M-3.2. Texas Drug Code Index

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:

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.

M-3.2.1. Acceptance to Medicaid and CHIP

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 individual 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 1 TAC Section 354.1921(c)(2) (Addition of Drugs to the Texas Drug Code Index). Further, the individual 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 1 TAC Section 354.1921(c)(2). Refer to the VDP website Texas Administrative Code page (txvendordrug.com/about/rules/texas-administrative-code) for more information.

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 

M-3.2.2. Acceptance to CSHCN Services Program

The Children with Special Health Care Needs Services Program is a comprehensive health benefits plan for low-income children with special health care needs. The program has an open formulary like Medicaid and is the payer of last resort for approximately 2,300 eligible people.

Refer to the contact information for questions related to program formulary coverage.

M-3.2.3. Acceptance to Healthy Texas Women Program

The HTW Program provides access to women's health and family planning services at no cost to eligible women in Texas. The program serves approximately 300,000 people annually. Women eligible for the HTW Program are:

  • At or below 200 percent of the federal poverty level Age 15 – 44
  • Not pregnant
  • Texas residents
  • United States citizens or qualified immigrants

The HTW Program is jointly funded by the state and federal governments.

HHSC must add the drug to the Medicaid formulary before adding it to the HTW formulary. 

The HTW drug rebate program covers products in the program. Participation in the rebate programs for HTW varies depending on the budget source used to pay for the original claim or encounter eligible for a rebate.

  1. Claims and encounters for clients under 18 (Rebate Programs called TWHP) are paid by the State of Texas General Revenue funding. Participation in this rebate program is voluntary with some exceptions.
  2. Claims and encounters for postpartum clients (Rebate Programs called HTW+) are paid by State of Texas General Revenue funding. Participation in this rebate program is voluntary with some exceptions.
  3. Claims and encounters for clients 18 and over (Rebate Program called HTW) are paid with Federal Funding and are subject to CMS federal rebate rules. Participation in this rebate program is mandated if the manufacturer has signed a National Drug Rebate Agreement with CMS.

Beginning Feb. 18, 2020, HHSC and CMS agreed to provide comprehensive women's health services through a Medicaid demonstration waiver over the next five years.

Refer to the contact information for questions related to program formulary coverage.

M-3.2.4. Healthy Texas Women Plus

The Healthy Texas Women Plus Program is an enhanced postpartum care services package for women in the HTW Program. The state-funded program began on Sept. 1, 2020.

HTW Plus services focus on treating major health conditions recognized as contributing to maternal morbidity and mortality in Texas, including postpartum depression and other mental health conditions, cardiovascular and coronary conditions, and substance use disorders, including drug, alcohol, and tobacco use. Eligible individuals meet the standard HTW eligibility criteria and have been pregnant 12 months before HTW enrollment.

M-3.2.5. Acceptance to Kidney Health Care Program

The Kidney Health Care Program is a CMS-designated State Pharmaceutical Assistance Program (SPAP) providing drug reimbursement for approximately 20,000 kidney dialysis and transplant patients. The program is one hundred percent state-funded. Its formulary is a closed formulary and contains medications related to end-stage renal disease. HHSC gives priority to manufacturers with signed rebate agreements.

Refer to the contact information for questions related to program formulary coverage.