Obtain prior authorization and show medical necessity

Prior authorization is required for transcatheter heart valve procedures (including TAVR, TEER, TMVI, transcatheter pulmonary and tricuspid procedures) and requests must document that the procedure meets the policy's medical necessity criteria (including InterQual criteria where referenced). Providers should obtain authorization prior to elective procedures billed with the listed CPT codes.

• Includes transfemoral and non‑transfemoral TAVR, TEER, TMVI, transcatheter pulmonary and tricuspid procedures.
• Authorization requests must reference InterQual when applicable and FDA‑labeled indications where required.

Use listed CPT codes on prior authorization and claims

Submit prior authorization using the applicable CPT/Category III codes listed in the policy; claims and authorizations must reference those codes to ensure appropriate adjudication.

• Examples include CPT codes 33361–33370, 33418–33419, 33477, and Category III codes such as 0345T, 0483T–0484T, 0543T–0545T, 0569T–0570T, 0805T–0806T, and 93799.
• Omission of appropriate codes may risk claim denial.

Document trial‑aligned indications and approach for TAVR requests

For TAVR prior authorization, document that the indication aligns with trial‑supported populations where applicable and include the proposed procedural approach and device selection.

• When transfemoral TAVR is requested, reference InterQual CP: Procedures, Transcatheter Aortic Valve Replacement (TAVR).
• For non‑transfemoral approaches include the clinical rationale consistent with trial populations and FDA‑labeled indications.

Include device name and trial‑like clinical evidence in authorization

Prior authorization must include specific clinical details: patient clinical status, prior therapies, the planned device, and evidence patient meets pivotal‑trial‑like indications (e.g., symptomatic severe TR for tricuspid devices like EVOQUE or anatomy appropriate for TriClip).

• List the device to be used (e.g., EVOQUE, TriClip, TricValve) and cite supporting trial evidence when available (TRISCEND II, TRILUMINATE).
• Describe prior therapies (medical therapy, GDMT) and why transcatheter therapy is indicated.

Justify Valve‑in‑Valve with surgical risk and prior valve details

For valve‑in‑valve (ViV) procedures, prior authorization must justify ViV by documenting failed bioprosthesis, symptomatic status, and that the individual is high or prohibitive surgical risk (include PROM/STS risk where available) and compare expected benefits/risks versus redo SAVR.

• Provide prior surgical risk assessment (example STS ≈9% cited in ViV cohorts) and note device suitability and expected procedural outcomes.
• Include registry or trial data supporting ViV when available (PARTNER ViV, CoreValve expanded use studies).

Demonstrate program and operator adherence to institutional recommendations

Prior authorization and clinical reviews may require documentation that the performing institution and operators meet recommended program and operator standards from multisociety expert statements and guideline sources.

• Reference adherence to institutional recommendations for TAVR and other transcatheter valve programs (Bavaria et al., Bonow et al., Hijazi et al.).
• Authorization may require evidence of program infrastructure and multidisciplinary heart team participation.

Reference device FDA listing (PMA/510(k)/De Novo) in requests

When requesting coverage, reference the specific FDA PMA/510(k)/De Novo product code or PMA listing for the device to be used (policy lists product codes by valve type, e.g., NPT for aortic, NPU/NKM for mitral, NPV for pulmonary, NPW/NPS for tricuspid, PUM for CEP).

• Provide the device PMA or 510(k)/De Novo identifier when known (policy gives example device listings such as Evolut, SAPIEN 3, MitraClip, EVOQUE, Harmony, SENTINEL).
• FDA status is informational but should be included to identify device labeling and instructions for use.

Evidence clinical thresholds, heart team, shared decision‑making, and center criteria

Prior authorization for covered transcatheter procedures must demonstrate the listed clinical thresholds (when applicable), heart team determination, documented shared decision‑making, and that the performing center meets on‑site surgery, ICU, and CMS/ST S‑ACC TVT Registry volume/structure requirements.

• Non‑transfemoral TAVR requires hemodynamic thresholds (mean gradient ≥40 mm Hg OR peak jet velocity ≥4.0 m/s OR aortic valve area ≤1.0 cm2), symptomatic status (NYHA II+), heart team assessment, shared decision‑making, and appropriate center capabilities.
• State that the center meets CMS volume requirements and on‑site heart valve surgery and experienced postprocedure ICU staffing.

Document ≥30 days of stable guideline‑directed medical therapy before T‑TEER

For tricuspid TEER, prior to authorization the medical record must document that the patient has received stable guideline‑directed medical therapy for heart failure for at least 30 days.

• Document the specific GDMT agents/doses and the stability period (≥ 30 days).
• Show persistent symptoms (NYHA class II or greater) despite GDMT to support procedural consideration.

Document prior consideration of conservative or surgical options

Frame transcatheter procedures within usual therapy pathways: conservative or surgical management is conventional and transcatheter approaches are minimally invasive alternatives for appropriate candidates; document prior conservative or surgical assessment.

• For bicuspid aortic valve, document surgical-first consideration; TAVR only for select higher‑risk individuals with rationale.
• For valve dysfunction, show why conservative measures or redo SAVR are not appropriate when proposing transcatheter therapy.

