HRSA Expected to Propose Further Delay of 340B Drug Ceiling Price Rule

The Health Resources and Services Administration is expected to propose a further delay in the effective date of a final rule on drug ceiling prices and civil monetary penalties for manufacturers in the 340B drug savings program, according to a notice under review at the Office of Management and Budget. HRSA has delayed the effective date of the rule many times. The most recent delay, which was announced last August, set July 1 as the effective date for the rule. It is not clear what date HRSA will propose for the new effective date. AHA in September opposed any further delay of the rule. "Given the skyrocketing prescription drug price increases that have presented hospitals and patients with remarkable challenges, the 340B program is as critical as ever in helping expand and improve access to comprehensive health care services for vulnerable patients and communities,” said Joanna Hiatt Kim, AHA vice president of payment policy. “We would be very disappointed if another delay of the 340B ceiling price and civil monetary penalties rule is proposed, especially considering that HRSA began rulemaking on this issue eight years ago.”