CurrentAlliance HealthPolicy 11B-2

Heart (Cardiac) Transplantation

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Defines Medicaid coverage criteria, eligibility, and limitations for pediatric and adult heart transplantation for beneficiaries of the NC Medicaid program.

Policy Summary

PayerAlliance Health

PolicyHeart (Cardiac) Transplantation

Policy CodePolicy 11B-2

Change TypeNo material changes

Effective Date

Last ReviewAug 15, 2023

Next Review Date

Key ActionVerify NC Medicaid beneficiary eligibility at each service and retain surgeon certification of FDA-approved implants/devices in the medical record.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

pediatric & adultpopulations explicitly addressed

11-14 ml/kg/minVO2 threshold (adult)

16listed contraindications

Noprior approval required

Coveredcadaveric donor expenses

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CurrentAlliance HealthPolicy 11B-2

Heart (Cardiac) Transplantation

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Get alerted when Policy 11B-2 changes without checking for updates manually.

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Defines Medicaid coverage criteria, eligibility, and limitations for pediatric and adult heart transplantation for beneficiaries of the NC Medicaid program.

Policy Summary

PayerAlliance Health

PolicyHeart (Cardiac) Transplantation

Policy CodePolicy 11B-2

Change TypeNo material changes

Effective Date

Last ReviewAug 15, 2023

Next Review Date

Key ActionVerify NC Medicaid beneficiary eligibility at each service and retain surgeon certification of FDA-approved implants/devices in the medical record.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

pediatric & adultpopulations explicitly addressed

11-14 ml/kg/minVO2 threshold (adult)

16listed contraindications

Noprior approval required

Coveredcadaveric donor expenses

Coverage Criteria for Heart Transplantation

Medical Necessity and Eligibility

Covered when ALL of the following are met

General medical necessity: Procedure is individualized, specific, and consistent with symptoms or confirmed diagnosis; not in excess of the beneficiary's needs; can be safely furnished with no equally effective, more conservative, or less costly statewide alternative; and not furnished primarily for convenience of the beneficiary, caretaker, or provider.

Section 3.1 general criteria

Pediatric specific criteria: One of the following pediatric conditions: 1) heart failure with persistent symptoms at rest requiring continuous IV inotropes, mechanical ventilator support, or mechanical circulatory support; OR 2) symptoms not meeting the above but having severe exercise limitation (if measurable, peak VO2 <50% predicted for age/sex), significant growth failure from cardiomyopathy or repaired/palliated congenital heart disease, near sudden death or life‑threatening arrhythmias untreatable with medication or an implantable defibrillator, restrictive cardiomyopathy with reactive pulmonary hypertension, reactive pulmonary hypertension with risk of developing fixed irreversible pulmonary vascular resistance, anatomical/physiologic conditions likely to worsen natural history in single‑ventricle infants, or other anatomic/physiologic conditions that may lead to consideration for transplant even without systemic ventricular dysfunction.peak VO2 <50% predicted

Section 3.2.1 pediatric criteria

Adult specific criteria: Adult beneficiaries with end‑stage, irreversible, refractory symptomatic heart disease requiring maximal continuous medical or mechanical support with low functional status and poor probability of survival, and at least one of: implanted ventricular assist device; refractory cardiogenic shock; dependence on IV inotropic support to maintain organ perfusion; maximal peak VO2 of 11–14 ml/kg/min (≈55% predicted) with major activity limitation; severe or recurrent unstable ischemia not amenable to bypass or PCI; recurrent symptomatic ventricular arrhythmias refractory to all therapies; or ischemic cardiomyopathy not amenable to medical therapy or revascularization.VO2 11-14 ml/kg/min

Section 3.2.1 adult criteria

Retransplantation is medically necessary for graft failure due to technical reasons or hyperacute rejection. Retransplantation for chronic rejection, moderate graft vasculopathy, or recurrent disease is medically necessary when the beneficiary meets the general criteria above.

