September 30, 2014 –The Office of Pharmacy Affairs published a notice in today’s Federal Register announcing plans to collect pricing information from manufacturers to help verify the accuracy of 340B ceiling prices, as required by the Affordable Care Act. [ms-protect-content id=”2799″]
In the notice, the Health Resources and Services Administration says it has already developed a system to prospectively calculate 340B ceiling prices from data obtained from the Centers for Medicare & Medicaid Services and OPA-identified commercial databases. However, to compare manufacturer-calculated prices to the prices calculated by the government, HRSA must require manufacturers to submit quarterly pricing data. The agency says it has developed a secure mechanism to receive manufacturer submissions and proposes to collect the following from manufacturers:
- Average manufacturer price
- Unite rebate amount
- Package sizes
- National drug code
- Manufacturer-determined 340B ceiling price for each product subject to a Pharmaceutical Pricing Agreement
HRSA also says that “once any discrepancies between the manufacturer and OPA-calculated prices have been resolved, the validated prices will be made available to registered covered entities via a secure Internet-accessible platform.”
OPA is requesting comments on the information collection, which will be due no later than Dec. 1, 2014. [/ms-protect-content]