Allogeneic Hematopoietic Cell Transplants for Sickle Cell Anemia and B-Thalassemia
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Medical necessity criteria and coverage stance for allogeneic hematopoietic cell transplantation (HCT) to treat sickle cell anemia and homozygous B-thalassemia for Centene-affiliated health plans; intended for clinicians and prior authorization staff.
Removed age limit criteria related to high risk of stroke and removed first-degree relative donor requirement for cord blood as the source of stem cells.
Added notes referencing related products (Zynteglo and Casgevy) and Medicare-specific criteria reference.
Coverage Criteria
Initial transplant coverage criteria
Covered when ALL of the following are met for specific indications:
See indication-specific nodes below.
Policy language was revised to remove a prior age limit for high stroke risk; younger recipients generally have better outcomes.
Requirement that cord blood donor be a first-degree relative was removed in the latest revision.
Autologous hematopoietic cell transplant (AHCT) for sickle cell anemia performed outside the context of gene therapy is considered to have insufficient evidence regarding safety and efficacy and is not covered under this policy.
Allogeneic hematopoietic cell transplant (allo-HCT) for sickle cell anemia or homozygous B-thalassemia when requested for indications other than those explicitly specified in this policy are considered unsupported by the available evidence and risk denial.
When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid provisions take precedence. Providers and reviewers should follow the applicable state Medicaid manual and any state-specific coverage rules in place for these services.
Autologous hematopoietic cell transplant (AHCT) for B-thalassemia performed outside the context of gene therapy is considered to have insufficient evidence regarding safety and efficacy and is not medically necessary under this policy. This same determination applies to AHCT for sickle cell anemia when not part of a gene therapy approach.
Coding and Related Metrics
| 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. |
Provider Actions and Requirements
Prior authorization required for listed transplant procedure codes
Prior authorization is required for claims using the referenced transplant procedure codes; providers must supply documentation demonstrating that the authorization criteria are met when submitting claims for CPT 38205, CPT 38240, or HCPCS S2150.
Confirm applicability of prior authorization with state/Medicare rules
Determine whether prior authorization applies per this clinical policy and in accordance with applicable state Medicaid or Medicare coverage determinations before proceeding.
- Review state Medicaid manual if member is enrolled in Medicaid
- Review Medicare NCDs, LCDs, and Coverage Articles for Medicare members
Step therapy not described
No step therapy requirements are described in this policy for allogeneic hematopoietic cell transplantation for sickle cell anemia or homozygous B-thalassemia.
Operational highlights and recent revisions
Note operational updates from the policy: age limit and certain donor-source restrictions were removed and criteria verbiage was reformatted; providers should follow the current criteria language when preparing authorization requests.
- Removed age limit related to stroke risk and removed first-degree relative donor requirement for cord blood
- Policy language and notes were reformatted during the latest annual review
Clinical criteria must be documented for indicated diagnosis
Documentation submitted for authorization must demonstrate that all listed medical necessity criteria for the specific indication (sickle cell anemia or homozygous B-thalassemia) are met, including donor match/source, planned conditioning regimen, transfusion dependence where specified, and absence of absolute contraindications.
- Evidence of HLA-matched donor or specified stem cell source per indication
- Planned use of a standard myeloablative conditioning regimen when required
- Clinical history demonstrating the listed disease-specific criteria (e.g., prior stroke, recurrent acute chest syndrome, transfusion dependence)
Policy developed by licensed clinicians; not a payment guarantee
This clinical policy was developed by appropriately experienced and licensed health care professionals based on literature, guidelines, and specialist review; it does not guarantee payment and coverage remains subject to the member's benefit documents and applicable administrative policies.
- Coverage decisions are subject to evidence of coverage, policy terms, exclusions, and limitations
- Health plan may change or withdraw the clinical policy; check plan-level administrative policies
Unsupported transplant types/indications risk denial
Requests for autologous HCT for sickle cell anemia or B-thalassemia outside the context of gene therapy, and allogeneic HCT for indications other than those specified in this policy, are considered unsupported and risk denial.
- Autologous HCT for these conditions is considered insufficient evidence unless performed in the context of gene therapy
- Allogeneic HCT requests for other indications than those listed in policy are not supported
Follow state Medicaid and Medicare coverage rules when applicable
When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid provisions take precedence; for Medicare members, review and apply all applicable NCDs, LCDs, and Medicare Coverage Articles.
- Refer to the state Medicaid manual for Medicaid enrollee coverage rules
- Refer to CMS website and applicable Medicare coverage determinations for Medicare members
Candidate Selection Criteria
Candidate selection
Candidate requirements described in policy criteria sections for each disease:
Absolute contraindications include inability to adhere to the required regimen even with caregiver support; uncontrolled infections with highly virulent or resistant microbes that are poorly controlled pre-transplant; and active substance use or dependence (including current tobacco/vaping/marijuana/IV use) without convincing evidence of risk-reduction behaviors unless urgent transplant timelines justify conditional acceptance.
Clinical documentation must demonstrate all listed medical necessity criteria are met.
Contraindications
Absolute contraindications include the following: inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support; infections with highly virulent and/or resistant microbes that are poorly controlled pre-transplant; and active substance use or dependence (including current tobacco use, vaping, nonprescribed marijuana, or IV drug use) without convincing evidence of risk-reduction behaviors unless urgent transplant timelines justify conditional acceptance with a commitment to risk-reduction.
Pre-Transplant Evaluation Requirements
Evaluation must document donor/source, transfusion status, and conditioning plan
Pre-transplant evaluation documentation must include donor HLA match and source, evidence of transfusion dependence for thalassemia where required, the planned conditioning regimen (standard myeloablative when specified), and documentation that listed absolute contraindications are absent.
- Donor HLA match/source (cord blood, bone marrow, or peripheral blood as specified)
- Transfusion dependence documentation for thalassemia candidates
- Planned conditioning regimen description
Transplant Center Requirements
No FACT-accreditation or minimum volume requirements stated here
The policy does not list explicit FACT-accreditation or volume requirements for transplant centers in this document portion; providers should follow any separate plan- or state-specific center requirements.
Post-Transplant Coverage
Background
Sickle cell anemia and B-thalassemia are monogenic hemoglobinopathies that cause structural or quantitative defects in hemoglobin, leading to hemolytic anemia, vaso-occlusion, progressive organ damage, and reduced quality of life. Hematopoietic cell transplantation (HCT) is recognized as the only curative therapy for sickle cell disease and is a potential curative option for transfusion-dependent homozygous B-thalassemia; outcomes and candidacy depend on disease features (for example, history of stroke or transfusion dependence), donor availability, and transplant-related risks. Data suggest younger recipients have better outcomes following HCT.
Definitions
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