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Exercise is just one part of the Ornish heart disease program. Patients Mike Rich and Dawn Diven hit the machines at the West Virginia University Heart Institute in Morgantown. Although supporters say lifestyle changes promoted by the program can reverse heart disease, some are skeptical. Photo by David Smith / AP Images for American Medical News

Medicare's new approach to familiar diseases

Some see coverage of intensive cardiac rehab and weight-loss counseling as growing acknowledgment that traditional medicine has limits in tackling heart disease and obesity.

By — Posted May 14, 2012

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When patients with a history of multiple heart attacks or coronary artery bypass surgeries come to Silverton Hospital in Woodburn, Ore., staff members see that something beyond the usual drugs and medical procedures might be needed.

Yet that something, while perhaps unconventional, may not be as radical as one might expect, said emergency physician Frank Lord, MD. Just exercise, a low-fat vegetarian diet and stress management through group support, meditation — and yoga.

The yoga element “was certainly a surprise to me,” said Dr. Lord, who oversees the one-year multidisciplinary program offered at Silverton known as Dr. Dean Ornish’s Program for Reversing Heart Disease. “But until patients learn how to deal with stress, it’s really difficult to be disciplined in the other areas needed to control their disease,” especially for those with chronic conditions.

A year after they go through the program, Silverton heart patients on average have lost 22 pounds, blood sugar levels have dropped by 23%, and depression scale scores have plummeted 41%.

“That’s what you hope for if you put someone on an antidepressant. And the weight loss for folks with a body mass [index] over 35 was within a pound of what you should find if they had done gastric bypass” surgery, Dr. Lord said.

Those kinds of results persuaded officials at the Centers for Medicare & Medicaid Services in 2010 to approve coverage of the Ornish program under the new benefit category of intensive cardiac rehabilitation. It is believed to be the first time Medicare has covered such a so-called integrative medicine program.

In a similar move, Medicare in 2011 approved its first-ever coverage of obesity screening and “intensive behavioral therapy,” otherwise known as weight-loss counseling, in a primary care setting.

Despite some reservations, the health care community largely has cheered the developments as long overdue recognition of the medical and behavioral factors underlying costly chronic diseases, and the need for less traditional preventive measures. Supporters also hope Medicare’s decisions encourage more private insurers to follow suit, giving physicians and patients the moral and financial boost to do their parts.

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Shanthi Manivannan, MD, medical director of the Ornish heart disease program at the WVU Healthcare's Ruby Memorial Hospital. Photo by David Smith / AP Images for American Medical News

“We as a country and certainly as a health care industry have had a fascination with technology, and yet we know from very good research that some of the most significant impact on patients’ health and wellness has to do with lifestyle issues,” said American Academy of Family Physicians President Glen Stream, MD. “Medicare’s recognition of that and willingness to pay for it is also a message to [physicians] that we need to refocus on the importance of including this in the care of our patients.” Neither the American Medical Association nor the AAFP has taken positions on the specific coverage initiatives.

Heart disease and obesity account for $400 billion and $150 billion, respectively, in annual health spending, according to the Centers for Disease Control and Prevention. As payers seek to control those costs, “we are certainly going to see a lot more innovation, and what we’re all looking for is different ways of encouraging and investing in a much more holistic approach to patients,” said Christine C. Ferguson, a professor at the George Washington University School of Public Health and Health Services and director of the school’s STOP Obesity Alliance.

However, she warned, “we are in the early stages of figuring out how to incorporate that [approach] without overwhelming the system. & We need to be cautious that we are not asking so much of primary care providers that they can’t be successful.”

Physician as team leader

A multiyear Medicare demonstration project and other studies reviewed by CMS showed the Ornish program significantly reduced several cardiac risk factors — including blood pressure, cholesterol and body mass index — slowing the disease and reducing the need for more invasive procedures and powerful drugs.

The intensive cardiac rehab benefit is available to patients who had a certain cardiac event. Medicare covers 72 hours of therapy in the “comprehensive lifestyle modification program.” Medicare covers only 36 hours of traditional cardiac rehab, which focuses mostly on exercise.

The Ornish program was designed for hospitals and physician offices. A handful of hospitals have received Medicare certification, though more run the program independently. Hundreds of health professionals, hospitals and clinics have expressed interest in training and certification. Medicare began coverage in January 2011, with the first patients receiving benefits that spring.

Proponents praised the program’s team-based approach, involving a physician supervisor, nurse case manager, dietitian, exercise physiologist, mental health professional and yoga instructor.

“We know treatment works so much better when we work on chronic diseases as a team,” said internist Shanthi Manivannan, MD, medical director of the Ornish program at West Virginia University Healthcare’s Ruby Memorial Hospital in Morgantown, W.Va., a Medicare-certified site.

“It’s almost impossible for physicians to take care of everything. They don’t have the expertise or the time,” Dr. Manivannan said. She coordinates with patients’ primary care doctors who supervise progress by, for example, setting limits on exercise protocols or adjusting medications.

Similarly, many of the newly covered obesity counseling sessions will not be provided entirely by physicians. Supervised nurse practitioners, clinical nurse specialists or physician assistants also can provide this primary care.

Medicare will cover weekly and monthly face-to-face sessions for six months — up to a year for those who lose at least 6.6 pounds. Qualifying patients must have a body mass index of 30 or higher, according to CMS.

Whether physicians counsel patients on weight loss themselves or serve in supervisory roles, they must engage patients in prevention and be their cheerleaders, said Steven F. Horowitz, MD, director of cardiology at Stamford Hospital in Connecticut.

