCTs evaluating the Pritikin Program were identified. The published evidence on this program consists of case series, and only one (Barnard et al [1983]) included patients with heart disease.18, (Other case series included patients without heart failure, eg, those with high cholesterol levels.) Sixty-four patients with documented coronary artery disease attended a 26-day residential treatment program between 1976 and 1977. During the program, patients were encouraged to walk for 30 to 45 minutes twice a day, learned how to prepare foods consistent with the Pritikin diet, and attended over 60 hours of group education classes. Serum samples were taken at baseline and the end of the program. Patients were called in March 1980 for a follow-up interview and asked to send in serum samples. At the 3- to 4-year follow-up, 12 (19%) of 64 patients had had bypass surgery, and4 patients had died. Fifty (81%) patients provided serum samples at follow-up, and the mean cholesterol level (166 mg/dL) was significantly lower than the baseline value (220 mg/dL). The trial was limited in the lack of a control group, especially a group receiving “standard” outpatient cardiac rehabilitation, and long-term mortality outcomes were not reported.

Section Summary: Pritikin Program
No RCTs have evaluated the Pritikin Program; a single case series in patients with heart disease was identified. Conclusions cannot be drawn from this series on the impact of intensive cardiac rehabilitation with the Pritikin Program compared with standard outpatient cardiac rehabilitation.

Summary of Evidence
For individuals who have diagnosed heart disease who receive outpatient cardiac rehabilitation, the evidence includes multiple RCTs and systematic reviews of these trials. Relevant outcomes are overall survival, disease-specific survival, symptoms, and morbid events. Meta-analyses of the available trials have found that cardiac rehabilitation improves health outcomes for select patients, particularly those with coronary heart disease, heart failure, and who have had cardiac surgical interventions. The available evidence has limitations, including lack of blinded outcome assessment, but, for the survival-related outcomes of interest, this limitation is less critical. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have diagnosed heart disease without a second event who receive repeat outpatient cardiac rehabilitation, the evidence includes no trials. Relevant outcomes are overall survival, disease-specific survival, symptoms, and morbid events. No studies were identified evaluating the effectiveness of repeat participation in a cardiac rehabilitation program. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have diagnosed heart disease who receive intensive cardiac rehabilitation with the Ornish Program for Reversing Heart Disease, the evidence includes an RCT and uncontrolled studies. Relevant outcomes are overall survival, disease-specific survival, symptoms, and morbid events. No RCTs have compared the Ornish Program with a “standard” cardiac rehabilitation program; an RCT compared it with usual care. The trial included patients with coronary artery disease and no recent cardiac events and had mixed findings at 1 and 5 years. The trial had a small sample size for a cardiac trial (N=48), and only 35 patients were available for the 5-year follow-up. The Ornish Program is considered by the Centers for Medicare & Medicaid Services as an intensive cardiac rehabilitation program, but the program described in the RCT could meet criteria for standard cardiac rehabilitation. No studies were identified comparing the Ornish Program with any other cardiac rehabilitation program. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have diagnosed heart disease who receive intensive cardiac rehabilitation with the Pritikin Program, the evidence includes a case series. Relevant outcomes are overall survival, disease-specific survival, symptoms, and morbid events. Studies are needed that compare the impact of intensive cardiac rehabilitation using the Pritikin Program with standard outpatient cardiac rehabilitation programs. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements
American College of Cardiology Foundation et al
In 2013, the American College of Cardiology Foundation and the American Heart Association updated their joint guidelines on the management of heart failure.2 These guidelines included the following class IIA recommendation on cardiac rehabilitation (level of evidence: B): “Cardiac rehabilitation can be useful in clinically stable patients with HF [heart failure] to improve functional capacity, exercise duration, health-related quality of life, and mortality.”The 2017 focused update of the guideline did not include additional information on cardiac rehabilitation.19,

