CurrentUnitedHealthcarePolicy CS166TN.N

Lower Extremity Endovascular Procedures (for Tennessee Only)

Tennessee-specific UnitedHealthcare medical policy for Medicaid and CoverKids describing medical necessity criteria, exclusions, applicable procedure and diagnosis codes, documentation expectations, definitions, and clinical evidence for lower extremity endovascular revascularization procedures.

Policy Summary

PayerUnitedHealthcare

PolicyLower Extremity Endovascular Procedures (for Tennessee Only)

Policy CodePolicy CS166TN.N

Change TypeRevised coverage criteria; added retreatment criteria

Effective DateFeb 1, 2026

Next Review Date

Key ActionDocument trial and failure of at least 12 weeks of supervised or structured community-based exercise, guideline-directed medical therapy, smoking cessation if applicable, and obtain imaging showing ≥50% stenosis (use CTA/MRA/DSA if duplex is non-diagnostic); ensure medical records supporting necessity are available upon request.

POLICY UPDATE CHANGES

Revised medically necessary coverage criteria for endovascular revascularization procedures for treating non-limb-threatening lower extremity ischemia in individuals with Claudication due to atherosclerotic disease of the aortoiliac and/or femoropopliteal arteries.

Added language indicating retreatment for in-stent restenosis is proven and medically necessary when specific criteria are met.

Added language clarifying medical records documentation may be required to assess benefit coverage and medical necessity.

Updated definition of 'Structured Community-Based Exercise Program' and updated Clinical Evidence and References sections.

≥50%Imaging stenosis threshold

Coverage Summary

Scope: This Tennessee-specific UnitedHealthcare Medical Policy (Policy Number CS166TN.N) for Medicaid and CoverKids addresses lower extremity endovascular revascularization procedures for the treatment of peripheral artery disease of the lower limbs. It defines applicable procedure and diagnosis codes, documentation expectations, definitions, clinical evidence, and medical necessity criteria for coverage determinations.

Overview: The policy covers endovascular interventions (e.g., angioplasty, stents, atherectomy, stent grafts) for both non-limb-threatening Claudication and Chronic Limb-Threatening Ischemia (CLTI), with a mixed coverage stance: selected endovascular procedures are proven and medically necessary when specific clinical and imaging criteria are met, while certain procedures and indications (for example iliac artery atherectomy and endovenous femoropopliteal bypass using a stent graft in PAD) are considered unproven / not medically necessary or investigational due to insufficient evidence.

Quick-reference thresholds & stats

ABI thresholdABI ≤ 0.90

Imaging stenosis threshold≥ 50% stenosis (moderate–severe; 50% or greater)

Supervised Exercise Therapy durationAt least 12 weeks

Core coverage criteria elements count3

Investigational technologies discussed count2 (Iliac atherectomy, DETOUR system)

Document revision date02/01/2026

Medical-Necessity Criteria

Not Medically Necessary / Investigational

Applicable Codes

Procedure codes (Applicable CPT / HCPCS / Category III)mixed

0238T	Transluminal peripheral atherectomy; iliac artery, each vessel (Category III)
0505T	Endovenous femoral-popliteal arterial revascularization with transcatheter placement of intravascular stent graft(s)
37220	Revascularization, endovascular, iliac artery, unilateral; with transluminal angioplasty
37221	Revascularization, endovascular, iliac artery, unilateral; with transluminal stent placement(s)
37222	Revascularization, endovascular, iliac artery, each additional ipsilateral vessel; with transluminal angioplasty
37223	Revascularization, endovascular, iliac artery, 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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No explicit procedure or diagnosis codes provided in this partmixed

No codes listed

Procedure codes referenced as not medically necessary in specific contextsmixedNot Covered

0238T	Transluminal peripheral atherectomy; iliac artery — policy lists transluminal peripheral atherectomy of the iliac artery as unproven and not medically necessary due to insufficient evidence and safety concerns (e.g., perforation risk).
0505T	Endovenous femoral-popliteal arterial revascularization with transcatheter placement of intravascular stent graft(s) — policy lists endovenous femoropopliteal bypass using a stent graft as unproven and not medically necessary for peripheral artery disease due to insufficient evidence of efficacy (DETOUR system discussed as investigational in some contexts).

Diagnosis codes (Applicable ICD-10)ICD-10

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 of native arteries of extremities with rest pain, left leg
I70.223	Atherosclerosis of native arteries of extremities with rest pain, bilateral legs
I70.228	Atherosclerosis of native arteries of extremities with rest pain, other extremity
I70.229	Atherosclerosis of native arteries of extremities with rest pain, unspecified extremity

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Provider Actions & Documentation Requirements

Documentation Required

Medical record documentation requirement

Patient medical record must contain documentation that fully supports medical necessity and be made available upon request. Examples of required records include: history, physical examination, and diagnostic test/procedure results.

