CurrentCignaPolicy 0129

Heart, Lung, and Heart-Lung Transplantation

Defines medical necessity criteria, contraindications, and selection considerations for heart transplantation, lung transplantation, and combined heart-lung transplantation, including special population and oncology clearance requirements; includes referenced guideline-based evaluation details and equity considerations. (Part 1 of 3 document: pages provided.)

Policy Summary

PayerCigna

PolicyHeart, Lung, and Heart-Lung Transplantation

Policy CodePolicy 0129

Change TypeMaterial updates to malignancy and lung transplant statements

Effective DateSep 15, 2025

Next Review DateSep 15, 2026

Key ActionObtain oncology clearance per published guidelines and document absence of listed contraindications prior to transplant authorization.

SourceLink

POLICY UPDATE CHANGES

Added policy statements regarding history of malignancy.

Revised policy statement on lung transplantation.

No clinical policy statement changes noted on 9/15/2024 annual review.

3Organ types covered (heart, lung, heart-lung)

1Document part (this is Part 1 of 3)

3,049Adult lung transplants in 2023 (US)

Pediatric lung transplants in 2023 (US)

~5%Proportion re-transplants (lung)

15+Procedure codes listed as medically necessary

Coverage Summary

This policy (Policy Number 0129) is CURRENT and effective 9/15/2025 with next review scheduled 9/15/2026. It defines medical necessity criteria, contraindications, and selection considerations for thoracic organ transplantation — specifically heart, lung, and combined heart-lung transplants — and is Part 1 of 3 of the document. The coverage stance is covered with criteria and references OPTN/SRTR data (heart and lung survival statistics and transplant volumes) and guideline sources including ISHLT and ACC/AHA summaries to support evaluation and listing recommendations. The policy includes procedure/CPT and HCPCS code lists for medically necessary transplant procedures and notes recent material updates including added statements on prior malignancy and focused revisions to lung transplant criteria.

Key thresholds & quick facts

NYHA functional classClass III or IV used as listing trigger for heart and heart-lung transplant

HIV control requiredCD4 > 200 cells/mm3 AND HIV-1 RNA undetectable AND stable ART >3 months (all required)

GFR absolute contraindicationGFR < 40 mL/min/1.73 m2 is a contraindication to lung transplant unless candidate is considered for multi-organ transplant

BODE index (COPD)BODE score 7–10 is a listing/referral trigger for lung transplant

FEV1 thresholdsFEV1 <20% predicted (COPD listing); CF pediatric referral/listing: refer <50% predicted, list <30% predicted; CF adult listing example FEV1 <25% noted

Notable survival statisticsHeart 1-yr 91.5%, 3-yr 85.9%, 5-yr 80.3%; Lung 1-yr 88.5%, 3-yr 71.3%, 5-yr 59.7%, 10-yr 31.8%; heart-lung median survival ~6.5 yrs (conditional survival longer)

Medical Necessity Criteria (by transplant type and scenario)

Heart Transplantation - Adult

Heart transplantation in an adult is considered medically necessary when ANY of the following are met:

ANY of the following

malignant ventricular arrhythmias unresponsive to medical and/or surgical therapy
refractory angina that is not amenable or correctable by alternative medical or surgical therapies and leaves the individual in a New York Heart Association functional class III or IV
end-stage heart failure
- disease that is not amenable or correctable by alternative medical therapies or leaves the individual in New York Heart Association functional class III or IV

Selection, Listing, and Candidate Thresholds

Lung transplantation candidate criteria (ISHLT/OPTN guidance)

Adults should meet all general criteria plus disease-specific thresholds; pediatric considerations listed separately.