Section 3.2.1 retransplantation statement

Patient/caregiver capability: Beneficiary and caregiver are willing and capable of complying with the post‑transplant treatment plan.

Section 3.2.1 requirement

Not Medically Necessary / Not Covered Criteria

Not covered when ANY of the following general or specific conditions apply

General noncoverage: Beneficiary does not meet eligibility in Section 2.0, or does not meet the clinical criteria in Section 3.0; the procedure duplicates another provider's service; or the procedure/product/service is experimental, investigational, or part of a clinical trial.

Section 4.1 general criteria not covered

Organ source exclusion: Organs that were sold rather than donated to the beneficiary.

Section 4.2 specific exclusion

Clinical contraindications (any single condition makes transplant not covered): Any of the following: alcoholic cardiomyopathy unless abstinent ≥6 months; systemic illness limiting life expectancy or recovery; diabetes with significant end‑organ complications (retinopathy, neuropathy, nephropathy, peripheral or cerebrovascular disease); acute severe hemodynamic compromise with failure of any vital end‑organ at time of transplant; severe peripheral vascular or cerebrovascular disease; current potentially life‑threatening malignancy; active infection (except VAD infections); irreversible hepatic dysfunction (transaminases ≥2× normal with coagulopathy); irreversible renal dysfunction (serum creatinine >2 mg/dl or creatinine clearance <50 cc/min); chronic bronchitis/COPD with FEV1 <60% predicted or any irreversible lung disease; cachexia; HIV positivity; morbid obesity (BMI >40, or BMI >35 with comorbid conditions); absence of documentation of nonsmoking status; recent substance use likely to impair compliance; psychosocial history limiting ability to comply with pre‑ and post‑transplant care; or current beneficiary/caretaker non‑compliance that would make adherence improbable.

Cadaveric/Deceased Organ Donation Coverage

Covered items

Cadaveric donor expense coverage: Donor transplant‑related medical expenses (procuring, harvesting, and associated surgical and laboratory costs) for cadaveric/deceased organ donations are covered for a heart transplant.

Cadaveric/deceased organ donation coverage (Section 1)

Coverage is expressly excluded when an organ has been sold rather than donated to the beneficiary. Claims for transplantation using organs that were purchased for the beneficiary are not covered under this policy.

Medicaid does not provide coverage for transplantation when the organ was sold rather than donated to the beneficiary. Providers should not bill for transplant services in these circumstances.

Heart transplants that require a planned, concurrent coronary artery bypass graft (CABG) procedure are considered experimental and are not covered by Medicaid. When CABG is intended to be performed concurrently with the transplant as part of the planned operation, the combined procedure is excluded from coverage.

Services will be denied when the beneficiary fails to meet the eligibility requirements in Section 2.0 or the clinical criteria in Section 3.0, when the service duplicates another provider's procedure, or when the procedure is experimental, investigational, or part of a clinical trial. Additionally, transplantation is not covered if any of the specific clinical contraindications listed in Section 4.2.1 are present.

Procedures are not covered when the beneficiary does not meet the program eligibility or the policy’s clinical criteria, when the service duplicates another provider’s service, when it is experimental/investigational or part of a clinical trial, or when any specific contraindication in Section 4.2.1 applies (for example, irreversible renal or hepatic dysfunction, active infection, recent substance use, morbid obesity, or documented noncompliance).

Candidate Selection and Exclusion Criteria

Candidate selection

Candidate selection criteria by age group

Pediatric candidates: Meet the pediatric specific criteria listed under Medical Necessity: either heart failure with persistent symptoms at rest requiring continuous IV inotropes, mechanical ventilator support, or mechanical circulatory support; OR other pediatric indications including severe exercise limitation (peak VO2 <50% predicted), significant growth failure due to cardiomyopathy or repaired/palliated congenital heart disease, near‑sudden death or life‑threatening arrhythmias untreatable with meds/ICD, restrictive cardiomyopathy with reactive pulmonary hypertension, reactive pulmonary hypertension at risk for fixed elevated PVR, anatomical/physiologic conditions worsening single‑ventricle infants, or conditions warranting transplant consideration without systemic ventricular dysfunction.peak VO2 <50% predicted

