The Health Resources & Services Administration (HRSA) published 340B Drug Pricing Program (340B Program) ceiling prices on April 1, 2019. 340B Program ceiling prices can now be accessed securely by 340B Program-participating covered entities through the HRSA Office of Pharmacy Affairs Information System (OPAIS). The newly posted prices can serve as a tool for covered entities to determine the maximum price they can be charged by a pharmaceutical manufacturer under the 340B Program.
This comes as a result of concerns raised by the U.S. Department of Health and Human Services (HHS) and the Office of Inspector General regarding instances where manufacturers were overcharging 340B Program-covered entities in 2010. As a result, in 2010 Congress created civil and monetary penalties for drug manufacturers that “knowingly and intentionally” overcharge covered entities for 340B Program drugs and mandated that the government calculate and make available to covered entities ceiling prices for 340B Program drugs as well as enforcement activities. However, there were several delays in implementing the rule and hospital groups brought a lawsuit against the agency. In November 2018, HHS announced that civil and monetary penalties would be enforced beginning January 1, 2019, and that pricing information would be collected from manufacturers and reviewed during the first quarter of 2019 to make 340B Program ceiling prices available April 1, 2019.
For more information regarding this new tool or other questions regarding the 340B Program contact Claire Torrella, Brian Bell or your trusted BKD advisor.