Medicare Advantage

Medical Policy

Title:

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

Policy #:

MA10.008d

Policy

This policy uses coverage criteria developed solely based on applicable Medicare statutes, regulations, NCDs, LCDs, CMS manuals and other applicable Medicare coverage documents.

MEDICALLY NECESSARY

A supervised exercise therapy (SET) program of up to 36 sessions over a 12-week period for the treatment of symptomatic peripheral artery disease (PAD) in individuals with intermittent claudication (IC) is considered medically necessary when all of the following criteria are met:

The individual must have a face-to-face visit with the professional provider responsible for the SET program for treatment of PAD.
The program consists of sessions lasting 30 to 60 minutes comprising a therapeutic exercise-training program for PAD in individuals with claudication.
The program is conducted in a hospital outpatient setting or in a physician’s office.
The program is administered under the direct supervision qualified professional providers to ensure benefits exceed harms: such providers must be trained in exercise therapy for PAD and in both basic and advanced life support techniques.

Additional therapy beyond 36 sessions (up to 72 sessions) may be considered medically necessary and, therefore covered over an extended period of time.

NOT MEDICALLY NECESSARY

All indications other than those listed in this policy are considered not medically necessary and, therefore, not covered.

NOT COVERED

SET beyond 72 sessions is not covered by the Company because this service is not covered by Medicare.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

Individuals should have a face-to-face visit with the prescribing professional provider for peripheral artery disease (PAD) treatment to receive information regarding cardiovascular disease and PAD risk factor reduction, which could include education, counseling, behavioral interventions, and outcome assessments.

Description

Peripheral artery disease (PAD) is a vascular disease that stems from atherosclerosis (plaque buildup), which narrows the arteries affecting the lower extremities. 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 individuals in whom ABI is not reliable due to noncompressible vessels, common for individuals 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 individuals with PAD is intermittent claudication (IC). IC is pain and discomfort from impaired circulation experienced in the legs that occurs while walking or exercising and resolves itself with rest. The pain from IC often limits PAD individuals to very light activity since they are only capable of walking short distances. Individuals with IC may have progression to critical limb ischemia, in which damage may be irreversible and lead to amputation. Exercise capacity that 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 quality of life could be minimized.

PAD is an underdiagnosed disease with debilitating consequences that disproportionately affects minority populations. Research has shown that supervised exercise therapy (SET) is 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.

SET involves the use of intermittent walking exercise, which alternates periods of walking to moderate-to-maximum claudication with rest. SET has been recommended as the initial treatment for individuals suffering from IC, the most common symptom experienced by people with PAD.

References

Centers for Medicare & Medicaid Services (CMS). Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) (CAG-00449N). 05/25/2017. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=287. Accessed January 16, 2025.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) (20.35). [CMS Web site]. 05/25/2017. Available at: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=371&ncdver=1&keywordtype=starts&keyword=supervised exercise&bc=0. Accessed January 16, 2025.

Centers for Medicare & Medicaid Services (CMS). CMS Manual System. May 11, 2018 Change Request 10295. Available at:
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R207NCD.pdf. Accessed January 16, 2025.

Centers for Medicare & Medicaid Services (CMS). MLN Matters. Effective May 25, 2017. MM10295 – Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD). Available at:
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10295.pdf. Accessed January 16, 2025.

Centers for Medicare & Medicaid Services (CMS). MLN Matters. Effective May 25, 2017. MM11022 – Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)—Clarification of Payment Rules and Expansion of International Classification of Diseases Tenth Edition (ICD-10) Diagnosis Codes. Available at:
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/mm11022.pdf. Accessed January 16, 2025.

Gerhard-Herman MD, Gornick HL, Mureebe L, et al. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2016;135(12). Available at: https://www.ahajournals.org/doi/10.1161/CIR.0000000000000470. Accessed January 16, 2025.

Hageman D, Fokkenrood HJP, Gommans LNM, et al. Supervised exercise therapy versus home-based exercise therapy versus walking advice for intermittent claudication. Cochrane Database Syst Rev. 2018;4:CD005263. 04/08/2018. Available at: Supervised exercise therapy vs home-based exercise therapy vs walking advice for patients with leg pain while walking (intermittent claudication). Accessed January 16, 2025.

Coding

CPT Procedure Code Number(s)

93668

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

I70.211 Atherosclerosis of native arteries of extremities with intermittent claudication, right leg

I70.212 Atherosclerosis of native arteries of extremities with intermittent claudication, left leg

I70.213 Atherosclerosis of native arteries of extremities with intermittent claudication, bilateral legs

I70.218 Atherosclerosis of native arteries of extremities with intermittent claudication, other extremity

I70.219 Atherosclerosis of native arteries of extremities with intermittent claudication, unspecified extremity

I70.311 Atherosclerosis of unspecified type of bypass graft(s) of the extremities with intermittent claudication, right leg

I70.312 Atherosclerosis of unspecified type of bypass graft(s) of the extremities with intermittent claudication, left leg

I70.313 Atherosclerosis of unspecified type of bypass graft(s) of the extremities with intermittent claudication, bilateral legs

