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Modifiedsierra health and lifePolicy 2026T0602S

Lower Extremity Endovascular Procedures — Coverage Criteria

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Clinical coverage criteria for endovascular revascularization (stents, angioplasty, atherectomy, intravascular lithotripsy, etc.) for lower extremity peripheral artery disease for UnitedHealthcare Commercial and Individual Exchange members; excludes upper extremities.

Policy Summary

Payersierra health and life

PolicyLower Extremity Endovascular Procedures — Coverage Criteria

Policy CodePolicy 2026T0602S

Change TypeMaterial coverage revisionadded unproven designation for IVL and added CPT codes

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionDocument trial and failure of at least 12 weeks of supervised or structured exercise therapy, ABI ≤ 0.90, and imaging showing ≥50% stenosis when requesting authorization.

SourceLink

POLICY UPDATE CHANGES

Intravascular lithotripsy for treating lower extremity ischemia is unproven and not medically necessary due to insufficient evidence of efficacy.

Added CPT codes 37262 and 37279 to applicable codes.

Updated Description of Services, Clinical Evidence, and References sections to reflect the most current information.

≥12 wksSupervised exercise requirement

≤0.90ABI threshold

≥50%Imaging stenosis

72.1%DETOUR 12‑mo primary patency

202DETOUR participants

05/01/2026Revision effective

Coverage Criteria for Lower Extremity Endovascular Revascularization

Medically necessary criteria for Claudication

Endovascular revascularization procedures are proven and medically necessary for non-limb‑threatening lower extremity ischemia (claudication) when ALL of the following are met:

Functional impairment: Impaired ability to work and/or perform activities of daily living

Conservative therapy failure: 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 anticoagulant therapy); and smoking cessation if applicableMinimum 12 weeks supervised exercise

Document prior therapies in medical record

Objective ischemia: Ischemic peripheral artery disease with Ankle‑Brachial Index of ≤ 0.90

Policy Summary

Payersierra health and life

PolicyLower Extremity Endovascular Procedures — Coverage Criteria

Policy CodePolicy 2026T0602S

Change TypeMaterial coverage revisionadded unproven designation for IVL and added CPT codes

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionDocument trial and failure of at least 12 weeks of supervised or structured exercise therapy, ABI ≤ 0.90, and imaging showing ≥50% stenosis when requesting authorization.

SourceLink

On This Page

If ABI inconclusive, include toe pressures or alternative testing per documentation

Imaging evidence: Imaging of the target vessel (duplex ultrasound, CTA, MRA, or digital subtraction angiography) demonstrates an anatomical lesion with moderate‑severe stenosis (≥ 50%); if duplex does not demonstrate ≥50% stenosis, another imaging modality is required≥50% stenosis

Include imaging modality and measured stenosis in documentation

Medically necessary criteria for retreatment (in-stent restenosis)

Retreatment for in‑stent restenosis of a previously treated vessel is medically necessary when ALL of the following are met:

Symptoms: Recurrent symptoms attributable to the previously treated vessel

Functional impact: Impaired ability to work and/or perform activities of daily living

Imaging evidence: Imaging of the previously treated vessel (duplex ultrasound, CTA, MRA, or DSA) demonstrates a moderate‑severe stenosis (≥ 50%); if duplex ultrasound does not demonstrate ≥50% stenosis, another imaging modality is necessary≥50% stenosis

Document prior interventions and imaging correlating lesion to symptoms

Coverage for Chronic Limb-Threatening Ischemia

Endovascular revascularization is proven and medically necessary for:

Chronic Limb‑Threatening Ischemia (CLTI): Chronic Limb‑Threatening Ischemia (eg, chronic ischemic rest pain, nonhealing wound/ulceration, or gangrene) with an applicable diagnosis code

Refer to Applicable Codes section for diagnosis coding

Not medically necessary / Unproven

The following are considered unproven and not medically necessary due to insufficient evidence:

Unproven indications: Interventions performed for non‑limb‑threatening infrapopliteal artery disease (eg, anterior tibial, posterior tibial, or peroneal arteries); asymptomatic individuals; procedures performed solely to prevent progression of claudication to CLTI; treatment of a nonviable limb

Unproven procedures: Transluminal peripheral atherectomy of the iliac artery; endovenous femoropopliteal bypass using a stent graft; intravascular lithotripsy for lower extremity ischemia

These interventions are designated unproven and not medically necessary due to insufficient evidence of efficacy

Iliac artery atherectomy — evidence summary

Evidence‑based stance summaries

Iliac artery atherectomy: There is insufficient high‑quality evidence to support the safety and efficacy of iliac artery atherectomy; most studies are retrospective or single‑arm, sample sizes are limited, and procedural risk includes potential life‑threatening perforation.

May be considered investigational in many contexts; claims may be at risk without supporting evidence

DETOUR endovenous femoropopliteal bypass

Investigational/novel endovenous bypass (DETOUR) evidence summary

DETOUR system: DETOUR is a novel endovenous femoropopliteal bypass delivered via the venous system with single‑arm studies (DETOUR I and DETOUR 2) showing high technical success and promising 12‑month primary patency, but randomized comparative data with open bypass are lacking and longer‑term outcomes are needed.

DETOUR 2 reported mean lesion length ~32.7 cm, 1‑year primary patency 72.1%, 30‑day freedom from major adverse events 93.0%, and 12‑month DVT incidence ~4.1%

Intravascular lithotripsy (IVL)

Intravascular lithotripsy (IVL) evidence summary

IVL (Shockwave): IVL demonstrates promising early outcomes for preparation of calcified peripheral lesions, with better lesion preparation and fewer flow‑limiting dissections versus PTA in limited trials; however, evidence is limited by small or single‑arm studies and intermediate follow‑up, and long‑term impact on clinically meaningful outcomes (eg, primary patency, target lesion revascularization, limb salvage) remains uncertain.

Additional randomized and longer‑term studies are needed

Endovascular versus surgical revascularization

Comparative effectiveness context

Endovascular vs surgical revascularization: Systematic reviews and randomized trials (including BEST‑CLI) indicate no consistent differences in mortality or major amputation overall between endovascular and surgical approaches; bypass may have lower reintervention rates in some cohorts, and supervised exercise therapy can offer comparable improvement in walking distance and quality of life for claudication.

BEST‑CLI cohort 1 favored surgery for the composite of major adverse limb event or death; cohort 2 showed similar outcomes between approaches

Not medically necessary — IVL for lower extremity ischemia

Coverage stance for IVL in lower extremity PAD

Primary policy decision: Intravascular lithotripsy for treating lower extremity ischemia is considered unproven and not medically necessary due to insufficient evidence of efficacy for clinically relevant long‑term outcomes such as primary patency, target lesion revascularization, and limb salvage.

Policy revision (05/01/2026) added IVL as not medically necessary; RCTs (eg, Disrupt PAD III) and evidence reviews demonstrate promising procedural results but limited long‑term comparative outcomes

This policy applies specifically to lower extremity peripheral artery disease and endovascular revascularization of the iliac, femoral/popliteal, tibial/peroneal, and inframalleolar vascular territories. This policy does not apply to upper extremities. Coverage determinations for procedures on the upper extremities should be evaluated under the applicable upper-extremity policy or the member's benefit plan.

Certain procedures or indications are considered investigational or lack high-quality evidence and therefore are not supported as routine coverage. Examples include routine iliac artery atherectomy, which has limited, primarily retrospective or single-arm data and carries procedural risk; novel approaches such as the DETOUR endovenous femoropopliteal bypass, for which randomized comparative data versus open bypass are lacking; and uses of intravascular lithotripsy (IVL)

External guidance from the National Institute for Health and Care Excellence (NICE) recommends that IVL for calcified arteries in PAD be used only with special arrangements for clinical governance, consent, and audit or research, reflecting the need for additional evidence on long-term outcomes despite moderate evidence of procedural safety.