General + Disease-specific

General adult criteria: high (>50%) risk of death from lung disease within 2 years without transplant AND high (>80%) likelihood of 5-year post-transplant survival provided adequate graft function (ISHLT 2021)>50% 2-year mortality; >80% 5-year survival
Disease-specific referral/listing triggers (examples)
- COPD: BODE index 7-10 OR FEV1 <20% predicted OR history of severe exacerbations OR moderate-severe pulmonary hypertension OR chronic hypercapniaBODE 7-10; FEV1 <20%

Oncology Clearance, Wait Times, and Cancer-Specific Guidance

Recommended wait time for SOT candidates with prior history of prostate cancer

Recommendations vary by risk group and clinical scenario:

ANY of the following

Very low / Low risk: Very low and low risk: PSA <10 ng/mL; T stage up to T2a; surveillance recommended; no wait time if on surveillancePSA <10 ng/mL; T1c-T2a
Surveillance strongly recommended
Low-volume intermediate risk: One of: PSA >10 ng/mL OR Gleason 7 (grade group 2 or 3); example T2b; if surveillance no wait time; if treatment and nomogram predicts <10% cancer-specific death over 15 years then no wait timePSA >10 ng/mL or Gleason 7

Provider Actions: Documentation, Authorization, and Billing

Documentation Required

NYHA class documentation

Document NYHA functional class (III or IV) when used as part of the medical necessity justification for heart transplant or heart-lung transplant.

Documentation Required

HIV control documentation

For candidates with HIV, document CD4 count >200 cells/mm3, undetectable HIV-1 RNA (viral load), stable antiretroviral therapy for more than three months, and absence of serious HIV-related complications prior to considering transplant.

Coding

Medically necessary transplant procedure CPT codesCPTCovered

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

Medically necessary HCPCS 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 including drugs, supplies, hospitalization, etc.

OPTN diagnosis groups (examples provided in policy)mixed

No codes listed

Medicare determinations referencedmixed

NCD 260.9

Heart Transplants (NCD), Revision Effective Date 2008-05-01

Background and Evidence

This policy addresses selection criteria and medical necessity for heart, lung, and heart-lung transplantation, referencing OPTN and ISHLT guidance and equity considerations. The document explicitly cites OPTN/SRTR outcome data and ISHLT/ACC/AHA guideline recommendations for candidate evaluation, listing, and contraindications. Health equity considerations are summarized, noting known disparities in access to heart and lung transplants related to factors such as blood type, DSA, height, weight, and age. This file is identified as Part 1 of 3; oncology clearance and detailed guidance on prior malignancy (including wait times, staging, and oncology collaboration) are provided in the Appendix and referenced consensus statements (e.g., Al-Adra et al., 2021) rather than reproduced in full in this part.

Source	Key data
OPTN/SRTR 2023 Annual Data Report - Heart
1‑year heart transplant survival 91.5%; 3‑year 85.9%; 5‑year adult survival 80.3% (reported)
OPTN/SRTR 2023 Annual Data Report - Lung
1‑year lung transplant survival (2022 recipients) 88.5%; 3‑year (2020 recipients) 71.3%; 5‑year (2018 recipients) 59.7%; 10‑year (2013 recipients) 31.8%
Primary consensus sources
Al‑Adra DP et al., Am J Transplant 2021 (pretransplant malignancy consensus) cited as primary consensus guidance; ISHLT and ACC/AHA/ISHLT guidance documents referenced for selection/contraindications

Definitions and Thresholds

Definitions (term → definition)

NYHANew York Heart Association functional classification

MCSD/DMCSMechanical circulatory support device / Durable mechanical circulatory support (eg, LVAD)

CORClass of Recommendation indicating strength of recommendation (I, IIa, IIb, III)

LOELevel of Evidence (eg, B-NR, C-LD, C-EO) indicating quality of supporting evidence

EFS24 / PFS24Event-free survival / Progression-free survival at 24 months used for hematologic malignancy timing

dFLCDifference between involved minus uninvolved serum free light chains (used in myeloma/amyloidosis assessment)

Medicare Determinations

Determination	Number	Effective Date	Type
Heart Transplants
260.9
2008-05-01
NCD
Heart Transplants
260.9
2008-12-01
NCD

Revision History

2025-09-15addedLatest

Annual review: Added policy statements regarding history of malignancy (material change) — oncology clearance and specific cancer-related contraindications and wait-time guidance incorporated into transplant candidacy criteria.

2025-07-15revised

Focused review: Revised policy statement on lung transplantation and updated contraindications language.

2024-12-15revised

Focused review: Revised policy statement on lung transplantation.