I70.318 Atherosclerosis of unspecified type of bypass graft(s) of the extremities with intermittent claudication, other extremity

I70.319 Atherosclerosis of unspecified type of bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

I70.411 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, right leg

I70.412 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, left leg

I70.413 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, bilateral legs

I70.418 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, other extremity

I70.419 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

I70.511 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, right leg

I70.512 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, left leg

I70.513 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, bilateral legs

I70.518 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, other extremity

I70.519 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

I70.611 Atherosclerosis of nonbiological bypass graft(s) of the extremities with intermittent claudication, right leg

I70.612 Atherosclerosis of nonbiological bypass graft(s) of the extremities with intermittent claudication, left leg

I70.613 Atherosclerosis of nonbiological bypass graft(s) of the extremities with intermittent claudication, bilateral legs

I70.618 Atherosclerosis of nonbiological bypass graft(s) of the extremities with intermittent claudication, other extremity

I70.619 Atherosclerosis of nonbiological bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

I70.711 Atherosclerosis of other type of bypass graft(s) of the extremities with intermittent claudication, right leg

I70.712 Atherosclerosis of other type of bypass graft(s) of the extremities with intermittent claudication, left leg

I70.713 Atherosclerosis of other type of bypass graft(s) of the extremities with intermittent claudication, bilateral legs

I70.718 Atherosclerosis of other type of bypass graft(s) of the extremities with intermittent claudication, other extremity

I70.719 Atherosclerosis of other type of bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

HCPCS Level II Code Number(s)

N/A

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From MA10.008d:

05/27/2026	This policy has been reissued in accordance with the Company's annual review process.
04/02/2025	This policy has been reviewed and reissued to communicate the Company's continuing position on supervised exercise therapy (SET) for symptomatic peripheral artery disease (PAD).
03/20/2024	This policy has been reissued in accordance with the Company's annual review process.
01/01/2024	Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.
03/22/2023	The policy has been reviewed and reissued to communicate the Company’s continuing position on Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD).
05/18/2022	This policy has been reissued in accordance with the Company's annual review process.
02/10/2021	This policy has been reissued in accordance with the Company's annual review process.
02/26/2020	This policy has been reissued in accordance with the Company's annual review process.
08/19/2019	This version of the policy will become effective 08/19/2019. The intent of this policy remains unchanged, but the policy has been updated in accordance with Medicare's Expansion of International Classification of Diseases Tenth Edition (ICD-10) Diagnosis Codes for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD). The following ICD-10 CM codes have been added to this policy: I70.411 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, right leg I70.412 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, left leg I70.413 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, bilateral legs I70.418 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, other extremity I70.419 Atherosclerosis of autologous vein bypass graft(s) of the extremities with intermittent claudication, unspecified extremity I70.511 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, right leg I70.512 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, left leg I70.513 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, bilateral legs I70.518 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, other extremity I70.519 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

Revisions From MA10.008c:

01/01/2019

This version of the policy will become effective 01/01/2019.

The intent of this policy remains unchanged, however, the policy is being updated to communicate that Providers should submit claims directly to the MA plan for reasonable and necessary items and services for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) and that claims should no longer be submitted to the local Medicare Administrative Contractor (MAC) for this service.

Revisions From MA10.008b:

07/16/2018

This version of the policy will become effective 07/16/2018. The following policy criteria have been revised in accordance with Medicare's SET therapy requirements:

The program is conducted in a hospital outpatient setting or in a physician’s office

Revisions From MA10.008a:

05/07/2018

In accordance with Medicare, the following revisions were made to this policy.

The following ICD-10 CM codes have been added to this policy:

I70.611, I70.612, I70.613, I70.619,

The following ICD-10 CM codes have been removed from this policy:

I70.511 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, right leg

I70.512 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, left leg

I70.513 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, bilateral legs

I70.518 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, other extremity

I70.519 Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

I70.619 Atherosclerosis of nonbiological bypass graft(s) of the extremities with intermittent claudication, unspecified extremity

I70.621 Atherosclerosis of nonbiological bypass graft(s) of the extremities with rest pain, right leg

I70.622 Atherosclerosis of nonbiological bypass graft(s) of the extremities with rest pain, left leg

I70.623 Atherosclerosis of nonbiological bypass graft(s) of the extremities with rest pain, bilateral legs

I70.628 Atherosclerosis of nonbiological bypass graft(s) of the extremities with rest pain, other extremity

I70.629 Atherosclerosis of nonbiological bypass graft(s) of the extremities with rest pain, unspecified extremity

I73.9 Peripheral vascular disease, unspecified

Revised place of service in accordance with Medicare, in the policy section:

FROM:

The program is conducted in a hospital outpatient setting or a physician’s office;

TO:

The program is conducted in a physician’s office

Revisions From MA10.008:

10/04/2017

This new policy has been developed to address a new decision memo by Centers for Medicare & Medicaid Services (CMS) Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) (CAG-00449N).

Version Effective Date:

1/1/2024

Version Issued Date: