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CurrentAetnaPolicy 0295

Peripheral Atherectomy and Thrombectomy Devices

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Clinical policy bulletin describing medical necessity, coverage, and investigational determinations for peripheral atherectomy and thrombectomy devices used to treat peripheral vascular disease for Aetna members.

Policy Summary

PayerAetna

PolicyPeripheral Atherectomy and Thrombectomy Devices

Policy CodePolicy 0295

Change TypeNo material changes

Effective Date

Last ReviewNov 3, 2023

Next Review Date

Key ActionFollow eviCore Peripheral Vascular Intervention Clinical Guidelines and document applicability of guideline selection criteria when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

0295policy number

1998-10-13effective date

2023-11-03last review

2024-03-14next review

96.9%Rotarex S technical success

>=82%some device primary success

Coverage Criteria and Evidence Summary

Medical necessity for peripheral atherectomy

Covered when ALL of the following are met (per referenced eviCore guidelines):

General medical necessity linkage: Procedure is for symptomatic peripheral vascular disease (limb‑threatening ischemia or functionally limiting claudication) and balloon angioplasty would be ineffective or is contraindicated

See eviCore Peripheral Vascular Intervention Clinical Guidelines for full selection criteria.

Lesion characteristics: Eccentric lesion that does not dilate with conventional balloon angioplasty, or vein bypass graft stenosis

Atherectomy is reasonable only when balloon angioplasty may be ineffective or contraindicated; document prior consideration/attempt of angioplasty where applicable.

Experimental / investigational (Not covered)

The following are considered experimental and investigational (not covered):

Policy Summary

PayerAetna

PolicyPeripheral Atherectomy and Thrombectomy Devices

Policy CodePolicy 0295

Change TypeNo material changes

Effective Date

Last ReviewNov 3, 2023

Next Review Date

Key ActionFollow eviCore Peripheral Vascular Intervention Clinical Guidelines and document applicability of guideline selection criteria when requesting coverage.

SourceLink

On This Page

Excluded interventions: Mechanical or laser peripheral atherectomy for renal artery, visceral artery, abdominal aorta, brachiocephalic trunk and branches

Effectiveness not established in peer-reviewed literature.

Trellis system: Isolated segmental pharmacomechanical thrombolysis (Trellis Peripheral Infusion System) for DVT, Paget‑Schroetter syndrome and other indications

Inadequate evidence in the peer‑reviewed published clinical literature.

Drug‑eluting balloons in excluded settings: Use of drug‑eluting balloons in vein grafts and dialysis/vascular accesses and for certain peripheral arteries where long‑term effectiveness is not established

Long‑term effectiveness not established.

IVL anatomical exclusions: Intravascular shockwave lithotripsy for anterior tibial, common/internal/external iliac, popliteal, posterior tibial, peroneal, and superficial femoral arteries, and for celiac artery occlusion or renal artery stenosis

Effectiveness for these peripheral arterial indications not established.

Comparative effectiveness and evidence summary

Summary of comparative effectiveness findings from the document:

Comparative effectiveness summary: Evidence does not demonstrate consistent long‑term superiority of atherectomy over PTA/stenting; PTA with stenting may have improved short‑term patency for SFA lesions, and DES may improve infra‑popliteal outcomes compared to PTA and BMS.

Conclusions based on observational studies, Cochrane reviews and pooled analyses showing heterogeneity and limited long‑term randomized data.

Registry-supported use cases

Situations where single-arm/registry data report favorable technical outcomes:

Registry/single-arm favorable outcomes: Directional or rotational atherectomy (for example, SilverHawk, Rotarex S) has shown high technical success and reasonable short‑ to mid‑term patency and limb salvage in selected femoro‑popliteal and in‑stent occlusion cases in non‑randomized studies.

Findings derived from registries and retrospective cohorts; technical success and patency vary by device and lesion selection.

Trial eligibility and procedural prerequisites

Study-defined eligibility and procedural prerequisites observed in trials

AV fistula DCB trial eligibility: Included patients with dysfunctional arm AV fistulae; excluded grafts, central venous stenoses, thrombosed or immature fistulas; required successful angioplasty with ≤30% residual stenosis prior to randomization.≤30% residual stenosis

Trial enrolled 285 patients; device assignment occurred after vessel preparation.

