ModifiedColorado Rocky Mountain Health PlansPolicy CS166.P

Lower Extremity Endovascular Procedures

Policy governing medical necessity and coverage criteria for endovascular revascularization procedures of the lower extremities (e.g., angioplasty, stents, atherectomy) for members of Colorado Rocky Mountain Health Plans; excludes upper extremities and has state-specific exceptions.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyLower Extremity Endovascular Procedures

Policy CodePolicy CS166.P

Change TypeMaterial — coverage stance and documentation updatesCPT code set revised

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionEnsure medical records document trial of at least 12 weeks of supervised or structured exercise, ABI (or TBI if non-compressible), imaging demonstrating ≥50% stenosis, and detailed history/physical before seeking coverage.

SourceLink

POLICY UPDATE CHANGES

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

Updated list and specificity of Medical Records Documentation Used for Reviews to require more detailed history/physical, exercise therapy monitoring protocol, smoking cessation attempts, and use of TBI if ABI non-compressible.

Updated applicable CPT codes to reflect annual edits by adding multiple codes and removing others.

CS166.PPolicy identifier

12 wksExercise therapy

≥50%Imaging stenosis threshold

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~55+Tibial/peroneal CPTs

UnprovenIVL coverage stance

Coverage Criteria for Lower Extremity Endovascular Procedures

Endovascular revascularization for Claudication (non-limb-threatening)

Covered when ALL of the following are met:

Primary criteria: 1) Impaired ability to work and/or perform activities of daily living; 2) All listed 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); and smoking cessation if applicable; 3) Ischemic peripheral artery disease with Ankle-Brachial Index ≤ 0.90; 4) Imaging of the target vessel (e.g., duplex ultrasound, CTA, MRA, or digital subtraction angiography) demonstrates anatomical location and moderate–severe stenosis (≥ 50%); if duplex ultrasound does not demonstrate ≥50% stenosis, another imaging modality is necessary to demonstrate the extent of stenosis.

Retreatment for in-stent restenosis (Claudication)

Retreatment is covered when ALL of the following are met:

Retreatment criteria: 1) Recurrent symptoms; 2) Impaired ability to work and/or perform activities of daily living; 3) Imaging of the previously treated vessel (e.g., duplex ultrasound, CTA, MRA, or digital subtraction angiography) demonstrates anatomical location and moderate–severe stenosis (≥ 50%); if duplex ultrasound does not demonstrate ≥50% stenosis, another imaging modality is necessary to demonstrate the extent of stenosis.

Chronic Limb-Threatening Ischemia

Endovascular revascularization is proven and medically necessary for treating Chronic Limb-Threatening Ischemia when diagnoses align with applicable codes.

CLTI: Endovascular revascularization procedures (e.g., stents, angioplasty, atherectomy) are considered medically necessary for Chronic Limb-Threatening Ischemia when the diagnosis corresponds to the Applicable Codes list (see Applicable Codes section).

Refer to Applicable Codes section.

Unproven / Not Medically Necessary Indications

Unproven/Not necessary: Interventions performed for non-limb-threatening infrapopliteal artery disease; asymptomatic individuals; to prevent progression of Claudication to Chronic Limb-Threatening Ischemia; transluminal peripheral atherectomy of the iliac artery; treatment of a nonviable limb; endovenous femoropopliteal bypass using a stent graft; intravascular lithotripsy for lower extremity ischemia — these are unproven and not medically necessary due to insufficient evidence of efficacy.

General coverage considerations

Coverage and appropriateness considerations

Conservative therapy first for intermittent claudication: Patients with intermittent claudication should first receive guideline-directed medical therapy and structured exercise before considering revascularization.

Based on multisociety appropriate use criteria (Bailey et al., 2019).

Revascularization selection: Choice of endovascular versus surgical revascularization depends on patient risk, lesion characteristics (anatomic location, lesion length, degree of calcification), and availability of conduit; for CLTI both approaches are considered appropriate.

Based on BEST-CLI and guideline panels.

