MedMatrix Rx
Daily 340B Morning Briefing for Hospital and Clinic Executives
Recent developments in the 340B program highlight significant changes and ongoing challenges for covered entities. Johnson & Johnson has mandated that 340B entities submit claims data to retain their pricing, with noncompliance resulting in pricing suspension. Meanwhile, the Health Resources and Services Administration (HRSA) has released audit results for FY25, revealing compliance issues across 176 audits. The National Association of Specialty Pharmacy (NASP) has voiced concerns regarding proposed changes to 340B drug reimbursement by CMS, particularly their impact on specialty pharmacies. Additionally, the American Society of Health-System Pharmacists (ASHP) is lobbying for expanded Medicare coverage and protections for the 340B program. These developments, along with ongoing legal battles regarding contract pharmacy access and patient eligibility, reflect the evolving landscape of the 340B program and its implications for safety net providers.
EXECUTIVE SUMMARY
01
J&J enforces claims data submission for 340B pricing.
Johnson & Johnson now requires 340B entities to submit claims data to maintain 340B pricing, with noncompliance leading to pricing suspension.
Johnson & Johnson now requires 340B entities to submit claims data to maintain 340B pricing, with noncompliance leading to pricing suspension.
Source: Becker’s Hospital Review
02
HRSA releases FY25 audit results for 340B program.
HRSA posted results for 176 audits, detailing findings and compliance issues within the 340B program.
HRSA posted results for 176 audits, detailing findings and compliance issues within the 340B program.
Source: HRSA
03
NASP comments on CMS 340B payment changes.
NASP submitted feedback on CMS’s proposed 2027 changes to 340B drug reimbursement, focusing on specialty pharmacy impacts.
NASP submitted feedback on CMS’s proposed 2027 changes to 340B drug reimbursement, focusing on specialty pharmacy impacts.
Source: NASP
04
ASHP advocates for 340B protections on Capitol Hill.
ASHP is lobbying Congress for expanded Medicare coverage and protections for the 340B Drug Pricing Program.
ASHP is lobbying Congress for expanded Medicare coverage and protections for the 340B Drug Pricing Program.
Source: Becker’s Hospital Review
05
State laws combat 340B price discrimination.
Several states have enacted laws to prevent PBMs from discriminatory reimbursement practices against 340B entities.
Several states have enacted laws to prevent PBMs from discriminatory reimbursement practices against 340B entities.
Source: Frier Levitt
06
Pharma groups oppose 340B rebate model pilot.
A bipartisan group of lawmakers urges HHS to cancel a 340B rebate model pilot, citing potential harm to safety net providers.
A bipartisan group of lawmakers urges HHS to cancel a 340B rebate model pilot, citing potential harm to safety net providers.
Source: Pharmaphorum
07
340B legal battles continue nationwide.
Ongoing court cases address contract pharmacy access, patient eligibility, and reimbursement under the 340B program.
Ongoing court cases address contract pharmacy access, patient eligibility, and reimbursement under the 340B program.
Source: Becker’s Hospital Review
EXECUTIVE SUMMARY — KEY TAKEAWAYS
Most important 340B implication. The enforcement of claims data submission by Johnson & Johnson marks a shift in the operational landscape for 340B entities. This requirement imposes additional administrative burdens and risks financial repercussions for noncompliance, potentially jeopardizing access to affordable medications for vulnerable populations. As covered entities face these new stipulations, they must also contend with the broader implications of HRSA’s audit findings and the ongoing legal disputes surrounding the program. The cumulative effect of these developments may strain the resources of safety net providers, challenging their ability to deliver essential services and maintain compliance in an increasingly complex regulatory environment.
Emerging risks.
- Hospitals may face compliance challenges with J&J’s new claims data requirement, risking 340B pricing suspension.
- State laws expanding 340B access could lead to increased legal disputes with pharmaceutical companies.
- Ongoing litigation may result in inconsistent 340B program interpretations across different jurisdictions.
- Potential changes in CMS reimbursement policies could financially impact 340B covered entities.
- Pharmaceutical companies may impose stricter conditions on 340B pricing, affecting drug availability.
Emerging opportunities.
- States can use the 5th Circuit ruling to strengthen 340B access laws.
- Covered entities might benefit from increased transparency and accountability in the 340B program.
- Hospitals could advocate for more favorable CMS reimbursement terms during policy reviews.
- Pharmacy benefit managers may find opportunities to align with state laws to avoid legal challenges.
- Healthcare providers can engage with lawmakers to shape future 340B program reforms.
Key actions for providers.
- Covered entities should ensure compliance with J&J’s claims data submission to maintain 340B pricing.
- Hospitals need to monitor state legislative developments affecting 340B program access.
- Legal teams should prepare for potential litigation related to state 340B laws and federal preemption issues.
- Healthcare organizations should participate in CMS rulemaking processes to influence 340B reimbursement policies.
- Pharmacy managers must stay informed about state laws prohibiting discriminatory reimbursement practices.
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 is restored within 10 days of compliant data submission.
- The policy affects all covered entity types.
- J&J aims to prevent duplicative discounts.
FEDERAL POLICY & REGULATORY DEVELOPMENTS
NASP comments on CMS 340B payment changes.
NASP · September 1, 2026
- NASP submitted comments on CMS’s CY 2027 HOPPS proposed rule.
- Feedback focuses on Medicare reimbursement for 340B drugs.
- NASP addresses specialty pharmacy impacts and compliance issues.
- The comments highlight potential patient access implications.
- NASP advocates for preserving specialty pharmacy services.
ASHP advocates for 340B protections on Capitol Hill.
Becker’s Hospital Review · September 16, 2026
- ASHP lobbies Congress for expanded Medicare pharmacist services.
- The group seeks protections for the 340B Drug Pricing Program.
- ASHP supports the Main Street Pharmacy Access Act.
- The Equitable Community Access to Pharmacist Services Act is also backed.
- ASHP emphasizes the role of pharmacists in healthcare access.
340B PROGRAM DEVELOPMENTS
HRSA releases FY25 audit results for 340B program.
HRSA · September 24, 2026
- HRSA posted results for 176 audits of 340B entities.
- The audits assess compliance and program integrity.
- Corrective Action Plans and sanctions are pending approval.
- Manufacturers advised not to contact audited entities until sanctions are posted.
- The audits aim to ensure adherence to 340B program requirements.
STATE DEVELOPMENTS
State laws combat 340B price discrimination.
Frier Levitt · September 3, 2026
- States enact laws to prevent PBM discriminatory reimbursement.
- Laws prohibit identifying claims as 340B for reduced payment.
- Maine and Rhode Island have specific prohibitions in place.
- Approximately 30 states have passed similar legislation.
- These laws aim to protect the financial integrity of safety-net providers.
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 or face pricing suspension. [source] | September 11, 2026 |
WHAT TO WATCH NEXT
- Monitor the 10th Circuit’s decision on Oklahoma’s 340B law appeal. [source]
- Watch for HRSA’s updates on Corrective Action Plans and sanctions from FY25 audits. [source]
- Follow developments on the bipartisan effort to cancel the 340B rebate model pilot. [source]
- Track CMS’s response to NASP’s comments on the 2027 HOPPS 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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