CurrentUnitedHealthcarePolicy CS166TN.N

Lower Extremity Endovascular Procedures (for Tennessee Only)

Defines medical necessity and exclusions for endovascular revascularization procedures (stents, angioplasty, atherectomy, stent grafts) for lower extremity peripheral artery disease for Tennessee Medicaid and CoverKids members. Specifies criteria for Claudication, CLTI, retreatment for in-stent restenosis, documentation requirements, definitions, and lists applicable CPT and ICD-10 codes referenced.

Policy Summary

PayerUnitedHealthcare

PolicyLower Extremity Endovascular Procedures (for Tennessee Only)

Policy CodePolicy CS166TN.N

Change TypeRevised / Added documentation and imaging criteria

Effective DateFebruary 1, 2026

Next Review Date

Key ActionPatient medical record must document relevant history, physical exam, diagnostic test results, and that criteria (e.g., ABI, imaging, failed conservative therapy) are met; documentation must be legible and available upon request.

POLICY UPDATE CHANGES

Revised medically necessary coverage criteria for endovascular revascularization for non-limb-threatening lower extremity ischemia due to claudication.

Added language that retreatment of previously treated vessel for in-stent restenosis is proven and medically necessary when recurrent symptoms, impaired ADLs/work ability, and imaging showing >=50% stenosis are present.

Added documentation and medical record requirements for assessing medical necessity and benefit coverage.

Updated definition of 'Structured Community - Based Exercise Program'.

Updated Clinical Evidence and References sections to reflect current information.

3Major covered indications (Claudication, CLTI, Retreatment for in-stent restenosis)

Coverage Summary

This policy provides coverage guidance for endovascular revascularization procedures for lower extremity peripheral artery disease (PAD). Coverage stance is mixed: certain endovascular procedures are proven and medically necessary for specific indications, while other procedures or uses are considered unproven or not medically necessary. The primary categories supported for coverage when policy criteria are met are: Claudication (non‑limb‑threatening lower extremity ischemia of the aortoiliac and/or femoropopliteal arteries), Chronic Limb‑Threatening Ischemia (CLTI), and Retreatment for in‑stent restenosis. The policy defines objective thresholds and documentation requirements for these covered indications (for example, ABI ≤ 0.90 for claudication and imaging confirmation of ≥ 50% stenosis using specified modalities), and also specifies exclusions and procedures considered investigational due to insufficient evidence (e.g., iliac artery atherectomy, endovenous femoropopliteal bypass with stent graft except as noted investigational).

Ankle-Brachial Index (ABI) thresholdABI ≤ 0.90

Imaging stenosis threshold (procedural coverage)Moderate–severe stenosis — 50% or greater (≥50%) on duplex, CTA, MRA, or digital subtraction angiography

If duplex is non-diagnosticIf duplex ultrasound does not demonstrate ≥50% stenosis, obtain another imaging modality (CTA, MRA, or digital subtraction angiography)

Supervised Exercise Therapy requirementMinimum 12 weeks (≥3 sessions/week; 30–45 minutes active walking per session) before revascularization for claudication

Anatomic stenosis threshold (summary)>= 50% (moderate–severe stenosis) for target or previously treated vessel

Medical‑Necessity Criteria

Endovascular Revascularization for Non-limb-threatening Claudication

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 tried and failed
- At least twelve (12) weeks of Supervised Exercise Therapy or a Structured Community-Based Exercise ProgramMinimum 12 weeks
- Pharmacologic therapy (e.g., lipid lowering therapy, antihypertensive therapy, antiplatelet therapy, and/or anticoagulants)

Not Medically Necessary / Investigational

Not Medically Necessary / Unproven Indications

Endovascular procedures are unproven and not medically necessary in any of the following circumstances:

ANY of the following

Interventions performed for non-limb-threatening infrapopliteal (anterior tibial, posterior tibial, or peroneal) artery disease
Individual is asymptomatic
Interventions to prevent progression of Claudication to CLTI
Transluminal peripheral atherectomy of the iliac artery

Coding

Referenced Procedure/CPT and HCPCS CodesCPT|HCPCS

0238T	Transluminal peripheral atherectomy; iliac artery, each vessel
0505T	Endovenous femoral-popliteal arterial revascularization with transcatheter stent graft(s)
37220	Revascularization, endovascular, iliac artery; with transluminal angioplasty
37221	Revascularization, endovascular, iliac artery; 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); with transluminal angioplasty
37225	Revascularization, endovascular, femoral, popliteal artery(s); with atherectomy
37226	Revascularization, endovascular, femoral, popliteal artery(s); with transluminal stent placement(s)
37227	Revascularization, endovascular, femoral, popliteal artery(s); with stent placement(s) and atherectomy

