The AAMC May 21 submitted a comment letter in response to the Health Resources and Services Administration’s (HRSA) notice to further delay the 340B Drug Pricing Program’s rule addressing drug manufacturers ceiling prices and the imposition of civil monetary penalties [see Washington Highlights, May 4]. The AAMC opposes HRSA’s decision to defer the effective date of this final rule to July 1, 2019, and urges HRSA to implement the provisions on July 1, 2018, as is currently required.
HRSA is proposing to delay yet again the effective date for the 340B regulation that increases transparency on manufacturers’ calculations of the ceiling prices for covered outpatient drugs and imposes civil monetary penalties for pharmaceutical manufacturers that “knowingly and intentionally” charge a covered entity more than the ceiling price. HRSA has delayed the implementation date numerous times, now proposing to further extend the effective date to July 1, 2019.
Requiring manufacturers to submit drug pricing information will allow HRSA to exercise its oversight authority over manufacturers’ ceiling price calculations. The Health and Human Services (HHS) Office of Inspector General (OIG) notes that this lack of transparency leaves 340B providers unable to determine whether they are paying accurate amounts to drug manufacturers. Implementing the final rule will be a major step in holding drug manufacturers accountable for ensuring covered entities are able to verify the ceiling price and that pricing for covered outpatient drugs does not exceed the 340B ceiling price.
Additionally, the AAMC joined five other hospitals associations on a group letter urging HRSA to implement this final rule immediately. The letter states, “Given that there is every reason to believe that the problem of 340B overcharges continues, it is inappropriate to postpone this rule. HHS’s interest in conducting additional rulemaking is not a sufficient reason to not enforce current law, especially one that is so vital to the nation’s safety net.”