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Clinical Policy Bulletin:
Ornish Cardiac Treatment Program
Ornish Cardiac Treatment Program
| Policy Consistent with the 1997 advisory statement of the American Heart Association (AHA), 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 recent 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. 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. 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 will review evidence to examine if the Ornish program demonstrates the statutorily mandated accomplishments and outcomes improvements 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. Section 144(a) requires that these accomplishments be demonstrated in peer-reviewed published research. 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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- Ornish D. Low-fat diets. N Engl J Med. 1998;338(2):127.
- Ornish D, Denke M. Dietary treatment of hyperlipidemia. J Cardiovasc Risk. 1994;1(4):283-286.
- Ornish D, Brown SE. Treatment of and screening for hyperlipidemia. N Engl J Med. 1993;329(15):1124-1125.
- Ornish D. Can lifestyle changes reverse coronary heart disease? World Rev Nutr Diet. 1993;72:38-48
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