Prior authorization required for heart transplant procedures

Prior authorization is required for the listed heart transplant procedures and related CPT/HCPCS codes when the member must meet the policy's transplant selection criteria prior to coverage.

• Applies to CPT and HCPCS codes listed in policy (see code table).
• Authorization contingent on meeting the transplant selection criteria and absence of absolute contraindications.

Heartsbreath HUD — restricted labeled use

Heartsbreath is an FDA Humanitarian Use Device (HUD) whose labeling limits use to patients transplanted within the previous year and specifies that the test is intended as an adjunct to endomyocardial biopsy performed within the prior month.

• Device labeling: use only in patients transplanted within 1 year and with EMB within prior month.
• Intended as an adjunct to, not a substitute for, endomyocardial biopsy.

AlloMap GEP — patient selection and pre-test evaluation

AlloMap gene expression profiling is intended for clinically stable cardiac transplant recipients aged ≥15 years and at least 6 months post-transplant, with a thorough history/physical by an appropriately trained transplant physician and non‑invasive echocardiographic assessment at the time of testing.

• Candidate age: ≥15 years and ≥6 months post-transplant for Class IIa indication.
• Perform thorough H&P by trained transplant physician and echocardiography at time of testing.

No explicit prior authorization requirements for dd‑cfDNA/statins in these excerpts

The policy background does not specify explicit prior authorization requirements for statins, dd‑cfDNA (e.g., Prospera/myTAIHEART) or related laboratory tests in the excerpts provided.

• No payer-level prior authorization actions for dd‑cfDNA or myTAIHEART are stated in these background sections.
• Prospera (0055U) and other dd‑cfDNA codes are listed among CPT codes not covered for indications in this CPB context.

Document clinical rationale and contemporaneous data when dd‑cfDNA used investigationally

When dd‑cfDNA testing is being considered in contexts where it is characterized as investigational, providers should document the clinical rationale and supporting contemporaneous data (e.g., paired EMB results or other clinical assessment) to justify testing.

• Document contemporaneous EMB histopathology when available and the clinical context for testing.
• Be prepared to provide supporting evidence if coverage is sought for investigational-use scenarios.

OCS Heart System — PMA regulatory status and limited indication

The TransMedics OCS Heart System has FDA premarket approval (PMA) with indications described for specified donor hearts; its regulatory status and limited approved indication should be noted when proposing its use.

• OCS Heart System granted PMA for use with DBD donor hearts meeting PMA-specified criteria.
• Policy notes there is currently insufficient evidence to broadly support routine OCS use outside those indications.

Justify OCS use with expected ischemic time and PMA‑listed donor risk factors

Use of the OCS should be justified in prior authorization documentation when the expected donor cross‑clamp/ischemic time meets PMA thresholds (≥4 hours) or when expected cross‑clamp time is ≥2 hours plus one or more PMA-listed donor risk factors.

• Document expected total ischemic or cross‑clamp time and whether it meets ≥4 hours OR ≥2 hours plus a listed risk factor.
• List relevant donor risk factors per PMA (e.g., donor age ≥55, prior cardiac arrest with downtime ≥20 min, history of alcoholism, diabetes, EF 40–50%, LVH, angiographic luminal irregularities).

No further prior authorization specifications in these excerpts

No additional prior authorization requirements are specified in these background excerpts beyond those already noted for transplant procedures and device-specific PMA indications.

• Policy states where prior authorization is required for transplant procedures; other explicit PA rules are not provided in these excerpts.
• Treating providers remain responsible for care decisions and benefit verification.

Total artificial heart (TAH) may be authorized as bridge to transplant

FDA‑approved SynCardia/CardioWest Total Artificial Heart (TAH) may be considered medically necessary and authorized as a bridge to transplant for transplant‑eligible patients at imminent risk of death (NYHA Class IV) due to biventricular failure.

• TAH is considered a bridge to transplant (medically necessary) for selected patients; destination therapy is experimental/investigational.
• Authorization should document NYHA Class IV status and transplant eligibility per institutional protocol.

