| MedMatrix Rx | WEEKLY 340B REVIEW |
Vol. 1 · No. 7
The shield holds, and the money moves anyway
A federal judge upheld South Dakota’s 340B contract pharmacy law by holding it does not regulate price. Illinois enacted a nearly identical statute the same day and drew two lawsuits before the ink dried. Meanwhile the rebate pilot and the recertification window both run on federal clocks that no state law reaches.
- South Dakota’s shield law survived. Chief Judge Lange dismissed all three challenges to S.B. 154 on August 7. AbbVie appealed August 10.
- Illinois drew three complaints. AbbVie and Novartis sued AG Raoul in N.D. Ill. on August 7, the day Public Act 104-0758 took effect; Bristol Myers Squibb followed.
- Hospital recertification opened August 10 and closes September 9, with new questions on shipping addresses and entity-owned pharmacies.
- The rebate pilot clock keeps running. Manufacturer plans are due August 24 for a January 1, 2027 start.
- The patient definition case briefed on. Provider groups filed their intervention reply August 11 in AbbVie v. Kennedy.
South Dakota won by conceding the point that matters
A federal judge saved the state’s 340B statute by holding it does not touch price. That reasoning is now the survival condition for every state shield law, and it marks the exact boundary those laws cannot cross. HRSA’s rebate pilot sits on the other side of it.
August 7 was a busy Friday. Chief Judge Roberto A. Lange dismissed all three manufacturer challenges to South Dakota’s 340B contract pharmacy law. Governor JB Pritzker signed Illinois House Bill 2371, effective on signature. And AbbVie and Novartis sued Illinois over it the same day, with Bristol Myers Squibb following. On Monday morning, August 10, AbbVie noticed an appeal to the Eighth Circuit. Hospital advocates called the South Dakota order a win. Read the sentence the win rests on and you will want to plan differently.
Here is the disposition, verbatim: “Because S.B. 154 does not function as a price regulation and is not federally preempted or otherwise unconstitutional or illicit, Plaintiffs have failed to state a claim, and the motions to dismiss are granted.” The court reached that result by following the Eighth Circuit’s line in Pharmaceutical Research and Manufacturers of America v. McClain, 95 F.4th 1136 (8th Cir. 2024), which upheld Arkansas Act 1103, and Novartis Pharmaceuticals Corp. v. Hanaway, No. 25-1619 (8th Cir. July 1, 2026), which affirmed the denial of a preliminary injunction against Missouri’s law. The shared rule: pharmacy practice is a traditional state police power, so a statute governing where a manufacturer must deliver a drug survives, while one governing what the drug costs would not.
Every state shield law that has survived appellate review has survived on that distinction. The Fifth Circuit landed in the same place in AbbVie v. Murrill, Nos. 24-30645, 24-30651, 24-30673 (5th Cir. Feb. 9, 2026), upholding Louisiana’s Act 358 as a regulation of drug distribution and the role of pharmacies in it, an area the 340B program leaves open to the states. Two circuits, one rationale, and it defines the ceiling. State contract pharmacy statutes protect the route your drugs travel. They do not reach the price, the discount mechanism, or the moment the money arrives. Those three sit in federal law, and all three are moving.
Give the other reading its due. Delivery protection matters. Contract pharmacies are how many covered entities reach patients beyond their own walls, and manufacturers have restricted that access entity by entity since July 2020. Three dismissals in one order raises the price of that campaign considerably. A CEO in Sioux Falls has real reason to be pleased this week.
State law defends the route your drugs travel. It says nothing about when the money shows up.
Now put it next to the calendar. HRSA published its revised 340B Rebate Model Pilot Program at 91 FR 48883 on August 3. Manufacturer plans are due August 24, and approved plans take effect January 1, 2027. Under the pilot, a covered entity buys the selected drug at wholesale acquisition cost, has up to 45 calendar days from dispensing to submit a rebate claim, then waits while the manufacturer pays or denies within 10 calendar days of a complete claim. HRSA scoped it to drugs selected for Medicare price negotiation, under 5.5 percent of total 340B sales on 2025 data.
