Allogeneic Hematopoietic Progenitor Cell Therapy
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Medical necessity criteria for non‑Medicare Centene-affiliated health plans for allogeneic hematopoietic progenitor cell therapies including Omisirge (omidubicel) and RegeneCyte (HPC Cord Blood), and guidance for patient selection and coding.
RegeneCyte (HPC Cord Blood) criteria (Criteria II) were added to the policy.
Removed Omisirge-specific language from the policy title and broadened policy description to include multiple allogeneic HPC products.
Added note to refer to Medicare-specific policy MC.CP.MP.249 for Medicare criteria.
Medical Necessity Criteria
Omisirge (omidubicel) — Initial coverage
Covered when ALL of the following are met
ALL of the following
- Age: Member/enrollee is >= 12 years of age
- Diagnosis of hematologic malignancies
- Planned transplant: Member/enrollee is planned for an umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection
- Administration: Request is for one administration post-myeloablative conditioning
RegeneCyte (HPC Cord Blood) — Initial coverage
Covered when ALL of the following are met
ALL of the following
- Planned transplant: Member/enrollee is planned for an unrelated donor hematopoietic progenitor cell transplantation procedure
- Preparative regimen: An appropriate preparative regimen for hematopoietic and immunologic reconstitution will be used in conjunction with the transplantation procedure
- Indication: Member/enrollee has a disorder affecting the hematopoietic system that is inherited, acquired, or resulting from myeloablative treatment
These medical necessity criteria apply to Centene-affiliated non‑Medicare health plans only. Medicare plan criteria are excluded from this document; for Medicare-specific criteria see policy MC.CP.MP.249.
Use of Omisirge (omidubicel) or RegeneCyte (HPC Cord Blood) that does not meet the product-specific medical necessity criteria listed in this policy — including age, diagnosis, planned transplant type, required preparative regimen, or the single administration post‑myeloablative conditioning requirement for Omisirge — is considered not medically necessary and may be denied.
Preparative Regimens and Administration
| Regimen | Coverage rationale / requirements |
|---|---|
| Single administration post‑myeloablative conditioning (Omisirge [omidubicel]) | Covered when all Omisirge medical necessity criteria are met, including member/enrollee age >= 12 years, diagnosis of hematologic malignancy, planned umbilical cord blood transplantation following myeloablative conditioning, and request is for one administration post‑myeloablative conditioning. |
| Unrelated‑donor hematopoietic progenitor cell transplantation with an appropriate preparative regimen (RegeneCyte, HPC Cord Blood) | Covered when all RegeneCyte medical necessity criteria are met, including planned unrelated donor hematopoietic progenitor cell transplantation, use of an appropriate preparative regimen for hematopoietic and immunologic reconstitution, and a disorder affecting the hematopoietic system that is inherited, acquired, or resulting from myeloablative treatment. |
Indication and Line of Therapy
salvage
ANY of the following
- Indication context: Used as part of allogeneic hematopoietic cell transplantation for treatment of hematologic malignancy or other hematopoietic disorders following myeloablative conditioning or as specified for unrelated donor transplantation
Prior Authorization, Documentation, and Billing
Prior Authorization Required
Prior authorization is required. Requests must reference the applicable medical necessity criteria for the specific product (Omisirge or RegeneCyte) and align with Centene non‑Medicare plan criteria.
Step therapy / sequencing
No step therapy or sequencing is specified for Omisirge or RegeneCyte. Coverage determination is made when the product‑specific medical necessity criteria are met; there is no prerequisite trial of alternative therapies required by this policy.
Required clinical documentation
Documentation must demonstrate patient age eligibility, diagnosis, and planned transplant regimen. Include clinical records showing: diagnosis of a qualifying hematologic malignancy or disorder of the hematopoietic system, evidence of planned myeloablative conditioning and umbilical cord blood (for Omisirge) or unrelated donor hematopoietic progenitor cell transplantation (for RegeneCyte), and the intended single administration (Omisirge) or appropriate preparative regimen (RegeneCyte).
- Document patient age (Omisirge: ≥ 12 years)
- Document diagnosis and indication (e.g., hematologic malignancy or inherited/acquired hematopoietic disorder)
- Document planned transplant type and preparative regimen (myeloablative conditioning)
- For Omisirge: planned umbilical cord blood transplantation and request for one administration post‑myeloablation
Denial triggers
Denial is likely if the request does not meet the listed medical necessity criteria for Omisirge or RegeneCyte. Common triggers include missing documentation of planned myeloablative conditioning or transplant type, request for off‑label use (age or indication not supported), or requests for multiple administrations when policy specifies a single administration.
- Denial trigger: patient age < 12 years for Omisirge
- Denial trigger: no documentation of myeloablative conditioning or planned umbilical cord blood transplantation (Omisirge)
- Denial trigger: no documentation of unrelated donor hematopoietic progenitor cell transplantation and appropriate preparative regimen (RegeneCyte)
- Denial trigger: request inconsistent with product‑specific administration (e.g., >1 administration for Omisirge)
Billing and Code References
Key Definitions
Clinical Background
Allogeneic hematopoietic cell transplantation uses donor hematopoietic progenitor cells to restore bone marrow function for patients with hematologic malignancies and other disorders of the hematopoietic system. Preparative regimens such as myeloablative conditioning are used to eradicate the recipient’s marrow and immune cells before infusion and are required to permit engraftment; these regimens produce profound marrow ablation and significant infection risk during the aplastic period. Omisirge and RegeneCyte are cord blood‑derived allogeneic HPC products intended to support hematopoietic reconstitution in this transplant setting and are addressed by separate, product‑specific coverage criteria in this policy.
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