Intensive Cardiac Rehabilitation Programs

Number: 0267

Policy

Aetna considers intensive cardiac rehabilitation (ICR) programs (i.e. Benson-Henry Institute Cardiac Wellness Program, Ornish cardiac treatment program, and Pritikin Program) a medically necessary alternative to traditional Phase II cardiac rehabilitation for persons who meet medical necessity criteria for cardiac rehabilitation as outlined in CPB 0021 - Cardiac Rehabilitation. Note: ICR sessions are limited to a series of 72 one-hour sessions, up to 6 sessions per day, over a period of up to 18 weeks.

Intensive cardiac rehabilitation programs are considered experimental and investigational as a treatment for diabetes, hyperlipidemia, prostate cancer, metabolic syndrome, and for all other indications.

Note: Subject to plan design and benefits, use of participating providers, referral requirements, etc., identifiable charges for individual services that would otherwise be covered, such as office visits or diagnostic testing, are eligible for reimbursement.  Charges for the program as a package or for individual services that are not normally covered, such as frozen food products, yoga or meditation, are not eligible for reimbursement.  Please check plan documents.

Background

This policy was adapted from the Centers of Medicare & Medicaid Services (CMS) National Coverage Determination (NCD) for Intensive Cardiac Rehabilitation (ICR) Programs.

Intensive cardiac rehabilitation (ICR) is a comprehensive program that is physician-supervised and furnishes cardiac rehabilitation services more frequently and often in a more rigorous manner than a traditional cardiac rehabilitation program.  At one point, traditional cardiac rehabilitation focused on exercise alone. Now there are cardiac rehabilitation programs that offer a composite of cardiac risk modification that include, not only a focus in exercise, but in lipid, blood pressure and stress reduction, smoking cessation, diet modification, and weight loss (CMS, 2014).

The Centers for Medicare & Medicaid Services (CMS) require an intensive cardiac rehabilitation (ICR) program to show, in peer-reviewed published research, that it accomplished one or more of the following for its patients:

• positively affected the progression of coronary heart disease;
• reduced the need for coronary bypass surgery; or
• reduced the need for percutaneous coronary interventions.

The ICR program must also demonstrate through peer-reviewed published research that it accomplished a statistically significant reduction in five or more of the following measures for patients from their levels before cardiac rehabilitation services to after cardiac rehabilitation services:

• low density lipoprotein;
• triglycerides;
• body mass index;
• systolic blood pressure;
• diastolic blood pressure; and
• the need for cholesterol, blood pressure, and diabetes medications.

As required by CMS §1861(eee)(4)(B) of the Act, to be eligible for an intensive cardiac rehabilitation program, an individual must have (CMS, 2014):

• had an acute myocardial infarction within the preceding 12 months;
• had coronary bypass surgery;
• stable angina pectoris;
• had heart valve repair or replacement;
• had percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; or
• had a heart or heart-lung transplant.

As of August 2010, the Centers for Medicare and Medicaid Services (CMS) determined that Dr. Ornish’s Program for Reversing Heart Disease and Pritikin Program met the intensive cardiac rehabilitation program requirements set forth by Congress in §1861(eee)(4)A) of the Social Security Act and in our regulations at 42 C.F.R. §410.49(c) and, as such, has been included on the list of approved ICR programs. In May 2014, The Benson-Henry Institute Cardiac Wellness Program was added to the list of CMS National Coverage Determination (NCD) for approved intensive cardiac rehabilitation (CMS, 2015).

Centers for Medicare & Medicaid Services (CMS) coverage of the Ornish program was a result of the Medicare Improvements for Patients and Providers Act, which defined by legislation the outcomes that Medicare would consider in evaluating cardiac rehabilitation programs for coverage.  In 2009, the Centers for Medicare and Medicaid Services generated a national coverage analysis (NCA) to establish a national coverage determination for the Dr. Ornish's Program for Reversing Heart Disease.  This NCA reviewed evidence to examine if the Ornish program demonstrates the statutorily mandated outcomes identified in section 144(a) of the Medicare Improvements for Patients and Providers Act of 2008: Payment and Coverage Improvements for Patients with Chronic Obstructive Pulmonary Disease and Other Conditions -- Coverage of Pulmonary and Cardiac Rehabilitation.  By legislatively mandating the outcomes that CMS must consider in evaluating cardiac rehabilitation programs for coverage, Medicare coverage of the Ornish program was ensured.

Ornish Cardiac Rehabilitation Program

Dr. Dean Ornish conducted a series of studies to ascertain if an intensive risk-modification regimen can arrest or even reverse progression of atherosclerosis.  The Ornish's cardiac treatment program for patients with coronary heart disease is a demanding regimen.  It includes:

• A smoking cessation program; and
• A vegetarian diet with less than 10 % of calories from fat, with minimal amounts of saturated fat (the "Reversal Diet"); and
• For the most part, no use of lipid-lowering drugs; and
• Group support and psychological counseling to identify sources of stress and the development of tools that help manage stress more effectively; and
• Moderate exercise, usually a walking program; and
• Reliance on the daily use of stress management techniques including various stretching, breathing, meditation, yoga and relaxation exercises.

The American Heart Association (AHA) currently recommends a regular exercise program and the AHA's Step II diet for reducing blood cholesterol levels (and thus the risk of coronary heart disease).  If diet and exercise alone do not enable patients to reach the goals they set with their doctors, then medication is recommended.  The AHA notes that Dr. Ornish's treatment for patients with coronary heart disease is a demanding regimen and it is unclear how many patients would adhere to a treatment plan on a long-term basis or how many could benefit from such a program.

