CMS considers coverage for Supervised Exercise Therapy.
Peripheral Artery Disease.
PAD is a vascular disease that stems from atherosclerosis (plaque buildup) which narrows the arteries affecting the lower extremities. The number of people diagnosed with PAD is estimated at more than 200 million worldwide, with approximately 12% of Americans having PAD. The presence of PAD becomes more prevalent with age, with PAD affecting more than 10% of patients in their 60s and 70s.
The diagnosis of PAD can be confirmed through the ankle-brachial index (ABI), which is the ratio of systolic pressure at the ankle to that in the arm, or the toe-brachial index for patients where ABI is not reliable due to noncompressible vessels, common for patients of advanced age or chronic diabetes. ABI results of 0.91 to 0.99 are considered borderline, with an ABI of 0.90 or less considered abnormal.
The most common symptom experienced by people with PAD is Intermittant Claudication, which affects about two million Americans, and eight million people globally. IC is pain/discomfort experienced in the legs that occurs while walking or exercising and resolves itself with rest. The pain from IC often limits PAD patients to very light activity since they are only capable of walking short distances. This often results in the elimination of many hobbies and work activities, which could have a dramatic impact on patients? functional independence and quality of life (QoL). Exercise capacity which may be measured by several methods including 6 minute walk test, maximum walking distance, long distance corridor walking and others has been associated with all-cause mortality. While improvement in walking distance and time to claudication is important as a treatment goal, it is also believed that the impact of IC on overall function and general QoL could be minimized.
PAD is an underdiagnosed disease with debilitating consequences that disproportionately affects minority populations. Research has shown SET to be an effective, minimally invasive method to alleviate the most common symptom associated with PAD. This could also prevent the progression of PAD and lower the risk of cardiovascular events that are prevalent in these patients.
Practice guidelines from the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) recommend SET as the initial treatment for patients suffering from IC (Gerhard-Hermanet al., 2016). While experts seem to agree that exercise therapy should be the initial treatment for PAD/IC, the number of endovascular revascularization (ER) procedures has been increasing (Spronk et al., 2008). The preference of physicians and patients for the more invasive ER treatment can be partly attributed to the limited access to SET programs, and the immediate result that is observed with ER (Spronk et al., 2008; van den Houten et al., 2016). ER has remained a more popular treatment option for claudication than SET, despite the ACCF/AHA recommendation that ER be reserved for cases where the patient is too functionally impaired for SET (Anderson et al., 2013).
- 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 (IC) for the treatment of symptomatic peripheral artery disease (PAD). Up to 36 sessions over a 12 week period are covered if all of the following 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; and
- be under the direct supervision of a physician (as defined in 1861(r)(1)), physician assistant, or nurse practitioner/clinical nurse specialist (as identified in 1861(aa)(5)) who must be trained in both basic and advanced life support techniques.
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.
- Medicare Administrative Contractors (MACs) 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 non-covered for beneficiaries with absolute contraindications to exercise as determined by their primary physician.
