On March 20, 2017, HHS issued an interim final rule further delaying until May 22, 2017, the effective date of a January 5, 2017, final rule for the 340B Drug Pricing Program that addresses the calculation of drug ceiling prices and imposition of civil monetary penalties on drug manufacturers who knowingly and intentionally charge a covered entity more than the ceiling price for a covered outpatient drug.  This is the second delay HHS has announced for this final rule.  The interim final rule also invited commenters to provide their views by April 19, 2017, on whether a longer delay of the effective date to October 1, 2017, would be more appropriate.

As previously reported here, the HHS Health Resources and Services Administration (HRSA) published a final rule on January 5, 2017, updating the price structure that drug manufacturers participating in the 340B Drug Pricing Program may charge to covered entities purchasing drugs under the Program.  HRSA also established in the final rule a maximum $5,000 civil monetary penalty per instance for manufacturers that knowingly and intentionally charge a covered entity more than the ceiling price for a covered outpatient drug. 

The provisions of the final rule were to become effective on March 6, 2017; however, HHS instead issued a subsequent final rule on March 6, delaying the effective date to March 21, 2017, in accordance with a January 20, 2017, executive order that froze the imposition of new Federal regulations.  In the March 20 interim final rule, HHS noted that after further consideration, in order to provide affected parties sufficient time to make changes to facilitate compliance, HHS decided to delay the effective date of the final rule to May 22, and is inviting comments on whether to delay that date further to October 1, 2017.  In addition, HHS indicated that since the effective date of the final rule has been moved to May 22, and may be further delayed, enforcement of the final rule would be correspondingly delayed. 

The interim final rule is available here.  Comments on the delay of the effective date to May 22 as well as comments on alternatively delaying the effective date until October 1, 2017, are due by April 19, 2017.