Manage Heartsbreath results: positive → EMB; negative may allow biopsy avoidance in select settings

A positive Heartsbreath test result should be followed by confirmatory endomyocardial biopsy; a negative result, given the high negative predictive value, may in some settings obviate biopsy but cannot substitute for biopsy in symptomatic patients.

• Positive Heartsbreath: obtain EMB confirmation due to low positive predictive value.
• Negative Heartsbreath: high NPV may allow deferral of biopsy in select screening settings, but not in symptomatic or suspicious cases per clinical guidance.

No formal step‑therapy sequencing specified; combined GEP + dd‑cfDNA used in practice to triage EMB

The policy excerpts do not specify step‑therapy sequencing requirements for post‑transplant surveillance; some single‑center practices used combined GEP and dd‑cfDNA testing to triage or cancel scheduled EMBs.

• No mandated sequencing; local protocols may combine GEP and dd‑cfDNA starting as early as 2 months post‑transplant in cited single‑center experience.
• EMB reflex often based on combined test thresholds per center practice.

Symptomatic patients: proceed to endomyocardial biopsy (EMB)

For symptomatic patients or those with clinical suspicion of rejection, endomyocardial biopsy remains the recommended diagnostic step; noninvasive tests (GEP, dd‑cfDNA) are not substitutes in these situations.

• Perform EMB for symptomatic patients or unexplained clinical abnormalities despite noninvasive testing.
• Noninvasive tests are adjuncts for surveillance in clinically stable patients, not replacements in symptomatic cases.

OCS trial outcomes: short‑term results comparable to cold storage; metabolic assessment noted

In OCS randomized and observational trials (e.g., PROCEED II), short‑term outcomes with OCS were similar to standard cold storage; metabolic assessment capability was noted but requires further study.

• PROCEED II found comparable 30‑day patient and graft survival between OCS and cold storage.
• OCS provides potential metabolic assessment during preservation; clinical implications need additional study.

Consider standard cold storage as the comparator/default versus OCS

Standard cold static storage is the comparator/default in clinical trials evaluating OCS; consider cold storage as the usual standard unless PMA criteria justify OCS use.

• PROCEED II and EXPAND trials compared OCS to standard cold storage.
• Use OCS per PMA indications or trial protocols rather than as routine replacement of cold storage.

No additional step‑therapy mandates in this policy excerpt

No step‑therapy requirements are specified elsewhere in this policy excerpt; local institutional protocols and trial protocols guide sequencing of advanced devices and tests.

• Policy contains no mandated step therapy algorithms for these technologies.
• Providers should follow institutional protocols and evidence-informed practice.

Required clinical documentation to support transplant eligibility

Pre‑transplant documentation must support NYHA functional class, potential for post‑transplant rehabilitation, anticipated life expectancy >2 years absent cardiovascular disease, adequate pulmonary/hepatic/renal function, infection and malignancy status, and HIV control per defined thresholds.

• Document NYHA class (III or IV for adults), rehabilitation potential, and life expectancy >2 years absent cardiovascular disease.
• Record adequate pulmonary, liver and renal function; absence or treatment status of active infections/malignancy; HIV control (CD4 >200 for >6 months, undetectable viral load, on stable ART >3 months).

Document prior EMB within 1 month when using Heartsbreath; reconcile discordant results

Per Heartsbreath labeling, ensure an endomyocardial biopsy has been performed within the prior month before using the test; document any discordant results and consider biopsy review prior to management changes.

• Heartsbreath intended as adjunct to an EMB performed within the previous month.
• Document and reconcile any discordant Heartsbreath and biopsy findings prior to altering therapy.

Pre‑test evaluation documentation required for AlloMap GEP testing

At the time of AlloMap GEP testing, document a thorough history and physical performed by an appropriately trained transplant physician and noninvasive assessment of allograft function (echocardiography).

• Record clinician performing evaluation and echocardiographic assessment results.
• Confirm patient meets AlloMap candidate criteria (age ≥15, ≥6 months post‑transplant) and lacks Class III exclusions.

Integrate and document test interpretation with clinical context

Integrate test reports (GEP, dd‑cfDNA, myTAIHEART) with the patient's clinical findings, history, and other laboratory results; document clinical judgment used when interpreting donor fraction or gene‑expression results.