Scope and Document Notes

Scope summary: the policy defines medical necessity criteria, contraindications, and selection considerations for heart, lung, and combined heart-lung transplantation and includes special population guidance (e.g., pediatrics, CHD, retransplantation) and oncology clearance requirements. This file is Part 1 of 3 and contains the core policy statements and referenced figures/tables; numeric thresholds, detailed cancer-specific wait times, and procedural appendices are located in the Appendix and subsequent policy parts. Pages and appendices are provided with the policy (see Appendix and References); for complete procedural details, figures, and numeric thresholds not reproduced in this part, readers should consult the Appendix and the remaining parts of the policy and the cited guideline/consensus sources (e.g., ISHLT, OPTN/SRTR, Al-Adra et al.).

Policy Summary

PayerCigna

PolicyHeart, Lung, and Heart-Lung Transplantation

Policy CodePolicy 0129

Change TypeMaterial updates to malignancy and lung transplant statements

Effective DateSep 15, 2025

Next Review DateSep 15, 2026

Key ActionObtain oncology clearance per published guidelines and document absence of listed contraindications prior to transplant authorization.

SourceLink

On This Page

disease that requires continuous intravenous inotropic or mechanical circulatory support

Heart Transplantation - Pediatric

Heart transplantation in a child is considered medically necessary when EITHER of the following are met:

ANY of the following

intractable heart failure
congenital abnormality not amenable to surgical correction

Lung Transplantation - General

Lung transplantation is considered medically necessary when EITHER of the following criteria are met:

ANY of the following

end-stage disease of lung parenchyma, airway and pulmonary vasculature that is not amenable to maximum alternative medical or surgical therapies with severe, progressive symptoms despite optimal medical management, resulting in an unacceptable quality of life
Selected NSCLC histologies
- current diagnosis of lung-limited adenocarcinoma in situ, minimally invasive adenocarcinoma, or lepidic predominant adenocarcinoma
- non-small cell lung cancer (NSCLC) Stage II or lower
- surgical resection is not feasible either because of multifocal disease or significant underlying pulmonary disease
- multifocal disease has resulted in significant lung restriction and respiratory compromise
- medical oncology therapies have failed or are contraindicated
- lung transplant is expected to be curative
- has oncology clearance in accordance with published guidelines and does not have a contraindication

Lung Transplantation - Not Medically Necessary

Lung transplantation is considered not medically necessary for EITHER of the following:

ANY of the following

coronary artery disease not amenable to percutaneous intervention or bypass grafting, or associated with significant impairment of left ventricular function
chest wall/spinal deformity that would pose a contraindication to transplantation

Heart-Lung Transplantation

Heart-lung transplantation is considered medically necessary when BOTH of the following criteria are met:

ALL of the following

end-stage cardiopulmonary disease where the replacement of either organ alone is unlikely to improve survival or quality of life
the individual remains at a New York Heart Association functional class III or IV despite maximal medical and surgical management

Heart, Lung, or Heart-Lung Transplantation with History of Malignancy

Heart, lung, or heart-lung transplantation is considered medically necessary in an individual with a history of malignancy when ALL of the following are met:

ALL of the following

meets the above criteria for heart, lung, or heart-lung transplantation
has oncology clearance in accordance with published guidelines and does not have a contraindication

Contraindications — Not Medically Necessary

Heart, lung, or heart-lung transplantation is considered not medically necessary in an individual with ANY of the following contraindications:

ANY of the following

History of specified malignancies
- Breast cancer, Stage IV
- Prostate cancer, metastatic and castration-resistant
- Renal cell carcinoma with sarcomatoid and/or rhabdoid histologic features; duct or medullary
- Bladder cancer, muscle invasive
- Gynecological cancer
  - Endometrial cancer, Stage IV or recurrent/metastatic
  - Ovarian cancer, epithelial Stage IV or recurrent
  - Cervical cancer (squamous cell/adenocarcinoma), Stage IV or recurrent/metastatic
- Lung cancer, Stage IIIA or higher
- Skin cancer
  - Cutaneous squamous cell carcinoma with distant metastasis
  - Merkel cell carcinoma with distant metastasis
  - Malignant melanoma, Stage III or IV
persistent, recurrent or unsuccessfully treated major or systemic infections
systemic illness or comorbidities that would be expected to substantially negatively impact the successful completion and/or outcome of transplant surgery
a pattern of demonstrated noncompliance which would place a transplanted organ at serious risk of failure
HIV disease
- CD4 count greater than 200 cells/mm3
- HIV-1 RNA undetectable
- stable antiretroviral therapy for more than three months
- absence of serious complications associated with or secondary to HIV disease (e.g., opportunistic infections, resistant fungal infections, Kaposi's sarcoma or other neoplasm)