American College of Physicians
In 2012, the American College of Physicians and 6 other cardiology associations published joint guidelines on the management of stable ischemic heart disease.20, The guidelines included the following statement on cardiac rehabilitation: “Medically supervised exercise programs (cardiac rehabilitation) and physician-directed, home-based programs are recommended for at-risk patients at first diagnosis.”The 2014 update to the guideline did not include additional information on cardiac rehabilitation.21,

American Heart Association et al
In 2007, the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation issued a consensus statement on the core components of cardiac rehabilitation programs.22, The core components included patient assessment before beginning the program, nutritional counseling, weight management, blood pressure management, lipid management, diabetes management, tobacco cessation, psychosocial management, physical activity counseling, and exercise training. Programs that only offered supervised exercise training were not considered cardiac rehabilitation.The guidelines specified the assessment, interventions, and expected outcomes for each of the core components. For example, symptom-limited exercise testing before exercise training was strongly recommended. The guidelines did not specify the optimal overall length of programs or number or duration of sessions. 

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Ongoing

     

NCT02619422

Multicenter, prospective, randomized, open, blinded for the end point evaluator to compare compliance to secondary prevention measures after acute coronary syndrome and intensive cardiac rehabilitation program vs standard program

509

Feb 2018 (ongoing)

NCT02762825

Novel Cardiac Rehabilitation in Patients Heart Failure and Preserved Ejection Fraction

66

Sept 2018 (ongoing)

NCT02795936a

Feasibility of Cardiac Rehabilitation in Patients With Heart Failure at the Moi Teaching and Referral Hospital

101

Jun 2018 (ongoing)

NCT03385837

Activity Level and Barriers to Participate of Cardiac Rehabilitation in Advanced Heart Failure Patients

50

Dec 2018 (ongoing)

NCT02984449

Preventive Heart Rehabilitation in Patients Undergoing Elective Open Heart Surgery to Prevent Complications and to Improve Quality of Life (Heart-ROCQ) - A Prospective Randomized Open Controlled Trial, Blinded End-point (PROBE)

350

Aug 2025

Unpublished

     

NCT01822769

Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

28

Dec 2017
(completed)

NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.

