Centene Allogeneic HCT Coverage Update

Coverage and Medical Necessity Criteria

Medical necessity — covered indications

Allogeneic hematopoietic cell transplant (HCT) is considered medically necessary when ONE of the following indication‑specific sets is met and there are no absolute contraindications.

ANY of the following

1. Sickle cell anemia
- Diagnosis of sickle cell anemia (e.g., HbSS)
- History of stroke, or is at high risk of stroke or end-organ damage demonstrated by at least one of the following: prior stroke, recurrent acute chest syndrome, recurrent vaso-occlusive crises, or clinically significant red blood cell alloimmunization on chronic transfusion therapy.
- An HLA‑matched, first‑degree relative donor is available.
2. Homozygous B‑thalassemia
- Diagnosis of homozygous B‑thalassemia that is transfusion‑dependent.
- An HLA‑matched donor is available.
- Acceptable stem cell sources
  - Cord blood as the source of stem cells.
  - Bone marrow as the source of stem cells.
  - Peripheral blood as the source of stem cells when the donor is unable or refuses to donate bone marrow.
- A standard myeloablative conditioning regimen will be used.
3. Other general requirements
- Transplant candidate evaluation supports transplant (cardiac, pulmonary, infectious disease, hepatic and other organ assessments satisfactory for transplant).
- No absolute contraindications present (see contraindications group).

Insufficient evidence / not covered contexts

The following situations are considered insufficient evidence for safety and efficacy or are not covered under this policy:

ALL of the following

Autologous hematopoietic cell transplant for sickle cell anemia when not performed in the context of an FDA‑approved or otherwise covered gene therapy approach is considered insufficient evidence / not supported by this policy.
Autologous hematopoietic cell transplant for B‑thalassemia when not performed in the context of an FDA‑approved or otherwise covered gene therapy approach is considered insufficient evidence / not supported by this policy.
Allogeneic hematopoietic cell transplant for sickle cell anemia or homozygous B‑thalassemia for indications other than those explicitly specified in the 'Medical necessity — covered indications' group is considered insufficient evidence / not supported by this policy.
Active substance use or dependence, including current tobacco use, vaping, non‑prescribed marijuana use, or IV drug use, without convincing evidence of risk‑reduction behaviors or documented commitment to cessation when required by transplant timelines, is typically a contraindication or results in insufficient evidence for coverage unless urgent transplant timelines justify a documented risk‑reduction plan.

Autologous hematopoietic cell transplant for sickle cell anemia or B‑thalassemia outside the context of gene therapy is considered insufficient evidence and is not covered by this policy. Allogeneic HCT for these conditions for indications other than those specifically listed in the Medical necessity — covered indications group is also considered insufficient evidence and not covered.

For Medicaid members/enrollees, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual for specific coverage rules and exceptions.

Autologous HCT for B‑thalassemia or sickle cell anemia performed outside the context of gene therapy lacks sufficient evidence of safety and effectiveness and is therefore not supported by this policy. Coverage for autologous approaches in these diseases may be considered only in the context of approved gene therapies or clinical trials per applicable benefit provisions.

Candidate Selection and Contraindications

Absolute Contraindications

Absolute contraindications to transplantation include situations that preclude a successful transplant course despite supports. Examples specified in the policy are: inability to adhere to the transplant regimen even with caregiver support; infections with highly virulent or resistant organisms that are poorly controlled pre‑transplant; and active substance use or dependence (including current tobacco use, vaping, marijuana use unless prescribed, or IV drug use) without convincing evidence of risk‑reduction behaviors, except in urgent transplant timelines where documented commitment to behavior reduction may be acceptable.

Preauthorization Evaluation and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for all allogeneic hematopoietic cell transplants (AHCT) for sickle cell anemia and homozygous B‑thalassemia. Submit requests to the payer before scheduling the procedure and include the procedure and facility codes. Requests that lack required documentation or that do not meet coverage criteria will be denied.

Prior authorization required — include transplant procedure and facility codes (e.g., CPT/HCPCS and appropriate revenue codes)
Coverage alignment: AHCT is covered only when the medical‑necessity criteria in this policy are fully met (see Policy/Criteria section)
Denial triggers: missing prior authorization; absence of documentation of indication‑specific history (stroke, recurrent acute chest syndrome, recurrent vaso‑occlusive crises, transfusion dependence, red blood cell alloimmunization), lack of documented HLA‑matched donor availability (or specified cord blood/source per criteria), failure to confirm planned myeloablative conditioning when required, or presence of absolute contraindications (e.g., uncontrolled virulent/resistant infection, inability to adhere to transplant regimen)
Required documentation: complete clinical evaluation that documents indication‑specific history (e.g., prior stroke, recurrent acute chest syndrome, recurrent vaso‑occlusive crises, red blood cell alloimmunization), donor availability and type (HLA match status, related/unrelated, cord blood vs bone marrow vs peripheral blood), transplant source and planned conditioning regimen, evidence of transfusion dependence for thalassemia cases, results of pretransplant assessments (infectious disease screening, organ function evaluation, psychosocial/caregiver support assessment), and plan for post‑transplant follow‑up

