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Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

    Intermediate

  • work Practice Area

    Health

Date & Time
  • event Date

    Wednesday, December 11, 2024

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.

$297.00
CLE
ALL

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.

Faculty

Jeffrey I. Davis
Member
Bass Berry & Sims Plc

Mr. Davis advises healthcare organizations on Medicare and Medicaid billing and reimbursement issues, with a special focus on the federal 340B drug pricing program. He also counsels clients on emerging healthcare regulatory issues, including COVID-19 relief funding, surprise medical billing, and hospital price transparency, and provides strategic insights to clients on public policy matters under consideration by the U.S. Congress and federal agencies, such as drug pricing policy and nonprofit hospital issues. Mr. Davis forged his deep knowledge of the 340B program and other Medicare and Medicaid reimbursement issues while working in the federal public policy arena. He spent more than seven years working as vice president and legislative and policy counsel for 340B Health, an association of more than 1,400 hospitals and health systems participating in the 340B program. In this role, he provided technical assistance to member hospitals, directed research and policy efforts, and helped lead government relations efforts to educate federal policymakers on 340B issues. Mr. Davis draws on this experience to advise hospitals, pharmacies, other provider organizations and vendors on 340B issues including enrollment, contracting, audits, compliance and self-disclosures.

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Emily J. Cook
Partner, Healthcare Regulatory & Compliance Practice Area Leader
McDermott Will & Emery, LLP

In addition to Ms. Cook’s role as a national authority on the 340B drug pricing program, she helps clients navigate the full suite of federal and state regulations that are essential to healthcare operations. Ms. Cook partners with a wide range of organizations, including non-traditional service providers and new market entrants to identify, protect and expand revenue opportunities, including via private-equity-backed ventures. Her comprehensive counsel encompasses evolving issues such as No Surprises Act implementation, development of new provider types, Medicare provider-based and co-location rules, and trends in qui tam litigation and government investigations. Ms. Cook’s deep insights into U.S. healthcare regulation stem from her previous tenure at the HHS Health Resources and Services Administration.

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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.

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?