HRSA Announces Delay of 340B Final Rule for CMPs and 340B Ceiling Price
On Friday, March 17, the Health Resources and Services Administration (HRSA) announced a delay of its 340B Final Rule (Final Rule) on Civil Monetary Penalties (CMP) and Calculation of the 340B Ceiling Price (340B Ceiling Price). The Final Rule, published in the Federal Register on January 5, 2017, will be delayed to May 22, 2017.
A copy of the announcement can be found here.
The Final Rule came after two proposed rules and comment periods issued in June 2015 and April 2016, respectively. See Huron’s client alert here for key points and considerations.
The provisions of the rule were to be effective March 6, 2017; however, the U.S. Department of Health and Human Services (HHS) issued a subsequent final rule (82 FR 12508 on March 6, 2017) delaying the effective date to March 21, 2017, in accordance with a January 20, 2017, memorandum from the assistant to the president and chief of staff, titled “Regulatory Freeze Pending Review.”
HHS recognized that the effective date was mid-quarter and stakeholders would need time to adjust systems, update policies and establish procedures. After further consideration, HHS would like to provide more time for the changes needed to help facilitate compliance. HHS is also inviting commenters to provide additional input on whether a longer delay of the effective date to October 1, 2017, is more appropriate.
HHS wants to ensure that the rulemaking “is coordinated with and takes into consideration overall 340B Program implementation.”
Huron will continue to monitor future 340B Program regulations and guidance, including the 340B Mega Guidance, and will provide updates when new regulations/guidance are released.