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CurrentAetnaPolicy 0785

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.

Policy Summary

PayerAetna

PolicyPeripheral Vascular Stents

Policy CodePolicy 0785

Change TypeNo material clinical or coverage changes in this revision

Effective DateJun 19, 2009

Last ReviewMar 8, 2024

Next Review DateAug 28, 2025

Key ActionObtain prior authorization per eviCore Peripheral Vascular Intervention Clinical Guidelines for medical necessity determinations for peripheral vascular stents.

SourceLink

06/19/2009policy effective date

08/28/2025next review

70%70%

Up to 10MPAD affected (US)

96.4%iCAST 9-mo patency

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
[[chunk 4]]

Policy Summary

PayerAetna

PolicyPeripheral Vascular Stents

Policy CodePolicy 0785

Change TypeNo material clinical or coverage changes in this revision

Effective DateJun 19, 2009

Last ReviewMar 8, 2024

Next Review DateAug 28, 2025

Key ActionObtain prior authorization per eviCore Peripheral Vascular Intervention Clinical Guidelines for medical necessity determinations for peripheral vascular stents.

SourceLink

On This Page

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.

General approach: Prefer optimal medical therapy for most patients with atherosclerotic renal artery stenosis based on randomized trials and systematic reviews showing no consistent renal or cardiovascular outcome benefit from routine stenting.

Supported by AHRQ, CORAL, ASTRAL, Steichen systematic review

Compelling indications for consideration of stenting: Rapidly progressive renal failure, recurrent flash pulmonary edema or refractory heart failure attributable to RAS, true resistant hypertension despite optimal medical therapy, hemodynamically significant bilateral RAS (>75%), progressive renal impairment thought due to the stenosis, OR intolerance to optimal medical therapy (eg, creatinine rise after RAS inhibitor).>75% bilateral RAS

Low‑level evidence; weigh procedural risks (atheroembolism, contrast nephropathy)

Device and ISR considerations: Routine use of PTFE‑covered stents or drug‑eluting stents for renal ISR or ARAS is not supported by high‑quality evidence; device use should be limited to cases with clear rationale and documented failure or intolerance of medical therapy.

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.

Femoro‑popliteal (FP) evidence: Randomized trials and systematic reviews show short‑term patency improvements for PTA plus stent versus PTA alone; drug‑eluting nitinol stents (eg, Zilver PTX, Eluvia) demonstrated superior 12‑month primary patency in RCTs, but benefits may diminish over longer follow‑up and clinical outcome data are limited.12‑month patency examples: 83.1% vs 32.8%

Dake et al; Eluvia trials

Stent grafts for long FP lesions: Heparin‑bonded ePTFE/nitinol stent grafts (eg, Viabahn) have shown favorable 12‑month primary patency (~73%) and clinical improvement in long‑segment FPA disease in single‑arm and randomized trials; outcomes and device selection should consider lesion length and IFU limits.~73% primary patency at 12 months

VIPER, Saxon et al; VIBRANT and systematic reviews

Iliac disease evidence: Trials of nitinol and covered balloon‑expandable devices (eg, LifeStream; COBEST) demonstrate high technical success and sustained patency advantages for covered stents, particularly in TASC C/D iliac lesions (COBEST 5‑year patency higher for covered stents).LifeStream 9‑month primary patency 89.1%; COBEST 5‑year patency advantage

CRISP‑US; COBEST; LifeStream BOLSTER

Guideline-based coverage statements

Guideline and consensus statements inform appropriateness of primary versus provisional stenting and device selection.

Iliac artery guidance: Stenting is effective and considered primary therapy for common and external iliac artery stenoses and occlusions.

AHA/ACC statements

Provisional stenting guidance: Provisional (salvage) stent placement is indicated after sub‑optimal balloon dilation (eg, persistent gradient, residual stenosis >50%, or flow‑limiting dissection).>50% residual stenosis

AHA/ACC statements

Femoropopliteal/tibial guidance: Primary stent placement is not recommended in femoral, popliteal, or tibial arteries; stents are appropriate as salvage therapy after failed PTA.

AHA/ACC guidance; Cochrane review

DES and covered stent guidance: Effectiveness of DES and covered stents for infra‑inguinal lesions is device‑specific and not universally established; further RCT evidence is required and FDA/labeling contraindications must be observed.