Section 3.2.1 pediatric list

Adult candidates with end‑stage, irreversible, refractory symptomatic heart disease requiring maximal continuous medical or mechanical support who have low functional status and poor survival probability, and at least one of: implanted VAD; refractory cardiogenic shock; dependence on IV inotropic support for organ perfusion; peak VO2 11–14 ml/kg/min (~55% predicted) with major activity limitation; severe/recurrent unstable ischemia not amenable to bypass or PCI; recurrent symptomatic ventricular arrhythmias refractory to all therapies; or ischemic cardiomyopathy not amenable to medical therapy or revascularization.

Contraindications

Donor transplant-related medical expenses associated with cadaveric/deceased organ donations for heart transplant — including procuring, harvesting, and associated surgical and laboratory costs — are covered. This coverage applies only to cadaveric or deceased donor organs; organs sold to the beneficiary remain excluded. Note that certain clinical contraindications and experimental procedures (see Section 4.2.1) will still render transplantation noncovered.

Evaluation Requirements

Documentation Required

Evaluation and documentation — verify eligibility and criteria

Standard transplant evaluation steps are not detailed in this partial document; providers must refer to Sections 2.0 and 3.0 to confirm the beneficiary meets eligibility and clinical criteria prior to transplant consideration. For beneficiaries under 21, EPSDT and prior approval guidance also apply as noted elsewhere in the policy.

Confirm beneficiary meets Section 2.0 eligibility and Section 3.0 clinical criteria before proceeding.
For beneficiaries under 21, follow EPSDT guidance and any applicable prior approval procedures.

Provider Actions, Documentation, and Billing Guidance

Prior Authorization

Prior approval requirement for beneficiaries under 21

If a service requires prior approval, that requirement continues to apply for beneficiaries under 21 years of age; providers must follow NCTracks and the EPSDT prior approval guidance referenced in the policy.

Follow NCTracks Provider Claims and Billing Assistance Guide and the EPSDT provider page for prior approval procedures.

Prior Authorization

No prior authorization required for heart transplant

Medicaid does not require prior approval for heart (cardiac) transplantation.

Coding and Claim Types

Claim Typesmixed

CMS-1500/837P	Professional claim transaction
UB-04/83711	Institutional claim transaction

Unlisted procedure/service guidanceCPT | HCPCS

CPT unlisted	Use CPT unlisted procedure/service codes per CPT instructions and submit special report
HCPCS unlisted	Use HCPCS unlisted procedure/service codes per HCPCS instructions and submit special report

Primary coding guidancemixed

CPT	Use the most specific CPT code in effect at time of service; refer to current CPT edition for descriptions.
HCPCS	Use the most specific HCPCS code in effect at time of service; refer to current HCPCS edition for descriptions.
UB-04 revenue codes	Refer to UB-04 Data Specifications Manual for valid revenue codes.

Unlisted Procedure or ServiceCPT

Unlisted CPT	Follow CPT instructions for Unlisted Procedure or Service and submit Special Report.
Unlisted HCPCS	Follow HCPCS instructions for Unlisted Procedure or Service and submit Special Report.

Unlisted Procedure or ServiceCPT

Unlisted CPT	Follow CPT instructions for Unlisted Procedure or Service and submit Special Report.
Unlisted HCPCS	Follow HCPCS instructions for Unlisted Procedure or Service and submit Special Report.

inv-14: Peak VO2 — example physiologic criterion for adults

Adult physiologic thresholdMaximal peak VO2 11-14 milliliters/kilogram/minute (approximately 55% predicted) with major limitation of activities

Pediatric referencePediatric criteria use peak VO2 <50% predicted when measurable

