Lower Extremity Endovascular Procedures

Coverage Summary

Scope: This policy covers lower extremity endovascular revascularization procedures (for example, stents, angioplasty, atherectomy, and endovenous stent grafts) for treatment of lower extremity peripheral artery disease for UnitedHealthcare Commercial and Individual Exchange plans. It explicitly excludes upper extremity procedures.

Applicable populations: UnitedHealthcare Commercial and UnitedHealthcare Individual Exchange members (policy applies to those benefit plans).

Covered versus excluded: The policy defines medical necessity criteria for endovascular revascularization of the aortoiliac and femoropopliteal segments when clinical criteria are met, and lists specific situations that are considered not medically necessary / unproven (for example, interventions for non-limb-threatening infrapopliteal disease, asymptomatic individuals, transluminal peripheral atherectomy of the iliac artery, procedures to prevent progression of claudication to CLTI, treatment of a nonviable limb, and endovenous femoropopliteal bypass using a stent graft).

Administrative details: Policy Number 2025706020; Effective Date 05/01/2025.

Medical-Necessity Criteria — Claudication (Intermittent, Non‑Limb‑Threatening)

Endovascular revascularization procedures (e.g., stents, angioplasty, and/or atherectomy) are proven and medically necessary for treating non-limb-threatening lower extremity ischemia in individuals with Claudication due to atherosclerotic disease of the aortoiliac and/or femoropopliteal arteries when ALL of the following criteria are met:

ALL of the following

Impaired ability to work and/or perform activities of daily living (ADL).
At least twelve (12) weeks of Supervised Exercise Therapy or a Structured Community-Based Exercise Program.
ALL of the following
- Pharmacologic therapy (e.g., lipid-lowering therapy, antihypertensive therapy, antiplatelet therapy, and/or anticoagulants)
- Smoking cessation, if applicable
Ischemic peripheral artery disease demonstrated by Ankle-Brachial Index (ABI) < 0.90< 0.90

Medical-Necessity Criteria — Chronic Limb‑Threatening Ischemia (CLTI)

Chronic Limb-Threatening Ischemia (CLTI) — Medically necessary

Endovascular revascularization procedures are proven and medically necessary for treating Chronic Limb-Threatening Ischemia (CLTI) with the diagnoses listed under Applicable Codes.

CLTI diagnosis: Diagnosis consistent with CLTI (chronic ≥ 2 weeks ischemic rest pain, nonhealing wounds/ulcers, or gangrene) attributable to objectively proven arterial occlusive disease

See Applicable Codes for listed diagnoses; refer to Applicable Codes section.

Not Medically Necessary / Unproven Procedures

Clinical conclusions: Guideline-aligned recommendations emphasize an exercise-first approach for intermittent claudication — guideline-directed medical therapy plus structured or supervised exercise is first-line, with revascularization reserved for lifestyle-limiting symptoms despite noninvasive therapy.

Evidence synthesis: Randomized trials and systematic reviews indicate supervised exercise and endovascular revascularization are comparable for improving walking distance and quality of life, and combination therapy may provide greater improvements.

For chronic limb-threatening ischemia (CLTI), both endovascular and surgical revascularization are considered appropriate and critical; surgical bypass may provide more durable patency in some cohorts but with higher length of stay and complications (BEST-CLI findings).

Procedure-specific evidence limitations: Insufficient quality evidence supports iliac artery atherectomy (safety concerns such as perforation and lack of randomized data). The DETOUR endovenous femoropopliteal bypass system has single-arm and registry data showing technical success and functional improvements, but evidence is limited by nonrandomized designs and lack of comparative long-term data.

Coding

Procedural CPT / HCPCS codes referencedCPT|HCPCS

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; includes imaging guidance
37220	Revascularization, endovascular; iliac artery, unilateral, initial vessel; with transluminal angioplasty
37221	Revascularization, endovascular; iliac artery, unilateral, initial vessel; with transluminal stent placement(s)
37222	Revascularization, endovascular; iliac artery, each additional ipsilateral vessel; with transluminal angioplasty
37223	Revascularization, endovascular; iliac each additional ipsilateral vessel; with transluminal stent placement(s)
37224	Revascularization; endovascular; femoral, popliteal artery(s), unilateral; with transluminal angioplasty
37225	Revascularization; endovascular; femoral, popliteal artery(s), unilateral; with atherectomy
37226	Revascularization, endovascular; femoral, popliteal artery(s), unilateral; with transluminal stent placement(s)
37227	Revascularization, endovascular; femoral, popliteal artery(s), unilateral; with transluminal stent placement(s) and atherectomy

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Diagnosis / ICD-10 codes referenced (selected examples)ICD-10

E08.52	Diabetes mellitus due to underlying condition 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
I70.221	Atherosclerosis of native arteries of extremities with rest pain, right leg
I70.222	Atherosclerosis of native arteries of extremities with rest pain, left leg
I70.223	Atherosclerosis of native arteries of extremities with rest pain, bilateral legs
I70.261	Atherosclerosis of native arteries of extremities with gangrene, right leg
I70.262	Atherosclerosis of native arteries of extremities with gangrene, left leg
I70.321	Atherosclerosis of unspecified type of bypass graft(s) of the extremities with rest pain, right leg
I70.331	Atherosclerosis of unspecified type of bypass graft(s) of the right leg with ulceration of thigh