Coverage exclusions and denial triggers include interventions performed for non–limb-threatening infrapopliteal artery disease, treatment of asymptomatic individuals, procedures performed solely to prevent progression of claudication to CLTI, and other listed unproven procedures. Claims for these indications may be at elevated risk for denial as not medically necessary.

Iliac artery atherectomy has an insufficient evidence base to support routine use. Available studies are predominantly retrospective, single-arm, or nonrandomized with small sample sizes and heterogeneous lesion and device characteristics. The procedure is also uncommon due to the reported risk of life‑threatening perforation. Given these limitations, routine coverage of transluminal peripheral atherectomy of the iliac artery is not supported by high-quality evidence.

Intravascular lithotripsy (IVL) is designated unproven and not medically necessary for lower extremity ischemia because current evidence—consisting of limited randomized data, systematic reviews, and multiple single‑arm series—does not establish durable, clinically meaningful benefits such as improved long‑term primary patency, reduced target‑lesion revascularization, or better limb salvage compared with standard approaches. Operationally, IVL requests for lower extremity ischemia should be treated as not meeting medical necessity in the absence of stronger comparative or long‑term outcome data.

Applicable Procedure and Diagnosis Codes

Applicable procedure codes (selection - iliac territory)CPT

0238T	Transluminal peripheral atherectomy; iliac artery, each vessel.
0505T	Endovenous femoral-popliteal arterial revascularization with intravascular stent graft(s).
37254	Revascularization, endovascular, iliac vascular territory; transluminal angioplasty, straightforward lesion, initial vessel.
37255	Revascularization, endovascular, iliac vascular territory; transluminal angioplasty, each additional vessel.
37256	Revascularization, endovascular, iliac vascular territory; transluminal angioplasty, complex lesion, initial vessel.

Applicable procedure codes (femoral/popliteal, tibial/peroneal, lithotripsy, atherectomy)CPT

37257	Iliac vascular territory, complex lesion each additional vessel.
37258	Iliac vascular territory, transluminal stent placement, straightforward lesion, initial vessel.
37259	Iliac vascular territory, transluminal stent placement, each additional vessel.
37260	Iliac vascular territory, transluminal stent placement, complex lesion, initial vessel.
37261	Iliac stent placement, complex lesion each additional vessel.
37262	Intravascular lithotripsy(ies), iliac vascular territory.
37263	Revascularization, femoral and popliteal vascular territory, transluminal angioplasty, straightforward, initial vessel.
37264	Femoral/popliteal angioplasty, each additional vessel.
37265	Femoral/popliteal angioplasty, complex lesion, initial vessel.
37266	Femoral/popliteal angioplasty, complex lesion each additional vessel.

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Covered CPT CodesCPTCovered

37276	Revascularization, femoral and popliteal territory with transluminal stent placement, with transluminal atherectomy; straightforward lesion, each additional vessel
37277	Revascularization, femoral and popliteal territory with transluminal stent placement, with transluminal atherectomy; complex lesion, initial vessel
37278	Revascularization, femoral and popliteal territory with transluminal stent placement, with transluminal atherectomy; complex lesion, each additional vessel
37279	Intravascular lithotripsy(ies), femoral and popliteal vascular territory
37280	Revascularization, tibial and peroneal territory with transluminal angioplasty; straightforward lesion, initial vessel
37281	Revascularization, tibial and peroneal territory with transluminal angioplasty; straightforward lesion, each additional vessel
37282	Revascularization, tibial and peroneal territory with transluminal angioplasty; complex lesion, initial vessel
37283	Revascularization, tibial and peroneal territory with transluminal angioplasty; complex lesion, each additional vessel
37284	Revascularization, tibial and peroneal territory with transluminal stent placement; straightforward lesion, initial vessel
37285	Revascularization, tibial and peroneal territory with transluminal stent placement; straightforward lesion, each additional vessel

