Heart Transplant
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Defines medical necessity criteria, contraindications, and clinical guidance for heart transplantation and retransplantation for Capital Bluecross members (adult and pediatric). Applies to benefit programs administered by Capital Bluecross; some product variations noted.
No material clinical or coverage changes in this revision.
Coverage Criteria for Heart Transplantation
Medical necessity — Accepted and Probable indications (adult and pediatric)
Covered when selection criteria below are met (adult and pediatric distinctions preserved):
Initial heart transplant - medical necessity
Covered when ALL of the following are met
Evidence includes retrospective studies and registry data demonstrating improved post-transplant survival.
Heart retransplantation - medical necessity
Covered when ALL of the following are met
Supported by systematic reviews, retrospective studies, and registry data showing benefit in appropriately selected patients.
Heart transplantation is considered investigational for situations that do not meet the specific selection criteria outlined for adults and pediatric candidates. The policy states that heart transplantation is indicated only when individual selection criteria are met and that procedures performed outside those criteria lack sufficient evidence to support benefit.
Transplantation is excluded when the procedure is expected to be futile due to comorbid disease or when anticipated post‑transplant care would be expected to significantly worsen comorbid conditions. Such situations are considered contraindications and coverage would be denied because the risks outweigh any expected survival benefit.
Policy history records administrative and coding updates (including periodic ICD‑10 code additions and other administrative revisions) and indicates regular consensus reviews; these entries document nonclinical updates without changes to the core policy statements on medical necessity or exclusions.
Use of heart transplantation based on a single inadequate indication — for example, an isolated low ejection fraction such as EF <20% alone, prior ventricular arrhythmias alone, or other single measures — is not sufficient to establish medical necessity unless accompanied by the other listed accepted or probable criteria. The policy explicitly identifies isolated maximal Vo2 values above specified cutoffs (e.g., Vo2 >15 mL/kg/min as an inadequate sole indication) as not supporting transplantation by themselves.
Heart transplantation is not medically necessary when comorbid conditions make the procedure futile or when expected outcomes indicate the patient is unlikely to benefit. The policy emphasizes that transplantation should only be pursued when it is expected to provide a survival benefit and is contraindicated where comorbid illness undermines that expectation.
Procedure and Diagnosis Codes
| I25.110 | Atherosclerotic heart disease of native coronary artery with unstable angina pectoris |
| I25.111 | Atherosclerotic heart disease of native coronary artery with angina pectoris with documented spasm |
| I25.118 | Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris |
| I25.119 | Atherosclerotic heart disease of native coronary artery with unspecified angina pectoris |
| I25.5 | Ischemic cardiomyopathy |
| I25.6 | Silent myocardial ischemia |
| I25.700 | Atherosclerosis of coronary artery bypass graft(s), unspecified, with unstable |
| I25.701 | Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris with documented spasm |
| I25.708 | Atherosclerosis of coronary artery bypass graft(s), unspecified, with other forms of angina pectoris |
| I25.709 | Atherosclerosis of coronary artery bypass graft(s), unspecified, with unspecified angina pectoris |
| I50.82 | Biventricular heart failure |
| I50.83 | High output heart failure |
| I50.84 | End stage heart failure |
| I50.89 | Other heart failure |
| I50.9 | Heart failure, unspecified |
| R09.02 | Hypoxemia |
| R57.0 | Cardiogenic shock |
| T86.22 | Heart Transplant Failure |
Provider Responsibilities and Administrative Requirements
Check product-specific prior authorization rules
This policy applies only to certain Capital BlueCross products; providers should consult the applicable product-specific medical policy manual (for example, FEP PPO references the FEP Medical Policy Manual) and follow that product’s prior authorization procedures when submitting requests for heart transplantation services.
Use listed procedure and diagnosis codes and show medical necessity
Prior authorization requests and claims must reference the listed procedure and diagnosis codes and demonstrate that the transplant is medically necessary per the policy and member benefit terms.
- Procedure codes listed: 33940, 33944, 33945, S2152 (see coding section).
- Diagnosis codes in policy (examples): I50.82, I50.83, I50.84, I50.89, I50.9, R09.02, R57.0, T86.22.
- Identification of a code in the coding list does not by itself denote coverage; final determination depends on member benefits and documented medical necessity.
Follow policy history and payer authorization processes
Prior authorization expectations, coding changes, and administrative updates are documented in the policy history; follow payer-specific authorization processes consistent with Capital BlueCross program administration.
- Policy history records administrative code updates (examples: ICD-10 code additions and removals with effective dates).
