MedMatrix Rx
340B Program Developments and Legal Battles
Recent developments in the 340B program highlight ongoing legal and regulatory challenges for covered entities. Johnson & Johnson has mandated that covered entities submit claims-level data starting September 15 to maintain 340B pricing, a move that could impact compliance and operational processes. Concurrently, Froedtert Memorial Lutheran Hospital has initiated a lawsuit against CVS Health, alleging an $18 million diversion of 340B savings from 2020 to 2025. In Oklahoma, efforts are underway to revive a state law aimed at increasing access to discounted drugs under the 340B program. Additionally, NASP has submitted comments to CMS regarding proposed changes to Medicare reimbursement for 340B-acquired drugs. These developments illustrate the complex landscape faced by 340B entities as they manage regulatory requirements and legal disputes.
EXECUTIVE SUMMARY
01
J&J enforces claims-data submission for 340B pricing.
Johnson & Johnson will require 340B covered entities to submit claims-level data starting September 15 to maintain 340B pricing.
Johnson & Johnson will require 340B covered entities to submit claims-level data starting September 15 to maintain 340B pricing.
Source: Becker’s Hospital Review
02
Froedtert sues CVS over $18M 340B diversion.
Froedtert Memorial Lutheran Hospital alleges CVS Health diverted $18 million in 340B savings between 2020 and 2025.
Froedtert Memorial Lutheran Hospital alleges CVS Health diverted $18 million in 340B savings between 2020 and 2025.
Source: Becker’s Hospital Review
03
Oklahoma seeks to revive state law on discounted drugs.
Oklahoma asks the 10th Circuit to revive a state law aimed at expanding access to discounted drugs under the 340B program.
Oklahoma asks the 10th Circuit to revive a state law aimed at expanding access to discounted drugs under the 340B program.
Source: Newsbreak
04
NASP comments on CMS 340B payment changes.
NASP submitted comments to CMS on proposed changes to Medicare reimbursement for 340B-acquired drugs under the CY 2027 HOPPS rule.
NASP submitted comments to CMS on proposed changes to Medicare reimbursement for 340B-acquired drugs under the CY 2027 HOPPS rule.
Source: NASP
05
ASHP advocates for 340B protections on Capitol Hill.
ASHP members met with congressional offices to advocate for 340B program protections and expanded Medicare coverage for pharmacist services.
ASHP members met with congressional offices to advocate for 340B program protections and expanded Medicare coverage for pharmacist services.
Source: Becker’s Hospital Review
06
Shields Health Solutions addresses 340B program management.
Shields Health Solutions discusses the impact of the IRA Maximum Fair Pricing and HRSA’s 340B Rebate Model Pilot Program on covered entities.
Shields Health Solutions discusses the impact of the IRA Maximum Fair Pricing and HRSA’s 340B Rebate Model Pilot Program on covered entities.
Source: Becker’s Hospital Review
07
State laws protect 340B pricing from PBM discrimination.
Several states have enacted laws prohibiting PBMs from discriminatory reimbursement practices against 340B entities.
Several states have enacted laws prohibiting PBMs from discriminatory reimbursement practices against 340B entities.
Source: Frier Levitt
EXECUTIVE SUMMARY — KEY TAKEAWAYS
Most important 340B implication. The enforcement of claims-data submission by Johnson & Johnson marks a significant shift in the operational landscape for covered entities, necessitating better data management capabilities. This requirement could impose additional administrative burdens on hospitals and clinics, particularly those already facing financial pressures. The lawsuit filed by Froedtert against CVS Health over alleged diversion of funds further shows the financial stakes involved in the 340B program. As states like Oklahoma attempt to revive laws to expand access to discounted drugs, covered entities must remain proactive in adapting to evolving regulations and legal challenges. The cumulative effect of these developments may lead to increased scrutiny and potential changes in how 340B entities manage their relationships with pharmaceutical manufacturers and pharmacy benefit managers, ultimately impacting their ability to provide affordable care.