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Relevant ICD-10 Diagnosis CodesICD-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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Applicable ICD-10 Diagnosis CodesICD-10

I70.669	Atherosclerosis of nonbiological bypass graft(s) of the extremities with gangrene, unspecified extremity
I70.721	Atherosclerosis of other type of bypass graft(s) of the extremities with rest pain, right leg
I70.722	Atherosclerosis of other type of bypass graft(s) of the extremities with rest pain, left leg
I70.723	Atherosclerosis of other type of bypass graft(s) of the extremities with rest pain, bilateral legs
I70.728	Atherosclerosis of other type of bypass graft(s) of the extremities with rest pain, other extremity
I70.729	Atherosclerosis of other type of bypass graft(s) of the extremities with rest pain, unspecified extremity
I70.731	Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of thigh
I70.732	Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of calf
I70.733	Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of ankle
I70.734	Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of heel and midfoot

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Applicable CPT Codes addedCPT

37262	CPT code added to applicable codes (as noted in policy history)
37279	CPT code added to applicable codes (as noted in policy history)

Regulatory/Informational codesmixed

PPN (FDA product code)

FDA product code for intravascular lithotripsy systems (informational)

Ankle-Brachial Index

Ankle-Brachial Index (ABI) thresholdABI ≤ 0.90

Definition of ABICompares systolic blood pressure in the ankle with the arm; ABI <0.90 indicates peripheral artery disease

Use in policyObjective ischemia criterion for claudication and retreatment decisions

Imaging stenosis threshold

Imaging stenosis thresholdModerate–severe stenosis defined as ≥ 50% on imaging

Imaging modalities acceptedDuplex ultrasound, CTA, MRA, or digital subtraction angiography; if duplex does not show ≥50%, another modality is necessary

Role in retreatmentRequired demonstration of ≥50% stenosis for in‑stent restenosis retreatment decisions

Supervised Exercise Therapy

Supervised Exercise Therapy (SET) minimum regimenMinimum 12 weeks, at least 3 sessions per week, 30–45 minutes of active walking per session goal

Program setting and supervisionTypically delivered in a hospital or outpatient facility, directly supervised by qualified health care professionals

Alternative structured programsStructured community-based programs may be acceptable when they include prescribed regimens and qualified oversight

DETOUR 2 lesion characteristics

Mean lesion length in DETOUR 232.7 cm

DETOUR 2 cohort size200 participants treated (202 enrolled)

Lesion characteristics in DETOUR 296% chronic total occlusions; 70% severely calcified

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization
Prior authorization implied — document clinical criteria and codes
Prior authorization is implied when clinical criteria must be met for lower-extremity endovascular revascularization (claudication or CLTI). Requests should document that the member meets all coverage criteria (functional limitation, trial of conservative therapy including supervised/structured exercise, ABI ≤ 0.90, and imaging demonstrating ≥ 50% stenosis) and reference the applicable procedural CPT codes being requested.
Document impaired ability to work and/or perform activities of daily living.
Document trial and failure of conservative therapies including ≥12 weeks of supervised or structured exercise, pharmacologic therapy, and smoking cessation if applicable.
Provide ABI value (≤ 0.90) and imaging showing ≥50% stenosis (or alternate imaging if duplex is inconclusive).
List and align requested CPT codes with the policy's Applicable Codes section.

Billing Rule
Align submitted procedures with listed CPT descriptors
Ensure the procedures submitted for authorization align exactly with the CPT codes listed in the policy for the treated vascular territory (e.g., femoral/popliteal, tibial/peroneal, inframalleolar, iliac). Authorization requests and claims must match the CPT descriptors in the Applicable Codes section.
Use femoral/popliteal CPTs (e.g., 37276–37279) for femoropopliteal territory procedures.
Use tibial/peroneal CPTs (e.g., 37280–37287, 37288–37296 series) for tibial/peroneal procedures.
Use inframalleolar CPTs (37296–37299) where applicable.
Include any adjunctive or add-on codes as listed (e.g., intravascular lithotripsy codes where applicable).