“I hear physicians say it’s impossible to change patients’ behavior, but they don’t have to,” he said. “Patients look up to their doctors, and our role is to enthusiastically support the concept” and refer them to other professionals who can help if necessary.

Convincing skeptics

Medicare’s coverage of intensive cardiac rehab and weight-loss counseling means more patients can access care that otherwise is unaffordable, said Dr. Horowitz, also medical director of Stamford’s Ornish program. “But there’s still a large population with private insurance who can’t participate, and while traditionally private payers follow Medicare, it doesn’t happen overnight.”

Sometimes Medicare follows others’ leads. Highmark Blue Cross Blue Shield was the first payer to cover the Ornish program in 1997, including for patients at risk for heart disease. The program has saved the insurer 30% to 60% — about $1,500 to $3,000 — per cardiac episode by cutting down on hospital admissions.

Instead of following the traditional disease treatment model, “we wanted to take a different approach and get to the very foundation of behavior change,” said Highmark representative Atiya Abdelmalik, RN. Highmark and WVU Healthcare — which started offering the Ornish program in 2002 — participated in the Medicare demo that led to the agency’s coverage decision.

The program’s founder, internist Dean Ornish, MD, of Sausalito, Calif., said it took him 16 years to get Medicare on board. “I’m grateful they finally did, because no matter how good a program is clinically, if it’s not reimbursable, it’s not sustainable.” Dr. Ornish is a clinical professor at the University of California, San Francisco’s Dept. of Medicine, and runs the Preventive Medicine Research Institute, which focuses on the effects of lifestyle on diseases.

Lifestyle changes such as those promoted by his heart program have been shown to impact other major chronic diseases, such as cancer and diabetes, he said. “I think one reason Medicare is paying for this is because it can be medically effective and cost-effective” in more ways than one.

But although such alternative programs may test the limits of conventional treatments, they have their own limits. Some cardiologists and health plans have expressed wariness about their effectiveness compared with conventional care.

In a December 2009 comment letter to CMS, the American College of Cardiology said “evidence demonstrating that the Ornish program’s effects on the course of coronary heart disease or revascularization rates is unclear.” The ACC said the program might meet the initial hurdle for Medicare coverage, but patient outcomes might not show that it improves enough cardiac conditions over a long enough period to meet the full requirements for an intensive cardiac rehab program.

In an April email, Vera Bittner, MD, MSPH, a professor of medicine and section head of preventive cardiology at the University of Alabama at Birmingham, indicated the ACC is supportive of Medicare access to cardiac rehab in general — and that it, like other preventive care, should follow a “patient-centered” approach. “Bundling of different counseling services, limiting services to a particular type of physician or a specific intervention or set of interventions, or specifying specific time intervals outside which services are not reimbursable will limit access to these services.”

In another comment letter to CMS, America’s Health Insurance Plans pointed to a 2009 study showing that some patients in the Ornish Medicare demo fared no better on long-term rehospitaliza­tion or mortality rates than patients who under­went traditional cardiac rehab, despite large differences in program costs.

The year-long Ornish program cost $5,650 per beneficiary, of which Medicare paid 80%. Traditional cardiac rehab lasted for 18 weeks and cost Medicare only $683.

The Ornish program requires strict dietary and lifestyle changes, which can result in low enrollment and adherence rates, the letter said. The insurers trade group similarly expressed to CMS concerns that the new obesity counseling might benefit only a small population.

Physicians also may lack the in-depth training to administer obesity counseling. Seventy-two percent of primary care physicians surveyed by the STOP Obesity Alliance in 2010 said nobody in their practices had been trained to deal with weight-loss issues, though 89% agreed it was their job.

Other obesity challenges mirror those of the medical home, added GWU’s Ferguson, a former Massachusetts health commissioner. There is a need for improved integration, a supportive payment system and sufficient primary care supply.

Several of the Medicare-approved Ornish program sites acknowledged that their operations are barely cost-neutral. Even hiring a single dietitian can be difficult for smaller physician practices, said the AAFP’s Dr. Stream.

Some physicians also want to ensure that preventive coverage does not overshadow surgical options for high-risk patients.

“Patients and their health care providers need an arsenal of treatments. & For the morbidly obese, bariatric surgery is the most effective therapy,” the American Society for Metabolic and Bariatric Surgery wrote in a CMS comment letter.

Dr. Ornish agreed that lifestyle modification programs, while a valid alternative to surgery for some, may not be suitable in every case. “This is meant to give patients the full range of options.”

Preventive programs aren’t necessarily going to be a moneymaker for practices, Silverton Hospital’s Dr. Lord said.

“But that’s not a reason to get into this,” he said. “The ones who really benefit are the patients, and it’s wonderful for them.”

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Alternative heart disease strategy shows promise

The Medicare-covered intensive cardiac rehabilitation program known as the Dr. Dean Ornish’s Program for Reversing Heart Disease has lowered patients’ risk of repeat heart attacks and other symptoms of heart disease through comprehensive lifestyle modifications. A recent study of 2,974 Highmark Blue Cross Blue Shield patients who went through the one-year program at 24 hospital sites in four states between 1998 and 2009 showed promising results:

Mean change in measure After 12 weeks After one year
Body mass index -6.6% -7.8%
Depression scale scores -47.4% -44.7%
Diastolic blood pressure -8.5% -4.8%
Exercise capacity 22.2% 24.4%
Hemoglobin A1c -11% -5.6%
Systolic blood pressure -8.7% -4.7%
Total cholesterol -14.9% -6.2%

Source: “The Effectiveness and Efficacy of an Intensive Cardiac Rehabilitation Program in 24 Sites,” American Journal of Health Promotion, March/April 2010

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