Iliac artery atherectomy: Atherectomy of the iliac artery is rarely appropriate due to insufficient evidence and risk (including perforation) — avoid routine use.

Recommendation from multisociety appropriate use criteria.

Covered and not medically necessary statements

Coverage stance and clinical criteria referenced from guidelines and policy history:

Conservative therapy before revascularization: Patients with intermittent claudication should first receive guideline-directed medical therapy and structured exercise; revascularization considered only for patients with lifestyle-limiting claudication despite these measures.

Based on multisociety appropriate use criteria.

CLTI revascularization: For patients with chronic limb‑threatening ischemia (CLTI), endovascular and surgical revascularization are considered appropriate and important to reduce limb loss and mortality.

Supported by multisociety and SVS guidance.

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

Explicitly added to policy history (06/01/2026).

This Medical Policy does not apply to the states listed in the policy Application section; providers should refer to the state-specific policy or guideline where noted for those jurisdictions. States explicitly excluded include Idaho, Indiana, Kansas, Kentucky, Nebraska, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, and Tennessee (see state-specific guidance as applicable).

For members outside the listed states, the coverage criteria in this policy apply as written; for members in the excluded states, local state policy or plan-specific guidelines take precedence.

Retreatment of a previously treated vessel for in‑stent restenosis and endovascular revascularization for Chronic Limb‑Threatening Ischemia are addressed in this policy with specific clinical requirements. The policy also lists a set of circumstances considered unproven and not medically necessary for lower extremity ischemia, including interventions for non‑limb‑threatening infrapopliteal disease, procedures performed in asymptomatic individuals, and use of certain novel techniques when evidence is insufficient.

Atherectomy of the iliac artery is discouraged and rated as rarely appropriate by multisociety appropriate use criteria due to limited and low‑quality evidence and a potential for serious complications such as vessel perforation. Use of iliac atherectomy should be exceptional, with clear documentation of rationale and acknowledgment of procedural risk.

The policy designates intravascular lithotripsy (IVL) for treatment of lower extremity ischemia as unproven and not medically necessary because current evidence is insufficient to demonstrate durable clinical benefit on outcomes such as target lesion revascularization, limb salvage, and functional status. Early procedural outcomes are promising, but longer‑term comparative data are lacking.

Endovascular interventions are not indicated for the following scenarios and are considered unproven/not medically necessary: interventions for non‑limb‑threatening infrapopliteal artery disease (e.g., anterior tibial, posterior tibial, or peroneal territories) when not limb‑threatening; procedures performed in asymptomatic individuals; interventions intended solely to prevent progression of claudication to chronic limb‑threatening ischemia; transluminal peripheral atherectomy of the iliac artery; and treatment of a nonviable limb.

Guideline panels recommend that patients with intermittent claudication first receive guideline‑directed medical therapy and structured or supervised exercise programs; revascularization should be reserved for those with lifestyle‑limiting symptoms despite these measures. For CLTI, endovascular revascularization is considered medically necessary when diagnoses align with the applicable codes.

Routine standalone use of IVL as a definitive treatment without documentation that calcium modification was necessary, or without comparative evidence against alternative strategies (e.g., PTA, adjunctive devices), is discouraged until higher‑quality comparative and longer‑term outcome data are available.

Systematic reviews and technology assessments indicate IVL achieves favorable acute procedural results (improved luminal gain, fewer flow‑limiting dissections) but the literature is limited by single‑arm series, small sample sizes, and short follow‑up. Because durability and comparative effectiveness remain uncertain, IVL is considered not medically necessary for lower extremity ischemia in this policy.

Applicable Procedure and Diagnosis Codes

Listed procedure codes (selection)CPT

0238T	Transluminal peripheral atherectomy; iliac artery, each vessel.
0505T	Endovenous femoral-popliteal arterial revascularization with transcatheter placement of intravascular stent graft(s) and closure.
37254	Revascularization, endovascular, iliac vascular territory, angioplasty; straightforward lesion, initial vessel.

