Last
week, the U.S. Department of Health and Human Services (HHS) proposed delaying
the effective date of its final rule on 340B drug ceiling prices and civil
monetary penalties for manufacturers to July 1, 2019. 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."