1–10 of 18

1/2

Referenced Diagnosis/ICD-10 Codes (examples)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

1–10 of 48

1/5

Additional ICD-10 and Injury/Complication Codes (examples)ICD-10

Q27.30	Arteriovenous malformation, site unspecified
Q27.32	Arteriovenous malformation of vessel of lower limb
Q27.39	Arteriovenous malformation, other site
Q27.8	Other specified congenital malformations of peripheral vascular system
Q27.9	Congenital malformation of peripheral vascular system, unspecified
Q87.2	Congenital malformation syndromes predominantly involving limbs
S35.511A	Injury of right iliac artery, initial encounter
S35.512A	Injury of left iliac artery, initial encounter
S81.801A	Unspecified open wound, right lower leg, initial encounter
S81.802A	Unspecified open wound, left lower leg, initial encounter

1–10 of 24

1/3

Informational — FDA product codes / PMA references (not coverage codes)mixed

NIO / NIP	FDA product codes referenced for stents and stent systems (informational)
DQY	FDA product code referenced for catheter systems (informational)

Provider Actions / Authorization & Documentation

Prior Authorization

Imaging requirement for coverage

Imaging results of the target or previously treated vessel must demonstrate the anatomic location and a moderate‑severe stenosis (50% or greater). Acceptable modalities include duplex ultrasound, computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography. If duplex ultrasound does not show ≥50% stenosis, obtain CTA, MRA, or digital subtraction angiography to confirm the degree and location of stenosis.

Duplex ultrasound
Computed tomography angiography (CTA)
Magnetic resonance angiography (MRA)
Digital subtraction angiography (DSA)

Documentation Required

Support medical necessity with records

Background & Evidence Summary

Peripheral artery disease (PAD) is narrowing of limb arteries from atherosclerosis that most commonly affects the legs and may cause asymptomatic disease or exertional leg pain (claudication); risk factors include age, smoking, diabetes, obesity, hypertension, and hyperlipidemia. PAD increases the risk of cardiovascular events and, if untreated, can progress to chronic limb‑threatening ischemia (CLTI). Treatment options range from lifestyle modification and medical therapy to supervised exercise programs, endovascular techniques (balloon angioplasty, stents, atherectomy, stent grafts) and open surgical bypass. Choice of endovascular technique depends on lesion characteristics such as anatomic location, lesion length, and degree of calcification, as well as patient risk and functional status; guideline recommendations endorse initial guideline‑directed medical therapy and structured exercise for intermittent claudication with revascularization considered for lifestyle‑limiting symptoms despite conservative therapy.

Evidence Highlights

Definitions

Revision History

02/01/2026revisedLatest

Replaced prior imaging criterion wording to require imaging results of the target vessel (duplex, CTA, MRA, or digital subtraction angiography) show anatomic location and a moderate-severe stenosis (50% or greater); change detail: 'Revised medically necessary coverage criteria for endovascular revascularization for non-limb-threatening lower extremity ischemia due to claudication.'

02/01/2026addedLatest

Specifies alternative imaging required when duplex ultrasound does not show ≥50% stenosis; change detail: 'Added language that retreatment of previously treated vessel for in-stent restenosis is proven and medically necessary when recurrent symptoms, impaired ADLs/work ability, and imaging showing ≥50% stenosis are present.'

Policy Summary

PayerUnitedHealthcare

PolicyLower Extremity Endovascular Procedures (for Tennessee Only)

Policy CodePolicy CS166TN.N

Change TypeRevised / Added documentation and imaging criteria

Effective DateFebruary 1, 2026

Next Review Date

On This Page

Imaging requirement: Imaging of target 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≥ 50% stenosis

If duplex ultrasound does not demonstrate ≥50% stenosis, obtain alternate imaging (CTA, MRA, or digital subtraction angiography)

Retreatment for In-stent Restenosis (Non-limb-threatening Claudication)

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

ALL of the following

Recurrent symptoms
Impaired ability to work and/or perform activities of daily living (ADL)
Imaging requirement: Imaging of the 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≥ 50% stenosis
If duplex ultrasound does not demonstrate ≥50% stenosis, obtain alternate imaging (CTA, MRA, or digital subtraction angiography)

Endovascular Revascularization for Chronic Limb-Threatening Ischemia (CLTI)

