MedMatrix Rx
Daily 340B Morning Briefing
Recent developments in the 340B program show significant shifts in policy and technology. The Health Resources and Services Administration (HRSA) has approved 10 drugmakers for a 340B rebate pilot, set to begin on January 1, 2027, which will transition 340B discounts to rebates for certain drugs. In a legal challenge, the Pharmaceutical Research and Manufacturers of America (PhRMA) has filed a lawsuit against the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) over recent policy changes affecting the program. Technology firms PharmaForce and Plenful have introduced new solutions aimed at streamlining 340B rebate management and submissions, easing administrative burdens for covered entities. Meanwhile, the American Hospital Association (AHA) has expressed opposition to rebate models within the 340B program, urging Congress to ban them permanently. These developments reflect ongoing debates over the impact of the 340B program on healthcare delivery.
EXECUTIVE SUMMARY
01
HRSA approves 10 drugmakers for 340B rebate pilot.
HRSA’s pilot will shift 340B discounts to rebates for certain drugs starting January 1, 2027.
HRSA’s pilot will shift 340B discounts to rebates for certain drugs starting January 1, 2027.
Source: Becker’s Hospital Review
02
PhRMA files lawsuit against CMS and HHS.
Pharmaceutical Research and Manufacturers of America sues CMS and HHS over 340B policy changes.
Pharmaceutical Research and Manufacturers of America sues CMS and HHS over 340B policy changes.
Source: CourtListener — D.D.C.
03
PharmaForce introduces 340B rebate solution.
PharmaForce’s new solution provides a connected workflow for 340B rebate management and payment reconciliation.
PharmaForce’s new solution provides a connected workflow for 340B rebate management and payment reconciliation.
Source: Business Wire
04
Plenful launches Rebate Intelligence for 340B.
Plenful’s AI platform automates 340B rebate submissions and reconciliations, easing administrative burdens.
Plenful’s AI platform automates 340B rebate submissions and reconciliations, easing administrative burdens.
Source: Becker’s Hospital Review
05
AHA opposes 340B rebate models.
The American Hospital Association urges Congress to ban rebate models in the 340B program permanently.
The American Hospital Association urges Congress to ban rebate models in the 340B program permanently.
Source: Becker’s Hospital Review
06
340B hospitals report less charity care than peers.
A report finds 340B hospitals spend less on charity care compared to non-340B hospitals, sparking debate.
A report finds 340B hospitals spend less on charity care compared to non-340B hospitals, sparking debate.
Source: Medical Daily
07
Berkeley Research Group reports on 340B spending.
Patients and payers spent $244.3 billion on 340B drugs in 2025, more than double the amount in 2021.
Patients and payers spent $244.3 billion on 340B drugs in 2025, more than double the amount in 2021.
Source: Becker’s Hospital Review
EXECUTIVE SUMMARY — KEY TAKEAWAYS
Most important 340B implication. The approval of the 340B rebate pilot by HRSA marks a change for covered entities, as it shifts the financial dynamics of the program. By moving from discounts to rebates, hospitals and clinics may face new challenges in managing their revenue streams and ensuring compliance with the revised regulations. This change could impact their ability to provide charity care, as a recent report indicates that 340B hospitals already spend less on charity care compared to their non-340B counterparts. The legal actions taken by PhRMA against CMS and HHS further complicate the situation, as outcomes from these lawsuits could set precedents affecting how 340B entities operate. As technology solutions emerge to assist with rebate management, covered entities must adapt quickly to use these tools while addressing the potential financial implications of the new rebate model.
Emerging risks.
- The shift to a rebate model may disrupt cash flow for hospitals reliant on upfront 340B discounts.
- Hospitals could face increased administrative burdens managing rebate submissions and reconciliations.
- Potential legal challenges may arise from stakeholders opposed to rebate models.
- Changes in reimbursement rates could impact hospital revenue and financial stability.
- The proposed CMS reform may lead to decreased incentives for hospitals to participate in the 340B program.
Emerging opportunities.
- Hospitals can use new rebate solutions to streamline 340B program management.
- Manufacturers may benefit from improved transparency and data-driven decision-making.
