UnitedHealthcare Lower Extremity Coverage Update

Coverage Summary

Scope: This policy defines UnitedHealthcare Commercial and Individual Exchange coverage criteria for lower extremity endovascular procedures for peripheral artery disease, covering indications, exclusions, retreatment criteria, required documentation, and applicable codes. It applies to endovascular revascularization interventions (e.g., stents, angioplasty, atherectomy) for claudication and chronic limb-threatening ischemia (CLTI).

Overview: UnitedHealthcare (Commercial and Individual Exchange) takes a mixed coverage stance for Lower Extremity Endovascular Procedures: endovascular revascularization is proven and medically necessary for selected individuals with functionally limiting Claudication and for CLTI when specified clinical criteria are met (see policy for conservative therapy, ABI/TBI and imaging thresholds). Certain indications and procedures are explicitly considered unproven / not medically necessary due to insufficient evidence (for example, interventions in asymptomatic individuals, interventions to prevent progression of Claudication to CLTI, non-limb-threatening infrapopliteal interventions, transluminal iliac atherectomy, treatment of a nonviable limb, and endovenous femoropopliteal bypass with stent graft). Medical records may be requested to confirm that the clinical criteria are satisfied.

Key thresholds and stats

ABI threshold≤ 0.90

Imaging stenosis threshold≥ 50% stenosis on target vessel imaging (duplex, CTA, MRA, or DSA); if duplex does not show ≥50% use alternate imaging

Supervised exercise therapy durationMinimum 12 weeks (sessions ≥3/week; 30–45 minutes active walking per session goal)

CLTI chronicity definitionChronic ≥2 weeks ischemic rest pain, nonhealing wound/ulcers or gangrene attributable to arterial occlusive disease

DETOUR FDA PMA milestoneDETOUR System FDA PMA granted June 7, 2023 (indications: femoropopliteal lesions 200–460 mm; CTOs 100–425 mm; or diffuse stenosis >70%)

Guidelines citedACC/AHA 2024, Society for Vascular Surgery guidance, IWGDF, NICE and other referenced guidelines/studies

Policy datesEffective: 2026-03-01; Last review: 2026-03-01

Endovascular Revascularization — Claudication (non-limb-threatening)

Endovascular revascularization for Claudication (non-limb-threatening)

Proven and medically necessary when ALL of the following are met:

ALL of the following

Impaired ability to work and/or perform activities of daily living (ADL)
Conservative therapies
- Supervised/Structured Exercise: At least twelve (12) weeks of Supervised Exercise Therapy or a Structured Community-Based Exercise Program12 weeks
  Sessions at least 3 times/week; 30-45 minutes active walking per session goal
- Pharmacologic therapy (e.g., lipid lowering therapy, antihypertensive therapy, antiplatelet therapy, and/or anticoagulants)

Retreatment — In-stent Restenosis (Claudication)

Retreatment for in-stent restenosis (Claudiation)

Proven and medically necessary when ALL of the following are met:

Recurrent symptoms
Impaired ADL/work: Impaired ability to work and/or perform activities of daily living (ADL)
Imaging ≥50%: Imaging of previously treated vessel (duplex ultrasound, CTA, MRA, or digital subtraction angiography) shows anatomic location and a moderate-severe stenosis (50% or greater). If duplex ultrasound does not demonstrate ≥50% stenosis, another imaging modality is necessary to demonstrate the extent of stenosis.≥ 50% stenosis
Alternate imaging required if duplex not diagnostic

Endovascular Revascularization — Chronic Limb-Threatening Ischemia (CLTI)

Endovascular revascularization for Chronic Limb-Threatening Ischemia (CLTI)

Proven and medically necessary for treating CLTI with the diagnoses listed under Applicable Codes.

CLTI definition: CLTI as defined under Definitions (chronic ≥2 weeks ischemic rest pain, nonhealing wound/ulcers or gangrene attributable to arterial occlusive disease)≥ 2 weeks

Reference Applicable ICD-10 codes group for diagnoses that qualify

For suspected CLTI, guideline-supported hemodynamic thresholds should prompt urgent evaluation and revascularization: consider urgent action when ABI < 0.4 or ankle pressure < 50 mm Hg, or when toe pressure < 30 mm Hg or TcPO2 < 25 mm Hg. Providers should document these measurements when submitting records and consider urgent vascular imaging and revascularization per the policy and IWGDF guidance.

