2017 PHARMACY LAW SYMPOSIUM DAY ONE – JULY 19, 2017
1:30 – 2:00 p.m. Registration and Networking
2:00 – 2:15 p.m. Welcome and Opening Remarks – Amy Cotton Peterson
2:15 – 3:15 p.m. Hot Topics in Pharmacy Law
Presenters: Jeff Davis, Brenda Shafer
Our popular Hot Topics session will cover recent developments and emerging judicial opinions in the industry, as well as DIR fees, clawbacks, states' rules on the drug diversion epidemic, cyber insurance, and more.
3:15 – 4:00 p.m. Privacy and Security: The Data Gets Bigger, the Stakes Get Higher
Presenters: Heather Buchta, Heather Siegelheim, Margaret Utterback
The attorneys on this panel will discuss topics including:
- Ongoing OCR audits
- Mobile apps in the health care space
- How employers can handle employee-related privacy risk, such as responding to phishing attempts, leaving sensitive information in insecure locations, and theft of private information
- Credit card-related security issues
- Updates on HIPAA breach reporting
- New HIPAA issues, including the OCR's attempts to modernize the 21-year-old law and the guidance it released on cloud computing
4:00 – 4:15 p.m. Break
4:15 – 5:00 p.m. New Technologies, Old Concerns
Presenters: Ed Rickert; Virginia Herold, California Board of Pharmacy; Larry Pinson, Nevada Board of Pharmacy; Cody Wiberg, Minnesota Board of Pharmacy; James Ward, Alabama Board of Pharmacy
More than ever, pharmacies are looking at leveraging technology in an effort to balance workload, expand access to pharmacy services, and improve patient care. However, existing pharmacy laws and regulations may be outdated, and are not always technology friendly. Pharmacy boards across the country are struggling to find ways to address the increased demand for innovative technology solutions while fulfilling their mandate to protect the public. In this session, you will hear from a panel of highly regarded regulators from pharmacy boards across the country who will share their views on this important topic.
5:00 – 5:15 p.m. Closing Remarks, Day Two Preview — Ed Rickert
WELCOME RECEPTION – JULY 19, 2016
6:00 – 7:30 p.m.
ROOF on theWit
201 North State Street
2017 PHARMACY LAW SYMPOSIUM DAY TWO – JULY 20, 2017
8:30 – 9:15 a.m. Breakfast and Networking
9:15 – 10:00 a.m. HR Headaches: Labor & Employment General Session
Presenters: Christine Cassetta, Gary Clark
Pharmacy employers face unique issues as they balance federal and state employment laws with the regulatory requirements of their state licenses. This session will cover state and federal laws that impact hiring decisions, employee substance abuse and impairment issues, and disability accommodations for pharmacists. We also will update you on the recent influx of state laws protecting employee privacy; best practices for investigating and managing whistleblower claims by licensed professionals; and best practices for terminating employees.
10:00 – 10:15 a.m. Break/Travel to Breakout Sessions
Breakout Sessions – 10:15 – 11:00 a.m.
Controlled Substances: How Do They Impact Your Bottom Line?
Presenters: Linden Barber, Larry Cote
More and more states are beginning to expand efforts to combat prescription drug and heroin abuse. In addition to a myriad of federal regulations, pharmacies, manufacturers, wholesalers, and PBMs are having to address changes to state law regarding controlled substances. This session will discuss recent state regulatory actions with respect to controlled substances and how they may impact business decisions and operations. The presenters will also discuss updates to DEA enforcement actions, and federal-level regulatory and policy changes.
Let's Make a Deal: Pharmacy Transactions
Presenter: Amy Cotton Peterson, Jonathan Howard
This session will focus on pharmacy transactions related to buying, selling, or investing in a pharmacy. We will dissect some of the key transactions that occurred over the last year, and discuss key regulatory issues and solutions that arise during pharmacy transactions, including FTC approvals, regulatory filings, assignments, accreditation, and other approval and transition issues.
Words Matter: Trends in Specialty Pharmacy and Payer Relationships
Presenters: Simone Colgan Dunlap, Susan Brichler Trujillo
Quarles & Brady attorneys will lead a discussion of trends in payment models, distribution channels, and managing regulatory risk.
Advantages and Challenges of Hospital Pharmacies
Presenters: Anne O'Brien, Brenda Shafer
As hospitals and health systems grow and look for efficiencies, they should be aware of possible benefits and pitfalls when providing and sourcing drugs. Pharmacies could consider favorable pricing programs such as "own use" and 340B to help manage drug costs. What are limitations on the use of drugs acquired at preferential prices? Is additional licensure required to supply off-site facilities, to make up first dose packets, or to install technology to provide ER patients with access to prescription drugs after hours? If the transition to USP 797 means that hospitals will outsource sterile compounding, how do they choose a supplier?
11:00 – 11:15 a.m. Break/Travel to Breakout Sessions
Breakout Sessions – 11:15 – 12:00 p.m.
Compounding Pharmacy Perspectives
Presenters: Ed Rickert, Ted Sullivan
This session will explore key issues raised by the overlapping state and federal regulation of compounding pharmacies and outsourcing facilities. Topics include cGMP, inspections, and registration requirements. Presenters also will highlight some of the regulatory issues related to sterile compounding, including the use of API found in approved drug products, and source of raw materials. Finally, presenters will discuss unique veterinary compounding concerns such as lack of clear statutory or regulatory rules for veterinary compounding, antibiotic use, and veterinarian compounding and office stock.
Current Trends in Government Investigations, Suits, and Settlements
Presenter: Mark Bina
The regulatory scrutiny by local, state, and federal government authorities is continuing to evolve. Pharmacies, manufacturers, wholesalers, PBMs, and others are not only defending against disciplinary claims, but recently have begun facing increasingly creative litigation claims by governmental authorities. This session will provide an overview of some of the national investigatory, disciplinary, and litigation trends; practical tips for managing governmental investigations and discovery; and examine how to best manage (and hopefully resolve) such cases.
Brand Loyalty: The Risks of Loyalty/Discount Cards
Presenters: Simone Colgan Dunlap, Shannon O'Boye
This session will address new pharmacy prescription savings programs; provide an update on the discount medical plan (DMPO) landscape; and delve into how to mitigate the legal and regulatory risks associated with loyalty and discount card programs by looking at, among other things, the nuances of the OIG's Retail Rewards Final Rule and recent government settlements and court opinions.
12:00 – 1:00 p.m. Lunch and Networking
1:00 – 2:00 p.m. Keynote Address
Marty Allain, .Pharmacy Senior Manager, National Association of Boards of Pharmacy
2:00 – 3:00 p.m. Straight from the Source: Moderated Panel of Long-standing Members of State Boards of Pharmacy
Moderator: Roger Morris
Panelists: Dennis McAllister, Arizona State Board of Pharmacy
Michael A. Moné, Ohio Board of Pharmacy
Donna Wall, Indiana Board of Pharmacy
Dennis Wiesner, Texas State Board of Pharmacy
Closing Remarks – Roger Morris
This always-popular session will provide an in-depth and unique perspective into state boards of pharmacy. A moderated Q&A session with a panel of current, long-term state board of pharmacy members will shed light on each person's perspective on governing the practice of pharmacy. The panel also will discuss emerging issues related to compounding, outsourcing, shared services, and technology's impact on the practice of pharmacy.