In the last two months, there’s been a flurry of activity surrounding the 340B program. Both the House and the Senate are seeking changes to the program, each with very different proposals. A bill that would reform the Internal Revenue Service (IRS) Schedule H form also includes a provision that would require additional reporting from 340B hospitals. A proposal from the Senate’s “Gang of Six” is also expected to be released later this year, adding to the debate. This is all happening while CMS takes a second try at cutting payments for 340B drugs in its Outpatient Prospective Payment System (OPPS) proposed rule, proposing to pay them at Average Sales Price (ASP) minus 33.4% starting in CY 2027.  

Additionally, Eli Lilly’s move to restrict access to the 340B program is also raising eyebrows. In June, the company started denying the 340B discounts to entities that don’t comply withits in-house pharmacy claims data collection requirements.In response, Reps. Doris Matsui and Jack Bergman spearheaded a bipartisan House letter calling on the Department of Health and Human Services (HHS) and HRSA to take enforcement action, restore 340B pricing, and clarify federal policy regarding manufacturers’ attempts to tie discount eligibility to claims data reporting. The effort was supported by 72 lawmakers from both parties. AHPA will continue monitoring these discussions.  

Topics: CMS, Congress, HHS, Prescription Drugs: 340B, Senate