ModifiedWellcare HawaiiPolicy MC.CP.MP.249

Allogeneic Hematopoietic Progenitor Cell Therapy

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This policy establishes medical-necessity criteria for Medicare health plan coverage of Omisirge (omidubicel), RegeneCyte (HPC cord blood), and TREGZI allogeneic cellular therapies used with hematopoietic cell transplantation for specified hematologic malignancies, severe aplastic anemia, or disorders affecting the hematopoietic system.

Policy Summary

PayerWellcare Hawaii

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy MC.CP.MP.249

Change TypeModified

Effective DateN/A

Last ReviewAug 1, 2026

Next Review DateN/A

Key ActionFor Medicare members, review all applicable Medicare coverage guidance before applying this policy's criteria.

SourceLink

POLICY UPDATE CHANGES

RegeneCyte-specific medical-necessity criteria were added for unrelated donor hematopoietic progenitor cell transplantation.

Severe aplastic anemia was added as a medically necessary indication for Omisirge.

The policy description and criteria were expanded to address the absence of applicable CMS coverage criteria and to include RegeneCyte.

The policy added medically necessary criteria for RegeneCyte and expanded the policy description to include RegeneCyte.

The policy added severe aplastic anemia as a medically necessary indication for Omisirge.

The policy added TREGZI to the description and added medically necessary criteria for TREGZI.

The policy removed Omisirge-specific language from the title as the policy scope expanded to additional cellular therapies.

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ModifiedWellcare HawaiiPolicy MC.CP.MP.249

Allogeneic Hematopoietic Progenitor Cell Therapy

Customize your policy alerts

Sign up for Wellcare Hawaii Policy MC.CP.MP.249 alerts

Get alerted when Policy MC.CP.MP.249 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerWellcare Hawaii

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy MC.CP.MP.249

Change TypeModified

Effective DateN/A

Last ReviewAug 1, 2026

Next Review DateN/A

Key ActionFor Medicare members, review all applicable Medicare coverage guidance before applying this policy's criteria.

SourceLink

POLICY UPDATE CHANGES

RegeneCyte-specific medical-necessity criteria were added for unrelated donor hematopoietic progenitor cell transplantation.

Severe aplastic anemia was added as a medically necessary indication for Omisirge.

The policy description and criteria were expanded to address the absence of applicable CMS coverage criteria and to include RegeneCyte.

The policy added medically necessary criteria for RegeneCyte and expanded the policy description to include RegeneCyte.

The policy added severe aplastic anemia as a medically necessary indication for Omisirge.

The policy added TREGZI to the description and added medically necessary criteria for TREGZI.

The policy removed Omisirge-specific language from the title as the policy scope expanded to additional cellular therapies.

Medical Necessity Criteria

Omisirge (omidubicel)

Omisirge is medically necessary when one of the following indication pathways is met:

One of the following pathways

Hematologic malignancies: Member/enrollee has a diagnosis of hematologic malignancy; is at least 12 years of age; is planned for an umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection; and the request is for one administration post-myeloablative conditioning.Age ≥12 years; one administration
Severe aplastic anemia: Member/enrollee has a diagnosis of severe aplastic anemia; is at least six years of age; and the request is for one administration following reduced-intensity conditioning.Age ≥6 years; one administration

RegeneCyte HPC Cord Blood

RegeneCyte is medically necessary when all of the following criteria are met:

RegeneCyte eligibility

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 of myeloablative treatment.

TREGZI

TREGZI is medically necessary when all of the following criteria are met:

TREGZI eligibility

ALL of the following
- Member/enrollee is at least 18 years of age.Age ≥18 years
- Member/enrollee has a diagnosis of hematological malignancy.
- Member/enrollee is planned for a matched donor hematopoietic stem cell transplantation following myeloablative conditioning to achieve hematopoietic and immunologic reconstitution and improve chronic graft-versus-host-disease (cGVHD)-free survival.

Coding and Clinical Thresholds

HCPCS CodesHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Omisirge hematologic malignancy criteria

Minimum age≥ 12 years

IndicationHematologic malignancy

Treatment planUmbilical cord blood transplantation following myeloablative conditioning; one administration post-conditioning

Omisirge severe aplastic anemia criteria

Minimum age≥ six years

IndicationSevere aplastic anemia

Treatment planOne administration following reduced-intensity conditioning

Provider Review and Coverage Actions

Prior Authorization

Review applicable Medicare coverage guidance

For Medicare members, review all applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Medicare Coverage Articles before applying the criteria in this clinical policy.

Denial Risk

Failure to meet product-specific medical-necessity criteria

Coverage may be denied when the requested therapy does not meet the product-specific age, diagnosis, donor-transplant, conditioning, administration, or hematopoietic-reconstitution criteria.

Omisirge: verify the applicable hematologic malignancy or severe aplastic anemia pathway, age requirement, conditioning, and one-administration requirement.
RegeneCyte: verify unrelated donor hematopoietic progenitor cell transplantation, an appropriate preparative regimen, and an inherited, acquired, or treatment-related hematopoietic disorder.

Clinical Background

Allogeneic hematopoietic cell transplantation (HCT) uses stem cells collected from a related or unrelated healthy donor rather than from the patient. After conditioning, the donor stem cells are infused to rescue the bone marrow and restore normal immune function.

Conditioning uses high-dose chemotherapy, with or without radiation therapy, to eradicate disease before transplantation. Myeloablative conditioning is intended to destroy hematopoietic cells in the bone marrow and can cause extensive, often irreversible pancytopenia within one to three weeks; preparative regimens may also cause mucositis, diarrhea, and infection risk.

Definitions

Myeloablative conditioning

RegimenA single agent or combination of agents

Intended effectAnticipated to destroy hematopoietic cells in the bone marrow

Typical consequenceExtensive, typically irreversible pancytopenia within one to three weeks

Allogeneic hematopoietic cell transplantation

Donor sourceStem cells collected from related or unrelated healthy donors

ConditioningHigh-dose chemotherapy, with or without radiation therapy, is used to eradicate the disease

Transplantation purpose

Allogeneic Transplantation Candidate Criteria

Allogeneic Hematopoietic Transplantation Candidate Criteria

Candidates must satisfy the applicable product-specific criteria for the planned allogeneic transplantation:

Applicable product-specific pathway

Omisirge: Candidate meets the applicable Omisirge pathway for hematologic malignancy or severe aplastic anemia, including the required age, transplantation, conditioning, and administration criteria.
RegeneCyte: Candidate is planned for unrelated donor hematopoietic progenitor cell transplantation with an appropriate preparative regimen for hematopoietic and immunologic reconstitution and has an inherited, acquired, or treatment-related disorder affecting the hematopoietic system.
TREGZI: Candidate is at least 18 years of age, has hematologic malignancy, and is planned for matched donor hematopoietic stem cell transplantation following myeloablative conditioning to achieve hematopoietic and immunologic reconstitution and improve cGVHD-free survival.