Based on a notice posted on its Office of Pharmacy Affairs (OPA) website, the Health Resources and Services Administration (HRSA) intends to issue in 2015 proposed guidance addressing key policy issues raised by the various stakeholders committed to the integrity of the 340B program. This notice signifies HRSA’s abandonment of a much-awaited “Mega-Rule,” which had been touted as a comprehensive set of rules governing major aspects of the 340B Program. The “Mega-Rule” has been under review at the Office of Management and Budget (OMB) since April 2014, but reportedly was removed from OMB late last week. HRSA’s change in direction can be attributed to a court ruling earlier this year in which the U.S. District Court for the District of Columbia held that the agency lacked statutory authority to issue another 340B Program regulation known as the orphan drug rule. Please see prior Health Headlines articles for additional discussion of the case here, here, here, and here. Going forward, HRSA reportedly will pursue formal legislative regulations only when specific authority exists in the 340B statute. To that end, the OPA website notice states that HRSA will also propose regulations in 2015 addressing civil monetary penalties for manufacturers, calculation of 340B ceiling price, and the administrative dispute resolution process.  

Reporter, Tracy Weir, Washington, DC, +1 202 626 2923, tweir@kslaw.com.