Additional listed procedure codesCPT

37255	Iliac angioplasty, each additional vessel.
37256	Iliac angioplasty, complex lesion, initial vessel.
37257	Iliac angioplasty, complex lesion, each additional vessel.
37258	Iliac stent placement, straightforward lesion, initial vessel.
37259	Iliac stent placement, straightforward lesion, each additional vessel.
37260	Iliac stent placement, complex lesion, initial vessel.
37261	Iliac stent placement, complex lesion, each additional vessel.
37262	Intravascular lithotripsy, iliac vascular territory.
37263	Femoral/popliteal angioplasty, straightforward lesion, initial vessel.
37264	Femoral/popliteal angioplasty, straightforward lesion, each additional vessel.

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Applicable CPT CodesCPTCovered

37288	Revascularization, tibial and peroneal vascular territory with transluminal stent placement; complex lesion, each additional vessel
37289	Revascularization, tibial and peroneal territory with transluminal atherectomy; straightforward lesion, initial vessel
37290	Revascularization, tibial and peroneal territory with transluminal atherectomy; straightforward lesion, each additional vessel
37291	Revascularization, tibial and peroneal territory with transluminal atherectomy; complex lesion, initial vessel
37292	Revascularization, tibial and peroneal territory with transluminal stent placement with transluminal atherectomy; straightforward lesion, initial vessel
37293	Revascularization, tibial and peroneal territory with stent and atherectomy; straightforward lesion, each additional vessel
37294	Revascularization, tibial and peroneal territory with stent and atherectomy; complex lesion, initial vessel
37295	Revascularization, tibial and peroneal territory with stent and atherectomy; complex lesion, each additional vessel
37296	Revascularization, inframalleolar vascular territory with transluminal angioplasty; straightforward lesion, initial vessel
37297	Revascularization, inframalleolar vascular territory with transluminal angioplasty; straightforward lesion, each additional 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
I70.229	Atherosclerosis of native arteries of extremities with rest pain, unspecified extremity
I70.231	Atherosclerosis of native arteries of right leg with ulceration of thigh

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Applicable ICD-10 Diagnosis CodesICD-10

M86.079	Acute hematogenous osteomyelitis, unspecified ankle and foot
M86.08	Acute hematogenous osteomyelitis, other sites
M86.09	Acute hematogenous osteomyelitis, multiple sites
M86.10	Other acute osteomyelitis, unspecified site
M86.151	Other acute osteomyelitis, right femur
M86.152	Other acute osteomyelitis, left femur
M86.159	Other acute osteomyelitis, unspecified femur
M86.161	Other acute osteomyelitis, right tibia and fibula
M86.162	Other acute osteomyelitis, left tibia and fibula
M86.169	Other acute osteomyelitis, unspecified tibia and fibula

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Applicable CPT codes (added)CPT

37254
37255
37256
37257
37258
37259
37260
37261
37263
37264

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Applicable CPT codes (removed)CPT

37220
37221
37222
37223
37224
37225
37226
37227
37228
37229

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Ankle-Brachial Index — numeric threshold used in coverage decisions

Ankle-Brachial Index (ABI) threshold≤ 0.90

ABI significanceABI compares systolic blood pressure in the ankle with the arm; ABI < 0.90 indicates peripheral artery disease

Use in coverage decisionsABI ≤ 0.90 is required to meet ischemic peripheral artery disease criterion for endovascular revascularization for claudication

Imaging stenosis threshold — percent stenosis considered for intervention

Imaging stenosis threshold

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization not specified

Prior authorization not specified in the provided excerpt. The policy text and applicable-code lists do not explicitly state a payer-level prior authorization requirement for the procedures described; verify prior authorization requirements with the member's benefit plan or payer portal prior to scheduling.

Prior Authorization

Prior authorization recommended for novel/endovascular devices

Prior authorization is recommended for novel or device-based endovascular procedures (e.g., DETOUR percutaneous femoropopliteal bypass, intravascular lithotripsy [IVL], and other emerging endovascular device techniques) because the evidence base is limited and these procedures may be considered investigational or have special review requirements.