ILD: ≥10% decrease in FVC over 6 months OR FVC >5% with radiographic progression; DLCO decline >10% in 6 months; desaturation <88% on 6MWT; confirmed pulmonary hypertension; hospitalization for declineFVC ≥10% decline; DLCO >10% decline; 6MWT desat <88%

Cystic fibrosis: FEV1 <25% predicted OR chronic respiratory failure with hypoxemia/hypercapnia OR any exacerbation requiring mechanical ventilation OR BMI <18 kg/m2 OR pulmonary hypertension OR frequent hospitalization or massive hemoptysisFEV1 <25%; BMI <18 kg/m2

PAH: ESC/ERS high risk or REVEAL >10 on therapy including IV/SC prostacyclin; progressive hypoxemia; progressive liver/kidney dysfunction due to PAH; life-threatening hemoptysisREVEAL >10

LAM: disease progression despite mTOR inhibitors, FEV1 <30% predicted, NYHA III/IV, resting hypoxemia, pulmonary hypertension, refractory pneumothoraxFEV1 <30%

ARDS: continuous mechanical ventilator support and/or ECLS, no expectation of recovery, irreversible lung damage

Pediatric-specific triggers

CF pediatric: Refer when FEV1 <50% predicted with markers of severity or rapidly declining; list when FEV1 <30% predictedRefer <50%; List <30%
PAH pediatric: Refer when intermediate/high-risk on EPPVDN or need for IV/SC prostacyclin, significant RV dysfunction, WHO class >III, elevated BNP/NT-proBNP, diminished growth, progressive disease despite therapy, hospitalizations, secondary organ dysfunction, life-threatening complications; list when EPPVDN high riskEPPVDN high risk for listing

Lung allocation groups (OPTN definitions)

Diagnosis group assignment for lung composite allocation score (Group A-D) per OPTN Administrative Rules (June 26, 2025).

ANY of the following

Group A: Examples include: Allergic bronchopulmonary aspergillosis; Alpha-1 antitrypsin deficiency; Bronchiectasis; Bronchopulmonary dysplasia; COPD/emphysema; Ehlers-Danlos; Granulomatous lung disease; Inhalation burns/trauma; Kartagener's; Lymphangioleiomyomatosis; Obstructive lung disease; Primary ciliary dyskinesia; Sarcoidosis with PA mean pressure ≤30 mm Hg or missing; Tuberous sclerosis; Wegener's - bronchiectasis
Group B: Examples include: Congenital malformation; CREST - pulmonary hypertension; Eisenmenger's variants (ASD, PDA, VSD, multi-congenital); Portopulmonary hypertension; Pulmonary arterial hypertension; Pulmonary vascular disease; PVOD; Pulmonic stenosis; Right hypoplastic lung; Scleroderma - pulmonary hypertension; Secondary pulmonary hypertension; Thromboembolic pulmonary hypertension
Group C: Examples include: Common variable immune deficiency; Cystic fibrosis; Fibrocavitary lung disease; Hypogammaglobulinemia; Schwachman-Diamond syndrome
Group D: Examples include: ABCA3 mutation; Alveolar proteinosis; Amyloidosis; ARDS or pneumonia; Bronchioloalveolar carcinoma (BAC); Carcinoid tumorlets; Chronic pneumonitis of infancy; CPFE; Constrictive bronchiolitis; COVID-19 ARDS or pulmonary fibrosis; CREST - Restrictive; Eosinophilic granuloma; Fibrosing mediastinitis; GVHD; Hermansky Pudlak; Hypersensitivity pneumonitis; Idiopathic interstitial pneumonia; Lung retransplant or graft failure; Rheumatoid disease; Sarcoidosis with PA mean pressure >30 mm Hg; Scleroderma - restrictive; Silicosis; Sjogren's; Surfactant protein deficiencies; Teratoma; Wegener's - restrictive

Absolute contraindications to lung transplantation (ISHLT)

Conditions generally precluding transplant except in exceptional circumstances.

