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    v1.0.28
    OpenPayerPolicy UpdatesHematology/OncologyCommunity Health Plan Washington AHCT Coverage Upd…
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    CurrentCommunity Health Plan WashingtonPolicy MC.CP.MP.108

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

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    Medical necessity criteria and coverage guidance for AHCT in members with sickle cell anemia or homozygous β-thalassemia, intended for Medicare health plans affiliated with Centene (affects providers requesting transplant authorization).

    Policy Summary
    PayerCommunity Health Plan Washington
    PolicyAllogeneic Hematopoietic Cell Transplants for Sickle Cell Anemia and β -Thalassemia
    Policy CodePolicy MC.CP.MP.108
    Change TypeClarified, Revised, Removed
    Effective Date
    Next Review Date
    Key ActionSubmit prior authorization with documentation demonstrating indication, donor availability/match status, and planned conditioning regimen.
    SourceLink
    POLICY UPDATE CHANGES

    Added clarifying language to Criteria I.A.1.b. regarding high risk of stroke.

    Removed first-degree relative donor requirement for cord blood as the source of stem cells for homozygous β-thalassemia in Criteria I.A.2.a.i.

    Removed Criteria I.A.2.d. regarding provider specializing in treating thalassemia.

    Updated verbiage in Note under Criteria I.B. for clarity.

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    85-90%pediatric HCT success
    ≈90%three-year survival
    65-90%overall survival range
    38205,38240,S2150informational codes

    Medical Necessity and Coverage Criteria

    Initial Transplant Eligibility

    Covered when ALL of the following are met for Medicare health plans affiliated with Centene:

    Top-level

    • Indication A

      • Sickle cell anemia indication

        • Donor: HLA-matched, first-degree relative donor is available

          HLA-matched first-degree relative required for sickle cell per policy

        • High stroke risk or end-organ damage: History of stroke or is at high risk of stroke or end-organ damage evidenced by at least one: prior stroke, recurrent acute chest syndrome, recurrent vaso-occlusive crises, or red blood cell alloimmunization on chronic transfusion therapy
      • Homozygous β-thalassemia indication

        • Donor and stem cell source: HLA-matched donor is available AND one of: cord blood is the source of stem cells, bone marrow is the source of stem cells, or peripheral blood is the source when the donor is unable or refuses bone marrow donation
        • Transfusion dependence: Member is transfusion-dependent due to thalassemia
        • Conditioning regimen: A standard, myeloablative conditioning regimen will be used
    • Contraindications

      • Absolute contraindications list: Infections with highly virulent and/or resistant microbes that are poorly controlled pre-transplant; inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support
    Note: Younger recipients generally have better outcomes following AHCT than older recipients according to cited data

    Insufficient Evidence / Not Covered

    Not enough evidence to support routine coverage:

    Exclusion statement: Autologous hematopoietic cell transplant for sickle cell anemia and for β-thalassemia are considered to have insufficient evidence and are not covered under this policy

    Autologous hematopoietic cell transplant (AHCT) for sickle cell anemia and for β-thalassemia is considered to have insufficient evidence regarding safety and efficacy to support routine coverage under this policy. The policy explicitly lists both indications—autologous HCT for sickle cell anemia and autologous HCT for β-thalassemia—as not supported by current evidence and therefore not covered as standard therapy.

    AHCT is not medically necessary when any absolute contraindication is present. Examples of absolute contraindications named in the policy include: uncontrolled infections with highly virulent and/or resistant microbes that are poorly controlled before transplant, and an inability of the member to adhere to the post‑transplant regimen even with caregiver support. Presence of these conditions would normally lead to denial of transplant as medically unnecessary.

    Conditioning Regimens and Transplant Approaches

    Regimen componentRequirement / description
    A standard, myeloablative conditioning regimen is required for transplants to treat homozygous β-thalassemia (ablative conditioning).
    Myeloablative (ablative) conditioning is necessary given major risk factors for β-thalassemia such as iron-overload related organ dysfunction; control of iron overload and organ damage is a significant consideration prior to transplant.
    Regimen componentRequirement / description
    Reduced-intensity conditioning (nonmyeloablative/reduced-intensity) may be appropriate for sickle cell anemia to induce stable mixed chimerism and full donor erythropoiesis.
    Reduced-intensity regimens can achieve stable chimerism in sickle cell patients; major transplant risk factors include age and history of cerebral events, and conditioning choice balances cure of chronic inflammation and prevention of organ damage against toxicity.