Ornish et al (1990) reported that comprehensive lifestyle changes may be able to bring about regression of atherosclerotic lesions by coronary angiography after only 1 year, without use of lipid-lowering drugs. The investigators reported on a prospective, randomized, controlled trial to determine whether comprehensive lifestyle changes affect coronary atherosclerosis after 1 year, 28 patients were assigned to an experimental group (low-fat vegetarian diet, stopping smoking, stress management training, and moderate exercise) and 20 to a usual-care control group.  Investigators analyzed 195 coronary artery lesions by quantitative coronary angiography.  The average percentage diameter stenosis regressed from 40.0 (SD 16.9) % to 37.8 (16.5) % in the experimental group yet progressed from 42.7 (15.5) % to 46.1 (18.5) % in the control group.  When only lesions greater than 50 % stenosed were analyzed, the average percentage diameter stenosis regressed from 61.1 (8.8) % to 55.8 (11.0) % in the experimental group and progressed from 61.7 (9.5) % to 64.4 (16.3) % in the control group.  Overall, 82 % of experimental-group patients had an average change towards regression. 

Gould et al (1995) found that intensive lifestyle modification reduced the size and severity of myocardial perfusion abnormalities by positron emission tomography (PET) in patients with coronary artery disease after 5 years of risk factor modification.  Investigators randomized patients to risk factor modification consisting of very low-fat vegetarian diet, mild to moderate exercise, stress management, and group support (experimental group, n = 20) or to usual care by their own physicians, consisting principally of antianginal therapy (control group, n = 15).  Main outcome measures included quantitative coronary arteriography and PET at baseline and 5 years after randomization.  Automated, objective measures of size and severity of perfusion abnormalities on rest-dipyridamole PET images and of stenosis severity on arteriograms were made by computer algorithms.  The investigators found that size and severity of perfusion abnormalities on dipyridamole PET images decreased (improved) after risk factor modification in the experimental group compared with an increase (worsening) of size and severity in controls.  The percentage of left ventricle perfusion abnormalities outside 2.5 SDs of those of normal persons (based on 20 disease-free individuals) on the dipyridamole PET image of normalized counts worsened in controls (mean +/- SE, + 10.3 % +/- 5.6 %) and improved in the experimental group (mean +/- SE, -5.1 % +/- 4.8 %) (p = 0.02); the percentage of left ventricle with activity less than 60 % of the maximum activity on the dipyridamole PET image of normalized counts worsened in controls  (+13.5 % +/- 3.8 %) and improved in the experimental group (-4.2 % +/- 3.8 %) (p = 0.002); and the myocardial quadrant on the PET image with the lowest average activity expressed as a percentage of maximum activity worsened in controls (-8.8 % +/- 2.3 %) and improved in the experimental group (+4.9 % +/- 3.3 %) (p = 0.001).  The size and severity of perfusion abnormalities on resting PET images were also significantly improved in the experimental group as compared with controls.  The relative magnitude of changes in size and severity of PET perfusion abnormalities was comparable to or greater than the magnitude of changes in percent diameter stenosis, absolute stenosis lumen area, or stenosis flow reserve documented by quantitative coronary arteriography.  The investigators concluded that modest regression of coronary artery stenoses after risk factor modification is associated with decreased size and severity of perfusion abnormalities on rest-dipyridamole PET images.  Progression or regression of coronary artery disease can be followed noninvasively by dipyridamole PET reflecting the integrated flow capacity of the entire coronary arterial circulation. 

Ornish, et al. (1998) sought to determine the feasibility of patients to sustain intensive lifestyle changes for a total of 5 years and the effects of these lifestyle changes (without lipid-lowering drugs) on coronary heart disease. Investigators randomized 48 patients with moderate to severe coronary heart disease to an intensive lifestyle change group or to a usual-care control group, and 35 completed the 5-year follow-up quantitative coronary arteriography.Experimental group patients (20 [71%] of 28 patients completed 5-year follow-up) made and maintained comprehensive lifestyle changes for 5 years, whereas control group patients (15 [75%] of 20 patients completed 5-year follow-up) made more moderate changes. In the experimental group, the average percent diameter stenosis at baseline decreased 1.75 absolute percentage points after 1 year (a 4.5% relative improvement) and by 3.1 absolute percentage points after 5 years (a 7.9% relative improvement). In contrast, the average percent diameter stenosis in the control group increased by 2.3 percentage points after 1 year (a 5.4% relative worsening) and by 11.8 percentage points after 5 years (a 27.7% relative worsening) (P=.001 between groups. Twenty-five cardiac events occurred in 28 experimental group patients vs 45 events in 20 control group patients during the 5-year follow-up (risk ratio for any event for the control group, 2.47 [95% confidence interval, 1.48-4.20]). The investigators concluded that more regression of coronary atherosclerosis occurred after 5 years than after 1 year in the experimental group. In contrast, in the control group, coronary atherosclerosis continued to progress and more than twice as many cardiac events occurred. 

