ModifiedUnitedHealthcarePolicy CS166NM.D

Lower Extremity Endovascular Procedures (for New Mexico Only)

This New Mexico–specific UnitedHealthcare medical policy governs coverage and medical necessity criteria for endovascular revascularization procedures of the lower extremities (e.g., angioplasty, stents, atherectomy, intravascular lithotripsy) and applies to providers and members in New Mexico.

Policy Summary

PayerUnitedHealthcare

PolicyLower Extremity Endovascular Procedures (for New Mexico Only)

Policy CodePolicy CS166NM.D

Change TypeCriteria revisionCPT code updatesIVL designated unproven

Effective DateJune 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document guideline-directed conservative therapy, imaging (including digital subtraction angiography examples), and ABI/stenosis data to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Revised medically necessary coverage criteria for endovascular revascularization procedures and for retreatment of previously treated vessels due to in-stent restenosis, replacing 'invasive angiography' with 'digital subtraction angiography' in examples of imaging results.

Added language that intravascular lithotripsy for treating lower extremity ischemia is unproven and not medically necessary due to insufficient evidence of efficacy.

Updated applicable CPT code list to reflect annual edits (multiple CPT codes added and a set removed).

≥12wSupervised exercise requirement

≤0.90ABI threshold for PAD

≥50%Imaging stenosis threshold

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50+Applicable procedure codes

NM-onlyPolicy jurisdiction

Medical Necessity and Coverage Criteria

Endovascular procedures for non-limb-threatening Claudication

Covered when ALL of the following are met

Main criteria: Impaired ability to work and/or perform activities of daily living; and All of the following conservative therapies have been tried and failed: at least 12 weeks of Supervised Exercise Therapy or a Structured Community-Based Exercise Program; pharmacological therapy (e.g., lipid-lowering, antihypertensive, antiplatelet, and/or anticoagulants); smoking cessation if applicable; and Ankle-Brachial Index ≤ 0.90; and Imaging of the target aortoiliac and/or femoropopliteal vessel (e.g., duplex ultrasound, CTA, MRA, or digital subtraction angiography) demonstrates ≥ 50% stenosis (if duplex < 50% then additional imaging is required).ABI ≤ 0.90; ≥ 50% stenosis

All elements must be present for coverage.

Retreatment for in-stent restenosis

Covered when ALL of the following are met

Retreatment criteria: Recurrent symptoms; impaired ability to work and/or perform activities of daily living; and imaging of the previously treated vessel (e.g., duplex ultrasound, CTA, MRA, or digital subtraction angiography) demonstrates ≥ 50% stenosis (if duplex < 50% then additional imaging is required).≥ 50% stenosis

Applies to retreatment of previously treated vessels due to in-stent restenosis.

Chronic Limb-Threatening Ischemia (CLTI)

Covered when diagnosis corresponds to CLTI and applicable codes are used

CLTI coverage: Endovascular revascularization procedures (e.g., stents, angioplasty, and/or atherectomy) are proven and medically necessary for treating Chronic Limb-Threatening Ischemia when the diagnoses listed under Applicable Codes are present.

See Applicable Codes section for code mapping.

Indications for revascularization

Revascularization coverage considerations

Primary criteria: Patients with intermittent claudication should first receive guideline-directed medical therapy and structured exercise; revascularization is considered only if lifestyle-limiting symptoms persist despite these noninvasive measures.

Based on multisociety appropriate use criteria.

Surgical versus endovascular revascularization

BEST-CLI trial findings informing clinical decision-making

Cohort-specific outcomes: In BEST-CLI cohort 1 (patients with a suitable single-segment great saphenous vein for bypass) surgical bypass had a lower incidence of major adverse limb event or death compared with endovascular therapy; in cohort 2 (no suitable single-segment great saphenous vein) outcomes were similar between surgical and endovascular approaches.

Use trial findings to inform modality choice when both options are feasible.

Atherectomy and adjunctive technologies

Adjunct and emerging technologies

Iliac atherectomy: Iliac artery atherectomy has insufficient high-quality evidence to support safety and efficacy and is uncommon due to risk (including life‑threatening perforation); it is considered rarely appropriate and should be reserved for select cases with careful justification.

Panel guidance and review findings.

Intravascular Lithotripsy (IVL): IVL may provide procedural benefits for calcified lesions (e.g., reduced residual stenosis, fewer flow‑limiting dissections) and improved mid-term patency in some studies, but comparative and long-term effectiveness data are limited; use when clinically indicated and documented, recognizing evidence limitations.

