D-3.1.1. Begins Day 1

Clinician-administered drugs (CAD) or biologicals, also known as physician-administered drugs, are injectable medications given in an office or outpatient clinic setting when oral medications are inappropriate. CADs may be reimbursable as a medical benefit through Medicaid. HHSC reviews newly-released Healthcare Common Procedure Coding System (HCPCS) codes for CADs and biologicals. If VDP pharmacists determine the CAD is appropriate for Medicaid, then the HCPCS codes are presented at a rate hearing as part of the process to become a benefit.

A COI application is not necessary for staff to initiate a review of the drug. HHSC's review of any new CAD does not guarantee the new CAD will become a benefit. HHSC follows the following steps to approve CADs after FDA approves the drug and assigns the NDC:

1. The drug manufacturer signs a rebate agreement with CMS. Once the drug is identified on the CMS rebate file, HHSC begins a clinical and fiscal review for providing the drug benefit.
2. The drug manufacturer submits an application to CMS for the assignment of an HCPCS code. Once assigned, Texas Medicaid receives the newly-created HCPCS code on the quarterly CMS file.
3. Medicaid works with HHSC Rate Analysis to determine the fiscal impact and assign a rate to the drug through the interim process.