References  

  1. Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. Jan 27 2015;131(4):e29-322. PMID 25520374.
  2. Corra U, Piepoli MF, Carre F, et al. Secondary prevention through cardiac rehabilitation: physical activity counselling and exercise training: key components of the position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur Heart J. Aug 2010;31(16):1967-1974. PMID 20643803.
  3. Leon AS, Franklin BA, Costa F, et al. Cardiac rehabilitation and secondary prevention of coronary heart disease: an American Heart Association scientific statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration with the American Association of Cardiovascular and Pulmonary Rehabilitation. Circulation. Jan 25 2005;111(3):369-376. PMID 15668354.
  4. Heart Failure Society of America, Lindenfeld J, Albert NM, et al. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail. Jun 2010;16(6):e1-194. PMID 20610207.
  5. Oldridge N. Exercise-based cardiac rehabilitation in patients with coronary heart disease: meta-analysis outcomes revisited. Future Cardiol. Sep 2012;8(5):729-751. PMID 23013125.
  6. Anderson L, Thompson DR, Oldridge N, et al. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. Jan 5 2016;1:CD001800. PMID 26730878.
  7. Davies EJ, Moxham T, Rees K, et al. Exercise based rehabilitation for heart failure. Cochrane Database Syst Rev. 2010(4):CD003331. PMID 20393935.
  8. Heran BS, Chen JM, Ebrahim S, et al. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. Jul 6 2011(7):CD001800. PMID 21735386.
  9. Taylor RS, Sagar VA, Davies EJ, et al. Exercise-based rehabilitation for heart failure. Cochrane Database Syst Rev. Apr 27 2014;4(4):CD003331. PMID 24771460.
  10. West RR, Jones DA, Henderson AH. Rehabilitation after myocardial infarction trial (RAMIT): multi-centre randomised controlled trial of comprehensive cardiac rehabilitation in patients following acute myocardial infarction. Heart. Apr 2012;98(8):637-644. PMID 22194152.
  11. Doherty P, Lewin R. The RAMIT trial, a pragmatic RCT of cardiac rehabilitation versus usual care: what does it tell us? [editorial]. Heart. Apr 2012;98(8):605-606. PMID 22505460.
  12. Pandey A, Kitzman DW, Brubaker P, et al. Response to endurance exercise training in older adults with heart failure with preserved or reduced ejection fraction. J Am Geriatr Soc. Aug 2017;65(8):1698-1704. PMID 28338229.
  13. Kitzman DW, Brubaker PH, Morgan TM, et al. Exercise training in older patients with heart failure and preserved ejection fraction: a randomized, controlled, single-blind trial. Circ Heart Fail. Nov 2010;3(6):659-667. PMID 20852060.
  14. Sumner J, Harrison A, Doherty P. The effectiveness of modern cardiac rehabilitation: A systematic review of recent observational studies in non-attenders versus attenders. PLoS One. May 2017;12(5):e0177658. PMID 28498869.
  15. Nilsson BB, Lunde P, Grogaard HK, et al. Long-term results of high-intensity exercise-based cardiac rehabilitation in revascularized patients for symptomatic coronary artery disease. Am J Cardiol. Jan 1 2018;121(1):21-26. PMID 29096886.
  16. Ornish D, Brown SE, Scherwitz LW, et al. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. Jul 21 1990;336(8708):129-133. PMID 1973470.
  17. Ornish D, Scherwitz LW, Billings JH, et al. Intensive lifestyle changes for reversal of coronary heart disease. Jama. Dec 16 1998;280(23):2001-2007. PMID 9863851.
  18. Barnard RJ, Guzy PM, Rosenberg JM, et al. Effects of an intensive exercise and nutrition program on patients with coronary artery disease: five-year follow-up. J Cardiac Rehabil 1983;3:183-190.
  19. Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF.AHA Guideline for the Management of Heart Failure. Circulation. 2017;136:e137-e161. PMID: 28455343.
  20. Qaseem A, Fihn SD, Dallas P, et al. Management of stable ischemic heart disease: summary of a clinical practice guideline from the American College of Physicians/American College of Cardiology Foundation/American Heart Association/American Association for Thoracic Surgery/Preventive Cardiovascular Nurses Association/Society of Thoracic Surgeons. Ann Intern Med. Nov 20 2012;157(10):735-743. PMID 23165665.
  21. Lanza GA, Grea F. Stable Ischemic Heart Disease: The Update to the 2012 Guideline. Accessed on January 6, 2019. https://www.acc.org/latest-in-cardiology/articles/2015/01/30/12/26/stable-ischemic-heart-disease-the-update-to-the-2012-guideline.
  22. Balady GJ, Williams MA, Ades PA, et al. Core components of cardiac rehabilitation/secondary prevention programs: 2007 update: a scientific statement from the American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; the Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical Activity, and Metabolism; and the American Association of Cardiovascular and Pulmonary Rehabilitation. Circulation. May 22 2007;115(20):2675-2682. PMID 17513578.
  23. Centers for Medicare and Medicaid Services (CMS). Medicare Claims Processing Manual (Publication 100-04 Chapter 32). 2017; https://www.cms.gov/Regulations-and- Guidance/Guidance/Manuals/downloads//clm104c32.pdf. Accessed February 14, 2018.
  24. Centers for Medicare & Medicaid Services (CMS). CMS Manual System: Pub 100-03 Medicare National Coverage Determinations. Cardiac Rehabilitation Programs for Chronic Heart Failure. 2014; http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R171NCD.pdf. Accessed February 14, 2018.
  25. Centers for Medicare % Medicaid Services (CMS). National Coverage Determination (NCD) for Intensive Cardiac Rehabilitation Programs (20.31). 2010; http://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=339&ncdver=1&CoverageSelection=National&KeyWord=intensive+cardiac&KeyWordLook Up=Title&KeyWordSearchType=And&clickon=search&bc=gAAAABAAAAAA&. Accessed February 14, 2018.
  26. Centers for Medicare & Medicaid Services (CMS). Decision Memo for INTENSIVE CARDIAC Rehabilitation (ICR) Program - Dr. Ornish's Program for Reversing Heart Disease (CAG-00419N). 2010; https://www.cms.gov/medicare-coverage-database/details/nca-decision- memo.aspx?NCAId=240&NCDId=339&ncdver=1&CoverageSelection=National&KeyWord=intensive+cardiac&K eyWordLookUp=Title&KeyWordSearchType=And&clickon=search&IsPopup=y&bc=AAAAAAAACAAAAA%3d%3 d&. Accessed February 14, 2018.

