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National Coverage Determination (NCD)

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

20.35

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Tracking Information

Publication Number
100-3
Manual Section Number
20.35
Manual Section Title
Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)
Version Number
1
Effective Date of this Version
05/25/2017
Ending Effective Date of this Version
Implementation Date
07/02/2018
Implementation QR Modifier Date

Description Information

Benefit Category
Incident to a physician's professional Service
Outpatient Hospital Services Incident to a Physician's Service
Physicians' Services


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

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.)
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
205
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018downloads/R205NCD.pdf
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)
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) 1 05/25/2017 - N/A You are here
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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