Article
What changed this week
On March 2, Novo Nordisk notified 340B covered entities that, starting April 1, it will require claims data for all of its drugs dispensed under the program, including at in-house and contract pharmacies. The policy mirrors one Eli Lilly announced Jan. 15, which was set to take effect Feb. 1. Novo says the change does not alter which entities qualify for 340B pricing or cap purchase volume.
On March 3, the AHA asked HRSA to take immediate enforcement action, including civil monetary penalties, against both manufacturers. It argued that conditioning discounts on new data submissions can effectively raise the price the statute requires, and that the labor and expense of compliance exceed anything 340B hospitals have faced. The AHA said HRSA never responded to its January request about Lilly’s policy and asked the agency, if it will not act, to explain why it considers the policies lawful.
Lilly counters that the data are the same kind providers already send insurers and that decades of guidance let manufacturers request information to prevent diversion and duplicate discounts.
Why this matters now
HHS said in February it would scrap its voluntary 340B rebate pilot. Manufacturers are now setting data conditions on their own. If two of the largest brand makers can do so without a regulator stepping in, others may follow, and the administrative load on 340B programs would grow with each one.
What 340B hospitals should do
- Size the workload. Work with pharmacy, revenue cycle and contract pharmacy partners to estimate the effort to submit claims-level data for every covered product.
- Check vendor readiness. The AHA flagged errors at the claims-data vendor. Decide who will monitor and correct submissions.
- Model the downside. Estimate what losing 340B pricing on Lilly and Novo products would cost if you decline to comply.
- Get legal input. Review your position with counsel and your state association before April 1, and document the decision.
- Brief the board. 340B savings support programs many boards care about, and they should understand this risk.
Archive entry for Mar 5, 2026, added Nov. 11, 2026.