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Monday, May 14, 2012

Ornish Cardiac Treatment Program

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Clinical Policy Bulletin:
Ornish Cardiac Treatment Program

Number: 0267


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 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 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.
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
90804 - 90857
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
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
  1. Ornish D. What if Americans ate less fat? JAMA. 1992;267(3):362.
  2. Ornish D. Can life-style changes reverse coronary atherosclerosis? Hosp Pract (Off Ed). 1991;26(5):123-126.
  3. 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.
  4. Ornish D, Brown SE, Scherwitz LW, et al. Lifestyle changes and heart disease. Lancet. 1990;336(8717):741-742.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. Ornish D, Scherwitz LW, Billings JH, et al. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998;16;280(23):2001-2007.
  11. Ornish D. Avoiding revascularization with lifestyle changes: The Multicenter Lifestyle Demonstration Project. Am J Cardiol. 1998;82(10B):72T-76T.
  12. Aldana SG, Whitmer WR, Greenlaw R, et al. Cardiovascular risk reductions associated with aggressive lifestyle modification and cardiac rehabilitation. Heart Lung. 2003;32(6):374-382.
  13. 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.
  14. Eckel RH. The dietary approach to obesity: Is it the diet or the disorder? JAMA. 2005;293(1):96-97.
  15. 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.
  16. 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.
  17. Frattaroli J, Weidner G, Merritt-Worden TA, et al. Angina pectoris and atherosclerotic risk factors in the multisite cardiac lifestyle intervention program. Am J Cardiol. 2008;101(7):911-918.
  18. No authors listed. NCA tracking sheet for intensive cardiac rehabilitation (ICR) program -- Dr. Ornish's program for reversing heart disease (CAG-00419N). Centers for Medicare & Medicaid Services: Baltimore, MD, 2009. Available at: Accessed March 1, 2010.
  19. Dod HS, Bhardwaj R, Sajja V, et al. Effect of intensive lifestyle changes on endothelial function and on inflammatory markers of atherosclerosis. Am J Cardiol. 2010;105(3):362-367.

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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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Weight Loss in a Pill: No Lemonade From Lemons -

Weight Loss in a Pill: No Lemonade From Lemons -

May 10, 2012, 12:54 pm

An Endless Quest for Weight-Loss Pills

Right after residency, I took a summer job in a family practice in a beach town on Long Island, covering Fridays and weekends for the regular doctors. The setting was quite different from my training in an urban hospital. It was a bit of a culture shock to go from a world of critically ill hospitalized patients to an outpatient suburban setting where most weekend appointments were for sore throats, rashes and sprained ankles. But I quickly became a pro at Lyme disease identification.

Joon Park Danielle Ofri, M.D.
One day, a woman in her early 40s came for an appointment. She asked me to prescribe fen-phen, a weight-loss pill that combined the drugs fenfluramine and phentermine and was being heavily marketed at the time.

I remember gazing at her from across the desk, thinking that she certainly didn’t look overweight, and asked her why she wanted weight-loss pills.

She grasped the skin around her stomach and said ruefully, “I’ve been try
ing to get rid of these extra pounds after having kids.”

I leaned over to see what she was holding in her grip. It looked like a normal amount of stomach to me.

Having just spent the past three years taking care of critically ill hospital patients who were dealing with heart attacks, septic shock, pneumonia and bleeding ulcers, I had a hard time seeing a few extra pounds as a medical issue. I was also a little leery of the whole idea of weight-loss pills, which seemed like a Band-Aid approach to what was usually a lifetime pattern of poor eating habits and inactivity.

I started to explain my concerns, noting that every medication has side effects. But before I could even get to any discussion about diet and exercise, she cut me off.
“I’ve taken fen-phen before,” she said, her voice more harsh now. “I just need a prescription from you, not a lecture.”

I was taken aback by the vociferousness of her response. I scanned her chart to see if she’d been heavier in the past. She hadn’t. In fact, she was quite healthy, with no major medical problems. I wondered if she might have an eating disorder that might alter her perception of her weight.

But we never got that far. When I reiterated my hesitations about prescribing pills for weight loss, she grew angry and stormed out in a huff.

A month later, The New England Journal of Medicine published an article linking fen-phen to heart valve abnormalities. Shortly after, the medication was pulled from the market. I wanted to feel vindicated, but I knew that during my tense exchange with my patient I hadn’t had any clinical premonitions about the drugs’ dangers, just a sense that she didn’t really need weight-loss pills.

This encounter came to mind recently when I read an essay called “Lemons for Obesity” in Annals of Internal Medicine. The author, Dr. Michael S. Lauer, was one of only two members of a 22-member Food and Drug Administration panel who earlier this year voted against approval of the new weight-loss drug Qnexa, a combination of phentermine and topiramate, an epilepsy drug with an unexpectedly salubrious side effect of weight loss.

Final approval of the drug has been delayed, but in the essay, Dr. Lauer gives a brief history of Qnexa’s approval process, including concerns of cardiovascular side effects and possible risks of cleft lip and cleft palate in babies born to mothers taking the drug. Then he makes an interesting analogy to the used-car market, citing the 1970 paper “The Market for Lemons” that eventually won a Nobel in economic science for its author, George Akerlof.

Lemons are harder to sell than quality products, so sellers do more promotion and offer steeper discounts, Dr. Akerlof had argued. In addition, used-car buyers (like patients) know much less about the product than used-car sellers (and pharmaceutical companies). Lay people rarely have much success when looking under the hoods of either cars or medicines. This combination of “information asymmetry” and aggressive marketing can allow lemons to dominate the market.

Dr. Lauer lists the impressive number of lemons for treating obesity. Fen-phen, ephedra, sibutramine and phenylpropanolamine all had to be pulled from the market for safety concerns. A drug popular in Europe, rimonabant, was denied approval in the United States because of side effects. The lone prescription drug currently available in America for weight loss, orlistat, offers only minor weight loss with the trade-off of major stomach problems in the form of oily, greasy stools.

The weight-loss field is strewn with lemons, more so than other areas of medicine, Dr. Lauer argues. Because of the enormous potential market for these drugs — two-thirds of American adults are overweight or obese — pharmaceutical companies rush new drugs to market after conducting only small clinical trials. The F.D.A. and doctors are complicit in the process, Dr. Lauer says, leaving the population at large to act essentially as guinea pigs.

Dr. Lauer cites another intriguing paper from the 1970s, by Amos Tversky and Daniel Kahneman, that highlights our biases when interpreting data, especially from small studies. There is an “illusion of validity” for any random data point, a seductive sense that is colored by what we hope will be true. Mountains of pharmaceutical claims are often made from mere molehills of data.

In the decades since my encounter with the patient who demanded fen-phen, I’ve become a lot less smug about the problem of obesity. I appreciate that there are factors at play beyond diet and exercise, but the “lemon lesson” has stayed with me. It’s hard to know at the outset which new drugs are lemons and which will become game-changers. But any drug that arrives on the scene with heavy promotion and only modest benefits deserves the same circumspect attitude as that too-good-to-be-true used car.

Danielle Ofri is the author of three books, including “Medicine in Translation: Journeys With My Patients.” She is an associate professor of medicine at New York University School of Medicine and editor in chief of the Bellevue Literary Review.