Context for usePeak VO2 is used to document severe exercise limitation as part of transplant candidate selection

inv-15: Serum creatinine — threshold value

Serum creatinine exclusion thresholdSerum creatinine greater than 2 mg/dl

Context

Definitions

inv-34: Heart (cardiac) transplantation — definition

DefinitionSurgical excision of a heart and the main arteries from a brain-dead donor with implantation into a beneficiary after removal of the recipient heart

Anatomic detailsNew heart is attached to major blood vessels including pulmonary arteries/veins, aorta, and vena cava

PurposeTreatment for end-stage or refractory heart disease requiring transplant

inv-35: EPSDT — Early and Periodic Screening, Diagnostic, and Treatment exception referenced for beneficiaries under 21 years of age

EPSDT exception referenceEPSDT (Early and Periodic Screening, Diagnostic, and Treatment) exception applies for Medicaid beneficiaries under 21; see Subsection 2.2.1

Documentation implicationFor beneficiaries under 21, EPSDT documentation must demonstrate medical necessity to correct or ameliorate a condition

Post-Transplant Coverage and Requirements

inv-42: post-transplant treatment plan compliance requirement — Beneficiary and caregiver must be willing and capable of complying with the post-transplant treatment plan for coverage.

Compliance requirementBeneficiary and caregiver must be willing and capable of complying with the post-transplant treatment plan for coverage

TimingThis requirement is part of the candidate selection and retransplantation statements in the coverage criteria

Coverage consequenceLack of willingness or capability to comply may render the transplant not covered under Medicaid policy

inv-43: Post-transplant services as covered under Medicaid policies and EPSDT when applicable — EPSDT exceptions apply for beneficiaries under 21; providers must comply with applicable laws, policies, and use FDA-approved devices wit...

EPSDT applicabilityEPSDT exceptions apply for beneficiaries under 21 and may override policy limitations where medically necessary

Background

Heart transplantation is the surgical excision of a donor heart and main arteries from a brain‑dead donor with implantation into a beneficiary after removal of the recipient’s heart and attachment to major vessels. It is performed as treatment for end‑stage or refractory heart disease when the beneficiary meets the program’s specified medical necessity criteria for pediatric or adult candidates.

Center Requirements

Note

Center requirements — eligibility verification and program participation

Provider(s) shall verify beneficiary eligibility each time a service is rendered and meet Medicaid qualifications for participation, including maintaining a current signed DHHS Provider Administrative Participation Agreement and billing only within the scope of clinical practice.

Verify eligibility at every service.
Maintain required agreements and bill only within licensed scope of practice.

Policy Summary

PayerAlliance Health

PolicyHeart (Cardiac) Transplantation

Policy CodePolicy 11B-2

Change TypeNo material changes

Effective Date

Last ReviewAug 15, 2023

Next Review Date

Key ActionVerify NC Medicaid beneficiary eligibility at each service and retain surgeon certification of FDA-approved implants/devices in the medical record.

SourceLink

On This Page

see individual items (e.g., creatinine >2 mg/dl; CrCl <50 cc/min; FEV1 <60% predicted; BMI >40 or >35 with comorbidities)

Section 4.2.1 detailed exclusions

Relative contraindication: Pulmonary infarction or embolism during the preceding eight weeks (relative contra‑indication).within past 8 weeks

Section 4.2.1 relative contraindication

Procedures considered experimental: Planned concurrent coronary artery bypass graft (CABG) surgery with heart transplant is considered experimental and is not covered.

Section 4.2.1 experimental procedure

Section 3.2.1 adult list

Candidate exclusion criteria

Contraindications that make a candidate ineligible for Medicaid-covered heart transplantation

Alcoholic cardiomyopathy (not covered unless abstinent for at least six months).6 months abstinent

Section 4.2.1 item 1

Systemic illness that would limit life expectancy or compromise recovery from cardiac transplantation.

Section 4.2.1 item 2

Diabetes with end‑organ complications: Diabetes mellitus with evidence of significant end‑organ complications (retinopathy, neuropathy, nephropathy, peripheral or cerebrovascular disease).

