CurrentAetnaPolicy 0621

Drug-Eluting Stents

Defines Aetna's coverage and medical necessity criteria for FDA‑approved drug‑eluting coronary stents and lists investigational or noncovered uses; affects clinicians and facilities performing percutaneous coronary interventions for Aetna members.

Policy Summary

PayerAetna

PolicyDrug-Eluting Stents

Policy CodePolicy 0621

Change TypeNo material change

Effective DateJun 18, 2002

Next Review DateJul 11, 2024

Key ActionObtain prior authorization documenting diagnosis and lesion severity to show PCI indications meet guideline thresholds (angiographic stenosis or FFR) and document ability to tolerate dual antiplatelet therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=50%Left main threshold

>=70%Non-left-main threshold

<=0.80FFR threshold

<10%Approx. restenosis rate (2nd gen DES)

11% vs 7.9%2‑yr MACE (Absorb vs XIENCE)

06/18/2002

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Coverage and Medical Necessity Criteria

Medical necessity for FDA‑approved coronary DES

Covered when ALL required clinical and lesion criteria below are met:

Population: Member has acute coronary syndrome, angina pectoris (stable ischemic heart disease) or silent ischemia and can tolerate anti-platelet or anti-coagulant therapy

Anatomic/physiologic lesion criteria (any): One of: 1) Coronary artery stenosis ≥50% in the left main coronary artery; OR 2) Angina pectoris that is refractory, contraindicated, or intolerant to optimal medical therapy and ≥70% stenosis in one or more coronary arteries; OR 3) Angina pectoris that is refractory, contraindicated, or intolerant to optimal medical therapy and coronary artery stenosis >50% with fractional flow reserve (FFR) ≤0.80see text

Document symptom status, angiographic percent stenosis or FFR, and suitability for dual antiplatelet therapy

Other covered indications

Covered when device is FDA‑approved for these specific conditions:

Intra-coronary stent re-stenosis: FDA‑approved DES for treatment of intra-coronary stent re-stenosis (preferred newer-generation DES, particularly EES)

UpToDate and guideline guidance endorse newer-generation DES for ISR

Kawasaki disease: FDA‑approved DES for treatment of coronary lesions in Kawasaki disease when clinical circumstances and guideline recommendations support PCI

AHA guidance: DES reasonable in Kawasaki patients not requiring long-term anticoagulation; may be considered when anticoagulation required if bleeding risk acceptable

Revascularization indications and device selection

Coverage consistent with guideline-based indications for PCI and individualized device selection:

Guideline-based indication: Patient has symptoms and coronary stenosis meeting guideline thresholds (angiographic ≥70% diameter narrowing, ≥50% for left main, or physiologic evidence of ischemia with FFR ≤0.80)see text

References: ACCF/AHA/SCAI 2011; ESC/EACTS 2014; UpToDate

Device selection considerations: Physician documents individualized decision for DES versus BMS or CABG considering lesion complexity (e.g., SYNTAX score), comorbidities (diabetes, renal failure), lesion characteristics (small vessel <3.0 mm, long lesions, bifurcation) and patient ability to comply with long-term dual antiplatelet therapysee text

SCAI recommends individualized decision-making and documentation

Evidence summaries and device-specific findings

Evidence summaries and device-specific findings from trials, registries, and meta-analyses:

SPIRIT III (EES vs PES): In SPIRIT III (1,002 pts) EES reduced 2-year target vessel failure (10.7% vs 15.4%; HR 0.68) and MACE (7.3% vs 12.8%; HR 0.55) versus PES, with fewer stent thrombosis/MI events between years 1–2

Antiplatelet therapy: aspirin indefinitely + thienopyridine ≥6 months

ZES versus PES findings: Randomized data and IVUS analyses indicate ZES had greater in-stent late lumen loss and more neointimal obstruction versus PES though differences in TVR/MACE were not consistently observed

