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. “By failing to implement the final rule, drug manufacturers can continue to overcharge 340B hospitals by violating the ceiling price policy without repercussion,” AHA said. HRSA’s 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’s implementation date from July 1, 2018 to July 1, 2019. In addition, AHA expressed support for HRSA’s decision to codify its “penny pricing policy” to strengthen the agency’s oversight of 340B ceiling prices and to discourage manufacturers from raising prices faster than inflation. “We 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,” AHA said.