Peripheral Vascular Stents
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Defines Aetna's coverage stance and medical necessity criteria for peripheral arterial and venous stent placement, and identifies experimental/investigational uses; applies to Aetna members and participating providers following eviCore Peripheral Vascular Intervention Clinical Guidelines.
Coverage Criteria and Evidence Summaries
Covered when ALL/ANY of the following are met (device- and indication-specific)
Aetna considers peripheral artery stenting with FDA‑approved stents medically necessary when the following device- and indication‑specific criteria are met.
Overall covered scenarios
- Popliteal artery aneurysm (primary or salvage): Aneurysm is symptomatic (painful, pulsatile, or associated with distal emboli) OR >= 2.0 cm on imaging; AND member is high peri-operative surgical risk; AND imaging documents >= 15 mm of normal artery proximal AND distal to the aneurysm>= 2.0 cm; >= 15 mm normal artery proximal AND distal
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- Iliac artery disease: Primary therapy for common iliac artery stenosis and occlusions OR external iliac artery stenoses and occlusions
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- Chronic mesenteric ischemia: Primary therapy for chronic mesenteric ischemia
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- Subclavian artery disease: Primary therapy for symptomatic posterior cerebral or cerebellar ischemia due to subclavian stenosis (subclavian steal) in high surgical risk individuals; OR primary therapy for symptomatic extremity ischemia after PTA
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- Brachiocephalic salvage: Salvage therapy for brachiocephalic arteries (eg, subclavian steal, upper‑extremity claudication, ischemic rest pain, non‑healing ulceration, focal gangrene) after suboptimal PTA
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- Femoral/popliteal/tibial salvage: Salvage therapy after sub‑optimal or failed balloon dilation (persistent translesional gradient, residual diameter stenosis >50%, or flow‑limiting dissection)>50% residual stenosis
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- Named device indications: Use of specific FDA‑approved devices for their labeled peripheral indications is covered (examples: Gore Viabahn for symptomatic SFA and selected iliac lesions; LifeStream balloon‑expandable covered stent for iliac artery disease; Eluvia and Zilver PTX for SFA/PPA with device‑specific caveats)
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- Peripheral venous stents: Covered for hemodialysis access graft/fistula stenosis/restenosis/occlusion (including salvage for recurrent cephalic arch stenosis), May‑Thurner syndrome, superior vena cava syndrome, and ilio‑caval venous occlusion when selection criteria and procedural documentation are met
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- Renal artery stenting (atherosclerotic disease): Covered when any of the following are met: intolerance to optimal medical therapy (eg, creatinine rise after RAS inhibitor) or failure of optimal medical therapy to control BP; hemodynamically significant bilateral RAS >75%; progressive kidney impairment attributable to the stenosis (including bilateral disease or solitary kidney); recurrent flash pulmonary edema or refractory heart failure due to RAS; unexplained progressive renal insufficiency especially without proteinuria>75% for bilateral RAS
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Renal artery stenting — evidence-informed coverage stance
Stenting for atherosclerotic renal artery stenosis may be considered in select high‑risk patients; routine stenting is not supported by RCTs and medical therapy is preferred for most patients.
Supported by AHRQ, CORAL, ASTRAL, Steichen systematic review
Low‑level evidence; weigh procedural risks (atheroembolism, contrast nephropathy)
Refer to limited feasibility and case‑series data
Peripheral (iliac / femoro-popliteal) stent evidence
Evidence for stent use in femoro‑popliteal and iliac disease shows device‑ and lesion‑specific differences; patency gains are often surrogate endpoints and clinical benefit varies with lesion complexity and device type.
Dake et al; Eluvia trials
VIPER, Saxon et al; VIBRANT and systematic reviews
CRISP‑US; COBEST; LifeStream BOLSTER
Guideline-based coverage statements
Guideline and consensus statements inform appropriateness of primary versus provisional stenting and device selection.
AHA/ACC statements
AHA/ACC statements
AHA/ACC guidance; Cochrane review
AHA/ACC and device labeling
Evidence summaries by vascular territory
Summaries of evidence by vascular territory emphasize differing levels of support for stenting across beds.
Dake et al; Eluvia trials
VIPER; Saxon et al
Series summaries
Chatterjee et al; pooled analyses
Evidence-based coverage considerations
Evidence‑based considerations that affect coverage decisions and authorization assessment.