A study (n = 84) by Aldana et al (2003) reported that patients with coronary heart disease who chose to participate in the Ornish program experienced greater improvements in cardiovascular disease risk factors at 3 months and 6 months than those who chose to participate in traditional cardiac rehabilitation or no formal program.  The longitudinal, observational study included 84 patients receiving cardiovascular disease standard of care who elected to participate in 1 of the 3 study groups: the Ornish Heart Disease Reversing Program, a traditional cardiac rehabilitation, and a control group that received no formal cardiac risk-reduction program. Assessments of CVD risk factors and anginal severity were obtained at baseline, 3 months, and 6 months. The investigators reported that Ornish program participants had significantly greater reductions in anginal frequency, body weight, body mass index, systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, glucose, dietary fat, and increases in complex carbohydrates than were documented in the rehabilitation or control groups. However, it is interesting to note that the control group experienced the greatest reduction in anginal pain severity.  The findings of this study need to be validated by further investigation with larger sample size and longer follow-up.

Koertge et al (2003) examined medical and psychosocial characteristics of 440 patients (mean age 58 years, 21 % women) with coronary artery disease at baseline and at 3-month and 12-month follow-ups.  All patients were participants in the Multicenter Lifestyle Demonstration Project.  Spousal participation was encouraged.  Both genders evidenced significant improvements in their diet, exercise, and stress management practices, which they maintained over the course of the study.  Both women and men also showed significant medical (e.g., plasma lipids, blood pressure, body weight, exercise capacity) and psychosocial (e.g., quality of life) improvement.  Despite their worse medical, psychosocial, and sociodemographic status at baseline, women's improvement was similar to that of men's.  The authors concluded that these results demonstrate that a multi-component lifestyle change program focusing on diet, exercise, stress management, and social support can be successfully implemented at hospitals in diverse regions of the United States.  Furthermore, this program may be particularly beneficial for women with coronary artery disease who generally have higher mortality and morbidity than men after a heart attack, angioplasty, or bypass surgery.

A direct comparative study of the Ornish program and three other commercial weight loss programs found that weight loss and impact on cardiac risk factors was similar with the Ornish Program as with the other popular diet programs, compliance was low with all 3 programs and completion concerns existed with the Ornish program.  Dansinger et al (2005) evaluated the adherence rates and the effectiveness of 4 popular diets (Atkins, Ornish, Weight Watchers, and Zone) for weight loss and cardiac risk factor reduction.  The main outcome measures were 1-year changes in baseline weight and cardiac risk factors, as well as self-selected dietary adherence rates per self-report.  The authors concluded that each popular diet modestly reduced body weight and several cardiac risk factors at 1 year.  Overall dietary adherence rates were low, although increased adherence was associated with greater weight loss and cardiac risk factor reductions for each diet group.  These investigators also noted that cardiovascular outcomes studies would be appropriate to further investigate the potential health effects of these diets.  More research is needed to identify practical techniques to increase dietary adherence, including techniques to match individuals with the diets best suited to their food preferences, lifestyle, and medical conditions.

In an editorial that accompanied the study by Dansinger et al (2005), Eckel (2005) stated that “What is truly needed now is evidence that weight loss by diet (and exercise and behavior modification) along with risk-factor improvement can be achieved and sustained for 5 to 10 years.  Given the results of the study by Dansinger et al, these may be difficult goals.  Next, it is important to determine whether diet and other lifestyle interventions affect hard outcomes, such as death, myocardial infarction, cancer incidence, and stroke”.

Miller et al (2009) found evidence that suggests that, during weight maintenance, less favorable biological effects are observed during a simulated, high-fat Atkins diet when compared to the South Beach and Ornish diet.  To study this issue, 3 popular diets -- Atkins, South Beach, and Ornish -- were tested in a randomized and counterbalanced cross-over study between January and December 2006.  Participants completed each of the three 4-week isocaloric dietary intervention phases followed by a 4-week washout period.  They were weighed weekly and caloric adjustments made if weight change exceeded 1 kg.  At the completion of each dietary phase, 3-day food records were analyzed, fasting blood sampled, and brachial artery reactivity testing performed.  Eighteen adults completed all 3 isocaloric dietary phases.  During the South Beach and Ornish maintenance phase, there were significant reductions in low-density lipoprotein cholesterol (11.8 %; p = 0.01, 16.6 %; p = 0.0006, respectively) compared to pre-diet baseline.  In addition, in contrast to the Atkins maintenance phase, significant reductions in low-density lipoprotein cholesterol and apolipoprotein B levels were observed after the South Beach (p = 0.003, p = 0.05; repeated measures analyses of variance) and Ornish maintenance phases (p = 0.0004, p = 0.006, repeated measures analyses of variance).  Brachial artery testing revealed an inverse correlation between flow-mediated vasodilatation and intake of saturated fat (r = -0.33; p = 0.016).  The authors stated that these findings support additional study in subjects with visceral obesity and the metabolic syndrome, where an increased risk of coronary disease at baseline may be accentuated with chronic consumption of a diet that exhibits unfavorable effects on lipids and endothelial function. 

