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340B Program Latest Developments: 340B-Related Litigation, HHS Advisory Opinion, New Dispute Process Final Rule

Recording of a 90-minute CLE video webinar with Q&A

This program is included with the Strafford CLE Pass. Click for more information.
This program is included with the Strafford All-Access Pass. Click for more information.

Conducted on Wednesday, June 30, 2021

Recorded event now available

or call 1-800-926-7926

This CLE course will guide healthcare counsel on the recent developments related to the 340B program. The panel will discuss what these developments mean for healthcare providers and drug manufacturers. The panel will address the new dispute resolution process, recent litigation, and recent U.S. Department of Health and Human Services (HHS) actions.


In December 2020, the HHS, Health Resources and Services Administration (HRSA) issued a long-awaited final rule for the 340B drug pricing program dispute resolution. The final rule establishes an administrative dispute resolution (ADR) process for drug manufacturers and 340B covered entities. The final rule may also play a role in connection with current 340B litigation related to manufacturer attempts to limit the use of 340B contract pharmacy arrangements.

Also, in December 2020, the HHS Office of the General Counsel released an advisory opinion indicating that the 340B statute requires drug manufacturers to offer 340B discounts on covered outpatient drugs dispensed through contract pharmacies.

Several drug manufacturers filed legal challenges to the final rule and the advisory opinion. The district court judge granted a preliminary injunction as to the implementation of the final rule in one of these challenges. In that case, the court determined the manufacturer established with a fair likelihood of success that HHS violated Administrative Procedure Act requirements in issuing the final rule and likely suffered irreparable harm.

In response to the on-going litigation, HHS indicated that it may take administrative measures to enforce 340B program rules and, among possible actions, prevent drug makers from denying discounts when healthcare providers use contract pharmacies. In May 2021, HRSA sent letters to six manufacturers notifying them that their actions were in violation of the 340B statute, ordering them to resume offering 340B pricing and issue refunds, and referencing the possibility that civil monetary penalties would be imposed if the manufacturers continued their behavior.

Listen as our authoritative panel of healthcare attorneys examines the recent developments related to the 340B program and what they mean for healthcare providers and drug manufacturers. The panel will address the new dispute resolution process, recent litigation, and recent HHS actions.



  1. 340B program
  2. Dispute resolution process
    1. Final rule
    2. Manufacturer litigation
  3. Recent HHS advisory and recent enforcement measures
  4. Best practices


The panel will review these and other key issues:

  • What is the dispute resolution process under the new final rule?
  • What do the manufacturers' challenges mean for implementation of the final rule?
  • What do the recent developments mean for future contract pharmacy arrangements?


Cook, Emily
Emily J. Cook

McDermott Will & Emery

Ms. Cook focuses her practice on providing complex regulatory and reimbursement counsel to health care providers...  |  Read More

Davis, Jeffrey
Jeffrey I. Davis

Of Counsel/Senior Advisor
Baker Donelson Bearman Caldwell & Berkowitz

Mr. Davis provides clients with healthcare regulatory counsel on issues affecting healthcare providers, including...  |  Read More

Levitt, Jonathan
Jonathan E. Levitt

Founding Partner
Frier Levitt

Beginning with a 2003 nationwide class action of independent pharmacies, Mr. Levitt began his journey to both...  |  Read More

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