COBEST; Lammer et al; Cochrane review
Hajibandeh systematic review; RCTs
CORAL; Cooper et al; Steichen review
Device labeling; VIPER; Ohki et al
Clinical appropriateness and factors influencing success
Clinical and procedural factors associated with improved or worsened outcomes that should inform appropriateness decisions.
LifeStream BOLSTER; Viabahn IFU
Johnston et al; Ohki et al
Follow‑up imaging and required procedural documentation
Jayaraj et al; Bondarev et al
Clinical evidence and practice implications
Practice implications and key clinical evidence points that influence coverage and device choice.
Jayaraj et al; UpToDate
Eluvia trials; FDA advisory; VIVA meta‑analysis
BD/Venovo safety notice
Plouin; UpToDate; CORAL critiques
Garcia‑Medina; Marsh et al
Coverage-relevant clinical summaries
Coverage‑relevant clinical positions derived from evidence and small randomized trials where available.
UpToDate; Plouin et al
Garcia‑Medina; Marsh et al
Kum et al; Mustapha
Cochrane update; Joshi et al
Coverage considerations and clinical criteria (summary)
Summarized considerations to guide coverage decisions, weighing patient factors, lesion anatomy, and comparative evidence.
Joshi et al; Cervin et al
Kim and Sumpio review
VIPER; Ohki et al; device studies
Kaufman; Mousa UpToDate
Reinhard et al; meta‑analyses
Renal artery stenting — coverage criteria
Coverage for renal artery stenting is most supportable when patients meet high‑risk clinical criteria or have failed optimal medical therapy.
Prospective cohort and guideline‑based selection
UpToDate; Courand et al
CORAL; systematic reviews
Femoropopliteal device evidence
Device‑level evidence and comparative outcomes for femoro‑popliteal interventions to guide device selection.
Zenunaj et al; meta‑analyses
Zhang and Yin; FDA advisory summaries
Gray et al; IMPERIAL long‑lesion sub‑study
Aetna excludes all drug-eluting arterial stents and PTFE-covered arterial stents except for specifically named devices (notably the Gore Viabahn PTFE-coated endoprosthesis and the Atrium/Atium iCast covered stent). The policy footnote and related experimental/investigational listing identify other DES platforms (for example, Zilver PTX in some peripheral uses) and PTFE-covered devices as not generally permitted outside the named, labeled indications or study settings. These exclusions reflect the lack of established effectiveness for many DES and covered stent uses in peripheral vascular disease and preserve coverage only for the named, device-specific indications supported by evidence or FDA approval.
Routine use of PTFE-covered stents or drug-eluting stents (DES) for renal in-stent restenosis (ISR) or for atherosclerotic renal artery stenosis (ARAS) is not supported by the evidence and is considered outside routine indications. The background review notes limited case-series data and feasibility studies but no consistent clinical-outcome benefit to justify routine application of covered stents or DES in the renal circulation.
Primary stent placement in the femoral, popliteal, or tibial arteries is not recommended as first-line therapy. Guideline statements and pooled trial data indicate that stents are appropriate as provisional or salvage therapy after sub-optimal balloon angioplasty (eg, persistent gradient, residual stenosis >50%, or flow‑limiting dissection), but routine primary stenting for short SFA lesions has not demonstrated consistent reductions in restenosis or need for repeat revascularization.
Device implantation is contraindicated when the lesion cannot be sufficiently dilated to permit passage of the delivery system or to allow proper stent deployment. Device labeling (for example, Zilver PTX and the Gore Viabahn Endoprosthesis) explicitly states that stents should not be used where full balloon dilatation or delivery-system passage cannot be achieved.
Renal-artery stenting for moderately severe atherosclerotic renovascular disease should not be performed routinely for prevention of clinical events. Multiple randomized trials and systematic reviews found no clear advantage of PTRAS over optimal medical therapy for most patients with ARAS, so revascularization is reserved for select high-risk presentations or failure/intolerance of medical management.
Use of bioresorbable/biodegradable stents outside of clinical trials is discouraged. Published series are small, heterogeneous, and of limited follow-up; one systematic review concluded that current evidence is insufficient to support routine use and recommended limiting these devices to study-related cases.
Stent grafts (covered endoprostheses) are unsuitable for "across-the-knee" applications in many device IFUs and study protocols. Available device labeling and trial reports note requirements such as at least one patent runoff vessel and other anatomic constraints; procedures performed outside these IFU limitations have been associated with worse outcomes.