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.

Femoropopliteal DES data: Paclitaxel‑eluting nitinol DES demonstrated superior 12‑month primary patency and event‑free survival versus PTA/provisional BMS in randomized trials (eg, Zilver PTX, Eluvia).12‑month patency examples: 83.1% vs 32.8% (Dake et al); Eluvia 86.8% vs 81.5%

Dake et al; Eluvia trials

Long‑segment FPA and stent grafts: Heparin‑bonded ePTFE/nitinol stent grafts (Viabahn) showed ~73% primary patency at 12 months in long‑segment FPA disease with clinical improvement in Rutherford class.~73% at 12 months

VIPER; Saxon et al

Mesenteric (splanchnic) disease: Endovascular mesenteric stenting is an accepted first‑line option in many centers for chronic mesenteric ischemia with variable 1‑year primary patency (~65%) and need for multi‑vessel revascularization consideration.1‑year primary patency ~65%

Series summaries

Subclavian artery: Stenting after PTA for proximal subclavian stenosis provides superior 1‑year patency versus PTA alone in pooled analyses and is an accepted therapy in high‑risk surgical patients.1‑year patency advantage

Chatterjee et al; pooled analyses

Evidence-based coverage considerations

Evidence‑based considerations that affect coverage decisions and authorization assessment.

Lesion complexity and stent type: Choice of stent (BMS, covered stent, DES) should consider lesion location, TASC class, and lesion length; covered stents appear beneficial for complex aorto‑iliac and long femoro‑popliteal lesions (eg, TASC C/D), while primary stenting is discouraged in infra‑inguinal arteries except as salvage.TASC C/D benefit for covered stents

COBEST; Lammer et al; Cochrane review

ISR and device selection: For in‑stent restenosis, drug‑coated balloons, heparin‑bonded Viabahn endoprosthesis, and other adjunctive approaches have shown improved freedom from TLR in RCTs versus standard balloon angioplasty; device‑specific evidence should guide selection.12‑month freedom from TLR improvements

Hajibandeh systematic review; RCTs

Renal‑artery revascularization evidence: Large randomized trials (eg, CORAL) did not demonstrate prevention of major renal or cardiovascular events with routine renal‑artery stenting compared with medical therapy; thus reserve stenting for high‑risk presentations or failure/intolerance of medical therapy.no event‑rate benefit in broad ARAS populations

CORAL; Cooper et al; Steichen review

Device labeling and IFU adherence: Ensure lesion anatomy permits device delivery and deployment per IFU (eg, Zilver PTX and Viabahn contraindications for non‑dilatable lesions); deviations from IFU are associated with worse outcomes and should be documented and justified.IFU adherence preferred

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.

Anatomic and device suitability: At least one patent runoff vessel is typically required for certain devices (eg, Viabahn); reference vessel diameter and lesion length limits apply for device labeling (eg, LifeStream: 4.5–12.0 mm; lesion length up to 100 mm).LifeStream: 4.5–12.0 mm; lesion length <=100 mm

LifeStream BOLSTER; Viabahn IFU

Procedure‑related factors: Dual antiplatelet therapy, appropriate device sizing (avoid >20% oversizing), minimizing total implant length and number of devices, and avoiding coverage of distal collaterals are associated with improved outcomes; deviations increase risk of re‑intervention and MALE.avoid >20% oversizing

Johnston et al; Ohki et al

Surveillance and documentation: Post‑procedure surveillance (eg, duplex US, ABI, Rutherford category) at 1, 3, 6, and 12 months and annually thereafter, and documentation of lesion length, reference vessel diameter, and completion angiography are expected to support medical necessity and device selection.serial imaging and clinical follow‑up

Follow‑up imaging and required procedural documentation

Venous stent considerations: For ilio‑femoral and May‑Thurner interventions, IVUS guidance for sizing and placement is recommended; staged treatment of bilateral disease (treat more symptomatic limb first) may obviate contralateral intervention in most patients.staged approach often effective

Jayaraj et al; Bondarev et al

Clinical evidence and practice implications

Practice implications and key clinical evidence points that influence coverage and device choice.

