CurrentCignaPolicy 0129

Heart, Lung, and Heart-Lung Transplantation

Defines medical necessity criteria, contraindications, and selection considerations for heart, lung, and combined heart-lung transplantation for adults and children, including special population guidance and references to OPTN/ISHLT criteria and oncology clearance requirements. Applies to Cigna-administered health benefit plans and related reimbursement rules.

Policy Summary

PayerCigna

PolicyHeart, Lung, and Heart-Lung Transplantation

Policy CodePolicy 0129

Change TypeMaterial revisions to malignancy, lung, and contraindication statements

Effective Date

Next Review Date

Key ActionProviders must obtain oncology clearance per published guidelines and document absence of contraindications for candidates with a history of malignancy prior to transplant.

POLICY UPDATE CHANGES

Added policy statements regarding history of malignancy.

Revised policy statement on lung transplantation.

Revised policy statement addressing contraindications.

No clinical policy statement changes.

Updated to new template and formatting standards.

3Covered Transplant Types (Heart, Lung, Heart-Lung)

3,049Adult lung transplants (2023)

88.5%One-year lung transplant survival

3Material revisions noted

OPTN/ISHLTReferenced guidelines

Coverage Summary

This policy defines medical necessity criteria, contraindications, and selection considerations for thoracic organ transplantation—specifically heart, lung, and combined heart-lung transplants—and states these procedures are covered with criteria when the listed requirements are met. Final benefit determinations are governed by the member's applicable plan documents (e.g., Evidence of Coverage, Certificate of Coverage) and other instructions for use, which supersede this policy where differences exist. The policy references OPTN and ISHLT allocation and candidate evaluation guidance (including status descriptions and ISHLT recommendations) to inform evaluation, listing, and comorbidity management.

Key thresholds and high‑level counts

Covered Transplant Types3 (Heart, Lung, Heart‑Lung)

Adult lung transplants (2023)3,049

One‑year lung transplant survival (2022 recipients)88.5%

Typical recommended wait‑time range (prior malignancy guidance)~0–5 years (disease/stage dependent)

HIV criteriaCD4 > 200 cells/mm3 and undetectable HIV‑1 RNA; stable ART >3 months

BMI recommendationWeight loss to achieve BMI < 35 kg/m2 is reasonable before listing

GFR contraindicationGFR < 40 mL/min/1.73 m2 is an absolute contraindication unless multi‑organ transplant considered

Medical-Necessity Criteria

Coding

Covered CPT (transplant and donor procedures)CPTCovered

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; unilateral.
32856	Backbench standard preparation of cadaver donor lung allograft prior to transplantation; bilateral.
33930	Donor cardiectomy-pneumonectomy (including cold preservation).
33933	Backbench standard preparation of cadaver donor heart/lung allograft prior to transplantation.
33935	Heart-lung transplant with recipient cardiectomy-pneumonectomy.

1–10 of 13

1/2

Covered HCPCS / Other transplant codesHCPCSCovered

S2060	Lobar lung transplantation.
S2061	Donor lobectomy (lung) for transplantation, living donor.
S2152	Solid organ(s), complete or segmental, procurement, transplantation, and related complications; global.

Medicare Coverage Determinations citedmixed

NCD 260.9

National Coverage Determination for Heart Transplants (revision effective 2008-05-01) cited; no LCD found in document.

No specific CPT/ICD/HCPCS codes listed in this partmixed

No codes listed

Provider Actions and Requirements

Documentation Required

Oncology clearance required for candidates with history of malignancy

Candidates with a history of malignancy must obtain oncology clearance per published guidelines prior to listing. Document the oncology evaluation, tumor board recommendations, cancer type/stage, treatments received, current disease status, and the disease-free interval (NED duration) as applicable. Include the appendix-defined wait-times and confirm adherence to disease-specific wait-time recommendations.

Oncology clearance letter or tumor board summary
Cancer type, stage, and histology
Treatment history and dates
Disease-free interval (NED duration) and surveillance plan
Documentation of adherence to appendix wait-times

Documentation Required

HIV criteria documentation

Background and Evidence

Background: This policy addresses transplantation of thoracic organs (heart, lung, and heart-lung), summarizing medical necessity criteria and contraindications for adults and children and incorporating OPTN/ISHLT allocation criteria and ISHLT candidate evaluation guidance. It notes that donor organ procurement and transport are addressed by Cigna Omnibus Reimbursement Policy R24. As with all Coverage Policies, benefits and final coverage decisions are determined by the applicable benefit plan documents and any controlling laws or regulations.

