CurrentUnitedHealthcarePolicy CS166OH.B

Lower Extremity Endovascular Procedures (for Ohio Only)

UnitedHealthcare medical policy (Ohio only) addressing coverage and medical necessity of endovascular revascularization procedures for lower extremity peripheral artery disease, with references to InterQual criteria and specific statements regarding iliac artery atherectomy and endovenous femoropopliteal bypass (DETOUR).

Policy Summary

PayerUnitedHealthcare

PolicyLower Extremity Endovascular Procedures (for Ohio Only)

Policy CodePolicy CS166OH.B

Change TypeAdded and Removed coverage language

Effective DateJanuary 1, 2025

Next Review Date

Key ActionProviders must refer to InterQual CP: Procedures, Endovascular Intervention, Peripheral Artery for clinical medical necessity criteria when requesting coverage for endovascular lower extremity procedures in Ohio.

POLICY UPDATE CHANGES

Added language that transluminal peripheral atherectomy of the iliac artery is unproven and not medically necessary due to insufficient evidence of efficacy.

Added language that endovenous femoropopliteal bypass using a stent graft is unproven and not medically necessary for treating peripheral artery disease due to insufficient evidence of efficacy.

Removed previous language indicating endovascular revascularization procedures were unproven/not medically necessary for non-limb-threatening infrapopliteal artery disease and for asymptomatic individuals.

Updated Clinical Evidence, FDA, and References sections to reflect current information and archived previous policy version CS166OH.A.

2Explicitly listed unproven procedures

1State applicability (Ohio only)

1Primary external criteria reference (InterQual)

Coverage Summary & Scope

UnitedHealthcare medical policy CS166OH.B applies only to the state of Ohio and addresses coverage and medical necessity of endovascular revascularization procedures for lower extremity peripheral artery disease (PAD). The policy is CURRENT with an effective date of January 1, 2025 and last reviewed on January 1, 2025. For clinical medical necessity determinations, the policy directs use of InterQual CP: Procedures, Endovascular Intervention, Peripheral Artery as the primary external criteria.

The policy makes Ohio-specific statements about services that will be evaluated under Ohio Administrative Code 5160-101 when requests are for services described as unproven or that have coverage/quantity limits. It also documents specific not-medically-necessary determinations (see policy) and notes that federal, state, or contractual requirements may govern coverage decisions.

Policy numberCS166OH.B

SubjectLower Extremity Endovascular Procedures (Ohio only)

Effective dateJanuary 1, 2025

Last reviewJanuary 1, 2025

StatusCURRENT

State applicabilityApplies only to Ohio

Peripheral artery disease (PAD) is atherosclerotic narrowing of lower extremity vessels that can cause claudication and, if untreated, progress to chronic limb-threatening ischemia (CLTI). Endovascular treatment modalities include balloon angioplasty, stents, stent grafts, and atherectomy; choice of technique depends on lesion location, length, and calcification.

The policy references key clinical trials and evidence summaries informing coverage: the randomized BEST-CLI trial comparing surgical and endovascular therapy for CLTI, and the DETOUR studies (DETOUR, DETOUR 2) evaluating the novel DETOUR endovenous femoropopliteal bypass system with stent grafts. DETOUR trials report technical success and 1-year primary patency (e.g., ~72.1% in DETOUR 2) but are single-arm and lack randomized comparisons.

The policy also cites guideline bodies and systematic reviews that inform practice and coverage considerations, including the ACC/AHA (joint guideline on lower extremity PAD), Society for Vascular Surgery (SVS) guidelines on CLTI and claudication, the International Working Group on the Diabetic Foot (IWGDF) recommendations for revascularization thresholds in diabetic foot disease, and National Institute for Health and Care Excellence (NICE) guidance on PAD.

Regarding specific modalities, the policy indicates that evidence for iliac artery atherectomy is limited and of insufficient quality (with procedural risk such as perforation), and that evidence for the DETOUR endovenous femoropopliteal bypass system, while promising, is limited by single-arm designs and lack of long-term randomized comparisons.

