by Lidia Rodriguez-Hupp, Chief Customer Officer
May 4, 2026
The federal government’s proposed 340B rebate pilot program rode a crescendo of attention in April, thanks to public comments submitted to HRSA, comments from the nation’s top health official and interest in Congress. HRSA was flooded with 5,589 responses by its April 20 request for information deadline.
That’s significantly more than the roughly 1,200 comments HRSA received last year during its first, aborted attempt to launch a pilot program. It’s also probably the most we’ve seen submitted to the agency since the days of “Mega Guidance” in 2015 (more on that below). So, great job to everyone who made their voices heard!
As part of our submitted comments, The Craneware Group used our real-world data to model the impact of HRSA’s proposed rebate pilot on a hypothetical community hospital with roughly $310 million in annual operating expenses. We found the hospital would incur $11 million in incremental drug acquisition costs and a 3.55% increase in annual operating costs — enough to erode its thin margin, plunge it into negative financial territory and no doubt lead to the loss of essential services.
So much for stretching scarce federal resources.
Notably, the typically quiet retail pharmacy giant Walgreens weighed in and urged against a rebate program, which it called “a fundamental restructuring, not a minor technical change.” Instead, it argues in its submitted comments for a 340B clearinghouse or repository administered by a neutral third-party vendor to prevent duplicate discounts.
Such an approach, the retailer said, would prevent manufacturer-specific deduplication requirements, preserve HRSA’s oversight authority, require only the minimum necessary data from covered entities and prohibit drugmakers from determining 340B eligibility for individual patients or claims, among other benefits.
“A 340B clearinghouse model represents the most ideal solution for covered entities, contract pharmacies, manufacturers, and the government by providing an efficient, coordinated framework that streamlines and enhances compliance, data exchange, and program integrity,” Walgreens wrote.
340B rebates on the Hill
Meanwhile, 340B rebates have caught the attention of lawmakers on Capitol Hill. Reps. Diana Harshbarger (R-Tenn.) and Earl “Buddy” Carter (R-Ga.), lead sponsors of the controversial 340B ACCESS Act, have circulated a letter urging colleagues to sign on in urging the Trump administration to move forward with the rebate pilot.
At the same time, nine Senate lawmakers — eight Democrats and an independent, Sen. Angus King Jr. of Maine — signed a letter urging Appropriations Committee leaders to adopt language barring the use of federal funds for a 340B rebate program. It’s similar to a bipartisan effort in the House led by Rep. Doris Matsui (D-Calif.), which garnered nearly 100 signatures.
Carter, who is running in a hotly contested GOP primary for U.S. Senate, has been especially vocal lately about 340B. He told Health and Human Services Secretary Robert F. Kennedy Jr., during a House subcommittee hearing on the agency’s proposed fiscal 2027 budget, that he was trying to give him “congressional help” in reining in 340B. The two went back and forth discussing their views that the program had morphed beyond its intended purpose.
Speaking of people who’ve been vocal about 340B, Kennedy has been on a tear making his views on the program clear.
During an appearance before the House Ways & Means Committee, he likened 340B — completely unprompted — to a “systematic and perverse transfer of wealth from rural America to more affluent areas.” Later, in an appearance before a Senate subcommittee, Kennedy said he was unsure of where the 340B rebate pilot sat when asked by Sen. Mike Rounds (R-S.D.) about the status of the proposal.
Rounds told Kennedy he had heard from many covered entities who were concerned about the proposed pilot program, adding, “in rural areas, it’s a really big deal.”
More manufacturer interference
The American Hospital Association once again sent a letter asking HRSA to stop drugmakers from requiring extensive 340B claims data from in-house pharmacies. The letter comes after Eli Lilly in April warned some covered entities they were out of compliance with the company’s new policy, which it unilaterally enacted effective Feb. 1, and risked losing access to 340B pricing on the affected claims. It also comes as AstraZeneca and Bristol Myers Squibb announced similar policies, making it five drugmakers to require in-house pharmacy claims data.
“Unfortunately, we are not aware of any action that HRSA has taken to address these unlawful drug company claims-data policies, even as more and more companies have announced policies similar to Lilly’s,” AHA wrote.
340B in the courts
Outside of rebates, the biggest new threat to 340B is probably AbbVie’s lawsuit against HRSA over the patient definition, which it called “outdated, overly expansive and erroneous” and said “has led to significant and troubling program abuses.”
The lawsuit appears to be targeting 340B referrals. It also carries strong echoes of HRSA’s 2015 “Mega Guidance,” which proposed major changes to the definition of an eligible patient and contract pharmacy relationships. It was withdrawn in 2017 after being deemed too burdensome on hospitals, questions about whether it exceeded HRSA’s regulatory authority and overwhelming public comment — proving that your voice matters!
Keep your eyes on this lawsuit.
Another major legal development took place in Washington D.C., where a federal court struck down HRSA’s longstanding GPO prohibition, ruling that the policy violates administrative law. Most affected hospitals I’ve spoken with are sticking with the status quo for purchasing drugs while it awaits an update from HRSA, which has 60 days to appeal the March 31 ruling.
Elsewhere, lots of action on state contract pharmacy access laws:
- The drug industry now has two wins at the appellate level after the U.S. 4th Circuit Court of Appeals in Virginia blocked Maryland and West Virginia from enforcing their contract pharmacy law. West Virginia officials are petitioning to have the full appeals court rehear the case, but a split in federal appellate decisions increases the chances the U.S. Supreme Court could take up the matter of state-level 340B contract pharmacy laws.
- A federal District Court judge ruled that North Dakota’s law was unconstitutional and could not be enforced.
- On a more positive note, a federal appeals court in New Orleans rejected two different challenges to Mississippi’s contract pharmacy law.
Three final news items:
- Indiana state regulators announced they will exempt FQHCs from its proposed new policy eliminating Medicaid reimbursement for 340B drugs. The policy, set to take effect July 1, will still apply to hospitals.
- Organon became the third drugmaker to move its contract pharmacy claims data submission to Truzo from 340B ESP, joining Alkermes and Puma Biotechnology.
- Stemline Therapeutics became the 41st drugmaker to enact contract pharmacy restrictions for its drug Orserdu, effective May 18. The company’s announcement on April 20 gives covered entities that lack an in-house pharmacy less than 30 days notice to designate a single contract pharmacy location and prepare to submit claims data via 340B ESP.
You’re not dreaming: The opposition is turning up the heat underneath the 340B program, trying to kill it with added complexity and death by a thousand cuts. It makes it so important that we stick together, tell positive stories about our safety net program as often as possible, and keep forging ahead.
We’re on the right side.
If you’d like to continue this conversation, please contact me at [email protected].