On July 11, 2018, the House Energy & Commerce Committee’s Health Subcommittee (the Subcommittee)  held a hearing titled, “Opportunities to Improve the 340B Drug Pricing Program.”  In addition to hearing from two witness panels, including the Government Accountability Office (GAO), the Subcommittee discussed a number of 340B-related bills pending before the Committee.

While Subcommittee members on both sides of the aisle expressed support for the 340B Program, the hearing highlighted members’ continued concerns regarding federal oversight of the Program, particularly in light of the GAO’s recent report on the Health Resources and Services Administration’s (HRSA) oversight of 340B contract pharmacies. In his opening remarks, Subcommittee Chairman Michael Burgess (R-TX) noted, “I think we all should be concerned by the fact that many of the covered entities that the GAO reviewed do not have in place a policy that ensures uninsured, low-income patients are not hit with a big hospital bill for their outpatient drugs.”

In response to concerns raised regarding HRSA’s oversight of the program, full Committee Ranking Member Frank Pallone (D-NJ) advocated for legislation that “would enhance 340B operations and give HRSA more resources and authority to operate the program, and collect covered entity and manufacturer information.”  Pallone and other Democratic members emphasized their opposition to proposed legislation which they believe would “curtail or restrict” the 340B Program, citing the 340B Protecting Access for the Underserved and Safety-net Entities Act (H.R. 4710) and the Protecting Safety-Net 340B Hospitals Act as examples.

Committee members and witnesses also raised concerns about a lack of clarity with respect to the 340B Program’s intent, and Rep. Doris Matsui (D-CA) highlighted her bill (H.R. 6071) to codify the definition of “patient” under the 340B Program. In expressing his support for Matsui’s legislation, Pallone pointed out the bill’s provisions requiring audit parity between covered entities and pharmaceutical manufacturers, a concern raised by multiple members during the hearing.

A link to the hearing and accompanying documents may be found here.