340B – A Shifting Landscape
Join us on June 26, from 10 to 11:30 am for a wide-ranging overview of the 340B Drug Pricing Program and recent changes in federal policy impacting when and how covered entities, including community health centers, can access these discounted drugs. Attorneys Andrew London and Samuel Hoff from Foley Hoag LLP and FQHC 340B Pharmacy compliance expert Felicity Homsted, PharmD of FQHC 340B Compliance, Inc., will discuss various aspects of the 340B program, including, but not limited to: the requirements for participation, the ADR process, audits of covered entities, the use of contract pharmacies, implications of manufacturer rebate models, updates on HRSA 340B policy, and the increased involvement in states in regulating access to 340B priced drugs. CEU credits will be provided.
During this session, participants will:
1. Review the changing landscape of the 340B program, including the history of the program, current requirements for participation, and program growth.
2. Understand the Alternative Dispute Resolution (ADR) process and HRSA’s authority to oversee disputes between covered entities and manufacturers.
3. Learn about changing federal landscape regarding manufacturer restrictions on the use contract pharmacies and the current state of legal challenges.
4. Evaluate the implications of manufacturer rebate policies, including ongoing litigation on rebates, and the status of HRSA’s policies and pilot program.
5. Understand trends in state policies impacting the 340B program and discuss the potential for similar efforts in Massachusetts.
Upcoming Events
Missed a live HCCA session? Reach out to legalcompliance@massleague.org to purchase past session recordings, slides, and supplemental materials ($175 each). Past sessions include a walkthrough of BORIM’s Patient Care Assessment requirements and guidance on lobbying for nonprofits.