ANY of the following

Lack of patient willingness or acceptance of transplant
Malignancy with high risk of recurrence or death related to cancer
Glomerular filtration rate < 40 mL/min/1.73m2 unless considered for multi-organ transplantGFR < 40 mL/min/1.73m2
Acute coronary syndrome or myocardial infarction within 30 days (excluding demand ischemia)within 30 days
Stroke within 30 dayswithin 30 days
Liver cirrhosis with portal hypertension or synthetic dysfunction unless considered for multi-organ transplant
Acute liver failure
Acute renal failure with rising creatinine or on dialysis and low likelihood of recovery
Septic shock
Active extrapulmonary or disseminated infection
Active tuberculosis infection
HIV infection with detectable viral loaddetectable viral load
Limited functional status (e.g., non-ambulatory) with poor potential for rehabilitation
Progressive cognitive impairment
Repeated episodes of non-adherence without evidence of improvement
Active substance use or dependence including current tobacco use, vaping, marijuana smoking, or IV drug use
Other severe uncontrolled medical condition expected to limit survival after transplant

Heart-lung transplantation

Indications and considerations for combined heart-lung transplant

ALL of the following

Indicated for selected patients with concomitant end-stage heart failure and end-stage lung disease when combined transplant is the only surgical option (e.g., complex CHD with Eisenmenger syndrome)
Prefer isolated organ transplant where possible due to increased waiting time, mortality on waitlist, and combined risks
Should be performed at centers with experience in multi-organ transplantation and specialist availability

Re-transplantation considerations

Selection cautions and indications for re-transplantation

ALL of the following

Re-transplantation outcomes are inferior to primary transplants and should be reserved for carefully selected candidates
Indicated for significant cardiac allograft vasculopathy (CAV) with refractory allograft dysfunction without ongoing acute rejectionISHLT Grade 3 CAV
Higher early mortality rates reported; consider reasons for graft failure (alloimmunization, non-adherence, reflux, infections)
Document cause of graft failure and exclude modifiable contributors

High-volume intermediate / High / Very high: PSA >20 ng/mL OR high-volume Gleason 7 OR Gleason 8-10; example T3; if treatment initiated and nomogram predicts <10% cancer-specific death over 15 years then no wait time; otherwise consider treatment and may require waitPSA >20 ng/mL; Gleason 8-10; T3

Metastatic castration-sensitive: Median survival ~5 to 6 years; may consider transplant if stable disease for 2 years with prolonged estimated life expectancystable 2 years

Metastatic castration-resistant: Median survival 2 to 3 years; Not a SOT candidate

Recommended wait time for SOT candidates with prior history of bladder cancer

Recommendations by stage/risk and typical 2-year local recurrence rates:

ANY of the following

NMIBC low risk: Solitary, <3 cm, low-grade, Ta tumor, absence of CIS; 2-year local recurrence 19%; Time interval to transplant = 6 months2-year recurrence 19%
Intermediate risk: Solitary tumor >3 cm OR recurrence within 12 months with low-grade Ta OR multifocal low-grade Ta OR low-grade T1 OR high-grade tumor <3 cm; 2-year recurrence 39%; Time interval = 6 months2-year recurrence 39%
High risk: Any CIS, high-grade Ta tumor >3 cm, high-grade T1, multifocal high-grade Ta, recurrent high-grade Ta, CIS, variant histology, lymphovascular invasion, high-grade prostatic urethral involvement, recurrence after BCG; 2-year recurrence 38%; Time interval = 2 years; note: progression rate to muscle invasion higher2-year recurrence 38%
MIBC postradical cystectomy: 2-year local recurrence 25 to 37%; Time interval = 2 years2-year recurrence 25-37%
MIBC postchemoradiation: 2-year local recurrence 25 to 30%; Time interval = Not an SOT candidate2-year recurrence 25-30%

Recommended wait time for SOT candidates with prior history of gynecologic cancer

Wait times depend on cancer type and risk factors (e.g., older age, lymph-vascular space invasion, grade 2 or 3 endometrioid, deep invasion).

