by Lidia Rodriguez-Hupp, Chief Customer Officer
October 2, 2026
One week later than anticipated, HRSA said it has approved plans from 10 drugmakers for its 340B rebate pilot program that starts next year. HRSA’s Oct. 1 announcement came one day before a deadline to comply with its own requirement that approved manufacturers give covered entities 90 calendar days notice before the Jan. 1, 2027 start date.
The approved plans comprise 18 drugs subject to the maximum fair price (MFP) provision of the Medicare Drug Price Negotiation Program for calendar years 2026 and 2027. Two eligible MFP drugs — AstraZeneca’s blood cancer medication Calquence and Novo Nordisk’s GLP-1 juggernaut Ozempic — were not among the approved plans, for reasons that were not clear, while four other drugs covered by MFPs in 2026 will no longer be included in the drug negotiation program in 2027, making them ineligible for 340B rebates.
Notably, all approved manufacturers plan to use the Beacon platform for uploading claims data. Beacon is the 340B rebates platform from Second Sight Solutions, the parent company of 340B ESP.
HRSA said it will allow up to 12 required data fields from either pharmacy or medical claims to effectuate the payment of rebates, not including purchasing or encounter-level data. Data must be submitted within 45 days from dispensation.
“Rebates may not be denied for covered-entity eligibility, diversion, or Medicaid duplicate-discount concerns — those must be raised with HRSA or, as applicable, pursued through statutory audit and ADR mechanisms,” HRSA says. “Other denials require documented rationale, and rebates may not be denied for perceived lack of WAC purchases.”
We’ll have more to say about the 340B rebate pilot as we comb through the details.
Meanwhile, CMS was set to launch its first-ever 340B data repository for Medicare Part D claims on Oct. 1 as a voluntary program. The agency is proposing to make the repository mandatory for all covered entities enrolled in Medicare starting Jan. 1, 2027.
Hospital groups and covered entities have generally been supportive of a repository clearinghouse but argue it should replace a 340B rebate program and manufacturer data submission requirements. They also want CMS to thoroughly validate the technology before making participation mandatory and threatening penalties for non-compliance.
340B in the courts
As we await potential legal responses to the rebate pilot, the judicial system continues to be busy hearing 340B cases.
The 13 drugmakers targeted by Arkansas Attorney General Tim Griffin for flouting the state’s 340B contract pharmacy access law used a federal law to move the lawsuit from state to federal court. Arkansas can try to persuade a judge to move the case back to state court, though it’s not clear whether they intend to try.
Interestingly, drug industry challenges against state 340B laws have taken place in federal courts, which have mostly ruled against manufacturers — and in fact, a federal judge last week upheld Arkansas’ law against a challenge from AstraZeneca.
However, two of three federal appellate courts that have heard the original contract pharmacy restrictions have ruled that the 340B statute does not bar manufacturers from placing limits on distribution (a ruling in the the third case remains pending). Arkansas, which became the first state to enact a contract pharmacy access law in 2021, is also the first to bring suit against manufacturers for violating its law.
Other legal developments:
- Eli Lilly is asking a federal court in Florida to dismiss a lawsuit by Tampa General Hospita The hospital sued Lilly over cutting off access to 340B pricing because it refused to submit extensive claims data for all relevant dispenses, including at in-house pharmacies. Lilly claims the hospital is improperly citing state law to enforce 340B.
- Two different federal judges rejected challenges from AstraZeneca and the Pharmaceutical Research and Manufacturers of America (PhRMA) against Colorado’s contract pharmacy access law. A third judge ruled against AbbVie’s challenge in June. All three plaintiffs have appealed their earlier bids for preliminary injunctions blocking enforcement.
- A federal appeals court by an 8-3 vote rejected Novartis’ bid to reconsider its three-judge ruling in favor of Missouri’s contract pharmacy law in front of the full court. The company had asked the appellate court to block enforcement of the law while its full lawsuit plays out.
- In New Mexico, a federal judge blocked AbbVie’s effort to halt enforcement of that state’s contract pharmacy law, which applies to community health centers.
CVS Health, embroiled in its own lawsuits from five different hospital groups, has told covered entities it plans to replace its 340B contract pharmacy and administrative service contracts with new ones starting next year. Hopefully the new terms won’t add fuel to Big Pharma’s contention that 340B contract pharmacies are enriching large, publicly traded companies.
LEGISLATIVE
The U.S. House has been in recess since Sept. 16 and the Senate leaves town Oct. 2. Lawmakers won’t return until after the Nov. 3 midterms. Depending on the outcome and the ramifications for control of the House and Senate in 2027, there could be some lame-duck shenanigans from the likes of outgoing Sen. Bill Cassidy, the Louisiana Republican who chairs the Senate HELP Committee and is eager to rein in 340B.
Meanwhile, the bipartisan SECURE 340B Act picked up three new cosponsors: Reps. Neal Dunn (R-Fla.), Vicente Gonzalez (D-Texas) and Carol Miller (R-W.Va.). The legislation, which would pause rebates, establish a neutral claims clearinghouse and tighten the patient definition, among other changes, has received mixed reviews from covered entities. The American Hospital Association sent the lead sponsors its comments, which argued for a permanent ban on rebates and said the proposed patient definition was too cumbersome. You can read them here.
Six GOP U.S. House members from New York state signed a letter urging CMS to scrap its proposed 37% reimbursement cut for 340B payments from Medicare Part B, arguing the cuts, which would start Jan. 1, would hurt safety net hospitals in the state.
Other 340B news
PhRMA’s new CEO is a familiar face: former U.S. Rep. Eric Cantor, a Virginia Republican who served two terms as House majority leader. He replaces Stephen Ubl, who is retiring. Cantor was a reliable drug-industry ally during his 14 years in Congress.
Meanwhile, PhRMA is out with its latest anti-340B “markups” ad. Called “Profits First Park,” the 30-second ad centers on a group of hospital executives who scheme to use their 340B proceeds to sponsor a football stadium, but the spot is rich with unintended irony. “Patients pay more and we profit?” asks one character, neatly summarizing pharma’s very business model. It’s also an industry that spent $656 million on NFL advertising last year. Pot, kettle, etc.
Elsewhere:
- Johnson & Johnson and Merck became the 15th and 16th manufacturers, respectively, to start requiring all 340B claims, including from in-house pharmacies. J&J went a step further, expanding its contract pharmacy restrictions to federal grantees
- Japanese drugmaker Takeda added its Mimrylo blood cancer medication to its contact pharmacy restrictions.
More to come. Stay on your toes and keep doing the good work!
If you’d like to continue this conversation, please contact me at [email protected].