Prior authorization required; must meet InterQual or policy criteria

Prior authorization is required for transcatheter heart valve procedures and must demonstrate that the request meets InterQual criteria where applicable or the policy's specified clinical criteria (for non‑transfemoral TAVR, pulmonary, and tricuspid procedures). When requesting coverage, include documentation that the procedure aligns with FDA‑labeled indications and the policy's clinical thresholds and program/center requirements.

• Refer to InterQual CP for transfemoral TAVR and for TEER where indicated.
• Non‑transfemoral TAVR requests must meet the policy's listed hemodynamic, symptomatic, heart‑team, shared decision‑making, and center qualification criteria.

Use applicable CPT/T codes and support unlisted code 93799

Use the applicable CPT and T codes listed in the policy when submitting authorization requests and for billing; include the unlisted code 93799 only with supporting documentation describing the service performed.

• Include codes such as 33363–33370, 33418–33419, 33477, and 93799 as applicable.
• When reporting 93799 (unlisted cardiovascular service), provide detailed supporting documentation of the procedure.

Document symptomatic severe AS and surgical risk with prior authorization

Prior authorization requests for aortic valve procedures should document symptomatic severe AS and the patient’s surgical risk or inoperable status, referencing trial‑level contexts when relevant (e.g., inoperable/high‑risk populations).

• Document objective severity of aortic stenosis (hemodynamic thresholds are specified elsewhere in the policy).
• Document alternative therapy considered and the patient's surgical risk/inoperability as used in pivotal trials.

Recommend prior authorization for transcatheter tricuspid procedures

Prior authorization is recommended for transcatheter tricuspid procedures to confirm indication, prior medical therapy, and surgical ineligibility given variable evidence and safety signals.

• Include documentation of symptomatic severe TR, prior stable (≥30 days) guideline‑directed medical therapy, NYHA class, pulmonary artery systolic pressure, and heart‑team risk assessment.
• Provide rationale for device selection given evolving evidence.

Prior authorization must justify ViV/TMVR with failed bioprosthesis and high surgical risk

Prior authorization for valve‑in‑valve (ViV) procedures should justify the intervention by documenting a failed surgical bioprosthesis and that the patient is high or prohibitive surgical risk (PROM/STS consistent with policy thresholds).

• Provide details on bioprosthesis type, mode of failure (stenosis, regurgitation, or mixed), and surgical risk assessment (e.g., STS/PROM score).
• Cite observational/registry evidence context if relevant to the individual case.

Prior authorization for routine CEP use requires individualized justification

Prior authorization for routine use of cerebral embolic protection (CEP) during TAVR should include clinical rationale and evidence that the patient is likely to benefit because large randomized trials have not shown routine CEP reduces periprocedural stroke.

• If CEP is requested, provide patient‑specific rationale rather than routine use alone.
• Include any high‑risk features that the provider believes increase stroke risk and justify CEP use.

Document institutional and operator qualifications for program approval

Ensure authorization requests include institutional and operator qualifications consistent with multisociety recommendations (program structure, operator experience) to support performance of TAVR and other transcatheter valve procedures at appropriate centers.

• Document center capabilities and adherence to expert consensus statements and guideline recommendations.
• For non‑transfemoral TAVR, confirm on‑site heart valve surgery, ICU resources, and personnel experienced in post‑operative care.

Device FDA status is informational; does not alone determine coverage

FDA device regulatory status is provided for information only; inclusion of FDA approval in the request does not alone establish coverage—authorization must still meet the policy's clinical criteria.

• List of PMAs and product codes is informational; cite device PMA only as supporting information.
• Coverage decisions require meeting policy clinical criteria regardless of FDA status.

Show center qualifications and volume/registry participation with authorization

Prior authorization and coverage requests must demonstrate that the procedure will be performed in a center meeting the policy's program and volume qualifications (on‑site heart valve surgery, postprocedure ICU, and CMS‑consistent volume/TVT Registry expectations).

• Include documentation that the performing center meets on‑site surgery, ICU, and CMS/TVT Registry requirements.
• Requests lacking center qualification documentation risk denial.

Confirm ≥30 days of stable GDMT before T‑TEER in authorization

For T‑TEER (transcatheter tricuspid edge‑to‑edge repair), prior authorization must confirm the patient has been on stable guideline‑directed medical therapy for heart failure for at least 30 days before the procedure.

• Document duration and components of GDMT and that symptoms persist despite optimal medical therapy.
• Include NYHA class and hemodynamic parameters required by policy.