DETOUR investigational device — consider prior review due to investigational study status
Intravascular lithotripsy (IVL) — consider prior review because evidence is evolving and payer may classify as unproven

Background and Rationale

Endovascular revascularization, including angioplasty, stent placement, and atherectomy, is an established treatment for lower extremity ischemia due to atherosclerotic disease when clinical and objective criteria are met. Claudication is exertional limb pain relieved by rest; Chronic Limb‑Threatening Ischemia (CLTI) involves rest pain, nonhealing wounds, or gangrene lasting ≥2 weeks and carries risk of limb loss. Diagnostic confirmation with ankle‑brachial index and vascular imaging guides appropriate patient selection and choice of revascularization modality.

Key Definitions

Ankle-Brachial Index definition and significance

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

Diagnostic thresholdABI < 0.90 indicates peripheral artery disease

Use in policyABI ≤ 0.90 is required documentation of ischemic peripheral artery disease for coverage of endovascular revascularization for claudication

Chronic Limb-Threatening Ischemia definition

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

Clinical significanceCLTI poses limb‑threatening risk and is an indication for endovascular revascularization when diagnoses align with applicable codes

Policy Revision History

2026-06-01material_changeLatest

Added policy language designating intravascular lithotripsy (IVL) for lower extremity ischemia as unproven and not medically necessary; updated Medical Records Documentation requirements to require more specific history/physical details, exercise therapy monitoring protocol, smoking cessation documentation, and use of TBI if ABI non-compressible; updated definition of Structured Community-Based Exercise Program; updated Applicable CPT codes list.

as listedcode_set_update

Large CPT code set update reflecting annual edits: added numerous codes (including 37254–37261, 37263–37278, 37280–37291, 37292–37299) and removed older codes (37220–37235); supporting updates made to Description of Services, Clinical Evidence, FDA, and References; previous policy version CS166.O archived.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyLower Extremity Endovascular Procedures

Policy CodePolicy CS166.P

Change TypeMaterial — coverage stance and documentation updatesCPT code set revised

Effective DateJun 1, 2026

Next Review DateN/A

SourceLink

On This Page

Novel or investigational devices (DETOUR, IVL): DETOUR and intravascular lithotripsy (IVL) show limited evidence; consider only with documented rationale and when alternatives are unsuitable; coverage may require prior authorization or case-by-case review.

DETOUR IDE and IVL trials provide limited/short-term data; long-term comparative outcomes are uncertain.

Use of atherectomy in iliac artery: Atherectomy of the iliac artery is rarely appropriate due to lack of data supporting benefit over angioplasty and stenting.

From multisociety appropriate use criteria.

≥ 50% stenosis on imaging

Imaging modalities referencedDuplex ultrasound, CTA, MRA, or digital subtraction angiography may be used to demonstrate ≥50% stenosis

Duplex ultrasound caveatIf duplex ultrasound does not demonstrate ≥50% stenosis, another imaging modality is necessary to demonstrate extent of stenosis

Supervised Exercise Therapy duration — minimum program length prior to intervention

Minimum SET durationMinimum 12 weeks

SET session guidanceSupervised sessions performed at least three times per week, training 30–45 minutes per 60-minute session

Role before revascularizationAt least 12 weeks of Supervised Exercise Therapy or a Structured Community-Based Exercise Program must be tried and failed prior to endovascular treatment for claudication

Miscellaneous coding key-value excerpt (placeholder)

Coding note (policy excerpt)Applicable CPT descriptions include tibial/peroneal/inframalleolar territory codes (37288–37299) describing angioplasty, stent placement, and atherectomy per lesion complexity

Code groupingPolicy lists multiple CPT codes for tibial, peroneal, and inframalleolar procedures and includes updated code sets in revisions

Prior authorization implicationInclusion of codes is for reference and does not guarantee coverage; prior authorization may apply per plan rules

