Eli Lilly sent warning letters to covered entities on May 12 threatening loss of 340B pricing access for any hospital not yet submitting in-house pharmacy claims data through the 340B ESP platform. Novo Nordisk's identical policy has been in effect since April 1. For procurement and pharmacy directors who thought the February court ruling settled this year's 340B turbulence, it did not.
The two issues are separate. Both require action now.
On the claims data front: Lilly's February 1 policy requires all covered entities to submit claims-level data for its full product portfolio within 45 days of dispense, with a 60-day window for administered products including Kisunla, Erbitux, and Cyramza. The AHA has called the requirement unlawful and urged HRSA to impose civil monetary penalties against both manufacturers. HRSA has not responded. Ten states are exempt: Colorado, Maine, Nebraska, North Dakota, Oregon, Rhode Island, South Dakota, Tennessee, Vermont, and West Virginia. Entities outside those states that have not registered on 340B ESP are now receiving Lilly's warning letters directly.
On the rebate model front: The February 10 federal court ruling in Maine vacated HRSA's pilot on procedural grounds, not on the merits. The judge was explicit that a rebate model is not inherently impermissible under the 340B statute. What HRSA got wrong was process: insufficient public comment, 30 years of upfront discount reliance ignored, and no adequate implementation runway. HRSA committed in the remand agreement to issue a fresh notice, allow public comment, and provide a minimum 90-day window before any new program goes live. The agency issued an RFI in February 2026. The comment period closed April 20. HRSA has also signaled it may expand any future rebate program from the original 9 drugs to as many as 25, covering 13 manufacturers subject to Medicare negotiated pricing through 2027.
Why it matters: The rebate model comment period has closed and HRSA is now reviewing submissions. A new program, built this time to survive APA challenge, is not a question of if but when. If HRSA moves forward, covered entities will get a 90-day runway. That sounds like time. It is not, if your cash flow model, TPA contracts, and pharmacy operations have never been stress-tested against paying WAC upfront and waiting for a manufacturer check.
Between the lines: The claims data fight and the rebate model fight are being waged by the same players using the same logic. Manufacturers want transaction-level visibility into every 340B dispense. The rebate model requires that data to function. Lilly and Novo Nordisk are building the infrastructure now, before any pilot exists, by conditioning pricing access on submission compliance. Whether HRSA sanctions them or not, the data submission expectation is already the operational reality for hospitals outside the exempt states.
By the numbers:
14,600: covered entities HRSA estimates would be subject to a future rebate model
45 days: Lilly's claims data submission window from dispense date
5 hours per week: HRSA's revised estimate of administrative burden per covered entity under a rebate model, up from 2 hours in the original pilot
$132: HRSA's assumed hourly compliance labor cost based on pharmacist wages and overhead
25: maximum number of drugs HRSA is now considering for inclusion, up from the original 9
What to do: Verify your 340B ESP registration status this week. Confirm your pharmacy team is submitting Lilly claims data within the 45-day window. Assign a compliance owner to track Novo Nordisk's April 1 policy separately, as its contract pharmacy suspension trigger means one non-compliant pharmacy can suspend access across all linked pharmacies, creating wider exposure than Lilly's policy. Brief your CFO on the rebate model timeline. HRSA has the RFI responses, has committed to a compliant process, and a 90-day notice is the only runway you will get.