Medical Necessity & Coverage Determinations

General Coverage Determination

Endovascular revascularization procedures (e.g., stents, angioplasty, and/or atherectomy) for treating lower extremity ischemia are proven and medically necessary in certain circumstances. For medical necessity clinical coverage criteria, refer to InterQual CP: Procedures, Endovascular Intervention, Peripheral Artery.

State applicability: Applies only to services in the state of Ohio; requests for services stated as unproven or services with coverage/quantity limits will be evaluated using Ohio Administrative Code 5160-101.
Primary external criteria reference: Medical necessity determinations for endovascular procedures are to follow InterQual CP: Procedures, Endovascular Intervention, Peripheral Artery.

Specific Not Medically Necessary / Unproven Procedures

The following procedures are considered unproven and not medically necessary due to insufficient evidence of efficacy:

Required Provider Actions & Prior Authorization

Documentation Required

Use InterQual criteria for medical necessity

Providers must refer to InterQual CP: Procedures, Endovascular Intervention, Peripheral Artery for clinical medical necessity criteria when requesting coverage for endovascular lower extremity procedures in Ohio.

Prior Authorization

Ohio-specific medical necessity evaluation

Requests for services that are stated as unproven or services with coverage/quantity limits will be evaluated for medical necessity using Ohio Administrative Code 5160-101; prior authorization or medical necessity review is implied for those services.

Ohio Administrative Code 5160-101 will be used to evaluate services stated as unproven or with coverage/quantity limits.
Prior authorization or medical necessity review is implied for such services under Ohio rules and this policy.

Procedure Codes Referenced

Procedure codes referenced (informational only)CPT

0238T	Transluminal peripheral atherectomy; iliac artery, each vessel (open or percutaneous)
0505T	Endovenous femoral-popliteal arterial revascularization; with transcatheter placement of intravascular stent graft(s) and closure by any method
37220	Revascularization, endovascular, iliac artery, unilateral, initial vessel; with transluminal angioplasty
37221	Iliac artery, unilateral, initial vessel; with transluminal stent placement(s)
37222	Iliac artery, each additional ipsilateral iliac vessel; with transluminal angioplasty
37223	Iliac artery, each additional ipsilateral iliac vessel; with transluminal stent placement(s)
37224	Revascularization, endovascular; femoral, popliteal artery(s), unilateral; with transluminal angioplasty
37225	Femoral, popliteal artery(s), unilateral; with atherectomy
37226	Femoral, popliteal artery(s), unilateral; with transluminal stent placement(s)
37227	Femoral, popliteal artery(s), unilateral; with transluminal stent placement(s) and atherectomy

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Clinical Evidence & Rationale

This policy's coverage positions are based on clinical trials, systematic reviews, and guideline recommendations — including BEST-CLI and the DETOUR studies — and on guidance from major professional bodies such as ACC/AHA, SVS, IWGDF, and NICE. InterQual criteria are used as the primary clinical decision support for medical necessity determinations.

BEST-CLI trialRandomized trial in CLTI: surgical group had lower incidence of major adverse limb event or death in Cohort 1; Cohort 2 outcomes similar between groups.

DETOUR system (DETOUR 2)Single-arm studies report high technical success and ~72.1% 1-year primary patency; evidence is limited and lacks randomized comparisons.

Iliac atherectomy evidenceInsufficient quality evidence; primarily observational data with reported risk of perforation and need for randomized trials.

Policy Revision History

2025-01-01addedLatest

Added language that transluminal peripheral atherectomy of the iliac artery is unproven and not medically necessary due to insufficient evidence of efficacy.

2025-01-01addedLatest

Added language that endovenous femoropopliteal bypass using a stent graft is unproven and not medically necessary for treating peripheral artery disease due to insufficient evidence of efficacy.

2025-01-01