Frequently Asked Questions
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 DSHS encourages manufacturers to consult with their own legal counsel.
What type of manufacturers are required to submit wholesale acquisition cost (WAC) information?
Per HSC 441, a drug manufacturer subject to statutory reporting is 'any person engaged in the business of producing, preparing, propagating, compounding, converting, processing, packaging, labeling, or distributing a drug, must comply with reporting requirements (exception: the term does not include a wholesale distributor or retailer of prescription drugs or a pharmacist licensed under Subtitle J, Title 3, Occupations Code).
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 Prescription Drug Price Disclosure Program?
This is managed by the Texas Department of Insurance (TDI). For changes to the Insurance Code, see Chapter 1369. Please contact TDI for more information.
What are the reporting requirements for a pharmacy benefit manager under the Prescription Drug Price Disclosure Program?
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.
When will price increase data reported to DSHS become available to the public?
Price increase data is currently available on the Data Overview webpage. Price increase data is posted no later than 60 days after DSHS receives it.
Will I be able to download the report data?
All Annual WAC and Price Increase Report data is available in Excel format for download on the Data Overview webpage.
Texas Wholesale Acquisition Costs (WAC) Disclosure Questions
Do the Annual WAC Disclosure and Price Increase reports now use the same template?
In previous years there were two different templates. There are two separate templates for the Annual WAC Report and the Price Increase Report. The templates have similar formats with minor differences. Both templates are available at the Submit Your Data webpage.
On the Annual WAC template, can columns I and J (price increase and price increase %) be left blank for the annual WAC disclosure?
If there is a price increase above the statutory limit, data for columns I and J must be completed. Otherwise, they can be left blank. For directions on how to fill out the annual report page (step 7 in the user guide), view this document.
For research and development (R&D) costs, the field in the new template looks for a "yes/no" response for each national drug code (NDC). What is this for?
If there is a price increase above the statutory limit and the price increase involved R&D costs, you answer "yes" for this field. For directions on how to fill out the annual report page (step 7 in the user guide), view this document.
Prior submissions required manufacturers to provide a list of products which have either been U.S. Food and Drug Administration (FDA) approved or lost patent exclusivity over the previous three years. In the new template, are manufacturers required to respond to the FDA approved and lost patent exclusivity for each NDC reported?
If there is a price increase above the statutory limit, you need to answer FDA approval in the last three years and loss of patent exclusivity in the past three years. For directions on how to fill out the annual report page (step 7 in the user guide), view this document.
Step 7 of the user guide requests users to manually enter information for each NDC reported. Can this screen be left blank (press next button) and proceed to the Annual Reporting Attachments (step 8 in the user guide) to attach one file with all the reportable NDCs? Does the website prevent a manufacturer from moving past step 7 if no information is entered?
Manufacturers can either individually enter their products on the annual report page (step 7 in the user guide) or attach and upload the approved annual report template on the attachments page (step 8 in the user guide). For directions on how to fill out the annual report page, view this document.
Will an invoice be generated to send through finance for payment?
No. Once the fee payment function is available, the system will not generate an invoice. Once the payment is collected, a receipt will be generated.
How are fee payments made to the Prescription Drug Price Disclosure Program?
Fee payments are made through the online system. Fee payment applications will appear on the main menu of the account once the report applications are submitted and approved. Payments can be made using credit card or electronic check (ACH). Once payment is made in the system, an electronic receipt is generated and emailed. All fee payments must be made online on the payment application. Physical checks are not an acceptable form of payment.
What is the reporting fee structure — flat fee report submitted or fee per NDC submitted?
There is a flat fee of $250 per report with an $8 transaction fee. The total fee for each report is $258.
Are there examples of a populated template with WAC disclosure data, patent expiration, FDA approval and R&D costs as part of the user guide?
Yes. To see an example of the Annual WAC Report template, view this document.
Texas Price Increase Questions
Why is the "Price Change Reporting" option (noted in the user guide) not available?
Price change reporting is now available. To submit a price change report, log in to the online licensing services webpage.
Are there examples of a populated template with the price increases?
Yes. To see an example of the Price Increase Report template, view this document.