by Lidia Rodriguez-Hupp, Chief Customer Officer
June 2, 2026
Officials at the Department of Health and Human Services have asked the White House’s Office of Management and Budget to review the latest plan for a 340B rebate pilot program, a sign of the Trump administration’s eagerness to resuscitate a proposal that had previously been shot down by courts.
The proposal is in the prerule stage and hasn’t yet been published publicly. It comes a little over a month after the close of the public comment period. HRSA received more than 5,500 comments but still has published fewer than half of them. So here we go again.
Meanwhile, some good news for 340B: Voters have ousted two of Congress’ most outspoken and powerful 340B foes, Sen. Bill Cassidy (R-La.) and Rep. Earl “Buddy” Carter (R-Ga.). They both finished last in three-way GOP Senate primaries.
Carter, a former pharmacy owner, recently claimed 340B has strayed from its original intent and is co-sponsor of the 340B ACCESS Act, which has the backing of Big Pharma.
Cassidy, a physician, chairs the powerful Senate Health, Education, Labor and Pensions (HELP) Committee, where he ran a lengthy investigation into 340B practices and has called for major changes to the program.
Both are now lame ducks whose ability to shape public policy will be significantly curtailed during their remaining months in office.
Cassidy’s defeat raises questions about who will replace him as chair of the HELP Committee, which has purview over 340B. We’ll get a much clearer picture of that after the midterms in November, which will determine which party controls the Senate starting in 2027.
Elsewhere on Capitol Hill
Staying with Carter, he and fellow Rep. Diana Harshbarger (R-Tenn.) circulated a letter signed by five other GOP colleagues urging the Trump administration to adopt a 340B rebate pilot program as a “critical step toward restoring transparency, accountability and program integrity.”
Eight days later, Rep. Mike Ezell (R-Miss.), one of the signatories, did a 180 and sent a followup letter to the heads of HRSA and HHS. “After much deliberation with healthcare experts and my local healthcare facilities, I feel there is a need for further discussion before any changes are implemented for the 340B program.” he wrote.
Switching to a rebate model, he went on, “could have disastrous effects, impacting not only my district but hospitals and, more importantly, rural hospitals across the country.”
Ezell’s 180 underlines how important it is for covered entities to press the importance of 340B to their elected congressional reps.
Meanwhile, more good news as the bipartisan “gang of six” 340B workgroup in the Senate has named Sen. John Boozman (R-Ark.), as its newest member, replacing former Sen. Markwayne Mullin. The group has been working to introduce the SUSTAIN 340B Act.
Covered entities and other 340B stakeholders have reacted positively to the news. Boozman is seen as a program supporter who represents the state that was first to enact a law prohibiting manufacturer restrictions on 340B contract pharmacies.
“The 340B program is a lifeline for hospitals and clinics across Arkansas, helping vulnerable patients access prescriptions while empowering providers to put savings toward additional services and care in their communities,” Boozman said in a statement.
Drugmaker data grabs
Now the bad news.
There are now eight drugmakers that have expanded their demands for 340B data to include claims from in-house pharmacies after Biogen, UCB and Amgen hopped on the bandwagon in May.
That’s bad enough, but Amgen takes it a step further. Starting Nov. 15, it will require covered entities to submit “standard, anonymized information about interactions between providers and patients resulting in the dispensing of 340B-priced Amgen products,” including information to help it validate:
- Diagnosis/billing
- Date-of-service eligibility
- 340B site eligibility
This is the first such requirement from a drugmaker, and it’s outrageous. There is no reason a manufacturer would need a diagnosis, for starters, to evaluate a 340B claim. And asking for location information completely subverts the purpose of a manufacturer audit.
Like contract pharmacy restrictions and the addition of in-house pharmacy claims data before it, we’ll probably see more manufacturers follow suit. Maybe this will be enough to get HRSA involved?
Meanwhile, Eli Lilly has sent letters to some covered entities warning them they may lose 340B pricing on its drugs if they don’t comply with the requirements of its new in-house claims data policy. In response, the American Hospital Association sent Lilly a letter asking it to drop its in-house pharmacy reporting requirement and instead throw its support behind a neutral data clearinghouse overseen by the government.
“Put simply, a “clearinghouse” is less burdensome and expensive than Lilly’s unilateral claims-data policy, but it provides the same transparency that both the AHA and Lilly are committed to ensuring,” the AHA wrote.
Finally, a colleague heard from Katheryne Richardson, chief strategy officer for Second Sight Solutions, the parent company of 340B ESP, during the annual Informa Connect life sciences summit in Philadelphia. She said 340B ESP ingests and shares data beyond what individual manufacturers require under their contract pharmacy policies.
So if you don’t filter your submissions appropriately, manufacturers receive all submitted claims — including retail and medical, and 340B and non-340B data — even when their policies call only for 340B retail claim submissions. They’re using everything you send, which they’ve never told us publicly.
Word to the wise.
CVS Health lawsuit
Three large health systems have filed separate lawsuits against CVS Health and its affiliate companies alleging that the healthcare giant colluded to lower 340B reimbursement to providers and pocket a share of the savings. The lawsuits from University of Michigan Health, University of Kansas and three Mt. Sinai hospitals in New York allege CVS illegally took $250 million between 2020 and 2025.
CVS owns pharmacy benefit manager Caremark, 340B TPA Wellpartner and specialty pharmacy CVS Specialty, among other pieces of the healthcare value chain. The lawsuit highlights the problem with allowing companies to vertically integrate and concentrate their power and market influence.
More attacks and dark money
The trade group Pharmaceutical Research and Manufacturers of America (PhRMA) is back with another seven-figure attack ad against 340B that likens the program to a “markup” that is “a goldmine for big hospital systems.” It portrays hospital executives lounging in a 340B executive spa.
Meanwhile, a new dark-money group called American Resolve Action has launched the “Hospital Accountability Project” and website alleging that hospitals are “gaming” 340B.
“The Trump administration’s 340B rebate model pilot is America First policy in action,” its website reads. “It is a long overdue first step towards tackling waste, rooting out fraud, and demanding accountability from institutions that benefit from federal safety-net programs.”
The organization does not disclose its donors but has ties to August Strategy Group, a Washington, D.C. lobbying and public affairs firm, according to 340B Report.
Other 340B news
- Big news out of Richmond, Va. as the U.S. 4th Circuit Court of Appeals agreed to rehear cases involving Maryland and West Virginia’s contract pharmacy laws before the full 15-judge appellate court. The court had previously ruled 2-1 via a three-judge panel that both states could not enforce their laws, the only federal appeals decisions to date to side with the drug industry.
- Minnesota lawmakers failed to pass 340B legislation before the legislative session ended. The state was the site of intense lobbying over a bill that would have strengthened enforcement for its existing contract pharmacy access law and eliminated the law’s July 2027 sunset provision.
- Amphastar became the 42nd manufacturer and LEO Pharma the 43rd to restrict contract pharmacy access. Amphastar also became the fifth to require use of the Truzo platform for submitting claims.
- Sanofi is now the ninth manufacturer with an all-claims policy for in-house pharmacies, effective June 15.
It’s been yet another month of fast and furious 340B news. Keep fighting the good fight and spreading the good word about 340B!
If you’d like to continue this conversation, please contact me at [email protected].