Centene Nonmyeloablative Allogeneic Transplant Coverage

Coverage Criteria for Nonmyeloablative / Reduced-Intensity Allogeneic Transplant

Initial Transplant Coverage Criteria

Covered when ALL of the following are met

Overall

Eligible Diagnoses: One of the following diagnoses: acute lymphoblastic leukemia; acute myelogenous leukemia; acquired bone marrow failure such as severe aplastic anemia; familial bone marrow failure syndromes (e.g., dyskeratosis congenita; Shwachman-Diamond syndrome; Diamond-Blackfan anemia; Kostmann syndrome; Fanconi anemia); paroxysmal nocturnal hemoglobinuria; chronic lymphocytic leukemias; chronic myelogenous leukemia; congenital immunodeficiency syndromes; non-Hodgkin's lymphoma (including primary refractory or relapsed disease excluding diffuse large B-cell lymphoma; follicular lymphoma; mantle cell lymphoma; diffuse large B-cell lymphoma in remission following second-line therapy for relapsed/refractory disease); myelodysplastic syndromes; lysosomal storage disorders types IH/IS, VI, VII; macrophage disorders such as hemophagocytic lymphohistiocytosis (HLH); myeloproliferative neoplasms (including chronic myeloid leukemia, juvenile myelomonocytic leukemia, primary myelofibrosis, essential thrombocytosis, polycythemia vera).
Complete list in policy.
Unsuitable for myeloablative conditioning (examples): Presence of one or more of the following: bilirubin > 2 mg/dL; hemostasis: INR > 1.6 (unless on oral anticoagulants); cardiac function: ejection fraction (EF) < 45% on MUGA or echocardiogram; pulmonary function: FEV1 ≤ 50% predicted OR DLCO ≤ 60% predicted; performance status: Karnofsky or Lansky score < 70% OR ECOG performance score > 2.
These are examples of significant organ dysfunction or severe comorbidities that render the patient unsuitable for conventional myeloablative allografting.

Not Supported Indications

Not supported / Not medically necessary for the following

Non-supported Indications - Solid Tumors: Solid tumors including, but not limited to: brain tumors; ovarian epithelial and mixed epithelial/germ cell cancers; primitive neuroectodermal tumors (including medulloblastoma and ependymoma); renal cell carcinoma; testicular cancer; Wilms tumor; Ewing sarcoma; melanoma; osteosarcoma; rhabdomyosarcoma; retinoblastoma; germ cell tumors; neuroblastoma; multiple myeloma (except in tandem transplant per CP.MP.162).

Listed as indications for which current evidence does not support RIC/nonmyeloablative allogeneic transplants.

Non-supported Indications - Autoimmune Disorders: Autoimmune disorders including, but not limited to: multiple sclerosis; rheumatoid arthritis; juvenile idiopathic arthritis; systemic lupus erythematosus; systemic sclerosis; dermatomyositis; polymyositis; scleroderma.

Evidence does not support use of nonmyeloablative/RIC allogeneic transplants for these conditions.

Non-supported Indications - Hemoglobinopathies: Hemoglobinopathies including, but not limited to: thalassemias and sickle cell anemia (refer to CP.MP.108 for allogeneic HCT for sickle cell and β-thalassemia).

Requests for nonmyeloablative/reduced-intensity conditioning (RIC) allogeneic transplants for hemoglobinopathies such as sickle cell anemia and β-thalassemia should be referred to policy CP.MP.108 for evaluation and coverage determination. The policy explicitly directs these requests to that related allogeneic HCT policy rather than applying the general RIC transplant criteria in this document.

Where no contract exists between the provider and the health plan, providers, members/enrollees and their representatives agree to be bound by the terms and conditions of this clinical policy by providing services to members/enrollees and/or submitting claims for payment for such services. For Medicaid members/enrollees, applicable state Medicaid coverage provisions take precedence when they conflict with this clinical policy; Medicare NCDs/LCDs should be reviewed prior to applying this policy.

