Drug manufacturers are escalating pressure on hospitals to comply with new claims data submission requirements under the 340B Drug Pricing Program. Eli Lilly is threatening to cut off 340B discounts for holdout health systems, requiring covered entities to submit detailed pharmacy and medical claims data through the 340B ESP platform within 45 to 60 days of each dispense. With 30% of covered entities still non-compliant, Novo Nordisk, AstraZeneca, and Bristol Myers Squibb have adopted similar policies, and provider advocates warn that without federal intervention, hundreds of additional manufacturers could follow suit.
An article in HFMA references analysis from Benjamin Youssef and Jesse Dresser, who warn that access to 340B pricing is increasingly conditioned on producing verified claim-level data through manufacturer-specified portals. They advise that pharmacy, revenue cycle, and compliance teams must be able to connect each dispense to a qualifying encounter, prescriber, and payer. For covered entities that lose pricing access despite good-faith compliance efforts, HRSA’s Administrative Dispute Resolution process is the primary federal remedy available to providers.