A study by Gardner and colleagues (2010) found that the Ornish diet poses a risk for deficiencies of vitamin B12, vitamin E and zinc.  The authors compared micronutrient intake between overweight or obese women randomly assigned to the Ornish diet and three other popular diets that varied primarily in macronutrient distribution.  Dietary data were collected from women in the Atkins (n = 73), Zone (n = 73), LEARN (Lifestyle, Exercise, Attitudes, Relationships, Nutrition) (n = 73), and Ornish (n = 72) diet groups by using 3 day, unannounced 24 hour recalls at baseline and after 8 week of instruction.  Nutrient intakes were compared between groups at 8 weeks and within groups for 8-week changes in risk of micronutrient inadequacy.  At 8 weeks, significant differences were observed between groups for all macronutrients and for many micronutrients (p < 0.0001).  Energy intake decreased from baseline in all 4 groups but was similar between groups.  At 8 week, a significant proportion of individuals shifted to intakes associated with risk of inadequacy (p < 0.05) in the Atkins group for thiamine, folic acid, vitamin C, iron, and magnesium; in the LEARN group for vitamin E, thiamine, and magnesium; and in the Ornish group for vitamins E and B-12 and zinc.  In contrast, for the Zone group, the risk of inadequacy significantly decreased for vitamins A, E, K, and C (p < 0.05), and no significant increases in risk of inadequacy were observed for other micronutrients. 

A study by De Souza et al (2008) compared the Ornish diet to several other popular diets, and found that the Ornish diet was highest in carbohydrate (75 % of energy) and dietary fiber (67 g/2,000 kcal) and lowest in fat (7 %), saturated fat (1 %), and cholesterol (6 mg/d).  The authors reported that Ornish diet exceeded the upper limit of the U.S. Food and Nutrition Board's Acceptable Macronutrient Distribution Range (AMDR) for carbohydrate, and toward the lower limit of AMDR for protein (18 %).  The very-low-fat content of the Ornish diet did not meet the minimum fat requirements of national organizations, yet provided healthful sources of protein (e.g., legumes and nuts), ample fruit and vegetables, and low amounts of saturated fat.

Dewell et al (2008) reported that a very-low-fat vegan diet can be useful in increasing intake of protective nutrients and phytochemicals and minimizing intake of dietary factors implicated in several chronic diseases.  Investigators examined protective (e.g., anti-oxidant vitamins, carotenoids, and fiber) and pathogenic (e.g., saturated fatty acids and cholesterol) dietary factors in a very-low-fat vegan diet.  A total of 93 early-stage prostate cancer patients participated in a randomized controlled trial and were assigned to a very-low-fat (10 % fat) vegan diet supplemented with soy protein and lifestyle changes or to usual care.  Three-day food records were collected at baseline (n = 42 intervention, n = 43 control) and after 1 year (n = 37 in each group).  Analyses of changes in dietary intake of macronutrients, vitamins, minerals, carotenoids, and isoflavones from baseline to 1 year showed significantly increased intake of most protective dietary factors (e.g., fiber increased from a mean of 31 to 59 g/day, lycopene increased from 8,693 to 34,464 mug/day) and significantly decreased intake of most pathogenic dietary factors (e.g., saturated fatty acids decreased from 20 to 5 g/day, cholesterol decreased from 200 to 10 mg/day) in the intervention group compared to controls.

In a randomized study, Aldana and colleagues (2007) evaluated the effect of the Ornish Program for Reversing Heart Disease on cardiovascular disease as measured by the intima-media thickness of the common carotid artery and compared this effect to outcomes from patients participating in traditional cardiac rehabilitation.  A total of 93 patients with clinically confirmed coronary artery disease (CAD) were randomly assigned to the intervention (n = 46) or traditional cardiac rehabilitation (n = 47) were included in this study.  Ultrasound of the carotid artery and other cardiovascular risk factors were measured at baseline, 6, and 12 months.  There was no significant reduction in the carotid intima-media thickness of the carotid artery in the Ornish group or the cardiac rehabilitation group.  Ornish Program participants had significantly improved dietary habits (p < 0.001), weight (p < 0.001), and body mass index (p < 0.001) as compared with the rehabilitation group.  The decrease in the number of patients with angina from baseline to 12 months was 44 % in the Ornish group and 12 % in the cardiac rehabilitation group.  The authors concluded that the Ornish Program appeared to causes improvements in cardiovascular risk factors; but did not appear to change the atherosclerotic process as it affects the carotid artery.

Frattaroli et al (2008) reported data from the Multisite Cardiac Rehabilitation Program showing reductions in angina pectoris and improvements in atherosclerotic risk factors with the intensive lifestyle intervention program.  The investigators reported that, at baseline, of 1,152 subjects with CAD enrolled in the Multisite Cardiac Rehabilitation Program, 108 patients (43 % women) reported mild angina and 174 patients (37 % women) reported limiting angina.  By 12 weeks of intensive lifestyle intervention, 74 % of these patients were angina free, and an additional 9 % moved from limiting to mild angina.  This improvement in angina was significant for patients with mild and limiting angina at baseline regardless of gender (p <0.01).  Significant improvements in cardiac risk factors, quality of life, and lifestyle behaviors were observed, and patients with angina who became angina free by 12 weeks showed the greatest improvements in exercise capacity, depression, and health-related quality of life (p <0.05).  The investigators suggested that, based upon these findings, observed improvements in angina in patients making intensive lifestyle changes could drastically reduce their need for re-vascularization procedures. 

