Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)

A. General

Research has shown supervised exercise therapy (SET) to be an effective, minimally invasive method to alleviate the most common symptom associated with peripheral artery disease (PAD) – intermittent claudication (IC). SET has been shown to be significantly more effective than unsupervised exercise, and could prevent the progression of PAD and lower the risk of cardiovascular events that are prevalent in these patients. SET has also been shown to perform at least as well as more invasive revascularization treatments that are covered by Medicare.

B. Nationally Covered Indications

Effective for services performed on or after May 25, 2017, the Centers for Medicare & Medicaid Services has determined that the evidence is sufficient to cover SET for beneficiaries with IC for the treatment of symptomatic 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.

C. Nationally Non-Covered Indications

SET is non-covered for beneficiaries with absolute contraindications to exercise as determined by their primary physician.

D. Other

Medicare Administrative Contractors (MACs) have the discretion to cover SET beyond the nationally covered 36 sessions over a 12-week period. MACs may cover an additional 36 sessions over an extended period of time. A second referral is required for these additional sessions

(This NCD last reviewed May 2017.)

02/2018 - The purpose of this Change Request (CR) is to inform contractors that effective May 25, 2017, the Centers for Medicare and Medicaid Services (CMS) issued an NCD to cover SET for beneficiaries with IC for the treatment of symptomatic PAD. (TN 204) (CR10295)

03/2018 - Transmittals 3969 and 204, dated February 2, 2018, are being rescinded and replaced by Transmittal 205, dated, March 2, 2018, to update the MAC implementation date from April 3, 2018 to April 2, 2018. All other information remains the same. (TN 205) (CR10295)

04/2018 - Transmittal 205, dated March 2, 2018, is being rescinded and replaced by Transmittal 206, dated, April 3, 2018 to remove the April 2018 implementation date and to remove the Place of Service (POS) indicators 19 and 22 in Pub. 100-04 business requirements 10295.04.1.1 and 10295.04.1.1.1 and the appropriate language in the policy Pub. 100-3 and Pub. 100-04 manuals have been updated to reflect this change. Additionally, the claims processing manual has been updated to delete duplicate messaging and formatting revisions. All other information remains the same. (TN 206) (CR10295)

05/2018 - Transmittals 206 and 4016, dated April 3, 2018, are being rescinded and replaced by Transmittals 207 and 4049, dated, May 11, 2018 to remove Pub. 100-04 business requirements 10295.04.1.1 and 10295.04.1.1.1 and to insert the appropriate policy language in both publications 100-3 and 100-04. All other information remains the same. (TN 207) (CR10295)