Alliance Health Lung Transplant Coverage Update

Medicaid Coverage Criteria for Lung or Lobar Lung Transplantation

Medicaid Coverage Criteria (Initial eligibility)

Covered when ALL of the following are met

General medical necessity: The procedure is individualized, specific, and consistent with the beneficiary's symptoms or confirmed diagnosis; not in excess of the beneficiary's needs; can be safely furnished; and no equally effective and more conservative or less costly treatment is available statewide.

See Section 3.1

Indications — end-stage pulmonary disease: Beneficiary has irreversible, progressively disabling, end-stage pulmonary disease and meets one of the listed disease indications (examples include idiopathic/interstitial pulmonary fibrosis with significant impairment of FVC (e.g., FVC <65% predicted); cystic fibrosis with severe impairment of FVC (e.g., <40% predicted), FEV1 (e.g., <30% predicted), and PaO2 (e.g., <60 mmHg); primary pulmonary hypertension; emphysema with FEV1 post bronchodilator <25% predicted; bilateral bronchiectasis; alpha-1 antitrypsin deficiency; bronchopulmonary dysplasia; sarcoidosis; scleroderma; lymphangiomyomatosis; eosinophilic granuloma; bronchiolitis obliterans; recurrent pulmonary embolism; pulmonary hypertension due to cardiac disease; Eisenmenger's syndrome; or chronic obstructive pulmonary disease).see individual disease thresholds in Section 3.2.1

Full list and physiologic examples in Sections 3.2.1 (chunks 14-15)

Patient and caregiver factors: Beneficiary and caregiver are willing and capable of complying with the post‑transplant treatment plan, and the beneficiary has adequate cardiac status.

Section 3.2.1 b–c

HIV‑positive candidate requirements: For beneficiaries who are HIV‑positive or have AIDS, all of the following must be present: CD4 count greater than 200 cells/mm3 for more than 6 months; HIV‑1 RNA undetectable; on stable antiretroviral therapy for more than 3 months; no other AIDS‑related complications (e.g., opportunistic infections or AIDS‑related neoplasms); and meeting all other transplant criteria.CD4 >200 cells/mm3 for >6 months

Section 3.2.1 d (chunk 15)

Not Covered Conditions

Medicaid does not cover procedures when ANY of the following general or specific conditions are met

General non‑coverage conditions: Beneficiary does not meet eligibility requirements in Section 2.0 OR does not meet the criteria in Section 3.0 OR the procedure duplicates another provider's service OR the procedure is experimental, investigational, or part of a clinical trial.

Section 4.1 (chunk 18)

Specific contraindications to lung or lobar lung transplantation: Presence of any one of the listed contraindications, including general contraindications (active drug, alcohol, or tobacco use within last 6 months; obesity >20–30% over ideal body weight; contraindication to immunosuppressive drugs; multiple uncorrectable congenital abnormalities), infection‑related contraindications (non‑curable chronic extrapulmonary infection such as chronic active hepatitis B or C; colonization with highly resistant/virulent organisms as a relative contraindication), disease‑related contraindications (current life‑threatening malignancy; bone marrow failure; severe congenital immunodeficiency; significant advanced other organ disease including hepatic dysfunction or renal dysfunction with creatinine >1.5 mg/dL or creatinine clearance <50 ml/min [<35 ml/min for pulmonary hypertension beneficiaries]; coronary disease not amenable to revascularization), and other factors (severe cerebral dysfunction; behavioral/psychiatric disorders likely to compromise adherence; advanced physiologic age; recent substance use; history of non‑compliance; absence of reliable social support).see Section 4.2.1 for renal and other specified thresholds

Donor Expense Coverage

Coverage for donor transplant-related medical expenses for lung transplants

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

See chunk 44

Living donor expenses: Donor transplant‑related medical expenses (procuring, harvesting, and associated surgical and laboratory costs) for living organ donations are covered for lung and lobar lung transplants; Medicaid reimburses only for the approved donor.

See chunk 45

Billing mechanism and limits: Donor transplant‑related medical expenses must be billed on the Medicaid beneficiary's transplant claim using the beneficiary's Medicaid identification number; Medicaid reimburses only for actual donor transplant‑related medical expenses and does not reimburse for unsuccessful donor searches.

See chunk 43

Lung or lobar lung transplantation is not covered when the beneficiary has certain general contraindications. These include active drug or alcohol use, or tobacco use within the last six months, obesity more than 20–30% over ideal body weight at the time of transplant, a documented contraindication to immunosuppressive drugs, or multiple uncorrectable congenital abnormalities that significantly affect quality and duration of life.

Transplantation is not covered for beneficiaries with certain infection-related contraindications. This includes non-curable chronic extrapulmonary infection, including chronic active viral hepatitis B or C. In addition, colonization with highly resistant or highly virulent bacteria, fungi, or mycobacteria is identified as a relative contraindication and must be considered within a comprehensive evaluation with other comorbidities.

