MedMatrix Rx
Daily 340B Morning Briefing for Hospital and Clinic Executives
A federal court decertified 11 clinics from the 340B program, siding with drugmakers Amgen and Genentech. Froedtert Memorial Lutheran Hospital filed a lawsuit against CVS Health over alleged 340B diversion. The National Association of Specialty Pharmacy submitted comments on CMS’s proposed 340B payment changes. Hospital and physician groups urged CMS to reconsider the 2027 outpatient rule, citing concerns over 340B drug payment cuts.
EXECUTIVE SUMMARY
01
Court decertifies 11 clinics from 340B program.
A federal judge ordered the decertification of 11 clinics from the 340B program, siding with drugmakers Amgen and Genentech.
A federal judge ordered the decertification of 11 clinics from the 340B program, siding with drugmakers Amgen and Genentech.
Source: Becker’s Hospital Review
02
Froedtert Hospital sues CVS over alleged 340B diversion.
Froedtert Memorial Lutheran Hospital filed a lawsuit against CVS Health, alleging $18 million in 340B savings diversion.
Froedtert Memorial Lutheran Hospital filed a lawsuit against CVS Health, alleging $18 million in 340B savings diversion.
Source: Becker’s Hospital Review
03
NASP comments on CMS’s proposed 340B payment changes.
NASP submitted comments to CMS on proposed changes to Medicare reimbursement for 340B-acquired drugs.
NASP submitted comments to CMS on proposed changes to Medicare reimbursement for 340B-acquired drugs.
04
Hospital groups urge CMS to withdraw 2027 outpatient rule.
AHA, AAMC, and AMGA urged CMS to reconsider the 2027 outpatient rule, citing 340B drug payment cuts and other concerns.
AHA, AAMC, and AMGA urged CMS to reconsider the 2027 outpatient rule, citing 340B drug payment cuts and other concerns.
Source: Becker’s Hospital Review
05
AHA criticizes CMS’s proposed 340B repayment acceleration.
AHA urged CMS not to finalize proposals that would accelerate Medicare payment clawbacks and cut 340B drug reimbursement.
AHA urged CMS not to finalize proposals that would accelerate Medicare payment clawbacks and cut 340B drug reimbursement.
Source: Becker’s Hospital Review
06
Milwaukee hospital alleges CVS diverted $18M in 340B savings.
Froedtert Memorial Lutheran Hospital claims CVS diverted $18 million in 340B savings between 2020 and 2025.
Froedtert Memorial Lutheran Hospital claims CVS diverted $18 million in 340B savings between 2020 and 2025.
Source: Becker’s Hospital Review
07
AAMC and AHA push for changes in 340B provisions.
AAMC and AHA filed comments urging changes to CMS’s Medicare Drug Price Negotiation Program rule and Sen. Cassidy’s 340B draft.
AAMC and AHA filed comments urging changes to CMS’s Medicare Drug Price Negotiation Program rule and Sen. Cassidy’s 340B draft.
Source: Becker’s Hospital Review
08
AHA pushes CMS for upfront Medicare drug prices.
AHA filed comments urging CMS to require upfront negotiated Medicare drug prices instead of retrospective rebates.
AHA filed comments urging CMS to require upfront negotiated Medicare drug prices instead of retrospective rebates.
Source: Becker’s Hospital Review
09
340B litigation continues with multiple active cases.
Several ongoing court cases involve 340B program disputes, including contract pharmacy access and reimbursement practices.
Several ongoing court cases involve 340B program disputes, including contract pharmacy access and reimbursement practices.
Source: Becker’s Hospital Review
10
HRSA revises 340B rebate model pilot.
HRSA has made revisions to its 340B rebate model pilot, impacting how rebates are managed within the program.
HRSA has made revisions to its 340B rebate model pilot, impacting how rebates are managed within the program.
Source: Drug Channels (Adam Fein)
EXECUTIVE SUMMARY — KEY TAKEAWAYS
Most important 340B implication. The decertification of 11 clinics from the 340B program highlights the strict compliance requirements for participation. This decision could set a precedent for future cases, potentially impacting other clinics and hospitals relying on the program for drug discounts. The ruling emphasizes the importance of meeting statutory requirements for 340B eligibility, which may lead to increased scrutiny and audits by regulators and drug manufacturers.
Emerging risks.
- Hospitals may face increased legal challenges regarding 340B compliance and eligibility.
- Drug manufacturers might intensify audits and compliance checks on 340B participants.
- Potential loss of 340B status could affect drug pricing and access for clinics.
- Ongoing litigation could lead to changes in 340B program rules and enforcement.
- Financial pressures from CMS’s proposed rules could impact hospital budgets.
Emerging opportunities.
- Hospitals can advocate for policy changes to protect 340B program benefits.
- Engage with CMS during comment periods to influence future rulemaking.
- Develop compliance programs to ensure adherence to 340B requirements.
- Collaborate with pharmacy associations to address reimbursement challenges.
- Use legal precedents to strengthen 340B program participation.
Key actions for providers.
- Review and update 340B compliance protocols to ensure eligibility.
- Monitor ongoing litigation and regulatory changes affecting the 340B program.
- Participate in advocacy efforts with healthcare associations to influence policy.
- Evaluate financial impacts of CMS’s proposed rules on hospital operations.