Ilio‑femoral venous stenting (MTS): Stenting (with angioplasty) is suggested for moderate‑to‑severe symptomatic May‑Thurner syndrome in the absence of DVT; IVUS is recommended for accurate sizing/placement and many patients experience contralateral symptom improvement after ipsilateral stenting (≈95%).

Jayaraj et al; UpToDate

Paclitaxel‑coated devices caution: Paclitaxel‑coated stents (eg, Eluvia) demonstrated high intermediate‑term patency (eg, Eluvia 12‑month primary patency 86.8%); regulatory advisories and meta‑analyses prompted careful benefit‑risk assessment and informed consent regarding potential long‑term safety signals despite mixed pooled mortality findings.Eluvia 12‑month patency 86.8%

Eluvia trials; FDA advisory; VIVA meta‑analysis

Venovo safety notice: Venovo venous stent urgent safety notice: proximal end may not expand on deployment; reported complaints (~250) and over‑manipulation risks necessitate awareness and adherence to manufacturer guidance.~250 complaints reported

BD/Venovo safety notice

Renal artery disease clinical nuance: For renal FMD, PTA without stent is first‑line and stents are reserved for PTA‑related dissection or perforation; for atherosclerotic RAS, stenting may benefit selected high‑risk patients but RCTs do not support routine use.

Plouin; UpToDate; CORAL critiques

Dialysis access stent‑grafts: Stent‑graft use in AVF for partially thrombosed aneurysms or residual wall‑adherent thrombus may be feasible; reported primary patency rates vary and documentation of cannulation plans is recommended.variable patency rates

Garcia‑Medina; Marsh et al

Coverage-relevant clinical summaries

Coverage‑relevant clinical positions derived from evidence and small randomized trials where available.

Renal artery FMD: PTA (angioplasty) without stent is preferred for renal artery fibromuscular dysplasia; stent placement is generally indicated only for PTA‑related dissection or rare perforation.

UpToDate; Plouin et al

Dialysis AV fistula stent‑grafts: Stent‑graft deployment may be considered for selected AVF indications (eg, partially thrombosed aneurysm or residual wall‑adherent thrombus) with acknowledgement of limited and variable patency data; document prior treatments and cannulation strategy.

Garcia‑Medina; Marsh et al

LimFlow (pDVA): Percutaneous deep vein arterialization is investigational but may be considered for no‑option CLI (Rutherford 5–6) with documentation of ineligibility for conventional revascularization and expectation of registry/trial enrollment where possible.Rutherford 5–6; no‑option CLI

Kum et al; Mustapha

Popliteal artery aneurysm (PAA): Endovascular stent‑graft repair may be appropriate in selected patients (eg, high surgical risk or lacking venous conduit) with informed discussion of potentially lower primary patency and need for surveillance compared with open repair; one small RCT (30 PAAs) showed similar assisted patency but shorter LOS and operating time for endovascular approach.

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.

PAA comparative outcomes and selection: Evidence limited to small trials and cohorts; endovascular repair offers shorter operating time and hospital LOS with similar assisted patency in small RCTs but may have higher occlusion risk in certain anatomies (eg, poor outflow, small graft diameter, angulation/elongation).evidence: 1 small RCT (30 PAAs)

Joshi et al; Cervin et al

When to consider ER over OSR: Endovascular repair may be appropriate for patients without suitable venous conduit, older/frail patients with significant comorbidities, or when shorter hospitalization/operating time is prioritized; open repair preferred for younger patients with available conduit.clinical judgment

Kim and Sumpio review

IFU and procedural adherence: Adherence to device IFU (sizing, oversizing limits, recommended landing zones) is associated with better patency; deviations (eg, distal oversizing >20% or diameter mismatch >1 mm in overlapping stents) correlate with worse outcomes and should be documented and justified.>20% oversizing linked to lower patency

VIPER; Ohki et al; device studies

Ilio‑caval stenting: Endovascular recanalization with angioplasty and stenting for symptomatic ilio‑caval occlusion shows high technical success and symptomatic improvement in observational series; IVUS use is recommended for lesion characterization and stent sizing.symptomatic ICVO

Kaufman; Mousa UpToDate

Renal artery stenting selection: RCTs do not support routine PTRAS for broad ARAS populations; reserve PTRAS for selected high‑risk patients (refractory hypertension, flash pulmonary edema, rapid renal decline) or documented failure/intolerance of optimal medical therapy, and consider physiologic lesion assessment to aid selection.severe RAS >=70% in high‑risk presentations

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.