- The CMS proposal could lead to cost savings for Medicare and beneficiaries.
- Hospitals might explore alternative revenue streams to offset potential losses from 340B changes.
- Stakeholders can engage in policy discussions to shape the future of the 340B program.
Key actions for providers.
- Hospitals should assess the financial impact of the CMS proposal on their operations.
- Covered entities need to prepare for the transition to rebate models by investing in technology solutions.
- Stakeholders should participate in public comment periods to influence policy outcomes.
- Hospitals must improve transparency and reporting to comply with new regulatory requirements.
- Entities should monitor ongoing litigation and policy developments affecting the 340B program.
TOP STORIES
HRSA approves 10 drugmakers for 340B rebate pilot.
Becker’s Hospital Review · October 2, 2026
- The pilot will replace upfront discounts with post-sale rebates for certain drugs.
- Participating manufacturers include AbbVie, Amgen, and Pfizer.
- The program starts on January 1, 2027.
- The pilot aims to improve claims-level transparency and prevent duplicate discounts.
PhRMA files lawsuit against CMS and HHS.
CourtListener — D.D.C. · October 7, 2026
- The lawsuit challenges CMS and HHS over 340B policy changes.
- PhRMA claims the changes violate procedural requirements.
- The case was filed in the U.S. District Court for the District of Columbia.
- The outcome could impact future 340B program regulations.
FEDERAL POLICY & REGULATORY DEVELOPMENTS
AHA opposes 340B rebate models.
Becker’s Hospital Review · September 25, 2026
- The AHA urges Congress to ban rebate models in the 340B program.
- The SECURE 340B Act includes new requirements for program integrity.
- The AHA warns of potential administrative burdens on hospitals.
- The association supports maintaining upfront discounts for covered entities.
Berkeley Research Group reports on 340B spending.
Becker’s Hospital Review · October 1, 2026
- Patients and payers spent $244.3 billion on 340B drugs in 2025.
- The spending more than doubled from $108.4 billion in 2021.
- The report shows the gap between acquisition costs and patient charges.
- The findings contribute to ongoing debates over 340B program impacts.
340B PROGRAM DEVELOPMENTS
PharmaForce introduces 340B rebate solution.
Business Wire · October 6, 2026
- The solution provides a connected workflow for 340B rebate management.
- It aims to streamline claim submissions and payment reconciliation.
- PharmaForce positions itself as a source of truth for 340B claims.
- The solution addresses challenges in managing rebate payments.
Plenful launches Rebate Intelligence for 340B.
Becker’s Hospital Review · October 6, 2026
- Plenful’s AI platform automates rebate submissions and reconciliations.
- The solution reduces manual burdens on 340B teams.
- It supports maintaining 340B savings amid rebate model changes.
- Plenful built the platform ahead of HRSA’s 2025 program proposal.
LITIGATION & ENFORCEMENT WATCH
| Court | Matter | Date |
|---|---|---|
| D.D.C. | PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA v. KENNEDY JR. — Complaint against center for medicare and medicaid innovation, centers for medicare & medicaid services, robert F. kennedy jr., mehmet oz, abe sutton, united states department of health and human services. Case filed October 7, 2026. [source] | October 7, 2026 |
| Bankr. D. Del. | Akorn Holding Company LLC — Motion to Approve Compromise under Rule 9019 Motion of the Chapter 7 Trustee for Entry of an Order Approving the Settlement and Compromise of Claims Against p&l Development, LLC Filed by George L. Miller. 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 |
| N.D. Ill. | Novartis Pharmaceuticals Corporation v. Raoul, in his official capacity as Attorney General for the State of Illinois — Order signed by the Honorable Edmond E. Chang. For the reasons stated in the Order, the motion for expedited discovery 34 is denied. Case filed August 7, 2026. [source] | September 24, 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 |
WHAT TO WATCH NEXT
- CMS’s proposed 340B payment reform expected to take effect in 2027. [source]
- HRSA’s 340B rebate model pilot program set to launch January 1, 2027. [source]
- Ongoing litigation in PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA v. KENNEDY JR. [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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