RCT and systematic review evidence referenced.

DETOUR endovenous bypass: DETOUR endovenous femoropopliteal bypass demonstrates favorable single-arm trial outcomes in selected patients with long femoropopliteal occlusions, but randomized comparisons to surgical bypass are lacking; consider investigational status and provide documentation of rationale when used.

Ongoing DETOUR 2 study described.

Medically Necessary Revascularization Criteria

Covered when clinical and guideline-based indications are met

Primary indication for revascularization in intermittent claudication: Patient has lifestyle‑limiting intermittent claudication despite guideline‑directed medical therapy and structured exercise.

Based on ACC/AHA/SCAI/SIR/SVM appropriate use criteria and SVS guidance

Indications for urgent imaging/revascularization: Ankle pressure < 50 mm Hg OR ABI < 0.4 OR toe pressure < 30 mm Hg OR transcutaneous oxygen pressure < 25 mm Hg, or extensive tissue loss/infection where higher pressure thresholds may prompt intervention.

IWGDF guidance

Modality selection considerations: Selection between endovascular and surgical revascularization depends on patient risk, lesion location, lesion length, and anatomical complexity; for CLTI, both modalities are appropriate and choice should be individualized.

SVS and multisociety guidance

Unproven / Not Medically Necessary Interventions

Technologies considered unproven or limited by evidence

Intravascular lithotripsy (IVL): Intravascular lithotripsy for treating lower extremity ischemia is designated unproven and not medically necessary due to insufficient evidence of efficacy; NICE recommends use only with special arrangements and longer‑term outcomes are needed.

Policy explicitly added this language; NICE guidance cited

Iliac artery atherectomy is considered rarely appropriate and is restricted due to lack of comparative data versus balloon angioplasty and stenting and safety concerns.

Multisociety appropriate use criteria and safety evidence

Endovenous femoropopliteal bypass with stent graft: Endovenous femoropopliteal bypass using a stent graft is unproven and not medically necessary due to insufficient evidence of efficacy.

Policy statement in coverage rationale

Endovascular revascularization procedures for non‑limb‑threatening infrapopliteal disease (e.g., anterior tibial, posterior tibial, or peroneal arteries) are considered unproven and not medically necessary for treatment of lower extremity ischemia when the disease is non‑limb‑threatening. The policy specifies these interventions are not covered when performed for disease that does not meet criteria for limb threat, for asymptomatic individuals, or when the intent is to prevent progression of Claudication to Chronic Limb‑Threatening Ischemia (CLTI). Documentation should demonstrate that the indication meets medically necessary criteria (see CLTI and medically necessary revascularization sections) before considering infrapopliteal endovascular interventions.

Endovenous femoropopliteal bypass using an endovascular stent graft is explicitly designated unproven and not medically necessary for treating peripheral artery disease due to insufficient evidence of efficacy. Because existing data are limited, use of this technique is not considered covered and prior authorization should reflect the investigational status when submitted.

Intravascular lithotripsy (IVL) for treating lower extremity ischemia is designated unproven and not medically necessary based on current evidence. While early and single‑arm studies show IVL safely facilitates plaque modification and may reduce residual stenosis and flow‑limiting dissections, randomized and long‑term comparative data are insufficient to conclude meaningful clinical benefit in durability, target lesion revascularization, or functional outcomes. NICE guidance similarly limits routine use to special arrangements pending longer‑term outcomes. Providers using IVL should expect prior authorization review and clear justification in the medical record.

Atherectomy of the iliac artery is limited by insufficient high‑quality evidence and recognized safety concerns, including the potential for life‑threatening perforation. Published studies are predominantly retrospective, single‑arm, or nonrandomized with small, heterogeneous cohorts, limiting generalizability. For these reasons iliac artery atherectomy is considered rarely appropriate and requires detailed clinical justification when proposed; noncoverage is possible when documentation does not support safety and efficacy for the individual case.

Revascularization performed solely for asymptomatic peripheral artery disease or for intermittent Claudication based only on hemodynamic measurements or imaging findings is not recommended and not considered medically necessary. The Society for Vascular Surgery (SVS) recommends against revascularization in asymptomatic individuals or when the decision is based only on ABI, toe pressures, or imaging without corresponding lifestyle‑limiting symptoms or clinical signs of limb threat. Coverage requires documentation of clinical symptoms and failure of appropriate conservative therapy where applicable.

