CurrentAlliance HealthPolicy 11B-6

Heart‑Lung Transplantation — Medicaid Coverage Criteria

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This policy governs coverage criteria, exclusions, and prior approval requirements for heart‑lung transplant procedures for beneficiaries enrolled in North Carolina Medicaid.

Policy Summary

PayerAlliance Health

PolicyHeart‑Lung Transplantation — Medicaid Coverage Criteria

Policy CodePolicy 11B-6

Change TypeNo material changes

Effective Date

Last ReviewAug 15, 2023

Next Review Date

Key ActionVerify beneficiary meets general medical necessity and at least one listed qualifying diagnosis before proceeding with heart‑lung transplant authorization.

SourceLink

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CurrentAlliance HealthPolicy 11B-6

Heart‑Lung Transplantation — Medicaid Coverage Criteria

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This policy governs coverage criteria, exclusions, and prior approval requirements for heart‑lung transplant procedures for beneficiaries enrolled in North Carolina Medicaid.

Policy Summary

PayerAlliance Health

PolicyHeart‑Lung Transplantation — Medicaid Coverage Criteria

Policy CodePolicy 11B-6

Change TypeNo material changes

Effective Date

Last ReviewAug 15, 2023

Next Review Date

Key ActionVerify beneficiary meets general medical necessity and at least one listed qualifying diagnosis before proceeding with heart‑lung transplant authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7listed qualifying diagnoses

11contraindications

3medical necessity items

noprior approval required?

1EPSDT exception

Coverage Criteria

Coverage criteria — Medicaid

Covered when ALL of the following are met:

General medical necessity: The procedure, product, or service is individualized, specific, and consistent with symptoms or confirmed diagnosis; can be safely furnished and no equally effective, more conservative or less costly treatment is available statewide; and is not furnished primarily for convenience of the beneficiary, caretaker, or provider.

From Section 3.1

Specific covered diagnoses (at least one): Irreversible primary pulmonary hypertension with heart failure; Non-specific severe pulmonary fibrosis; Eisenmenger complex with irreversible pulmonary hypertension and heart failure; Cystic fibrosis with severe heart failure; Chronic obstructive pulmonary disease with heart failure; Emphysema with severe heart failure; Pulmonary fibrosis with uncontrollable pulmonary hypertension or heart failure.

From Section 3.2.1

Medicaid exclusions for heart-lung transplantation

Heart‑lung transplantation is not covered when any of the following apply:

Exclusion criteria: The beneficiary's psychosocial history limits ability to comply with pre- and post-transplant medical care; there is current beneficiary or caretaker non-compliance that would make adherence to a disciplined medical regimen improbable; active substance use; or recent substance use without documentation of a completed substance abuse/therapy program plus six months of negative sequential random drug screens.

From Sections 4.2.2–4.2.4 (Medicaid exclusions).

Donor Transplant-Related Expenses

Covered services

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-lung transplant.

From Donor transplant-related medical expenses statement.

Medicaid does not cover the procedure, product, or service when any of the following apply: the beneficiary does not meet the eligibility requirements in Section 2.0; the beneficiary does not meet the coverage criteria in Section 3.0; the procedure, product, or service duplicates another provider's service; or the procedure, product, or service is experimental, investigational, or part of a clinical trial.

None apply.

Heart‑lung transplantation is not medically necessary when listed contraindications or behaviors would make adherence to the required pre‑ and post‑transplant care improbable. Examples include significant psychosocial history limiting ability to comply with care, current beneficiary or caretaker non‑compliance with medical management, active substance use, or recent substance use without documentation of a completed treatment program and six months of negative sequential random drug screens. Other medical contraindications (see policy) such as morbid obesity (e.g., BMI > 40 or BMI > 35 with comorbid conditions) also render the transplant not medically necessary.

Heart‑lung transplantation is considered not covered when the beneficiary has psychosocial factors that limit the ability to comply with pre‑ and post‑transplant care, when there is current beneficiary or caretaker non‑compliance that would make adherence to a disciplined medical regimen improbable, or when there is active substance use or a recent history of substance use without documentation of program completion plus six months of negative sequential random drug screens.

Candidate Selection Criteria

Candidate criteria

Candidate selection requires meeting general medical necessity and having one of the listed end‑stage cardiopulmonary diagnoses.

