New 340B ADR Final Rule: Key Procedural Changes, Eligible Claims, Panel Requirements, Reconsideration Process
Recording of a 90-minute CLE video webinar with Q&A
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.
Outline
- Introduction: history of the final rule
- 2020 rule
- 2022 proposed rule
- The final rule (including key differences from the 2022 proposed rule)
- Statutory requirements
- Purpose
- Key revisions
- Eligible claims
- Procedural changes
- ADR panel composition
- Reconsideration process
- Others
- Impact on 340B ADR claims
- Those already pending as of the rule's effective date
- Those filed since the effective date
- 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
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
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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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
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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