Changes to the rules governing calculation of the ceiling price and application of civil monetary penalties under the 340B drug pricing program will not be implemented until October 1, 2017 under a rule published by the Health Resources and Services Administration (HRSA) on May 19, 2017. The rule initially was scheduled to go into effect March 6, 2017, but the Trump Administration had pushed that date back to May 22 while the additional delay was contemplated. HRSA noted that while many commenters supported the October 1, 2017 date, some commenters opposed the delay due to concerns that it "would result in a lack of oversight, regulation and basic enforcements for manufacturers, which would continue to hamper the 340B Program and lessen covered entities' ability to stretch scarce resources." The Trump Administration "disagrees that further delay of the final rule would result in a lack of oversight, regulation, and basic enforcements for manufacturers," however, and instead continues to believe that delay "is necessary to provide adequate time for compliance and to mitigate implementation concerns."
This article is presented for informational purposes only and is not intended to constitute legal advice.