Device responses differ by platform and imaging endpoints

Network meta-analysis (CoCr-EES): CoCr-EES showed significantly lower 1- and 2-year definite stent thrombosis rates versus BMS and several other DES in network meta-analysis of 49 trials (~50,844 patients)

Supports favorable safety profile of 2nd-generation EES

Coverage considerations by anatomic site

Consider coverage for DES in non-coronary arterial beds when clinical and anatomical criteria and evidence-based indications are met:

Infrapopliteal DES (CLI): Patient has critical limb ischemia (Rutherford ≥4) with infrapopliteal lesion(s) hemodynamically significant and suitable for endovascular therapy; trials (PES-BTK-70, PADI) demonstrate improved patency and reduced TLR or amputation rates in selected CLI populationsRutherford ≥4; lesion selection per trial inclusion

Most endpoints are patency/TLR rather than broad patient-oriented outcomes

Femoropopliteal / SFA: DES or drug-coated balloons may be considered for femoropopliteal lesions (particularly long lesions), but overall evidence is inconsistent and some reviews consider use experimental for certain peripheral bedslesion characteristics (long lesions) may favor stenting

Benefits mainly for patency/restenosis endpoints

Vein graft stenosis:

Stent outcomes in CKD/HD populations

Clinical considerations from observational and registry analyses in CKD and dialysis populations:

CKD/HD patient outcomes: Hemodialysis and severely decreased GFR are associated with higher rates of cardiac mortality and repeat revascularization after stent implantation; in some analyses the benefit of DES in reducing repeat revascularization is attenuated in low-GFR patients

Registry and propensity-matched analyses demonstrate higher TLR and cardiac death in HD patients

BP-DES vs DP-DES evidence synthesis

Randomized trials and meta-analyses comparing biodegradable polymer (BP-DES) and durable polymer (DP-DES):

Very late stent thrombosis: Multiple RCTs and pooled analyses report a reduced risk of very late stent thrombosis with BP-DES versus DP-DES in several meta-analyses

Consistent signal for very late ST reduction across pooled analyses

Overall clinical endpoints: BP-DES generally show comparable mortality, MI, and TLR/TVR rates to DP-DES in many analyses; superiority for broad clinical endpoints is not consistently demonstrated

Heterogeneity across studies and comparators noted

Non-inferiority trial findings: Device-specific RCTs (e.g., EVOLVE II, SYNERGY, other BP-EES trials) demonstrated non-inferiority to durable polymer EES for 12-month target lesion failure, supporting acceptable safety/effectiveness at 1 year12-month TLF endpoints

Long-term advantages need further confirmation

Coverage stance and evidence considerations

Overall evidence-based coverage considerations informing device preference:

Preferred standard: Second-generation everolimus-eluting stents (EES) have the most favorable safety and efficacy profile and are considered the standard of care for PCI

Supported by trials and meta-analyses showing superior outcomes for 2nd-generation EES

BP-DES use: BP-DES have demonstrated non-inferiority to some durable polymer EES with signals for reduced very late stent thrombosis in pooled analyses, but comparative effectiveness is mixed and larger long-term trials are needed

When used, document rationale and consider DAPT strategy

BVS/BRS use: Bioresorbable vascular scaffolds (BVS/BRS) have demonstrated similar or worse outcomes compared with EES in multiple analyses, with signals for increased stent/scaffold thrombosis and higher MACE in some studies (eg, ABSORB); caution and explicit documented rationale are required if considered

FDA communications highlight increased MACE with Absorb GT1 BVS at 2 years

Evidence summaries and guideline remarks

Evidence and guideline observations: Observational and randomized evidence summarized; guideline remarks note preference for newer-generation DES (particularly EES) for ISR and conditional recommendations for Kawasaki disease (DES reasonable when anticoagulation not required; may be considered if anticoagulation required with acceptable bleeding risk)

No new explicit coverage rules provided in these chunks

Coverage implications from specialty and comparative DES evidence

Coverage implications from specialty and comparative DES evidence — select scenarios requiring individualized justification:

Coronary artery aneurysm (CAA) / covered stents: Case reports/series (81 patients) report high procedural success (95.1%) but elevated MACE driven by target lesion revascularization; use should be reserved for selected patients with documented clinical indication and informed consent

Limited evidence; further trials needed

Myocardial bridging: Small studies show symptomatic improvement after DES but ISR/TLR (~18.7%) and risks (stent fracture, perforation) are higher; ACC commentary notes PCI for bridging is of very limited usefulness — consider DES only for carefully selected, refractory cases after documentation of ischemia and failure of optimal medical therapy

Require individualized decision-making and documentation

Pulmonary vein stenosis (PVS): Small series report mixed results; one study found higher restenosis with coronary DES versus large-diameter BMS and advised against coronary DES for PVS/O — consider PVS DES use experimental and reserve for select cases with justification

Drug-eluting stents (DES) are considered experimental and investigational when used for indications not specifically supported by established evidence. Examples of such noncovered indications include: Takayasu (aorto-arteritis), arteriovenous graft outflow vein stenosis in hemodialysis patients, chronic kidney disease with multi‑vessel disease, coronary artery aneurysms, esophageal or gastric outlet obstruction, myocardial bridging, pancreato‑biliary diseases (including bile duct obstruction), pulmonary vein stenosis, stenotic lesions of non‑coronary arteries (carotid, intracranial, peripheral, renal, vertebral), vein graft stenosis, and venous stenosis associated with dialysis vascular access.

Certain stent types are explicitly identified as not covered. Biodegradable (bioresorbable/bioabsorbable) polymer DES, antibody‑coated coronary stents, and magnetically‑coated bioabsorbable stents are considered investigational and are not covered under the policy; the HCPCS codes C1874 and C1875 are noted as not covered when used to report these device types.

DES implantation is contraindicated when patients cannot receive recommended antiplatelet and/or anticoagulant therapy or when anatomic lesion characteristics prevent complete balloon inflation or proper stent placement. FDA labeling for specific devices (for example, the EluNIR Ridaforolimus system) likewise lists inability to tolerate antiplatelet/anticoagulant therapy as a contraindication and such situations may preclude coverage.

Use of DES outside the vascular circulation (for example, enteral or biliary tracts) remains investigational. Non‑vascular DES have different design and delivery requirements than vascular DES, and current data are limited; routine clinical use in non‑vascular tracts is not established.

The use of DES in the bile duct for malignant obstruction is considered investigational. A randomized trial of a multiplex paclitaxel‑eluting biliary stent (MSCPM‑II) was closed early for excessive early occlusion and showed no significant improvement in stent patency or survival compared with covered metal stents, supporting the conclusion that biliary DES are not established as standard therapy.

Carotid artery stenting with DES is seldom used and not supported by the evidence cited. Because carotid arteries are relatively large and bare‑metal stents have low restenosis rates in this territory, there is insufficient evidence of benefit from coronary‑type DES for carotid indications.

Preliminary animal data (for example, sirolimus‑eluting stents in animal arteriovenous graft models) are noted as investigational and do not constitute clinical evidence to support coverage for human indications such as dialysis access.

Evidence for absorbable/bioresorbable scaffolds (e.g., Absorb GT1 BVS) raises specific safety concerns. Observed increases in MACE and stent/scaffold thrombosis versus contemporary metallic DES have prompted FDA communications and the policy advises caution; use of the Absorb GT1 BVS may be excluded or subject to additional review where no specific documented rationale exists or when deployed in small vessels.

Antibody‑coated stents are described as a developmental technology and are currently not FDA approved. Their safety and effectiveness have not been established for routine clinical use.

Coronary DES used for pulmonary vein stenosis demonstrated a high rate of restenosis in a comparative series; the authors concluded coronary DES should not be performed for pulmonary vein stenosis/occlusion and recommended alternative strategies (for example, large‑diameter bare‑metal stents) be preferred based on available data.

The policy excerpts cite multiple references and discussions of investigational uses, but do not present additional explicit blanket coverage exclusions beyond those listed in the exclusions section of the policy.

