CMS Proposes Coverage of Supervised Exercise Therapy for Symptomatic PAD

March 3, 2017—The Centers for Medicare & Medicaid Services (CMS) issued a proposed decision memo for supervised exercise therapy (SET) for symptomatic peripheral artery disease (PAD). CMS is seeking comments on the proposed decision and will respond to public comments in a final decision. The proposed decision memo (CAG-00449N) is available on the CMS website here.

In September 2016, CMS accepted a formal complete request from the American Heart Association to initiate a national coverage analysis for SET for symptomatic PAD. The request letter is available online here.

According to the memo, CMS proposes that the evidence is sufficient to cover SET for beneficiaries with intermittent claudication for the treatment of symptomatic PAD. Beneficiaries must have a face-to-face visit with the physician responsible for PAD treatment to obtain the referral for SET. At this visit, the beneficiary must receive information regarding cardiovascular disease and PAD risk factor reduction, which could include education, counseling, behavioral interventions, and outcome assessments.

The memo outlines the requirements for an SET program. The program must include: sessions lasting 30 to 60 minutes with a therapeutic exercise training program for PAD in patients with claudication; three sessions per week; up to 12 weeks of sessions; and the program must be conducted in a hospital or outpatient hospital setting and be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms and who are trained in both basic and advanced life support techniques and in exercise therapy for PAD. The program must be under the direct supervision of a physician.

CMS proposes that Medicare Administrative Contractors have the discretion to cover SET beyond 36 sessions over 12 weeks and may cover an additional 36 sessions over an extended period of time. A second referral is required for additional sessions, and the medical record must include a justification for additional sessions.

SET is not covered for beneficiaries with absolute contraindications to exercise, such as exercise-limiting cardiovascular disease, amputation, or wheelchair confinement and other major comorbidities that would preclude exercise, advised the CMS proposed decision memo.

Commenting on this development to Endovascular Today, Michael R. Jaff, DO, and Ido Weinberg, MD, stated, "Arguably, the most effective intervention for PAD patients who suffer from intermittent claudication is regular exercise, and specifically, supervised exercise. Nonetheless, supervised exercise has long been missing from the official armamentarium available in the United States due to lack of reimbursement. For the past several decades, the peer-reviewed literature has demonstrated the value of supervised exercise. Not only does it improve pain-free walking distances, but exercise also improves body weight, atherosclerotic risk factors, and an overall sense of well-being. The decision by CMS is particularly important as it may serve to incentivize health care organizations to offer more rounded solutions for patients who until now have been offered early intervention. CMS and all those who supported this process should be congratulated."

Dr. Jaff is Professor of Medicine, Harvard Medical School and President, Newton-Wellesley Hospital in Newton, Massachusetts. Dr. Weinberg is Assistant Professor of Medicine at Harvard Medical School and Medical Director of VasCore, the Vascular Ultrasound Core Laboratory at Massachusetts General Hospital in Boston, Massachusetts.