Document required clinical/echo criteria and surgeon/heart‑team determination

Coverage requires documentation that the patient meets the clinical and echocardiographic criteria listed in the policy (e.g., severe AS hemodynamics, MR grades, TPV RVOT thresholds) and, when specified, a determination of surgical risk or inoperability by at least two physicians or a multidisciplinary heart valve team.

• Demonstrate severity using policy thresholds (e.g., AVA ≤1.0 cm2 or mean gradient ≥40 mm Hg or peak velocity ≥4.0 m/sec).
• When required, document two-physician or multidisciplinary heart team concurrence on inoperability/high surgical risk.

Obtain prior authorization verifying severe symptomatic AS and documented surgical risk/inoperability

Prior authorization should confirm symptomatic severe aortic stenosis by objective measures and include documented surgical risk or inoperability adjudication (including STS risk score or two‑physician agreement) and planned access route consistent with device labeling.

• Include severity measurements (AVA, mean gradient, or peak velocity) and NYHA symptom class.
• Provide STS predicted 30‑day surgical mortality and documentation of ≥2 physicians' determination when indicating inoperability or elevated risk.

Prior authorization must document expanded‑indication rationale and heart‑team review

Requests involving expanded device indications (for example, SAPIEN 3 for asymptomatic severe AS or Evolut Redo‑TAVR) must include documentation of heart‑team assessment and device‑specific FDA approval/labeling or trial support used to justify the indication.

• For asymptomatic SAPIEN 3 use, cite FDA expanded indication and multidisciplinary heart‑team suitability.
• For Redo‑TAVR, include supporting RESTORE/registry evidence and documentation that patient meets high‑risk criteria per label.

Use Medical Policy and verify member benefits before adjudication

Consider the Medical Policy language when adjudicating coverage and verify benefit/coverage per the member's contract; the policy should inform but not replace contract or legal determinations.

• Verify the member's contract benefits in effect on the date of service.
• Use Medical Policy to assess medical necessity but confirm plan coverage terms separately.

Require prior authorization confirming heart‑team review and FDA‑consistent indication for mitral procedures

Prior authorization for transcatheter mitral procedures must confirm multidisciplinary heart‑team review and that the indication aligns with FDA‑labeled criteria (e.g., MitraClip for selected secondary MR after GDMT; Tendyne when surgery/TEER unsuitable).

• Include evidence of GDMT optimization and echocardiographic anatomic assessment (TEE) when applicable.
• Document heart‑team determination that surgery or TEER is unsuitable when TMVR or mitral ViV is requested.

Verify member contract benefits and legal precedence on date of service

Determine eligibility using the member's contract benefits in effect on the date services are rendered; federal and state law and contract language take precedence over Medical Policy.

• Always verify plan-specific coverage and any contract exclusions applicable to the date of service.
• Do not substitute Medical Policy for contract or legal requirements.

Prior authorization implied for listed CPT codes—use exact codes

The CPT codes listed under 'When services may be Medically Necessary when criteria are met' imply prior authorization is required; submit authorization requests referencing those specific CPT codes.

• Listed CPT codes include 33361–33369, 33418–33419, and 33477 among others.
• Prior authorization should reference the exact CPT code(s) for the planned procedure.

Provide exact procedure CPT/HCPCS and ICD‑10‑PCS codes on authorization requests

Submit authorization requests using the exact procedure CPT/HCPCS and ICD‑10‑PCS codes listed in the policy; when specified, use unlisted cardiac procedure code 33999 for procedures the policy identifies as such.

• Use codes such as 33999 when the policy specifies unlisted cardiac procedure coding.
• Include the precise CPT/HCPCS or ICD‑10‑PCS code(s) for the performed transcatheter valve procedure.

Follow contract and legal precedence over Medical Policy

Medical Policy should be consulted to assess medical necessity, but federal/state law and the member's contract language and benefits take precedence and must be used to determine eligibility.

• If contract language or applicable law conflicts with policy, follow the contract/law.
• Verify member benefits for the date of service before approving coverage.

Verify current policy revisions and coding prior to authorization/claim submission

Check the policy for recent revisions and coding updates; verify current prior authorization requirements and code lists before submitting authorizations or claims.

• Document history records coding and MN/INV/NMN revisions—confirm applicable CPT and ICD‑10‑PCS codes.
• Recheck the policy for any updates to prior authorization or code requirements.