FDA safety communications relevant to these devices are cited in the policy. For example, the FDA’s March 18, 2017 communication regarding the Absorb GT1 bioresorbable vascular scaffold (BVS) described an increased rate of major adverse cardiac events compared with an approved metallic DES; such device‑specific safety communications are referenced to inform coverage considerations.

The policy lists ICD‑10 diagnosis codes for which DES use is not covered; claims for DES placed for indications explicitly listed as not covered (for example, unstable angina I20.0 and other non‑coronary vascular diagnoses enumerated in the exclusion list) are at risk for denial.

For stable coronary artery disease, the evidence synthesis cited indicates that sequential innovations in catheter‑based revascularization have not demonstrated reductions in death or myocardial infarction versus medical therapy. Therefore, per the policy, PCI (including DES) should not be used as initial management when optimal medical therapy is appropriate; revascularization is reserved for patients meeting guideline‑based indications.

The MSCPM‑II randomized biliary stent trial (multiplex paclitaxel‑eluting stent versus covered metal stent) was closed early for high early occlusion and found no significant improvement in stent patency or survival with the paclitaxel‑eluting device; this negative trial supports the policy’s position that biliary DES remain investigational.

Use of DES in femoropopliteal and some peripheral arterial beds has produced mixed results; UpToDate and trial summaries indicate inconsistent advantages over alternative therapies and therefore DES in certain peripheral settings may be considered experimental pending stronger evidence.

Biodegradable‑polymer DES are discussed as promising but remain considered investigational by some technology assessments (for example, the ASERNIP‑S review) pending more rigorous comparative studies demonstrating clear clinical advantages over contemporary durable‑polymer everolimus‑eluting stents (EES).

Routine use of everolimus‑eluting bioresorbable vascular scaffolds (BVS) instead of contemporary EES is not supported by consistent evidence. Multiple large trials and meta‑analyses have shown similar or worse outcomes with some BVS, including increased scaffold thrombosis and higher target‑lesion failure in mid‑term follow‑up, so EES remain the preferred standard of care.

Across the cited evidence the policy emphasizes cautionary conclusions and recommends individualized decision‑making rather than issuing broad algorithmic 'not medically necessary' statements for every novel use; many recommendations are framed as cautionary guidance and evidence limitations rather than absolute exclusions.

Percutaneous coronary intervention for myocardial bridging is of very limited usefulness. Stenting has been associated with high rates of target lesion revascularization, stent fracture, thrombosis and perforation; DES implantation is reserved for highly selected patients with refractory symptoms after optimal medical therapy and documented ischemia.

While the policy lists numerous investigational and noncovered indications and device types, several referenced sections present cautionary or conditional language rather than explicit 'not medically necessary' declarations; the document therefore mixes investigational exclusions with cautionary guidance.

Billing and Diagnosis Codes

Related CPT / HCPCS procedure codesmixed

0075T-0076T	Transcatheter placement of extracranial vertebral artery stent(s), including radiologic supervision and interpretation, open or percutaneous.
37236-37237	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, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed.
37238-37239	Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including angioplasty within the same vessel, when performed [vein].
61635	Transcatheter placement of intravascular stent(s), intracranial (e.g., atherosclerotic stenosis), including balloon angioplasty, if performed.
92928-92929	Percutaneous transcatheter placement of intracoronary stent(s), with coronary angioplasty when performed.
92933-92934	Percutaneous transluminal coronary atherectomy, with intracoronary stent, with coronary angioplasty when performed.
92937-92938	Percutaneous transluminal revascularization of or through coronary artery bypass graft (internal mammary, free arterial, venous), any combination of intracoronary stent, atherectomy and angioplasty, including distal protection when performed.
92941	Percutaneous transluminal revascularization of acute total/subtotal occlusion during acute myocardial infarction, coronary artery or coronary artery bypass graft...
92943-92944	Percutaneous transluminal revascularization of chronic total occlusion, coronary artery, coronary artery branch, or coronary artery bypass graft, any combination of intracoronary stent, atherectomy and angioplasty.
C1874	Stent, coated / covered, with delivery system [covered for (FDA)-approved everolimus, paclitaxel, sirolimus, and zotarolimus eluting stents only]

