Sierra Health and Life lower extremity coverage update

Coverage Criteria for Lower Extremity Endovascular Revascularization

Revascularization for Claudication

Covered when ALL of the following are met

Claudication revascularization criteria: Impaired ability to work and/or perform activities of daily living (ADL); AND all conservative therapies have been tried and failed: at least 12 weeks of Supervised Exercise Therapy or a Structured Community-Based Exercise Program; AND pharmacologic therapy (e.g., lipid-lowering, antihypertensive, antiplatelet, and/or anticoagulant therapy); AND smoking cessation, if applicable; AND ischemic peripheral artery disease with Ankle-Brachial Index (ABI) ≤ 0.90; AND imaging of the target vessel (duplex ultrasound, CTA, MRA, or digital subtraction angiography) demonstrates anatomic location and a moderate–severe stenosis (≥50%); if duplex ultrasound does not demonstrate ≥50% stenosis, another imaging modality is required to demonstrate the extent of stenosis.ABI ≤ 0.90; stenosis ≥ 50%

Retreatment for In-stent Restenosis

Covered when ALL of the following are met

Retreatment for in-stent restenosis: Recurrent symptoms; AND impaired ability to work and/or perform activities of daily living (ADL); AND imaging of the previously treated vessel (duplex ultrasound, CTA, MRA, or digital subtraction angiography) demonstrates anatomic location and a moderate–severe stenosis (≥50%); if duplex ultrasound does not demonstrate ≥50% stenosis, another imaging modality is required to demonstrate the extent of stenosis.stenosis ≥ 50%

Chronic Limb Threatening Ischemia (CLTI)

Covered when diagnosed with CLTI

CLTI coverage: Endovascular revascularization procedures (e.g., stents, angioplasty, and/or atherectomy) are proven and medically necessary for treating Chronic Limb Threatening Ischemia (CLTI) when the diagnosis corresponds to the Applicable Codes and clinical documentation supports CLTI presentation.

Applicable Codes list referenced

Unproven / Not Medically Necessary

Unproven indications: Interventions for non-limb-threatening infrapopliteal artery disease; asymptomatic individuals; procedures performed to prevent progression of claudication to CLTI; transluminal peripheral atherectomy of the iliac artery; treatment of a nonviable limb; and endovenous femoropopliteal bypass using a stent graft are considered unproven and not medically necessary due to insufficient evidence of efficacy.

Intermittent Claudication — when revascularization is appropriate

Revascularization for intermittent claudication

Intermittent Claudication Revascularization Criteria: Patient has lifestyle-limiting intermittent claudication; AND guideline-directed medical therapy and structured or supervised exercise (e.g., ≥12 weeks supervised exercise or a structured community-based program) have been attempted and are insufficient or not tolerated; AND lesion characteristics and patient risk profile (anatomic location, lesion length, degree of stenosis/calcification) support an endovascular or surgical approach per multidisciplinary guideline recommendations.supervised exercise ≥ 12 weeks

Based on ACC/AHA multi-society appropriate use criteria and guideline recommendations.

CLTI — BEST-CLI trial findings informing modality selection

Chronic Limb-Threatening Ischemia (CLTI) — trial-based comparative outcomes

BEST-CLI cohort findings: BEST-CLI trial: in Cohort 1 (suitable single-segment great saphenous vein available), surgical bypass had a lower incidence of major adverse limb event or death compared with endovascular therapy after median follow-up; in Cohort 2 (no suitable saphenous vein), outcomes were similar between surgical and endovascular modalities. These findings inform modality selection when an autologous vein is available.

Findings influence choice of bypass vs endovascular in vein-available patients.

Iliac Atherectomy — evidence stance

Iliac artery atherectomy

Iliac atherectomy evidence: Atherectomy of the iliac artery is rarely appropriate due to insufficient quality evidence regarding safety and efficacy and because the procedure carries a risk of life-threatening perforation; randomized trials with long-term follow-up are lacking.

Panel rated iliac atherectomy rarely appropriate.

DETOUR system — investigational/limited evidence

Endovenous femoropopliteal bypass (DETOUR)

DETOUR evidence: DETOUR System has single-arm trial data demonstrating technical success and moderate 12-month primary patency (DETOUR 2 12-month primary patency ~72.1% and DETOUR I primary patency ~81% at 1 year) and acceptable 30-day safety, but lacks randomized comparative trials versus open surgical bypass; larger randomized studies are needed before broad adoption for PAD treatment.12-month primary patency ~72.1% (DETOUR 2); 81% (DETOUR I)

DETOUR 2 met prespecified endpoints but remains limited by nonrandomized design.

