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Allogeneic Hematopoietic Progenitor Cell Therapy
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Defines medical necessity criteria for non-Medicare Ambetter Georgia plans for two FDA‑approved allogeneic hematopoietic progenitor cell therapies (Omisirge/omidubicel and RegeneCyte/HPC cord blood) and summarizes background, evidence, and coding implications. Affects providers requesting coverage for these therapies for eligible members/enrollees.
Added medically necessary indication for Omisirge for severe aplastic anemia (patients age ≥ 6 years) following reduced intensity conditioning.
Added Criteria II to include medically necessary criteria for RegeneCyte (unrelated donor HPC cord blood transplantation).
Expanded policy description to include RegeneCyte in addition to Omisirge and removed Omisirge-specific title language.
Coverage Criteria
Omisirge medical necessity
Omisirge (omidubicel) is medically necessary for non‑Medicare plans affiliated with Centene when ONE of the following indication-specific groups is met.
Supports faster neutrophil recovery (median ~12 days) and fewer infections vs umbilical cord blood transplantation per randomized study (n=125).
Based on single‑arm study in patients ≥6 years showing early and sustained neutrophil engraftment and transfusion independence.
RegeneCyte medical necessity
RegeneCyte (HPC, cord blood) is medically necessary for non‑Medicare plans affiliated with Centene when ALL of the following are met:
Effectiveness and expected engraftment outcomes are supported by COBLT and other datasets (median neutrophil recovery reported ~22–27 days in cord blood cohorts).
This policy applies to non‑Medicare health plans affiliated with Centene. Medicare‑specific medical necessity criteria are maintained separately; see the Medicare cross‑reference policy MC.CP.MP.249 for coverage rules applicable to Medicare beneficiaries.
Coding and code lists included in this policy are for informational purposes only. Inclusion or exclusion of any code does not guarantee coverage; providers must follow current professional coding guidance and the payer’s coverage determinations. Statements in this policy describing covered services, limitations, or medical necessity criteria guide coverage decisions but do not by themselves constitute a guarantee of payment.
Coding and Billing
Provider Actions and Prior Authorization
Obtain prior authorization with supporting clinical documentation
Prior authorization is required for requests and must be supported by clinical documentation that demonstrates the product‑specific medical necessity criteria (age, diagnosis, planned transplant type, and conditioning regimen). Billing codes referenced in the policy include J3590 (Unclassified biologics) and C9399 (Unclassified drugs or biologicals).
- Show member age and qualifying diagnosis (hematologic malignancy or severe aplastic anemia for Omisirge; disorder affecting the hematopoietic system for RegeneCyte).
- Document planned transplant type (umbilical cord blood transplantation for Omisirge; unrelated donor HPC transplantation for RegeneCyte).
- Document preparative/conditioning regimen type (myeloablative for Omisirge hematologic malignancy indication; reduced intensity for Omisirge severe aplastic anemia; appropriate preparative regimen for RegeneCyte).
Use the policy as a medical‑necessity guide (does not guarantee payment)
This clinical policy is a guide to medical necessity used to assist in making coverage decisions and administering benefits; it does not constitute a contract or guarantee of payment and specific prior authorization procedures or timelines are determined by the Health Plan.
- Coverage decisions and benefit administration remain subject to plan terms, state/federal requirements, and Health Plan‑level administrative policies.
- The policy effective date is determined by the Health Plan and may differ from the posting date.
Provider responsibility and professional judgment
Providers must exercise professional medical judgment when making treatment decisions and are responsible for submitting claims for services; the policy does not dictate clinical care.
- Providers are independent contractors and are responsible for medical advice and treatment of members.
- Submitting a claim implies agreement to be bound by the terms and conditions of this policy where a contracting relationship exists.
Follow plan authorization pathways and coding guidance
Providers should follow Health Plan prior authorization processes and coding guidance when submitting requests and claims; the policy’s inclusion of codes is informational and does not guarantee coverage.
- Reference the most up‑to‑date professional coding guidance prior to claim submission.
- Plan‑level administrative policies and procedures govern authorization and billing details.
Required documentation to support medical necessity
Document submission must demonstrate member age, specific diagnosis, planned transplant type, and the preparative/conditioning regimen to support medical necessity under the criteria.
- Age evidence: ≥12 years for Omisirge when treating hematologic malignancy; ≥6 years for Omisirge when treating severe aplastic anemia.