Use of nonmyeloablative/RIC allogeneic transplants for the conditions listed in the policy is not supported by current evidence and is considered not medically necessary under this policy. These non-supported categories include: selected solid tumors (examples listed in policy such as ovarian epithelial and mixed epithelial/germ cell cancers; primitive neuroectodermal tumors including medulloblastoma and ependymoma; renal cell carcinoma; testicular cancer; Wilms tumor; Ewing sarcoma; melanoma; osteosarcoma; rhabdomyosarcoma; retinoblastoma; germ cell tumors; neuroblastoma; and others), autoimmune disorders (including but not limited to multiple sclerosis, rheumatoid arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, polymyositis, scleroderma), and hemoglobinopathies (including thalassemias and sickle cell anemia).

Coding and Clinical Thresholds

Covered CPT Codes (procedures referenced)CPT

38204	Management of recipient hematopoietic progenitor cell donor search and cell acquisition.
38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic.
38207	Transplant preparation of hematopoietic progenitor cells; cryopreservation and storage.
38208	Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, without washing, per donor.
38209	Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, with washing, per donor.
38210	Transplant preparation of hematopoietic progenitor cells; specific cell depletion within harvest, T-cell depletion.
38211	Transplant preparation of hematopoietic progenitor cells; tumor cell depletion.
38212	Transplant preparation of hematopoietic progenitor cells; red blood cell removal.
38213	Transplant preparation of hematopoietic progenitor cells; platelet depletion.
38214	Transplant preparation of hematopoietic progenitor cells; plasma (volume) depletion.

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Covered HCPCS/S codesHCPCS

S2142

Cord blood-derived stem-cell transplantation, allogeneic.

S2150

Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; including: pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and posttransplant care in the global definition.

DLCO threshold

DLCO thresholdDiffusing capacity of the lung for carbon monoxide (DLCO) ≤ 60% of predicted value

Clinical implicationDLCO ≤ 60% is listed as an example of pulmonary dysfunction rendering a patient unsuitable for myeloablative conditioning

Source updateThreshold was updated from DLCO ≤ 50% to DLCO ≤ 60% of predicted value (see policy revision notes).

FEV1 threshold

FEV1 thresholdForced expiratory volume in 1 second (FEV1) ≤ 50% of predicted value

Role in evaluationFEV1 ≤ 50% is an example pulmonary function abnormality that may justify nonmyeloablative/RIC approach

Candidate Selection Criteria

Candidate selection

Candidate must meet both diagnosis-based eligibility and be unsuitable for myeloablative conditioning due to organ dysfunction/comorbidities.

Candidate: Member has an eligible diagnosis (see policy list of diagnoses) AND is unsuitable for conventional high-dose myeloablative allografting because of significant dysfunction of another major organ system and/or severe comorbidities (examples provided).

See policy for full enumerated diagnoses and specific organ/comorbidity thresholds.

Contraindications and Factors Affecting Eligibility

The policy removed previously listed absolute contraindications and instead provides examples of significant organ dysfunction and severe comorbidities that affect candidacy and choice of conditioning intensity. Examples cited in the policy include bilirubin > 2 mg/dL, INR > 1.6 (unless on oral anticoagulants), cardiac ejection fraction < 45%, pulmonary function thresholds such as FEV1 ≤ 50% predicted or DLCO ≤ 60% predicted, and poor performance status (for example Karnofsky/Lansky < 70% or ECOG > 2). These findings are presented as examples of conditions that render patients unsuitable for conventional myeloablative allografting and relevant when considering RIC/nonmyeloablative approaches.

Pre-Transplant Evaluation Requirements

Documentation Required

Provider responsibilities — evaluation documentation

Pre-transplant evaluation must document baseline organ function, comorbidities, and other data necessary to determine medical necessity and appropriateness of allogeneic hematopoietic cell transplantation. Medical necessity determinations used for coverage decisions will be based on documentation in the medical record and must be consistent with plan benefit documents and applicable federal/state laws and regulations. Coverage is conditional on the member’s plan documents and any applicable federal/state rules; authorization does not guarantee payment if services are not covered under the member's benefit plan.

