In our final episode of 2020, we are joined by Maureen Testoni, the president and CEO of 340B Health. Our episode follows up last week’s bonus episode on 340B Health’s recent joint lawsuit against the Department of Health and Human Services regarding drug manufacturers’ refusals to provide 340B discounts when drugs are dispensed at community-based contract pharmacies. Maureen provides additional analysis on the issue and discusses her concerns with how some drug companies are attempting to change 340B into a rebate program. She also discusses the role 340B has played in helping hospitals respond to the COVID-19 pandemic this year. 

340B Savings Help Hospitals Fight COVID-19

340B hospitals are using 340B savings during the pandemic to expand care to patients through telehealth and enhanced medication therapy management services. Maureen shares stories of hospitals throughout the country that have expanded services to reach more chronically ill patients in need or to secure the additional beds they need to care for COVID-19 patients. HRSA’s extended flexibilities to 340B are key in helping hospitals provide more services and avoid drug shortages.

Steps Hospitals Should Take When Drug Companies Refuse to Provide 340B Pricing

If drug manufacturers overcharge or refuse to provide 340B discounts to covered entities on drugs dispensed to contract pharmacies, Maureen strongly recommends the affected hospitals file notices of overcharge with HRSA to start the process of enforcement. Advocacy outreach to the new administration and new Congress also will be necessary for educating policymakers about 340B and the threats to the program posed by drug manufacturers not following the statute. 

Manufacturers Attempt to Convert 340B Into Rebate Program

Maureen shares her concerns about drug companies working to convert 340B into a rebate program. She says a rebate process would make it very expensive for covered entities to access 340B savings, as they would have to pay for the drugs at the higher wholesale acquisition cost. With this model, manufacturers also potentially could deny the rebate, and there would be no clear process for hospitals to appeal. 340B Health has communicated its concerns about drug manufacturers converting 340B into a rebate program to HHS and has urged the agency to block such a move. Nearly half the members of the House of Representatives sent a letter to HHS expressing its concerns about the issue. Maureen also recommends 340B hospitals review with their counsel the terms and conditions presented by any drug manufacturers asking them to participate in a rebate program.

Check out all 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’d like us to cover in this podcast, email us at [email protected].

Resources: 

1. BONUS 340B INSIGHT EPISODE: TAKING THE 340B CASE TO COURT
2. Hospitals and Pharmacists File Lawsuit Over Drug Companies’ Refusals Of 340B Discounts
3. State Attorneys General Letter to HHS Regarding Drug Manufacturer Denials of 340B Discounts 
4. Nearly Half of U.S. House of Representative Oppose Move to Convert 340B Into a Rebate Program  
5. 340B Health Webinar: 340B & the Courts: How Lawsuits Shape 340B Enforcement