CurrentCommunity Health Plan WashingtonPolicy MC.CP.MP.249

Allogeneic Hematopoietic Progenitor Cell Therapy

Medical necessity criteria for FDA-approved allogeneic hematopoietic progenitor cell therapies Omisirge (omidubicel) and RegeneCyte (HPC Cord Blood) for Medicare health plans affiliated with Centene Corporation; describes when these products are considered medically necessary.

Policy Summary

PayerCommunity Health Plan Washington

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy MC.CP.MP.249

Change TypeExpanded scope to include RegeneCyteadministrative updates

Effective Date

Next Review Date

Key ActionProviders must request coverage and demonstrate that all policy criteria are met (age, diagnosis, transplant plan and preparative regimen specifics) and document that Omisirge requests are for one administration post-myeloablative conditioning.

SourceLink

POLICY UPDATE CHANGES

Added Criteria II to include medically necessary criteria for RegeneCyte.

Removed Omisirge-specific language from title and updated description to include RegeneCyte.

Added 'Medicare' to health plans in Policy/Criteria I.

2FDA-approved products covered by policy

≥ 12Minimum age for Omisirge

1Administration per transplant defined (Omisirge)

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Medical Necessity Criteria

Omisirge (omidubicel) — Medicare medical necessity

Omisirge is medically necessary when ALL of the following are met:

ALL of the following

Member/enrollee is ≥ 12 years of age>= 12 years
Diagnosis of hematologic malignancies
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
Request is for one administration post-myeloablative conditioning

RegeneCyte (HPC Cord Blood) — Medicare medical necessity

RegeneCyte is medically necessary when ALL of the following are met:

ALL of the following

Member/enrollee is planned for an unrelated donor hematopoietic progenitor cell transplantation procedure
An appropriate preparative regimen for hematopoietic and immunologic reconstitution will be used in conjunction with the transplantation procedure
Member/enrollee has a disorder affecting the hematopoietic system that is inherited, acquired, or a result from myeloablative treatment

Suggested Billing Codes

Unclassified biologics/drugs referencedHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Authorization and Documentation Requirements

Prior Authorization

Medical necessity documentation for product use

Providers must request coverage and demonstrate that all applicable policy medical necessity criteria are met for Omisirge and RegeneCyte before coverage will be considered. For Omisirge, documentation must support age ≥ 12 years, diagnosis of a hematologic malignancy, planned umbilical cord blood transplantation following myeloablative conditioning, and that the request is for one administration post-myeloablative conditioning. For RegeneCyte, documentation must support a planned unrelated donor hematopoietic progenitor cell transplantation procedure, use of an appropriate preparative regimen for hematopoietic and immunologic reconstitution, and a qualifying disorder affecting the hematopoietic system (inherited, acquired, or resulting from myeloablative treatment).

J3590
C9399

Documentation Required

Single administration specification (Omisirge)

When requesting Omisirge, providers must document that the request is for a single administration delivered post-myeloablative conditioning as specified in the Omisirge medical necessity criteria.

Clinical Context

Allogeneic hematopoietic cell transplantation (HCT) is an established treatment for hematologic malignancies and other disorders of the blood and immune system in which stem cells collected from related or unrelated donors are infused to restore bone marrow function following intensive preparative therapy. During the conditioning phase, myeloablative conditioning (MAC)—single agent or combination regimens anticipated to destroy hematopoietic cells—produces extensive, typically irreversible pancytopenia within 1–3 weeks, leaving patients at high risk for serious infections and other complications that increase morbidity, mortality, and health care resource use (e.g., longer hospital and ICU stays).

Omisirge (omidubicel) and RegeneCyte (HPC Cord Blood) are FDA‑approved, cord blood–derived allogeneic hematopoietic progenitor cell therapies intended to accelerate hematopoietic recovery after transplantation and thereby reduce infection risk and utilization of healthcare resources when used with appropriate conditioning regimens. Omisirge is a nicotinamide‑modified product approved for patients ≥ 12 years of age undergoing umbilical cord blood transplantation after MAC and has been shown in a phase 3 randomized trial to shorten time to neutrophil recovery (median ~12 days vs ~22 days), reduce bacterial/fungal infections, and decrease hospital and ICU lengths of stay. RegeneCyte is approved for unrelated donor hematopoietic progenitor cell transplantation in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution and has demonstrated hematopoietic reconstitution across multiple studies with reductions in time to neutrophil, erythrocyte, and platelet recovery.

When requesting coverage, providers must document that members meet the specific medical necessity criteria for the selected product (for Omisirge: age ≥ 12 years, diagnosis of hematologic malignancy, planned umbilical cord blood transplantation following myeloablative conditioning, and that the request is for one administration post‑MAC; for RegeneCyte: plan for an unrelated donor hematopoietic progenitor cell transplantation, use of an appropriate preparative regimen for hematopoietic and immunologic reconstitution, and a qualifying disorder affecting the hematopoietic system). These products are intended to reduce time to hematopoietic recovery and the incidence of infection, thereby potentially lowering downstream resource utilization when used in accordance with the policy criteria.

Defined Terms

Definitions

TermMyeloablative conditioning (MAC)

DefinitionA preparative regimen consisting of single agent or combination agents anticipated to destroy hematopoietic cells in the bone marrow causing extensive, typically irreversible pancytopenia within 1–3 weeks.

Policy Changes

2025-05-25criteria_addedLatest

Added Criteria II to include medically necessary criteria for RegeneCyte and updated background and description to include RegeneCyte as the policy expanded from Omisirge-only.

06/24administrative_update

Annual review: added 'Medicare' to health plans in Policy/Criteria I and updated description and background with no impact on criteria; removed Omisirge-specific language from the policy title and updated description to include RegeneCyte.

02/24