Specialty Pharmacy Law Conference

This unique, one-day conference is intended for general counsel and in-house counsel for national and regional specialty pharmacies, manufacturers, practicing attorneys in health care law, compliance officers, and executives. Presentations will cover current legal and regulatory requirements and the extraordinary complexities associated with operating a specialty pharmacy.

Attendees can receive continuing legal education credits as well as pharmacy continuing education (CE) credits:

8.0 general credits in 60-minute states.

9.5 general credits in 50-minute states.


MONDAY, September 19th
Time	Session/Event
7:00 AM - 7:45 AM	Registration/Breakfast
7:45 AM - 8:00 AM	Welcome
8:00 AM - 9:00 AM	Establishing a Legally Compliant Referral Network
Location: Lafayette 3
Faculty: Jeffrey S. Baird, JD (Brown & Fortunato) Martin R. Dix, JD (Akerman) Karla L. Palmer, JD (Hyman Phelps & McNamara PC)
This program will discuss the federal anti-fraud laws that pharmacies must follow, including Stark, the AKS, the False Claims Act, the beneficiary inducement statute, and The Travel Act. The program will also discuss examples of state anti-fraud laws. The program will then pivot to a discussion of the types of relationships that are legally permissible … and those that should be avoided. Examples of relationships to be discussed include (i) working with physicians in clinical studies; (ii) entering into Medical Director Agreements with physicians; (iii) sponsoring physicians as speakers; (iv) entering into preferred provider arrangements with hospitals and long term care facilities; (v) providing value-added services to patients; and (vi) joint ownership of a pharmacy by one or more physicians and pharmacists.preferred provider arrangements with hospitals and long term care facilities.

9:00 AM - 10:00 AM	PBM Audits Gone Awry: Avoid Adverse Results by Successfully Preparing for and Responding to Audits
Location: Lafayette 3
Faculty: Galina Davis, MBA (Senderra Rx) Jesse C. Dresser, JD (Frier Levitt) Bradley W. Howard, JD (Brown & Fortunato) Brad Wasser, Esq. (Duane Morris)
Even the best pharmacies are routinely audited by PBMs. If the pharmacy fails to properly respond to an audit, then questions may emerge about whether the pharmacy is committing fraud, waste or abuse. The stakes can be very high, as payers may turn audit files over to the Department of Justice, Office of Inspector General, Defense Criminal Investigative Services, or any number of federal and state enforcement agencies. An effectively coordinated response from the pharmacy team can impress payers and avoid the dire consequences often flowing from misunderstandings about the pharmacy’s operations and the prescriptions in question. This program will focus on (i) the most current trends in audits, (ii) how a pharmacy can proactively prepare for an audit before even submitting claims, (iii) examples of inadequate responses that expose the pharmacy to risk, (iv) the investigative aftermath of poorly-coordinated responses, and (v) steps to successfully respond to an audit.
10:00 AM - 10:15 AM	BREAK
10:15 AM - 11:15 AM	States Without Borders
Location: Lafayette 3
Faculty: Sheila Arquette, RPh (NASP) Van A. Anderson, JD, MBA (McKesson Corporation) Nicholas Mezza, JD, MPH (Quarles & Brady, LLP)
A panel of pharmacy law experts will discuss the increasing trend of state boards of pharmacy imposing their regulations on nonresident pharmacies. The panel will discuss the legal basis and Constitutional boundaries for regulating out-of-state activity, including past and pending cases before the Supreme Court of the United States. The panel will also identify recent examples of such regulations, explain their impact on specialty pharmacies, and talk through courses of action.

