Key facts for NCD 20.35
- Benefit category
- Incident to a physician's professional Service, Outpatient Hospital Services Incident to a Physician's Service, Physicians' Services
- Effective date
- 05/25/2017
- Implemented 07/02/2018
- Transmittal
- Transmittal 205
- Versions published
- 1
- Manual chapter
- 20
- NCD Manual (Pub. 100-03)
TL;DR
NCD 20.35 sets Medicare's national policy for supervised exercise therapy (set) for symptomatic peripheral artery disease (pad) under the benefit category "Incident to a physician's professional Service, Outpatient Hospital Services Incident to a Physician's Service, Physicians' Services", effective 05/25/2017 and implemented 07/02/2018. 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… It has been revised once since publication and binds every Medicare Administrative Contractor nationally.
Item or service described
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.
Indications and limitations of coverage
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.)
Text reproduced from the CMS Medicare Coverage Database record for NCD 20.35 version 1. View the original on cms.gov.
Revision history
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)
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)
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)
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)
How this NCD shows up on remittances
A service denied under a National Coverage Determination returns CARC 50 (not deemed medically necessary) with remark N386 (decision based on an NCD); a denial citing a local policy instead carries N115. Because NCDs bind nationally, the appeal path is documentation that the patient meets the indications above, not a contractor-policy argument.
How QuickIntell applies NCD 20.35
QuickAuth checks the ordered service and diagnosis against NCD and LCD criteria before the encounter, QuickCode validates the diagnosis pairing on the claim, and QuickRCM routes CARC 50 denials with the policy text and the covered-code list attached so the appeal starts with evidence.
Frequently asked questions — NCD 20.35
What does NCD 20.35 cover?
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: The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database.
When did NCD 20.35 take effect?
The current version (1) is effective 05/25/2017, implemented 07/02/2018, published in transmittal 205. This is the only published version.
Does a Local Coverage Determination override NCD 20.35?
No. A National Coverage Determination binds all Medicare Administrative Contractors; an LCD can only address services or circumstances the NCD leaves open. Claims denied under this NCD typically return CARC 50 with remark N386 (NCD) rather than N115 (LCD).
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database NCDs via the CMS Coverage APIVersion API snapshot 2026-09-27 · effective 2026-09-20 · file national-coverage-ncd.jsonSHA-256 a90fadfd264b9ef4…
Disclaimer
This page reproduces the CMS National Coverage Determination text and, for laboratory NCDs, the CMS ICD-10 edit lists, as an operational reference. Coverage decisions depend on the full policy, the claim and the contractor; nothing here is legal, clinical or billing advice. CPT codes are shown as numbers only; CPT descriptors are copyright AMA.