That design does not restrict where your drugs go. It converts a discount you take at purchase into a receivable you collect afterward, on the manufacturer’s processing clock. HRSA disputes that this costs you anything. The notice says the 10-day rule is meant to land ahead of standard wholesaler payment terms, “thereby reducing or eliminating the need for covered entities to ‘float’ the WAC price,” and that HRSA “expects the cash-flow impacts on covered entities to be minimal.” That holds only where your wholesaler terms run longer than your full claim cycle, and only where claims clear on the first submission. Check both against your own accounts payable before you accept it.
Whichever way that comes out, South Dakota’s statute has nothing to say about it. Neither does Illinois’s. Neither would a shield law in any other state, because the moment one reached the discount mechanism itself, it would fail the test that saved South Dakota.
Which brings us to Chicago. The Eighth and Fifth Circuits have both gone against manufacturers. The Northern District of Illinois sits in the Seventh, which has not ruled on a state 340B delivery statute. A company hunting for an easy target would have picked a weaker one; Illinois House Bill 2371 cleared the Senate 55 to 0 and the House 113 to 1 on concurrence. A company hunting for a circuit split picks the strongest available statute in a fresh circuit and files fast. Two complaints landed the day the statute took effect, before anyone had operated under it for a single business day, and a third followed. That is not a response to an injury. It is a route to a court that can reject the Eighth Circuit’s reasoning for everyone.
So the ledger reads: hospitals are winning the fight over delivery, in a forum whose logic caps what those wins can protect, while the fight over the money runs on a federal schedule with dates in the next four months. Three things follow.
Model the pilot as a working capital event. The arithmetic that matters is the gap between paying wholesale acquisition cost at purchase and collecting the rebate afterward, times your volume in the selected drugs. Size the gap honestly: up to 45 days to submit, 10 more for the manufacturer to pay or deny, plus whatever your own claim assembly takes. Get that number in dollars and days from pharmacy and finance before January. Your bank will ask for it eventually.
Treat recertification as the deadline you actually control. The hospital window opened August 10 and closes September 9. OMB approved HRSA’s revised enrollment and recertification collection on June 4, 2026, adding questions that identify wholly owned pharmacies and health care service delivery sites. Your shipping address records and your ownership documentation are now the answer to a federal question rather than internal housekeeping. Failing to recertify removes you from the program, and no court order fixes that.
Put your specific numbers in the two windows still open. Comments on the CY2027 outpatient rule, which proposes paying for 340B drugs at average sales price minus 33.4 percent, close August 31. Feedback on Senator Cassidy’s discussion draft closes August 28. Both will govern longer than any of this litigation. Institution-level data on service lines funded and patients reached moves drafting; position statements do not.
Congress wrote the 340B bargain in 1992 so safety-net providers could stretch scarce dollars across more patients. State legislatures have since fenced one part of that bargain, and courts have upheld the fence by explaining how little it encloses. Read Judge Lange’s opinion for what it protects. Then read the Federal Register for what it does not.
Douglas McCormack, Founder of Acumen Partners and Chair of MedMatrix Rx, is a health policy attorney, startup CEO, and investor in early-stage health care ventures.
South Dakota’s 340B contract pharmacy law survives; AbbVie appeals to the Eighth Circuit
What happenedOn August 7, 2026, Chief Judge Roberto A. Lange of the U.S. District Court for the District of South Dakota granted the state’s motions to dismiss in three consolidated challenges to Senate Bill 154, codified as SDCL chapter 58-29G, Drug Discount Program Protections, at sections 58-29G-1 through 58-29G-4: AbbVie Inc. v. Jackley, No. 3:25-cv-03006-RAL; AstraZeneca Pharmaceuticals LP v. Jackley, No. 4:25-cv-04156-RAL; and Pharmaceutical Research and Manufacturers of America v. Jackley, No. 3:25-cv-03021-RAL (consolidated order of August 7, 2026, filed at the AstraZeneca docket). The court held that “S.B. 154 does not function as a price regulation and is not federally preempted or otherwise unconstitutional or illicit,” following the Eighth Circuit’s decisions in Pharmaceutical Research and Manufacturers of America v. McClain, 95 F.4th 1136 (8th Cir. 2024), and Novartis Pharmaceuticals Corp. v. Hanaway, No. 25-1619 (8th Cir. July 1, 2026), and rejected the takings and dormant Commerce Clause claims. AbbVie filed a notice of appeal to the Eighth Circuit on Monday, August 10; AstraZeneca and PhRMA had not appealed as of that afternoon (South Dakota Searchlight, August 10).