Risk factors determine wait times; refer to source for detailed recommendations

Refer to Al-Adra et al., Am J Transplant 2021

Recommended wait time for SOT candidates with prior history of lung cancer

Guidance summarized from consensus statement; specific timing details likely in other policy parts or source references.

Specific recommended wait times not detailed in this part; refer to source statement (Al-Adra et al., Am J Transplant 2021)

Recommended wait times pretransplantation for patients with history of skin cancer

Wait times and recommended pretransplant treatments vary by histology and stage:

ANY of the following

Cutaneous squamous cell carcinoma (cSCC): Low-risk: surgical excision/Mohs; No delay necessary. High-risk (not including perineural invasion): excision/Mohs; Wait = 2 years. High-risk with perineural invasion or ≥2 risk factors: excision + adjuvant radiation; Wait = 2-3 years. Local nodal metastatic disease: excision + node dissection + ART; Wait = 5 years. Distant metastasis: refer for oncology; Not eligible for transplantation
Merkel cell carcinoma (MCC): Local with negative SLN: wide local excision + ART; Wait = 2 years. Local with nodal metastasis: wide local excision, lymph node dissection, ART; Wait = 3-5 years. Distant metastasis: refer for oncology; Not eligible
Malignant melanoma (MM): In situ: wide local excision; No wait necessary and follow-up posttransplant 3 months. Stage Ia: wide local excision; Wait = 2 years. Stage Ib/IIIA: wide local excision + SLNB; Wait = 2-5 years. Stage IIb/IIc: wide local excision + SLNB; Wait = 5 years. Any stage III or IV: refer for oncology; Not eligible for transplantation

Recommended wait time for SOT candidates with prior history of hematological malignancies

Time intervals listed by hematologic malignancy subtype assuming event-free status as specified:

ANY of the following

Diffuse large B cell lymphoma: Equivalent survival after EFS24 achieved; Time interval = 2 yearsEFS24
Follicular lymphoma: No added mortality after EFS24; Time interval = 2 yearsEFS24
Peripheral T cell lymphoma, NOS: 23% relapse within 5 years after EFS24; 5-year survival 78% after EFS24; Time interval = 2 yearsEFS24
Burkitt lymphoma: 0.6% relapse after EFS24; Time interval = 2 yearsEFS24
Hodgkin lymphoma: 10% relapse at 10 years after EFS24; Time interval = 2 years; PET negative patients after initial treatment have low relapse rateEFS24
Monoclonal B cell lymphocytosis: Time interval = No wait time
Chronic lymphocytic leukemia (CLL): Time interval = 2 to 3 years after treatment; consider if in remission with no CLL-IPI scores >4

Criteria for safe SOT candidates with a prior history of myeloma or amyloidosis

Criteria include disease-specific laboratory and response metrics (figure referenced); dFLC defined as difference between involved and uninvolved serum free light chains.

Specific numeric criteria and thresholds depicted in figure (not reproduced here); refer to source for detailed numeric thresholds for myeloma and amyloidosis

See figure in source (Al-Adra et al., Am J Transplant 2021) for numeric thresholds including dFLC

Documentation Required

Oncology clearance for candidates with malignancy

For individuals with a history of malignancy, obtain oncology clearance in accordance with published guidelines (See Appendix) and document absence of listed contraindications prior to transplant authorization. See Appendix for detailed guidance on cancer-specific wait times, staging, and required oncology clearance statements.

Prior Authorization

Apply transplant timing recommendations for SOT candidacy

Providers must adhere to the specified recommended wait times based on cancer type and stage (e.g., 6 months, 2 years, 3–5 years, or not eligible) and include documentation of the applicable wait time and cancer status when requesting transplant authorization.

