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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.
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