Several 340B developments have occurred in the first weeks of 2023, with many more expected to come this year. In this episode, we speak with 340B Health President and CEO Maureen Testoni about her outlook for 340B. Our discussion includes her analysis of the latest in the 340B contract pharmacy dispute, the 340B advocacy landscape at the federal and state levels, and Medicare issues affecting 340B.

*Editor’s note: We spoke with Maureen prior to Bayer and EMD Serono announcing they will restrict 340B discounts. When these restrictions start in March, at least 21 companies will be limiting 340B discounts, with 14 of these companies conditioning 340B pricing on providers sharing contract pharmacy claims data.* 

U.S. Appeals Court Decision on 340B Contract Pharmacies

Litigation continues on drug companies imposing restrictions on 340B pricing to hospitals and other providers when drugs are dispensed through community and specialty pharmacy partners. Maureen discusses a recent U.S. federal appeals court decision and the next steps in the litigation process. She also explains the trends in the drugmakers’ restrictions.  

2023 Advocacy Landscape for 340B 

Two recent national newspaper stories portrayed 340B in a negative light, but they did not include a complete picture about how 340B works. Maureen discusses what the increased media attention means for 340B advocacy this year and what hospitals should do to advocate for the program. She also shares an overview of 340B legislative activity at the state level.  

Medicare Payment Issues for 340B Hospitals

Maureen shares what she will be watching for during the implementation of a new Medicare drug price-setting law. She also explains the status of repayments to 340B hospitals for unlawful Medicare cuts. 

340B Administrative Dispute Resolution (ADR) Process

HHS has proposed revisions to the ADR process for resolving disputes between covered entities and drug manufacturers over 340B pricing. Maureen examines how these revisions will clarify the process and further changes that 340B hospitals are requesting.

Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at [email protected].

Resources 

1. Statement on Third Circuit Appeals Court Decision on Drugmakers’ 340B Restrictions
2. Statement on Bayer and EMD Serono Restricting 340B Discounts Through Community-based Pharmacies 
3. 340B Health Comment Letter to HRSA on Proposed Changes to the 340B Administrative Dispute Resolution 
4. 340B Coalition Winter Conference 2023