CurrentCentenePolicy CP.MP.249

Allogeneic Hematopoietic Progenitor Cell Therapy

Medical necessity criteria for use of Omisirge (omidubicel) and RegeneCyte (HPC Cord Blood) for non‑Medicare Centene-affiliated health plans; who may qualify and under what conditions.

Policy Summary

PayerCentene

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy CP.MP.249

Change TypeAdded RegeneCyterevised Omisirge pediatric indication

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that the member meets the policy's age- and indication-specific medical necessity criteria.

SourceLink

POLICY UPDATE CHANGES

RegeneCyte (HPC Cord Blood) criteria were added to the policy as Criteria II.

Criteria I updated to include severe aplastic anemia as a medically necessary indication for Omisirge.

Added note referring Medicare criteria to separate Medicare policy MC.CP.MP.249 and specified 'non‑Medicare' health plans.

≥12min age Omisirge (malignancy)

≥6min age Omisirge (aplastic anemia)

87% vs 83%neutrophil recovery (Omisirge vs CB)

12d vs 22dmean time to neutrophil recovery

Policy Summary

PayerCentene

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy CP.MP.249

Change TypeAdded RegeneCyterevised Omisirge pediatric indication

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that the member meets the policy's age- and indication-specific medical necessity criteria.

SourceLink

On This Page

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Medical Necessity and Coverage Criteria

Medical necessity criteria — Omisirge and RegeneCyte

Covered when ALL of the following are met for each listed product-specific criteria:

Omisirge - Hematologic malignancies: Member/enrollee is >= 12 years of age AND 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 AND request is for one administration post-myeloablative conditioning.age >= 12

Omisirge is FDA‑approved for this population and demonstrated faster neutrophil recovery (mean ~12 days) and fewer infections versus standard cord blood transplantation.

Omisirge - Severe aplastic anemia: Member/enrollee is >= 6 years of age AND request is for one administration following reduced intensity conditioning.age >= 6

FDA approval and single‑arm study data support neutrophil engraftment and transfusion independence in most patients.

RegeneCyte (HPC Cord Blood): Member/enrollee is planned for an unrelated donor hematopoietic progenitor cell transplantation procedure AND an appropriate preparative regimen for hematopoietic and immunologic reconstitution will be used in conjunction with the transplantation procedure AND member/enrollee has a disorder affecting the hematopoietic system that is inherited, acquired, or a result from myeloablative treatment.

RegeneCyte (HPC Cord Blood) is indicated to support hematopoietic reconstitution; effectiveness demonstrated across clinical studies.

This policy applies to non‑Medicare Centene‑affiliated health plans. Medicare members should be referred to MC.CP.MP.249 for Medicare‑specific coverage criteria and operational requirements.

Inclusion or exclusion of codes in this policy does not by itself indicate coverage. Codes referenced are for informational purposes only; providers must consult current professional coding guidance before submitting claims and confirm that the requested services meet the policy's clinical medical necessity criteria.

Referenced Codes and Key Study Metrics

Referenced codesmixed

J3590	Unclassified biologics.
C9399	Unclassified drugs or biologicals.

Neutrophil recovery time and study metrics

Omisirge — mean/median time to neutrophil recovery87% of subjects achieved neutrophil recovery in an average of 12 days (Omisirge) vs 83% in an average of 22 days (standard cord blood transplantation).

Cord blood (historical/standard CBT) — mean/median timeNeutrophil recovery achieved in an average/median of 22–27 days in cord blood transplantation (22 days in randomized study; median 27 days in COBLT).

RegeneCyte — median time to neutrophil recovery (COBLT)In the COBLT study supporting RegeneCyte, among 324 patients the median time to neutrophil recovery was 27 days (76% achieved neutrophil recovery by day 42).

Clinical outcomes linked to faster recoveryOmisirge recipients had fewer bacterial or fungal infections, fewer ICU days, shorter total hospital length of stay, and fewer deaths within first 100 days compared with cord blood transplantation recipients.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Omisirge (omidubicel) and RegeneCyte. Submit supporting clinical documentation that demonstrates the member meets the applicable medical necessity criteria in this policy prior to administration.

Prior authorization required for Omisirge and RegeneCyte
Include indication, age, conditioning regimen, and planned transplant details

Documentation Required

Provider Documentation Requirements

Providers must document and submit clinical records that clearly show the member meets the specific criteria for the requested product (age thresholds, diagnosis, planned conditioning regimen, and whether administration is post-myeloablative or following reduced intensity conditioning). Ensure documentation of the unrelated donor transplant plan for RegeneCyte and the single administration request for Omisirge when applicable.

For Omisirge: age and indication (hematologic malignancy ≥ 12 years or severe aplastic anemia ≥ 6 years), planned umbilical cord blood transplantation, and conditioning type (post-myeloablative or reduced intensity as specified)

Preparative Regimens and Use Context

Regimen	Applicability / Notes
Reduced‑intensity preparative regimens
Permitted when RegeneCyte or Omisirge is used in indications that specify reduced intensity conditioning (Omisirge coverage for severe aplastic anemia requires one administration following reduced intensity conditioning; RegeneCyte requires an appropriate preparative regimen — myeloablative or reduced intensity — in conjunction with unrelated donor transplantation).

Indication / Line of Therapy Rules

Salvage

Salvage use for transplantation: Use is limited to patients meeting the product‑specific transplantation criteria above (e.g., Omisirge for planned umbilical cord blood transplantation after myeloablative conditioning or RegeneCyte for unrelated donor hematopoietic progenitor cell transplantation) and when an appropriate preparative regimen will be used; requests outside these transplantation‑related indications do not meet salvage criteria.

Policy ties use to transplantation procedures rather than general salvage therapy.

Key Definitions

Myeloablative conditioning (MAC) — definition

DefinitionMyeloablative conditioning (MAC) is a regimen, single agent or combination, anticipated to destroy hematopoietic cells in the bone marrow; extensive pancytopenia occurs within one to three weeks after administration and is typically irreversible.

Clinical effectMAC causes destruction (ablation) of marrow stem cells that produce new blood cells, leading to prolonged/irreversible pancytopenia.

Typical timing of pancytopeniaExtensive pancytopenia occurs within 1–3 weeks after MAC administration.

Allogeneic hematopoietic progenitor cell therapy — definition

DefinitionAllogeneic hematopoietic progenitor cell therapy: donor-derived umbilical cord blood–derived cell products (e.g., Omisirge, RegeneCyte) intended to accelerate hematopoietic recovery following transplantation and support hematopoietic and immunologic reconstitution.

Clinical and Product Background

Allogeneic hematopoietic cell transplantation (HCT) uses donor‑derived hematopoietic progenitor cells after a preparative regimen (myeloablative or reduced intensity) to restore hematopoiesis and immune function. Myeloablative conditioning is intended to ablate the recipient’s marrow, producing profound pancytopenia prior to donor cell infusion. Donor‑derived cord blood–based products (for example, Omisirge and RegeneCyte) are cellular therapies developed to accelerate hematopoietic recovery after transplantation and to reduce complications such as infection related to prolonged neutropenia. This policy defines the non‑Medicare medical necessity criteria under which these allogeneic hematopoietic progenitor cell therapies may be covered when used in conjunction with an appropriate preparative regimen and transplant procedure.