Unproven / Not Medically Necessary Indications

any

Interventions performed for non-limb-threatening infrapopliteal (e.g., anterior tibial, posterior tibial, or peroneal) artery disease

Individual is asymptomatic

To prevent the progression of Claudication to CLTI

Transluminal peripheral atherectomy of the iliac artery (CPT 0238T)

Treatment of a nonviable limb

Documentation & Pre-Claim Requirements

Documentation requirements for reviews (updated 03/01/2026)

Medical records documentation used for reviews must include ALL of the following:

Documentation requirements

History & physical: Relevant history and physical to include member symptoms and pertinent findings due to ischemia with specific description of location, aggravating, and alleviating factors of limb pain
Treatments tried/failed: Treatments tried, failed, and/or contraindicated; include the dates, duration, and monitoring protocol for exercise therapy specific to peripheral vascular disease (PVD), the method, dates, and duration of attempted smoking cessation trial, and reason for discontinuation (e.g., pharmacologic therapy)
Include monitoring protocol for supervised/structured exercise
Ischemia documentation:

Procedure and Diagnosis Codes

Unproven / Not Medically Necessary procedure codes (examples listed in policy text)CPTNot Covered

0238T	Transluminal peripheral atherectomy, open or percutaneous; iliac artery, each vessel.
0505T	Endovenous femoral-popliteal arterial revascularization, with transcatheter placement of intravascular stent graft(s) and closure, including crossing of the occlusive lesion in an extraluminal fashion.

Applicable CPT procedure codes (reference list; inclusion does not imply coverage)CPT

37254	Revascularization, endovascular... iliac vascular territory; straightforward lesion, initial vessel.
37255	Iliac vascular territory; straightforward lesion, each additional vessel.
37256	Iliac vascular territory; complex lesion, initial vessel.
37257	Iliac vascular territory; complex lesion, each additional vessel.
37258	Iliac vascular territory; transluminal stent placement; straightforward lesion, initial vessel.
37259	Iliac vascular territory; transluminal stent placement; each additional vessel.
37260	Iliac vascular territory; transluminal stent placement; complex lesion, initial vessel.
37261	Iliac vascular territory; transluminal stent placement; complex lesion, each additional vessel.
37263	Femoral and popliteal vascular territory; transluminal angioplasty; straightforward lesion, initial vessel.
37264	Femoral and popliteal; straightforward lesion, each additional vessel.

1–10 of 44

1/5

Diagnosis codes associated with CLTI and PAD (Applicable ICD-10 codes listed)ICD-10Covered

E08.52	Diabetes mellitus due to underlying condition with diabetic peripheral angiopathy with gangrene.
E09.52	Drug or chemical induced diabetes mellitus with diabetic peripheral angiopathy with gangrene.
E10.52	Type 1 diabetes mellitus with diabetic peripheral angiopathy with gangrene.
E11.52	Type 2 diabetes mellitus with diabetic peripheral angiopathy with gangrene.
E13.52	Other specified diabetes mellitus with diabetic peripheral angiopathy with gangrene.
I70.221	Atherosclerosis of native arteries of extremities with rest pain, right leg.
I70.222	Atherosclerosis ... rest pain, left leg.
I70.223	Atherosclerosis ... rest pain, bilateral legs.
I70.228	Atherosclerosis ... rest pain, other extremity.
I70.229	Atherosclerosis ... rest pain, unspecified extremity.

1–10 of 32

1/4

Applicable ICD-10 Diagnosis Codes - Peripheral artery disease, bypass graft complications, ulceration, gangrene, rest pain, aneurysm, thromboembolism, embolism, dissection, gangrene, cellulitis, osteomyelitis, congenital and trauma related vascular conditions, complications of vascular prosthetic devicesICD-10

I70.461	Atherosclerosis of autologous vein bypass graft(s) of the extremities with gangrene, right leg
I70.462	Atherosclerosis of autologous vein bypass graft(s) of the extremities with gangrene, left leg
I70.463	Atherosclerosis of autologous vein bypass graft(s) of the extremities with gangrene, bilateral legs
I70.468	Atherosclerosis of autologous vein bypass graft(s) of the extremities with gangrene, other extremity
I70.469	Atherosclerosis of autologous vein bypass graft(s) of the extremities with gangrene, unspecified
I70.521	Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with rest pain, right leg
I70.522	Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with rest pain, left leg
I70.523	Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with rest pain, bilateral legs
I70.528	Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with rest pain, other extremity
I70.529	Atherosclerosis of nonautologous biological bypass graft(s) of the extremities with rest pain, unspecified extremity

