Allogeneic Hematopoietic Progenitor Cell Therapy
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Medical necessity criteria for use of Omisirge (omidubicel) and RegeneCyte (HPC Cord Blood) for non‑Medicare Centene-affiliated health plans; who may qualify and under what conditions.
RegeneCyte (HPC Cord Blood) criteria were added to the policy as Criteria II.
Criteria I updated to include severe aplastic anemia as a medically necessary indication for Omisirge.
Added note referring Medicare criteria to separate Medicare policy MC.CP.MP.249 and specified 'non‑Medicare' health plans.
Medical Necessity and Coverage Criteria
Medical necessity criteria — Omisirge and RegeneCyte
Covered when ALL of the following are met for each listed product-specific criteria:
Omisirge is FDA‑approved for this population and demonstrated faster neutrophil recovery (mean ~12 days) and fewer infections versus standard cord blood transplantation.
FDA approval and single‑arm study data support neutrophil engraftment and transfusion independence in most patients.
RegeneCyte (HPC Cord Blood) is indicated to support hematopoietic reconstitution; effectiveness demonstrated across clinical studies.
This policy applies to non‑Medicare Centene‑affiliated health plans. Medicare members should be referred to MC.CP.MP.249 for Medicare‑specific coverage criteria and operational requirements.
Inclusion or exclusion of codes in this policy does not by itself indicate coverage. Codes referenced are for informational purposes only; providers must consult current professional coding guidance before submitting claims and confirm that the requested services meet the policy's clinical medical necessity criteria.
Referenced Codes and Key Study Metrics
Prior Authorization, Documentation, and Denial Triggers
Prior Authorization Required
Prior authorization is required for Omisirge (omidubicel) and RegeneCyte. Submit supporting clinical documentation that demonstrates the member meets the applicable medical necessity criteria in this policy prior to administration.
- Prior authorization required for Omisirge and RegeneCyte
- Include indication, age, conditioning regimen, and planned transplant details
Provider Documentation Requirements
Providers must document and submit clinical records that clearly show the member meets the specific criteria for the requested product (age thresholds, diagnosis, planned conditioning regimen, and whether administration is post-myeloablative or following reduced intensity conditioning). Ensure documentation of the unrelated donor transplant plan for RegeneCyte and the single administration request for Omisirge when applicable.
- For Omisirge: age and indication (hematologic malignancy ≥ 12 years or severe aplastic anemia ≥ 6 years), planned umbilical cord blood transplantation, and conditioning type (post-myeloablative or reduced intensity as specified)
- For RegeneCyte: documentation of unrelated donor hematopoietic progenitor cell transplantation plan and appropriate preparative regimen
Coding and Billing Note
Coding guidance is informational and not a guarantee of coverage. Confirm current code updates before claim submission.
Denial Triggers
Claims may be denied if required criteria or documentation are missing or if the member does not meet age or indication requirements.
- Denial triggers include: member below policy age thresholds, indication not consistent with policy criteria, lack of documentation of transplant plan or preparative regimen, and requests for more than the single administration specified
- Inclusion or listing of codes in this policy does not guarantee coverage
Preparative Regimens and Use Context
| Regimen | Applicability / Notes |
|---|---|
| Reduced‑intensity preparative regimens | |
| Permitted when RegeneCyte or Omisirge is used in indications that specify reduced intensity conditioning (Omisirge coverage for severe aplastic anemia requires one administration following reduced intensity conditioning; RegeneCyte requires an appropriate preparative regimen — myeloablative or reduced intensity — in conjunction with unrelated donor transplantation). |
Indication / Line of Therapy Rules
Salvage
Policy ties use to transplantation procedures rather than general salvage therapy.
Key Definitions
Clinical and Product Background
Allogeneic hematopoietic cell transplantation (HCT) uses donor‑derived hematopoietic progenitor cells after a preparative regimen (myeloablative or reduced intensity) to restore hematopoiesis and immune function. Myeloablative conditioning is intended to ablate the recipient’s marrow, producing profound pancytopenia prior to donor cell infusion. Donor‑derived cord blood–based products (for example, Omisirge and RegeneCyte) are cellular therapies developed to accelerate hematopoietic recovery after transplantation and to reduce complications such as infection related to prolonged neutropenia. This policy defines the non‑Medicare medical necessity criteria under which these allogeneic hematopoietic progenitor cell therapies may be covered when used in conjunction with an appropriate preparative regimen and transplant procedure.
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