CMS Pub. 100-03, ch. 1, § 20.35

Artery Disease (PAD)

(Rev. 207, Issued: 05-11-18, Effective: 05-25-17, Implementation: 07-02-18)

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 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.)