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Benefit and Prior Authorization Information for Omidubicel-onlv (Omisirge)

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Effective for dates of service on or after July 1, 2026, omidubicel-onlv (Omisirge) is a benefit of Texas Medicaid when providers submit a claim with procedure code J3590. Prior authorization will be required beginning September 1, 2026.

Omidubicel-onlv (Omisirge) is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood. It’s indicated for the following:

  • Hematologic malignancies in clients who are 12 years of age or older and are scheduled for umbilical cord blood transplantation (UCBT) following myeloablative conditioning to reduce the time to neutrophil recovery and the risk of developing infection
  • Severe aplastic anemia (SAA) in clients who are six years of age or older, following reduced intensity conditioning

Omidubicel-onlv (Omisirge) infusion treatment is administered once per lifetime.

Prior Authorization Requirements

Providers must submit prior authorization requests for omidubicel-onlv (Omisirge) on the Special Medical Prior Authorization (SMPA) Request Form.

Prior authorization for omidubicel-onlv (Omisirge) may be approved for 12 months for clients with one of the following diagnoses:

  • Hematologic malignancies in clients who meet all the following criteria:
    • The client is 12 years of age or older.
    • The client has a confirmed diagnosis of a high-risk hematologic malignancy and is scheduled for UCBT after undergoing a myeloablative conditioning regimen, such as radiation and chemotherapy (diagnosis code D701, D708, D709, or Z9481).
    • The client is receiving therapy to reduce the time to neutrophil recovery and the risk of developing infection.
    • The client does not have a matched related or unrelated donor for allogeneic hematopoietic stem cell transplantation (HSCT).
    • The client does not have a history of receiving prior allogeneic HSCT.
  • SAA in clients who meet all the following criteria:
    • The client is six years of age or older.
    • The client has a confirmed diagnosis of SAA following a reduced intensity conditioning regimen (diagnosis code D611, D612, D6189, or D619).
    • The client has a history of intolerance or failure to respond to immunosuppressive therapy.
    • The client does not have a matched related or unrelated donor.

Note: Regardless of the diagnosis, the client must not have a known sensitivity to dimethyl sulfoxide, Dextran 40, gentamicin, human serum albumin, or bovine material.

Required Monitoring Parameters

After omidubicel-onlv (Omisirge) infusion, providers must monitor the client for the following:

  • Allergic reactions, particularly in clients with a history of allergic reactions to antibiotics
  • Graft failure
  • Graft-versus-host disease
  • Engraftment syndrome
  • Infections
  • Secondary malignancies
  • Other post-transplant complications

For more information, call the TMHP Contact Center at 800-925-9126.

Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to Medicaid members who are enrolled in their MCO. Administrative procedures, such as prior authorization, precertification, referrals, and claims and encounter data filing, may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the member’s specific MCO for details.