CurrentCommunity Health Plan WashingtonPolicy MC.CP.MP.249

Allogeneic Hematopoietic Progenitor Cell Therapy

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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; governs coverage decisions for patients meeting the listed clinical criteria.

Policy Summary

PayerCommunity Health Plan Washington

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy MC.CP.MP.249

Change TypeExpanded indications (Omisirge) and added RegeneCyte criteria

Effective Date

Next Review Date

Key ActionObtain prior authorization documenting indication, patient age, planned transplant type, and conditioning regimen to demonstrate criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added Criteria II. to include medically necessary criteria for RegeneCyte.

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

Updated description and background to reflect RegeneCyte approval and Omisirge new indication.

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CurrentCommunity Health Plan WashingtonPolicy MC.CP.MP.249

Allogeneic Hematopoietic Progenitor Cell Therapy

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Sign up for Community Health Plan Washington Policy MC.CP.MP.249 alerts

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Policy Summary

PayerCommunity Health Plan Washington

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy MC.CP.MP.249

Change TypeExpanded indications (Omisirge) and added RegeneCyte criteria

Effective Date

Next Review Date

Key ActionObtain prior authorization documenting indication, patient age, planned transplant type, and conditioning regimen to demonstrate criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added Criteria II. to include medically necessary criteria for RegeneCyte.

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

Updated description and background to reflect RegeneCyte approval and Omisirge new indication.

Coverage Criteria

Omisirge — medically necessary indications

Omisirge (omidubicel) is covered when ONE of the following indication-specific sets of conditions is met:

A. Hematologic malignancies

Member/enrollee is >= 12 years of age.
Member/enrollee 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.

B. Severe aplastic anemia

Member/enrollee is >= 6 years of age.
Request is for one administration following reduced intensity conditioning.

RegeneCyte — medically necessary criteria

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

RegeneCyte criteria

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.

This policy defines the coverage scope for FDA‑approved allogeneic hematopoietic progenitor cell therapies included herein: Omisirge (omidubicel) and RegeneCyte (HPC Cord Blood). Coverage is limited to the specific, product‑based clinical indications and patient characteristics detailed in the medical necessity criteria: age thresholds, planned transplant type (e.g., umbilical cord blood transplant or unrelated donor hematopoietic progenitor cell transplantation), and the preparative conditioning regimen (myeloablative vs reduced‑intensity) specified for each product. Use of these products outside the FDA‑indications, for ages not listed in the criteria, following conditioning regimens not described in the criteria, or in transplant settings that do not meet the documented planned transplant type, is not supported by this policy and may be excluded from coverage.

Indications or requests that do not meet the explicit coverage criteria for Omisirge or RegeneCyte — including failure to document the planned transplant type, the required patient age, the specified conditioning regimen, or the one‑time administration requirement where applicable — are considered not medically necessary under this policy and are not supported for coverage.

Coding

Referenced HCPCS / unclassified codesHCPCS

J3590	Unclassified biologics.
C9399	Unclassified drugs or biologicals

inv-06: Platelet recovery threshold

Platelet recovery threshold20,000/uL

Source contextPlatelet recovery (20,000/uL) used as study endpoint and threshold for reporting platelet reconstitution

Reporting timepoint examplePlatelet recovery (20,000/uL) reported at Day 100 in clinical studies

Provider Actions & Billing

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required before coverage of RegeneCyte or Omisirge (omidubicel). Documentation submitted with the request must include the clinical indication, member age, transplant type (e.g., unrelated donor hematopoietic progenitor cell transplantation or umbilical cord blood transplantation), the conditioning/ preparative regimen (myeloablative or reduced‑intensity), and confirmation that the request is for a single administration as specified by the clinical criteria.

Indication, age, transplant type, conditioning regimen must be documented
Single administration requirement must be specified where applicable

Documentation Required

Provider action — submit documentation

Provider Action: Submit prior authorization with supporting clinical documentation (diagnosis, age, transplant plan, conditioning regimen, and planned single administration when required) and obtain approval prior to scheduling the procedure.

Transplant Candidate Criteria

Transplant candidate criteria

Candidate selection criteria as specified in policy:

Omisirge hematologic malignancy candidates

Member age >= 12 years.
Planned umbilical cord blood transplant following myeloablative conditioning.
Single administration of Omisirge post-conditioning.

Omisirge severe aplastic anemia candidates

Member age >= 6 years.

Evaluation & Documentation Requirements

Documentation Required

Evaluation documentation — transplant type, conditioning, age, and one‑time administration

Provide evaluation documentation that includes the planned transplant type, the preparative/conditioning regimen (myeloablative vs reduced‑intensity), confirmation of age eligibility per the product-specific criteria, and that the request is for one administration when required.

Planned transplant type (e.g., umbilical cord blood transplant for Omisirge; unrelated donor HPC transplant for RegeneCyte).
Conditioning regimen specified as myeloablative or reduced intensity.
Patient age documented to meet the policy thresholds.
Statement that the product is requested as a single administration when applicable.

Center Requirements

Note

Center requirements — no FACT or volume requirements specified

The policy does not specify center accreditation (FACT) or minimum transplant volume requirements; no facility‑level requirements are stated in the policy text.

Absence of FACT accreditation or volume standards in the policy means such criteria are not required by this policy.

Post-Transplant Monitoring & Outcomes

inv-17: Clinical follow-up and monitoring of engraftment parameters

Neutrophil recoveryPrimary engraftment outcome; median time reported (Omisirge study) ≈12 days; RegeneCyte/other studies median 22–27 days

Platelet recoveryMeasured using threshold 20,000/uL; median times reported range from 50 to 122 days across studies; percent achieving by Day 100 varies (e.g., 57%–72%)

Erythrocyte (red cell) recoveryReported as erythrocyte recovery at Day 100 (e.g., 65% in one study) with median time to erythrocyte recovery ~64 days

Key monitoring timepointsCommon study timepoints for assessing engraftment: Day 42 and Day 100

Background

Allogeneic hematopoietic cell transplantation (HCT) delivers donor hematopoietic stem and progenitor cells to reconstitute marrow function after a preparative conditioning regimen. Conditioning can be myeloablative (intended to irreversibly destroy marrow hematopoiesis, producing profound pancytopenia) or reduced‑intensity to decrease regimen‑related toxicity. Cord blood–derived progenitor cell products such as Omisirge (omidubicel) and RegeneCyte (HPC Cord Blood) are intended to accelerate neutrophil and platelet recovery after transplantation, thereby reducing infection risk and hospital resource use. Clinical evidence for Omisirge includes a phase 3 randomized controlled trial demonstrating faster neutrophil recovery and reduced infections in patients with hematologic malignancies, and a single‑arm prospective study showing early neutrophil engraftment in patients with severe aplastic anemia (median neutrophil recovery ≈ 11 days in the reported series).

Definitions

inv-12: Definition of Myeloablative Conditioning (MAC)

DefinitionMyeloablative conditioning (MAC): a preparative regimen anticipated to irreversibly destroy hematopoietic cells in the bone marrow, causing extensive pancytopenia within 1–3 weeks.

Expected effect timingExtensive pancytopenia occurs within one to three weeks after administration of a MAC regimen and is typically irreversible.

Regimen characteristicsConsists of a single agent or combination of agents intended to destroy marrow hematopoietic cells prior to transplantation.

Contraindications

This policy document does not list any explicit absolute or relative contraindications for Omisirge or RegeneCyte; no contraindication statements are provided in the policy text.