Lung Transplantation — Clinical Coverage Criteria
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Clinical coverage criteria for single or bilateral lung transplantation (including pediatric considerations, lobar and re-transplantation) applicable to Fallon Health products; governs prior authorization and medical necessity determinations for covered members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Lung Transplantation
Primary coverage (Community Care, adults)
Covered when ALL of the following are met for Community Care members 18+:
InterQual is available via Fallon Health transparency tool
Pediatric listing criteria
Pediatric considerations for listing when specific thresholds are met:
FEV1 <30% is commonly used indicator of 2-year survival and guides referral/listing timing
EPPVDN criteria referenced for pediatric PAH
Lung re-transplantation
Re-transplantation is considered with enhanced scrutiny:
Particular caution when re-transplantation is within first year or for restrictive allograft syndrome; consider rate of deterioration and donor availability
Medicare variation
Medicare beneficiaries:
Where Medicare coverage criteria are established, the Plan's criteria do not apply
Coverage criteria by indication
Covered when disease progression meets established transplant evaluation thresholds and ISHLT selection criteria are satisfied
Selection guidance is consensus‑based and informed by registry data
CF patients generally have better 5‑year post‑transplant survival due to younger age
REVEAL and other risk factors inform mortality risk and timing
Anti‑fibrotic agents have not demonstrated clear mortality benefit; earlier referral is warranted given rapid progression
Claims for lung transplants that do not meet the coverage criteria described in this policy are excluded and may be denied. In addition, lung transplantation requests will be excluded when the member has an absolute contraindication documented at the time of listing or at the time of the request.
Candidates who present with absolute contraindications identified by ISHLT and CMS guidance are not eligible for listing or coverage until those conditions are resolved or optimized. Examples of such contraindications include active primary or metastatic malignancy, significant multisystem disease (advanced heart, liver, kidney, gastrointestinal or other systemic disease likely to cause poor post‑transplant outcome), and active or significant extra‑pulmonary infection. Other high‑risk factors cited by the guidance include persistent cigarette smoking, obesity, chronic corticosteroid dependence that cannot be reduced to low dose, and psychiatric or behavioral conditions likely to interfere with adherence to the post‑transplant regimen.
Not all services and procedures referenced in this policy are covered for every Fallon product or employer group. Coverage is governed by the member's specific benefit plan, applicable state or federal mandates, and any relevant Medicare/MassHealth rules; if a conflict exists, the member's benefit plan provisions or applicable mandate will govern. Providers should consult the member's Evidence of Coverage and applicable program guidance when determining coverage.
Transplantation is not appropriate when the expected post‑transplant outcome is likely to be poor due to comorbid conditions, severely limited physiologic reserve related to advanced age, or other high‑risk factors identified by ISHLT that substantially increase perioperative or long‑term mortality. In such situations, the procedure may be considered not medically necessary for the individual patient until modifiable risks are addressed and outcomes are expected to improve.
The policy acknowledges that randomized controlled trial data to define lung transplant selection are limited; therefore selection criteria rely largely on the ISHLT 2021 consensus document, registry analyses, and expert opinion. Where the evidence base is limited, the policy follows these consensus recommendations rather than specifying additional explicit not‑medically‑necessary statements for particular scenarios in the portion of the document provided.
Candidate Selection and Eligibility
General candidate selection
General candidate selection principles:
Early referral recommended to allow time to address modifiable barriers (eg, obesity, malnutrition, comorbidities, social support)
Candidate selection
Candidate selection follows ISHLT consensus and disease-specific indicators
Timing of referral is critical for some conditions (eg, PAH)
FEV1 commonly used as surrogate for 2‑year survival in CF
REVEAL and other prognostic tools inform risk assessment
Early referral advised given rapid disease course
Absolute and Relative Contraindications
This policy aligns exclusions and contraindication guidance with the most recent ISHLT consensus and CMS/Medicare considerations. Absolute contraindications referenced by ISHLT and discussed in the policy include active primary or metastatic malignancy, significant multisystem disease likely to cause poor post‑transplant outcomes, and active or significant extra‑pulmonary infection. The policy notes that contraindications may change over time and that modifiable conditions should be optimized when possible prior to listing.
The document references the ISHLT 2021 update to absolute contraindications for lung transplant candidacy and follows its framework. It states that ISHLT lists several absolute contraindications and emphasizes that these candidates are considered too high risk to achieve successful outcomes post‑transplant; the policy uses that consensus guidance when applying exclusions and listing decisions.
Pre-Listing Evaluation Requirements
Require thorough pre‑listing evaluation for modifiable barriers
Perform a thorough pre‑listing evaluation to identify and address modifiable barriers (for example: obesity, malnutrition, comorbid medical conditions, and social support deficits) and to document reasons that might be remediable prior to listing for transplant.
