Benefit and Prior Authorization Information for Omisirge

Attention: All Providers  

Effective date: July 1, 2026

Call to action: Texas Children's Health Plan (TCHP) would like to inform providers that 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 patients 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 patients 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 patients with one of the following diagnoses:

• Hematologic malignancies in patients who meet all the following criteria:
  • The patient is 12 years of age or older.
  • The patient 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 patient is receiving therapy to reduce the time to neutrophil recovery and the risk of developing infection.
  • The patient does not have a matched related or unrelated donor for allogeneic hematopoietic stem cell transplantation (HSCT).
  • The patient does not have a history of receiving prior allogeneic HSCT.
• SAA in patients who meet all the following criteria:
  • The patient is six years of age or older.
  • The patient has a confirmed diagnosis of SAA following a reduced intensity conditioning regimen (diagnosis code D611, D612, D6189, or D619).
  • The patient has a history of intolerance or failure to respond to immunosuppressive therapy.
  • The patient does not have a matched related or unrelated donor.

Note: Regardless of the diagnosis, the patient 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 patient for the following:

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

Next step for providers: Providers should share this information with their staff.

If you have any questions, please email Provider Relations atproviderrelations@texaschildrens.org. 

For access to all provider alerts:www.texaschildrenshealthplan.org/provideralerts.