Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to eligible clients. Administrative procedures such as prior authorization, pre-certification, referrals, and claims/encounter data filing may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the client's specific MCO for details.
Effective for dates of service on or after July 1, 2018, Luxturna (procedure code C9032) is a benefit of Texas Medicaid for clients ages 1 to 65.
Luxturna is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy who have viable retinal cells in each eye as determined by the treating physician.
Luxturna (procedure code C9032) is a benefit for ophthalmologist and durable medical equipment (DME) pharmacy providers when provided in the office or outpatient hospital setting.
Procedure code C9032 is limited to one dose per eye, per lifetime.
Prior Authorization Requirements
Procedure code C9032 requires prior authorization. A Special Medical Prior Authorization (SMPA) Request Form must be completed, signed, and dated by the prescribing provider and will not be accepted beyond 90 days from the date of the prescribing provider's signature.
Note: Prior authorization is not required for the physician services associated with the administration of Luxturna. Physician services include the procedural costs and the associated supplies for administration of the medication.
Prior authorization is valid for six months after the approval date.
If Luxturna is dispensed by a DME pharmacy via white bagging, the prescribing provider must provide the prior authorization number to the dispensing DME pharmacy. The dispensing DME pharmacy may not request prior authorization.
The dispensing DME pharmacy will be responsible for obtaining the prior authorization number from the prescribing provider.
The prescribing provider (physician or hospital) may coordinate with the DME pharmacy provider for the initial prior authorization request for Luxturna™. DME pharmacy providers may assist in providing necessary information such as their National Provider Identifier (NPI), fax number, and business address to the prescribing provider. However, the Special Medical Prior Authorization (SMPA) Request Form must be submitted by the Medicaid-enrolled prescribing provider, not the DME pharmacy provider.
Prior Authorization Criteria
Prior authorization for procedure code C9032 will be considered when all of the following criteria is met:
- Client is between the ages of 1 to 65
- There is a documented diagnosis of a confirmed biallelic RPE65 mutation-associated retinal dystrophy (e.g., Leber’s congenital amaurosis subtype 2, retinitis pigmentosa, early onset severe retinal dystrophy)
- Genetic testing documents biallelic mutations of the RPE65 gene
- Systemic corticosteroids equivalent to prednisone 1 mg/kg/day are administered for a total of 7 days, starting 3 days before administration of Luxturna to each eye and followed by a tapering dose
- Client has viable retinal cells in each eye as determined by the treating physician, assessed in the previous 6 months. Verification of viable retinal cells must be documented and evident by one of the following:
- An area of retina within the posterior pole of greater than 100 μm thickness shown on optimal coherence tomography
- Greater than or equal to 3 disc areas of retina without atrophy or pigmentary degeneration within the posterior pole
- Remaining visual field within 30 degrees of fixation as measured by a III4e isopter or equivalent
- Client has not previously received RPE65 gene therapy in the intended eye
- Injection of the second eye must be administered at least 6 days after the first eye
- For each eye indicated for treatment, the client must not have had intraocular surgery within 6 months
Luxturna must be prescribed and administered by a retinal surgeon at an ocular gene therapy treatment center with experience performing intraocular surgery.
When submitting a claim for procedure code C9032, the dispensing DME pharmacy must include the prior authorization number on the claim form. The DME pharmacy provider submitting the claim must be identified in “Section D: Service provider or facility information” of the prior authorization request. The dispensing DME pharmacy will not be reimbursed unless the prior authorization request has been approved.
Note: DME pharmacy providers may refer to the current Texas Medicaid Provider Procedures Manual, Appendix B: Vendor Drug Program, subsection B.3.5.1, “Pharmacy Delivery Method for Clinician-Administered Drugs,” for more information about white bag delivery.
For more information, call the TMHP Contact Center at 800-925-9126.