Analyzing 340B News from the Courts to Pharma Manufacturer Actions

In this episode we speak with Maureen Testoni, President and CEO for 340B Health, on new 340B policy developments in recent weeks that include a major court decision and drug manufacturer challenges to 340B contract pharmacies. Prior to the interview, we answer a member question on changes this year to the 340B hospital recertification process.

Some key takeaways from the conversation with Testoni include:

Court Decision Upholds CMS Medicare Part B Cuts: Since 2018, The Centers for Medicare & Medicaid Services (CMS) has cut payments by nearly 30% to many 340B hospitals. Testoni explains how the D.C. Circuit Court of Appeals for the District of Columbia has overturned a lower court decision and has ruled that the government has the authority to continue with the cuts. Testoni shared potential next steps in the case.

CMS Proposes Steeper Medicare Part B Cuts for 2021: Following the D.C. Circuit Court of Appeals decision to allow CMS Medicare Part B cuts to hospitals, Testoni analyzed how CMS’ proposed 2021 Medicare Outpatient Perspective Payment Systems rule could result in an even steeper cut for 340B hospitals. She explained how 340B Health plans to work with members to respond.

Recent Actions by Pharmaceutical Companies: Several drug companies are refusing or threatening to not provide 340B pricing on drugs that will be distributed at a contract pharmacy. Two of these companies are asking 340B covered entities for claims data to be shared with them. Testoni says that these actions violate the 340B statute and that requests for claims data create multiple challenges for covered entities. She also gives insight to what 340B hospitals should do when manufacturers ask for claims data or do not offer 340B pricing on medications purchased for distribution at a contract pharmacy.

Progress on Protecting 340B Hospitals During the Pandemic: For 340B hospitals whose program eligibility is determined by their DSH adjustment percentage, there is concern that changes in payor mix during the COVID-19 pandemic puts them at risk for losing program eligibility. Testoni provides updates on two new bills in Congress that have been introduced to address this problem.

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

Episode Resources

1. 340B Health Recertification Webinar
2. U.S. Court of Appeals Decision on CMS Medicare Part B Cuts to 340B Hospitals
3. CMS 2021 Proposed Outpatient Prospective Payment System Rule
4. Bipartisan Bill Would Protect 340B Status During Emergency