On January 16, 2018, Senator Cassidy (R-LA) introduced the bill, Helping Ensure Low-income Patients have Access to Care and Treatment (HELP Act). Senator Cassidy is a member of both the Senate Finance Committee and the Senate Health, Education, Labor and Pensions (HELP) Committee, and is a physician by training. Senator Cassidy has indicated that the purpose of his bill is to increase transparency and accountability in the 340B Drug Discount Program, and ensure the discounts reach patients.
The HELP Act would require all covered entity types to include 340B modifiers on all Medicaid claims (both fee-for-service and managed care) and all outpatient Medicare claims (including Part B, Medicare Advantage, and Part D). Additionally, Disproportionate Share Hospitals (DSH) and children’s hospitals would have to include 340B modifiers on claims to private payers for outpatient drugs.
Similar to other congressional proposals, the HELP Act would impose a two-year moratorium on registration of new DSHs, and their associated child sites, for participation in the 340B program. Additionally, following the two-year moratorium, the HELP Act would require DSHs and children’s hospitals to satisfy more strict requirements before associated sites could be registered as child sites under 340B. DSHs and children’s hospitals also would have to publicly report on: aggregate revenue from 340B drugs; patient mix (broken down by payment source and child site); costs incurred for charity care at each child site; percentage of revenues at each child site derived from infusion or physician-administered injections; and all third-party vendors providing services related to 340B.
Finally, the HELP Act requires the Office of the Inspector General and the General Accountability Office to provide reports to Congress on various aspects of the 340B program.
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If you would like to learn more or have questions about the recertification process, contact Jason Reddish, Elizabeth Karan, Michael Glomb, or the Feldesman Tucker attorney with whom you typically work.