Provider Requirements, Prior Authorization, and Denial Risks

Prior Authorization

Prior authorization required; referenced CPT/HCPCS codes listed

Prior authorization is required and must demonstrate medical necessity per the policy's listed criteria; the policy informationally lists CPT and HCPCS codes relevant to transplantation (38205, 38240, S2150).

Submit supporting clinical documentation demonstrating that the member meets indication-specific medical necessity criteria.
Reference informative procedure codes as needed: CPT 38205, CPT 38240, HCPCS S2150.

Prior Authorization

Follow Medicare/Medicaid and Health Plan coverage and administrative requirements

When requesting coverage, providers must follow applicable Medicare and Medicaid coverage requirements and any Health Plan administrative policies, including review of NCDs/LCDs where applicable.

Review applicable NCDs, LCDs, and Medicare Coverage Articles for Medicare members.
Follow Health Plan administrative policies and state Medicaid manual provisions where applicable.

Procedure and Billing Codes

Referenced CPT CodesCPT

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

Referenced HCPCS CodesHCPCS

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.

Reported pediatric HCT outcomes

Reported pediatric HCT success rate85-90% pediatric success rate reported for specific groups with sickle cell disease

Three-year survival (survey data)~90% three-year survival reported regardless of stem cell source

Estimated eligible children in U.S.5,000–7,000 of 70,000–100,000 children with homozygous sickle cell anemia may be eligible for transplantation

Center and Program Requirements

Note

Center requirements: coding referenced; no explicit accreditation requirement specified here

The policy references standard transplantation coding and programmatic practices but does not specify explicit center accreditation requirements (e.g., FACT) within this document window.

Use standard transplant coding (e.g., CPT 38205, 38240; HCPCS S2150) and follow programmatic best practices; verify any plan-level center requirements separately.

Post-Transplant Coverage and Bundled Services

Transplant bundle (HCPCS S2150)

HCPCS S2150 descriptionBone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; includes 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

Scope of bundled servicesIncludes harvesting, transplantation, management of related complications, and defined pre- and posttransplant care days as part of the global bundle

Policy referencePolicy references S2150 for informational purposes when describing bundled transplant services

Definitions

Homozygous B‑thalassemia (definition & clinical summary)

DefinitionAutosomal recessive hemoglobinopathy (Cooley's anemia) caused by mutations reducing B-globin synthesis leading to ineffective erythropoiesis and severe, transfusion-dependent anemia

PathophysiologyMutations (over 200 described) decrease B-globin production causing toxic a-globin aggregates and destruction of erythroid precursors (ineffective erythropoiesis)

Clinical featuresPresents with severe anemia, transfusion dependence, iron overload risk, and end-organ complications; overall survival and thalassemia-free survival post-HCT reported 65–90% depending on reports

Sickle cell anemia (definition & clinical summary)

DefinitionStructural hemoglobinopathy caused by a B-globin substitution (Glu6Val) producing deoxygenated hemoglobin polymerization and sickling of red blood cells

Pathophysiology

Background and Clinical Context

Sickle cell anemia and homozygous B‑thalassemia are monogenic hemoglobinopathies that cause chronic hemolytic anemia and end‑organ complications. Sickle cell anemia results from a beta‑globin amino acid substitution leading to hemoglobin polymerization and vaso‑occlusion; homozygous B‑thalassemia (Cooley’s anemia) results from mutations that reduce beta‑globin synthesis producing ineffective erythropoiesis and transfusion dependence. Allogeneic HCT is identified in the literature and in this policy as the only curative option for these disorders; outcomes vary based on recipient age, donor match, conditioning regimen, iron overload in thalassemia, and history of cerebral events in sickle cell disease.

OpenPayer

Allogeneic Hematopoietic Cell Transplants for Sickle Cell Anemia and B-Thalassemia

Coverage and Medical Necessity Criteria

Candidate Selection and Contraindications

Absolute Contraindications

Preauthorization Evaluation and Documentation Requirements

Provider Requirements, Prior Authorization, and Denial Risks

Procedure and Billing Codes

Center and Program Requirements

Post-Transplant Coverage and Bundled Services

Definitions

Background and Clinical Context