CurrentCentenePolicy CP.MP.141

Clinical Policy: Nonmyeloablative Allogeneic Stem Cell Transplants

Defines medical necessity criteria and non-supported indications for nonmyeloablative/reduced-intensity conditioning (RIC) allogeneic hematopoietic stem cell transplants for members of Centene-affiliated health plans, and lists related CPT/HCPCS procedure codes for informational/coding purposes.

Policy Summary

PayerCentene

PolicyClinical Policy: Nonmyeloablative Allogeneic Stem Cell Transplants

Policy CodePolicy CP.MP.141

Change TypeRevision (multiple material updates)

Effective Date

Next Review Date

Key ActionProvider must document member diagnosis matching one of the covered indications and document organ function/comorbidity criteria demonstrating unsuitability for myeloablative conditioning when applicable.

POLICY UPDATE CHANGES

Updated Criteria L.B.4.b. DLCO threshold from <50% to <60% of predicted value.

Policy no longer lists absolute contraindications; wording combined/rephrased other contraindications.

Criteria I.A.13.e added to include polycythemia vera.

Clarifies handling of prescribed marijuana and expectations for substance use reduction in urgent cases.

Coding table for sickle cell disorders removed from policy materials.

Hodgkin lymphoma is no longer listed among supported indications.

15+Covered Indications (listed examples)

20+References

Coverage Summary

This policy addresses nonmyeloablative or reduced-intensity conditioning (RIC) allogeneic hematopoietic stem cell transplants — preparative regimens that are less intense than myeloablative conditioning, rely more on immunosuppression than cytotoxicity to permit donor engraftment, and may reduce morbidity and mortality compared with high-dose conditioning. The policy defines the intended population as members who are candidates for allogeneic HCT for listed hematologic malignancies, marrow failure syndromes, macrophage and lysosomal storage disorders, selected lymphomas and myeloproliferative neoplasms, and those who are unsuitable for conventional high-dose myeloablative allografting because of significant organ dysfunction or severe comorbidities.

The policy describes the purpose as establishing medical necessity criteria and listing non-supported indications for RIC/nonmyeloablative allogeneic transplants, guiding documentation of diagnosis and organ function/comorbidity thresholds to determine suitability for nonmyeloablative/RIC approaches and informing coding/administrative use of related CPT/HCPCS procedure codes.

Key thresholds — organ function / performance status

Bilirubin> 2 mg/dL

INR> 1.6 (unless on oral anticoagulants)

Ejection fraction (EF)< 45% (by MUGA or echocardiogram)

FEV1< 50% of predicted

DLCO< 60% of predicted

ECOG performance status≥ 2

Medical-Necessity Criteria

Provider Actions

Documentation Required

Demonstrate diagnosis and eligibility

Provider must document member diagnosis matching one of the covered indications and document organ function/comorbidity criteria (bilirubin, INR, EF, pulmonary function tests, performance status) demonstrating unsuitability for myeloablative conditioning when applicable.

Documentation Required

Substance use commitment when urgent timeline

If urgent transplant timelines exist and substance use is present, provider must document the member's commitment to reducing substance use behaviors; marijuana prescribed by a licensed practitioner is excluded from disqualifying substance use under policy.

Coding

Informational CPT codes referencedCPT

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

1–10 of 13

1/2

Informational HCPCS codes referencedHCPCS

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

Background and Evidence

Conditioning regimens described in the policy include nonmyeloablative and reduced-intensity conditioning (RIC) approaches that do not destroy all hematopoietic cells. RIC regimens generally destroy more hematopoietic cells and are more toxic than nonmyeloablative regimens but less toxic than myeloablative regimens; both are categorized as nonfully ablative and are used interchangeably in the policy.

Historically, allogeneic hematopoietic cell transplantation has been used for decades to treat cancers and blood-system diseases; myeloablative conditioning uses high-dose chemotherapy (with or without radiation) to eradicate disease followed by stem cell infusion, but is limited by increased morbidity and mortality in older patients, those with comorbidities, or those with prior intensive therapy. Less-intense (nonmyeloablative/RIC) regimens were developed to permit donor engraftment with reduced conditioning-related toxicity while maintaining graft-versus-disease effects.

The policy notes that all preparative regimens carry toxicity risks — common adverse effects include loss of appetite, fatigue, alopecia, nausea/vomiting, mucositis, diarrhea, transient pancytopenia, and increased infection risk — and emphasizes that reducing toxicity without losing efficacy is a key goal of nonmyeloablative/RIC approaches.

Guideline and evidence sources referenced in the policy include NCCN Clinical Practice Guidelines, multiple UpToDate reviews, and the CMS National Coverage Determination (Stem cell transplantation).

The policy summary states that these sources and the peer-reviewed literature inform the listing of covered indications, organ function thresholds, contraindications/substance-use handling, and non-supported indications for nonmyeloablative/RIC allogeneic transplants.

Nonmyeloablative / Reduced-intensity conditioning (RIC): Conditioning regimens that do not destroy all hematopoietic cells. RIC generally is more toxic than nonmyeloablative conditioning but less toxic than myeloablative conditioning; both are considered nonfully ablative regimens.

Medicare Determinations

Name (number/type)	Effective year
Stem cell transplantation (formerly 110.8.1) (110.23) — NCD	2024

Revision History

02/24revised

Updated Criteria L.B.4.b. DLCO threshold from <50% to <60% of predicted value.

02/24revised

Removed Hodgkin's lymphoma from Criteria I.A.9. per updated NCCN recommendations.

02/24added

Added Criteria L.A.13.e. to include polycythemia vera in myeloproliferative neoplasms list.