Enforcement of Manufacturer Overcharge Penalty Rule Delayed Until July 1, 2018; HRSA Might Propose New Rule

By , Published On: October 17, 2017

HRSA has finalized its proposal to delay enforcement of its final rule imposing civil monetary penalties (CMPs) on manufacturers that overcharge 340B program covered entities until July 1, 2018.[1]  The rule, which Congress directed HRSA to develop within six months of passage of the Affordable Care Act back in 2010, was finalized on January 5, 2017.[2]  HRSA has delayed implementation of the CMP rule four times since then.

The agency also submitted a new proposed rule to the Office of Management and Budget on October 6, 2017 that apparently will address both the overcharge CMPs and the 340B ceiling price spot check tool required under the Affordable Care Act.[3]  It is unclear whether the new proposed rule will modify the CMP final rule or replace it entirely.  HRSA reportedly is nearing implementation of another Affordable Care Act requirement – that covered entities be given the means to verify the 340B ceiling price of drugs they purchase – but the new proposed rule could delay that release.[4]

If you would like to learn more, contact Jason Reddish, Michael Glomb, or the Feldesman Tucker attorney with whom you usually work.  Follow us on Twitter and Facebook for more updates.


[1] 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation, 82 Fed. Reg. 45,511 (Sept. 29, 2017).

[2] See Karan, Elizabeth J. and Glomb, Michael B., HHS Releases the Final 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation (Jan. 6, 2017), at https://www.feldesmantucker.com/hhs-releases-final-340b-drug-pricing-program-ceiling-price-manufacturer-civil-monetary-penalties-regulation/; see also 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation, 82 Fed. Reg. 1,210 (Jan. 5, 2017); 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation, 82 Fed. Reg. 12,508 (Mar. 6, 2017); 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation, 82 Fed. Reg. 14,332 (Mar. 20, 2017); 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation, 82 Fed. Reg. 22,893 (May 19, 2017).

[3] See Office of Management and Budget, Office of Information and Regulatory Affairs, at https://www.reginfo.gov/public/do/eoDetails?rrid=127613.

[4] 42 U.S.C. § 256b(d)(1)(B)(iii).