CurrentAmbetter NevadaPolicy CP.MP.249

Allogeneic Hematopoietic Progenitor Cell Therapy (Omisirge, RegeneCyte)

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.

Policy Summary

PayerAmbetter Nevada

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy (Omisirge, RegeneCyte)

Policy CodePolicy CP.MP.249

Change TypeAdded RegeneCyte criteriarevised Omisirge indications

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation of indication, patient age, planned transplant type, and conditioning regimen.

SourceLink

POLICY UPDATE CHANGES

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).

2therapies covered

≥12min age Omisirge (malignancy)

≥6min age Omisirge (aplastic anemia)

J3590,C9399

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Medical Necessity and Coverage Criteria

inv-01: Omisirge (omidubicel) Medical Necessity

Omisirge (omidubicel) — covered when ONE of the following groups of criteria is met:

Group A - Hematologic malignancies: ALL of: member is >= 12 years of age; member is planned for an umbilical cord blood transplantation following myeloablative conditioning to reduce time to neutrophil recovery and incidence of infection; request is for one administration post-myeloablative conditioning.all

Supports use after myeloablative conditioning to speed neutrophil recovery and reduce infection risk.

Group B - Severe aplastic anemia: ALL of: member is >= 6 years of age; request is for one administration following reduced intensity conditioning.all

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:

RegeneCyte criteria: ALL of: member 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 has a disorder affecting the hematopoietic system that is inherited, acquired, or a result from myeloablative treatment.all

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

Referenced CPT/HCPCS codes (informational)HCPCS

J3590	Unclassified biologics.
C9399	Unclassified drugs or biologicals

Neutrophil recovery time comparisons — Omisirge vs cord blood / RegeneCyte

Omisirge (omidubicel) — median time to neutrophil recoveryApproximately 12 days (median) in pivotal studies supporting Omisirge use.

Cord blood (RegeneCyte/CBT) — median time to neutrophil recovery (COBLT Study)27 days (median) in the COBLT prospective study.

RegeneCyte — median times to neutrophil recovery across studies22–27 days (medians reported: 22 days in Study 3; 25 days in Study 2; 27 days in Study 1).

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

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

Documentation Required

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.

Therapy Line and Salvage Indications

inv-13: salvage

Use in the transplant context (salvage):

Transplant context: Use in conjunction with planned umbilical cord blood transplantation (Omisirge) or unrelated donor hematopoietic progenitor cell transplantation (RegeneCyte) following an appropriate conditioning/preparative regimen.all

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

Myeloablative conditioning (MAC) — definition

DefinitionA preparative regimen anticipated to destroy the hematopoietic cells in the bone marrow, causing extensive, typically irreversible pancytopenia.

Onset timingExtensive pancytopenia occurs within one to three weeks after administration of a myeloablative conditioning regimen.

Clinical implicationMAC is highly toxic and intended to ablate marrow stem cells prior to allogeneic hematopoietic cell transplantation.