The following information is provided to assist pharmaceutical drug manufacturers in complying with Chapter 441 of the Texas Health and Safety Code. The following does not constitute legal advice, and HHSC encourages manufacturers to consult with their own legal counsel.
These FAQs concern only the WAC report requirements that HHSC and DSHS are implementing at this time. FAQs concerning price increase reports will be issued at a later date.
What type of manufacturers are required to submit wholesale acquisition cost (WAC) information?
At this time, HHSC is collecting only the WAC pricing information for U.S. FDA-approved prescription drugs from drug manufacturers. HHSC will begin collecting additional information from drug manufacturers related to WAC increases at a later date.
Manufacturers required to report include:
- Manufacturers that identify as virtual manufacturers, or those that contract manufacturing to another entity;
- Manufacturers that hold a new drug application or an abbreviated new drug application with the Food and Drug Administration;
- Manufacturers that have a biological license application;
- Manufacturers of drugs listed in the United States Pharmacopeia/National Formulary;
- Companies that repackage drugs;
- Own label distributors; and
- Private label distributors.
What is WAC (wholesale acquisition cost)?
Wholesale acquisition cost is one of the ways prescription drugs are priced. WAC is sometimes referred to as the list price of a prescription drug and is what the drug manufacturer charges a drug wholesaler. WAC does not include any rebates, prompt pay, other discounts, or other reductions in price, nor does it reflect any health insurance coverage adjustments.
What types of manufacturers are not required to submit WAC information?
These reporting requirements do not apply to manufacturers of animal or veterinary drug products, outsourcing facilities, or producers of blood and blood components intended for transfusion.
Are medical gas manufacturers required to report?
Firms that manufacture prescription medical gases are required to report.
When are prescription drug manufacturers expected to begin submitting WAC pricing information?
For 2020 reporting, manufacturers may begin submitting data on Jan. 15, 2020. Beginning in 2021, the WAC reporting deadline is Jan. 15 of each year, and manufacturers will be required to submit their data no later than Jan. 15 each year.
What WAC pricing data is required to be submitted by Jan. 15 of each year?
Manufacturers should submit the WAC price in effect on Jan. 1 of each year for all NDCs.
How should the WAC price be reported?
The WAC price should be reported per unit applicable to dosage form.
What are the reporting requirements for a health benefit plan issuer under the Drug Cost Transparency law?
What are the reporting requirements for a pharmacy benefit manager under the Drug Cost Transparency law?
This is managed by TDI. Please contact TDI for more information.
How will information reported about prescription drug prices be used?
The information will be made available to the public through this website.
The cost of my drugs has gone up, but I can't find my drug on the report of price increases. Why?
HHSC is initially only collecting information on the WAC of prescription drugs. Information related to drug cost increases will be collected at a later date.
When will price increase data reported to HHSC become available to the public?
Once HHSC begins collecting price increase data, the data will be posted no later than 60 days after HHSC receives it.
Will I be able to download the report data?
HHSC is working to develop a mechanism for data to be easily downloaded in a usable file format. More information on downloading data will be available on this website.