High‑risk renal revascularization criteria: Severe atherosclerotic renal artery stenosis (typically >= 70%) AND one or more of: true resistant hypertension (eg, daytime ambulatory BP >135/85 despite >=3 antihypertensives including a diuretic), rapidly declining renal function attributable to the stenosis, or recurrent flash pulmonary edema/refractory heart failure.>=70% stenosis

Prospective cohort and guideline‑based selection

Alternative supporting indications: Unilateral RAS with short duration of BP elevation, failure of optimal medical therapy to control BP, or intolerance to optimal medical therapy (eg, creatinine rise after RAS inhibitor) — consider revascularization after documented trials of medical therapy and physiologic assessment when feasible.

UpToDate; Courand et al

When medical therapy is preferred: In unselected ARAS populations without high‑risk features, randomized controlled trials and meta‑analyses do not show improved major renal, cardiovascular, or mortality outcomes with PTRAS versus best medical therapy; medical therapy is preferred unless high‑risk features or failure/intolerance are present.

CORAL; systematic reviews

Femoropopliteal device evidence

Device‑level evidence and comparative outcomes for femoro‑popliteal interventions to guide device selection.

DES vs DCB/adjunctive strategies: Drug‑eluting stents (DES) often demonstrate superior 1‑year primary patency and freedom from clinically driven TLR versus PTA or DCB alone in some analyses; DCB outcomes may approximate DES when combined with adjunctive procedures (eg, atherectomy + provisional BMS).1‑year endpoints

Zenunaj et al; meta‑analyses

Paclitaxel safety assessment: Meta‑analyses and pooled RCT data have raised safety questions about paclitaxel‑coated devices; more recent larger meta‑analyses of many RCTs found no consistent short‑ or long‑term increase in all‑cause mortality but recommend continued surveillance and caution in device selection and informed consent.1‑,2‑,5‑year mortality analyses

Zhang and Yin; FDA advisory summaries

Long‑lesion evidence (Eluvia/IMPERIAL): Eluvia demonstrated non‑inferior or superior intermediate‑term primary patency versus Zilver PTX (eg, 12‑month patency 86.8% vs 81.5%); single‑arm long‑lesion studies show high 12‑month patency for Eluvia in lesions up to 190 mm.Eluvia 12‑month patency 86.8%

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.

Coding: Covered and Non-covered Codes

Peripheral Artery Stenting CPT codes covered if selection criteria are metCPTCovered

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.

Peripheral Venous Stenting CPT codes covered if selection criteria are metCPTCovered

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.

HCPCS codes covered if selection criteria are metHCPCSCovered

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.

ICD-10 codes covered if selection criteria are metICD-10Covered

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.

ICD-10 codes not covered for indications listed in the CPBICD-10Not Covered

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].

inv-39: Normal artery length for popliteal aneurysm stenting

Minimum normal landing zone>= 15 mm of normal artery proximal AND distal to the aneurysm

Clinical contextRequired when performing primary or salvage endovascular repair of popliteal artery aneurysm

Documentation requirementImaging must specifically demonstrate the >=15 mm proximal and distal normal artery segments

inv-40: Hemodynamically significant bilateral renal artery stenosis threshold

Hemodynamic threshold> 75% stenosis in both renal arteries

Indication contextOne of the covered criteria for renal artery stenting when bilateral hemodynamically significant disease is present

DocumentationAngiographic or imaging documentation of percent stenosis required to support hemodynamic significance

inv-41: Popliteal aneurysm size threshold

Size threshold>= 2.0 cm (or symptomatic) to qualify for primary or salvage stent therapy

Clinical equivalenceAsymptomatic aneurysm >=2.0 cm meets the size criterion if other conditions (e.g., anatomy, surgical risk) are met

DocumentationImaging should document aneurysm size to support indication for stent-graft repair

inv-42: Lesion length (device trial sizing examples)

LifeStream lesion lengthLesion lengths up to 100 mm (LifeStream indication) — document lesion length when selecting device