- Providers must follow the applicable Capital BlueCross authorization process for the member’s product.
No step-therapy requirement for transplant selection
Step therapy is not applicable to selection for heart transplantation; candidacy is determined by meeting the clinical transplant criteria rather than by sequential medication trials.
Document maximal medical therapy and objective prognostic testing
Document aggressive/"maximal" medical therapy and objective prognostic evaluation (including Vo2max and/or predictive models such as the SHFM) to show the patient has exhausted appropriate medical management prior to transplant consideration.
- Vo2max is emphasized as an objective measure of functional reserve; accepted adult threshold: Vo2 <10 mL/kg/min (accepted) or <14 mL/kg/min (probable).
- Consider and document use of predictive models (e.g., SHFM) and evidence of optimization of pharmacologic and device therapy.
Include a listed ICD-10-CM diagnosis code on claims
Ensure claims include one of the documented ICD-10-CM diagnosis codes provided in the policy and that clinical records reference those codes to align the diagnostic rationale with the transplant service requested.
- Claims lacking one of the listed ICD-10-CM diagnosis codes may not align with this policy's documented diagnostic rationale for heart transplant services.
- Use diagnosis codes from the policy to support the clinical indication on claims and in authorization requests.
Provide required clinical documentation of indication and UNOS status
Document clinical evidence that the individual meets accepted or probable indication criteria (examples: Vo2 measurements, dependence on IV inotropes or mechanical circulatory/ventilatory support, refractory cardiogenic shock, recurrent refractory arrhythmias) and UNOS status when applicable.
- For adults, document hemodynamic compromise (Vo2 <10 mL/kg/min with anaerobic metabolism, refractory cardiogenic shock, or dependence on IV inotropes) or other accepted/probable indication criteria.
- For pediatrics, document requirements such as continuous IV inotropes, mechanical ventilatory support, mechanical circulatory support, or Vo2 <50% predicted when applicable.
- Record UNOS/OPTN status (1A, 1B, or 2) as applicable to prioritization.
Document medical necessity; coding list is not definitive for coverage
Document medical necessity in the clinical record; note that the coding list in the policy is not all‑inclusive and the presence of a code does not guarantee coverage—coverage is determined by member benefit and documented medical necessity.
Use the policy-listed ICD-10-CM diagnosis codes on claims
Use the ICD-10-CM diagnosis codes specified in the policy when filing claims and in clinical documentation to support heart transplant-related services.
- Policy-listed ICD-10-CM codes include I50.82, I50.83, I50.84, I50.89, I50.9, R09.02, R57.0, and T86.22.
Potential denial triggers to document and address before submission
Claims and authorization requests may be denied if contraindications are present; known current malignancy, recent high‑risk malignancy, untreated systemic infection, irreversible noncardiac end‑stage disease, severe psychosocial issues, or fixed pulmonary hypertension may trigger denial.
- Known current malignancy (including metastatic disease) or recent malignancy with high risk of recurrence.
- Untreated systemic infection or chronic infection that makes immunosuppression unsafe.
- Systemic disease likely to be exacerbated by immunosuppression, psychosocial conditions or chemical dependency affecting adherence.
- Fixed pulmonary hypertension: PVR >5 Wood units or transpulmonary gradient ≥16 mm Hg despite treatment; severe pulmonary disease not expected to improve with heart transplant.
Do not list patients with expected futility or worsening comorbidity
Transplantation is contraindicated and will be denied when expected futility exists due to comorbid disease or when post‑transplant care would be expected to significantly worsen comorbid conditions.
Claims lacking listed diagnosis codes risk denial
Claims lacking one of the policy-listed ICD-10-CM diagnosis codes (for example, I50.84 End stage heart failure; R57.0 Cardiogenic shock; T86.22 Heart Transplant Failure) may be subject to denial because they do not reflect the diagnostic rationale provided in this policy.
- Example codes called out in the policy: I50.84, R57.0, T86.22.
- Ensure one of the documented policy codes appears on claims and in clinical documentation to align with medical necessity rationale.
Candidate Selection and Prioritization
Candidate prioritization — selection and prioritization per UNOS/OPTN and clinical urgency
Candidate selection and prioritization per UNOS/OPTN and clinical urgency:
These factors are used by UNOS/OPTN to prioritize donor thoracic organs by medical urgency and distance.
UNOS/OPTN pediatric criteria apply as noted.
Candidate selection — emphasized candidate selection elements
Candidate selection elements emphasized in this section
Aggressive medical therapy and optimization should be documented; evidence supports use of prognostic assessment to identify those who have exhausted therapy.
