MedMatrix Rx
Your Daily 340B Morning Briefing
Recent developments in the 340B program show significant changes and ongoing legal challenges. The Health Resources and Services Administration (HRSA) has approved 10 drugmakers for a revised 340B rebate model pilot, set to begin on January 1, 2027, which will replace upfront discounts with post-sale rebates. Concurrently, the Centers for Medicare & Medicaid Services (CMS) has launched a 340B Data Repository for voluntary submissions, ahead of a mandatory deadline in 2027. Legal disputes continue to unfold, with an amended complaint filed in Mary Hitchcock Memorial Hospital v. Eli Lilly and a motion to dismiss in Florida Health Sciences Center v. Eli Lilly. Reports indicate that 340B hospitals are providing less charity care compared to their non-340B counterparts, raising questions about the program’s intended benefits for underserved populations.
EXECUTIVE SUMMARY
01
HRSA Approves 10 Drugmakers for 340B Rebate Pilot.
HRSA approved 10 drugmakers for a revised 340B rebate model pilot, replacing upfront discounts with post-sale rebates starting January 1, 2027.
HRSA approved 10 drugmakers for a revised 340B rebate model pilot, replacing upfront discounts with post-sale rebates starting January 1, 2027.
Source: Becker’s Hospital Review
02
CMS Launches 340B Data Repository.
CMS opened a Medicare Part D Claims Data 340B Repository on October 1 for voluntary submissions, ahead of 2027 mandatory deadline.
CMS opened a Medicare Part D Claims Data 340B Repository on October 1 for voluntary submissions, ahead of 2027 mandatory deadline.
Source: Becker’s Hospital Review
03
Mary Hitchcock Memorial Hospital v. Eli Lilly Amended Complaint Filed.
An amended complaint was filed on September 30, 2026, in the case of Mary Hitchcock Memorial Hospital v. Eli Lilly and Company.
An amended complaint was filed on September 30, 2026, in the case of Mary Hitchcock Memorial Hospital v. Eli Lilly and Company.
Source: CourtListener — D.N.H.
04
Henry Ford Hospital v. CVS Health Corporation Motion Reply Filed.
A reply to a response to a motion was filed on September 23, 2026, in the case of Henry Ford Hospital v. CVS Health Corporation.
A reply to a response to a motion was filed on September 23, 2026, in the case of Henry Ford Hospital v. CVS Health Corporation.
Source: CourtListener — E.D. Mich.
05
Florida Health Sciences Center v. Eli Lilly Motion to Dismiss Filed.
A memorandum in support of a motion to dismiss was filed on September 23, 2026, in the case of Florida Health Sciences Center v. Eli Lilly.
A memorandum in support of a motion to dismiss was filed on September 23, 2026, in the case of Florida Health Sciences Center v. Eli Lilly.
Source: CourtListener — M.D. Fla.
06
Plenful Launches Rebate Intelligence Solution.
Plenful introduced an AI-driven Rebate Intelligence Solution to automate rebate submissions and reconciliation under HRSA’s revised 340B model.
Plenful introduced an AI-driven Rebate Intelligence Solution to automate rebate submissions and reconciliation under HRSA’s revised 340B model.
Source: Becker’s Hospital Review
07
PharmaForce Introduces Connected 340B Rebate Solution.
PharmaForce unveiled a solution integrating 340B rebate and Maximum Fair Price workflows, improving claim management and reconciliation.
PharmaForce unveiled a solution integrating 340B rebate and Maximum Fair Price workflows, improving claim management and reconciliation.
Source: Businesswire
08
HRSA’s 340B Rebate Pilot to Start in 2027.
HRSA’s revised 340B rebate model pilot will begin on January 1, 2027, involving 10 manufacturers and 21 drugs.
HRSA’s revised 340B rebate model pilot will begin on January 1, 2027, involving 10 manufacturers and 21 drugs.
Source: Healthcare Dive
09
Berkeley Research Group Reports on 340B Drug Spending.
A report estimates patients and payers spent $244.3 billion on 340B drugs in 2025, more than double the 2021 figure.
A report estimates patients and payers spent $244.3 billion on 340B drugs in 2025, more than double the 2021 figure.
Source: Becker’s Hospital Review
10
340B Hospitals Report Less Charity Care Than Non-340B Hospitals.
A report found 340B hospitals provided less charity care as a percentage of operating expenses compared to non-340B hospitals.
A report found 340B hospitals provided less charity care as a percentage of operating expenses compared to non-340B hospitals.