Candidate eligibility: Beneficiary enrolled in NC Medicaid who meets general medical necessity criteria (individualized/specific to symptoms or confirmed diagnosis; safe to furnish; no equally effective, more conservative or less costly statewide treatment; not primarily for convenience) AND has at least one qualifying end-stage cardiac or pulmonary diagnosis listed in Section 3.2.1.

From Sections 3.1 and 3.2.1; provider must verify eligibility each time service is rendered.

EPSDT considerations

Refer to EPSDT special provisions where applicable for beneficiaries under 21:

EPSDT note: See Subsection 2.2.1 regarding the EPSDT Exception to Policy Limitations for Medicaid beneficiaries under 21 years of age; EPSDT may allow exceptions to policy limitations when medically necessary.

From Subsection 2.2.1 and related EPSDT provisions.

Contraindications

Absolute or relative contraindications include emotional problems or recent substance use likely to impair compliance; history of non‑compliance with medical management; lack of social support that would impair compliance; active potentially life‑threatening malignancy (except when transplant is performed for cure); other major organ system disease or infection; morbid obesity (defined as BMI > 40, or BMI > 35 with comorbid conditions); HIV positivity; and absence of documentation of nonsmoking status. Additional exclusions include organs sold rather than donated and services funded by governmental, foundation, or charitable grants.

A beneficiary’s psychosocial history that limits their ability to comply with pre‑ and post‑transplant medical care is a contraindication to coverage for heart‑lung transplantation.

Current beneficiary or caretaker non‑compliance that would make adherence to a disciplined medical regimen improbable is a contraindication to coverage for heart‑lung transplantation.

Active substance use, or a recent history of substance use without documentation of a completed substance abuse/therapy program plus six months of negative sequential random drug screens, is a contraindication to coverage for heart‑lung transplantation.

Evaluation and Documentation Requirements

Documentation Required

Evaluation documentation: diagnosis, smoking, psychosocial, social support, compliance

Document the beneficiary's diagnosis and disease severity, smoking status, psychosocial assessment, social support, and treatment compliance history in the medical record to demonstrate absence of listed contraindications and support medical necessity for heart‑lung transplantation.

Record end‑stage cardiac and pulmonary diagnosis and objective severity.
Document nonsmoking status or smoking cessation evidence.
Include psychosocial assessment and evidence of adequate social support.
Include history of treatment compliance to show ability to follow post‑transplant protocols.

Documentation Required

Surgeon certification: FDA requirements for implants/devices

Retain a surgeon‑signed statement in the beneficiary's medical record certifying that any implants, products, or devices meet applicable FDA requirements and that FDA/OPTN‑approved procedures, products, and devices are used for implantation as required by policy.

Provider Actions and Requirements

Prior Authorization

Obtain prior approval when required (EPSDT does not waive)

Prior approval is required for services that require prior approval per policy; EPSDT does not eliminate prior approval requirements for beneficiaries under 21.

Verify whether the specific service requires prior approval before rendering care
For beneficiaries under 21, EPSDT does not waive any prior approval requirement

Prior Authorization

No prior approval required for heart‑lung transplant

Medicaid shall not require prior approval for heart‑lung transplantation.

Prior Authorization

Check full policy for prior authorization details

Coding and Billing

Coding sections referenced (ICD-10-CM, PCS, Modifiers, Billing units, Place of service, Donor billing)mixed

No codes listed

Claim Typesmixed

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

Unlisted CPT ProceduresCPT

unlisted CPT

Refer to CPT Codebook instructions for Unlisted Procedure or Service and include Special Report as documented in the current CPT.

Unlisted HCPCS ProceduresHCPCS

unlisted HCPCS

Refer to HCPCS National Level II instructions for Unlisted Procedure or Service and include Special Report as documented in the current HCPCS edition.

inv-12: Body Mass Index (BMI) — BMI > 40, or BMI > 35 with comorbid conditions

BMI threshold (absolute)BMI > 40

BMI threshold (relative)BMI > 35 with comorbid conditions

Policy contextMorbid obesity listed as a contraindication to coverage for heart-lung transplantation

inv-13: Substance use monitoring — 6 months of negative sequential random drug screens

Required substance use documentationCompleted substance abuse or therapy program documented

Drug screen requirement

Post-Transplant Coverage

inv-45: Post‑transplant services as allowed under EPSDT and subject to prior approval

EPSDT allowancePost-transplant services may be allowed under EPSDT for beneficiaries under 21 when medically necessary to correct or ameliorate a condition

Prior approval noteIf a service requires prior approval, EPSDT does NOT eliminate the prior approval requirement

Documentation requirementProvider must show how the service meets EPSDT criteria in documentation

inv-46: Post-transplant services — follow applicable agreements, laws, NC Medicaid clinical coverage policies; use FDA/OPTN-approved devices

Compliance with agreements and lawsFollow all applicable agreements, federal, state and local laws, and NC Medicaid clinical coverage policies

Use of approved devices

Provider / Center Requirements

Note

No center accreditation/volume requirements specified here

This policy references the heart‑lung transplant procedure description but does not specify center accreditation or volume requirements in this excerpt of the policy.

