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 Ambetter Nevada plans.
Criteria for RegeneCyte (HPC Cord Blood) were added as a medically necessary indication.
Omisirge criteria were updated to include severe aplastic anemia as a medically necessary indication.
Policy clarifies it applies to non‑Medicare health plans and references a separate Medicare policy (MC.CP.MP.249).
Medical Necessity and Coverage Criteria
inv-01: Omisirge (omidubicel) Medical Necessity
Omisirge (omidubicel) — covered when ONE of the following groups of criteria is met:
Supports use after myeloablative conditioning to speed neutrophil recovery and reduce infection risk.
Indication based on FDA approval for severe aplastic anemia when a compatible donor is not available.
inv-02: RegeneCyte (HPC Cord Blood) Medical Necessity
RegeneCyte (HPC Cord Blood) — covered when ALL of the following are met:
Intended for unrelated donor HPC transplantation in hematopoietic disorders per FDA approval and supporting studies.
This policy applies to non‑Medicare health plans affiliated with Centene Corporation. Medicare members and requests that fall under Medicare coverage rules should be reviewed against the separate Medicare policy MC.CP.MP.249.
Uses that are not within the specified indications, age ranges, conditioning contexts, or that do not accompany an appropriate transplant or preparative regimen are not supported by this policy and may be considered not medically necessary. Examples include requests for Omisirge or RegeneCyte outside the listed diagnoses or ages, administration that does not follow the specified myeloablative or reduced intensity conditioning context, or use without an appropriate preparative regimen for hematopoietic and immunologic reconstitution.
| Product / Indication | Required preparative regimen / conditioning | Key coverage details |
|---|---|---|
| RegeneCyte (HPC Cord Blood) — disorders affecting the hematopoietic system | ||
| An appropriate preparative regimen for hematopoietic and immunologic reconstitution will be used in conjunction with the unrelated donor hematopoietic progenitor cell transplantation | ||
| Member is planned for an unrelated donor hematopoietic progenitor cell transplantation; product is for inherited, acquired, or myeloablative‑treatment‑related hematopoietic disorders |
Billing and Coding Information
Prior Authorization, Documentation, and Billing Actions
Prior Authorization Required
Prior authorization is required. Requests must include clinical indication, patient age, planned transplant type, and conditioning regimen. Authorization is for a single administration timed to the specified conditioning (post-myeloablative for hematologic malignancies; following reduced-intensity conditioning for severe aplastic anemia).
- Prior authorization required prior to administration
- Authorization applies to one administration per policy indications
Required Clinical Documentation
Medical records must document the diagnosis, patient age, planned transplant (umbilical cord blood or unrelated donor hematopoietic progenitor cell transplantation), the conditioning/preparative regimen (myeloablative or reduced-intensity as applicable), and clinical notes supporting the indication and timing of administration.
- Document diagnosis and age
- Document planned transplant type and conditioning regimen
- Document timing that administration will occur post-conditioning
Billing/Coding Guidance
Billing may use unclassified codes when no specific product code is available. Use J3590 (Unclassified biologics) or C9399 (Unclassified drugs or biologicals) as appropriate and include supporting documentation linking the billed code to the authorized therapy and administration date.
Denial Risk / Exclusion Actions
Requests that do not meet the age thresholds, specified indications, single-administration timing, or appropriate conditioning/preparative regimen may be denied. Failure to provide the required documentation (diagnosis, age, transplant plan, conditioning regimen, administration timing) increases risk of claim denial.
- Noncompliance with age or indication criteria may result in denial
- Missing or incomplete documentation is a common denial reason
Provider Action Highlight
Providers: ensure prior authorization is obtained and all required documentation (diagnosis, age, transplant plan, conditioning regimen, and timing) is included with the request and retained to support claims.
- Obtain prior authorization before administration
- Include required clinical documentation with the request and claims
Therapy Line and Salvage Indications
inv-13: salvage
Use in the transplant context (salvage):
Not specified by line number; intended as part of the transplant strategy for eligible patients.
Clinical Background and Context
Allogeneic hematopoietic cell transplantation is an established treatment approach for hematologic malignancies and other disorders of the hematopoietic system. Conditioning regimens given before donor cell infusion are categorized by intensity; myeloablative conditioning (MAC) is a preparative regimen expected to destroy marrow hematopoietic cells and cause extensive, typically irreversible pancytopenia. These regimens create profound cytopenias and infection risk in the weeks following conditioning, so strategies that accelerate neutrophil recovery after transplant can reduce infectious complications and associated resource use. This policy addresses two donor‑derived therapeutic products—Omisirge (omidubicel) and RegeneCyte (HPC cord blood)—that are intended to be used in conjunction with planned umbilical cord blood or unrelated donor hematopoietic progenitor cell transplantation and appropriate preparative regimens to support hematopoietic reconstitution.
Key Definitions
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