IVL Disrupt PAD III vessel‑preparation RCT subgroup: Patients with moderate or severe femoro‑popliteal calcification underwent vessel preparation with IVL or PTA prior to DCB/stenting; procedural success defined as ≤30% residual stenosis without flow‑limiting dissection before DCB/stent.≤30% residual stenosis

Reported subgroup randomized 153 patients per arm; procedural success favored IVL.

The policy lists specific anatomic sites and related procedures that are considered experimental and investigational and therefore not covered. These exclusions include mechanical or laser peripheral atherectomy performed on the renal artery, visceral arteries, abdominal aorta, and the brachiocephalic trunk and its branches. Related HCPCS entries for intravascular lithotripsy tied to celiac/renal indications and tibial/peroneal territories are also identified among not-covered codes and reflect these anatomic exclusions.

NICE concluded that current evidence for percutaneous atherectomy of femoro‑popliteal lesions is inadequate in quantity and quality and recommended that the procedure be used only under special arrangements for clinical governance, consent, audit, or research. The guidance advised that further research should define patient selection, protocols, lesion types, and report long‑term patency, and that use outside such governance arrangements is not supported by existing evidence.

Combination use of atherectomy and a drug‑eluting/drug‑coated balloon (DEB/DCB) for treatment of in‑stent restenosis (ISR) is described as experimental due to insufficient clinical data. Although atherectomy could theoretically improve acute results, available literature does not establish long‑term effectiveness for the atherectomy plus DEB approach in ISR.

Trial populations and device studies frequently applied strict inclusion/exclusion criteria and selected lesions that may not reflect real‑world complexity; several reports note that results may not be generalizable to complex disease and total occlusions (CTO), which were under‑represented in trials. The policy highlights that low CTO representation and trial selection bias limit applicability of trial outcomes to these complex lesion subsets.

Regulatory and HTA guidance caution against routine use of paclitaxel‑coated balloons (DCBs) or drug‑eluting stents (DESs) for patients with intermittent claudication because of potential mortality signals; consequently, routine use for intermittent claudication is discouraged and may be limited to selected cases where benefits outweigh risks.

Randomized AV fistula DCB trials excluded several vascular access types and conditions from enrollment: grafts, central venous stenoses, thrombosed fistulas, and immature fistulas were not studied. Trials also required successful angioplasty with ≤30% residual stenosis prior to randomization, so device safety and effectiveness data do not apply to excluded access types or inadequately prepared lesions.

Intravascular shockwave lithotripsy (IVL) is noted as having limited comparative and long‑term evidence. The policy states that routine use of IVL is not recommended pending further high‑quality studies to define effectiveness across lesion locations and versus alternative therapies such as atherectomy.

The policy enumerates a range of interventions considered experimental or investigational and not medically necessary because effectiveness has not been established. These include atherectomy for renal and visceral arteries and major trunk vessels, isolated segmental pharmacomechanical thrombolysis (Trellis system), use of DEBs in vein grafts and dialysis/vascular accesses, certain intravascular lithotripsy indications (including celiac and renal arterial applications and specific peripheral territories), and combinations such as atherectomy plus DEB for ISR.

Randomized evidence summarized in the policy indicates that when conventional balloon angioplasty (PTA) is feasible, rotational or other atherectomy techniques have not demonstrated consistent added benefit. Cochrane reviews and comparative trials found no clear superiority of rotational atherectomy over PTA for many lesion types and stressed that PTA should be attempted or considered before routine use of atherectomy.

Meta‑analyses of drug‑coated balloons versus uncoated balloon angioplasty show improved anatomic endpoints (for example, primary vessel patency and binary restenosis) but no consistent advantage in clinical endpoints such as amputation, death, ABI change, or Rutherford category through 12 months; this limits justification for routine DEB use based solely on anatomic measures.

Health‑technology assessments have concluded that patient‑related outcomes have not consistently improved with drug‑eluting stents or balloons compared with uncoated devices. The HTA reports emphasize , noting heterogeneous results and potential safety concerns that temper enthusiasm for widespread adoption without stronger long‑term data.

The policy reiterates regulatory guidance (MHRA and HTA assessments) that advises caution with paclitaxel‑containing devices: specifically, do not use paclitaxel DCBs or DESs routinely for intermittent claudication until further notice because potential mortality risk may outweigh benefits in this population.

IVL evidence to date includes randomized and observational analyses evaluating vessel preparation, but the policy emphasizes an evidence gap for long‑term clinical outcomes and head‑to‑head comparisons. Accordingly, IVL is not recommended for routine use and its adoption should await additional high‑quality comparative trials that clarify which lesion types and patient groups benefit most.