Govil et al  (2008) reported that patients of low socioeconomic status (SES) can make lifestyle changes and show improved outcomes in coronary heart disease (CHD), similar to patients with higher SES.  Investigators examined lifestyle, risk factors, and quality of life over 3 months, by SES and gender, in 869 predominantly white, non-smoking CHD patients (34 % female) in the Multisite Cardiac Lifestyle Intervention Program.  SES was defined primarily by education.  At baseline, less-educated participants were more likely to be disadvantaged (e.g., past smoking, sedentary lifestyle, high fat diet, over-weight, depression) than were higher-SES participants.  By 3 months, participants at all SES levels reported consuming 10 % or less dietary fat, exercising 3.5 hours per week or more, and practicing stress management 5.5 hours per week or more.  The investigators stated that these self-reports were substantiated by improvements in risk factors (e.g., 5-kg weight loss, and improved blood pressure, low-density lipoprotein cholesterol, and exercise capacity; p < 0.001), and accompanied by improvements in well-being (e.g., depression, hostility, quality of life; p < 0.001).

Daubenmier et al (2007) found that improvements in dietary fat intake, exercise, and stress management were individually, additively and interactively related to coronary risk and psychosocial factors.  Investigators evaluated the additive and interactive effects of 3-month changes in health behaviors (dietary fat intake, exercise, and stress management) on 3-month changes in coronary risk and psychosocial factors among 869 nonsmoking CHD patients (34 % female) enrolled in the Multisite Cardiac Lifestyle Intervention Program.  Analyses of variance for repeated measures were used to analyze health behaviors, coronary risk factors, and psychosocial factors at baseline and 3 months.  Multiple regression analyses evaluated changes in dietary fat intake and hours per week of exercise and stress management as predictors of changes in coronary risk and psychosocial factors.  The investigators observed significant overall improvement in coronary risk.  Reductions in dietary fat intake predicted reductions in weight, total cholesterol, low-density lipoprotein cholesterol, and interacted with increased exercise to predict reductions in perceived stress.  Increases in exercise predicted improvements in total cholesterol and exercise capacity (for women).  Increased stress management was related to reductions in weight, total cholesterol/high-density lipoprotein cholesterol (for men), triglycerides, hemoglobin A1c (in patients with diabetes), and hostility. 

Ornish, et al (2005) evaluated the effects of comprehensive lifestyle changes on prostate specific antigen (PSA), treatment trends and serum stimulated LNCaP prostate cancer cell growth in men with early, biopsy proven prostate cancer after 1 year. Patient recruitment was limited to men who had chosen not to undergo any conventional treatment, which provided a nonintervention randomized control group. A total of 93 volunteers with serum PSA 4 to 10 ng/ml and cancer Gleason scores less than 7 were randomly assigned to an experimental group that was asked to make comprehensive lifestyle changes or to a usual care control group. The investigators reported that none of the experimental group patients but 6 control patients underwent conventional treatment due to an increase in PSA and/or progression of disease on magnetic resonance imaging. PSA decreased 4% in the experimental group but increased 6% in the control group (p = 0.016). The growth of LNCaP prostate cancer cells was inhibited almost 8 times more by serum from the experimental than from the control group (70% vs 9%, p <0.001). Changes in serum PSA and also in LNCaP cell growth were significantly associated with the degree of change in diet and lifestyle. The investigators concluded that intensive lifestyle changes may affect the progression of early, low grade prostate cancer in men. The investigators noted that further studies and longer term followup are warranted. 

Ornish et al (2008) reported on a pilot study showing that improvements in nutrition and lifestyle are associated with increases in telomerase activity.  The authors assessed whether 3 months of intensive lifestyle changes increased telomerase activity in peripheral blood mononuclear cells (PBMC).  The authors asked 30 men with biopsy-diagnosed low-risk prostate cancer to make comprehensive lifestyle changes.  The primary end-point was telomerase enzymatic activity per viable cell, measured at baseline and after 3 months.  Of the 30 patients, 24 patients had sufficient PBMCs needed for longitudinal analysis.  PBMC telomerase activity expressed as natural logarithms increased from 2.00 (SD 0.44) to 2.22 (SD 0.49; p = 0.031).  Raw values of telomerase increased from 8.05 (SD 3.50) standard arbitrary units to 10.38 (SD 6.01) standard arbitrary units.  The increases in telomerase activity were significantly associated with decreases in low-density lipoprotein (LDL) cholesterol (r = -0.36, p = 0.041) and decreases in psychological distress (r = -0.35, p = 0.047).  The authors stated that larger randomized controlled trials are warranted to confirm the findings of this pilot study. 

Pischke et al (2007) reported evidence that coronary heart disease patients at risk for heart failure with an left ventricular ejection fraction (LVEF) less than or equal to 40 %, can make changes in lifestyle to achieve similar medical and psychosocial benefit to patients with an LVEF greater 40 %.  Researchers compared 50 patients (18 % female) with angiographically documented LVEF less than or equal to 40 % (mean = 33.4 +/- 7.3; range of 15 to 40 %) to 186 patients (18 % female) with LVEF greater than 40 % (mean of 58.2 +/- 9.6; range of 42 to 87 %), who were participants in the Multicenter Lifestyle Demonstration Project (MLDP).  All were non-smoking CHD patients.  Coronary risk factors, lifestyle and quality of life (SF-36) were assessed at baseline, 3 and 12 months.  The researchers found that, regardless of LVEF, patients showed significant improvements (all p < 0.05) in lifestyle behaviors, body weight, body fat, blood pressure, resting heart rate, total and LDL-cholesterol, exercise capacity, and quality of life by 3 months; most improvements were maintained over 12 months. 