- Assess and document modifiable barriers (obesity, malnutrition, comorbidities, social support).
- Identify remediable issues and plan interventions prior to listing.
Comprehensive ISHLT‑based evaluation including disease‑specific prognostic indicators
Ensure a comprehensive pre‑listing evaluation consistent with ISHLT consensus guidance that includes assessment of disease‑specific prognostic indicators (for example, FEV1 in cystic fibrosis) as part of the documentation supporting listing decisions.
- Include disease‑specific prognostic measures (e.g., FEV1 for CF) in the evaluation report.
- Document that evaluation followed ISHLT 2021 selection guidance.
Document ISHLT‑recommended comprehensive evaluation and prognostic data (e.g., FEV1)
Complete a comprehensive evaluation per ISHLT 2021 prior to listing that documents disease‑specific prognostic indicators (for example, FEV1 <30% predicted in CF) and demonstrates progression despite optimized therapy when applicable.
- For pediatric CF patients, document FEV1 and note when FEV1 <30% predicted is present.
- For PAH and IPF, document persistent deterioration despite optimized medical therapy and relevant risk scores or prognosis data.
Prior Authorization, Documentation, and Provider Responsibilities
Prior authorization required; InterQual used for Community Care adults
Obtain prior authorization for lung transplantation; Fallon Health will apply InterQual CP: Procedures, Transplantation, Lung criteria for Community Care members age 18 and older when making medical necessity determinations.
Follow Medicare/MassHealth/applicable benefit rules for determinations
Follow applicable Medicare NCDs/LCDs, MassHealth guidance, and the member's benefit plan when requesting authorization and when documenting medical necessity; Fallon Health will apply these rules for Medicare, MassHealth, and NaviCare members as described.
Document prior consideration of all appropriate alternative therapies
Document that the facility has considered or tried all other medically appropriate medical and surgical therapies expected to yield survival comparable to transplantation before listing.
No specified step therapy — follow ISHLT and clinical evidence
No specific step‑therapy sequence is mandated by this policy; therapy selection and timing should be guided by ISHLT consensus guidance and the clinical evidence for the indication.
Facility must be CMS‑approved and have written selection criteria
Ensure the transplant facility is CMS‑approved and maintains written patient selection criteria; include documentation that demonstrates adherence to those selection criteria in authorization submissions.
Include required documentation and note CPT codes are informational
Submit documentation consistent with Fallon Health coverage determinations and applicable Medicare/MassHealth/NaviCare instructions; include relevant procedural codes (informational CPT codes are provided in the policy) but note that inclusion of a code does not guarantee coverage.
Non‑covered claims and absolute contraindications may lead to denial
Claims for lung transplants that do not meet the policy's coverage criteria or for members with an absolute contraindication (per ISHLT/CMS guidance) are excluded and may be denied.
Coding omission risk (32855–32856 history may affect reimbursement)
Be aware that policy history removed or clarified codes 32855–32856 as not separately reimbursable in prior updates; failure to include applicable codes consistent with current policy and claim rules could affect reimbursement.
Informational Coding and Key Thresholds
| 32850 | Donor pneumonectomy(s) (including cold preservation), from cadaver donor. |
| 32851 | Lung transplant, single; without cardiopulmonary bypass. |
| 32852 | Lung transplant, single; with cardiopulmonary bypass. |
| 32853 | Lung transplant, double (bilateral sequential or en bloc); without cardiopulmonary bypass. |
| 32854 | Lung transplant, double (bilateral sequential or en bloc); with cardiopulmonary bypass. |
| 32855 | Backbench standard preparation of cadaver donor lung allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare pulmonary venous/atrial cuff, pulmonary artery, and bronchus; unilateral. |
| 32856 | Backbench standard preparation of cadaver donor lung allograft prior to transplantation, including dissection of allograft from surrounding soft tissues to prepare pulmonary venous/atrial cuff, pulmonary artery, and bronchus; bilateral. |
Background and Scope
Lung transplantation is a surgical replacement of one or both lungs for patients with end‑stage lung disease after other medical and surgical interventions have been considered. Early referral (distinct from listing) is recommended to identify and address modifiable barriers such as malnutrition, obesity, or inadequate social support; listing reflects a determination that the patient has limited life expectancy without transplant and that transplantation offers a reasonable prospect of improved survival. Donor organs are scarce, so selection prioritizes candidates with realistic prospects for favorable long‑term outcomes.
Definitions and OPTN Groups
Transplant Center and Program Requirements
Center must be CMS‑approved for Medicare beneficiaries
For Medicare beneficiaries, ensure the transplant is performed at a CMS‑approved organ transplant program; verify the facility appears on the CMS Approved Transplant Program List.
Re-Transplantation and Post-Transplant Services
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