The Health Resources and Services Administration (HRSA) June 1 released a final rule delaying the implementation of the 340B Drug Pricing Program ceiling price and manufacturer civil monetary penalties to July 1, 2019. The regulation was set to take effect on July 1, 2018. HRSA has delayed implementation of this final regulation numerous times [see Washington Highlights, May 4].
In this final rule, HRSA states that this delay will allow for additional rulemaking to consider alternative and supplemental regulatory provisions to the 340B program and that it would be counterproductive to effectuate the final rule prior to issuance of additional and alternative rulemaking on these issues. The June 1 rule also mentions that the Department of Health and Human Services (HHS) is developing new policies to address the rising costs of prescription drugs, which will include the 340B Program.
The AAMC submitted a comment letter opposing this delay [see Washington Highlights, May 25]. The letter stated, “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. There is no reasonable rationale for delaying its implementation yet again.”