Source: Becker’s Hospital Review
EXECUTIVE SUMMARY — KEY TAKEAWAYS
Most important 340B implication. The shift to a post-sale rebate model under HRSA’s revised 340B pilot could impact covered entities’ financial strategies and operational workflows. With the introduction of this model, covered entities may need to adjust their financial management systems to effectively track and reconcile rebates. This change, coupled with the findings that 340B hospitals are providing less charity care, suggests that the intended purpose of the 340B program—to support safety-net providers in serving vulnerable populations—may be at risk. Covered entities must adapt to these dynamics to ensure they continue to fulfill their mission while managing the complexities of the new rebate structure.
Emerging risks.
- The shift to a rebate model may disrupt cash flow for 340B entities, impacting financial stability.
- Increased administrative burdens from new CMS data submission requirements could strain resources.
- Legal challenges to the rebate model may create uncertainty and hinder implementation.
- Entities may face compliance risks with new reporting and rebate processes.
Emerging opportunities.
- Entities can use new CMS data tools for improved transparency and compliance.
- Participation in the HRSA pilot provides a chance to shape future 340B rebate processes.
- Automation solutions like Plenful’s can reduce manual workload and improve efficiency.
- Engagement with HRSA’s pilot could improve understanding of rebate impacts on operations.
- Proactive adaptation to new models may position entities as leaders in 340B compliance.
Key actions for providers.
- Review and adapt financial strategies to accommodate the shift to post-sale rebates.
- Invest in technology solutions to streamline data submission and rebate processes.
- Engage with HRSA and CMS to stay informed on pilot developments and compliance requirements.
- Train staff on new reporting and rebate procedures to ensure smooth transitions.
- Monitor legal developments related to 340B rebate models to anticipate changes.
TOP STORIES
HRSA Approves 10 Drugmakers for 340B Rebate Pilot.
Becker’s Hospital Review · October 2, 2026
- HRSA approved 10 drugmakers for a revised 340B rebate model pilot.
- The pilot replaces upfront discounts with post-sale rebates starting January 1, 2027.
- Approved manufacturers include AbbVie, Amgen, AstraZeneca, and Pfizer.
FEDERAL POLICY & REGULATORY DEVELOPMENTS
AHA Seeks Permanent 340B Rebate Ban.
Becker’s Hospital Review · September 25, 2026
- AHA urges Congress to permanently ban rebate models in the 340B program.
- The request was made in comments on the SECURE 340B Act.
- AHA warns of new administrative burdens from the legislation.
340B PROGRAM DEVELOPMENTS
Berkeley Research Group Reports on 340B Drug Spending.
Becker’s Hospital Review · October 1, 2026
- Patients and payers spent $244.3 billion on 340B drugs in 2025.
- This spending is more than double the $108.4 billion spent in 2021.
- The figure exceeds HRSA’s reported 340B sales total of $100 billion for 2025.
340B Hospitals Report Less Charity Care Than Non-340B Hospitals.
Becker’s Hospital Review · September 28, 2026
- 340B hospitals reported charity care equal to 2.16% of operating expenses.
- Non-340B hospitals reported 2.82% charity care, a significant difference.
- The report used CMS cost report data linked to HRSA’s 340B records.
LITIGATION & ENFORCEMENT WATCH
| Court | Matter | Date |
|---|---|---|
| Bankr. D. Del. | Akorn Holding Company LLC — Motion to Approve Compromise under Rule 9019 Filed by George L. Miller. Hearing scheduled for 11/20/2026 at 10:00 am at US Bankruptcy Court, 824 Market St., 6th Fl., Courtroom 3, Wilmington, Delaware. Case filed February 23, 2023. [source] | October 6, 2026 |
| D.N.H. | Mary Hitchcock Memorial Hospital v. Eli Lilly and Company — Amended Complaint. Case filed July 27, 2026. [source] | September 30, 2026 |
| 8th Cir. | Astrazeneca Pharmaceuticals, LP v. Marty Jackley — Reply to response to petition for initial hearing en banc. Case filed August 11, 2026. [source] | September 25, 2026 |
| 8th Cir. | Pharm. Res. & Mfr. of America v. Marty Jackley — Motion to file a reply to response,. Case filed August 25, 2026. [source] | September 25, 2026 |
| E.D. Mo. | AbbVie Inc. v. Hanaway — Memorandum and order: Accordingly, the Court grants Intervenors’ motion to intervene. see order for details. Case filed July 22, 2024. [source] | September 24, 2026 |
| E.D. Mich. | Henry Ford Hospital v. CVS Health Corporation — Reply to Response to Motion. Case filed July 16, 2026. [source] | September 23, 2026 |
| M.D. Fla. | Florida Health Sciences Center, Inc. v. Eli Lilly and Company — Memorandum in support re Motion to Dismiss. Case filed July 2, 2026. [source] | September 23, 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 |
WHAT TO WATCH NEXT
- HRSA’s revised 340B rebate model pilot starts January 1, 2027. [source]
- AHA’s push for a permanent 340B rebate ban in Congress. [source]
- Impact of new CMS data repository on 340B program compliance. [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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