Transplantation is not covered in the presence of certain disease-related contraindications, including current potentially life‑threatening malignancy, bone marrow failure (any cell line), severe congenital immunodeficiency, or significant/advanced other organ disease such as hepatic dysfunction and renal dysfunction (e.g., creatinine > 1.5 mg/dL or creatinine clearance < 50 ml/min, or < 35 ml/min for pulmonary hypertension beneficiaries). Coronary artery disease not amenable to revascularization and other systemic diseases that impair function or life expectancy also preclude coverage.

Specific exclusions that preclude coverage are reiterated and include active drug or alcohol use or tobacco use within the last six months, obesity >20–30% over ideal body weight, contraindication to immunosuppressive drugs, and multiple uncorrectable congenital abnormalities. Additional exclusions cover behavioral or psychiatric disorders likely to compromise adherence, advanced physiologic age, history of non‑compliance, absence of reliable social support, and emotional problems or recent substance use.

Medicaid does not reimburse for unsuccessful donor searches. Donor transplant-related medical expenses must be billed on the Medicaid beneficiary's transplant claim using the beneficiary's Medicaid identification number, and Medicaid reimburses only for actual donor transplant-related medical expenses.

A procedure is not covered if the beneficiary fails to meet the eligibility requirements in Section 2.0 or the clinical criteria in Section 3.0, if the service duplicates another provider's procedure, or if the procedure is experimental, investigational, or part of a clinical trial.

Service is considered not covered/not medically necessary when any of the general non-coverage conditions apply (for example, failure to meet Sections 2.0 or 3.0, duplication of services, or investigational status) or when any of the specific contraindications listed by Medicaid are present.

Coding, Reporting, and Clinical Thresholds

Claims/Attachment A sections referencedmixed

No codes listed

Accepted claim typesmixed

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

Unlisted Procedure or ServiceCPT|HCPCS

Unlisted CPT/HCPCS

Providers shall use appropriate unlisted procedure or service codes and follow CPT/HCPCS instructions for unlisted codes and special reports

Coding and reportingmixed

CPT	Use the most specific CPT code in effect at time of service; if none exists, use appropriate unlisted CPT code per CPT instructions
HCPCS	Use the most specific HCPCS code in effect at time of service; if none exists, use appropriate unlisted HCPCS code per HCPCS instructions
UB-04	Use UB-04 Data Specifications Manual for valid revenue codes

Unlisted Procedure or Service (special report)mixed

Unlisted CPT/HCPCS

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

Examples of physiologic thresholds — lung transplant candidacy

FVC threshold (fibrosis example)Forced vital capacity (FVC) less than 65% of predicted (example for interstitial pulmonary fibrosis)

FEV1 thresholds (cystic fibrosis examples)Forced expiratory volume in 1 second (FEV1) less than 40% and less than 30% predicted (examples for cystic fibrosis scenarios)

PaO2 thresholdArterial partial pressure of oxygen (PaO2) less than 60 mmHg

FEV1 post-bronchodilator threshold (emphysema)FEV1 post bronchodilator less than 25% predicted

Renal dysfunction — creatinine and creatinine clearance thresholds

Provider Actions, Billing Rules, and Documentation Requirements

Denial Risk

General conditions triggering non-coverage

Medicaid shall not cover the procedure, product, or service related to this policy when any of the following general conditions apply. Providers should verify eligibility and applicable criteria before billing.

a. The beneficiary does not meet the eligibility requirements listed in Section 2.0.
b. The beneficiary does not meet the criteria listed in Section 3.0.
c. The procedure, product, or service duplicates another provider's procedure, product, or service.
d. The procedure, product, or service is experimental, investigational, or part of a clinical trial.

Documentation Required

Required clinical documentation

Coverage requires documentation that supports medical necessity and that the procedure, product, or service is individualized, consistent with the beneficiary's symptoms or confirmed diagnosis, and that no equally effective and more conservative or less costly treatment is available statewide. Retain all documentation in the medical record and make available on request.

Background and Policy Scope

Single, double, and lobar lung transplantation are surgical procedures intended to prolong survival and improve function for beneficiaries with end‑stage pulmonary disease. Single lung transplantation is performed through a thoracotomy with vascular and bronchial anastomoses; bilateral (double) lung transplantation may be performed via median sternotomy or transverse thoracotomy with bilateral bronchial anastomoses; and lobar transplantation uses donor lobes sized to the recipient thorax and may involve living‑related or cadaveric donors.

Key Definitions

Thoracotomy

DefinitionA thoracotomy is a surgical incision made to open the chest cavity; it is used in single and bilateral lung transplantation where the native lung is removed and the donor lung vessels and bronchi are anastomosed.

Context of useThoracotomy is described as the initial surgical approach for single lung transplantation; double lung approaches may use transverse thoracotomy techniques.

Relation to proceduresThoracotomy enables access for major vessel and bronchial anastomoses during lung transplant operations.

Trachea

DefinitionTrachea — the windpipe; a tube of cartilage lined with mucous membrane passing from the larynx to the bronchi of the lungs.

Role in transplantationIn earlier double lung transplant techniques, donor lungs were connected at the trachea; bronchial anastomoses are used in more recent techniques.