Source	Key data
OPTN/SRTR 2023 Annual Data Report - Heart
1-year survival: 91.5%; 3-year survival: 85.9%; 5-year (adult patients 2016-2018): 80.3%
OPTN/SRTR 2023 Annual Data Report - Lung
2023 adult lung transplants: 3,049; 1-year survival (2022 recipients): 88.5%; 3-year (2020 recipients): 71.3%; 5-year (2018 recipients): 59.7%
ISHLT Registry / Heart-Lung outcomes
Heart-lung median survival ~6.5 years; conditional survival to 1 year improves median to ~12.8 years; outcomes poorer for IIP (e.g., median 1.9 years)
ISHLT Guidance / Selection Recommendations
Recommendations for evaluation components (CPET, RHC prior to listing in adults), age/BMI guidance (evaluate HT ≤70; consider >70 selectively; weight loss to BMI <35 reasonable), comorbidity assessments and oncology collaboration for candidates with prior malignancy
ISHLT Consensus - Lung candidate thresholds
Consider lung transplant when >50% 2-year mortality without transplant and >80% likelihood of 5-year post-transplant survival; disease-specific triggers (BODE, FEV1, FVC/DLCO declines, REVEAL/ESC-ERS criteria)
Medicare / NCD reference
NCD Heart Transplants (260.9) cited (revision effective 2008-05-01 / 2008-12-01 entries listed)

Definitions and Thresholds

Definitions (term = definition)

NYHANew York Heart Association functional class

MCSDMechanical circulatory support device

LVADLeft ventricular assist device

PVRIPulmonary vascular resistance indexed to body surface area

DMCSDurable mechanical circulatory support (eg, continuous‑flow LVAD) used as bridge‑to‑transplant or destination therapy

NEDNo evidence of disease

FALD scoreFontan‑associated liver disease score used to guide heart vs combined heart‑liver transplant (score ≥2 may favor combined)

Medicare Determinations

Name	Number	Effective Date	Type
OPTN adult heart allocation criteria reference


NCD
Heart Transplants
260.9
2008-05-01
NCD
Heart Transplants
260.9
2008-12-01
NCD

Revision History

9/15/2023Administrative

Annual review: Updated to new template and formatting standards.

9/15/2024Administrative

Annual review: No clinical policy statement changes.

12/15/2024Material

Focused review: Revised policy statement on lung transplantation.

Appendix & References

Appendix and references placeholder: Render the policy appendices and full reference lists when populating the view. Include the referenced guideline lists such as OPTN Policies/Allocation rules, ISHLT guidance (evaluation and selection, Leard 2021, ISHLT 2023/2024 guidance), ACC/AHA guidance, ISHLT Leard 2021 lung candidate selection, and the expert consensus statements by Al-Adra et al. (2021) for pretransplant malignancy timing. The full reference list appears in the original policy (References section); the evidence section notes reference counts and specific guideline citations.

Policy Summary

PayerCigna

PolicyHeart, Lung, and Heart-Lung Transplantation

Policy CodePolicy 0129

Change TypeMaterial revisions to malignancy, lung, and contraindication statements

Effective Date

Next Review Date

Key ActionProviders must obtain oncology clearance per published guidelines and document absence of contraindications for candidates with a history of malignancy prior to transplant.

On This Page

For candidates with HIV, provide documentation that viral control and immune status meet transplant program criteria. Include laboratory evidence and treatment adherence details.

CD4 count (must be >200 cells/mm3)
HIV-1 RNA viral load (undetectable)
Duration and stability of antiretroviral therapy (≥ 3 months)
Absence of serious HIV-related complications (e.g., opportunistic infections, Kaposi sarcoma)

Documentation Required

OPTN/ISHLT status and evaluation documentation

Document OPTN/ISHLT status and complete pre-transplant evaluations required for listing. Provide results of physiologic testing, organ-specific assessments, infection screening, and frailty evaluation as indicated by the transplant program.

Cardiopulmonary exercise testing (CPET) when indicated
Right heart catheterization (RHC) hemodynamics
Pulmonary function tests (PFTs) with diffusion capacity
Chest CT imaging (high-resolution as indicated)
Kidney and liver function assessment (lab tests, imaging if indicated)
Comprehensive infection screening (TB, CMV, EBV, hepatitis, etc.)
Frailty/mobility assessment and other objective functional status measures

Documentation Required

Comprehensive pre-transplant evaluation documentation

Provide comprehensive pre-transplant evaluation documentation including imaging, immunologic risk assessment, and psychosocial support. Include caregiver availability and evidence of understanding of post-transplant care requirements.

Recent imaging studies relevant to the organ(s) (e.g., CT chest, echocardiogram)
HLA sensitization testing (PRA, donor-specific antibodies)
Psychosocial evaluation with substance use assessment
Caregiver/support system confirmation and education documentation
Financial/insurance assessment and discharge planning notes

Prior Authorization

Refer to experienced centers for CHD/Fontan and multi-organ transplants

Refer candidates with complex congenital heart disease (CHD)/Fontan physiology or those requiring multi-organ transplants to centers with demonstrated experience in pediatric and adult CHD and multi-organ transplantation. Prior authorization review should consider center expertise.