Routine stent placement is not recommended as first-line therapy for renal artery fibromuscular dysplasia (FMD). PTA (angioplasty) without stent is the preferred initial treatment for FMD; stent placement is generally reserved for angioplasty-related complications (eg, flow‑limiting dissection) or rare perforation.
Stent placement as first-line therapy for renal artery FMD is excluded except when required to manage PTA-related complications such as dissection or perforation. The policy and background emphasize angioplasty-alone as effective in most FMD cases and reserve stents for procedural salvage.
Randomized trials and pooled analyses have not demonstrated broad clinical benefit of PTRAS compared with medical therapy for unselected ARAS patients. Accordingly, routine percutaneous transluminal renal angioplasty and stenting (PTRAS) for unselected patients is discouraged; selection should be limited to patients with compelling, high‑risk clinical features or documented failure/intolerance of optimal medical therapy.
Broad application of PTRA/stenting for ARAS in unselected patients without high‑risk features may be excluded from coverage rationale. Systematic reviews and RCT meta‑analyses report BP improvements in some analyses but no clear reductions in stroke, renal events, cardiac events, or mortality to justify routine revascularization for most patients.
Peripheral artery stenting is listed as experimental/investigational for multiple specific indications where evidence is lacking. Examples include celiac artery stenting for compression syndrome, primary tibial/infra‑popliteal therapy, certain uses in aorto‑iliac disease and renal vascular disease, biodegradable stents for PAD, Eluvia for iliac stenosis, hybrid foot vein arterialization, and LimFlow/pDVA for CLI unless treated in defined investigational settings.
Renal artery stenting without compelling indications is not medically necessary. Randomized trials (eg, Bax; ASTRAL; CORAL) and systematic reviews have demonstrated no consistent renal- or cardiovascular-event benefit of routine PTRAS over optimal medical therapy, and routine revascularization for low‑risk, stable ARAS patients is not supported.
Routine primary stenting for short superficial femoral–popliteal artery (SFA) lesions is not supported by pooled trial data. Meta‑analyses of randomized trials found higher immediate technical success with routine stenting but no clear reduction in restenosis or target‑vessel revascularization to support universal primary stenting for short lesions.
There is insufficient high‑quality evidence that DES or covered stents universally provide clinically meaningful advantages for infra‑inguinal peripheral artery disease in scenarios such as in‑stent restenosis (ISR). Available RCTs and systematic reviews show device‑ and study‑specific results; broad endorsement of DES or covered stents for all ISR cases is not supported.
Stenting of renal arteries is not supported as an intervention to prevent cardiovascular or renal events in general ARAS populations. The CORAL trial and related RCTs did not show reductions in major clinical endpoints with routine stenting plus medical therapy compared with medical therapy alone.
Routine revascularization for ARAS in low‑risk, stable patients lacks evidence of added benefit. Randomized controlled trials with medium‑term follow‑up found no meaningful differences in renal function, cardiovascular events, or mortality compared with optimal medical therapy; revascularization should be reserved for selected high‑risk presentations.
Evidence limitations are repeatedly noted: many studies are retrospective or single‑arm, sample sizes are small, follow‑up is limited, and outcome adjudication is often not independent. These methodological constraints limit generalizability and preclude asserting sustained superiority for several device indications until larger, longer randomized trials are available.
PTRAS has a low strength of evidence for improving mortality, need for renal replacement therapy, or major cardiovascular events compared with medical therapy in broad ARAS populations. Systematic reviews and RCTs support this conclusion and emphasize that any benefit is most likely limited to selected high‑risk patients.
Routine renal artery stenting in patients without high‑risk clinical features or without failure/intolerance of optimal medical therapy is discouraged. Trials and systematic reviews recommend medical therapy as first‑line for most atherosclerotic RAS patients and reserve intervention for those with specific high‑risk presentations (eg, flash pulmonary edema, refractory heart failure, rapidly declining renal function, or true resistant hypertension).