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Covered and not-covered ICD-10 diagnosis codesICD-10

I20.1-I20.9	Angina pectoris.
I24.9	Acute ischemic heart disease, unspecified [Acute coronary syndrome].
I25.10-I25.119	Atherosclerotic heart disease of native coronary artery with/without angina pectoris.
I25.6	Silent myocardial ischemia.
M30.3	Mucocutaneous lymph node syndrome [Kawasaki].
T82.01xA-T82.9xxS	Complications of cardiac and vascular prosthetic devices, implants and grafts [intra-coronary stent re-stenosis].
I20.0	Unstable angina (listed as ICD-10 not covered).
Z99.2	Dependence on renal dialysis [not covered for arteriovenous graft outflow vein stenosis in persons undergoing hemodialysis].

Anatomic stenosis thresholds — angiographic thresholds for revascularization.

General angiographic threshold>= 70% diameter narrowing for revascularization in non-left-main coronary arteries

Left main coronary artery threshold>= 50% diameter narrowing for left main CAD

Guideline contextMost studies/guidelines define 'significant' stenosis as >=70%; left main treated at >=50% per ACCF/AHA/SCAI guidance

Physiologic threshold (FFR) — FFR <= 0.80 qualifies >=50% stenosis as significant.

FFR physiologic cutoffFFR <= 0.80 qualifies a >=50% stenosis as physiologically significant

ESC guideline note

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization required for coronary drug-eluting stents (DES). Requests must document that the member meets guideline-based indications for PCI (see documentation callout). FDA‑approved coronary DES (e.g., everolimus-, sirolimus-, paclitaxel-, zotarolimus- and ridaforolimus‑eluting stents) are covered when policy clinical criteria are met.

Applicable codes: C9600–C9608, 92928–92944 when selection criteria are met; HCPCS C1874/C1875 covered only for FDA‑approved everolimus, paclitaxel, sirolimus, and zotarolimus eluting stents

Prior Authorization

Show Guideline‑Based Indication

Prior authorization submissions must show a guideline-based indication for revascularization: symptom status (angina/ACS/silent ischemia), evidence of lesion severity by angiography (≥70% diameter stenosis; ≥50% for left main) or physiologic testing (FFR ≤0.80), and documentation that symptoms are refractory/intolerant/contraindicated to optimal medical therapy when applicable.

Include ICD-10 diagnosis code(s) and clinical rationale, lesion location and percentage stenosis, or FFR value; document prior optimal medical therapy and symptom persistence

Background and Evidence Context

Background: Drug‑eluting stents are implanted during percutaneous coronary interventions to maintain vessel patency by releasing antiproliferative agents (for example, everolimus, sirolimus, paclitaxel, zotarolimus, ridaforolimus) to inhibit neointimal proliferation and reduce in‑stent restenosis. Second‑generation DES, particularly everolimus‑eluting stents (EES), have demonstrated favorable safety and efficacy compared with earlier devices, and modern devices and drug‑coated balloons have reduced restenosis rates to under approximately 10% in many settings.

Evidence summaries and device-specific findings (supporting nodes)

Supporting evidence nodes (background clinical trials, registries, and meta-analyses):

SPIRIT III summary: SPIRIT III randomized 1,002 patients to EES versus PES and found lower 2-year target vessel failure and MACE with EES

Supports preference for 2nd-generation EES

ZES vs PES and IVUS findings: ZES demonstrated greater late lumen loss and neointimal obstruction versus PES in randomized and IVUS analyses

Imaging endpoints varied by device

Definitions and Key Terms

Drug-eluting stent (DES) definition.