Ornish et al (2013) reported on a follow-up to this small pilot study that found that comprehensive lifestyle intervention was associated with increases in relative telomere length after 5 years of follow-up, compared with controls.  This follow-up study compared ten men and 25 external controls with biopsy-proven low-risk prostate cancer and had chosen to undergo active surveillance.  Eligible participants were enrolled between 2003 and 2007 from previous studies and selected according to the same criteria.  Men in the intervention group followed a program of comprehensive lifestyle changes, and the men in the control group underwent active surveillance alone.  The authors took blood samples at 5 years and compared relative telomere length and telomerase enzymatic activity per viable cell with those at baseline, and assessed their relation to the degree of lifestyle changes.  The authors found that relative telomere length increased from baseline by a median of 0·06 telomere to single-copy gene ratio (T/S) units (IQR-0·05 to 0·11) in the lifestyle intervention group, but decreased in the control group (-0·03 T/S units, -0·05 to 0·03, difference p = 0·03).  When data from the 2 groups were combined, adherence to lifestyle changes was significantly associated with relative telomere length after adjustment for age and the length of follow-up (for each percentage point increase in lifestyle adherence score, T/S units increased by 0·07, 95 % CI: 0·0 to -0·12, p = 0·005).  At 5 years, telomerase activity had decreased from baseline by 0·25 (-2·25 to 2·23) units in the lifestyle intervention group, and by 1·08 (-3·25 to 1·86) units in the control group (p=0·64), and was not associated with adherence to lifestyle changes (relative risk 0·93, 95 % CI: 0·72 to 1·20, p = 0·57).  The authors said that larger randomized controlled trials are warranted to confirm this finding.

Silberman et al (2010) found that the intensive lifestyle intervention was feasible and sustainable for most patients who enrolled and was associated with subjective and objective improvements in health outcomes.  Investigators employed a non-experimental (prospective time series) design to investigate changes in cardiovascular disease in 2,974 men and women from 24 socioeconomically diverse sites who participated in an intensive cardiac rehabilitation program at baseline, 12 weeks, and 1 year.  Paired t-tests were used to assess differences by comparing baseline values to those after 12 weeks, baseline values to those after 1 year, and values after 12 weeks to those after 1 year.  The investigators reported that 88 % remained enrolled in the program after 12 weeks, and 78.1 % remained enrolled in the program after 1 year.  Patients showed statistically significant improvements after 12 weeks in body mass index (BMI), triglycerides, low density lipoprotein cholesterol, total cholesterol, hemoglobin A1c, systolic blood pressure, diastolic blood pressure, depression, hostility, exercise, and functional capacity.  These differences also remained significant after 1 year.  There was additional significant improvement between 12 weeks and 1 year only in BMI, high density lipoprotein cholesterol, functional capacity, and hostility, and significant recidivism between 12 weeks and 1 year in all other measures (except triglycerides) and depression, yet improvements from baseline to 1 year remained significant in all measures (except HDL, which was unchanged) (p < 0.005).

In a pilot study, Dod and colleagues (2010) evaluated the influence of the Multisite Cardiac Lifestyle Intervention Program on endothelial function and inflammatory markers of atherosclerosis.  A total of 27 subjects with CAD and/or risk factors for CAD (non-smokers, 14 men; mean age of 56 years) were enrolled in the experimental group and asked to make changes in diet (10 % calories from fat, plant based), engage in moderate exercise (3 hours/week), and practice stress management (1 hour/day).  Twenty historically (age, gender, CAD, and CAD risk factors) matched subjects were enrolled in the control group with usual standard of care.  At baseline endothelium-dependent brachial artery flow-mediated dilatation (FMD) was performed in the 2 groups.  Serum markers of inflammation, endothelial dysfunction, and angiogenesis were performed only in the experimental group.  After 12 weeks, FMD had improved in the experimental group from a baseline of 4.23 +/- 0.13 to 4.65 +/- 0.15 mm, whereas in the control group it decreased from 4.62 +/- 0.16 to 4.48 +/- 0.17 mm.  Changes were significantly different in favor of the experimental group (p < 0.0001).  Also, significant decreases occurred in C-reactive protein (from 2.07 +/- 0.57 to 1.6 +/- 0.43 mg/L, p = 0.03) and interleukin-6 (from 2.52 +/- 0.62 to 1.23 +/- 0.3 pg/ml, p = 0.02) after 12 weeks.  Significant improvement in FMD, C-reactive protein, and interleukin-6 with intensive lifestyle changes in the experimental group suggests greater than or equal to 1 potential mechanism underlying the clinical benefits seen in previous trials.  The findings of this small pilot study need to be validated by well-designed studies with larger number of subjects and longer follow-up.

Zeng et al (2013) reported outcomes of a Medicare-sponsored demonstration of 2 intensive lifestyle modification programs (LMPs) in patients with symptomatic coronary heart disease:

1. The Cardiac Wellness Program of the Benson-Henry Mind Body Institute (MBMI) and
2. The Dr. Dean Ornish Program for Reversing Heart Disease (Ornish).  This multi-site demonstration, conducted between 2000 and 2008, enrolled Medicare beneficiaries who had had an acute myocardial infarction or a cardiac procedure within the preceding 12 months or had stable angina pectoris.  Health and economic outcomes were compared with matched controls who had received either traditional or no cardiac rehabilitation following similar cardiac events.  Each program included a 1-year active intervention of exercise, diet, small-group support, and stress reduction.  Medicare claims were used to examine 3-year outcomes.  The analysis included 461 elderly, fee-for-service, Medicare participants and 1,795 controls.  Cardiac and non-cardiac hospitalization rates were lower in participants than controls in each program and were statistically significant in MBMI (p < 0.01).  Program costs of $3,801 and $4,441 per participant for the MBMI and Ornish Programs, respectively, were offset by reduced health care costs yielding non-significant 3-year net savings per participant of about $3,500 in MBMI and $1,000 in Ornish.  A trend towards lower mortality compared with controls was observed in MBMI participants (p = 0.07).  The authors concluded that intensive, year-long LMPs reduced hospitalization rates and suggested reduced Medicare costs in elderly beneficiaries with symptomatic coronary heart disease.  The findings of this study showed that the Ornish program is associated with a very modest 3-year net saving of $1,000, and there was no difference in mortality between the Ornish subjects and controls.