Document surgical‑first rationale for bicuspid aortic valve when applicable

For bicuspid aortic valve disease, document that surgical repair remains the first‑line option for most patients and that TAVR is considered only for patients at increased surgical risk with device/technique justification.

• Include heart team assessment explaining why surgery is not preferred and why TAVR with current device technology is appropriate.

Show GDMT optimization and persistent symptoms before T‑TEER

For T‑TEER authorization, include documentation that guideline‑directed medical therapy (GDMT) was optimized prior to device therapy and that the patient remains symptomatic despite GDMT.

• Provide specifics of GDMT optimization and duration, symptom status, and echocardiographic suitability for TEER.
• Reference TRILUMINATE and guideline indications when relevant.

Document heart‑team consideration of redo SAVR versus ViV and rationale for ViV

When proposing ViV versus redo SAVR, prior authorization should document the heart team's consideration of both options and rationale for choosing ViV (including patient surgical risk, expected hemodynamics, and device suitability).

• Include STS/PROM scores and the valve type/size of the failed bioprosthesis.
• Document technical feasibility and anticipated outcomes compared with redo SAVR.

Document surgical‑first preference and why transcatheter is chosen when surgery unsuitable

Follow guideline preference for surgery when feasible: document when surgical repair/replacement was considered but judged unsuitable or high risk, and that transcatheter therapy is reasonable based on guideline recommendations.

• For mitral disease, document that surgical mitral valve repair was considered and why TEER or TMViV is preferred in this patient.
• Cite guideline elements (ACC, ESC/EACTS) used in decision‑making.

Flag investigational or limited‑approval devices and provide evidence

If the device is investigational or lacks full FDA approval (examples in policy: AltaValve, Cardioband, Carillon, Harpoon, Intrepid, NeoChord, TricValve, TriGUARD 3), state this in the request and provide supporting evidence; such devices may require additional review or be considered investigational for coverage.

• Flag products without full FDA approval and include study/registry data if available.
• Note that FDA approval alone is informational and not sufficient for coverage decisions.

Reference InterQual or alternate UnitedHealthcare criteria in authorization

UnitedHealthcare uses InterQual as the primary criteria source; if InterQual lacks applicable criteria for the requested procedure, state which UnitedHealthcare policy or guideline is being relied upon in the authorization submission.

• Cite InterQual CP: Procedures when available; otherwise reference UnitedHealthcare Medical Policies, Coverage Determination Guidelines, or applicable guidelines.
• Clarify which version of InterQual or guideline was used.

Provide complete medical record documentation to support necessity

The patient's medical record must include legible documentation supporting medical necessity: relevant history, physical exam, diagnostic test results, and prior therapy details; these records must be available on request for review.

• Include echocardiographic/hemodynamic measurements (mean gradients, valve area, PASP) and NYHA class documentation.
• Provide prior therapy notes, operative reports for prior bioprosthesis, and heart‑team consultation notes.

Describe valve pathology, symptoms, surgical fitness, and device/approach rationale

Clinical documentation should explicitly describe the valve disorder (stenosis vs regurgitation), symptomatic status, fitness for surgery, chosen transcatheter approach, and device rationale to support medical necessity and authorization review.

• For aortic stenosis include mean gradient, peak jet velocity, or valve area as applicable.
• For tricuspid and mitral procedures include TR/MR severity, PASP, LVEF, LV dimensions, and GDMT status.

Submit trial/device‑specific clinical outcomes and identifiers

Include clinical trial identifiers, device names (e.g., EVOQUE, TriClip, TricValve), and relevant outcomes (mortality, bleeding, new pacemaker implantation, TR/MR severity, KCCQ, NYHA class, 6‑minute walk distance) when available to support the clinical rationale in prior authorization or chart submission.

• Examples: TRISCEND II outcomes for EVOQUE (mortality, bleeding, pacemaker rates); TRILUMINATE outcomes for TriClip (KCCQ, HF hospitalizations).
• Provide trial or registry data when using trial‑like indications to justify coverage.

Provide detailed prior valve and outcome documentation for ViV requests

For ViV procedures, include the indication (failed bioprosthesis), prior surgical risk assessment (e.g., STS or PROM), prior valve type and internal diameter/size, procedural success and immediate outcomes (mortality, stroke, pacemaker implantation, mean valve gradient), and rationale when choosing ViV over redo SAVR.

• Document prior valve model, size, and whether the surgical bioprosthesis is small (≤21 mm) as this affects outcomes.
• Report immediate procedural metrics (mean gradient, effective orifice area) and short‑term complications.

Document center designation and operator qualifications

Document that procedures are performed at Comprehensive Valve Centers or by operators with appropriate expertise; provide center designation, on‑site surgical capability, ICU staffing, and operator experience to support authorization and compliance with program expectations.

• Include evidence of multidisciplinary heart team involvement and operator procedural volumes when available.
• Show adherence to multisociety recommendations for program structure.

