BALTIMORE — Physician-supervised intensive diet and lifestyle change programs for secondary prevention of cardiovascular disease have gained the endorsement of the Medicare Coverage Advisory Committee.
The committee voted to recommend that Medicare cover such programs in patients with documented cardiovascular disease, including the program developed by Dean Ornish, M.D. “I'm pleased by the opportunity to have all the evidence considered,” he said.
Medicare is not obliged to accept the recommendation of the advisory committee.
Dr. Ornish, president of the Preventive Medicine Research Institute, Sausalito, Calif., outlined his program, which consists of putting patients on a very low-fat diet (about 10% fat), getting them on a moderate exercise program, teaching them stress management techniques such as stretching and meditation, and enrolling them in support groups.
In a 1-year study of 28 patients who took part in the program and 20 controls, he found that the average percentage diameter stenosis regressed from 40% to 37.8% in the experimental group, compared with an average progression from 42.7% to 46.1% in the control group. In addition, there was a 91% reduction in angina in the intervention group, compared with a 165% increase in the control group.
Dr. Ornish also investigated whether other providers could be trained to implement his program, so he set up demonstration projects in other sites with more than 2,000 patients.
In the first project, funded by Mutual of Omaha, the researchers studied 194 patients with angiographically documented coronary artery disease and compared them with 139 controls.
After 3 years, 77% of intervention patients who met insurance company criteria to undergo bypass or angioplasty were able to avoid it, saving Mutual of Omaha $30,000 per patient, Dr. Ornish reported.
He admitted that his program requires a lot of commitment. For the first few months, participants attend two 4-hour sessions, each consisting of exercise, meditation or other stress reduction, a support group meeting, and a lunch/lecture. Later, they decrease to once-weekly sessions, but continue for 9 months.
In a payment demonstration project for Medicare, Dr. Ornish found that patients' body weight decreased both at 12 weeks and at 1 year.
The primary determinant of how much patients improved on the program was adherence. “The more people changed, the better they got,” he said.
Advisory committee members expressed several concerns about Dr. Ornish's results. Clifford Goodman, Ph.D., a senior scientist with the Lewin Group, a Falls Church, Va., consulting firm, noted that some of the improvements in the patient groups started to reverse slightly after a year, and speculated that many patients may be self-selecting for the program at a time when their weight and other negative indicators are at their peak. “How much of the effect we're observing is simply regression to the mean?” he asked.
Dr. Ornish admitted that there was some regression but added, “there is a direct correlation between degree of adherence and outcomes at 1 year.”
Adherence was a concern for several panel members who wondered whether patients could really keep up with strict regimens such as Dr. Ornish's.
But Dr. Ornish said he was merely asking for these types of programs to be treated the same way as other interventions. “We will pay for bypass surgery and angioplasty, but diet and lifestyle interventions, Medicare generally doesn't pay for it,” he said, adding that many insurers pay for cholesterol-lowering statin drugs even though studies have shown that patients go off the drugs after a few months because they don't like the side effects.
Also testifying were spokesmen from two Blue Cross Blue Shield plans—Mountain State in West Virginia and Highmark in Pennsylvania—that pay patients to enroll in the Ornish program. Both said their plans were happy with the clinical outcomes and the cost savings.
David Lambert, vice president of health services for Mountain State Blue Cross Blue Shield, said his plan began covering the Ornish program for heart disease prevention in 2002. More than 400 patients, average age 56, have participated, with a 90% completion rate, he said.
“They collectively reduced their risk of a cardiac event by 50% as measured by the ATP Framingham risk tool, and lowered their LDL by 21%,” he said, noting that the average cost of the behavioral management program was $5,700, compared with the average cost of heart surgery, which ranges from $57,000 to $67,000. “By avoiding one procedure, it pays for 10 members to complete the program.”
The committee also heard from Alex Clark, Ph.D., of the University of Alberta's Centre for Health Evidence in Edmonton. The Centers for Medicare and Medicaid Services contracted with Dr. Clark's center to review outcomes studies for patients with symptomatic coronary artery disease undergoing one of three types of therapy: cardiac rehabilitation (group education and counseling only), comprehensive cardiac rehabilitation (such as Dr. Ornish's program, which includes exercise in addition to group education and counseling), and individual counseling. All studies had to have outcomes for at least 50 patients to be included in the review.