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

ALL of the following

CLTI definition: Diagnosis meets CLTI definition: chronic (≥ 2 weeks) ischemic rest pain, nonhealing wound/ulcers or gangrene attributable to objectively proven arterial occlusive disease≥ 2 weeks
Codes: Applicable diagnosis code(s) from the Applicable Codes list
Refer to Applicable Codes section for specific ICD-10 codes

Medically Necessary - Endovascular Revascularization for Non‑Limb‑Threatening Claudication (aortoiliac and/or femoropopliteal)

Covered / medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of Claudication due to atherosclerotic disease of the aortoiliac and/or femoropopliteal arteries
Conservative therapy failure: Failure of guideline-directed medical therapy and structured exerciseMinimum 12 weeks for supervised exercise
Per ACC/AHA and SVS guidance: patients should first receive medical therapy and structured exercise; revascularization considered for lifestyle-limiting claudication despite noninvasive approaches
Imaging demonstrating anatomic location and a moderate-severe stenosis (50% or greater) using duplex ultrasound, CTA, MRA, or digital subtraction angiography≥ 50% stenosis
If duplex ultrasound does not show ≥50% stenosis, another imaging modality is required

Medically Necessary - Retreatment for In‑Stent Restenosis (Non‑Limb‑Threatening Claudication)

Retreatment is proven and medically necessary when ALL of the following are met:

ALL of the following

Recurrent symptoms
Impaired ability to work and/or perform activities of daily living (ADL)
Imaging results of the previously treated vessel show anatomic location and a moderate-severe stenosis (50% or greater)≥ 50% stenosis
If duplex ultrasound does not demonstrate ≥50% stenosis, another imaging modality will be necessary to demonstrate extent of stenosis

Not Established / Insufficient Evidence - Iliac Artery Atherectomy

Coverage stance based on available evidence:

Iliac artery atherectomy has insufficient quality evidence to support safety and efficacy

Most studies are retrospective, single-arm or non-randomized; procedure uncommon due to risk of life-threatening perforation; randomized trials with long-term follow-up are needed

Investigational / Insufficient Evidence - DETOUR Endovenous Femoropopliteal Bypass System

Evidence summary and coverage implication:

DETOUR Endovenous femoropopliteal bypass system: single-arm and ongoing trials report technical success, patency and functional improvements but evidence is very-low to low quality and lacks randomized comparisons to open bypass; FDA actions (Breakthrough designation, PMA) are informational only

Larger high-quality comparative studies are needed; FDA approval/decisions do not by themselves determine coverage

Patient medical records must document relevant history, physical examination findings, and results of pertinent diagnostic tests or procedures, and explicitly show that policy criteria are met (for example ABI, imaging demonstrating ≥50% stenosis, and failed conservative therapy when required). Documentation must be legible, maintained in the medical record, and available upon request for review.

Documentation Required

Conservative therapy documentation

Before approving procedures for Claudication, document a trial and failure of conservative therapy including at least 12 weeks of Supervised Exercise Therapy or a Structured Community‑Based Exercise Program, receipt of guideline‑directed pharmacologic therapy (e.g., lipid‑lowering, antihypertensive, antiplatelet, and/or anticoagulant therapy), and smoking cessation efforts when applicable.

Minimum 12 weeks of Supervised Exercise Therapy or Structured Community‑Based Exercise Program
Pharmacologic therapy (lipid‑lowering, antihypertensive, antiplatelet and/or anticoagulant as appropriate)
Documented smoking cessation counseling/efforts, if applicable

Documentation Required

Imaging requirement for stenosis confirmation

If duplex ultrasound does not demonstrate a stenosis of 50% or greater, obtain an alternative imaging modality (CTA, MRA, or digital subtraction angiography) to demonstrate the anatomic location and extent of stenosis before proceeding.

Obtain CTA, MRA, or digital subtraction angiography when duplex is non‑confirmatory

Documentation Required

Functional impact requirement for retreatment

For retreatment of in‑stent restenosis, document recurrent symptoms and impaired ability to work and/or perform activities of daily living (ADLs) plus imaging of the previously treated vessel showing anatomic location and a moderate‑severe stenosis (50% or greater). If duplex ultrasound does not show ≥50% stenosis, obtain CTA, MRA, or digital subtraction angiography to confirm.

Recurrent symptoms
Impaired ability to work and/or perform ADLs
Imaging evidence of ≥50% stenosis (duplex, CTA, MRA, or digital subtraction angiography)