MedMatrix Rx
Daily 340B Morning Briefing for Hospital and Clinic Executives
Recent developments in the 340B program highlight significant shifts in pricing and access. Johnson & Johnson has mandated that 340B covered entities submit claims-level data starting September 15 to maintain pricing. This move aims to improve transparency. Concurrently, Froedtert Memorial Lutheran Hospital has filed a lawsuit against CVS, alleging the diversion of $18 million in 340B savings from 2020 to 2025. In legislative efforts, Oklahoma is seeking to revive a state law to expand access to discounted drugs through the 340B program. Additionally, a comparison of recent congressional proposals reveals a focus on reforming the program to improve transparency and integrity. These developments show the ongoing challenges and changes within the 340B landscape, impacting how covered entities manage pricing and access to essential medications.
EXECUTIVE SUMMARY
01
Johnson & Johnson mandates claims data submission for 340B pricing.
Starting September 15, Johnson & Johnson requires 340B covered entities to submit claims-level data to maintain pricing.
Starting September 15, Johnson & Johnson requires 340B covered entities to submit claims-level data to maintain pricing.
Source: Becker’s Hospital Review
02
Milwaukee hospital sues CVS over alleged 340B diversion.
Froedtert Memorial Lutheran Hospital claims CVS diverted $18 million in 340B savings between 2020 and 2025.
Froedtert Memorial Lutheran Hospital claims CVS diverted $18 million in 340B savings between 2020 and 2025.
Source: Becker’s Hospital Review
03
Trump announces nationwide Medicaid drug pricing model.
All 50 states will join a program providing ‘most favored nation’ pricing to some drugs within Medicaid.
All 50 states will join a program providing ‘most favored nation’ pricing to some drugs within Medicaid.
Source: MedPage Today
04
Oklahoma seeks to revive state law on 340B drug access.
Oklahoma asked the 10th Circuit to revive a law expanding access to discounted drugs through the 340B program.
Oklahoma asked the 10th Circuit to revive a law expanding access to discounted drugs through the 340B program.
Source: NewsBreak
05
Comparison of recent 340B bills highlights key program changes.
Three congressional proposals aim to reform the 340B program, focusing on transparency and program integrity.
Three congressional proposals aim to reform the 340B program, focusing on transparency and program integrity.
Source: AHA
EXECUTIVE SUMMARY — KEY TAKEAWAYS
Most important 340B implication. The Johnson & Johnson mandate for claims data submission is a critical shift for 340B covered entities, as it introduces new compliance requirements that could impact their operational processes and financial sustainability. This requirement may necessitate significant investments in data management systems and resources to ensure accurate reporting, potentially diverting funds from patient care initiatives. Furthermore, the lawsuit by Froedtert Memorial Lutheran Hospital against CVS over alleged diversion of 340B savings highlights the ongoing risks that covered entities face in protecting their financial interests within the program. As states like Oklahoma push for expanded access to discounted drugs, covered entities must remain vigilant and proactive in adapting to these evolving regulatory and legal landscapes to safeguard their access to vital resources.
Emerging risks.
- Covered entities risk losing 340B pricing if they fail to submit claims data to Johnson & Johnson.
- Legal disputes over 340B program rules could lead to changes in contract pharmacy arrangements.
- States enacting laws to protect 340B arrangements may face legal challenges from manufacturers.
- HRSA’s proposed rebate model could disrupt current 340B pricing mechanisms if implemented.
Emerging opportunities.
- Entities can strengthen compliance systems to meet new data submission requirements from manufacturers.
- Hospitals could use legal rulings to secure more favorable 340B contract pharmacy terms.
- State laws supporting 340B arrangements may increase access to discounted drugs for patients.
- Engaging in HRSA’s RFI process allows entities to influence future 340B program designs.
Key actions for providers.
- Submit required claims data to Johnson & Johnson by the September 15 deadline to maintain 340B pricing.
- Monitor ongoing litigation for developments that may affect 340B contract pharmacy operations.
- Advocate for state-level legislation that supports 340B program access and compliance.
- Participate in HRSA’s RFI process to provide input on potential rebate model designs.
TOP STORIES
Johnson & Johnson mandates claims data for 340B pricing.
Becker’s Hospital Review · September 11, 2026
- J&J requires claims-level data submission from 340B entities starting September 15.
