CMS Supervised Exercise Therapy (SET) for PAD: What Billing Teams Need to Know About NCD 371
CMS has modified its National Coverage Determination for Supervised Exercise Therapy (SET) for symptomatic Peripheral Artery Disease (PAD) under NCD 371, with an updated effective date of March 12, 2026. If your practice or hospital outpatient department treats Medicare patients with intermittent claudication, this policy directly affects how you document, refer, and bill for SET services. Here's what changed and what your revenue cycle team needs to do now.
| Field | Detail |
|---|---|
| Payer | Centers for Medicare & Medicaid Services (CMS) |
| Policy | Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) |
| Policy Code | NCD 371 |
| Change Type | Modified |
| Effective Date | 2026-03-12 |
| Impact Level | Medium — coverage structure is unchanged, but teams billing this service must confirm their documentation protocols align with the current requirements |
| Specialties Affected | Vascular surgery, cardiology, internal medicine, physical therapy (hospital outpatient), primary care (for referral obligations) |
| Key Action | Confirm that your SET program meets all four structural requirements and that face-to-face referral visits are documented before the first session is billed. |
What CMS Covers Under NCD 371: SET for Peripheral Artery Disease
The Centers for Medicare & Medicaid Services has determined that evidence is sufficient to cover Supervised Exercise Therapy for Medicare beneficiaries with intermittent claudication (IC) as a treatment for symptomatic PAD. This coverage has been in effect for services performed on or after May 25, 2017, and NCD 371 remains the governing national policy.
CMS's rationale is grounded in clinical evidence: SET has been shown to be significantly more effective than unsupervised exercise for IC, and performs at least as well as more invasive revascularization procedures that Medicare already covers. It's also considered a minimally invasive intervention that may slow PAD progression and reduce cardiovascular event risk—a meaningful consideration for a population that typically carries substantial comorbidity burden.
The core coverage allowance is up to 36 sessions over a 12-week period, subject to strict program requirements.
Medical Necessity Criteria: All Four Requirements Must Be Met
This is where denials happen. CMS does not cover SET broadly—it covers SET within a program that meets all of the following structural components simultaneously. Your SET program must:
| # | Covered Indication |
|---|---|
| 1 | Consist of sessions lasting 30–60 minutes comprising a therapeutic exercise-training program specifically designed for PAD patients with claudication. Sessions outside that time window are not compliant. |
| 2 | Be conducted in a hospital outpatient setting or a physician's office. Community fitness centers, home-based programs, or other settings are not covered under the national determination. |
| 3 | Be delivered by qualified auxiliary personnel who are trained in exercise therapy for PAD—training that must be sufficient to ensure benefits exceed harms. |
| 4 | Be under the direct supervision of a physician (as defined under §1861(r)(1)), physician assistant, or nurse practitioner/clinical nurse specialist (as identified under §1861(aa)(5))—and that supervising clinician must be trained in both basic and advanced life support techniques. |
All four criteria must be met for every covered session. A gap in any one of them creates a medical necessity vulnerability on audit.
The Face-to-Face Referral Requirement: Non-Negotiable
Before a beneficiary can begin a covered SET program, they must have a face-to-face visit with the physician responsible for their PAD treatment to obtain the SET referral. This is not a formality—it's a coverage requirement.
At that visit, the beneficiary must receive information regarding cardiovascular disease and PAD risk factor reduction. CMS specifies that this can include education, counseling, behavioral interventions, and outcome assessments. Your documentation for this visit needs to reflect that these elements were provided, not just that the referral was written.
Missing or inadequate documentation of this visit is one of the most common reasons SET claims are denied or recouped on audit. Make sure the referring physician's note explicitly reflects the PAD risk factor education provided.
Extended Coverage: MAC Discretion Beyond 36 Sessions
The national coverage determination sets a floor, not a ceiling—at least in certain cases. Medicare Administrative Contractors (MACs) have the discretion to cover an additional 36 sessions beyond the nationally covered 36, for a potential total of 72 sessions. This extended coverage applies over an extended time period beyond the initial 12 weeks.
Critically, a second referral is required before billing for those additional sessions. That second referral must be obtained before the extended sessions begin—billing additional sessions against only the original referral is a compliance risk.
Check with your MAC directly to confirm whether they have exercised this discretion, what documentation they require, and whether any local coverage articles govern the additional sessions. MAC-level policies vary, and you cannot assume discretionary coverage applies in your jurisdiction without verification.
Non-Covered Indications Under NCD 371
CMS is explicit: SET is nationally non-covered for beneficiaries with absolute contraindications to exercise, as determined by their primary physician. This determination must be documented in the medical record.
If a patient presents with a contraindication and you provide SET services anyway, those claims will not be covered under Medicare—and billing them creates compliance exposure. The primary physician's role in screening patients for contraindications before referral is a key checkpoint in your workflow.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
Affected Codes
This policy does not list specific CPT or HCPCS codes within the NCD 371 policy document. For the applicable billing codes for SET services, consult the CMS Claims Processing Transmittals associated with this NCD—specifically Transmittals 3969, 3992, 4016, and 4049—which contain the operative claims processing instructions. Your MAC's website and billing guides are also authoritative sources for the correct codes in your jurisdiction.
What Your Billing Team Should Do
| # | Action Item |
|---|---|
| 1 | Audit your current SET program against all four structural criteria before March 12, 2026. Pull the program documentation and confirm session length, setting, personnel qualifications, and supervising clinician credentials are all documented and compliant. If anything is out of alignment, you have time to correct it. |
| 2 | Review your face-to-face referral workflow immediately. Confirm that your EHR or documentation template for the initial PAD visit captures evidence of cardiovascular disease and PAD risk factor education—not just the referral order. Retrospectively, check recent SET referrals to confirm documentation adequacy. |
| 3 | Contact your MAC to confirm extended session discretion. If you're billing—or planning to bill—beyond the initial 36 sessions, verify that your MAC covers the additional 36 sessions, understand their documentation requirements, and confirm that a second referral has been obtained and is on file before those claims go out. |
| 4 | Implement a contraindication screening checkpoint. Create a workflow step that confirms the referring physician has evaluated and documented that the patient has no absolute contraindications to exercise before SET begins. This protects you on both the coverage and the liability side. |
| 5 | Train clinical and billing staff together. The compliance requirements here span clinical decisions (supervision level, session structure, contraindication screening) and billing operations (referral documentation, session counts, MAC policies). A joint training session will close gaps that exist when these teams work in silos. |
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