CurrentCentenePolicy MC.CP.MP.249

Allogeneic Hematopoietic Progenitor Cell Therapy (Omisirge, RegeneCyte)

Medical necessity criteria for use of Omisirge (omidubicel) and RegeneCyte (HPC Cord Blood) for Medicare health plans affiliated with Centene, describing covered indications and supporting clinical evidence.

Policy Summary

PayerCentene

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy (Omisirge, RegeneCyte)

Policy CodePolicy MC.CP.MP.249

Change TypeAdded RegeneCyte criteriatitle expandedclarified Medicare qualifier

Effective Date

Next Review Date

Key ActionObtain prior authorization demonstrating the patient meets the product-specific medical necessity criteria.

SourceLink

POLICY UPDATE CHANGES

Added criteria for RegeneCyte as a medically necessary allogeneic hematopoietic progenitor cell therapy.

Removed Omisirge-specific language from the policy title to expand the policy scope to multiple products.

Specified that Criteria I applies to Medicare health plans affiliated with Centene Corporation.

2products covered (Omisirge, RegeneCyte)

≥12minimum age for Omisirge

125pivotal Omisirge study subjects

324RegeneCyte study patients

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

Initial therapy — Omisirge

Omisirge (omidubicel) is covered when ALL of the following are met:

Omisirge criteria: A. Member/enrollee is >= 12 years of age; B. Diagnosis of hematologic malignancies; C. 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; D. Request is for one administration post-myeloablative conditioning.

Based on FDA approval and pivotal randomized trial showing faster neutrophil recovery (median ~12 days) and reduced infections compared with standard UCBT.

Initial therapy — RegeneCyte

RegeneCyte (HPC Cord Blood) is covered when ALL of the following are met:

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

Based on FDA approval supported by COBLT and other observational studies demonstrating hematopoietic reconstitution endpoints (neutrophil, platelet, erythrocyte recovery).

Payment/coverage is limited to the specific products and indications listed in this policy. Requests for Omisirge or RegeneCyte that do not meet the product-specific medical necessity criteria set forth in this policy will not be covered. Examples include requests that do not satisfy the age, diagnosis, transplant type, or conditioning requirements specified for each product.

Use of Omisirge or RegeneCyte outside the listed indications or patient populations described in the criteria is considered not medically necessary. For example, Omisirge in patients < 12 years or Omisirge use when myeloablative conditioning is not planned are outside the scope of coverage; similarly, RegeneCyte use outside an unrelated donor hematopoietic progenitor cell transplantation with an appropriate preparative regimen is not covered.

Coding and Clinical Timing

Informational referenced HCPCS codesHCPCS

J3590	Unclassified biologics.
C9399	Unclassified drugs or biologicals

Neutrophil recovery timing — examples

Omisirge (omidubicel) — median neutrophil recoveryApproximately 12 days (87% of subjects achieved neutrophil recovery in an average of 12 days in the pivotal randomized study)

Standard umbilical cord blood transplantation (UCBT) — median neutrophil recoveryApproximately 22 days (83% of subjects in the comparator arm achieved neutrophil recovery in an average of 22 days)

RegeneCyte cohorts — median neutrophil recovery (reported ranges)Median times reported across studies/cohorts: 22–27 days (Study 3 median 22 days; COBLT Study median 27 days; retrospective Study 2 median 25 days)

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Requests for Omisirge (omidubicel) or RegeneCyte for allogeneic hematopoietic progenitor cell transplantation require prior authorization demonstrating medical necessity and transplant details.

Member age and diagnosis (see required documentation)
Planned transplantation type and timing (umbilical cord blood transplantation following myeloablative conditioning for Omisirge; unrelated donor hematopoietic progenitor cell transplantation for RegeneCyte)
One administration post-myeloablative conditioning (Omisirge)
Appropriate preparative regimen to be used in conjunction with transplantation (RegeneCyte)

Step Therapy

Step therapy: There are no step therapy requirements specified for Omisirge or RegeneCyte in this policy. Providers do not need to document trial of alternative therapies as a prerequisite for prior authorization if clinical criteria are met.

Candidate Selection and Eligibility

Candidate selection — product-specific

Candidate eligibility is defined by product-specific criteria tied to transplant type and conditioning:

Omisirge candidate: Patient >=12 years with hematologic malignancy planned for umbilical cord blood transplantation following myeloablative conditioning; single administration post-conditioning.

FDA indication per package insert and policy; intended to shorten time to neutrophil recovery and reduce infections.

RegeneCyte candidate: Patient planned for unrelated donor hematopoietic progenitor cell transplantation with an appropriate preparative regimen for hematopoietic and immunologic reconstitution; patient has an inherited, acquired, or myeloablation-related disorder affecting the hematopoietic system.

FDA indication per package insert and policy; effectiveness defined by hematopoietic reconstitution (COBLT and observational studies).

Terminology and Conditioning Regimens

Myeloablative conditioning (MAC) — definition and expected effects/timing

Definition of Myeloablative Conditioning (MAC)A preparative regimen (single agent or combination) anticipated to destroy hematopoietic cells in the bone marrow; causes extensive pancytopenia typically within 1–3 weeks and is generally irreversible.

Expected hematologic effect timingExtensive pancytopenia occurs within one to three weeks after administration of a MAC regimen.

Clinical implicationsMAC results in profound marrow ablation requiring stem cell rescue and increases risk of mucositis, diarrhea, infection, and other toxicities during the aplastic period.

Pre-Transplant Evaluation

Note

Pre-transplant evaluation for MAC suitability and comorbidities

Perform a pre-transplant evaluation that includes assessment of suitability for myeloablative conditioning and identification of comorbidities, prior chemotherapy exposure, and other transplant risk factors that could affect candidacy or outcomes.

Assess suitability for myeloablative conditioning (MAC) and document anticipated MAC regimen.
Evaluate comorbidities, prior intensive chemotherapy, and other risk factors affecting transplant tolerance and outcomes.

Contraindications

The policy text does not specify any absolute or relative contraindications to the use of Omisirge or RegeneCyte. No contraindication lists or prohibitions are provided in the coverage criteria; clinical suitability should be determined by the treating team as part of pre-transplant evaluation.

Facility and Program Requirements

Note

No center accreditation or volume requirements specified

The policy does not specify center-level requirements such as FACT accreditation or minimum procedural volume; no center-specific accreditation or volume thresholds are stated.

Post-Transplant Administration and Limits

Hematopoietic progenitor cell therapy administration — coverage

Omisirge administration coveredPolicy covers one administration of Omisirge post-myeloablative conditioning for eligible patients (single administration only).

RegeneCyte coverage linkageRegeneCyte coverage is tied to the unrelated donor hematopoietic progenitor cell transplantation procedure and an appropriate preparative regimen; use is covered in conjunction with the transplantation.

Scope of covered serviceBoth products are allogeneic, cord-blood–derived hematopoietic progenitor cell therapies intended to accelerate hematopoietic recovery as specified in product-specific criteria.