340B Drug Pricing Program Final Rule Delayed … Again

Holland & Knight LLP
Contact

Holland & Knight LLP

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.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Holland & Knight LLP | Attorney Advertising

Written by:

Holland & Knight LLP
Contact
more
less

Holland & Knight LLP on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.