Endovascular revascularization for non‑limb‑threatening infrapopliteal disease, for asymptomatic individuals, or when performed solely to prevent progression of Claudication to CLTI is listed as not medically necessary. The policy aligns with SVS guidance that infrapopliteal revascularization for claudication (absent CLTI) lacks evidence of benefit and may cause harm; such procedures will not be covered unless clear documentation demonstrates they meet the medically necessary CLTI or other covered criteria.

Routine use of intravascular lithotripsy as a standard treatment for lower extremity ischemia is not recommended given the limited high‑quality comparative evidence. Although IVL shows procedural advantages in calcified lesions (for example, reduced residual stenosis and fewer flow‑limiting dissections), comparative randomized trials and longer‑term outcome data are inadequate to demonstrate improved clinical durability or reductions in reintervention. Therefore IVL should not be considered routine first‑line therapy and is designated unproven for broad use.

The policy reiterates that IVL for lower extremity ischemia is unproven and not medically necessary. While available single‑arm series and limited trials report promising acute procedural results, the body of evidence lacks sufficiently powered randomized comparisons and long‑term follow‑up to establish effectiveness for clinical outcomes; as a result, claims for IVL may be denied if performed outside the specified medically necessary criteria or without adequate justification.

Applicable Procedure and Diagnosis Codes

Applicable ICD-10 CodesICD-10

I70.261	Atherosclerosis of native arteries of extremities with gangrene, right leg
I70.262	Atherosclerosis of native arteries of extremities with gangrene, left leg
I70.263	Atherosclerosis of native arteries of extremities with gangrene, bilateral legs
I70.268	Atherosclerosis of native arteries of extremities with gangrene, other extremity
I70.269	Atherosclerosis of native arteries of extremities with gangrene, unspecified extremity
I70.321	Atherosclerosis of unspecified type of bypass graft(s) of the extremities with rest pain, right leg
I70.322	Atherosclerosis of unspecified type of bypass graft(s) of the extremities with rest pain, left leg
I70.323	Atherosclerosis of unspecified type of bypass graft(s) of the extremities with rest pain, bilateral legs
I70.329	Atherosclerosis of unspecified type of bypass graft(s) of the extremities with rest pain, unspecified extremity
I70.331	Atherosclerosis of unspecified type of bypass graft(s) of the right leg with ulceration of thigh

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Actions Required by Providers

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is expected for applicable revascularization procedure codes. Submit documentation per policy when requesting authorization.

Providers should reference the updated applicable CPT code list when requesting authorization (see Applicable Codes).
Prior authorization may be required for novel devices or investigational procedures; case review may be requested.

Documentation Required

Medical Records Documentation Used for Reviews

Documentation Requirement: The patient's medical record must contain documentation that fully supports the medical necessity for the requested services. This includes, but is not limited to, a relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. Documentation should be legible, maintained in the patient's medical record, and made available upon request. Insufficient medical records/documentation may result in denial of the request or claim.

Background and Evidence Summary

Peripheral artery disease (PAD) is atherosclerotic narrowing of arteries that reduces blood flow to the lower extremities and commonly presents as Claudication (exercise‑induced reproducible limb pain relieved by rest) or progresses to Chronic Limb‑Threatening Ischemia (CLTI) when rest pain, nonhealing ulcers, or gangrene indicate limb threat. Management emphasizes guideline‑directed medical therapy and structured or supervised exercise for intermittent claudication; revascularization (endovascular or surgical) is considered medically necessary when symptoms are lifestyle‑limiting despite conservative care or when objective hemodynamic and imaging thresholds indicate limb threat. The policy references society guidance (ACC/AHA, SVS, IWGDF, NICE) and major trials to inform modality selection and expectations for documentation and prior authorization.

