US House Committee releases 340B legislation ahead of July 11 hearing

The US House Energy and Commerce Health Subcommittee recently posted more than a dozen bills and discussion drafts related to the 340 drug savings program as it prepares to hold a July 11 hearing on improving the program. Among other changes, the bills would void recent outpatient prospective payment system changes in the payment amount for certain drugs and biologicals purchased under the 340 program (H.R. 4392); limit the orphan drug exclusion under the program (H.R. 2889); establish a moratorium on the registration of certain new 340B hospitals and associated sites (H.R. 4710); require certain disproportionate share hospitals under the 340B program to submit reports on low-income use of outpatient hospital services (H.R. 5598); clarify the intent of the program and enhance program integrity (H.R. 6071); and provide for certain user fees under the program (H.R. 6240). The discussion drafts would raise the minimum disproportionate share adjustment percentage for certain hospitals to qualify for the program; provide for a 340B program administrator; define “patient” for purposes of the program; require the Department of Health and Human Services to implement the Government Accountability Office’s recommendations relating to 340B contract pharmacies; require covered entities to report certain information on savings from discounted prices under the program and the relationship between those savings and charity care expenditures; require HHS to conduct program audits in accordance with generally accepted government auditing standards; establish certain 340B fee amounts for certain low-income patients; and allow HHS to prescribe regulations to carry out the program.

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