Coding: Covered and Non-covered Codes
| 37236 | Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous; initial artery. |
| 37237 | Each additional artery (List separately in addition to code for primary procedure). |
| 37221 | Revascularization, endovascular, open or percutaneous, iliac artery, unilateral, initial vessel; with transluminal stent placement(s). |
| 37223 | With transluminal stent placement(s) (List separately in addition to code for primary procedure). |
| 37226 | Revascularization, endovascular, femoral, popliteal artery(s), unilateral; with transluminal stent placement(s). |
| 37227 | Revascularization, endovascular, femoral, popliteal artery(s), unilateral; with transluminal stent placement(s) and atherectomy. |
| 0505T | Endovenous femoral-popliteal arterial revascularization, with transcatheter placement of intravascular stent graft(s) and closure by any method. |
| 37238 | Transcatheter placement of an intravascular stent(s); initial vein. |
| 37239 | Each additional vein (List separately). |
| 37248 | Transluminal balloon angioplasty, initial vein. |
| 37249 | Each additional vein. |
| C1874 | Stent, coated/covered, with delivery system. |
| C1875 | Stent, coated/covered, without delivery system. |
| C1876 | Stent, non-coated/non-covered, with delivery system. |
| C1877 | Stent, non-coated/non-covered, without delivery system. |
| C2617 | Stent, noncoronary, temporary, without delivery system. |
| C2625 | Stent, noncoronary, temporary, with delivery system. |
| C2623 | Catheter, transluminal angioplasty, drug-coated, non-laser. |
| I70.1 | Atherosclerosis of renal artery. |
| I72.4 | Aneurysm of artery of lower extremity (popliteal artery aneurysm). |
| I96 | Gangrene, not elsewhere classified. |
| K55.9 | Vascular disorder of intestine, unspecified (chronic mesenteric ischemia). |
| G45.8 | Other transient cerebral ischemic attacks and related syndromes. |
| I70.201 | Unspecified atherosclerosis of native arteries of extremities, leg. |
| I73.00 - I73.9 | Other peripheral vascular disease. |
| I77.1 | Stricture of artery [tibial]. |
| I77.4 | Celiac artery compression syndrome. |
| N28.0 | Ischemia and infarction of kidney [ischemic nephropathy]. |
Provider Actions, Prior Authorization, and Documentation
Prior authorization required per eviCore for stents and related codes
Prior authorization is required per eviCore Healthcare Peripheral Vascular Intervention Clinical Guidelines for medical necessity determinations for peripheral vascular stents and associated CPT/HCPCS codes (e.g., 37236, 37237, 37221, 37223, 37226, 37227, 0505T, 37238, 37239, 37248, 37249).
- PA requirement applies to peripheral vascular stent procedures and listed related CPT/HCPCS codes.
Prior authorization recommended for renal artery stenting
Consider submitting a prior authorization for renal artery stenting when compelling clinical indications are documented (for example: recurrent flash pulmonary edema, rapidly progressive renal failure, or refractory hypertension despite optimal medical therapy), because routine stenting for ARAS without compelling indications is not supported by RCT evidence.
- Document presence of high‑risk features (flash pulmonary edema, rapidly declining renal function, true resistant hypertension) when requesting authorization.
Prior authorization justification for stent placement (iliac primary/provisional use)
When requesting authorization for iliac or other peripheral stent placement, justify whether stent use is primary (accepted for common/external iliac arteries) or provisional/salvage (for other segments after suboptimal balloon angioplasty), and provide documentation supporting that choice.
- For iliac arteries, primary stenting is an accepted therapy — cite anatomy and lesion documentation.
- For femoral/popliteal/tibial segments, document provisional use after suboptimal balloon dilation (residual stenosis >50%, persistent gradient, or flow-limiting dissection).
Device-label matching required
Ensure the device indication matches the labeled indication and contraindications; prior authorization should confirm device labeling fits the anatomy (e.g., vessel size and ability to permit delivery) and that contraindications (such as lesions that cannot be dilated to allow device passage) are not present.
- Confirm device IFU requirements (vessel diameter, lesion dilatability) are met and document in the authorization request.
Consider lesion severity and stent type for authorization
Prior authorization decisions should consider lesion severity, location, TASC class/length, and stent type because randomized trials and device studies show differing patency and outcome profiles by lesion length and stent platform.
- Provide lesion length, TASC class, and rationale for selecting covered versus bare or drug‑eluting stent in the PA submission.
Device-specific authorization requirement (iCast/Advanta V12 PMA example)
Identify device‑specific indication and supporting evidence for covered balloon‑expandable devices (example: iCast/Advanta V12 has longer‑term data and FDA PMA for iliac arterial occlusive disease); include device name and relevant trial evidence in the authorization request.
