by Lidia Rodriguez-Hupp, Chief Customer Officer
March 2, 2026
Well, that didn’t take long.
After courts blocked its 340B rebate pilot and scuttled the planned Jan. 1 launch, the federal government has acted quickly to resurrect the program.
The latest comes courtesy of a Feb. 25 Information Collection Request in which HRSA says it plans to pursue a 340B rebate pilot program covering the drugs subject to Medicare Part D price negotiations from 2026 and 2027.
That would mean as many as 25 drugs from 13 companies, assuming all manufacturers choose to take part, submit plans and win approval for participation. It would also likely make Jan. 1, 2027 its targeted launch date.
HRSA also released a request for information on whether to move forward with the pilot. It later extended the public comment period from 30 to 60 days, to April 20, as several provider organizations had requested — underlining the importance of making your voice heard. This time, at least, HRSA appears to be listening to stakeholders.
The agency also added this bit of color:
“OPA expects that data submitted by covered entities to manufacturers will be comparable to data already being collected and maintained by covered entities through existing third-party vendor relationships or data that is already being provided to manufacturers with respect to certain contract pharmacy policies, in-house pharmacy claims requests, and data elements provided for claims with drugs dispensed under the Medicare Drug Price Negotiation Program. Therefore, the burden associated with a potential 340B Rebate Model Pilot Program data requests may not be significant.”
We’ll see about that. So far, covered entities who are using the Beacon platform to submit claims for Inflation Reduction Act maximum fair price rebates are reporting widespread confusion over how manufacturers are identifying 340B claims.
“Providers and consultants also said limited visibility into manufacturer vendor systems has raised concerns over how the drug industry is identifying 340B claims for de-duplication,” 340B Report recently wrote. One consultant told the publication she worried manufacturers may overcount 340B claims and give providers fewer MFP discounts than they are entitled to.
It once again raises the idea of having the government run a neutral clearinghouse to de-duplicate 340B and MFP claims as an alternative to a manufacturer-controlled rebate model. CMS already operates the Medicare Transaction Facilitator, a similar clearinghouse for MFP. A neutral de-duplication clearinghouse was also part of the original bipartisan draft SUSTAIN 340B Act released in 2024, and the American Hospital Association has championed the idea.
Whaddya say, HRSA?
At any rate, HRSA has agreed to provide at least 90 days notice between any future drugmaker 340B rebate model approvals and the program’s start date, up from 60 last go-round.
A few other rebate-related tidbits:
- The massive spending package President Trump signed Feb. 3 to fund the government through September includes language requiring HRSA to provide an update on 340B rebates to Appropriations Committee leaders within 30 days, or by March 5.
- Also of interest: S. Reps. Jack Bergman (R-Mich.) and Jake Auchincloss (D-Mass.) introduced a bipartisan bill to exempt community health centers from any proposed rebate model. They’re reportedly also working on separate legislation to exempt other covered entity types including critical access hospitals, sole community hospitals and Ryan White Clinics.
Finally, a recent 340B Report story shed some light on the bipartisan Senate “Gang of Six” and its efforts to craft a version of the long-awaited SUSTAIN 340B Act.
Most encouragingly, there is reportedly strong consensus among members against switching 340B to an after-purchase rebate model, as HRSA is proposing. But some members also told the publication that progress has been slowed by concerns over claims that 340B savings are tied to hot-button issues like gender-affirming care, immigration and abortion.
340B at the State Level
Speaking of such dubious associations, two new dark-money organizations are targeting efforts by Virginia state lawmakers to enact a contract pharmacy access law.
One of them, a group called People Over Profits, ran ads alleging that 340B increases the cost of health insurance and cancer drugs while boosting hospital CEO pay and pharmacy benefit manager profits. Another, called Community Action for Responsible Hospitals, sent text messages asking residents to urge lawmakers to oppose the legislation, claiming that health systems were “abusing” 340B “to rake in profits by overcharging patients.”
In 2024, former Virginia Gov. Glenn Youngkin, a Republican, vetoed a contract pharmacy access bill despite overwhelmingly bipartisan support from lawmakers after a series of dark-money ads that alleged 340B fuels illegal immigration. The state is now governed by Abigail Spanberger, a Democrat who established herself as a staunch 340B supporter during her years in the U.S. House.
There have been several legal developments:
- A federal appeals court in New Orleans upheld Louisiana’s contract pharmacy access law against a challenge from AbbVie, AstraZeneca and the trade group PhRMA. It affirmed a lower-court ruling from 2024 and was the third time a federal appeals court has upheld a state contract pharmacy access law.
- A Hawaii federal judge rejected AstraZeneca’s request to block enforcement of that state’s contract pharmacy law while its full lawsuit proceeds.
- In a different lawsuit challenging Hawaii’s law, a federal judge rejected the state’s request to dismiss separate complaints by AbbVie and PhRMA, allowing those cases to continue.
- The Minnesota Court of Appeals upheld that state’s contract pharmacy access law, conflicting with the ruling in 2025 of a federal judge who said the statute was unenforceable. The conflicting rulings create uncertainty about the law, which passed in 2024 and is set to expire on July 1, 2027.
Worryingly, the federal government for the first time has waded into the legal battle over state-level 340B contract pharmacy laws by taking the side of drugmakers.
Both the Departments of Justice and Health and Human Services filed briefs urging federal appellate courts to strike down laws in Colorado and Rhode Island as unconstitutional because they interfere with federal 340B law.
It raises questions about why the Trump administration is looking to assert federal authority in this issue. Republicans traditionally have championed the ability of states to make their own decisions.
At any rate, it’s not clear what effect the government’s briefs will have on these cases, if any. So far, federal courts that have weighed in on these laws have sided overwhelmingly with the states.
Let’s hope that continues.
If you’d like to continue this conversation, please contact me at [email protected].