Prior Authorization
Provide evidence summaries and clinical justification for investigational/limited‑evidence procedures
When seeking authorization for investigational or limited-evidence procedures (e.g., iliac atherectomy, DETOUR), include an evidence summary and clinical rationale supporting medical necessity; reference available trial data when applicable.
For iliac atherectomy, summarize lack of high-quality evidence and known procedural risks.
For DETOUR, provide lesion characteristics and reference DETOUR study outcomes (e.g., lesion length, technical success, patency rates).
For IVL, include available RCT or systematic review data and explain whether IVL is used as vessel preparation or standalone therapy.

Prior Authorization
Advisory — IVL CPT codes added but IVL designated unproven/NMN
IVL CPTs 37262 and 37279 have been added to the policy’s applicable codes; however, IVL for lower-extremity ischemia is designated unproven and not medically necessary—authorization requests for IVL codes may therefore be subject to denial.
Include specific documentation of indication and rationale if requesting IVL (codes 37262, 37279).
Be aware that IVL is labeled unproven/not medically necessary for lower-extremity ischemia in this policy.

Step Therapy
Conservative therapy trial required (≥12 weeks supervised/structured exercise)
Document trial and failure of conservative therapies before authorization for claudication interventions; at minimum, provide records of a supervised or structured community-based exercise program for at least 12 weeks as specified in the policy.
Record duration and components of supervised exercise therapy (minimum 12 weeks, ≥3 sessions/week, 30–45 minutes active walking per session when possible).
Document pharmacologic therapy and smoking cessation counseling where applicable.

Billing Rule
Ensure CPT descriptor matching in claims/authorization
Match claims/authorization documentation to the precise CPT descriptors listed for femoral/popliteal, tibial/peroneal, inframalleolar, and iliac procedures to avoid miscoding and facilitate review.
Ensure the procedural narrative corresponds to the CPT descriptor (territory, lesion complexity, additional vessels, and adjunct procedures).
List primary procedure and separately report each additional vessel code as directed by CPT descriptors.

Step Therapy
Step‑therapy expectation — prioritize noninvasive and standard endovascular options
Prioritize conservative, noninvasive care before device-heavy or advanced interventions; authorization reviewers will consider prior use of guideline-directed medical therapy and supervised exercise when evaluating requests.
Provide documentation of prior supervised exercise and medical therapy when applicable.
Explain why standard endovascular options were insufficient if requesting advanced or investigational interventions.

Note
Noninvasive first‑line — document failure of guideline‑directed therapy
Guideline-directed medical therapy and supervised exercise are recommended as first-line treatment for intermittent claudication; authorization for revascularization should show persistent lifestyle-limiting symptoms despite these measures.
Include documentation of ongoing lifestyle-limiting claudication despite guideline-directed therapy and supervised exercise.
Reference guideline recommendations when justifying intervention necessity.

Documentation Required
Required documentation: conservative therapy, ABI, and imaging (≥50% stenosis)
Medical records submitted for review must include documentation of prior conservative therapies, an ABI measurement (≤ 0.90 when applicable), and imaging demonstrating ≥ 50% stenosis of the target vessel (or alternative imaging if duplex is inconclusive).
Provide ABI numeric value and testing date.
Attach imaging reports (duplex, CTA, MRA, or DSA) with percent stenosis and anatomical location.
Include notes on supervised exercise participation and pharmacologic therapy.

Note

Documentation Required
DETOUR — document lesion, technical success, venous outcomes and follow‑up
For DETOUR procedures, include detailed periprocedural and outcome documentation: lesion length, chronic total occlusion status, calcification severity, technical success, venous harvest/stent‑graft details, and follow‑up outcomes (patency, adverse events).
Report mean or measured lesion length (DETOUR 2 mean lesion length 32.7 cm where available).
Document CTO status, calcification degree, technical success, and 30‑day/12‑month outcome measures (patency, DVT incidence).

