June 11, 2018

340B Drug Pricing Program Final Rule Delayed … Again

Holland & Knight Healthcare Blog

In a notice published on June 5, 2018, the Health Resources and Services Administration (HRSA) announced that the January 2017 340B Drug Pricing Program final rule (the “Final Rule”) will again be delayed. The Final Rule, which had an original intended implementation date of March 2017, is further delayed until July 1, 2019. This is the fifth postponement of the Final Rule by HRSA. According to the notice, the delay is to “allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for any additional rulemaking.”

The 340B Drug Pricing Program permits certain hospitals and other health care providers (known as “covered entities”) to purchase “covered outpatient drugs” from manufacturers at a discount. The Final Rule, which applies to all drug manufacturers that are required to offer discounts under the 340B Drug Pricing Program, establishes a process for calculating the ceiling price for drugs purchased under the program and civil monetary penalties for manufacturers that charge in excess of such prices.

Related Insights