HRSA again proposes delay for 340B drug ceiling price rule

The Health Resources and Services Administration today proposed delaying until July 1, 2018 the effective date of its final rule on 340B drug ceiling prices and civil monetary penalties for manufacturers. The final rule has been subject to multiple delays since January, and most recently was scheduled to take effect Oct. 1, 2017. The “additional time is needed to more fully consider previous objections regarding the timing of the effective date and challenges associated with complying with the rule, as well as other objections to the rule,” the notice states. Ashley Thompson, AHA senior vice president for public policy analysis and development, said, “Given the skyrocketing prescription drug price increases that have presented hospitals and their patients with remarkable challenges, the 340B program is as critical as it has ever been in helping eligible hospitals obtain a reduced price for outpatient drugs, allowing them to stretch scarce federal resources to expand and improve access to comprehensive health care services for our nation’s most vulnerable patients. This is why we are once again disappointed in the continued delay of the 340B ceiling price and civil monetary penalties rule. HRSA’s rulemaking on these issues began seven years ago, and 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.” Comments on the rule are due 30 days after it is published in the Federal Register.