No specified step‑therapy rules; document prior medical management

No formal step‑therapy rules are specified in this policy excerpt; however, requests should document prior medical management and guideline‑directed therapy where relevant.

• Where GDMT is expected (eg, TR, secondary MR), provide documentation of prior and current medical therapy.
• Absence of explicit step rules does not obviate the need to show prior appropriate care when relevant.

Document surgical consideration for bicuspid aortic valve; surgery preferred first

When aortic valve disease is bicuspid, document that surgical repair/replacement was considered; because surgery remains first‑line for most bicuspid patients, TAVR should be reserved for those with increased surgical risk or suitable anatomy.

• Include rationale why the patient is not an appropriate surgical candidate or why anatomy favors TAVR.
• Document heart‑team assessment and shared decision‑making.

Document GDMT consideration/attempt prior to device therapy where applicable

Authorization requests for device therapy should document that guideline‑directed medical therapy (GDMT) has been considered or attempted when GDMT is the recommended comparator (eg, for secondary MR or TR), consistent with trial populations referenced in the policy.

• Provide records showing GDMT regimen, duration, and persistence of symptoms despite therapy.
• If citing trial evidence, indicate whether the patient fits the trial population.

Consider SAVR first for low‑risk failed bioprostheses; document rationale for ViV

For failed aortic bioprostheses, consider redo SAVR as the preferred first option for low‑risk patients; prior authorization for ViV should document why ViV is being selected for high‑risk or inoperable patients.

• Provide STS/PROM or other surgical risk metrics demonstrating high/inoperable risk when choosing ViV over redo SAVR.
• Include device‑specific considerations and expected hemodynamic outcomes.

Document that surgery was considered; TEER is for inoperable/high‑risk patients

When surgery is an appropriate option for primary severe MR or other valve disease, document that surgery was considered; TEER is indicated for inoperable or high‑risk patients and authorization should reflect that surgical repair was not suitable.

• Include heart‑team assessment documenting surgical candidacy and reasons for deeming patient high‑risk or inoperable.
• Provide NYHA class and relevant anatomic suitability information per InterQual where applicable.

Provide governance/consent/audit documentation for procedures with limited evidence

For procedures with limited or evolving evidence (per NICE), document special arrangements for clinical governance, informed consent, audit, or research when requesting coverage.

• Include documentation of governance arrangements, consent process, and audit or research protocols if the procedure falls under NICE special‑arrangements guidance.
• Lack of such arrangements may affect coverage decisions.

Ensure complete medical‑record documentation of history, exam, diagnostics, and baseline status

The patient's medical record must contain complete, legible documentation supporting medical necessity: relevant history, physical exam, diagnostic test results, baseline status (eg, NYHA class), and prior therapies.

• Include baseline TR/MR/AS severity, NYHA functional class, and hemodynamic measurements.
• Make records available upon request; incomplete documentation may result in denial.

Provide detailed documentation when using unlisted code 93799

For procedures coded with an unlisted cardiovascular service (93799), include a narrative description of the procedure, indication, and device(s) used to support medical necessity and facilitate review.

• Attach operative report, device identifiers, and rationale for using an unlisted code.
• Provide comparative rationale if a standard CPT code does not appropriately describe the service.

Maintain and provide required clinical outcome documentation postprocedure

Follow‑up and outcome documentation should be available in the medical record to support ongoing coverage and to demonstrate clinical benefit: report NYHA functional class, valve function/regurgitation severity, peak conduit or valve gradients, right ventricular systolic pressure, and any reinterventions.

• Include postprocedure gradients, NYHA class changes, and records of complications or reinterventions.
• Maintain follow‑up outcomes consistent with trial and registry reporting to support continued coverage.

Document clinical‑evidence linkage and baseline status when citing trials

When citing clinical trials or device evidence to support coverage, include documentation of clinical trial enrollment or baseline trial‑relevant patient characteristics (eg, baseline TR severity, NYHA class) and explain how the patient matches the evidence base.

• If relying on TRISCEND II, TRILUMINATE, or other trials, document that the patient’s presentation aligns with trial inclusion criteria.
• Provide baseline status and prior therapy details to support applicability of trial outcomes.

Include detailed supporting documentation for ViV/TMVR requests

Provide the recommended supporting documentation for ViV/TMVR requests: indication with failed bioprosthesis type and mode of failure, surgical risk assessment (STS/PROM), NYHA class, device and procedural details, and anticipated technical success/risks.

• Document valve type, size, dysfunction mechanism (stenosis/regurgitation), and prior operative details.
• Include STS or PROM score and heart‑team determination that redo surgery is high‑risk or not feasible.