Emerging risks.
- Failure to submit claims data to J&J may lead to loss of 340B pricing.
- Lawsuits against state laws could limit contract pharmacy access.
- Federal court rulings may alter 340B program operations.
- Noncompliance with new state laws could result in legal challenges.
- Ongoing litigation may increase operational uncertainty for covered entities.
Emerging opportunities.
- Hospitals can use state laws to protect 340B pricing.
- Engage in advocacy to influence federal 340B policy changes.
- Use legal victories to strengthen contract pharmacy arrangements.
- Participate in HRSA’s 340B Rebate Model Pilot Program for insights.
- Collaborate with specialty pharmacies to optimize 340B savings.
Key actions for providers.
- Submit required claims data to J&J by September 15.
- Monitor legal developments in Illinois and other states.
- Review compliance with state 340B protection laws.
- Engage with NASP and ASHP for advocacy support.
- Prepare for HRSA’s 340B Rebate Model Pilot Program launch.
TOP STORIES
J&J enforces claims-data submission for 340B pricing.
Becker’s Hospital Review · September 11, 2026
- J&J requires 340B entities to submit claims data starting September 15.
- Noncompliance leads to pricing suspension after two notices.
- Pricing restored within 10 days upon data submission.
Froedtert sues CVS over $18M 340B diversion.
Becker’s Hospital Review · August 31, 2026
- Froedtert alleges CVS diverted $18M in 340B savings.
- The lawsuit was filed in the Eastern District of Wisconsin.
- Defendants include CVS Health, CaremarkPCS, and WellPartner.
FEDERAL POLICY & REGULATORY DEVELOPMENTS
NASP comments on CMS 340B payment changes.
NASP · September 1, 2026
- NASP submitted comments on CY 2027 HOPPS proposed rule.
- Comments address Medicare reimbursement for 340B drugs.
- NASP highlights implications for specialty pharmacy services.
ASHP advocates for 340B protections on Capitol Hill.
Becker’s Hospital Review · September 16, 2026
- ASHP seeks expanded Medicare coverage for pharmacist services.
- Advocates for 340B program protections.
- Supports pharmacy residency training.
340B PROGRAM DEVELOPMENTS
Shields Health Solutions addresses 340B program management.
Becker’s Hospital Review · September 11, 2026
- Discusses impact of IRA Maximum Fair Pricing and 340B Rebate Model.
- Highlights operational considerations for covered entities.
- Emphasizes care for vulnerable populations.
State laws protect 340B pricing from PBM discrimination.
Frier Levitt · September 3, 2026
- States enact laws to prevent PBM reimbursement discrimination.
- Laws prohibit 340B-specific reimbursement tactics.
- Aim to protect financial integrity of safety-net providers.
STATE DEVELOPMENTS
Illinois — Enacts HB 2371, Restricting 340B Contract Pharmacy Arrangements
ACI 340B · September 18, 2026
- Illinois Governor signs HB 2371 into law, imposing restrictions on 340B contract pharmacy arrangements.
- The law requires covered entities to maintain a direct relationship with patients to dispense 340B drugs.
- Manufacturers and PhRMA file lawsuits challenging the law’s validity.
- Biogen, GSK, and Sobi exempt Illinois covered entities from certain policies.
- Amgen exempts Louisiana and Minnesota covered entities from similar restrictions.
Louisiana — Amgen Exempts Covered Entities from 340B Contract Pharmacy Restrictions
ACI 340B · September 18, 2026
- Amgen announces exemption for Louisiana covered entities from 340B contract pharmacy restrictions.
- The exemption allows Louisiana entities to continue using contract pharmacies for 340B drug distribution.
- This move follows similar exemptions granted to Illinois and Minnesota covered entities.
- The exemption aims to mitigate potential disruptions in 340B drug access for Louisiana patients.