- Diagnosis: hematologic malignancy or severe aplastic anemia for Omisirge; disorder affecting the hematopoietic system for RegeneCyte.
- Transplant plan: umbilical cord blood transplantation for Omisirge; unrelated donor HPC transplantation for RegeneCyte.
- Conditioning/preparative regimen: myeloablative conditioning for Omisirge hematologic malignancy indication; reduced intensity conditioning for Omisirge severe aplastic anemia; appropriate preparative regimen for RegeneCyte.
Provider expectations: clinical judgment and claims submission
Providers are expected to exercise professional medical judgment in providing care and must submit claims for services; the policy is a guide to medical necessity and does not replace clinical decision‑making.
- The policy is not intended to dictate how providers practice medicine; providers remain solely responsible for member care.
- The Health Plan may change, amend, or withdraw the clinical policy and additional administrative policies may apply.
Denial risk if submitted criteria are not met
Requests that fail to meet the stated age thresholds, indication‑specific transplant plan, or conditioning regimen requirements are likely to be denied.
- Example triggers: Omisirge requested for hematologic malignancy in a patient younger than 12 years; Omisirge requested after non‑myeloablative conditioning when myeloablative conditioning is required for that indication; product requested for an indication not listed in the criteria.
Medicaid precedence: follow state Medicaid provisions
For Medicaid members, applicable state Medicaid coverage provisions take precedence over this clinical policy; failure to adhere to state Medicaid requirements may result in denial.
- Refer to the state Medicaid manual for relevant coverage provisions that override this policy when conflicts exist.
Covered Regimens and Administration
| Regimen | Indication / eligibility | Notes | Coverage status |
|---|---|---|---|
| Single administration of Omisirge (omidubicel) given post‑myeloablative conditioning in conjunction with planned umbilical cord blood transplantation | Hematologic malignancies; member/enrollee ≥ 12 years of age; planned for umbilical cord blood transplantation following myeloablative conditioning; request is for one administration post‑myeloablative conditioning | Intended to reduce time to neutrophil recovery and incidence of infection; pivotal randomized data support faster neutrophil recovery (median ~12 days) compared with conventional cord blood cohorts | Covered with criteria |
| Regimen | Indication / eligibility | Notes | Coverage status |
|---|---|---|---|
| Single administration of Omisirge (omidubicel) given following reduced intensity conditioning | Severe aplastic anemia; member/enrollee ≥ 6 years of age; request is for one administration following reduced intensity conditioning | Effectiveness based on single‑arm study showing early and sustained neutrophil engraftment (median neutrophil recovery ~11 days in study cohort) and high rates of transfusion independence | Covered with criteria |
| Regimen | Indication / eligibility | Notes | Coverage status |
|---|---|---|---|
| Use of RegeneCyte (HPC, cord blood) in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution as part of an unrelated donor hematopoietic progenitor cell transplantation procedure | Member/enrollee planned for unrelated donor hematopoietic progenitor cell transplantation; has a disorder affecting the hematopoietic system that is inherited, acquired, or resulting from myeloablative treatment; appropriate preparative regimen will be used with the transplantation procedure | RegeneCyte is FDA‑approved for unrelated donor HPC transplantation; clinical datasets (COBLT and others) report median time to neutrophil recovery in cord blood cohorts approximately 22–27 days | Covered with criteria |
Line of Therapy
Salvage
Intended for use post‑conditioning (myeloablative for Omisirge hematologic malignancy indication; reduced intensity for Omisirge severe aplastic anemia) or with an appropriate preparative regimen for RegeneCyte.
Definitions
Background and Clinical Context
Allogeneic hematopoietic cell transplantation (HCT) uses hematopoietic progenitor cells from related or unrelated donors to reconstitute hematopoiesis following a preparative conditioning regimen. Donor sources include umbilical cord blood–derived products and unrelated donor hematopoietic progenitor cells. Conditioning regimens range from myeloablative approaches, intended to ablate marrow hematopoiesis, to reduced‑intensity regimens; the chosen regimen determines the degree of marrow ablation and influences engraftment timing and infection risk. The therapies discussed in this policy (Omisirge/omidubicel and RegeneCyte/HPC cord blood) are used as part of the transplant procedure to promote hematopoietic and immunologic reconstitution after conditioning.
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