DES definition (clinical)A coronary stent coated with an antiproliferative drug (e.g., everolimus, sirolimus, zotarolimus, paclitaxel, ridaforolimus) that is slowly released to inhibit neointimal proliferation and reduce in-stent restenosis

PurposePlaced during percutaneous transluminal coronary angioplasty to maintain vessel patency and reduce restenosis

ExamplesFDA‑approved examples include Promus, Synergy, Xience, Taxus, Endeavor/Resolute, EluNIR (ridaforolimus)

Significant stenosis definition (anatomic/physiologic).

Anatomic significant stenosis>= 70% diameter narrowing (>=50% for left main) commonly considered 'significant'

Physiologic significant stenosisFFR <= 0.80 defines physiologic significance, especially for 40–70% angiographic lesions

Policy Dates and Revision History

2002-06-18policy_effective

Policy became effective.

2023-09-12policy_last_reviewLatest

Policy last reviewed.

2024-07-11policy_next_review_scheduled

Next scheduled policy review date.

Policy Summary

PayerAetna

PolicyDrug-Eluting Stents

Policy CodePolicy 0621

Change TypeNo material change

Effective DateJun 18, 2002

Next Review DateJul 11, 2024

SourceLink

On This Page

EluNIR (ridaforolimus) evidence and FDA indication: EluNIR RES is FDA-approved for de novo native coronary lesions ≤30 mm with reference diameter 2.50–4.25 mm; labeling lists contraindications including inability to receive antiplatelet/anticoagulant therapy or lesion anatomy preventing placementlesion length ≤30 mm; RVD 2.50–4.25 mm

Device-specific trials (BIONICS, BioNIR) demonstrated non-inferiority for TLF/LLL at 6–12 months

DES in STEMI (patient-level meta-analysis): Sirolimus- and paclitaxel-eluting stents reduced TVR at long-term follow-up in primary PCI for STEMI but were associated with increased very late stent thrombosis and re-infarction

6,298 patients from 11 trials; mean follow-up ~1,201 days

Takayasu arteritis and restenosis predictors: Small retrospective series (48 TAK pts, 73 lesions) reported high ISR; baPWV ≥17.00 m/s independently predicted DES restenosis and MACEbaPWV ≥17.00 m/s

Small sample limits inference

CKD with multi-vessel disease comparative outcomes: Meta-analysis of 11 studies (29,246 pts) found PCI with DES had higher long-term all-cause mortality, cardiac death, MI, and repeat revascularization versus CABG in CKD with MVD, though lower short-term mortality

Suggests CABG may have long-term advantage in CKD with MVD

Pancreato-biliary DES trials: Randomized trial of a paclitaxel-eluting biliary stent (MSCPM-II) was closed early for high early occlusion and showed no patency or survival benefit versus covered metal stents

Biliary DES remain investigational

DES may be considered for significant saphenous vein graft stenosis based on observational data showing reduced MACE/TVR/TLR, but RCT data are inconclusive

follow-up ≥6 months in studies

Require careful documentation and consideration

Dialysis access and ESRD: Evidence in ESRD/dialysis patients is mixed; DES may reduce TLR/TVR in some analyses but registry data show higher mortality/TLR in HD patients — decisions should be individualizedconsider dialysis dependence and GFR

Document risks and expected benefit

Biliary/other non-vascular applications: DES for malignant biliary obstruction and other non-vascular tracts remain investigational; randomized data (MSCPM-II) closed early for early occlusion and showed no clear patient benefitunresectable malignant biliary obstruction

Generally not established as standard therapy

Prefer LD-BMS or alternative strategies per available data

BP-EES versus DP-DES comparative findings: Meta-analysis of RCTs (~15,572 patients) found no significant differences in clinical outcomes between BP-EES and contemporary DP-DES (MACE 9.4% vs 7.3%; RR 1.13, p=0.05), indicating no clear superiority for BP-EES

Evidence limitations include variable DAPT duration and study heterogeneity

ESC/EACTS indicates symptomatic stable angina with >50% stenosis and FFR <=0.80 supports revascularization

UpToDate/PCI practiceFFR-directed PCI may identify ischemia in 40–70% angiographic lesions (FFR <=0.80)

Angiographic stenosis thresholds restated — 70% general, 50% left main; FFR mention.

