Dr. Dean Ornish, founder of the Preventive Medicine Research Institute, addressing the Medicare Coverage Advisory Committee last month. Dr. Ornish presented data showing that lifestyle interventions reverse atherosclerosis, prevent cardiac events and save money. The committee will soon decide whether the evidence is strong enough to warrant national Medicare coverage of Dr. Ornish’s comprehensive approach to diet and lifestyle change. Photo © Elsevier/Vivian E. Lee.

BALTIMORE—Late in January, the Medicare Coverage Advisory Committee (MCAC) took a cautious but promising first step toward holistic health care by convening to consider whether Medicare should cover the type of physician-supervised diet and lifestyle intervention pioneered by Dean Ornish, M.D., at the non-profit Preventive Medicine Research Institute, Sausalito, Calif.

The twelve-member committee reviewed aggregate data from Dr. Ornish’s demonstration projects involving more than 2,000 individuals with advanced coronary artery disease. The studies show clearly that patients who consistently follow a low-fat, plant-based diet, exercise regularly, and practice stress reduction can not only stop progression of CAD, they can actually reverse atherosclerosis without revascularization procedures or drug therapy. They also reviewed data from other programs.

Dr. Ornish, who asked the committee last fall to consider his approach for national coverage, believes that the lifestyle change strategy is not only better medicine, but also more cost effective than conventional treatment based on bypass surgery, angioplasty and complex pharmacotherapy.

The atmosphere at the hearing was generally positive, as Dr. Ornish presented his data and live testimony from patients in his program. Reviewers’ questions were well-informed and sufficiently deep to indicate that members of the committee have seriously considered the downsides of conventional care and the potential benefits of an integrative approach like Dr. Ornish’s. Others giving testimony included Dr. Jim Barnard of the Pritikin Program, Dr. Caldwell Esselstyn of The Cleveland Clinic, Dr. Herbert Benson of the Mind/Body Medical Institute cardiac program, and Dr. Mark Wexman of Marin General Hospital.

Five Key Questions

The MCAC review process centered on five questions: How well does the evidence address the effectiveness of physician-supervised behavioral interventions for patients with symptomatic CAD as compared to usual management? How confident are you in the validity of the scientific data? How likely is it that physician-supervised behavioral interventions will positively affect outcomes when compared to usual management? How confident are you that physician-supervised behavioral change will produce a clinically important net health benefit? How likely is it that the results can be generalized to the Medicare population (aged 65+) and facilities or physicians in community practice?

Committee members, including several leaders in the cardiovascular field, voted their positions on each question using Olympics-style placards conferring points on a 1–5 scale, with 1 representing “Poorly,” 5 representing “Very Well” and 3 representing “Reasonably Well.”

On nearly all questions, physician-supervised lifestyle change programs earned aggregate scores of 3.5 or better, indicating that on the whole MCAC is convinced of the clinical merits. The data left little ground for doubting that lifestyle change can reverse atherosclerosis, prevent MIs, and save money.

The questions are whether this sort of program can be replicated for broad use across the country, and whether the early benefits—contingent on patient adherence—can be preserved over the long term. Though Dr. Ornish presented data from studies extending out for several years, including data on more than 1,000 patients followed for at least three years, some MCAC members called for positive findings in a large cohort followed for 5 years or more.

Then, there is the challenge of how to classify a reimbursable lifestyle change program. Currently, the Medicare reimbursement framework really only recognizes drugs, surgical procedures, and medical devices. The Ornish program falls outside all of these.

Medicare at the Tipping Point

The next step in the process is that MCAC must make a final recommendation to the Centers for Medicare and Medicaid Services on whether physician-guided lifestyle change programs warrant coverage. A date for this final determination has not yet been set. If the recommendation is positive, Medicare will begin planning an implementation and reimbursement strategy. Even if MCAC votes in favor of the Ornish approach, it could be years before we see a national benefit.

Still, Dr. Ornish believes it is a significant advance just to have MCAC consider national coverage. If Medicare ultimately does provide reimbursement, it will be the first time a federal program has backed a truly comprehensive and holistic approach to health care. Other insurance companies will follow Medicare’s lead.

“We are asking for reimbursement for any comprehensive diet and lifestyle interventions that have been proven to stop or reverse the progression of CHD. We are asking for coverage on a non-proprietary, non-branded, non-profit basis. Our goal is to give away our program and to work with established agencies and organizations to make it freely available. Medicare is the tipping point,” Dr. Ornish told Holistic Primary Care in an interview.

The hearings are, in some respects, the culmination of 28 years of clinical research for Dr. Ornish and his colleagues. What began as a simple scientific inquiry soon became an object lesson in health policy and medical economics.

