Centene nonmyeloablative allogeneic HCT Coverage Update

Coverage Criteria — Indications and Limits

inv-01: Covered Indications and Candidate Requirements

Covered when ALL of the following are met for a candidate receiving nonmyeloablative/RIC allogeneic transplant:

Primary indication: Member has one of the listed hematologic or related diagnoses (examples include acute lymphoblastic leukemia; acute myelogenous leukemia; chronic lymphocytic leukemia; chronic myelogenous leukemia; non-Hodgkin lymphoma including primary refractory or relapsed disease; mantle cell lymphoma; diffuse large B‑cell lymphoma in remission after second‑line therapy; myelodysplastic syndromes; myeloproliferative neoplasms including chronic myeloid leukemia, primary myelofibrosis, essential thrombocytosis, polycythemia vera; macrophage disorders such as hemophagocytic lymphohistiocytosis (HLH); acquired bone marrow failure such as severe aplastic anemia; familial bone marrow failure syndromes including Fanconi anemia, Dyskeratosis congenita, Shwachman‑Diamond syndrome, Diamond‑Blackfan anemia, Kostmann syndrome; paroxysmal nocturnal hemoglobinuria; lysosomal storage disorders types I, VI, VII; juvenile myelomonocytic leukemia).

Listing is illustrative and follows policy text.

Unsuitability for myeloablative transplant OR organ function thresholds: Member is unsuitable for conventional high‑dose myeloablative allografting because of untreatable significant dysfunction of another major organ system and/or severe comorbidities; OR when evaluated, the member meets the organ function and performance thresholds listed below.

Policy provides numeric organ function and performance thresholds.

Required organ function and performance thresholds (examples): At evaluation, the member meets the following numeric thresholds: bilirubin <= 2 mg/dL (policy lists >2 mg/dL as an example of significant dysfunction); INR <= 1.6 unless on oral anticoagulants; cardiac ejection fraction by MUGA or echocardiogram >= 45%; pulmonary function: FEV1 >= 50% of predicted and DLCO >= 60% of predicted; acceptable performance status by Karnofsky/Lansky or ECOG (ECOG <= 2).

Threshold values and testing modalities specified in policy.

Nonmyeloablative/reduced‑intensity conditioning (RIC) allogeneic transplants are not supported for the following categories of indications: solid tumors (examples include brain tumors, primitive neuroectodermal tumors such as medulloblastoma and ependymoma, ovarian epithelial cancers, renal cell carcinoma, testicular cancer, Wilms tumor, melanoma, Ewing sarcoma, osteosarcoma, retinoblastoma, rhabdomyosarcoma, germ cell tumors, and neuroblastoma), autoimmune disorders (examples include multiple sclerosis, rheumatoid arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, polymyositis), and hemoglobinopathies (examples include thalassemias and sickle cell anemia).

Coverage for nonmyeloablative/RIC allogeneic hematopoietic stem cell transplantation is subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents. Where state Medicaid coverage provisions conflict with this clinical policy, state Medicaid provisions take precedence. For Medicare members, applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Medicare Coverage Articles should be reviewed and applied as appropriate.

Use of nonmyeloablative/RIC allogeneic transplants for the listed excluded indications described in this policy (solid tumors, autoimmune disorders, and hemoglobinopathies) is considered not supported by current evidence and therefore would be at risk for denial if submitted for those indications.

Candidate Eligibility and Requirements

inv-22: Candidate Eligibility Criteria

Candidate must have a covered diagnosis and meet organ function and performance criteria:

Diagnosis: Member has a listed covered hematologic or related diagnosis as specified in policy (see covered indications list).

Refer to primary covered indications for exact diagnostic examples.

Organ function and comorbidities: Member is unsuitable for myeloablative transplant due to significant organ dysfunction or severe comorbidities OR meets required numeric thresholds: bilirubin <= 2 mg/dL (policy cites bilirubin >2 mg/dL as an example of exclusionary dysfunction), INR <= 1.6 unless on oral anticoagulants, cardiac EF >= 45% by MUGA or echocardiogram, FEV1 >= 50% predicted, DLCO >= 60% predicted, and acceptable performance status (Karnofsky/Lansky or ECOG scores).

Policy specifies these laboratory, cardiac, pulmonary, and functional thresholds as part of candidacy assessment.

Contraindications and Substance Use Considerations

The policy language has been revised to remove prior absolute contraindications in Criteria I.C and to update substance use verbiage. The updated language excludes marijuana use only when prescribed by a licensed practitioner and requires a candidate to demonstrate a commitment to reducing substance use behaviors if an urgent transplant timeline exists. In addition, the pulmonary function threshold in contraindications and candidacy criteria was changed by revising the DLCO cutoff from <50% to <= 60% predicted (candidates must have DLCO >= 60% predicted for candidacy) as part of the recent policy updates.

Pre-Transplant Evaluation Requirements

Prior Authorization

Provider action: Prior Authorization for Listed CPT/HCPCS Codes

Prior Authorization Required. Prior authorization is required for all listed CPT and HCPCS codes associated with allogeneic hematopoietic cell transplantation (including non-myeloablative / reduced intensity conditioning regimens). Submit requests to Centene prior to scheduling the transplant to allow clinical review and determination of coverage.