DETOUR mean lesion length — trial metric

DETOUR mean lesion length32.7 cm

Study cohortDETOUR 2 IDE enrolled 202 participants (200 treated) with severe femoropopliteal disease

Lesion characteristics96% of lesions were chronic total occlusions and 70% were severely calcified

DETOUR chronic total occlusion rate — trial metric

DETOUR chronic total occlusion rate96% CTO lesions

Technical successTechnical success achieved in 100% of participants treated in DETOUR 2

One-year patencyPrimary patency at 12 months was 72.1%

Disrupt PAD III arm sizes — RCT arm enrollment sizes

DISRUPT PAD III arm sizesn = 153 per arm

Primary end pointProcedural success defined as residual stenosis ≤ 30% without flow‑limiting dissection prior to vessel treatment

Primary patency outcomePowered secondary end point was primary patency at 1 year; IVL showed higher primary patency at 1 and 2 years in mid‑term results

Hemodynamic thresholds for urgent revascularization (ankle pressure, ABI, toe pressure, TcPO2)

Ankle pressure / ABI threshold for urgent evaluationAnkle pressure < 50 mm Hg or ABI < 0.4 — consider urgent vascular imaging and revascularization

Toe pressure thresholdToe pressure < 30 mm Hg — consider urgent assessment for revascularization

TcPO2 thresholdTranscutaneous oxygen pressure < 25 mm Hg — consider urgent assessment for revascularization

Denial Risk

Denial conditions — insufficient clinical documentation or unmet criteria

Procedures may be denied if clinical criteria are not documented or met. Documentation demonstrating lifestyle-limiting symptoms, trial and failure of required conservative therapy, physiologic testing (ABI or TBI), and imaging evidence of ≥50% stenosis is required to support medical necessity.

ABI > 0.90 without supporting TBI when ABI non-compressible — may not meet ischemia criteria
Lack of ≥50% stenosis on appropriate imaging — may result in denial
Failure to document trial and monitoring of ≥12 weeks of supervised or structured exercise therapy and guideline-directed medical therapy — may result in denial

Note

No explicit authorization/denial workflow in excerpt

This section lists applicable procedure and diagnosis codes and clinical criteria but does not include explicit operational authorization or denial rules (e.g., automatic prior auth, timeframe for decisions, or stepwise approval workflow). Providers should confirm authorization rules with the payer.

Code lists are for reference only and do not guarantee coverage or authorization
Confirm prior authorization and submission requirements via payer channels

Denial Risk

Risk of denial for intravascular lithotripsy (IVL)

There is a specific risk of denial for intravascular lithotripsy (IVL). The policy language identifies IVL as unproven and not medically necessary for treating lower extremity ischemia due to insufficient evidence of efficacy; claims for IVL may therefore be denied.

Policy states IVL is unproven and not medically necessary for lower extremity ischemia
Clinical evidence is evolving; payers may deny IVL as investigational or not medically necessary

Step Therapy

Conservative therapy requirement before revascularization

Conservative therapies are required and must be documented before endovascular revascularization for claudication. At minimum, the member must have tried and failed: a supervised exercise therapy program or structured community-based exercise for ≥12 weeks, guideline-directed pharmacologic therapy, and smoking cessation when applicable.

Minimum 12 weeks of Supervised Exercise Therapy or a Structured Community-Based Exercise Program with monitoring protocol and documentation
Guideline-directed medical therapy (lipid-lowering, antihypertensive, antiplatelet and/or anticoagulant therapy)
Smoking cessation attempts, if applicable

Terminology notePreviously termed critical limb ischemia; current nomenclature emphasizes chronic, limb‑threatening nature

Claudication definition

Claudication definitionFatigue, cramping, aching, or pain of vascular origin in lower extremity muscles consistently induced by walking and relieved by rest

Functional impactWhen claudication limits function it is termed functionally limiting Claudication and may justify revascularization after conservative therapy fails

Typical relief timeframeSymptoms usually relieved by rest within approximately 10 minutes

