Implementation and Enforcement of 340B Final Rule Delayed
In a Federal Register notice scheduled to be published on March 20, 2017, the Health Resources and Services Administration (HRSA) announced that it will delay the effective date of the January 5, 2017 final rule (the Final Rule) that provided guidance on the calculation of drug ceiling prices and the imposition of civil monetary penalties on certain drug manufacturers participating in the 340B Drug Pricing Program. Arent Fox’s Health Care Counsel Blog previously featured an analysis of the Final Rule, which can be found here.
In this most recent announcement, HRSA indicated that it would delay the effective date of the Final Rule to May 22, 2017, and is actively seeking comment from the industry as to whether implementation should be further delayed to October 1, 2017. Comments on this proposal are due to the agency no later than April 19, 2017. Although HRSA did not provide specific details, it also indicated that regardless of whether the effective date of the Final Rule is delayed to May or October 2017, “enforcement will correspondingly be delayed.” This announcement provides both manufacturers and covered entities participating in the 340B Drug Pricing Program an opportunity to explain to the agency how their operations and systems will be impacted by the provisions of the Final Rule.
Arent Fox LLP’s Pharmaceutical & Device Compliance team regularly advises clients on commenting on proposed rules affecting the pharmaceutical industry, as well as on compliance with existing rules. If you have any questions or need assistance, please contact Stephanie Trunk or Erin Atkins in our Washington, DC office, Thomas Jeffry in our Los Angeles office, or the Arent Fox professional who regularly handles your matters.