Confirm member benefit eligibility on date of service

Use the member's contract benefits in effect on the date services are rendered to determine eligibility; plan terms determine coverage even where Medical Policy provides criteria.

• Confirm member benefits on date of service.
• Do not assume policy criteria guarantee coverage without plan benefit verification.

Document maximally tolerated GDMT (two‑physician confirmation) before TEER for secondary MR

For functional (secondary) MR, document that MR severity persists despite maximally tolerated guideline‑directed medical therapy as determined by at least two physicians before TEER is authorized.

• Record details of GDMT and duration of optimization.
• Include multidisciplinary heart‑team confirmation that medical therapy was maximized and the patient remains symptomatic.

No other step‑therapy rules specified in this policy segment

No step‑therapy (prior authorization) sequencing rules beyond those stated (GDMT requirement for secondary MR) are described in these policy sections.

• Policy does not list additional step‑therapy requirements in the provided chunks.

Prioritize contract and legal requirements when determining coverage

When making coverage decisions, prioritize the member's contract benefits and applicable federal/state law; Medical Policy is intended to guide medical necessity determinations but does not override contract or legal requirements.

• If contract provisions differ from policy, follow the contract or law.
• Document benefit verification and any contractual limitations in the authorization file.

Submit AS severity measures, STS score, and surgeon/heart‑team concurrence with authorization

Include clinical documentation of AS severity (AVA, mean gradient, or peak velocity), the STS risk score, and when applicable, concurrence of at least two surgeons or a multidisciplinary heart team when requesting authorization for TAVR or ViV procedures.

• Provide objective hemodynamic measurements per policy thresholds (e.g., AVA ≤1.0 cm2, mean gradient ≥40 mm Hg, peak velocity ≥4.0 m/sec).
• Include STS score and documentation of two‑physician agreement for inoperability/high surgical risk.

Include multidisciplinary heart‑team evaluation documentation in the record

Documentation for authorization should reflect multidisciplinary team assessment (including cardiology and cardiac surgery and other subspecialists as needed) confirming eligibility and planned approach.

• Record attendees and their determinations in the heart‑team note.
• Include imaging review and rationale for chosen access route.

Document heart‑team suitability determination and exhaustion/optimization of alternatives

Documentation must include heart‑team determination of suitability and evidence that alternative therapies were optimized or exhausted (for example, GDMT for secondary MR) when such requirements apply.

• For TMVR/ViV requests, document that surgery or TEER is unsuitable per heart‑team assessment.
• For secondary MR, document GDMT optimization and persistent symptoms.

Ensure FDA registry tracking requirements and selection criteria are met for mitral ViV

For Edwards Lifesciences mitral ViV expanded approval, the FDA requires manufacturer registry tracking; include evidence of registry enrollment or that the procedure meets the FDA‑approved cohort conditions when applicable.

• FDA required 3‑year registry tracking for intermediate‑risk mitral ViV patients or until enrollment goals are met.
• Ensure documentation supports that patient selection aligns with FDA cohort criteria.

Provide exact procedure and diagnosis codes; use unlisted code 33999 when specified

When requesting authorization or submitting claims, provide the exact CPT/HCPCS and ICD‑10‑PCS procedure codes listed in the policy; the policy also specifies use of unlisted code 33999 where applicable.

• Include the specific CPT codes for TAVR, TMVr, and TPV listed in the policy (e.g., 33361–33369, 33418–33419, 33477).
• Use 33999 only when the policy identifies the procedure as unlisted and documents justify that selection.

Use member's contract benefits on the date of service to determine eligibility

Use the member's contract benefits in effect on the date of service to determine eligibility; policy language does not supersede contract provisions.

• Verify benefit limitations, prior‑authorization requirements, and exclusions on the DOS.
• Document benefit verification results in the authorization record.

Check policy history and coding updates when validating authorizations and claims

Review document history and coding updates before processing requests—policy history documents additions and removals of MN/INV/NMN statements and CPT/ICD‑10‑PCS code changes.

• Confirm whether recent code additions (e.g., 0483T, 0484T, CPT 33370) affect the current prior authorization or coverage stance.
• Reference the policy's document history to justify coding and coverage decisions.

Risk of denial if policy criteria are not met—provide complete supporting documentation

Services will be denied (Not Medically Necessary) when the policy's coverage criteria are not met; submit complete supporting documentation to avoid denial.

• If objective criteria (hemodynamics, symptom class, heart‑team determination) are missing or not met, the service is Not Medically Necessary.
• Ensure submitted records directly address each required criterion to reduce denial risk.