Revascularization coverage criteria

Covered when the following guideline-based conditions are met:

General prerequisites: Patient has symptomatic PAD with documentation of guideline-directed medical therapy and, for intermittent claudication, structured or supervised exercise (minimum 12 weeks) unless contraindicated; or the patient has CLTI requiring revascularization.supervised exercise ≥ 12 weeks

References: ACC/AHA appropriate use criteria; SVS guidelines

Intermittent claudication pathway: Revascularization considered only for patients with lifestyle-limiting claudication who have failed or are intolerant of medical therapy and supervised exercise.

ACC/AHA and SVS recommend conservative therapy first

CLTI pathway: Patients with chronic limb-threatening ischemia (CLTI) are appropriate candidates for endovascular or surgical revascularization to reduce risk of limb loss and adverse cardiovascular outcomes.

SVS and multi-society guidance

Device approvals (informational)

Informational device approvals and limitations:

DETOUR system: DETOUR System: FDA premarket approval (PMA P220021) for percutaneous revascularization of symptomatic femoropopliteal lesions 200–460 mm in length with chronic total occlusions 100–425 mm or diffuse stenosis >70% in patients who may be suboptimal candidates for surgical or alternative endovascular treatments; informational only and not a guarantee of coverage.lesion length 200–460 mm; CTO 100–425 mm; stenosis >70%

FDA PMA P220021

This policy applies to lower extremity endovascular revascularization procedures (e.g., stents, angioplasty, and atherectomy) for peripheral artery disease of the aortoiliac and femoropopliteal territories. This policy does not apply to upper extremity procedures; coverage determinations and clinical criteria described here are limited to the lower limbs and should not be used to adjudicate upper-extremity interventions.

Transluminal peripheral atherectomy of the iliac artery is not supported by sufficient high-quality evidence and carries procedure-specific risks (including perforation). The available literature is largely single-arm or retrospective and lacks randomized, long-term comparative data; multi-society appropriate-use guidance therefore rates iliac atherectomy as rarely appropriate compared with balloon angioplasty and stenting.

Revascularization is not recommended for individuals with asymptomatic PAD or for patients with intermittent claudication based solely on hemodynamic measurements or imaging findings. Guideline and appropriate-use statements emphasize that revascularization for claudication should only be considered when lifestyle-limiting symptoms persist despite guideline-directed medical therapy and structured/supervised exercise, rather than on imaging or ABI alone.

Endovascular revascularization is excluded for non‑limb‑threatening infrapopliteal disease (for example, isolated anterior tibial, posterior tibial, or peroneal lesions without CLTI) and for preventive procedures intended only to avoid progression of claudication to CLTI. Society guidance recommends against infrapopliteal interventions for intermittent claudication because of lack of demonstrated benefit and potential harm.

The DETOUR endovenous femoropopliteal bypass system is a novel percutaneous transvenous bypass technique using stent grafts routed through the femoral vein. Although single-arm studies (DETOUR I and DETOUR 2) report technical success, acceptable 12‑month patency and early functional gains, the evidence is nonrandomized and lacks direct comparison with open surgical bypass. Because of limited comparative and long-term data, use of the DETOUR system outside defined investigational or protocolized contexts remains investigational/unsupported for routine coverage.

Atherectomy techniques applied to the iliac artery are uncommon and associated with potential for serious complications. Given the predominance of low-quality observational studies and the absence of randomized comparative trials demonstrating superiority over angioplasty and stenting, transluminal peripheral atherectomy of the iliac artery is considered rarely appropriate and not supported as a routine alternative to angioplasty ± stent.

Applicable Procedure, Diagnosis, and Device Codes

Applicable CPT/HCPCS Codesmixed

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; angioplasty, straightforward lesion, initial vessel.
37255	Revascularization, endovascular, iliac; angioplasty, each additional vessel.
37256	Revascularization, endovascular, iliac; angioplasty, complex lesion, initial vessel.
37257	Revascularization, endovascular, iliac; angioplasty, complex lesion, each additional vessel.
37258	Revascularization, endovascular, iliac; stent placement, straightforward lesion, initial vessel.
37259	Revascularization, endovascular, iliac; stent placement, each additional vessel.
37260	Revascularization, endovascular, iliac; stent placement, complex lesion, initial vessel.
37261	Revascularization, endovascular, iliac; stent placement, complex lesion, each additional vessel.