Supervised Exercise Therapy definition (SET) — program description and minimum session guidance

Supervised Exercise Therapy (SET) descriptionA supervised, treadmill‑based program focused on intermittent walking with rest periods, supervised by qualified health professionals

Minimum session guidanceTraining performed a minimum of 30–45 minutes of active walking per 60‑minute session, at least three times per week for a minimum of 12 weeks

Program goal and alternativesTraining uses intermittent bouts to moderate–maximal claudication pain with progressive increases; non‑treadmill modalities can be used when appropriate

Structured Community-Based Exercise Program — definition and scope

Structured Community-Based Exercise Program descriptionHome or community‑based, self‑directed walking program prescribed by qualified health professionals with counseling, behavioral techniques, activity monitors, and possible periodic supervised sessions

Program supervisionQualified health care professionals prescribe regimen similar to SET and provide guidance, counseling, and periodic assessments

Role relative to SETMay be used as an alternative to SET; at least 12 weeks of a Structured Community‑Based Exercise Program can satisfy conservative therapy requirement

Revascularization procedures per CPT descriptions — tibial/peroneal/inframalleolar territories

Tibial/peroneal/inframalleolar CPT proceduresCodes 37288–37299 describe endovascular revascularization procedures (angioplasty, stent placement, atherectomy) for tibial, peroneal, and inframalleolar territories

Procedure componentsDescriptions include all maneuvers necessary for artery access, catheterization, lesion crossing, imaging guidance, and radiological supervision and interpretation

Lesion complexityCodes distinguish straightforward vs complex lesions and initial vs additional vessels for accurate billing

Claudication definition (alternate chunk)

Claudication (alternate)Leg pain, numbness, or cramping during exercise that is relieved by rest — a manifestation of PAD

Risk factorsAge, smoking, diabetes, obesity, hypertension, and high cholesterol increase PAD risk

Treatment optionsInclude lifestyle changes, medications, endovascular techniques, and surgery

Chronic Limb-Threatening Ischemia (CLTI) definition (alternate chunk)

CLTI (alternate) definitionAdvanced PAD with rest pain, tissue loss, or ischemic ulceration risking limb loss; indication for revascularization

Clinical actionEndovascular revascularization procedures are medically necessary for CLTI when diagnoses align with applicable codes

DistinctionCLTI distinguished from acute limb ischemia by chronic duration (≥2 weeks)

Intravascular lithotripsy (IVL) definition — vessel preparation technique

Intravascular lithotripsy (IVL) definitionA vessel preparation technique using ultrasound waves to disrupt arterial calcium to facilitate angioplasty/stenting

Adjunct rolePerformed as an adjunct to prepare calcified lesions to reduce residual stenosis and flow‑limiting dissections during procedures

Evidence cautionPolicy designates IVL as unproven/not medically necessary for lower extremity ischemia due to insufficient evidence of efficacy despite encouraging early results

DETOUR system definition — endovenous femoropopliteal bypass concept

DETOUR system descriptionAn endovenous femoropopliteal bypass using stents routed through the femoral vein to restore arterial flow for long occlusive superficial femoral artery lesions

Study evidenceDETOUR 2 IDE enrolled 202 participants (200 treated) showing technical success and 1‑year primary patency of 72.1%, but evidence limited by lack of randomization and long‑term data

Coverage stanceEndovenous femoropopliteal bypass (DETOUR) is considered unproven and not medically necessary due to insufficient comparative evidence

Structured Community-Based Exercise Program (updated definition)

Structured Community-Based Exercise Program (updated)Home/community-based, self‑directed walking program prescribed and monitored by qualified professionals, may include behavioral techniques, activity monitors, and periodic supervised sessions (policy definition updated)

Equivalence to SETCan satisfy conservative therapy requirement when performed for at least 12 weeks with documented monitoring protocol

Documentation requirementPolicy history requires documentation of monitoring protocol and specifics of exercise therapy when used for prior conservative therapy attempts