Review other payer or regulatory requirements for center accreditation/volume if needed

Documentation Required

Meet Medicaid participation and DHHS agreement requirements

Centers must meet Medicaid qualifications for participation and have a current, signed DHHS Provider Administrative Participation Agreement.

Meet Medicaid participation qualifications
Maintain a current, signed DHHS Provider Administrative Participation Agreement

Documentation Required

Maintain required Medicaid participation credentials

Definitions

inv-30: Definitions — Policy states 'None Apply' for definitions specific to this document

Definitions applicable to this policyNone Apply

Interpretation noteNo policy-specific terms are defined within this document

Where to find general definitionsRefer to other NC Medicaid clinical coverage policies or provider manuals for general definitions

inv-31: Active substance use definition — recent history requiring completed program plus six months of negative sequential random drug screens

Active substance use (current)Beneficiaries with active substance use are not covered for heart-lung transplantation

Recent history requirementFor recent substance use, must document completion of a substance abuse/therapy program

Background

A heart‑lung transplant replaces both the heart and lungs from a single cadaver donor and is performed to prolong survival and improve cardiopulmonary function in patients with end‑stage cardiopulmonary disease. The operation involves procurement of a donor heart‑lung block and implantation into the recipient.

Revision History

08/15/2023amendmentLatest

Policy posted with updated template language due to North Carolina Health Choice Program's move to Medicaid; policy posted 8/15/2023 with an effective date of 4/1/2023 and Amended Date of August 15, 2023.

07/01/2021revision

Prior approval requirement removed and claim type Institutional (UB-04/83711) added; specific ICD-10 PCS and CPT codes removed and prior approval language removed from Section I.

01/06/2020

Policy Summary

PayerAlliance Health

PolicyHeart‑Lung Transplantation — Medicaid Coverage Criteria

Policy CodePolicy 11B-6

Change TypeNo material changes

Effective Date

Last ReviewAug 15, 2023

Next Review Date

Key ActionVerify beneficiary meets general medical necessity and at least one listed qualifying diagnosis before proceeding with heart‑lung transplant authorization.

SourceLink

On This Page

Surgeon-signed certification of FDA requirements must be available for review.
Use FDA and OPTN‑approved procedures, products, and devices for implantation per policy.

Documentation Required

Retention of surgeon‑signed FDA certification in record

Retain the surgeon‑signed FDA certification statement in the medical record and ensure use of FDA/OPTN‑approved implants, products, and devices; this statement must be made available for review as part of the beneficiary's evaluation and post‑transplant documentation.

Keep certification in the beneficiary's medical record.
Make the certification available upon request for audits or reviews.

Refer to other sections of the policy for prior authorization rules; this excerpt does not specify additional prior authorization requirements beyond Section 5.1.

Confirm prior authorization expectations in the full policy or payer implementation guides if unclear

Step Therapy

No step therapy specified — document lack of effective alternatives

No step therapy rules are specified in this policy excerpt; coverage requires that no equally effective, more conservative, or less costly treatment is available statewide.

Document that no equally effective, more conservative, or less costly statewide treatment is available

Documentation Required

Document medical necessity and supporting clinical information

Providers must document medical necessity consistent with EPSDT when applicable, including evidence of diagnosis and severity supporting end‑stage cardiopulmonary disease and documentation addressing psychosocial support, smoking status, compliance history, and BMI/comorbidities.

Include documentation of medical necessity per EPSDT for beneficiaries under 21
Provide evidence of diagnosis and disease severity
Document psychosocial support, smoking status, treatment compliance, and BMI/comorbidities

Documentation Required

Surgeon certification for implants/devices must be retained

A surgeon‑signed statement certifying all FDA requirements for implants, products, and devices must be retained in the beneficiary's medical record and made available for review.

