by Lidia Rodriguez-Hupp, Chief Customer Officer
September 1, 2026
With Congress on its annual August recess, things have settled into a late summer lull for 340B following an extraordinarily busy and consequential period for the program.
Manufacturers have now presumably filed their proposals for the 2027 rebate pilot program, but we have no details on them yet. If there are lawsuits, my best guess is they will come after HRSA releases details of the manufacturer plans. And that would have to happen by Oct. 1 to meet the agency’s revised requirement giving covered entities 90 days before implementing an approved rebate plan effective Jan. 1, 2027.
Meanwhile, as I recently wrote, 340B entities would be wise to prepare for the probability that the rebate pilot will launch in earnest on Jan. 1.
The biggest news from the past month was the introduction, at long last, of the SUSTAIN 340B Act by the bipartisan “gang of six” Senate lawmakers.
You might recall that in 2024, this bipartisan 340B work group released a discussion draft but was unable to agree on an actual bill. Two years later — with a slightly different mix of members, and against the backdrop of HRSA’s rebate pilot — the group finally got a real bill introduced.
Like the SECURE 340B Act introduced earlier this summer in the House, the Senate measure would pull the plug on rebates and codify 340B as a point-of-purchase discount program. Both bills would also establish parameters on the use of contract pharmacies and the definition of an eligible patient.
There’s a lot more to SUSTAIN — you can read a summary here — and plenty to scrutinize. But that’s for another day. Neither bill is going anywhere in this Congress, which is quickly running out of calendar workdays and is consumed by the upcoming midterm elections.
That said, it’s a highly positive development that we now have two major, bipartisan pieces of 340B legislation for the next Congress to take up — particularly if control of the House, Senate or both swings to the Democrats.
States get more legal wins
Illinois becomes the 23rd state to protect contract pharmacy access after Gov. J.B. Pritzker signed a law Aug. 7. It also prohibits manufacturers ordering the submission of claims data that is not required by state or federal law. The new law quickly prompted lawsuits from at least five manufacturers and drug-industry trade groups.
Pritzker also signed a separate bill that directs the state’s insurance department to issue a report on various aspects of the 340B program in Illinois by July 2028.
Speaking of manufacturer lawsuits, federal judges in August delivered yet more victories for states. Among the rejected complaints:
- Three industry lawsuits against South Dakota’s 340B law, which protects contract pharmacies and bars the collection of claims data not required under federal law
- AstraZeneca’s complaint against a similar law in Maine
- A lawsuit targeting Mississippi’s 340B law, also filed by AstraZeneca
New recertification paperwork
The annual 340B recertification period is under way through Sept. 9, and hospitals and other covered entity types face new requirements around shipping addresses and supporting documents.
Under changes finalized by HRSA this summer, covered entities must identify their relationship with each shipping address — for example, whether it’s a pharmacy, healthcare delivery site or other receiving location. For an entity-owned pharmacy, HRSA may require documentation demonstrating ownership.
The changes could add new administrative work for hospitals and health systems, particularly those with complex pharmacy and shipping arrangements. They could also affect how certain pharmacies are classified in the 340B database. If a pharmacy is not owned by the covered entity, HRSA will now require entities to register it as a contract pharmacy. That distinction could have significant operational and financial implications, given manufacturer restrictions affecting some contract pharmacy arrangements.
Hospitals also face clarified documentation expectations for child-site registrations. The new instructions state that hospitals should be prepared to submit a trial balance that clearly indicates unique and separate reimbursable outpatient costs and charges for each service being registered.
HRSA characterizes this as a clarification of existing documentation rather than a new collection requirement.
Other 340B news
U.S. Rep. Hillary Scholten (D-Mich.) introduced a bill that would shield certain hospitals from losing 340B eligibility if their disproportionate share adjustment percentage dips below the required threshold.
The bill would shield DSH and children’s hospitals, rural referral centers and sole community hospitals to remain eligible until 2030. It’s a response to concerns hospitals have raised about seeing their DSH percentage drop as a result of changes coming to Medicaid in 2027 from the omnibus “Big Beautiful Bill” signed into law in 2025.
Elsewhere:
- More trouble for CVS Health as a fifth 340B health system has filed suit alleging the vertically integrated healthcare giant illegally reduced contract pharmacy reimbursements due to the hospital.
- Genentech became the 14th manufacturer to require extensive claims-level data, including from in-house pharmacies
Even though Congress is quiet for now, stay vigilant and focused on doing the good work.
If you’d like to continue this conversation, please contact me at [email protected].