Section 4.2.1 item 3

Acute severe hemodynamic compromise at time of transplant accompanied by failure of any vital end‑organ (contraindication because survival likely compromised).

Section 4.2.1 item 4

Severe peripheral/cerebrovascular disease: Severe peripheral vascular disease or cerebrovascular disease.

Section 4.2.1 item 5

Active malignancy: Current, potentially life‑threatening malignancy.

Section 4.2.1 item 6

Active infection (except infection of a ventricular assist device).

Section 4.2.1 item 7

Irreversible hepatic dysfunction (transaminases twice normal with associated coagulopathy).transaminases >= 2x normal

Section 4.2.1 item 8

Irreversible renal dysfunction (serum creatinine >2 mg/dl or creatinine clearance <50 cc/min).creatinine >2 mg/dl OR CrCl <50 cc/min

Section 4.2.1 item 8

Pulmonary disease: Chronic bronchitis or COPD with FEV1 <60% predicted or any irreversible lung disease.FEV1 <60% predicted

Section 4.2.1 item 9

Cachexia, even without major end‑organ failure.

Section 4.2.1 item 10

HIV positivity: Human Immunodeficiency Virus (HIV) positivity.

Section 4.2.1 item 11

Morbid obesity defined as BMI >40, or BMI >35 with comorbid conditions.BMI >40 or BMI >35 with comorbidities

Section 4.2.1 item 12

Smoking documentation absent: Absence of documentation of nonsmoking status.

Section 4.2.1 item 13

Recent substance use likely to impair compliance with post‑transplant protocols.

Section 4.2.1 item 14

Psychosocial or compliance issues: Beneficiary psychosocial history or current beneficiary/caretaker non‑compliance that limits ability to comply with pre‑ and post‑transplant medical care, or current non‑compliance making adherence improbable.

Section 4.2.1 items 15–16

Billing Rule

Cadaveric donor transplant-related expenses covered

Donor transplant-related medical expenses for cadaveric/deceased organ donations — including procuring, harvesting, and associated surgical and laboratory costs — are covered for heart transplants.

Coverage applies to cadaveric/deceased organ procurement, harvesting, and associated surgical and laboratory costs.

Documentation Required

Compliance and surgeon FDA-certification must be documented

Providers must comply with all applicable agreements, laws, and NC Medicaid clinical policies in effect at the time of service, and must utilize FDA-approved procedures, products, and devices for heart transplantation; retain a surgeon-signed statement certifying FDA requirements in the beneficiary's medical record.

Use FDA-approved implants, products, and devices for implantation.
Retain a statement signed by the surgeon certifying all FDA requirements in the beneficiary's medical record and make it available upon request.

Step Therapy

Step therapy not required

No general or specific step therapy requirements apply to heart transplantation under this policy.

Documentation Required

Verify eligibility and retain EPSDT/prior approval documentation

Providers must verify NC Medicaid beneficiary eligibility each time a service is rendered. For beneficiaries under 21, EPSDT documentation must demonstrate medical necessity to correct or ameliorate a condition; prior approval requirements (when applicable) still apply.

Verify eligibility at each encounter.
For under-21 beneficiaries, document EPSDT medical necessity per NCTracks and EPSDT guidance.

Documentation Required

Surgeon-signed FDA certification must be retained in the record

A statement signed by the surgeon certifying that all FDA requirements for the implants, products, and devices used in heart transplantation have been met must be retained in the beneficiary's medical record and made available for review upon request.

Billing Rule

Report the most specific ICD-10-CM/PCS and CPT/HCPCS codes

Report ICD-10-CM/PCS and CPT/HCPCS codes to the highest level of specificity in effect at the time of service; refer to the applicable codebook edition for descriptions as code descriptions are not listed in the policy.

Use current ICD-10-CM/PCS, CPT, HCPCS and UB-04 Data Specifications Manual editions in effect at time of service.

