Medicare will pay for intensive diet and exercise programs developed under the Ornish and Pritikin brands for reducing cardiovascular event risk, the Centers for Medicare and Medicaid Services announced.
The agency's review of published data on the Ornish and Pritikin intensive cardiac rehabilitation programs found that they effectively slowed or reversed progression of coronary heart disease and reduce the need for coronary artery bypass grafts (CABG) and percutaneous interventions.
Consequently, they are approved for coverage under Part B of Medicare, CMS said. Legislation that went into effect this year established a new benefit for intensive cardiac rehabilitation programs.
Because Medicare will make these programs available to all beneficiaries regardless of income, it expects the decision will "reduce the disparate impact of heart disease in minority populations."
The Pritikin regimen originated in the 1950s solely as a diet, but exercise components were added in later years. It now consists of a program delivered in physician offices that includes a specific diet, exercises, and counseling for three to four weeks.
The Ornish program is newer and incorporated exercise from its beginnings in the 1970s. It also includes stress management, smoking cessation, and group support sessions in addition to the diet and exercise regimen.
CMS staff reviewed six studies of the Pritikin program and nine on the Ornish version appearing in peer-reviewed publications. Most of these were conducted or sponsored by the Ornish and Pritikin companies -- eight of the nine Ornish studies, for example, had company founder Dean Ornish, MD, as lead or senior author.
Nevertheless, CMS accepted the reported data as valid and adequate to demonstrate the effectiveness of the programs under the agency's statutory and regulatory requirements.
The agency also relied on an external assessment published in 2005 that found the programs reduced markers of coronary heart disease such as angina frequency and vascular stenosis.
Other benefits identified in the studies included reduced LDL cholesterol levels, body weight, blood pressure, and rates of events including CABG and angioplasty procedures.