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Aetna Aetna
Clinical Policy Bulletin:
Ornish Cardiac Rehabilitation Program
Number: 0267


Policy

Aetna considers the Ornish's cardiac treatment program medically necessary alternative to standard intensive cardiac rehabilitation for persons who meet medical necessity criteria for intensive cardiac rehabilitation outlined in CPB 21 -- Cardiac Rehabilitation.

The Ornish Cardiac Rehabilitation Program is considered experimental and investigational 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

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 = .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 = .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 = .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. 

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.  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 three 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, three popular diets -- Atkins, South Beach, and Ornish --were tested in a randomized and counterbalanced crossover 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 three 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, et al. (2010) found that the Ornish diet poses a risk for deficiencies of vitamin B12, vitamin E and zinc. The authors compred 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/2000 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 (eg, 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., antioxidant vitamins, carotenoids, and fiber) and pathogenic (e.g., saturated fatty acids and cholesterol) dietary factors in a very-low-fat vegan diet. Ninety-three 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 1152 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 revascularization 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, nonsmoking 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, overweight, 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 < .001), and accompanied by improvements in well-being (e.g., depression, hostility, quality of life; P < .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. (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 endpoint 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: 15-40%) to 186 patients (18% female) with LVEF greater than 40% (mean=58.2+/-9.6; range: 42-87%), 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<.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 followup 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 two 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 0·02-0·12, 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 0·72-1·20, 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 2974 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 percent 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 < .005).

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.

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: (i) the Cardiac Wellness Program of the Benson-Henry Mind Body Institute (MBMI) and (ii) 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. 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 < .05). The Ornish program costs averaged more than twice those of M/BMI ($9,895 and $4,458, respectively; difference P < .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. The findings suggest that 4 patients could attend a traditional CR program for the cost of 1 patient in an enhanced program. 

 
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
90785
90832 - 90840
97802 - 97804
99381 - 99397
99401 - 99404
99406 - 99407
99411 - 99412
HCPCS codes not covered for indications listed in the CPB:
S0340 Lifestyle modification program for management of coronary artery disease, including all supportive services; first quarter/stage
S0341 Lifestyle modification program for management of coronary artery disease, including all supportive services; second or third quarter/stage
S0342 Lifestyle modification program for management of coronary artery disease, including all supportive services; fourth quarter/stage
Other HCPCS codes related to the CPB:
G0270 Medical nutrition therapy; reassessment and subsequent intervention(s) following second referral in same year for change in diagnosis, medical condition or treatment regimen (including additional hours needed for renal disease), individual, face-to-face with the patient, each 15 minutes
G0271 Medical nutrition therapy; reassessment and subsequent intervention(s) following second referral in same year for change in diagnosis, medical condition or treatment regimen (including additional hours needed for renal disease), group (2 or more individuals), each 30 minutes
S9449 Weight management classes, non-physician provider, per session
S9451 Exercise classes, non-physician provider, per session
S9452 Nutrition classes, non-physician provider, per session
S9453 Smoking cessation classes, non-physician provider, per session
S9454 Stress management classes, non-physician provider, per session
S9470 Nutritional counseling, dietitian visit
ICD-9 codes not covered for indications listed in the CPB (not all-inclusive):
272.0 - 272.4 Hypercholesterolemia/hyperglyceridemia/hyperlipidemia/hyperchylomicronemia
305.1 Tobacco use disorder
390 - 459.9 Diseases of the circulatory system
V15.82 History of tobacco use
V45.81 Aortocoronary bypass status
V45.82 Percutaneous transluminal coronary angioplasty status
V45.89 Other postprocedural status [cardiac procedures]
V57.89 - V57.9 Other and unspecified rehabilitation procedure
V58.49 Other specified aftercare following surgery
V65.3 Dietary surveillance and counseling