Vo2max has been adopted by ACC/AHA as an objective selection criterion; SHFM and other models may be used though not universally adopted.
Contraindications to Heart Transplantation
A known current malignancy, including metastatic cancer, is listed as a potential contraindication to solid organ transplantation. Active or untreated malignancy raises concerns about tolerating lifelong immunosuppression and may lead to denial of transplant coverage.
Known current malignancy is specifically identified as a contraindication; the policy also draws attention to recent malignancy with a high risk of recurrence as an exclusion criterion. Both active cancer and recent high‑risk cancers are considerations that can preclude candidacy for transplantation.
The policy enumerates multiple contraindications to transplantation; among these, existing malignancy and recent cancers with appreciable recurrence risk are highlighted as reasons to defer or deny transplant due to the risks of immunosuppression and poor expected outcomes.
Contraindications include conditions that render transplantation unsafe or unlikely to benefit the patient; known current malignancy (including metastatic disease) and recent high‑risk malignancy are examples provided in the policy guidance.
The policy notes that transplant candidacy must consider active systemic disease; current malignancy or recent malignancy with high recurrence risk are explicit contraindications that may lead to denial of coverage.
Known current malignancy, including metastatic cancer, is captured as a reason to withhold transplantation until the cancer is addressed or deemed low risk for recurrence; such malignancies are treated as contraindications in the policy.
Active cancer or recent high‑risk malignancy is identified among potential contraindications to solid organ transplant, reflecting concern that immunosuppression would worsen oncologic outcomes or that survival benefit from transplant would be unlikely.
The presence of a current malignancy is repeatedly cited in the policy as a factor that may disqualify a patient from heart transplantation until oncologic risk is appropriately mitigated.
An absolute contraindication identified by the policy is when transplantation is expected to be futile because of comorbid disease or when required post‑transplant care would be expected to significantly worsen comorbid conditions. In such cases, the procedure should not be performed and coverage would be denied.
Pre-Transplant Evaluation Requirements
Hemodynamic assessment for suspected pulmonary hypertension
When pulmonary hypertension is suspected, hemodynamic assessment must include measurement of pulmonary vascular resistance and transpulmonary gradient to assess for fixed pulmonary hypertension that may preclude isolated heart transplant.
- Measure pulmonary vascular resistance (PVR) and transpulmonary gradient when evaluating pulmonary hypertension.
Hemodynamic assessment and related testing
Hemodynamic testing and related evaluation should document pulmonary vascular resistance and transpulmonary gradient where indicated as part of the pre‑transplant assessment.
Hemodynamic assessment required for transplant evaluation
Hemodynamic assessment, including PVR and transpulmonary gradient measurements when indicated, is required to evaluate candidates with suspected pulmonary hypertension prior to transplant listing.
Include Vo2max, SHFM, and NYHA class in evaluation
Evaluation should include objective prognostic assessment such as Vo2max testing and prognostic models (for example SHFM), and documentation of NYHA functional class, to support that the patient has exhausted medical therapy and is an appropriate transplant candidate.
- Vo2max testing (adult and pediatric where applicable) and SHFM or similar models are recommended.
- Document NYHA classification as part of the evaluation.
Transplant Center and Regulatory Requirements
UNOS status required for listing consideration
Candidates must meet UNOS guidelines for status 1A, 1B, or 2 and not be status 7 (temporarily inactive) to be considered for transplant listing.
- Confirm UNOS/OPTN status as part of documentation.
Regulatory note — CFR Title 21 (1270, 1271)
Providers and transplant centers should be aware that solid organ transplants and related human cells/tissues are regulated under CFR Title 21, parts 1270 and 1271; this regulatory status is noted in the policy.
- Regulatory oversight applies to human cells and tissues intended for transplantation (21 CFR parts 1270 and 1271).
Post-Transplant Care and Coverage Considerations
Definitions and Key Terms
Background and Epidemiology
Heart transplantation is a treatment for refractory end‑stage heart disease and may be lifesaving or improve quality of life for appropriately selected patients. The policy emphasizes that recipients require lifelong immunosuppression and that objective measures such as maximal oxygen consumption (Vo2max) are commonly used in selection and prioritization under UNOS/OPTN criteria.
Policy Revision History
Administrative update: clinical benefit added to the policy record.
Consensus review: no change to policy statements; references reviewed and updated; ICD-10 code I47.21 added.
Consensus review: no change to policy statement; background and references updated.
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