Documentation Required
IVL procedural documentation — role, adjuncts, complications, and outcomes
When IVL is used, document whether IVL served as vessel preparation or as standalone therapy, detail adjunctive devices (eg, drug‑coated balloon or stent), procedural complications, and follow‑up patency or reintervention data.
State IVL device and CPT used, and whether IVL was adjunctive or primary therapy.
Provide subsequent device use and clinical outcomes with follow‑up intervals.

Note
Coverage decision reference — member plan and legal mandates govern
Reference the member-specific benefit plan and applicable federal/state mandates when making coverage decisions; this policy is informational and the benefit plan governs in case of conflict.
Check for Medicare NCD/LCDs when applying policy to Medicare Advantage members.
Use member plan language and legal mandates to resolve any coverage conflicts.

Denial Risk
Unproven/Not medically necessary indications — risk of denial
Do not request authorization or perform interventions for indications listed as unproven/not medically necessary (e.g., non‑limb‑threatening infrapopliteal disease, asymptomatic individuals, procedures to prevent progression of claudication, iliac atherectomy, endovenous femoropopliteal bypass with stent graft, IVL for lower‑extremity ischemia) unless within documented investigational or research protocols.
Such indications may trigger denial because the policy lists them as unproven/not medically necessary.
If pursuing investigational options, include trial identifiers and strong justification per prior-auth guidance.

Denial Risk
Denial risk — mismatched or missing CPT/diagnosis coding and documentation
Absence of applicable CPT/diagnosis codes on the request or mismatched clinical documentation to the codes listed increases the risk of denial; ensure submitted codes and clinical narrative are concordant with the policy's Applicable Codes and clinical criteria.
Verify that the CPT and ICD-10 codes reported match the treated territory, lesion complexity, and clinical indication.
Attach supporting imaging and ABI results that correspond to the coded territory.

Denial Risk
Iliac atherectomy — limited evidence and increased review/denial risk
Iliac artery atherectomy lacks sufficient quality evidence and carries procedural perforation risk; claims for iliac atherectomy may be subject to increased review or denial unless strong supporting evidence and justification are provided.
If requesting coverage, include evidence and rationale addressing safety concerns and lack of randomized data.
Clarify why alternative revascularization strategies are inappropriate for the patient.

Denial Risk
Denial risk for IVL — policy designates IVL unproven/NMN for lower‑extremity ischemia
Claims for intravascular lithotripsy (IVL) to treat lower‑extremity ischemia may be denied as not medically necessary because the policy designates IVL unproven for this indication; include comprehensive justification and outcomes data if submitting for prior authorization.
Include available RCT or systematic review citations and explain whether IVL was adjunctive or standalone.
Provide follow‑up patency, reintervention, and functional outcomes to support medical necessity.

Background and Evidence Context

Peripheral artery disease of the lower extremities can present as exertional limb pain (claudication) or progress to advanced ischemia. Claudication is activity‑related limb discomfort that improves with rest. Chronic limb‑threatening ischemia (CLTI) is characterized by chronic (≥2 weeks) ischemic rest pain, nonhealing ulceration, or gangrene and carries a substantially higher risk of limb loss. Objective assessment with an Ankle‑Brachial Index (ABI) ≤ 0.90 and imaging demonstrating ≥50% stenosis of the target vessel are key elements used to determine candidacy for endovascular revascularization.

Important evidence gaps remain for several novel or infrequently performed procedures. Iliac artery atherectomy is supported mainly by low‑quality, nonrandomized studies and poses notable procedural risk. The DETOUR endovenous femoropopliteal bypass has single‑arm data (DETOUR studies report acceptable 12‑month patency and procedural success) but lacks randomized comparative trials versus open bypass. For IVL, early procedural outcomes are encouraging, yet the limited RCT evidence and predominance of single‑arm series mean long‑term comparative effectiveness and clinically meaningful benefits remain uncertain. These gaps justify the policy’s investigational or not‑medically‑necessary designations for these specific procedures until higher‑quality evidence becomes available.