The above policy is based on the following references:
  1. Ornish D. Low-fat diets. N Engl J Med. 1998;338(2):127.
  2. Ornish D, Denke M. Dietary treatment of hyperlipidemia. J Cardiovasc Risk. 1994;1(4):283-286.
  3. Ornish D, Brown SE. Treatment of and screening for hyperlipidemia. N Engl J Med. 1993;329(15):1124-1125.
  4. Ornish D. Can lifestyle changes reverse coronary heart disease? World Rev Nutr Diet. 1993;72:38-48.
  5. Ornish D. What if Americans ate less fat? JAMA. 1992;267(3):362.
  6. Ornish D. Can life-style changes reverse coronary atherosclerosis? Hosp Pract (Off Ed). 1991;26(5):123-126.
  7. Ornish D. Reversing heart disease through diet, exercise, and stress management: An interview with Dean Ornish. J Am Diet Assoc. 1991;91(2):162-165.
  8. Ornish D, Brown SE, Scherwitz LW, et al. Lifestyle changes and heart disease. Lancet. 1990;336(8717):741-742.
  9. Ornish D, Brown SE, Scherwitz LW, et al. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990;336(8708):129-133.
  10. Gould KL, Ornish D, Kirkeeide R, et al. Improved stenosis geometry by quantitative coronary arteriography after vigorous risk factor modification. Am J Cardiol. 1992;69(9):845-853.
  11. Gould KL, Ornish D, Scherwitz L, et al. Changes in myocardial perfusion abnormalities by positron emission tomography after long-term, intense risk factor modification. JAMA. 1995;274(11):894-901.
  12. Franklin TL, Kolasa KM, Griffin K, et al. Adherence to very-low fat diet by a group of cardiac rehabilitation patients in the rural southeastern United States. Arch Fam Med. 1995;4(6):551-554.
  13. Billings JH. Maintenance of behavior changes in cardiorespiratory risk reduction: A clinical perspective from the Ornish Program for reversing coronary heart disease. Health Psychol. 2000;19(1 Suppl):70-75.
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  18. Dansinger ML, Gleason JA, Griffith JL, et al. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: A randomized trial. JAMA. 2005;293(1):43-53.
  19. Eckel RH. The dietary approach to obesity: Is it the diet or the disorder? JAMA. 2005;293(1):96-97.
  20. Pischke CR, Weidner G, Elliott-Eller M, Ornish D. Lifestyle changes and clinical profile in coronary heart disease patients with an ejection fraction of < or = 40% or > 40% in the Multicenter Lifestyle Demonstration Project. Eur J Heart Fail. 2007;9(9):928-934.
  21. Aldana SG, Greenlaw R, Salberg A, et al. The effects of an intensive lifestyle modification program on carotid artery intima-media thickness: A randomized trial. Am J Health Promot. 2007;21(6):510-516.
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  23. Dewell A, Weidner G, Sumner MD, et al. A very-low-fat vegan diet increases intake of protective dietary factors and decreases intake of pathogenic dietary factors. J Am Diet Assoc. 2008;108(2):347-356.
  24. Ornish D, Lin J, Daubenmier J, Weidner G, et al. Increased telomerase activity and comprehensive lifestyle changes: A pilot study. Lancet Oncol. 2008;9(11):1048-1057.
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  29. Centers for Medicare & Medicaid Services (CMS). NCA tracking sheet for intensive cardiac rehabilitation (ICR) program -- Dr. Ornish's program for reversing heart disease (CAG-00419N). Baltimore, MD: CMS; 2009. Available at: https://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=240. Accessed March 1, 2010.
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  35. Chainani-Wu N, Weidner G, Purnell DM, et al. Changes in emerging cardiac biomarkers after an intensive lifestyle intervention. Am J Cardiol. 2011;108(4):498-507.
  36. Zeng W, Stason WB, Fournier S, et al. Benefits and costs of intensive lifestyle modification programs for symptomatic coronary disease in Medicare beneficiaries. Am Heart J. 2013;165(5):785-792.


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