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Applicable CPT CodesCPTCovered

37281	Revascularization, endovascular, tibial and peroneal territory, transluminal angioplasty; straightforward lesion, initial vessel
37282	Revascularization, endovascular, tibial and peroneal territory, transluminal angioplasty; complex lesion, initial vessel
37283	Revascularization, endovascular, tibial and peroneal territory, transluminal angioplasty; complex lesion, each additional vessel
37284	Revascularization, endovascular, tibial and peroneal territory, transluminal stent placement; straightforward lesion, initial vessel
37285	Revascularization, endovascular, tibial and peroneal territory, transluminal stent placement; straightforward lesion, each additional vessel
37286	Revascularization, endovascular, tibial and peroneal territory, transluminal stent placement; complex lesion, initial vessel
37287	Revascularization, endovascular, tibial and peroneal territory, transluminal stent placement; complex lesion, each additional vessel
37288	Revascularization, endovascular, tibial and peroneal territory, transluminal atherectomy; straightforward lesion, initial vessel
37289	Revascularization, endovascular, tibial and peroneal territory, transluminal atherectomy; straightforward lesion, each additional vessel
37290	Revascularization, endovascular, tibial and peroneal territory, transluminal atherectomy; complex lesion, initial vessel

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Applicable ICD-10 Codes (selected 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
I70.231	Atherosclerosis of native arteries of right leg with ulceration of thigh
I70.232	Atherosclerosis of native arteries of right leg with ulceration of calf

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Applicable PAD and graft-related ICD-10 codes (selected)ICD-10

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
I70.735	Atherosclerosis of other type of bypass graft(s) of the right leg with ulceration of other part of foot

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Additional vascular ICD-10 diagnosesICD-10

I72.3	Aneurysm of iliac artery
I72.4	Aneurysm of artery of lower extremity
I72.8	Aneurysm of other specified arteries
I72.9	Aneurysm of unspecified site
I73.00	Raynaud's syndrome without gangrene
I73.01	Raynaud's syndrome with gangrene
I73.1	Thromboangiitis obliterans [Buerger's disease]
I73.81	Erythromelalgia
I74.3	Embolism and thrombosis of arteries of the lower extremities
I74.4	Embolism and thrombosis of arteries of extremities, unspecified

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Wound, osteomyelitis, congenital, and injury codesICD-10

I96	Gangrene, not elsewhere classified
L03.115	Cellulitis of right lower limb
L03.116	Cellulitis of left lower limb
M86.051	Acute hematogenous osteomyelitis, right femur
M86.052	Acute hematogenous osteomyelitis, left femur
M86.059	Acute hematogenous osteomyelitis, unspecified femur
M86.061	Acute hematogenous osteomyelitis, right tibia and fibula
M86.062	Acute hematogenous osteomyelitis, left tibia and fibula
M86.069	Acute hematogenous osteomyelitis, unspecified tibia and fibula
M86.071	Acute hematogenous osteomyelitis, right ankle and foot

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Complication codes for vascular graftsICD-10

T82.312A	Breakdown (mechanical) of femoral arterial graft (bypass), initial encounter
T82.318A	Breakdown (mechanical) of other vascular grafts, initial encounter
T82.319A	Breakdown (mechanical) of unspecified vascular grafts, initial encounter
T82.338A	Leakage of other vascular grafts, initial encounter
T82.392A	Other mechanical complication of femoral arterial graft (bypass), initial encounter
T82.398A	Other mechanical complication of other vascular grafts, initial encounter
T82.399A	Other mechanical complication of unspecified vascular grafts, initial encounter
T82.818A	Embolism due to vascular prosthetic devices, implants and grafts, initial encounter
T82.868A	Thrombosis due to vascular prosthetic devices, implants and grafts, initial encounter
T82.898A	Other specified complication of vascular prosthetic devices, implants and grafts, initial encounter