- Engage legal counsel to address 340B-related disputes and compliance issues.
TOP STORIES
Court decertifies 11 clinics from 340B program.
Becker’s Hospital Review · August 20, 2026
- A federal judge sided with drugmakers Amgen and Genentech.
- The court found clinics did not meet 340B statutory requirements.
- Certifications for 11 clinics were set aside.
- Sagebrush Health Services funding did not qualify under 340B rules.
Froedtert Hospital sues CVS over $18M in alleged 340B diversion.
Becker’s Hospital Review · August 31, 2026
- Froedtert Hospital alleges CVS diverted $18 million in 340B savings.
- The lawsuit was filed in U.S. District Court for the Eastern District of Wisconsin.
- CVS Health and its subsidiaries are named as defendants.
- The alleged diversion occurred between 2020 and 2025.
NASP comments on CMS’s proposed 340B payment changes.
NASP — National Association of Specialty Pharmacy · September 1, 2026
- NASP submitted comments on CY 2027 HOPPS proposed rule.
- The comments focus on Medicare reimbursement for 340B-acquired drugs.
- NASP addresses operational and compliance considerations.
- Potential implications for specialty pharmacy services were highlighted.
FEDERAL POLICY & REGULATORY DEVELOPMENTS
Hospital groups urge CMS to reconsider 2027 outpatient rule.
Becker’s Hospital Review · August 31, 2026
- AHA, AAMC, and AMGA submitted objections to CMS.
- Concerns include 340B drug payment cuts and site-neutral payment expansion.
- The comment period closed on August 31, 2026.
- Groups urged CMS to withdraw or scale back key provisions.
AHA criticizes CMS’s proposed 340B repayment acceleration.
Becker’s Hospital Review · August 26, 2026
- AHA opposed CMS’s proposal to accelerate Medicare payment clawbacks.
- The proposal would increase repayment rates from 0.5% to 3%.
- AHA warned the timeline would cost hospitals over $600,000 on average.
- More than 500 hospitals could face repayments exceeding $1 million annually.
AAMC and AHA push for changes in 340B provisions.
Becker’s Hospital Review · August 26, 2026
- AAMC and AHA filed comments on CMS and Sen. Cassidy’s 340B proposals.
- They seek prospective application of Maximum Fair Price.
- AAMC addressed CMS’s Medicare Drug Price Negotiation Program rule.
- AHA focused on the 340B Drug Pricing Integrity and Affordability for Patients Act.
340B PROGRAM DEVELOPMENTS
HRSA revises 340B rebate model pilot.
Drug Channels (Adam Fein) · August 25, 2026
- HRSA made revisions to its 340B rebate model pilot.
- The changes impact how rebates are managed within the program.
- The pilot aims to improve rebate processing efficiency.
- Stakeholders are assessing the implications of these revisions.
STATE DEVELOPMENTS
Washington State Health Care Authority Updates 340B Program Guidelines
Washington State Health Care Authority · September 8, 2026
- Clarified that contract pharmacies cannot bill Medicaid for 340B drugs.
- Emphasized the need for covered entities to ‘carve-in’ for both fee-for-service and managed care to avoid duplicate discounts.
- Provided detailed eligibility and reporting requirements for 340B participants.
Nebraska Prohibits Discrimination Against 340B Entities by PBMs
Nebraska Legislature · August 18, 2026
- Enacted a law preventing PBMs from reimbursing 340B entities or contract pharmacies at lower rates than non-340B pharmacies.
- Bars PBMs from imposing fees or adjustments based on 340B participation.
- Protects patient choice to receive drugs from 340B entities or contract pharmacies.
Ohio Mandates Reporting for 340B Covered Entities
Ohio Revised Code · August 15, 2026
- Requires 340B covered entities to submit annual reports to the Department of Health by July 1 each year.
- Specifies that reports must be in a form and manner determined by the Department of Health.
- Applies to all 340B covered entities operating in Ohio.
Indiana Prohibits PBMs from Undermining 340B Benefits
Indiana Code · August 20, 2026
- Bars PBMs from including provisions in contracts with 340B covered entities that reduce 340B benefits.
- Specifies that such provisions are unenforceable and must be replaced with standard payment rates.
- Excludes Medicaid managed care organizations and fee-for-service Medicaid from this provision.
LITIGATION & ENFORCEMENT WATCH
| Court | Matter | Date |
|---|---|---|
| D.D.C. | COREWELL HEALTH WILLIAM BEAUMONT UNIVERSITY HOSPITAL v. KENNEDY [source] | September 3, 2026 |
| D. Maryland | State of New York v. U.S. Department of Health and Human Services [source] | August 27, 2026 |
| E.D. Pa. | AZURITY PHARMACEUTICALS, INC. v. GITOMER [source] | August 17, 2026 |
| M.D. Fla. | Azurity Pharmaceuticals, Inc. v. Bhattacharya [source] | August 17, 2026 |
WHAT TO WATCH NEXT
- Monitor the outcome of Froedtert Memorial Lutheran Hospital’s lawsuit against CVS Health for alleged 340B diversion. [source]
- Watch for CMS’s response to NASP’s comments on the proposed 340B payment changes. [source]
- Follow the developments in COREWELL HEALTH v. KENNEDY case filed in D.D.C. [source]
- Track HRSA’s implementation of the revised 340B rebate model pilot. [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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