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 eligible members receiving related transplant procedures.

Policy Summary

PayerCommunity Health Plan Washington

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy MC.CP.MP.249

Change TypeAdded RegeneCyte criteriaMedicare-specific clarification

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that the member meets the product-specific medical necessity criteria (age, diagnosis, planned procedure type, conditioning regimen and single administration for Omisirge or unrelated donor transplantation and appropriate preparative regimen for RegeneCyte).

SourceLink

POLICY UPDATE CHANGES

Medicare-specific policy language was added to Policy/Criteria I.

Criteria II was added to include medically necessary criteria for RegeneCyte.

Description updated to note absence of CMS coverage criteria and to include RegeneCyte.

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CurrentCommunity Health Plan WashingtonPolicy MC.CP.MP.249

Allogeneic Hematopoietic Progenitor Cell Therapy

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Policy Summary

PayerCommunity Health Plan Washington

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy MC.CP.MP.249

Change TypeAdded RegeneCyte criteriaMedicare-specific clarification

Effective Date

Next Review Date

SourceLink

POLICY UPDATE CHANGES

Medicare-specific policy language was added to Policy/Criteria I.

Criteria II was added to include medically necessary criteria for RegeneCyte.

Description updated to note absence of CMS coverage criteria and to include RegeneCyte.

Medical Necessity and Coverage Criteria

inv-01: Omisirge (omidubicel) — Initial therapy

Covered when ALL of the following are met

Omisirge medical necessity: All of the following must be satisfied for Omisirge: 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 phase 3 trial evidence

inv-02: RegeneCyte (HPC cord blood) — Initial therapy

Covered when ALL of the following are met

RegeneCyte medical necessity: All of the following must be satisfied for RegeneCyte: 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 resulting from myeloablative treatment.

Based on FDA approval and multiple study datasets (COBLT, registry, CIBMTR)

This policy applies specifically to Medicare health plans affiliated with Centene Corporation. The policy language in the coverage criteria (Policy/Criteria I and II) identifies Omisirge (omidubicel) and RegeneCyte as medically necessary only when the product-specific conditions listed are satisfied for members enrolled in these Medicare plans. For non‑Medicare plans, providers should refer to the separate policy CP.MP.249 Allogeneic Hematopoietic Progenitor Cell Therapy as noted in the policy description.

Use of Omisirge or RegeneCyte outside the explicit criteria in this policy is not supported. Examples include prescribing Omisirge for patients younger than 12 years, using Omisirge when the transplant is not planned following myeloablative conditioning, requesting more than a single post‑conditioning administration of Omisirge, or using RegeneCyte outside the setting of an unrelated donor hematopoietic progenitor cell transplantation with an appropriate preparative regimen. The policy criteria are based on the FDA approvals and relevant clinical studies and the package insert safety information; deviations from those indications risk denial of coverage.

Coding and Clinical Timelines

Referenced HCPCS CodesHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Neutrophil recovery timing (median) — Omisirge vs RegeneCyte (inv-06)"

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

Umbilical cord blood transplantation comparatorMedian neutrophil recovery ~22 days in cord blood transplantation group in randomized study

RegeneCyte study medians (COBLT, registry, pooled)Reported median times to neutrophil recovery of 27 days (COBLT), 25 days (pooled retrospective/docket data), and 22 days (CIBMTR observational database)

RegeneCyte overall neutrophil recovery proportionsStudies reported 76–81.5% achieving neutrophil recovery by Day 42 across datasets

Prior Authorization, Documentation, and Denial Conditions

Prior Authorization

Prior Authorization Required

Prior authorization required for Omisirge (omidubicel) and RegeneCyte — approval is contingent on meeting the product-specific medical necessity criteria listed in the policy.

Omisirge (omidubicel): member must meet age, diagnosis, planned procedure, conditioning, and single administration post-conditioning criteria.
RegeneCyte: member must meet unrelated-donor transplant plan, appropriate preparative regimen, and hematopoietic disorder criteria.

