2016 Expected to Be Monumental Year for 340B Drug Discount Program

December 7, 2015

Elizabeth S. Elson and Anil Shankar of Foley & Lardner LLP (Lexology, 12/7) examined “recent and upcoming key initiatives related to the 340B Program.” The 2016 regulatory agenda for the U.S. Department of Health and Human Services (HHS) includes the Health Resources Services Administration’s (HRSA's) mega-guidance, as well as HRSA’s planned final rule “related to the implementation of civil monetary penalties for drug manufacturers that overcharge 340B Program covered entities” and their proposed rule “regarding the 340B Program administrative dispute resolution process.” The HHS Office of Inspector General (OIG) issued a report concerning “shared savings arrangements between the Medicare program and 340B covered entities.” Also included in OIG’s 2016 Work Plan is a plan to “assess the risk of duplicate discounts for drugs purchased through the 340B Program that are paid through Medicaid managed care organizations (MCOs), and will describe states’ efforts to prevent them.”