by Lidia Rodriguez-Hupp, Chief Customer Officer
February 2, 2026
Things in 340B move pretty fast these days.
So it was with last month’s Buzz, which we published over the holiday break mere hours before a federal judge’s bombshell ruling put the brakes on HRSA’s 340B rebate pilot program. Days later, an appellate panel upheld that preliminary injunction, and the government announced plans to drop its appeal.
That last-minute pause, issued three days before the rebate pilot was set to begin on Jan. 1, marked a stunning cap to a last-ditch-effort lawsuit filed only Dec. 1. It brought welcome relief to 340B entities who had been bracing for the worst.
It’s nice to catch a break, but all indications are that we haven’t seen the last of rebates from HRSA, which says it plans to reconsider its pilot program “promptly.” I shared my thoughts on what’s next for rebates, along with the rest of 340B in 2026, in a LinkedIn article that I encourage you to read.
In a recent webinar, my Craneware Group colleagues said they believe the rebate pilot is likely to return either later this year or early in 2027. What’s more, the most recent filings from the government show that Department of Justice lawyers stepped into the case for HHS, which may improve their ability to get things right the second time.
MFP issues
We are hearing many complaints about Beacon, the platform that drugmakers had designated for processing 340B rebate claims, from covered entities with in-house pharmacies that are using it to process maximum fair price (MFP) Inflation Reduction Act rebates for eligible Medicare Part D claims.
Users say it suffers from a confusing interface, is incorrectly identifying claims and denying them based on incorrect assumptions that the drugs were purchased under 340B. Users also complain there is little recourse for how to flag issues or to learn whether they will be fixed.
It begs the question of what things would be like if the platform was also trying to process 340B rebates.
Separately, Johnson & Johnson, which had been set to take part in the rebate pilot, announced a plan to prevent duplicate Part D MFP refund payments on 340B claims. The company says it will essentially “rely on available data (limited and imperfect) to determine which claims are 340B-eligible,” taking into account the use of claims modifiers, claims that entities identify as 340B-eligible “and evidence of 340B purchasing.”
Lilly’s latest roadblock
Meanwhile, the next big challenge confronting 340B comes from Eli Lilly, which will require all covered entity types to begin submitting claims data for all 340B dispenses, including in-house pharmacies and medical claims. The policy applies to its entire drug portfolio but exempts 10 states with contract pharmacy access laws that don’t prohibit the collection of claims data.
Lilly frames this move as no big deal, since covered entities have already been sending it contract pharmacy claims data since 2021, which “permitted us to identify countless instances of Medicaid duplicate discounts, instances where multiple covered entities sought replenishment on the same unit of 340B program, and to produce the evidence required by HRSA to initiate audits.” It’s expanding this data submission “to help identify the full universe of duplicate discounts and other program abuses, preserve our ability to initiate audits, and expand transparency even further,” it says.
Please.
The reality is this gives Lilly access to a much wider pool of 340B data; what they intend to do with it is unclear. It will also be an onerous administrative burden. The American Hospital Association said as much in a letter asking HRSA Administrator Thomas Engels to stop Lilly’s plan before it begins Feb. 1.
“At best, Lilly’s new requirements will be prohibitively costly for 340B hospitals. At worst, they will be unworkable. Either way, they will prevent hospitals from obtaining the 340B discounts they are owed by statute,” the letter reads.
Lilly was the first manufacturer to announce contract pharmacy restrictions back in 2020, and they triggered a domino effect of other drugmakers enacting similar policies. The same thing is likely here unless HRSA steps up or someone can mount a successful legal challenge.
Other 340B news
- Big Pharma is now 4-0 in administrative dispute resolution decisions after ADR panels sided in four separate cases with drugmakers, arguing their contract pharmacy restrictions did not constitute overcharges. The panels each cited the 2023 decision from a federal appeals court upholding those restrictions. They’re the first ADR decisions since former President Joe Biden released a new ADR rule in 2024.
- As of this writing, funding for Health and Human Services and HRSA was in limbo amid threats of yet another government shutdown. The House approved an appropriations package that would boost HRSA funding by $929 million to $8.9 billion through September, sending it to the Senate. which needed to vote on it before midnight, Feb. 1 to avoid a government shutdown. The first Senate floor vote failed, with lawmakers at odds over funding for the Department of Homeland Security and Immigration and Customs Enforcement (ICE). Notably, the bill includes neither extensions on ACA subsidies, which were at the center of last fall’s government shutdown, nor President Trump’s proposal to shift oversight of HRSA from HHS to CMS.
It’s all enough to make you pine for the days — I can barely remember them — when 340B was a quiet and obscure program that attracted little attention.
At any rate, we should focus our efforts on stopping 340B rebates for good and ensuring the program runs (mostly) as Congress intended.
Stay vigilant!
If you’d like to continue this conversation, please contact me at [email protected].