- When using iCast/Advanta V12 or similar CBE devices, reference available long‑term patency data (e.g., iCast 5‑year outcomes) in the PA.
Device indication and sizing documentation required
Document device indication and sizing parameters when requesting authorization for covered balloon‑expandable stents (for example, LifeStream is indicated for common/external iliac lesions with reference vessel diameters 4.5–12.0 mm and lesion lengths up to 100 mm).
- Include reference vessel diameter and lesion length measurements in the PA submission to support device selection.
Device safety communications and paclitaxel advisory
Be aware of device safety communications that may affect authorization and clinical decision‑making (for example, the BD Venovo urgent safety notice regarding proximal end not expanding on deployment and FDA advisories about paclitaxel‑coated devices); include acknowledgement of known safety notices when relevant.
- If seeking authorization for paclitaxel‑coated devices (e.g., Eluvia), note FDA advisories and weigh benefits versus potential long‑term safety concerns.
- If using Venovo devices, document awareness of the BD safety notice and planned management strategies if deployment issues arise.
pDVA (LimFlow) prior authorization (investigational/novel therapy note)
Prior authorization for percutaneous deep vein arterialization (LimFlow/pDVA) should document that the patient is no‑option CLI (Rutherford 5–6) and ineligible for conventional revascularization because pDVA is investigational/novel with limited feasibility and pilot data.
- Provide documentation of no‑option status, Rutherford class, and prior revascularization attempts when requesting authorization for pDVA.
Prior authorization: PAA endovascular repair — evidence considerations
For endovascular repair of popliteal artery aneurysm, prior authorization should reflect limited/moderate‑quality evidence comparing endovascular versus open repair; document anatomy, symptoms or aneurysm ≥2.0 cm, surgical risk, and rationale for endovascular approach.
- Include imaging showing aneurysm size and anatomy, peri‑operative surgical risk assessment, and reasons open repair is unsuitable or higher risk.
Prior authorization for renal artery stenting — confirm high‑risk clinical criteria
Prior authorization for renal artery stenting must confirm high‑risk clinical criteria (severe stenosis ≥70% with true resistant hypertension, rapidly declining renal function/ischemic nephropathy, or recurrent flash pulmonary edema) or document intolerance/failure of optimal medical therapy.
- Supply angiographic stenosis percentage, BP control history and medications, eGFR trends, and episodes of flash pulmonary edema when seeking PA.
Prior authorization guidance — follow plan procedures and CPBs
Follow the plan's procedures for authorization and use Clinical Policy Bulletins and Clinical Policy documents (and eviCore guidance where applicable) as references when preparing prior authorization submissions; inclusion of requested CPB documentation does not guarantee coverage.
- Adhere to the insurer's PA process and include the CPB‑requested clinical and imaging documentation to support the request.
Conservative therapy expectation (first‑line for many PAD patients)
Conservative management is expected as first‑line therapy for many patients with PAD — more than 70% remain stable or improve with conservative care — so authorization requests should document prior conservative therapy and indications for escalation to revascularization.
- Document trials of conservative care (exercise programs, medical risk‑factor optimization) and clinical progression prompting endovascular intervention.
Medical therapy before stenting — optimize medical management first
Optimize and document aggressive medical therapy before electing renal artery stenting, as trials and systematic reviews found no clear net benefit of revascularization over optimal medical management in many ARAS patients.
- Provide evidence of optimized antihypertensive regimen, adherence, medication intolerance (if present), and eGFR trends in the PA submission.
Preferred initial therapy and escalation — angioplasty with provisional stenting recommended
Guideline statements support balloon angioplasty with provisional stenting as the preferred initial approach for femoral/popliteal/tibial arteries; authorization should document that initial PTA was attempted or justify primary stent use only when accepted by guideline/device labeling.
- For femoro‑popliteal/tibial lesions, document PTA result and clinical justification for provisional or primary stent placement.
Consider PTA first for select lesions
Consider PTA alone first for selected lesions (for example, mesenteric or subclavian beds) and document angioplasty attempts or failure when seeking authorization for stenting; pooled data favor stenting as rescue after failed PTA in some territories.
- Include procedural notes showing PTA attempt, residual stenosis, gradient, or dissection when requesting stent authorization.