Commentators on this demonstration project have observed that it was extremely difficult to sign up enrollees in the Ornish program; the Ornish program was significantly more expensive than traditional cardiac rehabilitation programs, but rehospitalization (at 12 months), mortality (at 36 months), or first time to cardiovascular hospitalization in Ornish patients showed no statistical improvements over matched patients in traditional cardiac rehabilitation or those not participating in cardiac rehabilitation.  Thus, there is no proven benefit to the aspects of the Ornish program that go beyond traditional cardiac rehabilitation.  It has also been argued that the CMS evaluation of the Ornish program reported by Zeng et al (2013) does not allow conclusions about the effectiveness of the programs because the enrollees were a self-selected group motivated to change behavior to lower their risk.  They were more highly educated than control groups, and education and associated socioeconomic traits have been linked to lifestyle changes that lower risk (see, e g., Chan et al, 2008).  Traits that affect health outcomes – such as disease severity – were not measured in the reported studies, and they could explain one group doing better than another unrelated to the effectiveness of the program itself.

Lee and Shephard (2010) reported that the Ornish program costs significantly more than traditional cardiac rehabilitation.  The authors estimated and compared the per-patient costs and revenues for 3 types of secondary prevention programs: the Dr Dean Ornish Program for Reversing Heart Disease (Ornish), the Benson-Henry Mind/Body Medical Institute's Cardiac Wellness Program (M/BMI), and traditional cardiac rehabilitation (CR).  The authors developed an Excel spreadsheet template for the costs of a secondary prevention program and calibrated it to 7 programs that provided the necessary data.  The calibration was based on budgets, cost accounting, statistical reports, and structured interviews (in person or by telephone).  The authors found that the 4 lifestyle programs (2 Ornish and 2 M/BMI) cost almost 4 times as much per patient as the 3 traditional CR programs (means of $7,176 and $1,828, respectively; difference p < 0.05).  The Ornish program costs averaged more than twice those of M/BMI ($9,895 and $4,458, respectively; difference p < 0.10).  Medicare-allowed charges (including co-payments) were $5,650 for Ornish, $4,800 for M/BMI, and about $32.50 per session or $683 overall for CR.  The authors noted that programs achieved the lowest costs per patient by carefully matching program capacity to demand.  In none of the programs did net revenues cover costs.  These findings suggested that 4 patients could attend a traditional CR program for the cost of 1 patient in an enhanced program. 

Pritikin Program

The Pritikin ICR program, inspired by Nathan Pritikin who in 1955 made lifestyle changes through diet and exercise to successfully reduce atherosclerosis after being told that he was at risk of death from a myocardial infarction, includes the following types of education for its patients:

• Cook heart-healthy meals that are delicious and affordable
• Become smart grocery shoppers
• Order intelligently in restaurants
• Lose weight utilizing evidence-based skills
• Quit smoking
• Manage stress
• Improve personal and professional relationships
• Transform negative attitudes into positive ones.

The Pritikin program (also known as the Pritikin Longevity Program) evolved into a comprehensive program that may be provided in a physician’s office and incorporates a specific diet (10%–15% of calories from fat, 15%–20% from protein, 65%–75% from complex carbohydrates), exercise and counseling (CMS, 2014).

