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 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.
Outline
- 340B program
- Dispute resolution process
- Final rule
- Manufacturer litigation
- Recent HHS advisory and recent enforcement measures
- Best practices
Benefits
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?
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
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
Mr. Davis provides clients with healthcare regulatory counsel on issues affecting healthcare providers, including Medicare and Medicaid billing and reimbursement. He assists hospitals, pharmacies, other healthcare providers and vendors on issues related to the federal 340B drug pricing program, including enrollment; contracting; audits; compliance with 340B, Medicare, and Medicaid requirements; and self-disclosures. Mr. Davis also provides clients with strategic advice related to public policy issues before the U.S. Congress and the administration, including drug pricing and nonprofit hospital issues.
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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
Beginning with a 2003 nationwide class action of independent pharmacies, Mr. Levitt began his journey to both understand all aspects of the drug space and develop skills relevant to multiple stakeholders. He has dedicated his practice to representing pharmacies, physician-dispensers, national provider associations, manufacturers, wholesalers, and plan sponsors. Mr. Levitt has an established track record of challenging abusive practices of pharmacy benefit managers and speaks at life sciences conferences across the country in an effort to share his firm’s specialized knowledge.
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