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FDA product codes referencedmixed

NIO	FDA product code for certain stents/stent systems (informational)
NIP	FDA product code for certain stents/stent systems (informational)
DQY	FDA product code for catheter systems used for PAD treatment (informational)

Provider Actions / Prior Authorization

Prior Authorization

Prior Authorization Expectation

Medical records documentation may be required to determine whether the member meets clinical criteria for coverage. Submission of records does not guarantee coverage. Benefit coverage is determined by the member-specific benefit plan and applicable laws; preauthorization decisions are made on a member-by-member basis.

Documentation Required

Document prior conservative therapies and functional impairment

Document the following in the medical record to support medical necessity for lower extremity endovascular procedures: impaired ability to work and/or perform activities of daily living (ADLs); at least 12 weeks of Supervised Exercise Therapy or a Structured Community‑Based Exercise Program; failure of conservative pharmacologic therapies (e.g., lipid‑lowering therapy, antihypertensive therapy, antiplatelet therapy, anticoagulants); smoking cessation counseling/attempts if applicable; objective evidence of ischemic peripheral artery disease such as Ankle‑Brachial Index (ABI) < 0.90; and imaging demonstrating the extent of stenosis (duplex ultrasound showing ≥50% stenosis, or if duplex <50% then CTA, MRA, or invasive angiography to demonstrate ≥50% stenosis).

Background & Evidence

Background: Peripheral artery disease (PAD) is atherosclerotic narrowing of arteries that most commonly affects the legs and limits blood flow. Symptoms range from none to leg pain, numbness, or cramping with exertion (claudication) and, when severe, can progress to chronic limb-threatening ischemia (CLTI) with rest pain, nonhealing wounds/ulcers, or gangrene.

Risk factors: PAD is associated with increased risk of heart attack and stroke; common risk factors include older age and smoking among others.

Treatment options: Management includes lifestyle changes and risk-factor modification, pharmacologic therapy, supervised or structured exercise programs, endovascular techniques (angioplasty, stents, endovenous stent grafts, atherectomy) and open surgical revascularization. Choice of endovascular technique depends on lesion characteristics such as anatomic location, lesion length, and degree of calcification.

Study / Source	Key findings/metrics
BEST-CLI trial	Randomized multicenter trial in CLTI: in Cohort 1 (suitable single-segment GSV) surgery had lower incidence of major adverse limb event or death vs endovascular after median 2.7 years; Cohort 2 results similar between groups
Cochrane systematic review (Fakhry et al., 2018)	Pooled evidence (10 studies, 1087 participants) showed endovascular revascularization and supervised exercise are comparable for improving walking distance and quality of life; combination therapy may yield greater improvements
DETOURZ trial (Lyden et al., 2024)	Single-arm prospective study: 200 treated; technical success 100%; 30‑day freedom from major adverse events 93.0%; 1‑year primary patency 72.1%; primary-assisted 77.7% and secondary patency 89% at 12 months; limitations: nonrandomized, limited long-term comparative data
CONFIRM registries (Lee et al., 2018)	Retrospective registry subanalysis of orbital atherectomy for iliac disease (n=62 patients, 68 lesions): low procedural complication rate with one perforation and one vessel closure; authors note need for randomized trials and long-term follow-up

Definitions

Ankle-Brachial Index (ABI): Compares systolic blood pressure in the ankle to the arm; an ABI < 0.90 indicates peripheral artery disease.

Chronic Limb-Threatening Ischemia (CLTI): Chronic (≥2 weeks) ischemic rest pain, nonhealing wounds/ulcers, or gangrene in one or both legs attributable to objectively proven arterial occlusive disease.

Claudication: Fatigue, cramping, aching, pain, or other discomfort of vascular origin in lower-extremity muscles consistently induced by walking and relieved by rest; functionally limiting claudication restricts daily activities.

Supervised Exercise Therapy: Intermittent walking exercise (usually treadmill) performed under direct supervision by qualified healthcare professionals for a minimum of 30–45 minutes of active walking per 60-minute session, at least 3 times per week for a minimum of 12 weeks.

Structured Community-Based Exercise Program: A home or community-based, self-directed walking program prescribed and supported by qualified professionals with guidance/counseling and may include periodic supervised sessions.

Clinical Thresholds

72.1%DETOUR 1-year primary patency (DETOURZ; 200 treated)

93.0%DETOUR 30-day freedom from major adverse events

>=12 weeksRequired supervised exercise duration before revascularization

ABI <0.90ABI threshold indicating peripheral artery disease for eligibility

Revision History

2025-05-01administrativeLatest

Template Update created shared policy version to support application to Rocky Mountain Health Plans membership; Application Individual Exchange; removed language indicating this Medical Policy does not apply to the state of Colorado; Supporting Information archived previous policy version 2025T0602N.

2025-05-01document_effective_dateLatest

Policy effective date.