• Document how test results influenced management decisions and any limitations noted by the clinician.
• Continue standard clinical monitoring even with negative noninvasive test results.

Report dd‑cfDNA fraction, chosen threshold, and contemporaneous EMB when available

When reporting dd‑cfDNA testing, include the donor‑derived fraction/percent, the threshold used for interpretation, and contemporaneous EMB histopathology when available to support clinical correlation.

• Report dd‑cfDNA fraction (e.g., 0.25%, 0.20%, 0.15%) and the interpretation cutpoint used.
• Include paired EMB results when available to contextualize test performance.

Document CTA image quality and diagnostic performance metrics for CAV evaluation

Cardiac CTA reports should document image quality at segment and patient levels and include diagnostic performance metrics (e.g., sensitivity, specificity, NPV) relative to invasive angiography when used for CAV assessment.

• Document segment‑level interpretability and overall study quality.
• Record comparison to invasive angiography/IVUS when available.

Document expected ischemic time and PMA‑listed donor risk factors when using OCS

When proposing OCS use, document expected cross‑clamp/ischemic time and any PMA‑listed donor risk factors (donor age ≥55, prior cardiac arrest with downtime ≥20 min, alcoholism, diabetes, EF 40–50%, LVH, angiographic luminal irregularities) to support justification per PMA indications.

• Record expected ischemic time (≥4 hours) or expected cross‑clamp time (≥2 hours) plus specific donor risk factors.
• Include donor clinical history, echocardiographic EF, and angiographic findings as applicable.

Policy bulletin is a partial description of plan benefits — providers must verify benefits

This clinical policy bulletin provides a partial description of plan benefits and is not a contract; providers must verify benefits and remain responsible for medical decisions and documentation.

• Treating providers are responsible for medical advice, treatment, and verifying member benefits.
• Policy content may be updated and is not a guarantee of coverage.

Denial risk: absolute contraindications and unmet selection criteria may trigger denial

Presence of any absolute contraindication (e.g., active untreated infection, uncontrolled HIV per defined criteria, active malignancy) or failure to meet the selection criteria may lead to denial of transplant coverage.

• Absolute contraindications include irreversible end‑organ disease (unless dual transplant), severe pulmonary hypertension with irreversible high PVR, active infections not effectively treated, uncontrolled HIV (CD4 <200 or not meeting viral load/ART criteria), and active malignancy.
• Documentation must demonstrate absence or acceptable management of these contraindications.

CMS finding: insufficient evidence for Heartsbreath to demonstrate improved outcomes

CMS determined that available evidence did not adequately define Heartsbreath's technical characteristics or show improved health outcomes for national coverage as an adjunct to biopsy; this finding could influence coverage decisions.

• CMS decision memorandum concluded insufficient evidence to demonstrate that Heartsbreath testing improves health outcomes.
• Document clinical justification if seeking coverage or use outside HUD labeling.

No explicit PA/denial triggers stated for some tests; investigational status may influence decisions

The excerpts do not state explicit payer-level authorization or billing denial triggers for some laboratory tests and therapies; however, investigational status in cited sources may prompt denials unless clinical rationale and evidence are provided.

• No explicit PA or denial triggers are listed for myTAIHEART or dd‑cfDNA in these excerpts; providers should include supporting evidence when requesting coverage.
• Investigational designations (UpToDate/ISHLT comments) may affect coverage determinations.

Denial risk: EviCore guidance — routine CCTA after transplant not supported

EviCore's cardiac imaging guideline states insufficient evidence to support routine use of CCTA after heart transplantation; absence of coronary calcification alone is not reliable to exclude CAV.

• EviCore guidance may be used by payers to deny routine CCTA for post‑transplant coronary evaluation.
• Document rationale and image quality if seeking coverage for CCTA in surveillance.

Denial risk: indication creep for OCS when used outside PMA criteria

Use of the OCS outside PMA‑stated indications (for donors without the PMA ischemic‑time expectations or listed risk factors) raised concerns about 'indication creep' in advisory discussions and may lead to scrutiny or denial.

• Advisory panel comments cautioned against broadening OCS indications beyond PMA criteria.
• Prior authorization should include explicit justification when proposed use extends beyond PMA‑specified scenarios.