HHSC will review the drugs submitted through the ECOI portal. Refer to the ECOI User Guide for detailed instructions about creating a new COI application, updating the COI after submission, and correct a returned COI application.

We use the National Average Drug Acquisition Cost (NADAC) to calculate pharmacy reimbursement in traditional Medicaid. If a manufacturer leaves a price field blank within the "Pricing Information" section of the ECOI, we will interpret this to mean the product does not have a price. Manufacturers should provide HHSC with their product's average manufacturer price (AMP) at the product's initial launch. If you do not, we require you to give the AMP within 30 days after the close of the calendar quarter when you calculate the AMP.

Manufacturers must provide pricing for any of the prices below within 10 days upon HHSC's request.

Manufacturers submit the following materials through ECOI portal, if applicable:

• FDA new drug application approval letter
• FDA abbreviated new drug application approval letter
• FDA over-the-counter monograph
• Copy of package insert
• Copy of Certificate of Liability Insurance
• Promotional material for physicians, if available
• Other additional applicable documents supporting responses, if available

Manufacturers must certify all drug information submitted through the ECOI is correct, and the product does not violate federal or state laws.

Manufacturers including false or incomplete information as part of their ECOI submission may be liable for civil or criminal penalties under state law, including Texas Human Resources Code, sections 36.052 and 37.10. The user submitting drugs in the ECOI must acknowledge the manufacturer's obligation to update HHSC with changes to formulation, product status, or availability as required by rule. Further, the user submitting through the ECOI must acknowledge the manufacturer's obligation to submit changes to the prices requested in the "Price Certification" section of the ECOI if requested by HHSC, by the tenth business day of the request as required by rule. Refer to TAC Section 354.1921 (Subchapter F: Addition of Drugs to the Texas Drug Code Index).

The drug review process takes up to 90 days once the submission is complete. If approved, HHSC adds the drug to the Medicaid formulary. If CHIP policy allows the drug, then we will also add it to the CHIP formulary. We will provide the manufacturer with one of the following responses:

• We approved your drug and the date we added it to the formulary
• We denied your drug and an explanation why