MedMatrix Rx
Daily 340B Morning Briefing for Executives
Recent developments in the 340B program highlight significant shifts in compliance and management requirements for covered entities. Johnson & Johnson has mandated that 340B covered entities submit claims-level data by September 15 to maintain pricing, with noncompliance resulting in suspension. The National Association of Specialty Pharmacy has provided feedback on CMS’ proposed payment changes, which include reimbursement and compliance issues. Additionally, Shields Health Solutions faces new complexities introduced by the IRA Maximum Fair Pricing and HRSA’s Rebate Model Pilot Program, set to launch in 2027. Legislative advocacy is also underway, as the American Society of Health-System Pharmacists seeks support for 340B program protections and expanded Medicare coverage for pharmacist services. These developments reflect the evolving landscape of the 340B program and the increasing need for covered entities to adapt to regulatory changes and compliance demands.
EXECUTIVE SUMMARY
01
J&J mandates claims data for 340B pricing.
Johnson & Johnson requires 340B covered entities to submit claims-level data starting September 15 to maintain pricing. Noncompliance leads to suspension.
Johnson & Johnson requires 340B covered entities to submit claims-level data starting September 15 to maintain pricing. Noncompliance leads to suspension.
Source: Becker’s Hospital Review
02
NASP comments on CMS 340B payment changes.
The National Association of Specialty Pharmacy submitted feedback on CMS’ proposed 340B payment changes, focusing on reimbursement and compliance issues.
The National Association of Specialty Pharmacy submitted feedback on CMS’ proposed 340B payment changes, focusing on reimbursement and compliance issues.
Source: NASP
03
Shields Health Solutions addresses 340B complexities.
Shields Health Solutions is adapting to new 340B program management challenges posed by the IRA Maximum Fair Pricing and HRSA’s Rebate Model Pilot Program.
Shields Health Solutions is adapting to new 340B program management challenges posed by the IRA Maximum Fair Pricing and HRSA’s Rebate Model Pilot Program.
Source: Becker’s Hospital Review
04
ASHP advocates for 340B protections on Capitol Hill.
The American Society of Health-System Pharmacists seeks legislative support for 340B program protections and expanded Medicare coverage for pharmacist services.
The American Society of Health-System Pharmacists seeks legislative support for 340B program protections and expanded Medicare coverage for pharmacist services.
Source: Becker’s Hospital Review
05
340B rebate model pilot to launch in 2027.
HRSA’s revised 340B Rebate Model Pilot Program will start January 1, 2027, affecting drugs under the Inflation Reduction Act’s nonduplication requirement.
HRSA’s revised 340B Rebate Model Pilot Program will start January 1, 2027, affecting drugs under the Inflation Reduction Act’s nonduplication requirement.
Source: Drug Channels
06
State laws protect 340B pricing from discrimination.
States like Maine and Rhode Island enact laws preventing PBMs from discriminatory reimbursement practices against 340B entities.
States like Maine and Rhode Island enact laws preventing PBMs from discriminatory reimbursement practices against 340B entities.
Source: Frier Levitt
EXECUTIVE SUMMARY — KEY TAKEAWAYS
Most important 340B implication. The requirement for claims-level data submission by Johnson & Johnson poses a critical compliance challenge for 340B covered entities. Failure to comply jeopardizes pricing and risks broader implications for operational sustainability and financial viability. As entities adjust to these new requirements, they must improve their data management capabilities and ensure adherence to evolving regulations. This shift may necessitate investments in technology and training to accurately capture and report claims data. Moreover, the impending launch of HRSA’s 340B Rebate Model Pilot Program in 2027 introduces additional complexities that entities must prepare for, potentially impacting their reimbursement strategies and overall program participation. The combination of these factors highlights the importance of proactive compliance measures and strategic planning in maintaining the integrity and benefits of the 340B program.
Emerging risks.
- Failure to submit claims data to J&J could result in suspension of 340B pricing for covered entities.
- The federal court ruling against HHS may encourage other manufacturers to challenge 340B policies.
- State laws expanding 340B access face potential legal challenges from pharmaceutical manufacturers.
- 340B program changes under CMS proposals could lead to reduced reimbursements for hospitals.
Emerging opportunities.
- Covered entities can use state laws to protect against discriminatory reimbursement practices.
- The 340B Rebate Model Pilot Program offers a chance to test new pricing strategies under HRSA’s guidance.
- Hospitals can engage with NASP and ASHP to influence CMS policy changes and protect 340B interests.
- Entities may explore partnerships with Shields Health Solutions to address new 340B program complexities.
Key actions for providers.
- Ensure compliance with J&J’s claims data submission to maintain 340B pricing.
- Monitor legal developments in the 340B dispute with HHS for potential impacts on contract pharmacy arrangements.
- Advocate for favorable state laws that support 340B program integrity and access.
- Participate in CMS comment periods to influence future 340B reimbursement policies.
TOP STORIES
J&J mandates claims data for 340B pricing.
Becker’s Hospital Review · September 11, 2026
- Johnson & Johnson requires claims-level data submission from 340B covered entities starting September 15.
- Noncompliance will lead to pricing suspension, with restoration upon data submission.
FEDERAL POLICY & REGULATORY DEVELOPMENTS
NASP comments on CMS 340B payment changes.
NASP · September 1, 2026
- NASP submitted comments on CMS’ proposed changes to 340B Medicare reimbursement.
- The focus is on operational and compliance implications for specialty pharmacies.
ASHP advocates for 340B protections on Capitol Hill.
Becker’s Hospital Review · September 16, 2026
- ASHP seeks congressional support for 340B program protections.
- Legislation includes expanded Medicare coverage for pharmacist-provided care.
340B PROGRAM DEVELOPMENTS
340B rebate model pilot to launch in 2027.
Drug Channels · August 25, 2026
- HRSA’s 340B Rebate Model Pilot Program starts January 1, 2027.
- The pilot addresses conflicts with the Inflation Reduction Act’s pricing requirements.
Shields Health Solutions addresses 340B complexities.
Becker’s Hospital Review · September 11, 2026
- Shields adapts to challenges from IRA Maximum Fair Pricing and HRSA’s Rebate Model.
- The approach aims to manage 340B program complexities effectively.
STATE DEVELOPMENTS
Illinois — Enacts HB 2371, Facing Multiple Legal Challenges
ACI 340B · September 18, 2026
- Illinois passed HB 2371, introducing new regulations on the 340B Drug Pricing Program.
- The law has been met with several lawsuits from manufacturers and PhRMA.
- Illinois now faces more ongoing legal challenges to its 340B law than any other state.
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 | Mandates claims data submission for 340B pricing from September 15. [source] | 2026-09-11 |
WHAT TO WATCH NEXT
- Monitor J&J’s enforcement of claims data submission starting September 15. [source]
- Watch for HRSA’s response to the federal court ruling favoring pharma companies. [source]
- Anticipate the launch of HRSA’s 340B Rebate Model Pilot Program on January 1, 2027. [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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