Why it mattersThe Eighth Circuit has now come out the same way twice, in McClain on the merits and in Hanaway on preliminary relief, and a district court in the circuit has applied that reasoning a third time. The opinion states the rule plainly enough to plan around: state shield laws survive because they govern where a manufacturer must deliver, not what the drug costs. That distinction protects contract pharmacy access, which is how many covered entities reach patients beyond their own walls. It also caps what any state statute can do about the rebate mechanism, the discount amount, or payment timing, all of which sit in federal law. As of August 15, 2026, the appeal remains pending.
- If you operate in an Eighth Circuit state (Arkansas, Iowa, Minnesota, Missouri, Nebraska, North Dakota, South Dakota), your contract pharmacy access rests on binding circuit precedent. Document current arrangements now while the ground is firm.
- Do not extend that comfort to pricing or payment timing. Nothing in this holding reaches the rebate pilot, claims-data conditions, or Medicare payment rates.
- Ask counsel where your state sits and what its shield statute actually covers: delivery only, or delivery plus data conditions and penalties. The scope varies materially state to state.
Three manufacturers open a new front against Illinois in the Seventh Circuit
What happenedGovernor JB Pritzker signed House Bill 2371, the Patient Access to Pharmacy Protection Act, on August 7, 2026; it became Public Act 104-0758 and took effect on signature. AbbVie and Novartis each sued that same day in the U.S. District Court for the Northern District of Illinois, naming Attorney General Kwame Raoul, and Bristol Myers Squibb followed with a third complaint (Legal Newsline, August 11; Capitol Fax, August 11). The Act bars manufacturers from denying, restricting, or interfering with the acquisition or delivery of 340B drugs to covered entities or their contract pharmacies unless federal law requires it. It cleared the Senate 55 to 0 and the House 113 to 1 on concurrence in the Senate amendments. The complaints plead Supremacy Clause preemption and a Fifth Amendment taking, and argue the statute compels manufacturers to transfer product to commercial pharmacies at 340B prices. Pritzker also signed HB 4327, Public Act 104-0769, the 340B Transparency, Reporting, and Accountability Act, directing the Illinois Department of Insurance to study 340B participation by covered entities and manufacturers (Governor’s office, August 7).
Why it mattersVenue and speed are the story. The Eighth Circuit has gone against manufacturers twice on this question and the Fifth Circuit once. The Seventh Circuit has not ruled on a state 340B delivery statute at all. Two complaints arrived the day the Act took effect, before any covered entity had operated under it for a business day, against a statute that cleared the Senate unanimously and lost a single vote in the House. That timing points toward building a circuit conflict rather than remedying a concrete injury. A split is what puts the question in front of the Supreme Court, and a Supreme Court answer would govern every state shield law at once.
- Illinois covered entities and their contract pharmacies operate under Public Act 104-0758 today. It is in effect and no court has enjoined it as of August 15, 2026.
- Watch for a preliminary injunction motion. That ruling, not the merits, will decide whether Illinois entities keep contract pharmacy access through 2027.
- If your state is considering a shield bill, expect the Illinois complaints to become the manufacturers’ template. Legislative drafting that stays on the delivery side of the line is what has survived so far.