Coding Section

 Codes Number  Description 
CPT 93015 

Cardiovascular stress test using maximal or submaximal treadmill or bicycle exercise, continuous electrocardiographic monitoring, and/or pharmacological stress; with physician supervision, with interpretation and report 

  93016

Same as 93015, but with physician supervision only, and without interpretation and report 

  93797

Physician or other qualified health care professional services for outpatient cardiac rehab; without continuous ECG monitoring (per session) 

  93798

; with continuous ECG monitoring (per session) 

  99215

Physician office visit for comprehensive examination, established patient 

ICD-9 Procedure   89.44 

Other cardiovascular stress test (includes EKG stress test) 

  89.7

General physical examination 

  93.36 

Cardiac retraining (cardiac rehabilitation regimen following myocardial infarction or coronary bypass graft procedure) 

ICD-9 Diagnosis   410.00-410.92 

Acute myocardial infarction code range

  412

History of, or “old,” myocardial infarction (MI is healed, presenting no symptoms, and greater than 8 weeks since MI) 

  413.9 

Angina pectoris (includes stable) 

  428.0 

Congestive heart failure, unspecified (includes compensated) 

  V42.0 

Organ or tissue replaced by transplant; heart 

  V45.81 

Other postprocedural status: aortocoronary bypass status 

  V45.82 

Other postprocedural status; percutaneous transluminal coronary angioplasty status 

HCPCS  S9472 

Cardiac rehabilitation program, nonphysician provider, per diem 

ICD-10-CM (effective 10/01/15) I20.8-I20.9 

Angina pectoris, other/unspecified code range

 

I21.01-I21.4 

ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction code range 

 

I50.1-I50.9 

Heart failure code range 

 

Z94.1 

Heart transplant status 

 

Z94.3 

Heart and lungs transplant status 

 

Z95.1 

Presence of aortocoronary bypass graft 

 

Z95.2-Z95.4 

Presence of heart valve code range 

 

Z95.5 

Presence of coronary angioplasty implant and graft 

 

Z98.61 

Coronary angioplasty status 

ICD-10-PCS (effective 10/01/15)   

Not applicable. Policy is only for outpatient services.

Type of Service 

Medical  

Place of Service 

Outpatient 

 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.  

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines. 

"Current Procedural Terminology© American Medical Association.  All Rights Reserved"  

History From 2014 Forward     

08/06/2019 

Annual review, no change to policy intent. Updating rationale and references. 

 08/13/2018

Annual review, no change to policy intent. Updating rationale and references.

08/28/2017 

Annual review, adding verbiage to indicate intensive cardiac rehabiliataion with the Ornish Program for reversing heart disease or Pritikin Program is investigational. Also updating background, description, rationale and references. 

08/11/2016 

Annual review, no change to policy intent. Updating background, description, rationale and references. 

08/11/2015 

Annual review, no change to policy intent. Updated background, description, rationale and references. Added coding. 

08/04/2014

Annual review. Added two additional diagnoses in the medical necessity area: current stable angina pectoris and compensated heart failure. Updated description, background, rationale and references.


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