After completing the Medicaid NDRA with CMS, manufacturers must complete the Texas Drug Code Index (TDCI) Certification of Information (COI to request the addition of the drug on the Medicaid and CHIP formularies.
Refer to 1 TAC Section 354.1921 (Addition of Drugs to the Texas Drug Code Index) on the VDP website "Texas Administrative Code" page for more information.
Beginning April 1, 2021, drug manufacturers must use the browser-based electronic COI portal to submit their requests. Drug manufacturers must register for the ECOI portal using the ECOI Portal Access (HHS Form 1403).
Manufacturers use the ECOI portal when their drug is new to the market, an existing drug on the TDCI has a new formulation, or there are labeler changes. Manufacturers with products on the TDCI are responsible for using the ECOI to report these changes no later than the date the manufacturer schedules the revisions to occur.
Drugs submitted through the ECOI portal should include the manufacturer's name on the label of the container sold to the pharmacy and the NDC of the company holding the drug as its own. All drugs on the TDCI must bear the FDA-defined labeler code, except for licensed full-service drug wholesalers marketing the final sale to the provider.
Texas HHS requires the following information when considering a drug for inclusion on the TDCI:
- A rebate agreement with CMS with a listing on the MDRP (data.medicaid.gov/dataset/0ad65fe5-3ad3-5d79-a3f9-7893ded7963a)
- A listing on First Databank (FDB)
Refer to the Drug Addition Process for the timelines and processes HHSC staff follow to add drugs to the TDCI and to add clinician-administered drugs through the medical benefit.