by Lidia Rodriguez-Hupp, Chief Customer Officer
November 2, 2026
Here we go again: A group of hospitals, led by the American Hospital Association and the Maine Hospital Association, have sued HRSA aiming to stop its 340B rebate pilot program from taking effect Jan. 1. And once again, they filed the lawsuit in the U.S. District Court in Maine.
The plaintiffs’ arguments also ring familiar to anyone who paid attention to the previous lawsuit filed nearly 10 months ago: that the government violated administrative law by ignoring the overwhelming testimony of 340B entities who said rebates will cost them time, money and the ability to offer critical safety-net health services. The AHA has said the pilot program will cost 340B hospitals more than $1 billion, roughly twice the government’s estimate of $537 million.
Whether this argument lands with Chief U.S. District Judge Lance Walker, who blocked HRSA’s 2026 rebate pilot days before it was set to begin, remains to be seen. While there is little doubt that HRSA lent more credibility to arguments from the pharmaceutical industry than from covered entities, the agency was much more deliberate this go-round about following administrative rules.
For his part, Walker granted motions from three drugmakers and the trade group PhRMA to intervene in the case. The plaintiffs have asked for a hearing in mid-November.
Meanwhile, the fight continues on other fronts. The National Association of Community Health Centers (NACHC) sent a letter signed by more than 50 organizations to leaders of the House Energy and Commerce Committee asking for a hearing on implementation of the 340B rebate pilot “as soon as possible.”
“Absent congressional action or oversight, the pilot will substantially change how discounted drugs are accessed and financed by safety-net providers before Congress has held a hearing or fully evaluated the consequences for patients, providers, pharmacies, and the broader health care system,” the letter reads.
In the Capitol, four House lawmakers — Reps. Rob Bresnahan Jr. (R-Pa.), Debbie Dingell (D-Mich.), Tracey Mann (R-Kan.) and Lois Frankel (D-Fla.) — introduced a bipartisan bill to pause any 340B rebate program through 2028. It had 16 co-sponsors since being introduced on Oct. 9.
Separately, a bipartisan group of 17 House lawmakers led by Reps. Doris Matsui (D-Calif.) and Mann reintroduced the PROTECT 340B Act on Oct. 29, with language added to end any 340B rebate program. It also adds a prohibition on PBMs and insurers discriminating against covered entities, and it would set up a third-party claims clearinghouse to prevent duplicate discounts.
Finally, Rep. Jack Bergman (R-Mich.) introduced the bipartisan Safety-Net Provider Drug Pricing Protection Act. It would exempt community health centers, several types of grantees and small rural hospitals — but not major hospitals — from 340B rebates, expanding on his earlier bill that focused exclusively on health centers. It has 14 co-sponsors.
This legislative activity is playing out against a backdrop of the Nov. 3 midterm elections and the increasingly likely prospect of Republicans losing control of the House, Senate or both. A group of House Democrats have formed what they call a “Cost-of-Living Healthcare Working Group,” spearheaded by Reps. Alexandria Ocasio-Cortez (D-N.Y.) and Terri Sewell (D-Ala.) aimed at undoing much of the Trump administration’s policies, expanding coverage and supporting 340B.
340B in the states
Another state attorney general has joined the fight against Big Pharma’s demands for claims data. Missouri A.G. Catherine Hanaway, a Republican, sent a cease-and-desist letter to Eli Lilly, warning the drugmaker its expanded claims-data demands violate the state’s consumer protection law. She joins Arkansas Attorney General Tim Griffin, who sued 13 drugmakers and 340B ESP parent Second Sight Solutions in July, though he cited violations of the state’s first-in-the-nation contract pharmacy access law.
It’s a sign that more state A.G.s are taking interest in manufacturer data demands from the perspective of protecting consumers. Keep an eye on Amgen, which starting Nov. 15 will “begin seeking standard healthcare visit and service claims data” related to 340B dispenses of its drugs, making it the only manufacturer to go that far.
Meanwhile, the full U.S. 4th Circuit Court of Appeals heard oral arguments Oct. 27 over contract pharmacy access laws in Maryland and West Virginia. The rare “rehearing en banc” was granted to reconsider earlier 2-1 rulings by three-judge panels that went against each state and were the only federal appellate decisions to rule against state contract pharmacy laws.
The hearing is significant. If the full 11-judge bench reverses the earlier rulings and declares the state laws are constitutional, there is no split at the appellate level, making it highly unlikely the U.S. Supreme Court would agree to hear the case.
In related news, a federal judge denied PhRMA’s request to block Vermont’s contract pharmacy law.
Compliance matters
HRSA has released its 340B audit findings from fiscal 2026, and the results are rather interesting.
- HRSA audited 38 covered entities in the fiscal year that ended Sept. 30. One had duplicate discounts and was ordered to repay manufacturers, while six had administrative errors that did not result in sanctions.
- Of the five manufacturers audited, four had adverse findings and three were ordered to refund covered entities.
Just something to keep in mind when manufacturers crow about how covered entities are abusing the program.
Speaking of bad behavior from the drug industry, the organization PhRMA has sued CMS over its GLOBE most favored nation drug-pricing model for Medicare Part B, which is set to begin Jan. 1. This after CMS agreed to drastically narrow the program from nearly 40 manufacturers to just three.
Finally, two procedural contract pharmacy developments:
- Pfizer announced that effective Dec. 1, covered entities participating in its Defined Distribution Oncology Network, or DON, may no longer use specialty pharmacies for DON drugs. They must instead use designated in-house DON specialty pharmacies or, if not currently participating in the DON, may use a single designated specialty pharmacy location. Pfizer also removed its Ibrance (palbociclib) metastatic breast cancer oral drug from its contract pharmacy policy.
- AstraZeneca added its breast cancer medication Etcamah to its policy, effective Oct. 26.
Will there be a winner in the race to stop 340B rebates? Time will tell. In the meantime, keep focused on doing good work.
If you’d like to continue this conversation, please contact me at [email protected].