Key Definitions and Terms

inv-45: Ankle-Brachial Index definition and threshold

DefinitionAnkle-Brachial Index compares systolic blood pressure in the ankle with the systolic blood pressure in the arm to indicate limb blood flow

Threshold indicating PADAn Ankle-Brachial Index of less than 0.90 indicates peripheral artery disease

Role in policyABI ≤ 0.90 is required as an objective hemodynamic criterion for coverage of endovascular revascularization for Claudication

inv-46: Chronic Limb-Threatening Ischemia definition

DefinitionChronic Limb-Threatening Ischemia is chronic (≥ 2 weeks) ischemic rest pain, nonhealing wounds/ulcers, or gangrene attributable to arterial occlusive disease

Clinical significanceCLTI is an advanced stage of PAD associated with high risk of limb loss and cardiovascular events if untreated

Policy Revision History

2026-06-01policy_revisionLatest

Revised medically necessary coverage criteria for endovascular revascularization and for retreatment of previously treated vessels; replaced 'invasive angiography' with 'digital subtraction angiography' in imaging examples; added language that intravascular lithotripsy for lower extremity ischemia is unproven and not medically necessary; updated applicable CPT code list with multiple additions and removals.

Policy Summary

PayerUnitedHealthcare

PolicyLower Extremity Endovascular Procedures (for New Mexico Only)

Policy CodePolicy CS166NM.D

Change TypeCriteria revisionCPT code updatesIVL designated unproven

Effective DateJune 1, 2026

Next Review DateN/A

SourceLink

On This Page

Include history of presenting symptoms, functional impact (e.g., impaired ability to work or perform activities of daily living), prior conservative therapies and duration, and response to therapy.

Include objective hemodynamic data such as Ankle-Brachial Index (ABI) values and imaging reports documenting lesion location and severity.

If duplex ultrasound does not demonstrate ≥50% stenosis, include additional imaging (CTA, MRA, or digital subtraction angiography) showing the extent of stenosis.

Billing Rule

Coding Accuracy Required

Use CPT Descriptors to Select Codes: Match operative reports, procedure notes, and device use to the official CPT descriptors to ensure accurate coding. Claims may be denied for incorrect CPT coding, particularly for tibial, peroneal, and inframalleolar procedures.

Select codes that reflect the vascular territory (iliac, femoropopliteal, tibial/peroneal, inframalleolar), procedure complexity (straightforward vs complex), and whether atherectomy, angioplasty, or stent placement was performed.
When multiple vessels or additional vessels are treated, append or list separately as indicated by CPT guidance.

Billing Rule

Applicable Diagnosis Coding

Applicable Diagnosis Coding: Use appropriate ICD-10 diagnosis codes that correspond to the clinical indication for revascularization. The policy provides a comprehensive list of applicable ICD-10 codes for claims; inclusion of a code in the policy does not guarantee coverage.

Ensure diagnosis codes reflect symptomatic peripheral artery disease (e.g., claudication, chronic limb-threatening ischemia) and any anatomic site specificity when available.
Examples of codes included in the policy reference list (not exhaustive): codes for peripheral artery disease and related conditions (see Applicable Codes section).

Documentation Required

Imaging Documentation Required

Imaging Documentation: Include imaging results that demonstrate the anatomical location and degree of stenosis. Acceptable imaging modalities include duplex ultrasound, computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA). If duplex ultrasound does not show ≥50% stenosis, additional imaging is required to document the lesion.

Reports should describe lesion location, percent stenosis (moderate–severe defined as ≥50%), and relevant anatomic details to support the need for revascularization.
Digital subtraction angiography is now referenced among acceptable imaging modalities in this policy update.

Step Therapy

Conservative Therapies Required Prior to Revascularization

Conservative Therapy Requirement: Conservative therapies must be attempted and documented prior to revascularization for intermittent claudication. This includes guideline-directed medical therapy and a supervised or structured exercise program.

Document at least 12 weeks of Supervised Exercise Therapy or a Structured Community-Based Exercise Program (or equivalent supervised regimen) with details on frequency, duration, and adherence.
Document pharmacologic optimization (e.g., antiplatelet therapy, lipid-lowering therapy, antihypertensive therapy, glycemic control when applicable) and smoking cessation counseling where applicable.

Denial Risk

Iliac Artery Atherectomy — Denial Risk

Iliac Artery Atherectomy — Insufficient Evidence / Risk: Iliac artery atherectomy has limited, low-quality evidence and carries a risk of life‑threatening perforation. Use of iliac atherectomy is rarely appropriate and may be noncovered or require special justification/case review.

Most available studies are retrospective or single‑arm with small sample sizes and heterogenous designs; randomized comparative evidence is lacking.
Given the procedural risk and limited evidence, provide strong clinical justification and detailed documentation if considering iliac atherectomy; anticipate potential denial or case review.

