The US Centers for Medicare & Medicaid Services (CMS) have released the proposed decision memo for the approval of supervised exercise therapy for the treatment of peripheral artery disease (PAD). This was triggered by the receipt last year of a request from the American Heart Association to initiate a national coverage analysis in order to establish a national coverage determination for said exercise therapy programmes.
A press release notes that supervised exercise therapy is a low-risk and non-invasive treatment option and is indicated for patients with documented PAD and claudication. Endovascular procedures and medical therapy are beyond the scope of this NCA.
CMS proposes, “The evidence is sufficient to cover supervised exercise therapy 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 supervised exercise therapy. At this visit, the beneficiary must receive information regarding cardiovascular disease and PAD risk factor reduction, which could include education, counselling, behavioural interventions, and outcome assessments.”
The announcement outlines that such a programme must include:
- Sessions lasting 30–60 minutes comprised of a therapeutic exercise-training programme for PAD in patients with claudication;
- Three sessions per week;
- Up to 12 weeks of sessions; and
- The programme 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 programme must be under the direct supervision of a physician.
Following the request, an initial 30-day public comment period drew 103 comments. There is now a second public comment period which will run until 1 April, during which time the CMS will consider “all public comments, and is particularly interested in clinical studies and other scientific information relevant to the topic under review.” Comments can be submitted via www.cms.gov/Medicare/Coverage/InfoExchange/publiccomments.html.