Denial Risk

Ineligibility risk for metastatic disease

Distant metastasis or metastatic castration-resistant prostate cancer are considered exclusions to transplant candidacy and may lead to denial of transplant requests.

Documentation Required

Multidisciplinary evaluation and diagnostics for CHD and Fontan patients

For CHD and single ventricle/Fontan candidates, perform and document a multidisciplinary evaluation including cardiac MRI and/or chest CT to define anatomy, assessment of pulmonary hypertension (hemodynamics), evaluation of patency of major veins and arteries, assessment of other organ systems, HLA sensitization, and psychosocial support.

Cardiac MRI and/or chest CT to define intrathoracic anatomy
Pulmonary hypertension assessment (including hemodynamics)
Patency of major veins and arteries and venous collaterals
Evaluation of other organ systems affecting post-transplant care (lung, liver, GI, kidney)
HLA antibody sensitization testing
Psychosocial evaluation of patient, family, and caregiver support

Prior Authorization

Transplant center selection for CHD and multi-organ cases

Refer CHD and multi-organ transplant candidates to centers with established pediatric/adult CHD and transplantation experience; prior authorization requests should reflect referral to or involvement of an experienced center when multi-organ transplant or complex CHD is being considered.

Documentation Required

Assess contraindications

Document absence of absolute contraindications prior to listing or authorization, including active infection, uncontrolled malignancy, GFR <40 mL/min/1.73 m2 (unless multi-organ), active substance dependence, and repeated non-adherence.

Documentation Required

Evaluate re-transplant candidacy carefully

For re-transplant consideration, document the cause of graft failure, exclude modifiable contributors (e.g., alloimmunization, non-adherence, gastroesophageal reflux, repeated infections), and acknowledge the higher early mortality risk when requesting authorization.

Documentation Required

Document cancer history and risk category

Document prior malignancy type, stage/risk features, and disease-specific metrics to support transplant decisions (e.g., PSA and Gleason for prostate cancer; TURBT recurrence risk and treatment for bladder cancer; EFS24/PFS24 status for hematologic malignancies).

Cancer type and stage/risk classification
PSA level and Gleason score for prostate cancer
TURBT recurrence risk and treatment details for bladder cancer
EFS24/PFS24 status and relevant hematologic response data

Denial Risk

Patients with distant metastasis ... may be denied

Transplant requests may be denied for candidates with distant metastasis (e.g., distant metastatic skin cancers) or metastatic castration-resistant prostate cancer; these are listed as not medically necessary exclusions.

Billing Rule

Use listed CPT/HCPCS for transplant procedures

When policy criteria are met, bill the specified CPT and HCPCS codes for donor and recipient transplant procedures and related global services; refer to the Coding Information / code table (Appendix) for the full list of procedure codes and descriptions.

32850
32851
32852
32853
32854
32855
32856
33930
33933
33935
33940
33944
33945
S2060
S2061
S2152

Numeric thresholds & clinical metrics

NYHA classIII or IV required for many heart and heart-lung transplant indications

HIV thresholdsCD4 > 200 cells/mm3 and undetectable HIV-1 RNA plus stable ART >3 months required to consider transplantation

GFR thresholdGFR <40 mL/min/1.73m2 is an absolute contraindication to lung transplant unless multi-organ transplant considered

BODE indexBODE score 7–10 is a COPD listing trigger

FEV1 thresholdsFEV1 <20% predicted for COPD listing; CF: refer when FEV1 <50% (or rapidly declining), list when FEV1 <30% (pediatrics) or <25% referenced for adults

Other numeric listing triggersILD: ≥10% decline in FVC over 6 months (or >5% with radiographic progression); DLCO decline >10% in 6 months; 6MWT desaturation <88%

Cancer / timing thresholdsBladder NMIBC low-risk: 6-month wait (2-yr local recurrence 19%); high-risk bladder: 2-year wait (2-yr recurrence ~38%); Prostate PSA thresholds used: <10, >10, >20 ng/mL to stratify timing/eligibility

2024-09-15clarified

Annual review: Administrative/template updates; no clinical policy statement changes (non-material).