1–10 of 20

1/2

Referenced clinical literature and guideline citationsmixed

Refs

Multiple citations including Society for Vascular Surgery practice guidelines, DETOUR System assessments, randomized trials (CLEVER, BEST-CLI), Cochrane review, J Vasc Surg, JAMA, NEJM, ACC/AHA 2024 PAD guideline, NICE CG147, IWGDF 2023 update and other systematic reviews and trial reports referenced in policy

Background and Evidence Summary

Background: This UnitedHealthcare Medical Policy (Effective March 1, 2026) applies to UnitedHealthcare Commercial and Individual Exchange benefit plans and sets the clinical criteria for endovascular revascularization in lower extremity peripheral artery disease, including both Claudication and Chronic Limb-Threatening Ischemia (CLTI). The policy explains required documentation that may be requested to assess whether members meet coverage criteria, including history/physical, treatment attempts, objective ischemia testing (ABI or TBI), and imaging demonstrating stenosis.

Study / Source	Key point
BEST-CLI trial (Farber et al., 2022)
Cohort 1 (suitable saphenous vein): surgery had lower major adverse limb event or death vs endovascular; Cohort 2 outcomes similar; reintervention lower with surgery in some analyses.
Pegler et al. systematic review (2025)
Meta-analysis of randomized trials (n=3840): no significant difference in major amputation or mortality between bypass and endovascular; bypass associated with lower reintervention.
DETOUR2 (Lyden et al., 2024)
Single-arm prospective study (n≈200): 30-day freedom from major adverse events 93.0%; 1-year primary patency 72.1%; technical success 100%; limitations include nonrandomized design and limited long-term comparative data.
Iliac atherectomy evidence
Insufficient quality evidence (mostly retrospective/single-arm); procedure uncommon due to risk of perforation; generalizability limited.
DETOUR (DETOUR I, DETOUR2) pooled findings
DETOUR I: single-arm studies showed 1-year patency ~81% and safety signals; DETOUR program shows functional improvements but lacks randomized comparisons to open bypass.
ACC/AHA 2024 Guideline (Gornik et al., 2024)
Multisociety guideline referenced for management of lower extremity PAD and recommendations that revascularization follow guideline-directed medical therapy and structured exercise; cited as authoritative guidance in policy.

Definitions: • Ankle-Brachial Index (ABI): compares systolic blood pressure in the ankle to the arm; an ABI < 0.90 indicates PAD. • Chronic Limb-Threatening Ischemia (CLTI): chronic (≥ 2 weeks) ischemic rest pain, nonhealing wounds/ulcers, or gangrene attributable to arterial occlusive disease. • Claudication: fatigue, cramping, aching or pain in lower extremity muscles induced by walking and relieved by rest; functionally limiting when it limits functional status. • Structured Community-Based Exercise Program: a home/community prescribed, primarily walking-based program with counseling, periodic supervised sessions, and activity monitoring as needed. • Supervised Exercise Therapy: treadmill-focused intermittent walking supervised by qualified professionals; sessions target 30–45 minutes of active walking, at least 3 times per week for a minimum of 12 weeks. • DETOUR System: Endologix percutaneous endovenous femoropopliteal bypass system using transvenous stent grafts (TORUS stent graft and ENDOCROSS device); FDA PMA approved June 7, 2023 for specified lesion length indications. • Toe-Brachial Index (TBI): recommended when ABI is non-compressible; an alternative objective ischemia test.

Revision History

2026-03-01material_changeLatest

Updated Medical Records Documentation Used for Reviews to include specific required elements: detailed history and physical with location/aggravating/alleviating factors of limb pain; treatments tried/failed with dates, duration, and supervised exercise monitoring protocol; method, dates, duration of attempted smoking cessation trial and reason for discontinuation; and addition of Toe-Brachial Index (TBI) when ABI is non-compressible.

Archivedarchived

Archived previous policy version 2026T0602Q.