340B Insight wants to make our podcast the best it can be. To help us succeed, we’d like to hear your thoughts. Please take just a few minutes to complete our listener survey, and we will enter you in a drawing to win a $100 gift card! To participate, please go to 340bpodcast.org/survey.

Between new developments on a rebate pilot program, discussions of possible cuts to Medicare payment for 340B drugs, and new action in states nationwide, this fall has been a jam-packed season for 340B. We sit down with 340B Health President and CEO Maureen Testoni to break down the latest.

Questions Remain About January’s 340B Rebate Pilot 

After the Health Resources & Services Administration (HRSA) released 340B rebate pilot program guidance over the summer, all nine manufacturers of the 10 drugs subject to Medicare price caps applied to HRSA to implement rebates for the drugs starting in January. Testoni says we expect to find out which plans are approved in early November, as drugmakers need to give eight weeks of notice so covered entities can prepare for the change. Testoni says questions remain about the rebate pilot, but information that the drugmakers’ rebate vendor has released so far provides enough detail for hospitals to start preparing for both rebates and price caps.

Potential Medicare Cuts Expected To Target 340B Hospitals

Earlier this year, the Trump administration released an executive order directing the Centers for Medicare & Medicaid Services (CMS) to survey hospitals on drug acquisition costs with the goal of using the results to set payment rates for Medicare Part B drugs starting in 2027. Testoni says she is concerned the proposed survey will lead to CMS targeting only 340B drugs for cuts that could bring payment rates down to actual acquisition costs, which would be a steeper cut than what the agency imposed during the first Trump administration.

States Keep Moving on Contract Pharmacy Protections, 340B Mandates

Nearly 20 states have contract pharmacy protection laws in place and a small number of drugmakers have sued to block all these statutes. But Testoni says so far, courts have denied those requests and the laws have stayed in effect despite significant opposition advocacy by drugmakers. An increasing number of states also have enacted laws requiring 340B hospitals to report substantial data on their 340B costs and savings, and some are looking to limit how hospitals can use those savings.

Resources:

1. Senate Hearing Features Both Bipartisan Support for 340B and Calls for Reforms
2. Read Our Comments on CBO’s 340B Growth Report
3. Review Our 340B Rebate Pilot and IRA Resources
4. Beacon Shares New Details on 340B Rebate Pilot Implementation