Angiographic thresholds restated>= 70% diameter narrowing generally; >= 50% for left main coronary artery

FFR considerationPhysiologic assessment (FFR <= 0.80) may reclassify 40–70% angiographic lesions as significant

SYNTAX relevanceUse angiographic thresholds in conjunction with lesion complexity (e.g., SYNTAX) when choosing CABG vs PCI

Stent vessel diameter classification — small <3.0 mm; large >=3.0 mm.

Small vessel definitionSmall vessel: reference vessel diameter < 3.0 mm

Large vessel definitionLarge vessel: reference vessel diameter >= 3.0 mm

Clinical implicationStent size influences benefit-risk and restenosis/clinical outcomes in trials (stent diameter matters)

Brachial-ankle pulse wave velocity (baPWV) threshold noted in one study.

baPWV threshold (study)>= 17.00 meters/second was an independent predictor of DES restenosis and MACE in Takayasu arteritis cohort

Study contextObserved in retrospective cohort of 48 TAK patients with 73 coronary lesions; limited sample size

Clinical use notebaPWV may help identify higher-risk DES patients in TAK but evidence is limited

Prior Authorization

Prior Authorization for Non‑Coronary DES

Prior authorization is recommended for use of DES in non‑coronary arterial beds (peripheral, carotid, renal, intracranial, pulmonary vein, dialysis access) and will require documentation of hemodynamic significance and indication given limited and device‑specific evidence.

For peripheral/infrapopliteal: Rutherford class, angiographic % stenosis, physiologic pressure measurements or duplex, and limb‑threatening ischemia status; for pulmonary vein stenosis or occlusion include TEE/angiographic measures and follow‑up plan

Documentation Required

Evidence Endpoints for Novel Stents

When novel stents or investigational device types are requested, provide trial endpoints and device performance data — common endpoints used in regulatory/OPC studies include 12‑month target lesion failure (TLF), target vessel failure (TVF), major adverse cardiac events (MACE), target lesion revascularization (TLR), and stent thrombosis (definite/probable).

If citing device trials, include 12‑month TLF/TVF rates, MACE, stent thrombosis rates and relevant performance goals or non‑inferiority margins

Prior Authorization

Prior Authorization Recommended for Specialty DES Use

Prior authorization is recommended for specialty or atypical DES uses (e.g., coronary artery aneurysms, myocardial bridging, pulmonary vein stenosis/occlusion, coronary artery aneurysm repair, vein graft) because evidence is limited and case‑series data may show higher adverse event or restenosis rates; include rationale and alternatives.

Document why standard alternatives (e.g., CABG, covered stent, balloon angioplasty, LD‑BMS) are not suitable; include prior therapies and risk/benefit discussion

Note

Prior Authorization — References

Prior authorization references only: clinical policy and guideline citations may be requested to support the decision; administrative details and policy history are available in the policy bulletin.

See Clinical Policy Bulletin and referenced guidelines (ACCF/AHA/SCAI) for detailed criteria and review processes

Denial Risk

Denial Risk — Noncovered Indications

Claims for indications listed as experimental/investigational (non‑covered) may be denied. Common noncovered indications include Takayasu arteritis, arteriovenous graft outflow vein stenosis for hemodialysis, myocardial bridging (routine), pulmonary vein stenosis in many contexts, carotid/vertebral/renal/peripheral artery stenoses, vein graft stenosis, and other listed conditions.

ICD‑10 codes not covered for listed indications are specified in policy (examples: I25.41, I65.01–I65.29, I70.x, N18.x)

Denial Risk

Denial Risk — Noncovered Stent Types (HCPCS)

HCPCS codes C1874 and C1875 are covered only for FDA‑approved metallic DES types specified in policy and are not covered for biodegradable/bioresorbable polymer DES, antibody‑coated, or magnetically‑coated bioabsorbable stents.