- Noncompliant entities will receive notices and face pricing suspension.
- Pricing will be restored within 10 business days upon data submission.
Milwaukee hospital sues CVS over $18M in alleged 340B diversion.
Becker’s Hospital Review · August 31, 2026
- Froedtert Memorial Lutheran Hospital alleges CVS diverted 340B savings.
- The lawsuit claims $18 million in losses from 2020 to 2025.
- Defendants include CVS Health, CaremarkPCS, and WellPartner.
Trump announces nationwide Medicaid drug pricing model.
MedPage Today · September 18, 2026
- All 50 states join a program for ‘most favored nation’ pricing in Medicaid.
- The model aims to lower net prices for selected drugs.
340B PROGRAM DEVELOPMENTS
Johnson & Johnson requires claims data for 340B discounts.
Healthcare Dive · September 14, 2026
- J&J’s policy reflects a trend of stricter data requirements by drugmakers.
- The requirement aims to prevent duplicative discounts in the 340B program.
STATE DEVELOPMENTS
Oklahoma seeks to revive state law on 340B drug access.
NewsBreak · September 17, 2026
- Oklahoma asked the 10th Circuit to revive a law expanding 340B drug access.
- The law faces objections from pharmaceutical companies.
- The state argues the law aligns with 340B program objectives.
LITIGATION & ENFORCEMENT WATCH
| Court | Matter | Date |
|---|---|---|
| 8th Cir. | Novartis Pharmaceuticals Corp. v. Catherine L. Hanaway — Judge order: The petition for rehearing en banc is denied. The petition for panel rehearing is also denied. Case filed March 28, 2025. [source] | September 16, 2026 |
| 8th Cir. | AbbVie, Inc. v. Marty Jackley — Motion to hold briefing schedule in abeyance. Case filed August 11, 2026. [source] | September 15, 2026 |
| D.N.M. | AbbVie Inc. v. Torrez — Memorandum opinion and order granting Motion for Leave to File Amicus Curiae Brief; and denying Plaintiffs’ Motion for Preliminary Injunction. Case filed December 10, 2025. [source] | September 14, 2026 |
| S.D.N.Y. | Mount Sinai Hospital v. CVS Health Corporation — Report of Rule 26(f) conference and case management plan: All fact discovery must be completed by November 10, 2027. Last date to amend any pleading pursuant to Fed. R. Civ. P. 15(a) is February 28, 2027. Case filed May 18, 2026. [source] | September 11, 2026 |
| D.D.C. | COREWELL HEALTH WILLIAM BEAUMONT UNIVERSITY HOSPITAL v. KENNEDY — Complaint against All Defendants. Case filed September 3, 2026. [source] | September 3, 2026 |
| D. Colo. | Pharmaceutical Research and Manufacturers of America v. Weiser — Order. The Recommendation of the United States Magistrate Judge is accepted and adopted on alternative grounds supported in the record. Defendants Motion to Dismiss is granted. Case filed August 6, 2025. [source] | September 1, 2026 |
| D.D.C. | ABBVIE INC. v. KENNEDY — Joinder. Case filed April 8, 2026. [source] | September 1, 2026 |
| D. Colo. | AstraZeneca Pharmaceuticals LP v. Weiser — Order. Defendants’ Motion to Dismiss is granted. AstraZeneca’s claims for relief are dismissed with prejudice. Case filed August 27, 2025. [source] | August 31, 2026 |
MANUFACTURER WATCH
| Manufacturer | Action | Date |
|---|---|---|
| Johnson & Johnson | Requires 340B entities to submit claims data for pricing, effective September 15. [source] | September 11, 2026 |
WHAT TO WATCH NEXT
- Johnson & Johnson’s claims data submission deadline for 340B pricing is September 15. [source]
- HRSA’s decision on the 340B rebate model following the RFI process. [source]
- Oklahoma’s appeal to the 10th Circuit regarding its state 340B law. [source]
- CMS’s response to objections on the 2027 outpatient proposed rule. [source]
End of briefing.
This briefing is provided for informational purposes only and does not constitute legal, regulatory, financial, or compliance advice. Automated summarization may contain errors or omissions, and source materials may change after publication. Recipients should independently verify all information against the cited primary sources before relying on it.
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