Effective for dates of service on or after July 01, 2026, omidubicel-onlv (Omisirge) is now a covered benefit under Texas Medicaid when billed using procedure code J3590. Prior authorization will be required starting September 01, 2026.

Omidubicel-onlv (Omisirge) is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood. It is indicated for two patient populations. The first is clients who are 12 years of age or older with hematologic malignancies who are scheduled for umbilical cord blood transplantation (UCBT) following myeloablative conditioning, to help reduce the time to neutrophil recovery and lower the risk of infection. The second is clients who are six years of age or older with severe aplastic anemia (SAA), following reduced intensity conditioning. This treatment is administered once per lifetime.

Prior Authorization Requirements

Providers must submit prior authorization requests using the Special Medical Prior Authorization (SMPA) Request Form. Prior authorization may be approved for 12 months for clients who meet the criteria for one of the following diagnoses.

For hematologic malignancies, all of the following must be met: the client is 12 years of age or older, has a confirmed diagnosis of a high-risk hematologic malignancy and is scheduled for UCBT after a myeloablative conditioning regimen such as radiation and chemotherapy under diagnosis code D701, D708, D709, or Z9481, is receiving therapy to reduce the time to neutrophil recovery and the risk of infection, does not have a matched related or unrelated donor for allogeneic hematopoietic stem cell transplantation (HSCT), and has no history of prior allogeneic HSCT.

For SAA, all of the following must be met: the client is six years of age or older, has a confirmed SAA diagnosis following a reduced intensity conditioning regimen under diagnosis code D611, D612, D6189, or D619, has a history of intolerance or failure to respond to immunosuppressive therapy, and does not have a matched related or unrelated donor.

Regardless of 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 the infusion, providers must monitor the client for allergic reactions particularly in those with a history of antibiotic allergies, graft failure, graft-versus-host disease, engraftment syndrome, infections, secondary malignancies, and other post-transplant complications.
For more information, call the TMHP Contact Center at 800-925-9126.

Note: Texas Medicaid MCOs must provide all medically necessary Medicaid-covered services to enrolled members. Administrative procedures may differ from traditional Medicaid fee-for-service and from one MCO to another. Providers should contact the member's specific MCO for details.