What happenedCorewell Health William Beaumont University Hospital filed Corewell Health William Beaumont University Hospital v. Kennedy, No. 1:26-cv-03111, in the U.S. District Court for the District of Columbia on September 3, with a sealed preliminary injunction motion. The Royal Oak, Michigan hospital switched from DSH to rural referral center in the January window on a projection that its disproportionate share adjustment might fall below 11.75 percent; the final FY2025 cost report showed 12.39 percent. HRSA rejected its April application to return to DSH status because the Authorizing Official did not attest to documents uploaded April 20, two days before a five-day deadline, declined reconsideration June 11, and set October 1 as the earliest effective date. The single APA count argues HRSA acted arbitrarily and, citing Albany Med Health System v. HRSA, No. 1:23-cv-03252 (D.D.C. Mar. 3, 2026), on appeal to the D.C. Circuit (No. 26-5147) without a stay, that the statute gives HRSA no authority to condition a hospital’s pricing on registration. It seeks DSH reinstatement retroactive to April 1.

Why it mattersAlbany Med vacated HRSA’s child-site registration notice; Beaumont asks a second D.D.C. judge to extend that reading to a parent hospital’s eligibility category. A win on that theory ends injuries like Beaumont’s for every hospital covered entity. It also removes the sector’s cleanest answer to critics who say nobody checks who is in the program, while Congress and the administration weigh who should run it.

What happenedHRSA posted a program update September 8 describing OPAIS form changes effective October 1, 2026, under the information collection HRSA noticed in the Federal Register January 8 (OMB No. 0915-0327). The update lists new shipping-address information to sort each location into shipping address, covered entity, child site, or contract pharmacy; new questions on street-address changes; Notice of Award documentation for STD and TB entities; CMS cost-report terminology, replacing “Medicare Provider Number” with “CMS Certification Number”; and clarified hospital instructions on Worksheet S and trial-balance documentation. HRSA says the changes “do not change the underlying statutory eligibility requirements for participation in the 340B Program.” RWC-340B‘s July 29 review of the approved forms adds the parts hospitals will feel: entity-owned pharmacies must prove ownership with a pharmacy license or the Medicare cost report, non-owned pharmacies must register as contract pharmacies, and child-site trial balances must show distinct cost and revenue per site. Recertification closed September 9; HRSA removes entities that missed it.

Why it mattersThe forms move OPAIS toward a cost-report reconciliation, the standard a CMS-run program would apply, and HRSA is adopting CMS vocabulary as it does it. The changes land seven months after Albany Med vacated the prior child-site notice and while Beaumont argues HRSA cannot impose registration conditions at all. HRSA is building a stricter gate whose legal footing is under challenge.

What happenedCMS opens the Medicare Part D Claims Data 340B Repository for voluntary submissions October 1, 2026, under a fact sheet and FAQ dated August 26 that America’s Essential Hospitals circulated September 8. Covered entities or their TPAs submit seven fields per Part D claim: 340B ID, claim record indicator, date of service, prescription reference number, fill number, NDC-11, and dispensing pharmacy NPI. Submissions run quarterly; the first deadline is December 31, 2026 for 2026 claims through September 30, and October to December claims are due March 31, 2027. CMS says the data “will not be shared outside of CMS,” including with manufacturers and Part D plans, and will not enter rebate calculations “unless and until we propose and finalize a policy to do so.” The CY2027 Physician Fee Schedule proposed rule would require Medicare providers and suppliers that are covered entities to submit for claims dated on or after January 1, 2027. Comments close September 14.

Why it mattersThis is the first federal claims-level 340B dataset, and CMS holds it. The statute requires CMS to remove 340B units from Part D inflation rebates, so the agency has a lawful reason to know which Medicare prescriptions carried a 340B discount. Once the mandate takes effect, a DSH hospital’s Part D 340B footprint sits in a CMS database next to its cost report. That helps if it displaces manufacturer data demands; it is a new exposure if CMS later proposes other uses, which the FAQ leaves open.

What happenedJohnson & Johnson sent covered entities two notices on September 4, and 340B Report reported them September 9. The contract pharmacy notice limits every covered entity type to a single contract pharmacy within 40 miles of the parent site, plus one specialty pharmacy for PAH drugs, effective September 15 for hospitals and November 3 for grantees, with a grantee designation deadline of October 20. The companion claims-data policy requires 340B claims regardless of dispensing location, which brings in-house pharmacies into the submission requirement, with a 45-day window after dispensing and a two-notice, five-business-day suspension process (Becker’s, Sept. 11). Grantees were a class J&J’s own 2022 policy exempted; ADAPs remain exempt. The move follows the pattern AHA described in an April 27 letter asking HRSA to act against data conditions, citing an Eli Lilly warning that hospitals would lose pricing unless they complied “without further delay.” States have moved the other way: Colorado and West Virginia bar manufacturers from requiring claims data as a condition of the 340B price, and Illinois’s H.B. 2371 bars data demands not required by state or federal law, at up to $1,000 per violation.

Why it mattersMost manufacturer contract pharmacy policies since 2020 exempted federal grantees; a policy that reaches both classes gives health centers and hospitals a shared injury. In-house pharmacy demands strip the stated rationale, contract pharmacy diversion risk, out of the demand. And in the week hospital groups circulated CMS’s August 26 assurance that repository data “will not be shared” with manufacturers, a manufacturer moved to collect claims data directly. Covered entities will run two parallel claims feeds for the same prescriptions.

What happenedThe Congressional Research Service published State Actions to Lower Drug Prices: Selected Legal Issues August 31; 340B Report covered it September 9. CRS writes that “at least three federal appeals courts have held that the state 340B laws are not preempted by the 340B statute,” citing the Eighth Circuit in PhRMA v. McClain (Arkansas) and Novartis Pharmaceuticals Corp. v. Hanaway (Missouri) and the Fifth Circuit in AbbVie Inc. v. Fitch (Mississippi) and AbbVie Inc. v. Murrill (Louisiana), while the Fourth Circuit panel in PhRMA v. McCuskey held West Virginia’s law likely preempted, affirming a preliminary injunction. The Fourth Circuit granted rehearing en banc, which set the panel opinion aside, and CRS says the court “is working to schedule the hearing in fall 2026.” In Illinois, five suits against H.B. 2371, signed August 7, sit before Judge Edmond E. Chang in the Northern District of Illinois: AbbVie Inc. v. Raoul, No. 1:26-cv-09523; Novartis Pharmaceuticals Corp. v. Raoul, No. 1:26-cv-09522; Bristol Myers Squibb Co. v. Raoul, No. 1:26-cv-09590; AstraZeneca Pharmaceuticals LP v. Raoul, No. 1:26-cv-09805; and PhRMA v. Raoul, No. 1:26-cv-09859. The state filed a combined opposition to the preliminary injunction motions the week of September 1 (McDermott). Colorado judges dismissed AstraZeneca’s and PhRMA’s challenges to that state’s law on August 31 and September 1 (340B Report).

Why it mattersA congressional research arm has written the circuit split down for Hill staff, which raises the odds the Cassidy draft addresses preemption in text. District courts, the Fifth Circuit, and the Eighth Circuit keep upholding shield laws, and the one contrary panel opinion no longer stands. Illinois is the live test of whether a law signed in August protects contract pharmacy arrangements this year.