11:15 AM - 12:15 PM	Double, Double Toil, and Trouble: Avoiding Regulatory Pitfalls Related to Thy Hubs Interactions
Location: Lafayette 3
Faculty: Simone Colgan Dunlap, JD (Quarles & Brady) Shannon Wiley, JD (Bass, Berry & Sims PLC)
This presentation will address key regulatory considerations implicated by pharmacy interactions with hubs--with a playful Shakespearian twist. If you have ever thought that hubs are greek to you, this presentation will give you the wings wherewith to fly confidently into the evolving world of hubs.
12:15 PM - 1:15 PM	LUNCH
1:15 PM - 2:15 PM	Let's Make a Deal: Ensuring a Smooth Transaction
Location: Lafayette 3
Faculty: Brad Gallagher, Esq. (Barclay Damon) Amy Cotton Peterson, M.S.P.T., J.D. (Quarles & Brady) John Jones, J.D. (Troutman Pepper)
This program will cover the aspects of buying and selling a pharmacy, including structuring the deal, preparing for and completing due diligence, and ensuring a smooth change in ownership. The pharmaceutical industry is highly regulated with a web of contracts to navigate. The presenters will provide an overview the due diligence process that should be completed by both a buyer and seller to ensure both parties are protecting themselves. The presenters will discuss common purchase agreement structures and considerations that will ensure that the buyer will be able to continue business operations without interruption post-closing. The presenters will discuss what needs to happen at and after the closing to ensure all parties to ensure a smooth transition of licenses, contracts, key contacts and other partners. Following this presentation, you will know what to expect when you decide to sell your pharmacy to the next generation or hopefully, expand your empire!

2:15 PM - 3:15 PM	Inside the FDA
Location: Lafayette 3
Faculty: Joshua Oyster, JD (Ropes & Gray LLP) Lee Rosebush, Esq. (Baker & Hostetler LLP)
This presentation will provide an update on the latest FDA actions and developments affecting the healthcare industry and particularly pharmacies. Key topics the speakers expect to cover include: • Drug compounding developments, such as the 503A Memorandum of Understanding (MOU) and the prohibition on wholesaling by 503B outsourcing facilities • Drug shortages • COVID-19 guidance documents and enforcement discretion policies • Pharmacy and pharmacist responsibilities under the Drug Supply Chain Security Act (DSCSA) • Pharmacist responsibilities as part of Risk Evaluation and Mitigation Strategies (REMS) • Cannabis and e-tobacco • Lab testing
3:15 PM - 3:30 PM	BREAK
3:30 PM - 4:30 PM	Demystifying Private Equity for Specialty Pharmacy
Location: Lafayette 3
Faculty: Rebecca Shanahan, JD (Shanahan Capital Ventures) Michael Hess, JD (Bass, Berry, & Sims PLC) Ed Nenon (SSM Partners) Paul Jardina (PromptCare) Taylor Phelps (Cantor Fitzgerald)
This panel of private equity specialists will discuss their perspectives on emerging policy issues with private equity and specialty pharmacy, as well as share their experiences on prior deals while giving their outlook on the future of specialty pharmacy.

4:30 PM - 5:30 PM	Post Rutledge Developments: Intended and Unintended Consequences
Location: Lafayette 3
Faculty: Linda J. Clark , JD (Barclay Damon, LLP) Jonathan Swichar, JD (Duane Morris)
In Rutledge v. Pharmaceutical Care Management Association, 141 S. Ct. 747 (2020), the U.S. Supreme Court held that an Arkansas law requiring fair and reasonable reimbursement by pharmacy benefit managers (PBMs) to independent pharmacies was not pre-empted by ERISA, and made clear that States have the authority to pass laws to protect such pharmacies from certain adverse conduct by PBMs. And, as expected, Rutledge quickly encouraged numerous States to propose or enact legislation intended to protect specialty pharmacies from these PBM actions. However, as will be discussed during this presentation, efforts by States to regulate PBMs has not been the sea change anticipated by pharmacies. Rather, the wave of State regulation has resulted in increased efforts by PBMs to eliminate the competition which specialty pharmacies pose to the PBMs’ affiliated pharmacies and has led to even more PBM/pharmacy disputes, which the Supreme Court surely assumed would be abolished by Rutledge.
5:30 PM - 5:45 PM	Closing Remarks