Viabahn trial contextViabahn/covered stent studies enrolled long lesions often >=10 cm with mean lesion lengths reported ~17–22 cm

Implication for device selectionMatch device labeling/IFU lesion-length limits to procedural lesion length in documentation

inv-43: Reference vessel diameter (LifeStream example)

Reference vessel diameter (LifeStream)4.5 mm to 12.0 mm (LifeStream indication) — document reference vessel diameter to support use

Device-specific sizing noteSelect covered balloon-expandable stent size within indicated diameter range per device IFU

Documentation requirementProcedural record should include measured reference vessel diameter when LifeStream is used

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

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

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

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).

Documentation Required

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.

Prior Authorization

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.

Prior Authorization

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.

Documentation Required

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.

Note

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.

Prior Authorization

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

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

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

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.

Step Therapy

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.

Step Therapy

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.

Step Therapy

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.

Step Therapy

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.

Note

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.

Step Therapy

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.

Step Therapy

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.

Step Therapy

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.

Step Therapy

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.

Note

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.

Step Therapy

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.

Note

Documentation Required

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.

Documentation Required

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.

Documentation Required

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.

Documentation Required

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.

Documentation Required

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.

Documentation Required

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.

Documentation Required

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.

Documentation Required

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.

Documentation Required

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.

Documentation Required

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.

Documentation Required

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 Required

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.

Note

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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.

Denial Risk

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

inv-94: SE stent — Self-expandable stent

SE stent definitionSelf-expandable (SE) stent that uses memory metal (e.g., nitinol) or weave to assume a pre-configured shape and provide radial force

Typical useOften used in longer occlusive lesions (eg, femoro-popliteal segment) and may be post-dilated for apposition

Performance notePatency rates of SE stents appear superior to BE stents in some series

inv-95: BE stent — Balloon-expandable stent

BE stent definitionBalloon-expandable (BE) stent deployed by inflating a balloon to expand and set the stent within the arterial segment

Historical examplePalmaz stent is an example of a BE design historically used for arterial segments

Clinical noteBE stents may be associated with higher restenosis rates than SE stents in some arterial segments

inv-96: Covered stent definition

Covered stent definitionA stent with a synthetic fabric covering (eg, PTFE) over the metal component intended to exclude plaque from the lumen and provide structural stability

Intended advantageDesigned to treat longer infra-inguinal lesions and to exclude diseased segments from flow

Evidence noteAnimal studies did not uniformly show reduced neointimal hyperplasia at stent ends; clinical benefits are device- and lesion-dependent

inv-97: Drug-eluting stent (DES) definition

DES definitionA stent that releases antiproliferative drug (eg, sirolimus or paclitaxel) from its surface to reduce neointimal hyperplasia and in-stent restenosis

Peripheral contextDES use in peripheral vessels has often been off-label and sustained clinical benefit over BMS/PTA remains under investigation

Examples/notesZilver PTX is a paclitaxel-eluting peripheral DES with FDA approval for femoropopliteal use; trial data show improved 12‑month patency in select studies

inv-98: Provisional stenting definition

Provisional stenting definitionPlacement of a stent as salvage therapy after sub-optimal or failed balloon dilation (eg, persistent gradient, residual stenosis >50%, or flow-limiting dissection)

Guideline contextRecommended initial approach is balloon angioplasty with stenting reserved for provisional/salvage use in many peripheral beds

DocumentationClinical justification should document residual lesion or flow-limiting complication to support provisional stenting

inv-99: Primary stenting definition

Primary stenting definitionRoutine initial placement of a stent as the primary endovascular therapy rather than performing PTA with stenting reserved for salvage

Guideline stancePrimary stent placement is not recommended in femoral, popliteal, or tibial arteries except as salvage

Coverage implicationPrimary stenting in these segments may be considered not medically necessary without specific justification

inv-100: Drug-eluting stent (DES) alternate definition/notes

DES alternate notesDES are stents with antiproliferative drug coatings (eg, paclitaxel, everolimus); while coronary DES success prompted peripheral interest, peripheral evidence is limited and further RCTs are warranted

Clinical cautionOff-label peripheral DES use is common in studies but generalizability and long-term outcome advantages remain uncertain