Documentation Required

Required Documentation to Support Medical Necessity

Providers must submit documentation that supports medical necessity at the time of prior authorization. Documentation should clearly demonstrate the member meets all applicable criteria (age, diagnosis, planned transplantation procedure, conditioning regimen, and whether the request is for the single post-conditioning administration when applicable).

Transplant Candidate Eligibility

inv-13: Transplant candidate criteria — Candidates must meet product-specific indications

Candidates must meet product-specific indications

Omisirge candidate: Age ≥12 and planned umbilical cord blood transplantation after myeloablative conditioning for hematologic malignancy; single post‑conditioning administration.

RegeneCyte candidate: Planned unrelated donor hematopoietic progenitor cell transplantation with an appropriate preparative regimen for hematopoietic and immunologic reconstitution for disorders affecting the hematopoietic system (inherited, acquired, or resulting from myeloablative treatment).

Contraindications and Safety Considerations

Contraindication and safety considerations for Omisirge and RegeneCyte are derived from the products’ package inserts and the broader transplant safety literature. The document references the package insert safety information and notes transplant‑related risks associated with increasing age, significant comorbidities, a history of aggressive or prior chemotherapy, and the toxicities of preparative regimens. While the policy does not enumerate absolute contraindications, providers should consider the package insert guidance and the increased procedural morbidity and mortality risk in older patients or those with substantial comorbid conditions when evaluating candidacy.

Pre-Transplant Evaluation Requirements

Step Therapy

Pre‑transplant evaluation — assess MAC eligibility and comorbidities

Pre‑transplant evaluation should include assessment of the member's eligibility for myeloablative conditioning and evaluation of transplant‑related comorbidities and risks as described in the policy background.

Assess eligibility for myeloablative conditioning (MAC) prior to planning Omisirge administration.
Evaluate comorbidities, prior aggressive chemotherapy, age-related risks, and other transplant‑related factors that affect candidacy.

Key Definitions

Myeloablative conditioning (MAC) — definition and expectations for preparative regimen (inv-12)"},{

Definition of myeloablative conditioning (MAC)A preparative regimen (single agent or combination) anticipated to destroy hematopoietic cells in the bone marrow; ‘myeloablative’ means it kills (ablates) marrow stem cells.

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

Clinical implicationsMAC produces profound marrow aplasia requiring stem cell rescue via transplantation and increases infection and toxicity risks during and after transplant.

Administration and Post-Transplant Notes

Product administration — Omisirge single dose; RegeneCyte within unrelated donor HPC transplantation (inv-17)

Omisirge administrationSingle administration of Omisirge given post‑myeloablative conditioning as the product is intended to be used in patients ≥12 years with planned umbilical cord blood transplantation.

RegeneCyte administration contextRegeneCyte is administered as part of unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution.

Post‑transplant duration limitsPolicy specifies single administration for Omisirge post‑MAC; no specific post‑transplant duration limitations are provided for services in the document.

Facility and Center Considerations

Note

Center and administrative compliance requirements

This clinical policy was developed by experienced and licensed health care professionals; providers must ensure care delivery complies with applicable Health Plan‑level administrative policies, state and federal requirements, and any other applicable administrative procedures.

Policy reflects standards of medical practice at time of approval and is a guide to medical necessity, not a guarantee of payment.
Follow Health Plan administrative policies and applicable legal/regulatory requirements when delivering services.

Clinical Background

Allogeneic hematopoietic cell transplantation (HCT) uses donor stem cells from related or unrelated healthy donors to replace a patient’s hematopoietic system after high‑dose conditioning therapies. Myeloablative conditioning regimens employ high‑dose chemotherapy, with or without radiation, that typically produce profound pancytopenia within one to three weeks and require stem cell infusion to restore marrow function. Because preparative regimens and transplantation carry substantial risks — including mucositis, infection from transient pancytopenia, organ toxicity, and increased morbidity in older or heavily pretreated patients — therapies that accelerate hematopoietic recovery (such as Omisirge and RegeneCyte in their approved indications) aim to reduce time to neutrophil, erythrocyte, and platelet recovery and lower infection risk, hospital days, and related complications.