Allogeneic Hematopoietic Progenitor Cell Therapy (Omisirge, RegeneCyte)
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Medical necessity criteria and coverage guidance for allogeneic hematopoietic progenitor cell therapies (Omisirge/omidubicel and RegeneCyte/HPC cord blood) for non-Medicare plans administered by the health plan.
Added medically necessary criteria for RegeneCyte (HPC Cord Blood) as Criteria II.
Updated Criteria I to include severe aplastic anemia as a medically necessary indication for Omisirge.
Specified this policy applies to non-Medicare health plans and references a separate Medicare policy MC.CP.MP.249 for Medicare criteria.
Coverage Criteria
Omisirge (omidubicel) - Covered Indications
Omisirge is covered when ALL of the following applicable criteria are met for each indication group:
RegeneCyte (HPC Cord Blood) - Covered Indications
RegeneCyte is covered when ALL of the following are met:
This policy applies to non‑Medicare health plans administered by the plan. Medicare-specific criteria are not governed by this policy; providers must refer to MC.CP.MP.249 for Medicare members.
Use of Omisirge (omidubicel) or RegeneCyte outside the specified age ranges, outside the listed clinical indications, or when not paired with the required transplantation procedure and described preparative regimen is not supported by this policy. Such uses may be considered not medically necessary and are subject to denial if documentation does not demonstrate the required age, indication, transplant plan, and appropriate conditioning or preparative regimen.
Covered Preparative Regimens and Regimen Pairing
| Product / Context | Required conditioning / preparative regimen | Coverage note |
|---|---|---|
| RegeneCyte (HPC cord blood) — unrelated donor transplantation | ||
| An appropriate preparative regimen for hematopoietic and immunologic reconstitution must be used in conjunction with the unrelated donor hematopoietic progenitor cell transplantation procedure. | ||
| Covered when all RegeneCyte criteria are met (planned for unrelated donor transplantation plus appropriate preparative regimen and qualifying hematopoietic disorder). |
Line of Therapy / Salvage Use
salvage
Coding and Reimbursement
| No codes listed |
Provider Actions & Prior Authorization
Prior authorization required; allowable billing codes
Prior authorization is required for requests for Omisirge (omidubicel) or RegeneCyte and must include documentation that the clinical criteria in this policy are met. Claims may reference unclassified biologics/drugs codes J3590 or C9399 per coding guidance.
Include transplantation plan and preparative regimen in request
Confirm the transplantation plan and preparative regimen when submitting authorization: Omisirge requires a planned umbilical cord blood transplantation (post-myeloablative or reduced intensity conditioning as specified) and RegeneCyte requires a planned unrelated donor hematopoietic progenitor cell transplantation with an appropriate preparative regimen.
- For Omisirge — indicate whether the indication is hematologic malignancy (≥ 12 years; post‑myeloablative conditioning) or severe aplastic anemia (≥ 6 years; following reduced intensity conditioning).
- For RegeneCyte — document plan for unrelated donor transplantation and the preparative regimen for hematopoietic and immunologic reconstitution.
Required documentation to support authorization
Provide clinical documentation that supports the diagnosis, patient age, the planned transplantation type, and the conditioning/preparative regimen as applicable to the requested product.
- Diagnosis supporting use (hematologic malignancy or severe aplastic anemia, or other hematopoietic disorder for RegeneCyte).
- Patient age consistent with product criteria (Omisirge ≥ 12 years for malignancy; Omisirge ≥ 6 years for severe aplastic anemia).
- Planned umbilical cord blood transplantation for Omisirge or unrelated donor hematopoietic progenitor cell transplantation for RegeneCyte.
- Type of conditioning: myeloablative or reduced intensity as required by indication.
- If applicable, include intent for one administration post-conditioning (Omisirge).
- Include billing code intent (e.g., J3590 or C9399) for claims processing.
Denial triggers — missing age, indication, or transplant/regimen documentation
Requests lacking the specific age, indication, planned transplantation, or appropriate conditioning/preparative regimen required by this policy may be denied.
- Use outside the specified age ranges or indications is not supported and may be considered not medically necessary.
- Failure to document planned umbilical cord blood transplantation (Omisirge) or unrelated donor transplantation and preparative regimen (RegeneCyte) may trigger denial.
Background
Allogeneic hematopoietic cell transplantation (HCT) is used to treat hematologic malignancies and other disorders of the hematopoietic system by infusing stem/progenitor cells from related or unrelated donors following a preparative (myeloablative or reduced‑intensity) conditioning regimen. Conditioning induces pancytopenia and places patients at high risk for infection and other complications; therapies that accelerate neutrophil recovery may reduce infectious complications and healthcare utilization.
This policy defines medical necessity criteria for two allogeneic cord blood–derived hematopoietic progenitor cell products for non‑Medicare members: Omisirge (omidubicel) — indicated for use to accelerate neutrophil recovery when administered as a single post‑transplant administration in the specified age groups and transplant/conditioning contexts (hematologic malignancy after myeloablative conditioning, or severe aplastic anemia after reduced‑intensity conditioning) — and RegeneCyte (HPC Cord Blood) — indicated for planned unrelated donor hematopoietic progenitor cell transplantation when used with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with inherited, acquired, or treatment‑related hematopoietic disorders.
Definitions
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