Denial Risk

Intravascular Lithotripsy (IVL) — Investigational / Denial Risk

Intravascular Lithotripsy (IVL) — Unproven/Denial Risk: IVL for lower extremity ischemia is considered unproven due to insufficient evidence of long‑term efficacy and durability for some indications. Procedures inconsistent with policy criteria or using IVL without adequate justification may be denied.

Early and mid‑term data are encouraging, but additional comparative, longer‑term studies are needed to establish superiority in clinically relevant outcomes.
When IVL is used, document the clinical rationale, lesion characteristics (e.g., heavy calcification), prior therapies attempted, and why alternative established treatments are not appropriate; anticipate case review and potential denial if criteria are not met.

Coverage noteEndovascular revascularization is proven and medically necessary for treating CLTI when diagnoses correspond to applicable codes

inv-47: Claudication definition (exercise-induced pain relieved by rest)

DefinitionClaudication is reproducible exercise-induced muscle pain of vascular origin in the lower extremities that is relieved by rest

Typical time to reliefSymptoms are usually relieved by rest within approximately 10 minutes

Functional impactFunctionally limiting Claudication restricts daily activities and may prompt consideration of revascularization after conservative therapy

inv-48: Supervised Exercise Therapy definition and parameters

DefinitionSupervised Exercise Therapy is a supervised, intermittent walking exercise program delivered by qualified health care professionals

Program parametersPerformed ≥3 times per week for a minimum of 12 weeks; training includes 30–45 minutes of active walking per session within a 60-minute session

Training approachFocuses on intermittent walking to moderate-to-maximum claudication pain with rest periods and progressive increases as function improves

inv-49: Structured Community-Based Exercise Program definition

DefinitionStructured Community-Based Exercise Program is a home or community-based, self-directed walking program prescribed by qualified clinicians with counseling and possible remote coaching

ComponentsMay include activity monitors, behavioral change techniques, periodic supervised sessions, and clinician counseling to progress exercise

SettingTakes place in the individual's personal setting rather than a clinical facility and mirrors goals of supervised programs when supervised therapy is not available

inv-50: Straightforward vs complex lesion — CPT descriptor distinction

CPT descriptor distinctionCPT descriptors distinguish 'straightforward lesion' versus 'complex lesion' for initial and additional vessels to guide proper code selection (e.g., different codes for straightforward vs complex tibial/peroneal or inframalleolar procedures)

Use for codingProviders should use the detailed CPT descriptors to match operative reports to the correct code based on lesion complexity and vessel count

ExamplesCodes 37289/37290/37291 and 37296–37299 include straightforward and complex lesion descriptors for tibial/peroneal and inframalleolar territories respectively

inv-51: Claudication (simple definition)

Simple definitionClaudication: leg pain, numbness, or cramping during exercise that is relieved by rest

Relation to PADIt is a common manifestation of chronic symptomatic peripheral artery disease

When to consider interventionRevascularization considered only after guideline-directed medical therapy and structured exercise fail for function-limiting symptoms

inv-52: Chronic Limb-Threatening Ischemia (CLTI) — definition

CLTI definitionAdvanced stage of PAD with chronic ischemic rest pain, nonhealing wounds/ulcers, or gangrene attributable to arterial occlusive disease

Risk implicationsAssociated with high risk of limb loss and systemic cardiovascular events when left untreated

Coverage relevanceEndovascular revascularization is proven and medically necessary for CLTI when appropriate diagnoses and codes are used

inv-53: Urgent vascular imaging/revascularization thresholds (IWGDF)

IWGDF urgent thresholdsConsider urgent vascular imaging and revascularization when ankle pressure < 50 mm Hg or ABI < 0.4

Toe and TcPO2 thresholdsConsider urgent assessment if toe pressure < 30 mm Hg or transcutaneous oxygen pressure < 25 mm Hg

Clinical contextHigher pressure thresholds may prompt intervention in patients with extensive tissue loss or infection

inv-54: SVS recommendations for intermittent claudication (against revascularization for asymptomatic cases)

SVS recommendationSVS recommends against revascularization in asymptomatic PAD or intermittent claudication based solely on hemodynamic measurements or imaging findings

Infrapopliteal interventionsSVS suggests against infrapopliteal revascularization for intermittent claudication due to lack of evidence of benefit and potential harm

Device evidence noteSVS notes limited data on specialized balloons such as IVL and calls for further study before routine use