Device selection considerations — choose device based on lesion/clinical factors
Select device based on lesion location, lesion characteristics, and available evidence; document rationale for device choice (BMS vs covered stent vs DES) in the authorization because device selection affects outcomes and suitability.
- Provide lesion length, vessel diameter, runoff status, and evidence supporting chosen device in the PA request.
Renal artery revascularization sequencing — medical therapy first-line; revascularization for select patients
For atherosclerotic renal artery stenosis, medical therapy is first‑line for most patients; revascularization is reserved for selected high‑risk presentations (refractory hypertension, recurrent flash pulmonary edema, rapidly declining renal function) and authorization should reflect this sequencing.
- Document attempts at optimal medical therapy, indications of failure/intolerance, and the high‑risk features that justify revascularization.
Preferred ISR treatment considerations — RCT evidence compares DCB, stent grafts, DES
When treating in‑stent restenosis (ISR) of peripheral arteries, authorization and documentation should reflect prior therapies and rationale for selecting modalities (drug‑coated balloon, stent graft/Viabahn, DES), as RCTs compare these approaches and influence coverage decisions.
- Include prior ISR treatments, imaging, and justification for chosen ISR therapy in the PA.
Staged ilio‑femoral stenting — treat more symptomatic limb first
For bilateral ilio‑femoral disease, consider a staged stenting approach starting with the more symptomatic limb; authorization should document the plan and rationale as staged treatment may reduce contralateral interventions.
- Document symptoms and planned sequencing (treat worse limb first) when requesting authorization for bilateral procedures.
Renal artery FMD step therapy — PTA first‑line; stent only for PTA complications
For renal artery fibromuscular dysplasia (FMD), percutaneous transluminal angioplasty (PTA) without stent is first‑line; prior authorization for stent placement should be limited to cases with PTA‑related complications (dissection or perforation) and documentation must reflect that sequence.
- When a stent is placed for FMD, document that PTA was performed and the specific complication necessitating stent placement.
Preferred vs alternative approach — OSR preferred in younger/active patients when venous conduit available
When choosing endovascular versus open surgical repair, document patient factors (age, activity level, availability of venous conduit, comorbidities) because open surgical repair is generally preferred in younger/active patients with suitable conduit while endovascular repair may be preferred in older/frail patients.
- Include assessment of venous conduit availability and peri‑operative risk in the authorization justification.
Medical therapy comparator expectation in trials (BMT/optimal antihypertensive regimen)
In trials, best medical therapy or optimal antihypertensive regimens are the comparator for renal interventions; prior authorization should document attempts at medical therapy and results before approving revascularization except in clearly high‑risk presentations.
- Provide details of antihypertensive regimen, response, and intolerance where relevant to the PA.
Popliteal aneurysm documentation requirements
Documentation must show that for popliteal artery aneurysm (PAA) the aneurysm is symptomatic or ≥2.0 cm, that the member is high peri‑operative surgical risk, and imaging demonstrates at least 15 mm of normal artery proximal AND distal to the aneurysm when stent grafting is proposed.
- Include imaging measurements showing aneurysm size and the required 15 mm zones of normal artery proximal and distal to the aneurysm.
Renal artery stenting documentation requirements
For renal artery stenting authorization, provide documentation that the patient is intolerant of optimal medical therapy or has met hemodynamic/clinical criteria (e.g., bilateral RAS >75%, progressive renal impairment attributable to stenosis, recurrent flash pulmonary edema) supporting revascularization.
- Supply angiographic stenosis severity, eGFR trends, antihypertensive medication history, and episodes of decompensation.
Suggested clinical documentation (pre/post BP, meds, eGFR, imaging)
Suggested clinical documentation to include pre‑ and post‑intervention blood pressure measurements, antihypertensive medication use, estimated GFR/eGFR, angiographic lesion severity, and technical success/peri‑procedural complications to support claimed benefits.
- Provide serial BP values, medication counts/doses, eGFR values over time, and procedural reports with angiographic images.
Recommended supporting clinical documentation (ABI, Rutherford, duplex, lesion characteristics)
Recommended supporting clinical documentation includes follow‑up data demonstrating patency and clinical benefit (ABI, Rutherford category, duplex ultrasound) and lesion characteristics (lesion length, TASC classification) used to support medical necessity.
- Include ABI, Rutherford class, duplex peak systolic velocity ratios or CTA/MRA reports, and lesion length/TASC classification in the record.