Billing and Coding

Covered CPT Codes (if selection criteria met)CPTCovered

37220-37247

Revascularization, endovascular

CPT codes not covered for listed indicationsCPTNot Covered

0234T	Transluminal peripheral atherectomy; renal artery
0235T	Transluminal peripheral atherectomy; visceral artery (except renal), each vessel
0236T	Transluminal peripheral atherectomy; abdominal aorta
0237T	Transluminal peripheral atherectomy; brachiocephalic trunk and branches, each vessel

HCPCS codes and intravascular lithotripsy codesHCPCSNot Covered

C2623	Catheter, transluminal angioplasty, drug-coated, non-laser
C1761	Catheter, transluminal intravascular lithotripsy, coronary
C9764	Revascularization, endovascular, open or percutaneous, any vessel(s); with intravascular lithotripsy [celiac artery occlusion / renal artery stenosis]
C9765	with intravascular lithotripsy, and transluminal stent placement(s) [celiac artery occlusion / renal artery stenosis]
C9766	with intravascular lithotripsy and atherectomy [celiac artery occlusion / renal artery stenosis]
C9767	with intravascular lithotripsy and transluminal stent placement(s), and atherectomy [celiac artery occlusion / renal artery stenosis]
C9772-C9775	Revascularization, endovascular, open or percutaneous, tibial/peroneal artery(ies) with intravascular lithotripsy and combinations

ICD-10 covered and not covered codesICD-10

I70.0-I70.92	Atherosclerosis (covered if selection criteria are met)
I74.3	Embolism and thrombosis of arteries of the lower extremities (covered if selection criteria are met)
I70.201-I70.209	Unspecified atherosclerosis of native arteries of extremities (not covered for indications listed)
I70.211-I70.219	Atherosclerosis of native arteries of extremities with intermittent claudication (not covered for indications listed)
I73.9	Peripheral vascular disease, unspecified (not covered for indications listed)
T82.856A - T85.856S	Stenosis of peripheral vascular stent [femoropopliteal artery in-stent re-stenosis] (listed among not covered)

Procedure without specific codemixed

No specific code

Isolated segmental pharmacomechanical thrombolysis (Trellis Peripheral Infusion System) - no specific CPT/HCPCS code

inv-24: Hemodynamically significant stenosis threshold

Hemodynamically significant stenosis> 70 percent stenosis

Clinical rationaleThreshold derived from carotid and coronary literature where symptomatic stenosis >70% associated with higher event rates and used as intervention cutoff

Common practiceStenoses <70% generally not considered critical or severe and often not treated as hemodynamically significant

Prior Authorization, Documentation, and Clinical Governance

Prior Authorization

Prior Authorization and Documentation Expectations

Prior authorization may be required for endovascular peripheral revascularization procedures and for use of specific devices (e.g., drug‑eluting balloons [DEB], drug‑eluting stents [DES], intravascular lithotripsy [IVL]). Clinical evidence and documentation supporting medical necessity may be requested during the prior authorization (PA) review. Providers should expect case‑by‑case review when the indication, device, or technique is novel, costly, or has limited/uncertain evidence.

Document adherence to applicable eviCore clinical criteria (Aetna references eviCore Peripheral Vascular Intervention Clinical Guidelines).
When PA is requested, be prepared to supply clinical evidence (progress notes, imaging, prior conservative therapies) demonstrating that less invasive options (plain angioplasty ± stent, uncoated balloon [UCB]) were not feasible or have failed, or that the patient meets criteria for limb‑threatening ischemia or functionally limiting claudication.
For expensive or newer technologies (DEB, DES, IVL), include device details (manufacturer, device name/model), lesion characteristics (location, length, degree of calcification, percent stenosis pre‑ and post‑vessel preparation), and prior interventions on the target vessel or graft.
If using paclitaxel‑coated devices in patients with intermittent claudication, note that regulatory and HTA guidance advises against routine use for intermittent claudication due to potential safety concerns; justify use carefully for critical limb ischemia or other cases where benefits may outweigh risks.
For procedures the policy lists as investigational (e.g., atherectomy of renal/visceral arteries, certain IVL or DEB uses in vein grafts/dialysis accesses), expect PA to be denied or additional justification and research/consent documentation to be requested.