Documenting organ function tests and results: liver function (bilirubin), coagulation (INR), cardiac function (MUGA or echocardiogram with EF), pulmonary function tests including FEV1 and DLCO.
Documenting performance status: Karnofsky/Lansky or ECOG score.
Documentation that member is a candidate for non-myeloablative or reduced-intensity conditioning when indicated, and rationale if standard myeloablative transplant is unsuitable due to comorbidities.

Note

Required clinical data

The pre-transplant evaluation should include, at minimum: history and physical; organ function testing results; infectious disease screening; performance status; comorbidity assessment; psychosocial evaluation; and transplant center multidisciplinary assessment. Specific objective testing should include:

Provider Actions, Authorization and Claims Guidance

Prior Authorization

Submit prior authorization demonstrating all candidate criteria

Prior authorization/medical necessity review must demonstrate the member meets all candidate criteria: an eligible diagnosis listed in the policy and unsuitability for myeloablative conditioning per the specified organ/comorbidity thresholds, and that the indication is not among the policy's non‑supported indications.

Include the specific eligible diagnosis from the policy list.
Document organ dysfunction or comorbidities meeting thresholds (e.g., bilirubin, INR, EF, FEV1, DLCO, performance status).
Confirm the indication is not a non‑supported category (solid tumors, autoimmune disorders, hemoglobinopathies).

Note

Use policy to guide medical necessity and follow plan procedures

This clinical policy is used to guide medical necessity determinations for coverage decisions; prior authorization requirements should follow the Health Plan's administrative policies and applicable coverage documents.

Review and follow the Health Plan's administrative policies and applicable coverage documents when processing prior authorizations.

Definitions

Nonmyeloablative / RIC

DefinitionNonmyeloablative / reduced-intensity conditioning (RIC): preparative regimens that do not fully ablate recipient hematopoiesis and are less toxic than myeloablative regimens; used interchangeably in this policy

MechanismThese regimens rely more on immunosuppression than high-dose cytotoxic therapy to permit donor engraftment

Clinical goalAim to reduce morbidity and mortality compared with myeloablative conditioning while permitting donor engraftment

Mixed chimerism

DefinitionMixed donor-host hematopoietic chimerism: coexistence of donor and recipient hematopoietic cells after transplantation

SignificanceRepresents successful engraftment without full marrow ablation and is an expected outcome of nonmyeloablative regimens

Background

Nonmyeloablative (reduced-intensity) conditioning regimens use less intensive cytotoxic therapy and rely more on immunosuppression to permit donor engraftment. These regimens do not fully ablate recipient hematopoiesis and aim to reduce morbidity and mortality compared with myeloablative conditioning by producing mixed donor‑host hematopoietic chimerism. They are intended for patients who are unsuitable for conventional high‑dose myeloablative allografting due to age, comorbidities, organ dysfunction, or prior intensive therapy.

Post-Transplant Care and Coverage

Post-transplant care and related complications

Post-transplant services codingS2150: Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; includes comprehensive transplant services

ScopeS2150 description encompasses pheresis, cell preparation/storage, hospitalization, outpatient follow-up, and pre-/posttransplant care days

Policy referencePost-transplant services and complications are referenced in S2150 and are encompassed within transplant billing guidelines

Transplant Center Requirements

Billing Rule

Adhere to standard transplant coding and comprehensive service documentation

Follow standard CPT/HCPCS coding guidance and transplant center expectations for comprehensive transplant services as referenced by the policy; coding and service scope (including pre‑ and post‑transplant care) are described in the S‑code definitions.

S2150 describes comprehensive transplant services including pre‑ and posttransplant care, drugs, supplies, hospitalization, and related complications.
Reference up‑to‑date professional coding guidance prior to claim submission.

OpenPayer

Nonmyeloablative Allogeneic Stem Cell Transplants