MedMatrix Rx
Daily 340B Morning Briefing for Executives
Recent developments in the 340B program highlight ongoing advocacy and legal challenges affecting covered entities. ASHP is lobbying on Capitol Hill for expanded Medicare coverage and protections for the 340B program. Concurrently, Oklahoma is seeking to reinstate a state law aimed at expanding access to 340B discounted drugs, facing significant opposition from the pharmaceutical industry. In the corporate sector, Johnson & Johnson has announced a new requirement for 340B providers to submit claims data to maintain pricing, which will impact all covered entity types. Additionally, the AHA has provided a comparative analysis of three congressional bills proposing changes to the 340B program, focusing on transparency and program integrity. These developments reflect a critical moment for the 340B program as stakeholders address legislative and regulatory challenges.
EXECUTIVE SUMMARY
01
ASHP Advocates for 340B Protections on Capitol Hill.
ASHP members are lobbying for expanded Medicare coverage and 340B program protections, focusing on key legislative acts.
ASHP members are lobbying for expanded Medicare coverage and 340B program protections, focusing on key legislative acts.
Source: Becker’s Hospital Review
02
Oklahoma Seeks to Revive State Law for Discounted Drugs.
Oklahoma has petitioned the 10th Circuit to reinstate a law expanding access to 340B discounted drugs, facing pharmaceutical industry opposition.
Oklahoma has petitioned the 10th Circuit to reinstate a law expanding access to 340B discounted drugs, facing pharmaceutical industry opposition.
Source: NewsBreak
03
Johnson & Johnson Imposes 340B Claims Data Requirement.
J&J will require 340B providers to submit claims data to maintain pricing, affecting all covered entity types.
J&J will require 340B providers to submit claims data to maintain pricing, affecting all covered entity types.
Source: Becker’s Hospital Review
04
340B Legislative Proposals Compared by AHA.
AHA compares three congressional bills proposing changes to the 340B program, focusing on transparency and program integrity.
AHA compares three congressional bills proposing changes to the 340B program, focusing on transparency and program integrity.
Source: AHA
05
NASP Comments on CMS’s 340B Payment Changes.
NASP submitted comments to CMS on proposed changes to 340B reimbursement, noting implications for specialty pharmacy services.
NASP submitted comments to CMS on proposed changes to 340B reimbursement, noting implications for specialty pharmacy services.
Source: NASP
EXECUTIVE SUMMARY — KEY TAKEAWAYS
Most important 340B implication. The most significant implication for covered entities lies in the evolving regulatory environment surrounding the 340B program, particularly in light of Johnson & Johnson’s new claims data requirement. This mandate could impose additional administrative burdens on providers, potentially affecting their operational efficiency and financial sustainability. As covered entities strive to comply with these requirements while advocating for program protections, they must also address the complexities of legislative proposals that seek to improve transparency and integrity within the program. The outcome of these initiatives will ultimately shape the future of the 340B program and its ability to provide discounted drugs to vulnerable populations.
Emerging risks.
- Pharmaceutical companies face increased legal exposure and potential financial penalties from ongoing 340B litigation.
- Covered entities risk losing 340B savings due to new manufacturer data requirements and potential noncompliance.
- State laws expanding 340B access may face legal challenges from manufacturers, creating uncertainty for covered entities.
- HRSA’s proposed rebate model could disrupt cash flow for covered entities if implemented, increasing financial strain.
Emerging opportunities.
- Covered entities can use legal victories to negotiate better terms with manufacturers.
- Advocacy efforts by organizations like ASHP may lead to strengthened 340B protections and expanded coverage.
- State laws supporting 340B access may serve as models for other states, broadening program reach.
- Engagement in HRSA’s RFI process allows stakeholders to influence future 340B rebate models.
Key actions for providers.
- Monitor ongoing litigation and adjust compliance strategies to mitigate legal risks.
- Engage with state and federal legislative processes to support favorable 340B policies.
