D-2.1. Day one

The formulary addition process begins when the drug manufacturer submits the completed COI requesting the inclusion of their drug to the TDCI. HHSC pharmacists start by reviewing the Centers for Medicare & Medicaid Services (CMS) rebate file (medicaid.gov/medicaid/prescription-drugs/medicaid-drug-rebate-program/) to determine if the drug has a rebate agreement. If the National Drug Code (NDC) is not on the CMS rebate file within six months, the process stops.

Next, staff will identify whether the U.S. Food and Drug Administration (FDA) includes the drug on the Orphan Drug Product designation database (accessdata.fda.gov/scripts/opdlisting/oopd).

HHSC pharmacists will determine if the drug is eligible as a clinician-administered drug (CAD) via the medical benefit.

• If the drug is not covered as a medical benefit, then staff proceed to Section 2.2.
• If the drug is covered as a medical benefit, staff use clinical expertise to determine if the CAD is appropriate for distribution through a pharmacy:
  • If the drug is not appropriate for distribution through a pharmacy, then it becomes a medical benefit and is not added to the TDCI (refer to Section 3).
  • If the drug is appropriate for distribution through a pharmacy, then staff proceed to Section 2.2.