Hospital recertification opened August 10 with new shipping and pharmacy ownership questions
What happenedHRSA’s annual 340B recertification window for hospitals opened Monday, August 10, 2026 and closes September 9, 2026 (340B Report, August 13). Hospitals face revised questions on drug shipping addresses and entity-owned pharmacies. The revisions trace to HRSA’s information collection request for enrollment and recertification, OMB No. 0915-0327, submitted for review in the Federal Register on January 8, 2026 and approved by OMB on June 4, 2026. HRSA describes the change as “providing additional clarification for covered entities to complete the shipping address section in 340B OPAIS”; commenting entities described it as “additional clarifying questions identifying wholly owned pharmacies and health care service delivery sites.” The collection also requires STD and TB grantees to supply a copy of the federal grant notice of award, with subgrantees supplying the executed written subrecipient agreement. HRSA estimates total annualized burden at 74,248 hours across roughly 46,183 respondents.
Why it mattersThis is the only item on the week’s list that a hospital controls outright, and the consequence of missing it is removal from the program. The new questions also tell you where HRSA is looking. Asking an entity to identify which shipping addresses belong to wholly owned pharmacies, and to document that ownership, builds the dataset an auditor would need to test entity-owned versus contract pharmacy claims later. Answers you file this month become the baseline for future audits.
- Reconcile every shipping address in OPAIS against your current wholesaler accounts before you certify. A stale address is cheap to fix in August and expensive to explain in an audit.
- Assemble ownership documentation for each entity-owned pharmacy: pharmacy license, and the Medicare cost report line that lists it. Have it ready rather than assembling it under a deadline.
- Give the authorizing official a written summary of what is being certified. The signature carries personal attestation weight, and the record should show what supported it.
The rebate pilot clock runs regardless of what any court decides
What happenedHRSA’s revised 340B Rebate Model Pilot Program notice published at 91 FR 48883 on August 3, 2026. Manufacturers must submit rebate plans no later than August 24, 2026, for participation effective January 1, 2027, covering drugs selected under the Medicare Drug Price Negotiation Program for initial price applicability years 2026 and 2027. Covered entities buy at wholesale acquisition cost, have up to 45 calendar days from dispensing to submit a rebate claim, and manufacturers must pay within 10 calendar days of a complete claim. If a submission comes back incomplete, the 10-day clock restarts when the missing data arrives. HRSA puts the pilot’s scope at less than 5.5 percent of total 340B sales based on 2025 data; the program as a whole covered 15,249 covered entities and 49,214 associated sites as of April 1, 2026. HRSA will act on manufacturer plans by September 24, 2026. Separately, S. 5244, the SUSTAIN 340B Act introduced August 5, 2026 by Senators Boozman, Moran, Baldwin, Capito, Kaine, and Hickenlooper, would end any 340B rebate model within one year of enactment and move HHS to an independent third-party clearinghouse; it sits with the Senate HELP Committee.
Why it mattersTen days is the payment window. The cycle runs much longer. It starts at purchase, when you pay wholesale acquisition cost instead of the ceiling price, extends across a submission window of up to 45 days, and closes only when a complete claim is paid. HRSA argues the gap costs entities little, on the reasoning that the 10-day rule lands ahead of standard wholesaler payment terms. That holds where your wholesaler terms run longer than your full claim cycle and your claims clear on the first pass. Test both assumptions against your own accounts payable rather than accepting them. The scope figure also looks small in aggregate; check it against your own purchase volume in the drugs CMS selected for negotiation. A bill that would end the program within a year does not change the January 1 date, and neither does the litigation over the prior version.
- Identify your purchase volume in the selected drugs and calculate the difference between wholesale acquisition cost and the 340B ceiling price. That figure, times your full claim cycle in days, is the working capital you need to arrange before January.
- Get the definition of a complete claim in writing from your 340B software vendor and your wholesaler. An incomplete submission restarts the manufacturer’s 10-day clock, so claim quality drives payment timing more than the deadline does.
- Watch for HRSA plan approvals expected September 24, 2026. Which manufacturers participate determines whether this touches your book at all.
