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Bass, Berry & Sims hosted its 9th Annual Pharmacy, Pharma Services & 340B Seminar at our office in Nashville, Tennessee, on October 9-10. Our attorneys were joined by panelists from Every Cure, Orsini Pharmaceutical Services, Humana, PANTHERx, BioMatrix Specialty Infusion Pharmacy, Acelpa Health, and The Travis Group, LLC.
The Seminar welcomed in-house counsel, compliance officers, and executives from across the pharmacy, pharma services and 340B industry to hear from these sector leaders about the latest trends and regulatory challenges facing the industry.
Panelists and Bass, Berry & Sims attorneys shared insights across a range of timely topics. Here is a high-level recap of key themes and discussions from the event.
Market Overview
Bass, Berry & Sims attorneys Michael Hess, Shannon Wiley and Jeff Davis provided insight on the current state of the pharmacy, pharma services and 340B market and highlighted trending topics, including AI development, direct to consumer models and other alternative dispensing models, as well as an increase in state legislative activity affecting players in the market.
From Preparing for a Transaction to Signing a Letter of Intent
Shayan Ahmed and Michael Hess, Bass, Berry & Sims attorneys, outlined best practices for "setting the stage" for a successful transaction, including pre-deal planning and preparation. Pre-deal planning activity generally includes selecting investment advisors, financial strategy development, key issue identification and mitigation, and management team readiness. They also highlighted recent market trends, including increases in competitive bid processes, private equity players, healthcare material transaction filings and lead times.
Representations and Warranties Insurance
Bass, Berry & Sims attorneys Jon Stanley and Margaret Dodson outlined the process for obtaining representation and warranties (RWI) insurance in connection with a transaction, including what can and cannot be covered, monetary costs of RWI insurance as well as associated non-monetary burdens. They also provided insights into navigating the claims process post-closing with the RWI insurer.
Navigating Healthcare Material Transactions Laws
Bass, Berry & Sims attorney Jeanne Marie Evans provided an overview of the 15 states that have enacted statutes containing notification or approval requirements for various types of healthcare transactions and highlighted laws in California, Oregon, Indiana and New York. Jeanne Marie noted that while many of these laws are targeted at hospitals and/or physician practices, such laws may encompass pharmacies and infusion centers, as well as management arrangements. Bass, Berry & Sims has developed an interactive map available online with further information detailing requirements in various states.
Post-Closing Integration
Shelley Thomas, Bass, Berry & Sims attorney; Amanda Burand, Chief Compliance Officer of Acelpa Health; and Morgan Harber, Chief Administrative Officer of BioMatrix Specialty Pharmacy, discussed how to best prepare for post-closing business integration from a legal, compliance, and operational perspective. They addressed high-risk issues and difficulties, common pitfalls and helpful third-party resources to assist companies with successful integration. The panelists highlighted the importance of following a post-closing checklist prepared by legal counsel during a transaction to ensure that the parties meet all applicable legal requirements following closing.
State Policy Updates: PBM and 340B Legislation
Jeff Davis, Bass, Berry & Sims attorney, and Jack Linehan, General Counsel of the Pharmaceutical Care Management Association (PCMA), discussed the rise of state-level anti-payor regulation affecting pharmacy benefit managers (PBMs), third party administrators (TPAs), health plans, and health plan sponsors (e.g., employers and unions) in the drug benefit pace. The panelists highlighted the potential short- and long-term impacts of state-level anti-payor regulation and provided updates on recent legal challenges to these laws based on ERISA preemption and related grounds.
The Use of AI in Pharmacy: Market Overview and Ethics Considerations
Lindsey Fetzer, Bass, Berry & Sims attorney; Harry Travis, President of The Travis Group, LLC; Chris Petelle, VP and Associate General Counsel of Humana; and Grant Mitchell, Co-Founder of Every Cure, discussed the significant developments relating to the use of AI in pharmacy practices. The panelists outlined the growing trend of AI implementation in pharmacy operations, from prescription intake to medication dispensing. They further highlighted the potential risks of AI in pharmacies, including potential HIPAA implications.
Specialty Pharmacy and Manufacturer Services Arrangement
Bass, Berry & Sims attorneys Shannon Wiley, Dante Lizza and Jennifer Michael; Samatha Borden, Chief Legal Officer of PANTHERx; and Matt Behrens, Chief Compliance Officer of Orsini Pharmaceutical Services, discussed legal and compliance issues related to pharmacy services agreements with manufacturers. The panelists examined several novel services proposed by manufacturers; highlighted fraud, waste, and abuse implications; and outlined key compliance concerns that pharmacies must consider when entering into services agreements.
Federal Policy Updates: IRA and 340B Activities
Jeff Davis, Bass, Berry & Sims attorney, provided an update on recent developments concerning the Inflation Reduction Act (IRA) and 340B Program. Jeff discussed legal challenges, industry reactions to the IRA and manufacturer 340B restrictions, and the future of the 340B Program in light of such recent developments.
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