by Lidia Rodriguez-Hupp, Chief Customer Officer
March 30, 2026
While the government’s proposed 340B rebate pilot project has entered something of a lull while the public comment period enters its final weeks, the safety net program for better or worse is under the spotlight as perhaps never before.
The 340B program was a hot topic in a recent hearing on Capitol Hill, courts issued some key rulings, and states continue to lead on protecting the program — mostly. Buckle up, and read on.
Fate of 340B Rebates
While HRSA continues to work behind the scenes, a bipartisan group of House lawmakers, including U.S. Rep. Doris Matsui (D-Calif.), has circulated a “Dear Colleague” letter drumming up support for adding language to an appropriations bill to block any spending on 340B rebate models. Matsui is the sponsor of the 340B PATIENTS Act, and our sources indicate her letter had around 100 signatures as of this writing. If the language makes it to appropriations legislation, it could be a very interesting development.
Contact your congressional representative and urge them to sign on. And don’t forget that HRSA continues to accept comments on its proposed 340B rebate pilot through April 20.
Meanwhile, the bipartisan Senate “gang of six” 340B work group is out one member after Sen. Markwayne Mullin (R-Okla.) was confirmed as the new secretary of the embattled Department of Homeland Security. No word yet on a replacement, but the group has been working to introduce legislation to make changes to 340B and reportedly has a strong consensus opposing after-purchase rebates.
340B on the Hill
The 340B program came under scrutiny during a March 18 hearing of the House Energy & Commerce Health subcommittee. Chairman Rep. Morgan Griffith (R-Va.) kicked things off by saying the use of program benefits had grown “opaque,” while witnesses representing physicians and employer group purchasers said 340B helps fuel health system acquisition of private practices and drives up the costs of health insurance.
Notably, Rep. Earl “Buddy” Carter (R-Ga.), a co-sponsor of the 340B ACCESS Act, which among other things would limit hospital eligibility, used most of his time to interrogate American Hospital Association (AHA) CEO Richard Pollack.
Carter, one of several Republicans running in a crowded Senate primary, chafed at suggestions that he wanted to do away with the program. “Nothing could be farther from the truth,” he said. “What I want is simply the 340B program to be what it was intended to be for,” which he said was FQHCs and rural hospitals.
Carter told Pollack that 340B is “masking the cost of other things that I can’t see. And if I can’t see them then I can’t help you with it.”
Pollack told him 340B benefits patients “in many ways” and said the AHA would be willing to discuss ways to increase program transparency. A hopeful sign?
340B ESP Operational Problems (No Surprise)
America’s Essential Hospitals (AEH) sent a letter to CMS Administrator Dr. Mehmet Oz to explain that some manufacturers are wrongly identifying claims as 340B-eligible and refusing to provide a maximum fair price refund under the Medicare drug price negotiation program.
“340B hospitals are forced to navigate a new system to rectify issues caused by manufacturers, even in states with prohibitions on manufacturers requiring 340B ESP use in the contract pharmacy context,” the letter reads. It also outlines suggested remedies.
Meanwhile, 340B stakeholders including AEH, AHA and Ryan White Clinics for 340B Access have written letters urging HRSA to block new claim data submission policies from Eli Lilly and Novo Nordisk. Those policies, which went or will go into effect Feb. 1 and April 1, respectively, require an expanded set of claims data (including medical) for all 340B dispensations, including at in-house pharmacies.
“The requirements at issue are not mere extensions of contract pharmacy requirements, but a vast new burden on all 340B hospital drug purchases and a significant new step in unilateral manufacturer actions to substitute their own rules for HRSA’s,” AEH wrote in its letter.
Unfortunately, the silence from HRSA suggests it has no intention of intervening.
340B in the Courts
A federal appeals court revived a California health system’s complaint against four manufacturers it alleged of overcharging for 340B drugs because it brought suit under the federal False Claims Act, which allows private parties to file whistleblower lawsuits on behalf of the government over alleged fraud.
The 9th Circuit Court of Appeals overturned a lower court ruling throwing out the lawsuit from Adventist Health System. A Supreme Court ruling from 2011 found that covered entities must take up 340B overcharges through administrative dispute resolution, not litigation, so this ruling is seen as potentially opening up a new legal pathway for program stakeholders.
That might be a good thing, since a sixth ADR panel sided with drugmakers in March, making Big Pharma 6-0 against covered entities.
Speaking of legal pathways for covered entities, the four drugmakers at the center of an antitrust lawsuit alleging they colluded to deny 340B pricing on insulin at contract pharmacies is asking the Supreme Court to take up the case. This comes after the 2nd Circuit Court of Appeals reversed a lower court’s ruling denying antitrust claims against AstraZeneca, Lilly, Novo Nordisk and Sanofi.
340B in the States
States remain the focus — and in most cases, the life raft — around 340B:
- A federal judge rejected the trade group PhRMA’s bid to block enforcement of Colorado’s contract pharmacy access law, marking the third ruling against the drug industry over the state’s law. PhRMA has appealed.
- A federal judge rejected AbbVie’s challenge to Tennessee’s law, which prohibits new manufacturers restrictions on contract pharmacies after July 1, 2025.
- Washington Bob Ferguson,signed a contract pharmacy access bill with provider and manufacturer reporting requirements.
- In Virginia, lawmakers sent Abigail Spanberger a measure to establish a study group to evaluate the 340B program in the state. The legislation reportedly originated as a contract pharmacy protection measure but was amended.
Of note, Community Voices for 340B, a nonprofit advocacy group, established a 340B litigation defense fund to help support stakeholders defending state contract pharmacy access laws against lawsuits from drugmakers and “level the playing field,” in its words. It’s seeking contributions and accepting applications for financial assistance.
Meanwhile, two states where 340B programs are not getting help from courts or elected officials are Indiana and Kansas.
- In Indiana, state officials are moving to eliminate the ability to receive 340B benefits on Medicaid managed care claims effective July 1. The state already requires covered entities to bill Medicaid fee-for-service claims at the 340B acquisition price. As 340B Report notes, because Indiana is a Medicaid expansion state, about two-thirds of the 340B savings will flow to the federal government. On top of hospital reporting requirements signed by Mike Braun, who established himself as a program foe during his time in the U.S. Senate, it’s a further sign of the program’s grim outlook in the Hoosier State.
- Finally, Kansas House Speaker Dan Hawkins shut down the chamber’s session early to avoid a floor vote on a contract pharmacy access bill that passed the state Senate last year. Hawkins is running as a Republican for state insurance commissioner and has reportedly taken various measures to stall the bill in the House. What’s next isn’t clear. The Kansas Legislature is supposed to officially adjourn on April 10.
Worryingly, HHS and the Department of Justice have again intervened on behalf of manufacturers in lawsuits targeting contract pharmacy access laws in Colorado and Maine. The government is arguing these state laws conflict with the federal statute; courts have mostly disagreed. It raises questions about whose side the Trump administration and RFK Jr. are really on: safety net providers, or pharmaceutical manufacturers?
Stay focused and active, friends. Let’s work together to defend 340B!
If you’d like to continue this conversation, please contact me at [email protected].