Documentation Required

Governance, Consent, and Audit

Clinical governance arrangements and, where applicable, multidisciplinary team review may be required for use of procedures/devices with limited evidence (per NICE and other guidance). Maintain clear records of informed consent when applying devices or techniques under special arrangements or research protocols.

Document multidisciplinary team review (vascular surgery, interventional radiology/ cardiology) when using atherectomy, intravascular lithotripsy, or other emerging technologies in complex cases.
When procedures are performed under research or audit arrangements, include protocol identifiers, enrollment consent, and outcomes reporting plans.

Documentation Required

Clinical Background and Context

Atherectomy encompasses endovascular plaque excision or debulking techniques (directional, rotational, or laser) intended to remove atherosclerotic material and widen the lumen without stretching the arterial wall. It was developed to address restenosis and abrupt reclosure after balloon angioplasty and may be considered when angioplasty alone is ineffective or contraindicated; however, the policy highlights limited randomized long‑term evidence and recommends use guided by eviCore clinical criteria and multidisciplinary selection.

Key Definitions and Trial Endpoints

inv-61: Definition — Atherectomy

DefinitionAtherectomy — a procedure using devices that cut and remove atherosclerotic plaque from a vessel wall or grind plaque into small particles allowing distal embolization to widen the lumen without stretching the arterial wall.

Device typesIncludes directional, rotational, and laser atherectomy devices cleared for peripheral use (e.g., SilverHawk, Rotarex S).

Indications contextConsidered when balloon angioplasty would be ineffective or is contraindicated, or for eccentric lesions that do not dilate with conventional PTA.

inv-62: Definition — Hemodynamically significant stenosis

DefinitionHemodynamically significant stenosis — stenosis greater than 70% is widely accepted as hemodynamically significant and often used as the threshold for intervention.

Evidence baseDerived from carotid endarterectomy trials and coronary literature where >70% stenosis associated with higher event rates.

Clinical implicationStenoses less than 70% are generally not considered critical or severe for intervention decisions.

inv-63: Definition — Trellis peripheral infusion systems

DefinitionTrellis Peripheral Infusion System — a catheter-based isolated-segment pharmacomechanical thrombolysis system that isolates a vein segment with proximal and distal balloons, infuses thrombolytic agent, and uses a rotating dispersion/oscillation wire to disrupt clot for aspiration.

Regulatory statusReceived FDA 510(k) clearance (e.g., K013635, K021958, K071664) for controlled and selective infusion into the peripheral vasculature.

Procedure noteAfter clot disruption, disrupted material may be aspirated and the isolated balloons are deflated and catheter removed.

inv-64: Definition — Atherectomy (alternate description)

Alternate descriptionAtherectomy — endovascular plaque excision or debulking technique (rotational, directional, or laser) intended to remove atherosclerotic material from arterial lesions, reducing elastic recoil by widening the lumen without arterial wall stretch.

Device characteristicsSome devices use a rotating cutter within a housing (e.g., Simpson Peripheral Atherocath) suited for short, discrete, eccentric stenoses; catheters may be bulky and less suitable for tibial or tortuous vessels.

Reported outcomesPrimary success rates reported in series range from approximately 82% to 100% for some devices in selected patients.

inv-65: Definition — DEB/DCB

DefinitionDrug-eluting / drug-coated balloon (DEB/DCB) — an angioplasty balloon coated with an anti-proliferative drug (commonly paclitaxel) used to deliver drug to the vessel during angioplasty to inhibit restenosis.

Clinical evidenceMeta-analyses and RCTs report improved anatomic endpoints (e.g., primary patency, binary restenosis) up to 12 months, but clinical outcome benefits (amputation, ABI, Rutherford) are less consistent; trials often require pre-dilatation prior to DCB use.

Trial examplesILLUMENATE, Rosenfield RCTs, and Stellarex single-arm studies evaluated DCBs with varied primary patency and CD-TLR results reported.

inv-66: Definition — DES

DefinitionDrug-eluting stent (DES) — a stent that releases an antiproliferative drug (e.g., paclitaxel, sirolimus) to reduce neointimal hyperplasia and restenosis.

EvidencePooled estimates indicate DES 1-year primary patency ~85% and TVR-free ~90.5% in some analyses; trials such as Zilver PTX showed improved 2-year patency versus PTA/BMS in femoro-popliteal disease.