Minnesota — Amgen Exempts Covered Entities from 340B Contract Pharmacy Restrictions
ACI 340B · September 18, 2026
- Amgen announces exemption for Minnesota covered entities from 340B contract pharmacy restrictions.
- Minnesota entities can continue using contract pharmacies for 340B drug distribution.
- This exemption aligns with similar actions taken for Illinois and Louisiana covered entities.
- The decision aims to ensure uninterrupted access to 340B drugs for Minnesota patients.
Illinois — Faces Multiple Legal Challenges to 340B Contract Pharmacy Law
ACI 340B · September 18, 2026
- Illinois’ HB 2371, restricting 340B contract pharmacy arrangements, faces multiple legal challenges.
- Manufacturers and PhRMA have filed lawsuits against the law, questioning its legality.
- The state is currently defending the law in court, with outcomes pending.
- The legal battles may influence future state-level 340B legislation.
LITIGATION & ENFORCEMENT WATCH
| Court | Matter | Date |
|---|---|---|
| 8th Cir. | Pharm. Res. & Mfr. of America v. Marty Jackley — Response to petition for initial hearing en banc. Case filed August 25, 2026. [source] | September 21, 2026 |
| M.D. Fla. | Florida Health Sciences Center, Inc. v. Eli Lilly and Company — Dismiss. Case filed July 2, 2026. [source] | September 21, 2026 |
| 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 |
MANUFACTURER WATCH
| Manufacturer | Action | Date |
|---|---|---|
| Johnson & Johnson | Requires 340B entities to submit claims data for outpatient drugs. [source] | September 4, 2026 |
SOCIAL MEDIA & STAKEHOLDER SENTIMENT
Recent commentary on the U.S. 340B Drug Pricing Program was identified by searching for articles, statements, and opinion pieces from hospital and health-center groups, provider and patient advocates, drug manufacturers, PBMs, and policy commentators published within the last 90 days.
Providers warn of another decade of 340B payment problems
TechTarget · August 31, 2026
- Main theme: Concerns over proposed cuts to 340B reimbursements and potential prolonged payment disputes.
- Stakeholder sentiment: The American Hospital Association (AHA) warns that the Centers for Medicare and Medicaid Services (CMS) may lack statutory authority for the proposed cuts, potentially leading to prolonged disputes.
- Potential implications: Potential prolonged disputes over 340B reimbursements could strain hospital resources and patient care.
- Credibility: TechTarget is a reputable source specializing in healthcare technology and policy.
HHS revives 340B rebate model despite hospital pushback
TechTarget · August 3, 2026
- Main theme: HHS reintroduces the 340B rebate model pilot program amid hospital opposition.
- Stakeholder sentiment: Hospitals express concern over the rebate model, fearing it may disrupt established 340B operations and impose financial burdens.
- Potential implications: Reintroduction of the rebate model could lead to financial strain on hospitals and potential service disruptions.
- Credibility: TechTarget is a reputable source specializing in healthcare technology and policy.
Medicare’s Proposed Cut to 340B Drug Payments Would Hit Safety-Net Hospitals While Benefiting For-Profit Hospitals
Kaiser Family Foundation (KFF) · July 29, 2026
- Main theme: Analysis of CMS’s proposed cuts to 340B drug payments and their impact on different hospital types.
- Stakeholder sentiment: The analysis indicates that safety-net hospitals would be adversely affected, while for-profit hospitals might benefit from the proposed cuts.
- Potential implications: Disproportionate impact on safety-net hospitals could affect care for underserved populations.
- Credibility: KFF is a well-respected non-profit organization providing health information.
WHAT TO WATCH NEXT
- J&J’s claims-data submission deadline on September 15. [source]
- Oklahoma’s appeal in the 10th Circuit regarding state drug law. [source]
- Implementation of HRSA’s 340B Rebate Model Pilot Program on January 1, 2027. [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.
© 2026 MedMatrix Rx. All rights reserved.