“Back when we were starting out with this, I used to think that if we just did good science, it would change medical practice. That was somewhat na?ve. While good science is important, you also need reimbursement to make changes in medical practice, because we as physicians do what we get paid to do, and we get trained to do what is reimbursable. Reimbursement plays a much bigger role in shaping medical practice than most people realize. Change reimbursement, and you change everything.”

Bypassing “Bypass Medicine”

Dr. Ornish’s journey into lifestyle-based medicine began back in 1977, when he was training with Dr. Michael DeBakey, a pioneer of coronary artery bypass surgery. “We’d bypass patients, they’d go home, eat the same food, smoke, not manage stress, not exercise; more often than not, their bypasses reoccluded, and we’d bypass the bypass. I began to realize this was an incomplete approach. In a way, bypass surgery became a metaphor for me for much of what we do in medicine: we bypass the root of the problem. But if you don’t address the underlying causes, the problem often comes back. On the other hand, the body often has a remarkable capacity to heal if you address the root causes.”

After finishing his internal medicine residency at Harvard Medical School and the Massachusetts General Hospital, Dr. Ornish moved to San Francisco and began the series of diet and lifestyle trials for which he ultimately became famous. He and his colleagues showed clearly that a well-designed and comprehensive team approach focused on heart-healthy dietary changes, frequent exercise, and stress reduction could have profound effects.

Studies that began as one-year trials soon became multi-year extended studies with increasingly sophisticated measures. With a note of irony, Dr. Ornish said he is using some of medicine’s most high-tech tools—coronary arteriography, PET scans and the like—to validate its most low-tech interventions. “In one randomized controlled trial, published in the Journal of the American Medical Association in 1995, our PET scans showed that 99% of patients were able to stop or reverse progression of coronary heart disease.”

Proving the clinical benefit was the easy part. For most of the last decade, Dr. Ornish has been engaged in translating the clinical outcomes into the sort of hard cost-savings numbers that convince health care payers.

Forward-Thinking Insurers

A series of pilot projects funded by forward-thinking insurers like Mutual of Omaha provided compelling data. The Mutual of Omaha project involved 8 hospitals in diverse regions, all of which implemented programs run by clinicians trained at the Preventive Medicine Research Institute. Almost 80% of patients who went through the programs avoided CABG or angioplasty—procedures they were told they needed. Mutual of Omaha saved almost $30,000 per patient in the first year. These findings were published in the American Journal of Cardiology.

Based on those numbers, Highmark Blue Cross Blue Shield of Pennsylvania began covering Ornish programs in three cities, and found they cut their heart disease costs by half in the first year. Cost savings continued over 3 years.

Currently, over 40 independent insurance companies provide some level of coverage for programs based on the Ornish approach. Each had to be convinced individually, a very arduous process. “It was harder than I ever expected.”

From Fear of Death to Joy of Life

Dr. Ornish’s ultimate aim is to foster compassionate, caring, and cost-effective health care that addresses the more fundamental reasons why people get sick. In the course of working with thousands of heart disease patients, he’s found that it is almost never too late to move in the direction of healing.

“I used to think younger patients with milder disease would derive much greater benefit from a lifestyle intervention than older people with advanced disease. This proved untrue. People aged 65 and over do just as well as people who are younger and have milder disease. The issue is not age, it is adherence.”

And that, most physicians contend, is the biggest challenge for any lifestyle-based approach. But Dr. Ornish believes it is not quite as difficult as many doctors believe it to be.

“The conventional wisdom is that taking pills is easy and changing lifestyle is hard. So why is it that two-thirds of patients prescribed statins aren’t taking them 4 months later? Statins and other drugs are of value, but they don’t make people feel better. When you make real lifestyle changes, most people feel the difference very quickly. Suddenly the chest pain goes away—you see a 90% reduction in angina within a month. There’s better blood flow to their hearts, their brains, their sex organs. They usually feel so much better, so quickly, that it reframes the reasons for making changes.”

He believes too many physicians use scare tactics to motivate change, and it seldom works. “Most people don’t make lasting changes out of fear of dying. It’s too scary. They want to enjoy their lives. You need to shift away from fear of dying and move toward joy of living.”

In his experience, it’s paradoxically often easier to make comprehensive changes than only small ones. “When people feel better, they are more likely to maintain these changes.”

While he is best known for his work in cardiovascular disease, Dr. Ornish is expanding the scope of his research to look at lifestyle interventions in the context of other common diseases, including prostate cancer. He is leading a randomized controlled trial looking at how the lifestyle program that works for CVD patients will affect men with prostate cancer. The preliminary data look promising.

For more information on Dr. Ornish’s work and his not-for-profit research institute, visit the Preventive Medicine Research Institute at www.pmri.org or www.ornish.com at WebMD.