Trial evidenceSome randomized femoropopliteal trials report superior 12‑month patency with paclitaxel-eluting stents compared with PTA/provisional BMS

inv-101: Stent graft / endoprosthesis definition

Stent graft / endoprosthesis definitionA metallic stent (eg, nitinol) lined with ePTFE or similar fabric to exclude diseased vessel segments and improve flow (eg, Gore Viabahn Endoprosthesis)

Clinical applicationUsed for long-segment femoro-popliteal disease and aneurysm exclusion; device IFU specifies vessel diameter and contraindications to use

IFU limitationsNot suitable if lesion cannot be dilated to permit delivery system passage or proper placement

inv-102: TASC classification definition

TASC classification definitionTransAtlantic Inter-Society Consensus (TASC) lesion classification (A–D) used to stratify femoropopliteal and aorto‑iliac lesion complexity and guide revascularization strategy

Clinical useTASC class influences choice of endovascular versus surgical therapy and interpretation of trial results (eg, greater CS benefit in TASC C/D)

DocumentationLesion TASC class is an expected element of procedural/clinical documentation supporting device selection

inv-103: Covered stent (CS/CBE) definition

Covered stent (CS/CBE) definitionCovered stent (including covered balloon‑expandable [CBE]) is a metal stent with a fabric covering (eg, PTFE) used to exclude diseased segments and improve patency in selected aorto‑iliac and long femoro‑popliteal lesions

Evidence noteRandomized and comparative trials (eg, COBEST, VIA/Viabahn) show improved patency for CS in selected complex lesions

Device-specific dataLong-term data vary by device; iCast/Advanta V12 has reported 5‑year primary patency ~74.7%

inv-104: DES definition (synonym entry)

DES synonym entryDES — drug‑eluting stent: stent that releases antiproliferative drug to reduce restenosis (eg, paclitaxel, sirolimus) — used in femoropopliteal territory with device‑specific evidence

Clinical cautionPeripheral DES outcomes are device‑ and study‑specific; sustained long‑term clinical outcome advantage not universally demonstrated

Regulatory noteZilver PTX is an FDA‑approved paclitaxel DES for femoropopliteal use; other DES remain investigational or device‑specific

inv-105: Bioresorbable/biodegradable stent definition and guidance

Bioresorbable/biodegradable stent definitionScaffold devices designed to be absorbed over time rather than remain permanent; used experimentally in PAD with limited and mixed evidence

Evidence guidanceCurrent peripheral data are limited, heterogeneous, and of insufficient quality to support routine use outside studies

Outcome summaryReported 6–12 month primary patency in femoral arteries ~61.6% in pooled small studies; technical success high but long‑term benefit uncertain

inv-106: MALE definition

MALE definitionMajor adverse limb event (MALE) — includes major amputation, thrombolysis/thrombectomy, or open bypass surgery as used in reported studies

Use in trialsMALE is commonly reported as a safety/efficacy endpoint in peripheral stent series and comparative studies

Documentation implicationProcedural follow‑up should record MALE events for outcome assessment

inv-107: LifeStream indication definition

LifeStream indication definitionLifeStream balloon‑expandable covered stent: indicated for atherosclerotic lesions in common and external iliac arteries with reference vessel diameters 4.5–12.0 mm and lesion lengths up to 100 mm

Device sizing requirementReference vessel diameter and lesion length should be documented when selecting LifeStream

Trial evidenceBOLSTER trial reported 9‑month primary patency 89.1% supporting clinical performance within indicated sizing limits

inv-108: May-Thurner syndrome (MTS) definition

May‑Thurner syndrome (MTS) definitionCompression of the left iliac vein by the right iliac artery leading to increased risk of left‑sided DVT and chronic venous obstruction

Treatment noteAngioplasty and stenting are treatment options for moderate‑to‑severe symptomatic MTS; IVUS is integral for sizing and accurate stent placement

Clinical outcomeStaged ilio‑femoral stenting often improves contralateral symptoms and IVUS aids assessment of in‑stent restenosis

inv-109: MTS additional definition (IVUS sizing note)

MTS IVUS sizing noteIntravascular ultrasound (IVUS) is recommended to determine vessel diameter, ensure full stent expansion, and guide accurate stent placement in MTS