Billing Rule

Follow codebook instructions and submit Special Report for unlisted codes

When using unlisted CPT or HCPCS procedure or service codes, comply with the Instructions for Use in the current CPT/HCPCS editions and submit the required Special Report as documented by the codebook.

Follow CPT and HCPCS instructions for unlisted procedures and include the Special Report per the current edition.

Denial Risk

Common denial triggers — eligibility, clinical criteria, duplication, experimental status

Services will be denied if the beneficiary does not meet eligibility in Section 2.0, does not meet the criteria in Section 3.0, the service duplicates another provider's service, or the service is experimental, investigational, or part of a clinical trial.

Denial Risk

General denial triggers — eligibility, criteria, duplication, experimental

Denial will occur when the beneficiary fails to meet Section 2.0 eligibility or Section 3.0 clinical criteria, when the service duplicates another provider's service, or when the service is experimental, investigational, or part of a clinical trial.

Denial Risk

Specific denial triggers — organ source and listed contraindications

Claims will be denied if the organ was sold rather than donated to the beneficiary or if any of the specific heart transplant contraindications listed in Section 4.2.1 are present.

Review Section 4.2.1 for specific contraindications (e.g., irreversible renal dysfunction, active infection, morbid obesity, recent substance use, psychosocial noncompliance).

Denial Risk

Denial risk — coding specificity required

Failure to report the most specific CPT/HCPCS code that accurately and completely describes the procedure, product, or service may result in incorrect billing or claim processing.

Part of irreversible renal dysfunction criteria that make a candidate ineligible

Relation to coveragePresence above this threshold results in heart transplantation not covered by Medicaid

inv-16: Creatinine clearance — threshold value

Creatinine clearance exclusion thresholdCreatinine clearance less than 50 cc/min

ContextListed with serum creatinine in irreversible renal dysfunction exclusion

ImplicationBelow this CrCl the candidate is not covered for heart transplantation under Medicaid policy

inv-17: BMI — threshold values and conditions

Absolute morbid obesity thresholdBMI greater than 40

Morbid obesity with comorbidity thresholdBMI greater than 35 with comorbid conditions

Coverage effectMeeting either BMI threshold is a contraindication to Medicaid-covered heart transplantation

inv-18: FEV1 — threshold value

Pulmonary function exclusion thresholdFEV1 less than 60% predicted

ContextChronic bronchitis/COPD with FEV1 <60% predicted or any irreversible lung disease are exclusions

Coverage implicationFEV1 below this threshold renders heart transplantation not covered by Medicaid policy

Prior approval noteIf a service requires prior approval, that requirement still applies for beneficiaries under 21 (follow NCTracks and EPSDT guidance)

inv-36: Unlisted Procedure or Service — definition and guidance

DefinitionUnlisted Procedure or Service: a CPT/HCPCS code used when no specific code exists for the procedure or service and requiring compliance with codebook instructions and a Special Report

Provider guidanceProviders must refer to and comply with CPT/HCPCS instructions for unlisted procedures and submit the Special Report in effect at time of service

Billing implicationUse current edition instructions for Unlisted CPT/HCPCS and include required documentation to support claim

Provider obligationsProviders must comply with applicable laws, NC Medicaid clinical coverage policies, and retain a surgeon-signed statement certifying FDA requirements for implants/devices in the medical record

Device requirementFDA-approved procedures, products, and devices for implantation must be utilized for heart transplantation

inv-44: Donor procurement, harvesting, and associated surgical and laboratory costs — Donor transplant-related medical expenses for cadaveric/deceased organ donations are covered.

Covered donor costsDonor transplant-related medical expenses (procuring, harvesting, and associated surgical and laboratory costs) for cadaveric/deceased organ donations are covered for a heart transplant

ScopeApplies specifically to cadaveric/deceased organ donations for heart transplantation

Policy referenceSee Cadaveric/Deceased Organ Donations section for coverage of donor-related expenses