Keep the surgeon‑signed certification in the medical record
Provide it upon request for review

Billing Rule

Include Special Report for unlisted procedure codes

When submitting claims using unlisted CPT or HCPCS procedure codes, include the required Special Report per the current CPT/HCPCS instructions for unlisted procedures to avoid processing issues.

Comply with CPT/HCPCS instructions for unlisted procedure codes
Include the Special Report as documented in the current codebook edition

Billing Rule

Support donor transplant‑related expense claims with documentation

When billing donor transplant‑related medical expenses for cadaveric/deceased organ donations, include documentation that supports the procurement, harvesting, and associated surgical and laboratory costs.

Document donor procurement, harvesting, and associated surgical and laboratory costs for cadaveric donations

Denial Risk

Failure to meet eligibility/coverage or presence of contraindications triggers denial

Claims will be denied when beneficiaries do not meet Section 2.0 eligibility, do not meet Section 3.0 coverage criteria, when the service duplicates another provider's service, is experimental/investigational or part of a clinical trial, or when specific contraindications exist (e.g., active malignancy, HIV positivity, morbid obesity, substance use, psychosocial or compliance issues).

Verify beneficiary eligibility per Section 2.0 and coverage criteria in Section 3.0
Ensure service is not duplicative or experimental
Confirm absence of listed contraindications (see Section 4.2.1)

Denial Risk

Psychosocial history limiting compliance will trigger denial

A psychosocial history that limits the beneficiary's ability to comply with pre‑ and post‑transplant medical care will result in Medicaid non‑coverage for heart‑lung transplantation.

Denial Risk

Current non‑compliance by beneficiary or caretaker triggers denial

Current beneficiary or caretaker non‑compliance that would make adherence to a disciplined medical regimen improbable will result in Medicaid non‑coverage.

Denial Risk

Active or recent substance use without required documentation triggers denial

Active substance use, or recent substance use without documentation of a completed substance abuse/therapy program plus six months of negative sequential random drug screens, will trigger denial of coverage.

If recent substance use, retain documentation of completed treatment program and six months of negative sequential random drug screens

Denial Risk

Omit Special Report for unlisted codes at your peril

Failure to include the Special Report when submitting unlisted CPT or HCPCS codes may lead to processing issues or denial of the claim.

Attach the Special Report with unlisted CPT/HCPCS submissions to avoid denial

Six months of negative sequential random drug screens

Coverage consequenceActive substance use or lack of required documentation results in noncoverage

Use FDA and OPTN-approved procedures, products, and devices for implantation

Surgeon certificationRetain a surgeon-signed statement certifying all FDA requirements for implants/devices in the beneficiary's medical record

inv-47: procurement, harvesting, associated surgical and laboratory costs — Donor transplant-related medical expenses for cadaveric/deceased donors are covered

Covered donor expensesDonor transplant-related medical expenses for cadaveric/deceased donors are covered

Scope of covered costsIncludes procuring, harvesting, and associated surgical and laboratory costs

Transplant typeApplies specifically to heart-lung transplants as stated in policy

Centers must meet Medicaid qualifications for participation and have a current, signed DHHS Provider Administrative Participation Agreement.

Documentation Required

Maintain DHHS Provider Administrative Participation Agreement

Centers must meet Medicaid qualifications for participation and have a current, signed DHHS Provider Administrative Participation Agreement.

Negative drug screen requirementPlus six months of negative sequential random drug screens are required

Coverage consequenceAbsence of the above documentation results in noncoverage for heart-lung transplantation

Updated policy template language and Attachment A: added instruction that Institutional Claims must be billed according to National Uniform Billing Guidelines and all claims must comply with National Coding Guidelines.

03/15/2019revision

Updated policy template language and added notice for beneficiaries enrolled in a Prepaid Health Plan (PHP) regarding contacting PHP for benefits/services effective November 1, 2019.

10/01/2015revision

Updated policy template language and added ICD-10 codes to comply with federally mandated 10/1/2015 implementation.

07/01/2010revision

Revised throughout to reflect Session Law 2009-451 transition of NC Health Choice Program administrative oversight to the Division of Medical Assistance (DMA).

05/01/2007revision

EPSDT information revised to clarify exceptions to policy limitations for beneficiaries under 21 years of age; UB-04 added as accepted claims form in Attachment A.

12/01/2011revision

Policy updated to include coverage criteria and requirements to meet current community standards of practice; made equivalent to NC DMA's Clinical Coverage Policy #11B-6 where applicable.

01/01/1985original_effective_date

Original effective date of the policy.