CurrentFidelis CarePolicy MC.CP.MP.108

Sickle Cell Anemia and β-Thalassemia Cell Transplant (Medicare)

Defines medical necessity criteria for allogeneic hematopoietic cell transplant (AHCT) for homozygous β-thalassemia in Medicare health plans affiliated with Centene; excludes sickle cell criteria and states insufficient evidence for autologous transplant.

Policy Summary

PayerFidelis Care

PolicySickle Cell Anemia and β-Thalassemia Cell Transplant (Medicare)

Policy CodePolicy MC.CP.MP.108

Change TypeRevised (title and donor/source clarifications)

Effective Date

Next Review Date

Key ActionDocument in the medical record that an HLA-matched donor is available and specify the stem cell source (cord blood, bone marrow, or peripheral blood with donor unable/refusing bone marrow).

SourceLink

POLICY UPDATE CHANGES

Updated title to Allogeneic Hematopoietic Cell Transplants for β-Thalassemia and removed information and criteria regarding sickle cell anemia.

Added clarifying language to Criteria I.A.1.b. regarding high risk of stroke and removed first-degree relative donor requirement for cord blood as source.

Minor rewording in Description and Background with no impact on criteria; references updated.

1Covered Indication (Homozygous β-thalassemia)

0Covered: Autologous HCT

3Stem Cell Sources Listed

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Coverage Summary

Overview: This policy defines medical necessity criteria for Allogeneic Hematopoietic Cell Transplant (AHCT) for Homozygous β‑thalassemia and applies to Medicare health plans affiliated with Centene. Coverage stance: covered_with_criteria. Effective/Last review date: Last review 2024-12-25.

Supporting evidence (reported outcomes): Studies and reviews report overall survival and thalassemia-free survival of approximately 65% to 90% in reports of HCT from HLA‑matched donors.

Policy metadata

policy_numberMC.CP.MP.108

subjectAllogeneic Hematopoietic Cell Transplant for Homozygous β-thalassemia

statusCURRENT

last_review2024-12-25

scope_summaryDefines medical necessity criteria for allogeneic hematopoietic cell transplant (AHCT) for homozygous β-thalassemia in Medicare health plans affiliated with Centene; excludes sickle cell criteria and states insufficient evidence for autologous transplant.

Medically Necessary Criteria

Autologous Hematopoietic Cell Transplantation for β-thalassemia

Coverage stance

ALL of the following

There is insufficient evidence regarding the safety and efficacy of autologous hematopoietic cell transplant for β-thalassemia

Transfusion-dependent: Requirement for ongoing red blood cell transfusions due to thalassemia (as documented in the medical record).

Myeloablative conditioning regimen: A standard conditioning regimen that ablates bone marrow prior to transplant as described in professional guidelines.

Provider Actions & Documentation Requirements

Documentation Required

Document donor availability and stem cell source

Document in the medical record that an HLA‑matched donor is available and specify the stem cell source (cord blood, bone marrow, or peripheral blood with donor unable/refusing bone marrow).

Documentation Required

Document transfusion dependence

Document that the member is transfusion‑dependent due to thalassemia.

Documentation Required

Document conditioning regimen

Document that a standard myeloablative conditioning regimen will be used.

Coding

Informational CPT codes related to allogeneic HCTCPT

38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic.
38240	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor

Informational HCPCS code covering comprehensive transplant servicesHCPCS

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 post-transplant care in the global definition

Background

Background: Allogeneic hematopoietic cell transplants (AHCT) are the only curative therapy for β‑thalassemia. Selection of candidates for AHCT is based on recipient and donor characteristics and evidence-based guidelines, with younger recipients generally having better outcomes and organ dysfunction from iron overload affecting suitability and outcomes.

Major risks: Important limitations and risks of AHCT include graft‑versus‑host disease, graft rejection, HCT‑related organ toxicities, and infertility/gonadal failure.

Evidence: Reports of HCT from HLA‑matched donors document overall survival and thalassemia‑free survival ranging approximately 65% to 90% across numerous studies.

Revision History

12/25material_revisionLatest

Updated title to Allogeneic Hematopoietic Cell Transplants for β-Thalassemia and removed information and criteria regarding sickle cell anemia; description updated to note absence of CMS coverage criteria and sourced criteria from expert panel and reviews (material).

08/24material_revision

Added clarifying language to Criteria I.A.1.b. regarding high risk of stroke and removed first-degree relative donor requirement for cord blood as the source of stem cells for homozygous β-thalassemia (material).

08/23