Roberts and Barnard (2005) discussed the results of a systematic review to report the effects of exercise and diet in the prevention of chronic disease and highlight the effects of lifestyle modification in order to reverse existing disease. "The review focused on lifestyle modification programs that included physical activity and dietary interventions". The authors stated that for coronary heart disease, "physical inactivity and dietary factors both contribute vitally to atherosclerosis and consequent CAD". In addition, studies indicate that "inactivity may be as predictive of CAD risk as conventional risk factors, exercise training may improve endothelial function and is superior to percutaneous angioplasty for short-term survival. Additionally, several dietary factors such as fiber, fat (amount and type), glycemic load, and fruit and vegetable consumption appear to significantly modulate CAD risk. Combined exercise and diet interventions mitigate atherosclerosis progression and may in fact induce plaque regression and/or improve myocardial flow reserve. These benefits are, at least in part, due to reductions in plasma lipids, lipid oxidation, and inflammation." Improvements in risk factors with diet may, in some instances, be as great as with statin therapy, and lifestyle interventions combined with statin therapy possess additive effects on lipid lowering. Moreover, although obesity contributes to CAD, risk can be modified independent of large changes in weight." Specifically for studies based on the Pritikin program, the authors reported, "one intervention that has been studied extensively is the Pritikin residential lifestyle intervention, designed to achieve changes in lifestyle that are very extensive in each subject. Participants undergo a complete medical history and physical examination, before a 26 -day (more recently 21-day or 11-day) physical activity and diet intervention. Meals are served buffet style, and all participants are allowed unrestricted eating except for the meals when 3 1/2 oz. of fish or fowl are provided. Prepared meals contain 10–15% of calories from fat, 15–20% of calories from protein, and 65–75% of calories from carbohydrates, primarily unrefined, according to analysis by computer dietary analysis software. Carbohydrates are in the form of high-fiber whole grains (greater than or equal to 5 servings/day), vegetables (greater than or equal to 4 servings/day), and fruits (greater than or equal to 3 servings/day). Protein is primarily derived from plant sources with small amounts of nonfat dairy (up to 2 servings/day) and fish or chicken. The diet contains less than 100 mg of cholesterol, and alcohol, tobacco, and caffeinated beverages are not served during the program. Before starting the exercise training, subjects undergo a graded treadmill stress test according to a modified Bruce protocol to determine the appropriate individual level of exercise intensity. On the basis of the results, the subjects are provided with an appropriate training heart rate value and given an individualized aerobic exercise program. The exercise regimen consists of daily treadmill walking at the training heart rate for 45–60 min. The training heart rate is defined as 70–85% of the maximal heart rate attained during the treadmill test. Additionally, the subjects perform flexibility and resistance exercise. Early studies documented that this combined physical activity and diet intervention decreased all serum lipids and angina in patients, the majority of whom had a prior myocardial infarction and/or multiple vessel disease and all of whom had been recommended for bypass surgery. The majority were taken off cardiac and/or blood pressure lowering drug therapy. The durability of the changes was evidenced by a 5-yr follow-up, which documented that adherence to the program resulted in maintenance of the changes and dramatically reduced the need for bypass surgery. The 4,587 men and women who completed the 26-day physical activity and diet intervention from 1977 to 1988 revealed an average Total-C reduction of 23%, from 234 to 180 mg/dl. LDL-C decreased by 23%, from 151 to 116 mg/dl, with male subjects exhibiting a greater reduction in Total-C (24 vs. 21%) and LDL-C (25 vs. 19%) compared with female subjects. HDL-C was reduced by 16%, but the ratio of Total-C to HDL-C was reduced by 11%. Serum TG decreased 33%, from 200 to 135 mg/dl, with male subjects showing a greater reduction than female subjects (38% vs. 23%)" (CMS, 2014; Roberts and Barnard, 2005).

Benson-Henry Institute Cardiac Wellness Program

The Benson Henry Institute Cardiac Wellness Program was developed by Herbert Benson, MD, over 40 years ago. The Cardiac Wellness Program is a multi-component intervention program that includes supervised exercise, behavioral interventions, and counseling, and is designed to reduce cardiovascular risk and improve health outcomes (CMS, 2014).

Zeng et al (2013) reported on outcomes of the Benson-Henry Mind Body Medical Institute (MBMI) intensive lifestyle modification program, which included 324 participants  The authors found that "[d]uring the active intervention and follow-up years, total, cardiac, and non-cardiac hospitalizations were lower in MBMI participants than their controls for each comparison (p<.001)." They further reported: "After year 1, the mortality rate was 1.5% in MBMI program participants compared with 2.5% and 4.2%, respectively, in CR and non-CR controls; after year 3, comparable figures were 6.2% in MBMI participants, 10.5% in CR controls, and 11.0% in non-CR controls. These mortality differences for MBMI reached borderline significance (p = .08)." "Program costs of $3,801 and $4,441 per participant for the MBMI and Ornish Programs, respectively, were offset by reduced health care costs yielding non-significant three-year net savings per participant of about $3,500 in MBMI and $1,000 in Ornish" (CMS, 2014; Zeng et al, 2013).

Dusek et al. (2008) reported the results of a randomized controlled trial of stress management compared to lifestyle modification in reducing systolic blood pressure (SBP) in older adults with isolated systolic hypertension (SH). "A total of 122 patients were randomly assigned to either stress management, specifically relaxation response (RR) training (n = 61) or lifestyle modification (n = 61). Inclusion criteria were age of 55 years or older, systolic blood pressure 140-159 mm Hg, diastolic blood pressure less than 90 mm Hg, and at least two antihypertensive medications. Patients were "ineligible if the dose of any antihypertensive medication had been changed within the 4 weeks prior to screening; if they had a major medical illness in the previous 6 months (heart, kidney or liver disease, stroke, cancer, endocrinopathy, or psychiatric illness); if they had an abnormal laboratory test; if they currently smoked; or if they previously practiced any mind/body techniques." Primary outcome was change in systolic blood pressure at eight weeks. Stress management intervention consisted of weekly relaxation response training instruction, guided relaxation elicitation and health education. Lifestyle modification consisted of weekly written and verbal information on stress reduction and cardiac risk factor modification. The authors reported: "After controlling for differences in characteristics at the start of medication elimination, patients in the relaxation response group were more likely to successfully eliminate an antihypertensive medication (p = 0.03). Although both groups had similar reductions in SBP, significantly more participants in the relaxation response group eliminated an antihypertensive medication while maintaining adequate blood pressure control." They concluded that "8 weeks of RR training and lifestyle modification reduced SBP by ~9 mm Hg in elderly patients with SH, but patients receiving RR training were more likely to eliminate at least one antihypertensive medication" (CMS, 2014; Dusek et al, 2008).

The above policy is based on the following references: