On Tuesday, September 30, 2014, the Health Resources and Services Administration (HRSA), which administers the 340B program, published a Federal Register notice requesting comments on its proposal to collect certain Medicaid pricing and other data from participating manufacturers. HRSA seeks to collect this information in order to verify the accuracy of 340B ceiling prices calculated by manufacturers.

The notice proposes to require participating manufacturers to report the following quarterly pricing data to HRSA for each covered outpatient drug:

  • Average Manufacturer Price (AMP)
  • Unit Rebate Amount (URA)
  • Package Sizes
  • National Drug Code (NDC)
  • Manufacturer calculated ceiling price

The notice references the Affordable Care Act’s (ACA) amendment of the 340B statute as support for the proposed reporting requirement.  Specifically, HRSA cites the new requirement that the Secretary of Health and Human Services develop a system to verify 340B ceiling prices calculated by manufacturers. The notice states that HRSA has already developed a system to prospectively calculate 340B ceiling prices from data obtained from the Centers for Medicare and Medicaid Services (CMS) as well as commercial databases identified by HRSA.  HRSA will use the manufacturer-reported pricing data to compare the HRSA-calculated and manufacturer-calculated ceiling prices. The notice states that once any discrepancies between the manufacturer and HRSA-calculated prices have been resolved, HRSA intends to post validated ceiling prices on a secure Internet-accessible platform made available to registered covered entities.

In an apparent reference to the ACA’s amendment to the 340B statute to require the Pharmaceutical Pricing Agreement (PPA) to include the new ACA-based “must offer” language, the notice states that “By signing the PPA, the manufacturer agrees to comply with all applicable statutory and regulatory requirements, including any changes that occur after execution of the PPA.” (emphasis added).

HRSA requests comments on:

  • The necessity and utility of the proposed information collection for the proper performance of the agency’s functions,
  • The accuracy of the estimated burden on manufacturers of reporting these data (estimated at 0.50 hours per submission),
  • Ways to enhance the quality, utility, and clarity of the information to be collected, and
  • The use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The notice indicates that comments must be received no later than December 1, 2014.