Relevant medical history
Physical examination findings
Results of pertinent diagnostic tests or procedures (e.g., ABI, imaging reports)

Documentation Required

Imaging requirement for stenosis

If duplex ultrasound does not demonstrate a stenosis of 50% or greater, another imaging modality (CTA, MRA, or digital subtraction angiography/DSA) is required to demonstrate the extent of stenosis.

Background & Clinical Evidence

Background: Peripheral artery disease (PAD) is caused by atherosclerotic narrowing of lower extremity arteries and most commonly affects the legs; symptomatic presentations include exertional leg pain relieved by rest (Claudication) and more severe presentations that can lead to rest pain, nonhealing ulcers, or gangrene (Chronic Limb-Threatening Ischemia, CLTI). Risk factors include age, smoking, diabetes, obesity, hypertension, and hyperlipidemia.

Role of endovascular techniques: Endovascular treatments for Claudication and CLTI include balloon angioplasty, stent placement, atherectomy, and endovenous stent grafts. The choice of technique depends on lesion characteristics such as anatomic location, lesion length, and degree of calcification as well as patient risk and clinical goals.

Selection factors and conservative therapy: For non-limb-threatening Claudication, revascularization is considered only after guideline-directed medical therapy and structured exercise (including at least 12 weeks of Supervised Exercise Therapy or an equivalent Structured Community-Based Exercise Program), optimization of pharmacologic therapy, and smoking cessation when applicable. For CLTI, endovascular or surgical revascularization is indicated to reduce limb loss risk and improve outcomes, with selection individualized by anatomy, risk, and expected durability.

Study / Source	Key findings
Pegler et al. systematic review (2025)	Meta-analysis of 14 cohorts (13 studies, n=3840) comparing bypass vs endovascular: no significant difference in major amputation or mortality; bypass had significantly lower reintervention rate.
BEST-CLI trial (Farber et al., 2022)	Randomized trial in CLTI: Cohort 1 (suitable saphenous vein) showed lower major adverse limb event or death with surgery vs endovascular; Cohort 2 outcomes were similar between groups; adverse event rates similar.
Systematic reviews / meta-analyses (Cochrane Fakhry 2018; Malgor 2015; Vemulapalli 2015)	Evidence mixed: endovascular and supervised exercise comparable for improving walking distance and quality of life; bypass may have more durable patency but higher morbidity; heterogeneity and study design limit conclusions.
Iliac atherectomy evidence (Lee et al.; policy review)	Insufficient quality evidence (mostly retrospective, single-arm); uncommon due to risk of life‑threatening perforation; procedural data limited and randomized trials lacking.
DETOUR system evidence (DETOUR I, DETOUR2, ECRI assessment)	Single-arm trials report high technical success and 1‑year patency (DETOUR I and DETOUR2); DETOUR2: 100% technical success, 72.1% primary patency at 12 months, but studies are nonrandomized and limited for long‑term comparison with open bypass; FDA granted PMA for specific femoropopliteal lesion lengths.

Definitions (policy)

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

Revision History

02/01/2026revisedLatest

Revised medically necessary coverage criteria: replaced prior imaging wording to require 'imaging results of the target vessel... show anatomic location and a moderate-severe stenosis (50% or greater)'; clarified that if duplex ultrasound does not demonstrate ≥50% stenosis, another imaging modality (CTA, MRA, or digital subtraction angiography) is required.

02/01/2026added (material)Latest

Added explicit medically necessary retreatment criteria for in‑stent restenosis requiring all three elements: recurrent symptoms; impaired ability to work and/or perform activities of daily living (ADL); and imaging of the previously treated vessel showing a moderate‑severe stenosis (50% or greater) with alternative imaging required if duplex ultrasound is non‑diagnostic.

Policy Summary

PayerUnitedHealthcare

PolicyLower Extremity Endovascular Procedures (for Tennessee Only)

Policy CodePolicy CS166TN.N

Change TypeRevised coverage criteria; added retreatment criteria

Effective DateFeb 1, 2026

Next Review Date

On This Page

Documentation Required

Conservative therapy trial documentation

Providers must document trial and failure of conservative therapies prior to coverage approval for Claudication: at least 12 weeks of supervised exercise therapy or a structured community-based exercise program, pharmacologic therapy (e.g., lipid-lowering, antihypertensive, antiplatelet, and/or anticoagulants), and smoking cessation when applicable.

At least 12 weeks of Supervised Exercise Therapy or a Structured Community-Based Exercise Program
Pharmacologic therapy (e.g., lipid-lowering, antihypertensive, antiplatelet, and/or anticoagulants)
Smoking cessation documentation, if applicable

Prior Authorization

Imaging requirement prior to coverage determination

Imaging demonstrating anatomic location and a moderate-severe stenosis (50% or greater) of the target vessel is required prior to coverage determination. If duplex ultrasound does not demonstrate ≥50% stenosis, alternative imaging (CTA, MRA, or digital subtraction angiography/DSA) must be obtained. Documentation of these imaging results is a prior authorization/documentation trigger for coverage decisions.

Imaging must show anatomic location and ≥50% stenosis
If duplex ultrasound is insufficient, obtain CTA, MRA, or digital subtraction angiography