Affected billing codes: all transplant-related facility and professional CPT/HCPCS codes (including but not limited to marrow/stem cell harvest, infusion, donor collection, and inpatient transplant DRG-related services).
Include clinical documentation supporting indication, prior therapies, and transplant type (non-myeloablative/RIC vs myeloablative).

Prior Authorization

Provider action: Prior authorization and coverage governance

Prior authorization and coverage governance: Coverage decisions depend on medical necessity criteria and transplant candidacy assessments. Providers must document that the member meets indications for allogeneic HCT and is unsuitable for myeloablative transplant only when applicable. Requests will be reviewed against policy criteria, payer-specific medical necessity rules, and applicable Medicare NCD/LCD/coverage articles for Medicare members.

Procedure and Billing Codes

Covered CPT Codes (examples)CPTCovered

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 / Revenue Codes (examples)HCPCSCovered

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; global definition including specified services.

inv-07: Cardiac ejection fraction — EF >= 45% (MUGA or echocardiogram required).

RequirementCardiac ejection fraction (EF) >= 45% as measured by multigated acquisition (MUGA) scan or echocardiogram.

Assessment methodEF must be documented from a MUGA scan or transthoracic echocardiogram as part of pre-transplant cardiac evaluation.

ContextEF threshold applied to determine suitability for nonmyeloablative/RIC allogeneic transplant when member is otherwise unsuitable for myeloablative transplant due to organ dysfunction or comorbidities.

inv-08: INR — INR <= 1.6 (unless on oral anticoagulants).

RequirementInternational Normalized Ratio (INR) <= 1.6 unless the member is on oral anticoagulants.

Assessment timing

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Obtain prior authorization with supporting medical necessity documentation

Prior authorization is required for the listed CPT and HCPCS codes; requests must include clinical documentation demonstrating the member meets all medical necessity coverage criteria for a nonmyeloablative/RIC allogeneic HCT and that the transplant is for a listed covered diagnosis.

Examples of CPT/HCPCS requiring authorization include CPT 38204–38240 and HCPCS S2142, S2150.
Attach clinical records showing diagnosis, organ function results, performance status, and prior therapies as applicable.

Note

Follow Health Plan prior authorization and coverage governance

Prior authorization processes are governed by the Health Plan's administrative policies and the member's coverage documents; Medicare and Medicaid-specific rules take precedence where applicable.

Follow the plan's administrative prior authorization procedures and verify member coverage terms before scheduling services.

Background and Rationale

Nonmyeloablative (reduced‑intensity) conditioning regimens use less cytotoxic conditioning than myeloablative regimens and rely more on immunosuppression to permit donor cell engraftment. The clinical intent is to reduce organ toxicity and transplant‑related mortality while enabling stable mixed donor‑host hematopoietic chimerism. These regimens are typically used for patients who are unsuitable for conventional high‑dose myeloablative allografting because of advanced age, significant comorbidities, or organ dysfunction.

Definitions

inv-20: Nonmyeloablative / Reduced-Intensity Conditioning (RIC) — definition and comparison to myeloablative regimens.

DefinitionNonmyeloablative / Reduced-Intensity Conditioning (RIC) refers to conditioning regimens that do not fully ablate host hematopoiesis; both terms are used interchangeably in this policy unless noted.

SpectrumRIC generally destroys more hematopoietic cells and is more toxic than nonmyeloablative conditioning but less toxic than myeloablative conditioning.

Clinical intentThese regimens rely more on immunosuppression than cytotoxicity to permit donor cell engraftment and aim to reduce organ toxicity and transplant-related mortality compared with myeloablative regimens.

inv-21: Non-Myeloablative Allogeneic Stem Cell Transplant — term definition as used in policy.

TermNon-Myeloablative Allogeneic Stem Cell Transplant = non-myeloablative (reduced-intensity) allogeneic hematopoietic cell transplantation as used in this policy.

Transplant Center and Program Expectations

Note

Follow standard coding and transplant program documentation practices

Reference standard coding and transplant program practices when preparing authorization requests and claims; the policy does not specify explicit accreditation or minimum volume requirements for transplant centers in this excerpt.

Use listed CPT/HCPCS codes for procedure and global service reporting (e.g., S2150 for global transplant definition).
Document institutional practices per routine transplant program standards when requested.

Note

Meet Health Plan administrative expectations for provider submissions

Comply with Health Plan administrative requirements and expectations for providers when seeking authorization or submitting claims; the policy excerpt does not list specific center accreditation or volume criteria.

Ensure administrative prior authorization steps and provider obligations to the plan are met.

Post-Transplant Global Care and Billing

inv-28: Post-transplant global care (as defined by S2150) — HCPCS S2150 describes a global definition for transplantation including pre- and post-transplant care.

HCPCS S2150 descriptionBone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; global definition including specified services such as 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 post-transplant care.

Policy useS2150 is included in the policy for informational coding purposes to describe a global definition for transplantation encompassing pre- and post-transplant care.

Coding noteS2150 may be used as an informational HCPCS code to represent the global transplant service scope; providers should follow plan-specific billing guidance and prior authorization requirements.

OpenPayer

Nonmyeloablative Allogeneic Stem Cell Transplants

Coverage Criteria — Indications and Limits

Candidate Eligibility and Requirements

Contraindications and Substance Use Considerations

Pre-Transplant Evaluation Requirements

Procedure and Billing Codes

Prior Authorization, Documentation, and Billing Guidance

Background and Rationale

Definitions

Transplant Center and Program Expectations

Post-Transplant Global Care and Billing