Aetna considers the Ornish's cardiac treatment program experimental and investigational.  There are no studies in the medical literature involving large cohorts of subjects validating significant benefits on atherosclerotic lesion progression, decreasing episodes of care, and prolongation or improvement of quality of life of individuals on this regimen.

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.

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.

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.

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”.

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.

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.