AHA to HRSA: Implement 340B Drug Ceiling Price Rule Without Further Delay

AHA today urged the Health Resources and Services Administration to implement without further delay its final regulation on 340B drug ceiling prices and civil monetary penalties for manufacturers. 鈥淏y failing to implement the final rule, drug manufacturers can continue to overcharge 340B hospitals by violating the ceiling price policy without repercussion,鈥 AHA said. HRSA鈥檚 rulemaking on these issues began eight years ago, and since January 2017, the implementation date for the final regulation has been delayed five times. Earlier this month, HRSA proposed to delay the rule鈥檚 implementation date from July 1, 2018 to July 1, 2019. In addition, AHA expressed support for HRSA鈥檚 decision to codify its 鈥減enny pricing policy鈥 to strengthen the agency鈥檚 oversight of 340B ceiling prices and to discourage manufacturers from raising prices faster than inflation. 鈥淲e look forward to working with HRSA on further guidance on the 340B ceiling reporting system and how 340B hospitals and covered entities can access ceiling price information to establish instances of manufacturer overcharging,鈥 AHA said.