Clinical rationaleIVUS improves sizing accuracy and helps detect in‑stent restenosis on follow‑up

Operational implicationDocumentation of IVUS use and measured diameters is expected when used for MTS interventions

inv-110: In-stent restenosis definition

In‑stent restenosis definitionFlow‑limiting stenosis within a previously placed stent, commonly due to intimal hyperplasia; defined here as >=50% narrowing by duplex US or angiography

Management optionsTreatment may include balloon angioplasty, deployment of another stent, drug‑coated balloons, or adjunctive atherectomy depending on lesion and device history

DocumentationMeasure and report percent restenosis by duplex or angiography when claiming ISR management

inv-111: PTA definition (renal FMD context)

PTA definition (renal FMD context)Percutaneous transluminal angioplasty (PTA) — endovascular dilation of a stenotic vessel segment; in renal fibromuscular dysplasia (FMD) typically performed without placement of a stent

FMD guidanceStent placement in renal FMD is generally reserved for PTA‑related dissection or perforation, not as first‑line therapy

DocumentationRecord reason for stent placement if used in FMD (eg, dissection) per policy guidance

inv-112: pDVA (LimFlow) definition

pDVA (LimFlow) definitionPercutaneous deep vein arterialization (pDVA/LimFlow): creation of an arterio‑venous fistula to divert arterial blood into the tibial venous system to perfuse the foot in no‑option CLI patients

Indication contextConsidered for no‑option critical limb ischemia (Rutherford 5–6) when conventional revascularization is not feasible

Evidence notePilot and small studies report high technical success but limited long‑term data; prior authorization and documentation of no‑option status recommended

inv-113: Popliteal artery aneurysm (PAA) definition

Popliteal artery aneurysm (PAA) definitionFocal dilatation and weakening of the popliteal artery that may thrombose, rupture, or embolize

Treatment optionsCan be managed with surgical bypass or endovascular stent‑graft repair; device selection depends on anatomy, outflow, and patient surgical risk

Clinical consequenceUntreated PAA risks thrombosis, rupture, or distal embolization potentially causing limb ischemia

inv-114: Ilio-caval venous occlusion (ICVO) definition

Ilio‑caval venous occlusion (ICVO) definitionObstructive lesion of the ilio‑caval venous segment causing chronic venous insufficiency; includes post‑thrombotic and non‑thrombotic (eg, May‑Thurner) causes

Clinical significanceRecanalization with angioplasty and stenting may relieve symptoms and improve venous drainage in selected patients

Diagnostic/technical noteIVUS and completion venography assist characterization and confirm stent positioning

inv-115: Atherosclerotic renal artery stenosis (ARAS) definition

Atherosclerotic renal artery stenosis (ARAS) definitionRenal artery narrowing due to atherosclerosis associated with resistant hypertension and impaired renal function; considered for revascularization in selected patients

Clinical implicationRCTs generally do not support routine PTRAS over medical therapy for broad ARAS populations; selection based on high‑risk features is emphasized

DocumentationDocument hemodynamic severity and clinical context when considering revascularization for ARAS

inv-116: Resistant hypertension definition

Resistant hypertension definitionDaytime ambulatory blood pressure >135/85 mm Hg despite use of at least 3 antihypertensive drugs including a diuretic (used in referenced studies)

Clinical relevancePatients with true resistant hypertension may be considered for renal revascularization when attributable to RAS

DocumentationRecord ambulatory BP measurements and antihypertensive regimen to support designation of resistant hypertension

inv-117: High-risk presentations for renal revascularization definition

High‑risk presentations for renal revascularizationSevere RAS (>=70%) with true resistant hypertension, rapidly declining renal function (ischemic nephropathy), or recurrent flash pulmonary edema/refractory heart failure

Alternative supporting indicationsFailure/intolerance of optimal medical therapy or short duration of BP elevation may also support consideration for revascularization

Documentation expectationPrior authorization should confirm high‑risk features and provide imaging and clinical data linking stenosis to presentation

Peripheral Vascular Stents

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Coverage Criteria and Evidence Summaries

Coding: Covered and Non-covered Codes

Provider Actions, Prior Authorization, and Documentation

Background and Rationale

Definitions and Key Terms

Policy Revision History