Do not bill C1874/C1875 for bioresorbable polymer stents or other non‑approved device types; use corresponding C96xx codes when applicable and criteria met

Denial Risk

Contraindications That May Trigger Denial

Contraindications that may trigger denial include inability to receive recommended antiplatelet or anticoagulant therapy, lesion anatomy that prevents proper stent delivery or balloon inflation, and hypersensitivity to stent components or required medications.

Device labeling contraindications (e.g., EluNIR RES) should be checked and documented prior to prior authorization

Denial Risk

Evidence Limitations May Trigger Coverage Denial

Evidence limitations for many non‑coronary stent uses (e.g., peripheral, carotid, pulmonary vein, dialysis access) may lead to coverage denial; much of the literature reports patency or restenosis end‑points rather than patient‑oriented outcomes such as walking distance, wound healing, amputation, or survival.

When requesting coverage for non‑coronary uses, provide patient‑oriented outcome data or rationale for why morphological endpoints justify intervention

Documentation Required

Risk Considerations in Hemodialysis / CKD Patients

Consideration for patients on hemodialysis (HD) or with severe CKD: clinical data indicate higher rates of target lesion revascularization and cardiac mortality after DES in HD patients and attenuated benefit of DES versus BMS in severe CKD; document renal status and discuss risks.

For HD/CKD patients include eGFR, dialysis status, prior revascularization history, and justification for DES over alternatives

Denial Risk

Safety Signal — Absorb BVS

Safety signal for Absorb bioresorbable vascular scaffold (BVS): increased MACE and higher stent thrombosis rates at 2 years versus metallic DES were observed; caution is advised and BVS may be restricted or require special arrangements (consent/audit/research).

Provide long‑term outcome data if requesting bioresorbable scaffolds; reference FDA and NICE guidance regarding special governance and monitoring

Note

None Specified in This Section

None specified in this section regarding additional administrative provider actions beyond those above.

Denial Risk

High Restenosis Risk May Preclude Coverage for DES in PVS/O

High restenosis risk in pulmonary vein stenosis/occlusion (PVS/O) and pulmonary vein interventions: small series show higher restenosis rates after coronary DES compared with large‑diameter BMS; coronary DES for PVS/O may be discouraged and require prior authorization with strong justification.

Document vessel diameters, stent type rationale, and planned surveillance (TEE/angiography) if DES is proposed for PVS/O

Note

No Explicit Provider Actions in Trial / Reference Sections

No additional explicit provider actions are listed in the referenced trials or policy history portions beyond submitting trial endpoints and following documentation guidance above.

Trials referenced (e.g., BIONYX, EVOLVE II, TARGET, ABSORB/ABSORB III) should be cited when relevant to a device request

Documentation Required

Device‑Specific Documentation (EluNIR RES)

Device‑specific documentation: for EluNIR Ridaforolimus Eluting Stent System and other labeled devices, include device name, FDA indication/labeling, patient suitability for antiplatelet therapy, lesion anatomy (length, reference diameter), and any procedural considerations or contraindications.

Attach device labeling or FDA summary if available; document allergy or hypersensitivity status and ability to comply with DAPT

Documentation Required

Device Study Endpoints

Device study endpoints and trial reporting: include 12‑month TLF/TVF, MACE, TLR, stent thrombosis (definite/probable), and OPC/non‑inferiority margins when submitting evidence for newer devices; highlight subgroup predictors (e.g., long lesions) affecting outcomes.

If available, include power calculations, non‑inferiority margins, and 24‑month safety data for assessment of medium‑term risk

Note

Trials — Evidence Submission

Trials: when citing clinical trials to support coverage or device selection, reference pivotal studies (e.g., SPIRIT III, EVOLVE II, TARGET, EVOLVE II, ABSORB/ABSORB III, BIONYX) and include relevant outcome measures and follow‑up durations.

Provide trial identifiers, sample sizes, primary endpoints, and key safety signals

Documentation Required