CurrentFidelis CarePolicy MC.CP.MP.249

Allogeneic Hematopoietic Progenitor Cell Therapy

Medical necessity criteria for FDA‑approved allogeneic hematopoietic progenitor cell therapies (Omisirge/omidubicel and RegeneCyte/HPC Cord Blood) for applicable Medicare health plans; defines who is eligible and the clinical circumstances for coverage.

Policy Summary

PayerFidelis Care

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy MC.CP.MP.249

Change TypeAdded RegeneCyte criteriaMedicare applicability noted

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation showing age, diagnosis, planned transplant type, preparative regimen, and single post‑conditioning administration as applicable.

SourceLink

POLICY UPDATE CHANGES

Medicare was added to health plans in Policy/Criteria I and RegeneCyte criteria (Criteria II) were added to the policy.

Description updated to note the absence of coverage criteria from CMS.

≥12Minimum age for Omisirge use

125Omisirge trial enrollees

87%Neutrophil recovery (Omisirge)

Apr 2023Omisirge FDA

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Coverage Criteria

inv-01: Omisirge — Initial coverage criteria

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

Omisirge medical necessity 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.

From Policy/Criteria I (Omisirge).

inv-02: RegeneCyte — Initial coverage criteria

RegeneCyte is covered when ALL of the following are met:

RegeneCyte medical necessity 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.

From Policy/Criteria II and RegeneCyte FDA approval text.

This policy was revised to expand coverage from a single product focus (Omisirge) to include a second FDA‑approved cord blood–derived allogeneic hematopoietic progenitor cell therapy, RegeneCyte. The expansion is documented as an added Criteria II set for RegeneCyte and an updated background to reflect RegeneCyte information. The change is material to the policy because it modifies the scope of covered products and adds new medical necessity criteria for an additional product class. Providers should note that eligibility and medical necessity must be determined separately for each product using the specific criteria sets now included in the policy (Omisirge criteria and RegeneCyte criteria).

The policy does not include explicit statements listing services as “not medically necessary.” The coding section reiterates that referenced CPT/HCPCS codes (including J3590 and C9399) are provided for informational purposes only and that inclusion or exclusion of codes in the policy text does not constitute a guarantee of coverage. Providers must rely on the written medical necessity criteria in this policy — and on payer-specific prior authorization guidance — rather than assuming coverage based solely on coding lists.

Coding and Billing

HCPCS referencedHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Neutrophil recovery time (median)

Omisirge (omidubicel) median neutrophil recoveryMedian 12 days to neutrophil recovery (randomized study; 87% achieved recovery).

RegeneCyte — Study 1 (COBLT) median neutrophil recoveryMedian 27 days to neutrophil recovery among 324 patients.

RegeneCyte — Study 2 median neutrophil recoveryMedian 25 days to neutrophil recovery in pooled literature/registry review (n=1,299).

RegeneCyte — Study 3 median neutrophil recoveryMedian 22 days to neutrophil recovery in observational database (n=54).

Prior Authorization & Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests will be reviewed for medical necessity per the policy criteria for Omisirge (omidubicel) and RegeneCyte. Authorization must be obtained prior to service.

Prior authorization required for Omisirge and RegeneCyte

Step Therapy

Step Therapy / Coding Note

No step therapy applies to these therapies. Billers should use HCPCS guidance: J3590 (Unclassified biologics) and C9399 (Unclassified drugs or biologicals) when applicable; include supporting documentation and the drug/biologic name and NDC when available to facilitate correct adjudication.

No step therapy for Omisirge or RegeneCyte
Use HCPCS J3590 or C9399 as appropriate — include drug name and NDC when available

Candidate Eligibility Criteria

inv-14: Omisirge candidates

Omisirge candidate criteria

Omisirge candidate eligibility: Member >= 12 years, hematologic malignancy, planned umbilical cord blood transplantation following myeloablative conditioning, request for single post-conditioning administration.

Policy/Criteria I.

inv-15: RegeneCyte candidates

RegeneCyte candidate criteria

RegeneCyte candidate eligibility: Planned for unrelated donor hematopoietic progenitor cell transplantation; use of an appropriate preparative regimen for hematopoietic and immunologic reconstitution in conjunction with the transplantation procedure; disorder affecting the hematopoietic system that is inherited, acquired, or resulting from myeloablative treatment.

Policy/Criteria II and RegeneCyte approval summary.

Definitions

Myeloablative conditioning (MAC)

Definition of myeloablative conditioning (MAC)A preparative regimen (single agent or combination) anticipated to destroy hematopoietic cells in the bone marrow, producing extensive pancytopenia typically within one to three weeks and usually irreversible.

Clinical consequenceMAC causes high risk of profound, typically irreversible pancytopenia and substantially increased infection risk during and after transplant.

Documentation expectationPolicy requires documentation that the planned transplant is following a myeloablative conditioning regimen for products indicated post‑MAC.

Background and Rationale

Allogeneic hematopoietic cell transplantation (HCT) uses donor hematopoietic progenitor cells after a preparative regimen to rescue bone marrow function and reconstitute the immune system. Myeloablative preparative regimens cause profound, typically irreversible pancytopenia and high infection risk in the early post‑conditioning period; therapies that shorten time to neutrophil and hematopoietic recovery can reduce morbidity and infection‑related complications. Omisirge (omidubicel) and RegeneCyte are cord blood–derived allogeneic hematopoietic progenitor cell therapies intended to be administered in the peritransplant setting to accelerate recovery of neutrophils and other blood lineages following myeloablative or otherwise appropriate preparative regimens.

Contraindications

This policy does not list any absolute or relative contraindications. Safety considerations and detailed product‑specific warnings and contraindications are referenced to the manufacturers’ package inserts and FDA materials cited in the background and references. Clinicians should consult the current FDA prescribing information and product labeling for each therapy (Omisirge or RegeneCyte) for up‑to‑date contraindications, warnings, and precautions when planning treatment.

Pre-Transplant Evaluation Requirements

Documentation Required

HCT evaluation and preparative regimen documentation required

Document standard HCT evaluation and explicitly record the preparative regimen type; for Omisirge and RegeneCyte, the plan must indicate myeloablative conditioning status (Omisirge) or an appropriate preparative regimen (RegeneCyte) as part of transplant planning.

Include documentation of standard HCT evaluation results and transplant candidacy.
Record the preparative regimen and whether it is myeloablative conditioning (MAC) when applicable.
Document planning for the post‑conditioning product administration (single administration for Omisirge).

Transplant Center Requirements

Note

No explicit center accreditation or volume requirements

The policy does not specify any transplant center accreditation, minimum procedural volume, or FACT accreditation requirements; no center‑level prerequisites are stated.

Absence of explicit transplant center accreditation or volume requirements in the policy text.

Post-Transplant Coverage

Allogeneic hematopoietic progenitor cell therapy (product administration)

Omisirge administrationSingle administration of Omisirge is indicated post‑myeloablative conditioning in patients undergoing umbilical cord blood transplantation (per Omisirge criteria).

RegeneCyte use contextRegeneCyte is used in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution (not limited to single‑dose language).

Post‑conditioning requirementRequests must document that product administration is planned in the post‑conditioning transplant setting (single post‑conditioning administration required for Omisirge).