HHS Proposes Further Delay for 340B Drug Ceiling Price Rule

The Department of Health and Human Services today proposed delaying to July 1, 2019 the effective date of its final rule on 340B drug ceiling prices and civil monetary penalties for manufacturers. In the proposal, HHS says it is in the process of developing policies to address drug pricing in government programs, including the 340B program, and “the Department believes it would be counterproductive to effectuate the final rule prior to issuance of additional or alternative rulemaking on these issues.” HHS will accept comments on the proposed rule for 15 days. In a statement, AHA Executive Vice President Tom Nickels said, "Given the skyrocketing prescription drug price increases that have presented hospitals and health systems 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. We are once again very disappointed in this proposed delay of the 340B ceiling price and civil monetary penalties rule, especially considering that HRSA began rulemaking on this issue more than seven years ago. While we appreciate that the Administration has stated a commitment to tackling high drug prices, these multiple delays are unjustified given the exhaustive rule development process that has already occurred. We urge the agency to implement this final rule without any further delay to shine needed light on drug company price increases. The irony is not lost on us that drug companies continue to push for increased reporting for hospitals and others while resisting any transparency on their part.”