Denial risk if trial‑aligned severity thresholds or inoperability assessments are not documented

Failure to document trial‑aligned severity thresholds or a surgical inoperability/high‑risk assessment (including STS score and two‑physician concurrence where required) may lead to denial of TAVR/ViV requests.

• Document STS score and the surgeons' concurrence when claiming inoperability per PARTNER/registry definitions.
• Provide the objective severe AS measurements as defined by the policy.

Denial risk if multidisciplinary heart‑team evaluation is not documented

Lack of documentation of a multidisciplinary heart‑team evaluation when required may result in denial of coverage for TAVR or other transcatheter valve procedures.

• Include a heart‑team note listing participants and their recommendations.
• Document why the heart‑team favored the transcatheter approach over surgery.

Precedence of law/contract—risk of incorrect determinations if not applied

Federal and state law and contract language take precedence over Medical Policy; failure to apply contract or legal requirements may lead to incorrect coverage determinations.

• Always confirm applicable legal or contractual exclusions prior to authorization.
• Document reliance on contract provisions or legal requirements when they affect coverage.

Denial risk for TEER if heart‑team assessment or GDMT optimization is not documented

For secondary MR, absence of a documented multidisciplinary heart‑team assessment or lack of documented GDMT optimization may trigger denial for TEER requests.

• Provide heart‑team confirmation that GDMT was optimized and MR persisted.
• Include echocardiographic anatomy and LVEF/LVESD parameters supporting TEER candidacy.

Services billed with listed codes may be denied if policy criteria are unmet

When policy criteria are not met, services billed with the listed procedure codes will be considered Not Medically Necessary and may be denied.

• Denial applies to listed CPT/ICD‑10‑PCS codes when the required clinical criteria are lacking.
• Ensure clinical documentation directly supports each listed code's medical necessity.

CPT 33370 is investigational and may be denied if submitted

CPT code 33370 (placement and removal of cerebral embolic protection devices) is designated investigational and Not Medically Necessary and may be denied if billed.

• Do not expect coverage for CPT 33370 absent a contract exception; document any device‑specific rationale but anticipate denial.
• If submitted, clearly indicate investigational rationale and review contract language for exceptions.

Verify contract and legal precedence before approving procedures

Federal and state law and contract provisions take precedence over this Medical Policy; verify contractual and legal rules first when making coverage decisions or processing authorizations.

• Confirm whether statutory or plan language affects coverage for specific devices or procedures.
• Document application of contract or legal precedence in the authorization record.

Denial risk: listed procedure codes considered Not Medically Necessary without meeting criteria

Services for the listed procedure codes are Not Medically Necessary when the policy criteria are not met; submit documentation addressing each criterion to reduce denial likelihood.

• If any required clinical criterion is absent, the claim/authorization is at risk for denial.
• Address device‑specific and patient‑specific criteria in the request to support medical necessity.

Denial risk for billed services when policy criteria are unmet

Services billed with the listed codes will be denied when the policy's criteria are not met; ensure complete alignment of documentation with policy thresholds and heart‑team findings.

• Cross‑check submitted documentation against the policy's numeric thresholds and structural/anatomic requirements.
• Include heart‑team notes and objective measurements to substantiate coverage.

Apply legal and contract precedence to avoid inappropriate adjudications

Federal and State law and the member's contract benefits take precedence; failure to consider these may result in inappropriate coverage approvals or denials.

• Always verify and record the member's contract benefits and any applicable legal constraints.
• If conflicts arise between policy and contract/law, follow contract/law and document rationale.

Confirm contractual/legal exclusions before finalizing coverage decisions

Federal and State law and contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy; check these first to avoid incorrect denials or approvals.

• Document any contract‑based exclusions that affect coverage for specified procedures or devices.
• When in doubt, consult legal or contract administration before finalizing coverage decisions.

Document contractual/legal precedence when it changes coverage outcomes

Federal and State law and contract language take precedence over Medical Policy; ensure these are applied and documented when determining eligibility for coverage.

• Record specific contract clauses or laws relied upon when denying or approving services.
• Do not substitute policy for mandatory contract or legal provisions.

Verify and document legal/contract constraints before authorization

Federal and State law and contract language take precedence over Medical Policy; verify and document applicable legal or contractual constraints prior to authorization.

• If a plan excludes investigational procedures, document the exclusion and basis in the authorization record.
• Document application of statutory or regulatory requirements that affect coverage.