- Prepare for potential operational changes due to HRSA’s rebate model by building data infrastructure.
- Collaborate with industry groups to advocate for 340B program stability and integrity.
TOP STORIES
ASHP Advocates for 340B Program Protections.
Becker’s Hospital Review · September 16, 2026
- ASHP is lobbying Congress for expanded Medicare coverage and 340B program protections.
- Key legislative acts include the Main Street Pharmacy Access Act and Equitable Community Access to Pharmacist Services Act.
FEDERAL POLICY & REGULATORY DEVELOPMENTS
AHA Compares Recent 340B Legislative Proposals.
AHA · September 14, 2026
- AHA analyzed three congressional bills proposing changes to the 340B program.
- Key focuses include transparency, program integrity, and HRSA’s oversight authority.
NASP Comments on CMS’s Proposed 340B Payment Changes.
NASP · September 1, 2026
- NASP addressed potential impacts of CMS’s proposed 340B payment changes.
- Comments focused on implications for specialty pharmacy services and patient access.
LITIGATION & ENFORCEMENT WATCH
| Court | Matter | Date |
|---|---|---|
| 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 |
| D.D.C. | ABBVIE INC. v. KENNEDY — Joinder. Case filed April 8, 2026. [source] | September 1, 2026 |
MANUFACTURER WATCH
| Manufacturer | Action | Date |
|---|---|---|
| Johnson & Johnson | Requires 340B providers to submit claims data for pricing. [source] | September 11, 2026 |
SOCIAL MEDIA & STAKEHOLDER SENTIMENT
The following items were identified through web searches for recent stakeholder and social commentary on the U.S. 340B Drug Pricing Program from the past 90 days, including reactions, statements, op-eds, and advocacy positions from various groups and platforms.
340B faces growing calls for transparency, patient-focused reform
Bio.News · June 25, 2026
- Main theme: Growing calls for transparency and patient-focused reforms in the 340B program.
- Stakeholder sentiment: Critical; Ashley John, Director of Issue Advocacy at Novartis, stated, “But we really have seen tremendous growth over the past few years… it is very clear that hospitals need better criteria for which patients they are serving.”
- Potential implications: Potential policy changes to enhance transparency and ensure the program benefits vulnerable patients.
- Credibility: Bio.News is a specialized news outlet covering biotechnology and healthcare policy.
340B Drug Pricing Program Under Threat from Manufacturers
ASHP · July 2026
- Main theme: Concerns over drug manufacturers’ actions threatening the 340B program.
- Stakeholder sentiment: Concerned; ASHP Chief Advocacy Officer Tom Kraus discusses tactics by drug manufacturers to weaken the program.
- Potential implications: Potential challenges to the financial stability of hospitals relying on the 340B program.
- Credibility: ASHP is a reputable organization representing pharmacists and healthcare providers.
340B Drug Pricing Program Expert Discussion with Shawn Gremminger and Tom Kraus
Drug Topics · August 2026
- Main theme: Expert debate on the 340B program’s role and challenges.
- Stakeholder sentiment: Mixed; experts Shawn Gremminger and Tom Kraus discuss the program’s role as a safety net versus calls for increased transparency.
- Potential implications: Potential policy shifts affecting the 340B program’s future.
- Credibility: Drug Topics is a publication focusing on pharmacy and healthcare news.
340B Drug Pricing Program Transparency Briefing Recap
National Alliance of Healthcare Purchaser Coalitions · August 2026
- Main theme: Recap of a briefing on 340B program transparency.
- Stakeholder sentiment: Supportive; Senator Roger Marshall emphasized the need for affordability in healthcare policy.
- Potential implications: Potential legislative actions to enhance transparency and accountability in the 340B program.
- Credibility: National Alliance of Healthcare Purchaser Coalitions is a coalition of employer healthcare purchasers.
WHAT TO WATCH NEXT
- HRSA’s decision on the 340B rebate model following the RFI process. [source]
- Further developments in the False Claims Act lawsuit against major pharma companies. [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.