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May 29, 2017
CMS Approves Coverage for Supervised Exercise Therapy for PAD Patients
May 30, 2017—The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to cover supervised exercise therapy (SET) for beneficiaries with intermittent claudication for the treatment of symptomatic peripheral artery disease (PAD). The CMS decision memo is available online. In March, the CMS announced the proposed decision memo.
According to the decision memo, up to 36 sessions during a 12-week period are covered if all of the defined components of a SET program are met.
The SET program must:
- Consist of sessions lasting 30–60 minutes comprising a therapeutic exercise training program for PAD in patients with claudication
- Be conducted in a hospital outpatient setting or a physician’s office
- Be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms and who are trained in exercise therapy for PAD
- Be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist who must be trained in both basic and advanced life support techniques
Additionally, 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.
CMS advised 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 these additional sessions.
SET is noncovered for beneficiaries with absolute contraindications to exercise as determined by their primary physician, stated the CMS decision memo.
Responding to the approval, Michael R. Jaff, DO, and Ido Weinberg, MD, commented to Endovascular Today:
The recent CMS decision has the potential to have an immense impact on PAD patients' lives and well-being.
Exercise has many well-documented benefits relevant to these patients. Through exercise, PAD patients can reduce the risk of adverse cardiovascular outcomes, achieve positive effects on mood, and—perhaps most relevant to this patient population—improve the ability to walk, which will improve functional status and eventually positively impact quality of life.
Unfortunately, despite these obvious benefits, exercise requires patient motivation and adherence which are often hard to attain. Indeed, for most PAD patients, only supervised exercise (as opposed to unsupervised, self-driven exercise) resulted in measurable benefits. However, until recently there was no formal way to offer such services to PAD patients.
We anticipate that the availability of reimbursement that will result from the CMS decision will result in a rapid increase in facilities offering supervised exercise for PAD patients. Thus, clinicians will finally have the opportunity to safely impact their patients' well-being in a completely positive and safe manner.
In theory, this may even result in a reduction in costly invasive procedures, which may also result in increased patient safety. Much credit for this decision should be shared by CMS, the American Heart Association, and the Society for Vascular Medicine.
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.
In an announcement from the American Heart Association, CEO Nancy Brown stated,
We are so pleased that patients with PAD will now be able to receive SET through Medicare. PAD affects 12% to 20% of Americans age 60 and older, and the incidence of PAD increases considerably with age. Medicare beneficiaries, a significant portion of which have PAD, will benefit considerably from participating in supervised exercise therapy sessions. Evidence shows this therapy can improve quality of life for patients and enhance clinical outcomes.
The American Heart Association, along with many other stakeholders, have long recommended supervised exercise as a first‐line, noninvasive, low risk therapy for individuals with PAD. The association has advocated for it since our first PAD guidelines were issued in 2005, and just last year, we filed a National Coverage Determination request asking CMS for this exact outcome. We couldn’t be more thrilled with today’s decision that will give more Americans the access they need to this important treatment option.
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