has approved Medicare
coverage for an intensive cardiac rehabilitation program based at Massachusetts General Hospital in Boston despite criticism from two former Senate majority leaders and a former CMS official that the clinical evidence doesn't support coverage because it does not demonstrate the program reverses heart disease.
The Benson-Henry Institute for Mind Body Medicine's Cardiac Wellness Program is a multicomponent program that includes supervised exercise, behavioral interventions and counseling, and is designed to reduce cardiovascular risk and improve health outcomes.
The CMS decision allows the institute to bill Medicare as an intensive cardiac rehabilitation (ICR) program instead of as a traditional cardiac rehabilitation service.
Since the ICR billing code was established in 2010, only two other programs have qualified to bill under it: the Ornish Program for Reversing Heart Disease and the Pritikin Program. The Benson-Henry Institute program is currently offered only at Massachusetts General.
The CMS' May 6 final coverage determination was preceded by a proposed decision that was panned by many observers, including former Senate majority leaders Dr. Bill Frist and Tom Daschle.
Dr. Greg Fricchione, director of the Benson-Henry Institute, said the CMS approval will offer the institute's Medicare patients a holistic cardiac rehabilitation experience, while also reducing morbidity, mortality and cost for Medicare in the long run.
Karen Lui, legislative and regulatory analyst for the American Association of Cardiovascular and Pulmonary Rehabilitation, said the coverage determination reflects CMS willingness to consider secondary prevention as beneficial.
The Medicare Improvements for Patients and Providers Act (MIPPA) of 2008 established coverage criteria for intensive cardiac rehabilitation programs. An ICR program provides the same services under the same conditions as traditional cardiac rehabilitation programs, but must demonstrate through peer-reviewed, published research, that it offers one or more of the following benefits. It must: positively affect the progression of coronary heart disease; reduce the need for coronary bypass surgery; or reduce the need for coronary angioplasty.
MIPPA states that an ICR program may be provided in a series of 72 one-hour sessions, including up to six sessions per day, over a period of up to 18 weeks. This differs from traditional cardiac rehabilitation program coverage, which limits rehabilitation sessions to no more than two one-hour sessions per day, up to a total of 36 sessions, provided over a period of up to 36 weeks. Medicare payment for ICRs is nearly six times higher than for traditional cardiac rehabilitation, according to CMS payment data.
Beneficiaries are eligible for the program if they have experienced some type of cardiac incident, including a heart attack, coronary bypass surgery, valve repair or replacement, or coronary stenting, and their attending physician must recommend them for a rehabilitation program.
An estimated 17% of the 42 million Medicare beneficiaries have a heart-failure diagnosis and account for about 800,000 hospital admissions annually, according to the CMS. But few beneficiaries take advantage of cardiac-rehabilitation programs after their cardiac incident. For instance, a 2009 study of more than 600,000 Medicare patients hospitalized for acute-coronary syndrome, percutaneous coronary intervention, or coronary artery bypass graft surgery found that only 12.2% participated in cardiac rehabilitation.
Studies have shown that people don't pursue rehabilitation, or drop out of programs early because of high copayments, the time requirements of participating in a program, or because their physicians don't refer them. ICR sessions can last 3 to 4 hours per day, two days per week.
There were no available estimates of how many Medicare beneficiaries might qualify for the Benson-Henry Institute program or what the potential costs to the Medicare program might be.
In his public comment to the CMS, Frist, a heart surgeon, said that when MIPPA was under consideration in Congress, he was involved in discussions with the agency and then-CMS administrator Mark McClellan emphasizing that the part of the bill's language which states that ICR programs must “positively affect the progression of coronary heart disease” was meant to describe a reversal of heart disease. That specification was intended to distinguish ICR from traditional cardiac rehabilitation. The Benson-Henry Institute's Cardiac Wellness Program doesn't attain this standard and should not receive Medicare ICR coverage under the enhanced payment code, Frist said.
Daschle agreed in his comments. “Traditional cardiac rehabilitation programs can play an important role in slowing progression of the disease, but they do not necessarily reverse it and that distinction is critical,” Daschle said. “I would strongly urge (the CMS) to insist that scientific evidence be provided and documented demonstrating that the (Benson-Henry) program clearly has the capacity to reverse the progression of coronary heart disease.”
Dr. John Whyte, former acting director of the division of medical items and devices in the coverage and analysis group at the CMS, said he participated in the agency's decisionmaking on ICR guidelines. He said CMS' internal expectation was that any ICR programs that received coverage would have to reverse heart disease. “The reason why reversal was so important was that there was the need to make sure that Medicare would not be paying for programs that were simply more expensive and would be additive to costs, with no value-added (beyond) traditional cardiac rehabilitation,” wrote Whyte, who is now the chief medical expert at the Discovery Channel.
In its coverage decision memo, however, the CMS said that whether or not the agency implied that reversal of heart disease would be necessary for an ICR program to qualify for special coverage, the agency is bound by statutory language which does not explicitly require heart-disease reversal. As a result, it approved coverage for the Benson-Henry Institute program because it met the explicit standards in the law.
Dr. Barry Straube, a former CMS chief medical officer who now is director of healthcare consulting for the Marwood Group, told Modern Healthcare that he recalls no conversations about ICR programs being required to reverse heart disease, nor was that requirement ever mentioned to him by a member of Congress.Follow Virgil Dickson on Twitter: @MHvdickson