April 28, 2015—The Health Resources and Services Administration has asked drugmakers to verify by May 15 that their information in the 340B program database is complete and up to date. [ms-protect-content id=”2799″]
HRSA made the request in an April 24 “Dear Manufacturer” letter. It explained it was doing so in connection with the congressionally mandated system it is creating “to verify the accuracy of manufacturer-calculated 340B selling prices against HRSA’s calculated 340B ceiling prices.”
“As part of this process and to enhance program integrity, we are requesting that you verify the accuracy and completeness of the information on file for your organization in the 340B program database by May 15, 2015,” the letter states. “Making any necessary corrections today will promote the security and integrity of your sensitive pricing data, as well as facilitate the rollout of the system later this year.” The letter tells manufacturers to “review the database record for each of your labeler codes and submit a manufacturer change request form to 340Bpricing@hrsa.gov if any updates are necessary.”
A few days earlier, HRSA published a Federal Register notice inviting public comment about its plan to collect the following information from drug companies for the 340B price verification system:
- Average manufacturer price
- Unit rebate amount
- Package sizes
- National drug code
- Period of sale (year and quarter)
- Manufacturer-determined 340B ceiling price for each NDC produced by a manufacturer subject to a PPA
Those comments are due on May 21, 2015.
In late 2011, HRSA began requiring health care providers to recertify once a year that they are still eligible for the drug discount program and that all of their information in the 340B database is correct. Congress included this requirement for providers in the Affordable Care Act. There is no comparable statutory or regulatory requirement for drugmakers. [/ms-protect-content]