Follow‑up imaging and surveillance guidance (duplex/CTA schedule)
Follow‑up imaging and clinical surveillance schedules used in studies (e.g., duplex ultrasonography, CTA) are reasonable to document outcomes: common timepoints include 1, 3, 6, and 12 months and annually thereafter; include imaging and PSV ratios or contrast imaging results to document patency.
- Submit duplex or CTA reports at standard follow‑up intervals to support continued medical necessity and monitor for restenosis.
Procedure and outcome documentation examples (technical details, embolic protection use)
Procedure and outcome documentation examples should include technical details (approach, devices used, number and size of stents), lesion crossing technique, use of embolic protection when applicable, and peri‑procedural complications to justify clinical benefit.
- Provide completion arteriography results, device identifiers, and notes on embolic protection or adjunctive therapies in the procedure report.
Trial‑defined endpoints to document (device success, MAVE, primary patency timepoints)
When trials are referenced for device coverage, document trial‑defined endpoints where relevant (device/procedural success, MAVE/MAVE rates, primary patency timepoints, freedom from TLR) to support clinical claims in authorization or appeals.
- Include available trial endpoint data or comparable outcome measures in submissions seeking coverage for newer devices.
Required procedural documentation (lesion location, length, RVD and device sizing)
Required procedural documentation should include lesion location, lesion length, reference vessel diameter (for LifeStream: 4.5–12.0 mm and lesion length up to 100 mm), pre‑ and post‑procedure ABI, Rutherford category, and completion arteriography results.
- Provide precise measurements and imaging corroboration to support device selection and expected outcomes.
Renal FMD procedural documentation (PTA performed and reason for stent if placed)
For renal FMD procedures, documentation should reflect that PTA (typically without stent) was performed and explicitly state the reason for stent placement if a stent was used (e.g., angioplasty‑related dissection or arterial perforation).
- Include procedural notes confirming PTA attempt and the complication prompting stent placement.
Dialysis fistula stent‑graft documentation requirements
For stent‑graft use in dialysis arteriovenous fistulae, document the specific indication (e.g., partially thrombosed aneurysm or residual wall‑adherent thrombus), prior treatments, and whether cannulation through the stent graft is anticipated as these factors affect expected patency and coverage considerations.
- Provide history of prior interventions, imaging of aneurysm/thrombus, and plan for dialysis access cannulation relative to the stent graft.
Imaging and procedural documentation — IVUS use and completion imaging
When IVUS is used to confirm and characterize venous stenosis and to size stents, include IVUS findings and completion imaging (venography/arteriography) in the procedural documentation to support device sizing and final result.
- Attach IVUS measurements, completion venography images, and stent sizing details to the PA or procedure record.
Documentation should demonstrate high‑risk clinical presentation for renal revascularization
Documentation for renal revascularization requests should demonstrate a high‑risk clinical presentation (for example, severe RAS ≥70% with true resistant hypertension, rapidly declining renal function/ischemic nephropathy, or recurrent flash pulmonary edema) or evidence of failed/intolerant optimal medical therapy.
- Provide ambulatory BP measurements, antihypertensive regimen details, eGFR trajectory, and hospitalization history for heart failure/flash pulmonary edema.
Treating provider responsibility disclaimer — CPB is partial description of benefits
Treating providers are responsible for medical advice and treatment; Clinical Policy Bulletins and CPBs provide partial descriptions of plan benefits but do not guarantee coverage — follow plan authorization processes and include requested documentation.
- Adhere to plan PA requirements and include CPB‑specified documentation when submitting requests.
Adherence to eviCore guidelines required
Adherence to eviCore Healthcare Peripheral Vascular Intervention Clinical Guidelines is required for medical necessity determinations; lack of adherence to those criteria could trigger denial of coverage.
- Follow eviCore criteria and include required clinical and imaging documentation to support authorization requests.
Potential denial for routine renal artery stenting
Stenting for atherosclerotic renal artery stenosis without a compelling indication may be denied because RCTs (Bax; ASTRAL; CORAL) showed no clear renal or cardiovascular event benefit and documented procedure‑related serious complications.
- Ensure authorization requests show compelling high‑risk criteria or failed/intolerant medical therapy to avoid potential denial.
