Interested in training for your team? Click here to learn more

New 340B ADR Final Rule: Key Procedural Changes, Eligible Claims, Panel Requirements, Reconsideration Process

A live 90-minute CLE video webinar with interactive 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.

Wednesday, December 11, 2024 (in 4 days)

1:00pm-2:30pm EST, 10:00am-11:30am PST

or call 1-800-926-7926

This CLE webinar will closely examine the U.S. Department of Health and Human Services' Health Resources and Services Administration's (HRSA) long-awaited 340B Administrative Dispute Resolution (ADR) second final rule that became effective June 18, 2024, including key procedural changes intended to make the ADR process more accessible to covered entities. The panel will also offer best practices for navigating the new 340B ADR process.

Description

HRSA's long-awaited second take on a 340B ADR final rule became effective June 18, 2024 and was revised to make the 340B ADR process more accessible and less "trial-like" than its 2020 predecessor. While the final rule retains certain provisions of the November 2022 proposed rule, it also incorporates key revisions based on comments received in response to the proposed rule. Counsel should be clear on the changes to assist their clients with navigating the ADR process.

The 340B ADR process is an administrative process designed to assist covered entities and drug manufacturers in resolving certain disputes when good faith efforts at resolution between the parties have been exhausted and failed.

Key changes to the final rule include: (1) limiting claims to disputes involving overcharges, duplicate discounts, and diversion; (2) removing the requirements to follow the Federal Rules of Evidence and Civil Procedure; (3) removing the $25,000 minimum threshold for filing an ADR petition; (4) changing the agency affiliation requirements for ADR panel members; (5) permitting claims to proceed through the ADR process even if the claim is the same as or similar to a claim pending in federal court; and (6) establishing a reconsideration process for ADR panel decisions.

Listen as our authoritative panel of healthcare attorneys provides a comprehensive examination of the 2024 340B ADR final rule. The panel will discuss key provisions that were retained from the prior 340B ADR regulations and 2022 proposed rule and others that were added to the final rule based on comments. The panel will discuss ADR procedural changes and best practices for helping clients navigate these new requirements when making a claim.

READ MORE

Outline

  1. Introduction: history of the final rule
    1. 2020 rule
    2. 2022 proposed rule
  2. The final rule (including key differences from the 2022 proposed rule)
    1. Statutory requirements
    2. Purpose
    3. Key revisions
      1. Eligible claims
      2. Procedural changes
      3. ADR panel composition
      4. Reconsideration process
      5. Others
  3. Impact on 340B ADR claims
    1. Those already pending as of the rule's effective date
    2. Those filed since the effective date
  4. Practitioner takeaways

Benefits

The panel will review these and other important considerations:

  • What are key 340B ADR procedural changes in the final rule?
  • Does the 2024 final rule succeed in making the 340B ADR process more accessible and less "trial-like" than what was required in the 2020 rule?
  • What is the practical effect of the changes to the 340B ADR regulations?
  • What is the impact of the 2024 340B ADR final rule on pending litigation challenging the prior version of the 340B ADR regulations? Are there provisions of the 2024 340B ADR final rule that could be subject to new challenges in court?

Faculty

Cook, Emily
Emily J. Cook

Partner, Healthcare Regulatory & Compliance Practice Area Leader
McDermott Will & Emery

In addition to Ms. Cook’s role as a national authority on the 340B drug pricing program, she helps clients...  |  Read More

Davis, Jeffrey
Jeffrey I. Davis

Member
Bass Berry & Sims

Mr. Davis advises healthcare organizations on Medicare and Medicaid billing and reimbursement issues, with a special...  |  Read More

Attend on December 11

Cannot Attend December 11?

You may pre-order a recording to listen at your convenience. Recordings are available 48 hours after the webinar. Strafford will process CLE credit for one person on each recording. All formats include course handouts.

To find out which recorded format will provide the best CLE option, select your state:

CLE On-Demand Video