    Procedure Codes and Reported Metrics

    Informational procedure codesCPT | HCPCS
    38205Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic.
    38240Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor.
    S2150Bone 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.
    Reported pediatric HCT outcomes
    Reported pediatric HCT success rate85–90% success rate reported for specific pediatric groups
    Three‑year survival after HCTApproximately 90% three‑year survival reported (survey data)
    Overall survival range in thalassemia reportsOverall survival and thalassemia‑free survival range ~65–90% across reports

    Authorization, Documentation, and Provider Requirements

    Prior Authorization

    Prior authorization required; submit evidence meeting policy criteria

    Prior authorization is required for allogeneic hematopoietic cell transplant (AHCT). Submit a prior authorization request that includes evidence demonstrating the member meets the policy's medical necessity criteria for AHCT (indication, donor availability/source, conditioning plan, and absence of absolute contraindications). Providers may reference the listed informational procedure codes when preparing the request: 38205, 38240, S2150.

    • Include documentation that shows the specific indication (sickle cell anemia or homozygous β-thalassemia) and that all policy criteria for that indication are met.
    • List donor type and HLA-match status and planned stem cell source (cord blood, bone marrow, or peripheral blood as applicable).
    • Provide the planned conditioning regimen (standard myeloablative for thalassemia; reduced-intensity when appropriate for sickle cell per clinical guidance) and confirmation that no absolute contraindications exist.
    Step Therapy

    No step therapy required — coverage based on eligibility criteria

    Disease Definitions

    Homozygous β‑thalassemia — definition and clinical features
    Definitionβ‑thalassemia major (homozygous β‑thalassemia; Cooley’s anemia) caused by autosomal mutations in the β‑globin gene leading to deficient β‑globin synthesis
    PathophysiologyIneffective erythropoiesis with toxic α‑globin aggregates destroying erythroid precursors and shortened red cell survival (hemolytic anemia)
    Clinical featuresTransfusion‑dependence and iron‑overload–related organ dysfunction; risk of multi‑organ injury from chronic anemia and ineffective erythropoiesis
    Sickle cell anemia — definition and clinical features
    DefinitionSickle cell anemia caused by homozygous Glu6Val (β‑globin) mutation producing sickled red cells
    PathophysiologyDeoxygenated hemoglobin polymerizes, producing rigid, sickled erythrocytes that occlude microvasculature and cause chronic hemolytic anemia

    Clinical Background and Rationale

    Sickle cell anemia and homozygous β-thalassemia are monogenic hemoglobinopathies for which allogeneic hematopoietic cell transplant (AHCT) is the only established curative option. These disorders cause chronic hemolytic anemia and progressive end‑organ injury; selection of transplant candidates balances the potential for durable cure against substantial risks such as graft rejection, graft‑versus‑host disease, infection, organ toxicities, and infertility. The policy notes that younger recipients generally have better post‑transplant outcomes than older recipients, and that disorder‑specific considerations (donor availability, stem cell source, and conditioning regimen) influence eligibility and planning for AHCT.

    Policy Summary
    PayerCommunity Health Plan Washington
    PolicyAllogeneic Hematopoietic Cell Transplants for Sickle Cell Anemia and β -Thalassemia
    Policy CodePolicy MC.CP.MP.108
    Change TypeClarified, Revised, Removed
    Effective Date
    Next Review Date
    Key ActionSubmit prior authorization with documentation demonstrating indication, donor availability/match status, and planned conditioning regimen.
    SourceLink
    On This Page
    Medical Necessity and Coverage CriteriaConditioning Regimens and Transplant ApproachesProcedure Codes and Reported MetricsAuthorization, Documentation, and Provider RequirementsDisease DefinitionsClinical Background and Rationale

    No step therapy sequence is specified for AHCT under this policy; coverage decisions are based on whether the member meets the transplant eligibility criteria rather than trials of other therapies.

    Documentation Required

    Required clinical documentation for AHCT authorization

    Documentation submitted for authorization must demonstrate the clinical indication, donor availability and HLA-match or cord blood source, relevant disease history supporting high-risk status or transfusion dependence, and the planned conditioning regimen.

    • For sickle cell anemia: evidence of HLA-matched, first-degree relative donor and history of prior stroke or high risk of stroke/end-organ damage (prior stroke, recurrent acute chest syndrome, recurrent vaso-occlusive crises, or RBC alloimmunization on chronic transfusion therapy).
    • For homozygous β-thalassemia: evidence the member is transfusion-dependent, an HLA-matched donor is available and the stem cell source (cord blood, bone marrow, or peripheral blood), and that a standard myeloablative conditioning regimen will be used.
    Denial Risk

    Absolute contraindications — will make AHCT not medically necessary

    Presence of any absolute contraindication listed in the policy renders AHCT not medically necessary and will result in denial of authorization.

    • Infections with highly virulent and/or resistant microbes that are poorly controlled pre-transplant.
    • Inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support.
    Clinical featuresRecurrent vaso‑occlusive pain crises, acute chest syndrome, increased stroke risk, multi‑organ injury, reduced quality of life and shortened lifespan