Guideline‑based limitation on primary stenting in femoral/popliteal/tibial arteries
Primary stent placement in the femoral, popliteal, or tibial arteries is not recommended by guidelines; submitting routine primary stenting in these beds without salvage/provisional justification may result in denial.
- Document that stent placement in these segments is being used as salvage after suboptimal PTA or provide guideline‑based justification.
Lesion non‑dilatable contraindication
Devices should not be used where lesions cannot be dilated sufficiently to permit passage of the delivery system or allow proper stent placement (for example, Zilver PTX and Gore Viabahn contraindications); lack of lesion dilatability documented in the PA may lead to denial.
- Document lesion pre‑dilatation results and confirm delivery system can be passed when requesting authorization.
Renal artery stenting limited utility per CORAL
Renal‑artery stenting did not confer significant prevention of clinical renal or cardiovascular events compared with medical therapy in CORAL and related trials; routine stenting for moderately severe ARAS should not be expected to be covered without high‑risk indications.
- When seeking authorization for ARAS cases, emphasize high‑risk clinical features or failure of medical therapy to support approval.
Device selection may affect short‑term outcomes (cephalic arch example)
Failure to use evidence‑based device selection may increase the risk of early restenosis or re‑intervention (for example, bare nitinol stents produced higher restenosis than stent grafts in recurrent cephalic arch stenosis); authorization and documentation should reflect appropriate device choice.
- Provide evidence and rationale for device choice to minimize denial risk related to inappropriate device selection.
Device suitability limits — need at least one patent runoff vessel; unsuitability across‑the‑knee
Device suitability limits (for example, requirement for at least one patent runoff vessel and unsuitability for across‑the‑knee applications) must be observed; procedures performed outside device limitations may lead to worse outcomes and potential noncoverage.
- Confirm and document runoff vessel status and IFU‑based anatomic suitability in the PA submission.
Venovo deployment adherence risk (BD safety notice implications)
Use or implantation of Venovo devices affected by the BD urgent safety notice (proximal stent end may not expand on deployment) may raise safety concerns; document awareness of the safety communication and planned management in the authorization to address potential safety/coverage questions.
- If Venovo is used, include mitigation plan for deployment issues and documentation of informed consent addressing the safety notice.
Renal artery FMD — stent placement discouraged as first‑line
Stent placement as first‑line therapy for renal artery fibromuscular dysplasia is discouraged — PTA without stent is preferred; authorization for stent placement in FMD should be limited to PTA‑related complications (dissection/perforation) and documented accordingly.
- Document PTA attempt and the complication requiring stent placement if PA is sought for FMD.
IFU non‑adherence may increase risk (oversizing, diameter mismatch examples)
Non‑adherence to manufacturer Instructions for Use (IFU) has been associated with worse outcomes (examples include distal oversizing >20% and diameter mismatch >1 mm between overlapping stent grafts); document IFU adherence or provide rationale for deviations to mitigate risk of denial or poor outcomes.
- When IFU deviations are necessary, include explicit rationale and risk/benefit discussion in the record and PA.
RCTs failed to show PTRA benefit in broad ARAS populations; interventions outside definitions may be excluded
Randomized clinical trials and meta‑analyses have generally failed to show benefit of PTRA/stenting over medical therapy in broad ARAS populations; interventions outside defined high‑risk presentations may therefore be challenged and could be excluded from coverage.
- Ensure PA documentation highlights high‑risk selection criteria or failed medical therapy to avoid exclusion based on trial evidence.
CPBs assist plan benefits; non‑adherence may affect coverage
Clinical Policy Bulletins and CPBs assist in administering plan benefits; lack of adherence to the policy may affect coverage determinations — include required documentation and follow plan PA procedures to reduce risk of denial.
- Attach CPB‑requested clinical data and follow insurer submission checklists when requesting authorization.
Background and Rationale
Background: Peripheral vascular disease encompasses aorto‑iliac, femoro‑popliteal, and infra‑popliteal segments and is commonly assessed by symptoms (claudication, rest pain, tissue loss) and noninvasive testing (ABI). Many patients with PAD improve or remain stable with conservative management (~70%), whereas those with critical limb ischemia typically require revascularization. Stent types include balloon‑expandable and self‑expandable devices; covered (PTFE) stents and DES have been developed but evidence of clinical superiority varies by vascular territory and indication.
Definitions and Key Terms
Policy Revision History
Policy originally effective as published
Most recent clinical policy review completed
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