ModifiedUnitedHealthcarePolicy CS166KY.11

Lower Extremity Endovascular Procedures (for Kentucky Only)

Medical policy governing endovascular revascularization procedures of the lower extremities for members in Kentucky, including coverage rationale, applicable codes, clinical evidence, and documentation requirements.

Policy Summary

PayerUnitedHealthcare

PolicyLower Extremity Endovascular Procedures (for Kentucky Only)

Policy CodePolicy CS166KY.11

Change TypeDocumentation clarification and reference updates

Effective DateFebruary 1, 2026

Next Review Date

Key ActionEnsure patient medical record includes legible documentation of history, exam, and diagnostic test results to support medical necessity and make records available upon request.

SourceLink

POLICY UPDATE CHANGES

Added language clarifying that medical records documentation may be required to assess whether the member meets clinical criteria for coverage and listing examples of required documentation.

Updated Clinical Evidence and References sections to reflect the most current information.

CS166KY.11identifier

Kentuckyapplicability

72.1%1-yr primary patency

93.0%30-day MACE-free

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Coverage Criteria and Policy Stance

Coverage stance and exceptions

Covered when meeting referenced clinical criteria or otherwise specified:

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

Refer to InterQual for detailed clinical criteria.

Specific not medically necessary procedures: Transluminal peripheral atherectomy of the iliac artery and endovenous femoropopliteal bypass using a stent graft are unproven and not medically necessary due to insufficient evidence of efficacy.

Policy explicitly states these procedures are not medically necessary.

Coverage considerations for DETOUR/percutaneous femoropopliteal bypass

Revascularization, including endovascular DETOUR approach, is considered when patients have lifestyle-limiting claudication or chronic limb-threatening ischemia despite guideline-directed medical therapy and when anatomy and patient risk are appropriate.

Revascularization consideration prerequisites: Patient has lifestyle-limiting claudication or chronic limb-threatening ischemia (CLTI) AND has failed guideline-directed medical therapy and structured exercise when indicated.

Based on multi-society and SVS recommendations to use medical therapy and supervised exercise as first-line for intermittent claudication.

Anatomic/Device-specific criteria: Lesion characteristics compatible with the DETOUR System: femoropopliteal lesions 200–460 mm total length, chronic total occlusions 100–425 mm, or diffuse stenosis >70%; patient may be considered suboptimal candidate for surgical or alternative endovascular treatments.Lesion length ranges as specified (200–460 mm; CTO 100–425 mm)

Reflects FDA PMA indication for the DETOUR System (informational only).

Risk/benefit considerations: Selection of endovascular versus surgical approaches should consider patient risk level, lesion complexity, and potential venous complications; evidence for DETOUR is limited and FDA approval is informational only.

Clinical judgment required; refer to published evidence and guideline statements.

Transluminal peripheral atherectomy of the iliac artery is considered not medically necessary. The policy identifies this procedure as unproven because there is insufficient evidence of efficacy to support its routine use for peripheral artery disease of the iliac segment.

Endovenous femoropopliteal bypass using a stent graft is likewise considered not medically necessary. The policy states this endovenous stent-graft bypass approach is unproven for treating peripheral artery disease due to insufficient evidence of efficacy.

Revascularization should not be performed for patients with asymptomatic peripheral artery disease or for those with intermittent claudication when the decision is based solely on hemodynamic measurements or imaging findings. Guidelines note there is no evidence that revascularization based only on these test results modifies disease progression.

For intermittent claudication without clinical features of chronic limb-threatening ischemia (CLTI), revascularization decisions should be driven by symptoms and failure of conservative therapy rather than isolated noninvasive diagnostic abnormalities.

The policy rationale for transluminal peripheral atherectomy of the iliac artery is that available evidence does not demonstrate sufficient efficacy to justify coverage. The procedure is explicitly described as unproven and therefore not medically necessary because the literature lacks robust data showing clinical benefit for iliac artery disease.

Infrapopliteal revascularization is generally not recommended for patients with intermittent claudication who do not have signs of CLTI. Professional society guidance advises against infrapopliteal intervention in this population due to a lack of evidence of benefit and a risk of potential harm.