Applicable CPT Codes (added)CPTCovered

37254	CPT code added (as listed in policy)
37255	CPT code added (as listed in policy)
37256	CPT code added (as listed in policy)
37257	CPT code added (as listed in policy)
37258	CPT code added (as listed in policy)
37259	CPT code added (as listed in policy)
37260	CPT code added (as listed in policy)
37261	CPT code added (as listed in policy)
37263	CPT code added (as listed in policy)
37264	CPT code added (as listed in policy)

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Removed CPT CodesCPT

37220	CPT code removed (as listed in policy)
37221	CPT code removed (as listed in policy)
37222	CPT code removed (as listed in policy)
37223	CPT code removed (as listed in policy)
37224	CPT code removed (as listed in policy)
37225	CPT code removed (as listed in policy)
37226	CPT code removed (as listed in policy)
37227	CPT code removed (as listed in policy)
37228	CPT code removed (as listed in policy)
37229	CPT code removed (as listed in policy)

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FDA/Device referencesmixed

P220021

FDA PMA identifier for DETOUR System (informational)

Ankle-Brachial Index (ABI) — key values

ABI threshold for PADAnkle-Brachial Index (ABI) ≤ 0.90

ABI interpretationABI compares systolic ankle to arm pressures; ABI < 0.90 indicates PAD

Use in coverage criteriaABI ≤ 0.90 is required to meet ischemic PAD criterion for revascularization for claudication

Imaging stenosis threshold — key values

Imaging stenosis threshold

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required for Listed CPT Codes

Prior authorization is required for the listed CPT codes for lower extremity endovascular revascularization procedures. Submit prior authorization requests that include the specific CPT procedure codes being requested and the relevant ICD-10 diagnosis codes documenting PAD, CLTI, ulcers, gangrene, or other applicable indications. Use the updated CPT code list; do not submit removed codes (e.g., 37220–37235).

Prior authorization required for covered tibial, peroneal, and inframalleolar endovascular revascularization CPT codes (e.g., 37281–37284, 37299 and other CPTs listed in Applicable Codes).
Include applicable ICD-10 diagnosis codes that document PAD, CLTI, rest pain, ulceration, gangrene, or related complications (see Applicable Codes list: I70.xx series, E10–E13 diabetic peripheral angiopathy codes, I74.x, I75.x, I77.x, I96, L03.xx, M86.xx, Q27.xx, etc.).
Do not submit removed/obsolete CPT codes (removed: 37220–37235). Use only the current CPT codes added in the 01/01/2026 update (see Policy History for added codes).

Documentation Required

Diagnosis Codes Required for Prior Authorization

Background and Evidence Summary

Peripheral artery disease (PAD) reduces blood flow to the lower extremities because of atherosclerotic narrowing. Patients with exertional limb pain from PAD (claudication) experience reproducible walking‑induced discomfort that is relieved by rest and which can limit work and activities of daily living. In the more severe spectrum, Chronic Limb‑Threatening Ischemia (CLTI) is characterized by chronic (≥2 weeks) ischemic rest pain, nonhealing wounds/ulcers, or gangrene and carries high risk for limb loss and cardiovascular morbidity.

Endovascular revascularization (angioplasty, stent, and selected adjunctive techniques) is an established therapeutic option for symptomatic aortoiliac and femoropopliteal atherosclerotic disease when specific clinical and anatomic criteria are met (for example, lifestyle‑limiting claudication after conservative therapy or CLTI). Trial evidence (including BEST‑CLI) and multi‑society guidelines inform modality selection: for CLTI, both endovascular and surgical approaches may be appropriate, with surgical bypass favored in selected patients with suitable autologous vein conduits and certain lesion profiles.

Definitions and Key Terms

Ankle-Brachial Index (ABI) — definition

DefinitionAnkle-Brachial Index (ABI) compares systolic ankle to arm pressures to indicate limb perfusion

Diagnostic cutoffABI less than 0.90 indicates peripheral artery disease (PAD)

Chronic Limb-Threatening Ischemia (CLTI) — definition

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

Clinical significanceCLTI denotes severe ischemia with high risk for limb loss and requires revascularization consideration

Terminology noteCLTI replaces prior term critical limb ischemia (CLI) to emphasize chronic, limb‑threatening nature

OpenPayer

Lower Extremity Endovascular Procedures — Coverage Criteria

Coverage Criteria for Lower Extremity Endovascular Revascularization

Applicable Procedure, Diagnosis, and Device Codes

Prior Authorization, Documentation, and Billing Guidance

Background and Evidence Summary

Definitions and Key Terms