Clinical roleDES may be promising for focal infra-popliteal lesions though results vary by stent/drug type and trial.

inv-67: Definition — TLR

DefinitionTarget lesion revascularization (TLR) — repeat procedure to treat restenosis at the index (target) lesion.

Clinical measurementReported as an outcome in studies and used to calculate freedom from TLR or rates of clinically driven TLR (CD-TLR).

Example endpointsStudies report freedom from TLR at 12 months (e.g., TALON registry freedom from TLR 80% at 12 months for SilverHawk).

inv-68: Definition — Primary patency

DefinitionPrimary patency — clinical trial endpoint generally defined as absence of restenosis (binary restenosis) or need for target lesion revascularization at a specified time point (e.g., 12 months).

ReportingOften reported per Kaplan-Meier estimates in trials (examples: Stellarex 89.5% at 12 months; ILLUMENATE reported higher primary patency with DCB vs PTA).

UsageUsed as key effectiveness endpoint in DCB/DES/atherectomy trials to compare treatments over timepoints (6, 12, 24 months).

inv-69: Definition — Clinically driven TLR (CD-TLR)

DefinitionClinically driven TLR (CD-TLR) — reintervention at the target lesion performed for clinical (symptomatic or hemodynamic) indications as reported in trials.

Trial reportingReported as rates or Kaplan-Meier estimates; lower CD-TLR reported with DCB versus PTA in some trials (e.g., Schroeder 2017: 5.9% vs 16.7% at 12 months).

DistinctionCD-TLR differs from angiographic TLR by requiring clinical or hemodynamic criteria to prompt reintervention rather than imaging alone.

inv-70: Definition — In-stent restenosis (ISR)

DefinitionIn‑stent restenosis (ISR) — flow‑limiting stenosis within a previously deployed stent, generally defined here as ≥50% narrowing of a previously stented vessel by Duplex US or angiography.

PathophysiologyISR is thought to be caused predominantly by intimal hyperplasia rather than progression of atherosclerotic disease.

Management optionsManagement may include balloon angioplasty, repeat stenting, bypass, or use of drug-eluting technologies such as DEBs, though evidence for superiority is mixed.

inv-71: Definition — Primary patency (trial definition)

Trial definitionPrimary patency (trial definition) — freedom from binary restenosis or need for target‑lesion revascularization at a specified timepoint (commonly 12 months) as assessed in randomized trials.

MeasurementOften determined by core-lab adjudicated imaging or duplex criteria and reported via Kaplan‑Meier estimates.

ExampleRosenfield 2015 defined primary patency at 12 months as freedom from binary restenosis or need for TLR; DCB showed 65.2% vs 52.6% for PTA.

inv-72: Definition — Intravascular lithotripsy (IVL)

DefinitionIntravascular lithotripsy (IVL) — a catheter-based balloon that generates acoustic shockwaves to disrupt vascular calcium, improving vessel compliance and facilitating angioplasty.

Clinical effectIVL can increase procedural success and reduce flow‑limiting dissections and need for post-dilatation or stenting compared with PTA in calcified femoro‑popliteal lesions (Disrupt PAD III results).

Intended useUsed as vessel preparation for calcified peripheral lesions prior to definitive therapy (e.g., DCB or stenting).

inv-73: Definition — Drug-coated balloon (DCB)

DefinitionDrug-coated balloon (DCB) — an angioplasty balloon coated with an anti-proliferative drug (commonly paclitaxel) used after angioplasty to reduce restenosis; studied in femoro‑popliteal and AV fistula settings.

Clinical useTrials commonly require successful pre-dilatation (≤30% residual stenosis) prior to DCB deployment; reported to improve primary patency and reduce CD-TLR in multiple RCTs versus PTA.

Evidence considerationsAlthough DCBs show improved anatomic endpoints up to 12 months, benefits on clinical outcomes remain less consistent and long-term safety has been scrutinized in some contexts.

inv-74: Definition — Rutherford classification

DefinitionRutherford classification — a clinical staging system for chronic limb ischemia ranging from 0 (asymptomatic) to 6 (major tissue loss), with objective criteria for ankle pressure and toe pressure described for each category.

Categories examples0: asymptomatic; 1–3: claudication severity (mild to severe); 4: ischemic rest pain; 5–6: tissue loss (minor to major).

Objective criteriaIncludes ankle pressure (AP), toe pressure (TP), and treadmill/exercise criteria to distinguish categories (e.g., AP <40 mmHg for rest pain).