Thus, when patients present with claudication alone and no CLTI, clinicians should favor guideline-directed medical therapy and supervised exercise rather than infrapopliteal revascularization.

Applicable Codes and Study Metrics

Applicable CPT/HCPCS Codesmixed

0238T	Transluminal peripheral atherectomy; iliac artery, each vessel.
0505T	Endovenous femoral-popliteal arterial revascularization with transcatheter placement of intravascular stent graft(s).
37220	Iliac artery; transluminal angioplasty.
37221	Iliac artery; transluminal stent placement(s).
37222	Additional ipsilateral iliac vessel; transluminal angioplasty.
37223	Additional ipsilateral iliac vessel; stent placement(s).
37224	Femoral/popliteal artery(s); transluminal angioplasty.
37225	Femoral/popliteal artery(s); atherectomy.
37226	Femoral/popliteal artery(s); stent placement(s).
37227	Femoral/popliteal artery(s); stent placement(s) and atherectomy.

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FDA product codes referencedmixed

NIO	Stents and stent systems for treatment of peripheral artery disease (see FDA database).
NIP	Stents and stent systems for treatment of peripheral artery disease (see FDA database).

Provider Requirements, Authorization, and Documentation

Note

Applicable Codes and Authorization Note

The following list(s) of procedure and diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by federal, state, or contractual requirements and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.

Applicable codes (examples shown in policy): 0238T; 0505T; 37220-37226 (and others listed in full policy).
Inclusion of a code in this policy is for reference only and does not guarantee coverage or payment.

Prior Authorization

Prior Authorization and FDA Information

Prior authorization determinations should reference applicable federal, state, and contractual requirements. UnitedHealthcare uses InterQual® for primary medical/surgical criteria; if InterQual does not have applicable criteria, UnitedHealthcare may use its Medical Policies, Coverage Determination Guidelines, and/or Utilization Review Guidelines as approved by the Kentucky Department for Medicaid Services. FDA approval or clearance is informational only and does not by itself establish coverage.

Clinical Background

Peripheral artery disease (PAD) is atherosclerotic narrowing of leg arteries that can present as exertional leg pain (claudication) or as more severe limb-threatening ischemia (CLTI). Management options span risk-factor modification, guideline-directed medical therapy, structured exercise programs, endovascular procedures (angioplasty, stents, stent grafts, atherectomy) and open surgical bypass, with the choice informed by symptoms, anatomic lesion characteristics, and patient risk.

Patients with claudication typically have effort-limited leg pain relieved by rest, while CLTI represents advanced ischemia with rest pain, ulceration, or gangrene and a high risk of limb loss if untreated. Revascularization is appropriate for lifestyle-limiting claudication unresponsive to conservative therapy or for CLTI, but certain specific procedures (for example, transluminal peripheral atherectomy of the iliac artery and endovenous femoropopliteal bypass using a stent graft) are labeled unproven and not medically necessary in this policy because of insufficient evidence of benefit.

Key Definitions and Device Description

inv-20: Definition — Peripheral artery disease (PAD)

DefinitionPeripheral artery disease (PAD) is a narrowing of vessels due to atherosclerosis that limits blood flow to the limbs, most commonly the legs.

Common symptomsMany people are asymptomatic; others have leg pain, numbness, or cramping during exercise relieved by rest (claudication).

Associated risksPAD is associated with increased risk of heart attack, stroke, and can progress to chronic limb threatening ischemia (CLTI) if untreated.

inv-21: Definition — Claudication

DefinitionClaudication: leg pain, numbness, or cramping during exercise that is relieved by rest.

Typical contextOccurs in patients with PAD and may limit walking or activity; relates to exercise-induced ischemia.

Policy Revision History

2026-02-01material_changeLatest

Added detailed medical records documentation language clarifying that documentation may be required to assess whether a member meets clinical criteria for coverage and listing examples of required documentation (medical history, physical exam, diagnostic test results); documentation must be legible, maintained in the record, and made available upon request.

2026-02-01content_update

Updated Clinical Evidence and References sections to reflect the most current information.

2026-02-01administrative