Definitions and Clinical Terms

inv-45: Ankle-Brachial Index definition — compares ankle and arm systolic pressures; ABI <0.90 indicates PAD

DefinitionCompares systolic blood pressure in the ankle with the systolic blood pressure in the arm

Diagnostic thresholdABI <0.90 indicates peripheral artery disease

Clinical useIndicates how well blood is flowing in the limbs and is used as objective ischemia evidence for coverage decisions

inv-46: Chronic Limb-Threatening Ischemia definition — CLTI criteria and alternate terminology

DefinitionChronic (≥2 weeks) ischemic rest pain, nonhealing wound/ulcers, or gangrene attributable to arterial occlusive disease

Nomenclature notePreviously termed critical limb ischemia; emphasizes chronic, limb-threatening nature and risk for amputation

Clinical significanceAssociated with high morbidity and may require urgent revascularization to reduce limb loss risk

inv-47: Claudication / Supervised Exercise Therapy / Structured Community-Based Exercise Program definitions

Claudication (definition)Exertional lower-extremity muscle pain, cramping, aching, or fatigue consistently induced by walking and relieved by rest

Supervised Exercise TherapyTreadmill-based program supervised by qualified staff, ≥3 sessions/week for ≥12 weeks, 30–45 minutes active walking per session

Structured Community-Based Exercise ProgramHome/community-based, prescribed walking regimen with guidance from qualified health professionals and periodic oversight

inv-48: Claudication — symptom definition

Symptom descriptionLeg pain, numbness, or cramping during exercise that is relieved by rest

EtiologyManifestation of peripheral artery disease due to atherosclerotic narrowing of leg arteries

Functional impactMay limit walking distance and activities of daily living; termed functionally limiting when it impairs daily function

inv-49: Chronic limb-threatening ischemia (CLTI) — definition and clinical significance

Core definitionChronic limb-threatening ischemia (CLTI) is chronic (≥2 weeks) ischemic rest pain, nonhealing wounds/ulcers, or gangrene attributable to arterial occlusive disease

Clinical riskAssociated with high risk of amputation and increased morbidity/mortality

Management implicationOften requires urgent evaluation and revascularization; best medical therapy and individualized revascularization decisions recommended

inv-50: Primary patency (as used in DETOUR studies) — definition used in outcomes reporting

Primary patency (DETOUR studies) — definitionFreedom from restenosis or clinically driven target lesion revascularization at specified time points (e.g., 12 months)

DETOUR 2 reportPrimary patency at 12 months reported as the prespecified effectiveness end point

UsageUsed as primary effectiveness outcome in DETOUR trials to assess durability of the procedure

inv-51: Intravascular lithotripsy (IVL) — definition and device-class description

DefinitionA catheter-based calcified plaque modification technique (e.g., Shockwave) that uses ultrasound waves delivered via a balloon catheter to disrupt vascular calcium

Clinical roleUsed to prepare heavily calcified peripheral arterial lesions prior to angioplasty, drug-coated balloon, or stenting

Evidence summaryEarly studies show improved vessel preparation and fewer flow-limiting dissections versus PTA, but long-term comparative effectiveness is uncertain

inv-52: Intermittent claudication and CLTI — concise definitions

Intermittent claudicationExertional limb pain consistently induced by walking and relieved by rest

Chronic Limb-Threatening Ischemia (CLTI)Includes rest pain, tissue loss (nonhealing ulcers), or gangrene and often requires urgent revascularization

Clinical distinctionClaudication generally managed first with medical therapy and supervised/structured exercise; CLTI represents advanced limb threat requiring urgent evaluation

Policy Revision History

2026-05-01policy_revisionLatest

Policy added statement that intravascular lithotripsy (IVL) for treating lower extremity ischemia is unproven and not medically necessary due to insufficient evidence of efficacy.

2026-05-01coding_update

Added CPT codes 37262 and 37279 to the list of applicable procedure codes.