Referral to a transplant center experienced in CHD/Fontan and multi-organ transplants is required for authorization review
Documentation of the receiving center's experience and outcomes may be requested

Documentation Required

Cancer disease-free interval documentation

When a history of cancer exists, clearly document the disease-free interval and oncologic details to support listing. Use appendix guidance for acceptable wait-times and clearance criteria.

Pathology reports and staging at diagnosis
Dates of definitive therapy and completion
Evidence of no active disease (NED) and duration
Confirmation that required oncology wait-times per appendix have been met

Denial Risk

Absolute contraindications risk

Be aware of absolute contraindications that may lead to denial of transplant listing. Document reasons clearly if any of these high-risk conditions are present.

Active, uncontrolled infection
Uncontrolled substance use or nonadherence
Active metastatic or progressive malignancy
Detectable HIV viral load or unstable HIV-related disease
Severe comorbidities expected to preclude successful transplant outcome

Documentation Required

Document cancer type, stage, treatments, and recurrence-free interval

Submit oncologic records to support assessment of transplant candidacy when there is a prior cancer history. Include documentation demonstrating current status and risk of recurrence.

Pathology and operative reports
Staging imaging and surveillance imaging
Tumor board notes and oncology specialist assessments
Documentation of no-evidence-of-disease (NED) and surveillance plan

Prior Authorization

Transplant candidacy review required

Transplant programs must complete a candidacy review prior to listing. For candidates with prior malignancy or atypical presentations, document tumor board discussion and application of disease-specific wait-times; special cases may require individualized review.

Formal transplant program candidacy determination
Tumor board discussion for candidates with prior or unusual malignancies
Application of disease-specific wait-times from appendix and published guidelines

Denial Risk

Not Eligible if active/metastatic disease or excluded histologies

Listing is not appropriate for candidates with active or metastatic disease or certain excluded histologies. Providers should document exclusionary diagnoses and contraindicated malignancy types when present.

Active/metastatic malignancy (e.g., Stage IV cancers as listed in the appendix)
Excluded histologies such as metastatic melanoma Stage III/IV, Merkel cell with distant metastasis, certain RCC or bladder and gynecologic cancers as specified
Persistent, recurrent, or unsuccessfully treated major systemic infections

Documentation Required

Pre-SOT work-up

Complete the pre-solid organ transplant (pre-SOT) diagnostic work-up and include disease-specific imaging and biopsy information where relevant to the primary cancer site.

PET-CT for systemic staging when indicated
Brain imaging for melanoma primaries or neurologic symptoms
Neck imaging for head and neck primaries
Biopsy results post-SBRT when required to confirm control

Documentation Required

Policy additions and revisions: revised contraindication and lung transplantation statements

Policy statements have been revised: contraindication language and the lung transplantation section were updated. Providers must apply the revised contraindication criteria and the clarified lung transplant guidance when assessing candidates with prior malignancy or other exclusionary conditions. Ensure documentation demonstrates application of the updated statements.

Revised contraindication statement: updated list of malignancies, active infections, comorbidities, and noncompliance that may preclude transplantation
Updated lung transplantation statement: clarified eligibility when lung-limited adenocarcinoma in situ/minimally invasive/lepidic predominant adenocarcinoma meets all listed criteria including oncology clearance and absence of contraindications
Apply appendix disease-specific wait-times and tumor board review per the updated policy

LVILymphovascular invasion

PNIPerineural invasion

MSIMicrosatellite instability

dFLCDifference between involved minus uninvolved serum free light chains

EFS24 / PFS24Event‑free / progression‑free survival at 24 months used for prognosis in some lymphomas

Compact list of numeric/clinical thresholds

HIV CD4 count> 200 cells/mm3

HIV viral loadUndetectable HIV‑1 RNA

BMIRecommend weight loss to BMI < 35 kg/m2 before listing

GFR< 40 mL/min/1.73 m2 = contraindication unless multi‑organ transplant considered

Pediatric PVRI< 9 Wood units·m2 (reasonable threshold)

NYHA classClass III–IV (indication for advanced therapies/consideration for transplant)

BODE index7–10 (COPD listing trigger)

FEV1 (COPD)< 20% predicted

FEV1 (CF pediatric)Referral <50% predicted; Listing <30% predicted (examples include <25% in some contexts)

FVC change (ILD)≥10% decrease or >5% with radiographic progression over 6 months

DLCO change (ILD)>10% decline over 6 months

6‑minute walk desaturation (ILD)SpO2 < 88%

REVEAL/ESC‑ERS (PAH)REVEAL score >10 or ESC/ERS high risk

7/15/2025Material

Focused review: Revised policy statement addressing contraindications and further revision to lung transplantation statements.

9/15/2025MaterialLatest

Annual review: Added policy statements regarding history of malignancy (added requirements and recommended wait times for various prior cancers and oncology clearance requirements prior to transplant).