340B Program reforms introduced in Congress; CMS proposes payment reforms 

On June 29, Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bill Cassidy (R-LA) released a discussion draft bill proposing several reforms to strengthen oversight of the 340B Drug Pricing Program by reducing fraud and abuse, increasing transparency and reporting, and clarifying program participation rules. Relatedly, on July 7, Reps. Scott Peters (D-CA) and John Joyce (R-PA) introduced the bipartisan Strengthening the Exercise of Controls and Upgrading Requirements for Efficiency in 340B (SECURE) Act. The prescriptive and operationally detailed reform proposal is described as the first comprehensive bipartisan proposal to modernize the 340B Drug Pricing Program since its creation in 1992. While both proposals face significant hurdles, they highlight continued Congressional attention on 340B and could shape future bipartisan discussions regarding program transparency, contract pharmacies, and manufacturer access to claims data.

CMS also included 340B payment reforms in the calendar year (CY) 2027 Outpatient Prospective Payment System (OPPS) proposed rule. If finalized as proposed, the OPPS rule would reduce Medicare payment for 340B drugs and expand site-neutral policies to additional outpatient services. The proposed reimbursement rate is based on survey data collected earlier this year and would be implemented in a budget-neutral manner, resulting in an 8.44% increase to payments for non-drug services. Hospitals have sharply criticized the proposal, suggesting that the survey sample size may not be statistically significant, and are expected to litigate the final rule when it is issued. Government Affairs is reviewing the proposed rule with impacted business areas and will share comments with our trade associations.