The patient definition case moves toward a ruling that would outrank every state statute
What happenedAbbVie Inc. v. Kennedy, No. 1:26-cv-01190, before Judge Randolph D. Moss in the U.S. District Court for the District of Columbia, continues to brief. AbbVie filed April 8, 2026, arguing HRSA’s reading of “patient” is broader than the 340B statute allows. Proposed intervenors 340B Health and others filed their reply supporting intervention on August 11, 2026, following AbbVie’s August 4 response and NACHC’s August 3 reply. The government’s reply on its motion to dismiss is due August 27, 2026 (Georgetown Health Care Litigation Tracker). In a separate matter, the First Circuit has scheduled oral argument for September 15, 2026 in American Hospital Association v. AbbVie Inc., No. 25-2237, an appeal from the denial of manufacturer intervention in the rebate pilot litigation (Georgetown Health Care Litigation Tracker).
Why it mattersContract pharmacy access decides where a 340B prescription can be filled. The patient definition decides which prescriptions qualify in the first place. A narrower federal definition would shrink the eligible population at every dispensing site, entity-owned and contract alike, in every state, regardless of any shield statute. That makes this the case with the widest reach on the current docket for a DSH hospital. The intervention fight matters for the same reason: the government is the only party now defending the agency’s reading, and it answers to an administration that has already moved twice on 340B rebates.
- Model what a narrower patient definition would cost. Start with the share of your 340B volume tied to referral relationships and specialty prescriptions written outside your employed provider group.
- Support your trade association’s intervention effort. If intervention fails, hospitals have no direct voice in a case that sets the rule for their eligibility.
- Review how your eligibility determinations are documented today. Whatever definition survives, the audit will ask you to prove the relationship prescription by prescription.
- AbbVie’s Eighth Circuit appeal of the South Dakota dismissal, and whether AstraZeneca and PhRMA follow (South Dakota Searchlight, August 10).
- A preliminary injunction motion in the Illinois cases. That ruling decides whether Public Act 104-0758 governs contract pharmacy access through 2027 (Capitol Fax, August 11).
- Manufacturer rebate plans due August 24, approvals expected September 24. Which manufacturers file determines whether the pilot touches your book (91 FR 48883).
- Two comment windows close within a week. Cassidy discussion draft feedback on August 28; CY2027 OPPS comments, including the proposed ASP minus 33.4 percent rate, on August 31 (McDermott+, July 2026).
- D.S.D. ORDERAbbVie v. Jackley, AstraZeneca v. Jackley, PhRMA v. Jackley: order granting dismissalAugust 7, 2026
- SD SEARCHLIGHTFederal judge dismisses challenges to South Dakota drug discount lawAugust 10, 2026
- CAPITOL FAXAbbVie, Novartis sue to block 340B drug discount lawAugust 11, 2026
- ILLINOIS GENERAL ASSEMBLYHB 2371, Public Act 104-0758, effective August 7, 2026August 7, 2026
- LEGAL NEWSLINEPharma makers sue Illinois over 340B contract pharmacy lawAugust 11, 2026
- OFFICE OF THE GOVERNORGov. Pritzker takes bill action: HB 2371 and HB 4327August 7, 2026
- 340B REPORTHospitals face new 340B requirements as annual recertification beginsAugust 13, 2026
- FEDERAL REGISTEREnrollment and re-certification of entities in the 340B program, OMB No. 0915-0327January 8, 2026
- FEDERAL REGISTERNotice regarding 340B Rebate Model Pilot Program, 91 FR 48883August 3, 2026
- LEGISCANS. 5244, referred to the Senate HELP CommitteeAugust 5, 2026
- GEORGETOWN LITIGATION TRACKERAbbVie Inc. v. Kennedy, No. 1:26-cv-01190 (D.D.C.)Updated August 12, 2026
- GEORGETOWN LITIGATION TRACKERAHA v. AbbVie Inc., No. 25-2237 (1st Cir.): argument September 15, 2026Updated August 2026
- MCDERMOTT+CY2027 OPPS proposed rule: ASP minus 33.4 percent, comments due August 31July 2026