Include governance, consent, and audit arrangements per NICE when applicable

Where NICE recommends special arrangements (governance, consent, audit/research) for evolving procedures (e.g., transapical mitral ViR, CEP use, ViV long‑term evidence caveats), include documentation of governance, informed consent, and audit or registry participation when applicable.

• If the procedure is being done under special arrangements, provide details of consent process, audit plan, and registry enrollment.
• NICE expects restricted use with governance when evidence is limited.

Supply hemodynamics, symptoms, heart‑team and center evidence for non‑transfemoral TAVR

For non‑transfemoral TAVR coverage, the documentation must support diagnosis of severe calcific native aortic stenosis using one of the hemodynamic measures (mean gradient ≥ 40 mm Hg, peak jet velocity ≥ 4.0 m/s, or aortic valve area ≤ 1.0 cm2), symptomatic status (NYHA II+), heart team determination, shared decision‑making, and that the procedure will be performed at a center meeting on‑site surgery, ICU, and CMS volume/structure requirements.

• Provide the exact hemodynamic measurements and symptom documentation.
• Include heart‑team notes and evidence that the center meets CMS and TVT Registry volume/structure expectations.

Place device therapy in the context of optimized medical therapy and treatment pathway

Before authorization, document whether the proposed procedure is adjunct to or replacement for optimized medical therapy; for T‑TEER specifically, show GDMT optimization and that device therapy is the next step.

• State prior medical management steps and dates, and why symptoms persist despite therapy.
• Indicate how the device fits into the therapeutic pathway (adjunct vs alternative).

Optimize and document GDMT prior to edge‑to‑edge repair

Optimize and document guideline‑directed medical therapy before considering transcatheter leaflet repair (T‑TEER); authorization reviewers expect evidence GDMT was tried and that device therapy addresses persistent symptomatic disease.

• Document specific GDMT agents/doses, duration, and response.
• For secondary MR/TR, include LVEF, LV dimensions, and persistent symptoms despite GDMT.

Missing or incomplete documentation may result in denial

If the submitted records lack required documentation of clinical criteria, device labeling, heart‑team decision, shared decision‑making, or center/operator qualifications, the request may be denied or cannot be assessed; provide complete, legible records to avoid denial.

• Incomplete documentation is a frequent cause of denial or inability to assess medical necessity.
• Include all test results, risk scores (STS/PROM), heart‑team notes, and device labeling references.

Use correct CPT coding on claims and authorizations to avoid denials

Claims will be denied or delayed if the procedure is not billed with the appropriate listed CPT codes or if coding does not reflect the performed transcatheter approach or use of devices (e.g., CEP device removal code 33370); ensure claims and authorization match the policy's listed codes.

• Use the listed CPT codes for the specific access route and devices (e.g., 33361–33370, 33418–33419, 33477, 93799).
• Include separate billing for cerebral embolic protection when used (33370).

Document procedural complication and conversion risks in requests

Be aware that conversion to surgical valve replacement occurs in a small proportion of procedures (0.4%–4%); device‑specific and approach‑specific complication rates (bleeding, stroke, pacemaker implantation) should be documented and discussed in the authorization as they may affect coverage decisions.

• Report known device risks (e.g., higher permanent pacemaker rates with some devices) and observed institutional complication rates.
• Document informed consent discussing these procedural and conversion risks.

Insufficient long‑term evidence may trigger denial or restriction

Procedures lacking sufficient high‑quality long‑term evidence (for example some TTVR systems, CAVI, and certain ViV uses) may be denied or receive restricted coverage; provide robust trial/registry data or consider enrollment in registries to support coverage.

• If evidence is limited, include trial identifiers, registry participation, and planned outcome reporting.
• NICE and policy note many emerging procedures require special governance/audit when evidence is evolving.

Routine CEP use lacks RCT‑proven benefit — justify use

Routine use of cerebral embolic protection (CEP) devices during TAVR is not supported by large RCTs (BHF PROTECT‑TAVI and PROTECTED TAVR) and may be subject to denial without specific justification; if CEP is proposed, submit rationale and device evidence.

• Provide trial evidence or patient‑specific justification for CEP use; routine use alone lacks RCT‑proven stroke reduction.
• Include device PMA/510(k)/De Novo listing (e.g., SENTINEL) when applicable.

Provide NICE‑style governance/consent/audit documentation when required

When NICE has recommended special arrangements for a procedure (governance, consent, audit or research), include documentation of those arrangements in the authorization; lack of such arrangements for evolving procedures could prompt non‑routine review or denial.

• Examples include transapical mitral ViR, CEP deployment, and some ViV long‑term evidence caveats.
• Provide the audit/consent documentation and governance plan when requested.

Requests not meeting policy criteria, FDA labeling, heart‑team, or center requirements risk denial

Procedures that do not meet the policy's specified clinical criteria, FDA‑labeled indications, heart‑team determination, documented shared decision‑making, or center and operator requirements are at risk for denial; ensure all policy conditions are explicitly documented in the request.

• Noncompliant requests lacking hemodynamic thresholds, symptom documentation, heart‑team notes, shared decision‑making, or center volume/structure evidence may be denied.
• FDA approval alone is informational and does not substitute for meeting policy clinical criteria.