On September 4, 2026, Johnson & Johnson (J&J) issued two notices that took effect September 15, collectively reshaping how covered entities access 340B pricing for J&J’s covered outpatient drugs. The first requires covered entities to submit claims-level data as a condition of receiving 340B pricing. The second limits each covered entity to a single contract pharmacy within forty miles of its parent site, with grantee organizations receiving an extended deadline of November 3. For hospitals, health systems, federally qualified health centers, and their affiliated pharmacies, the pressing question is what to do now, not whether these policies are legally permissible.
J&J’s September notices are the latest escalation in a manufacturer-driven trend to condition 340B pricing on claims-data submission. Exelixis was among the first to impose such a requirement for in-house pharmacy dispensing. Eli Lilly followed in January 2026 with a broader mandate, then enforced it in June by directing wholesalers to stop honoring 340B pricing for noncompliant hospitals. Tampa General Hospital sued Lilly over the resulting price increases in July 2026, and a bipartisan group of 72 House members wrote to the U.S. Department of Health and Human Services (HHS) and the Health Resources and Services Administration (HRSA) requesting immediate enforcement action against manufacturers that have suspended 340B access. Novo Nordisk has imposed a parallel claims-data requirement, and a growing number of other manufacturers have issued their own versions of the claims-data submission policies.
J&J’s Prior 340B Rebate-Model Litigation Provides Important Context
J&J’s own history in the 340B space adds important context. In 2024, J&J attempted to move Xarelto and Stelara to a rebate-based model. HRSA and a federal court blocked that effort, with the court largely sustaining HRSA’s authority to prohibit rebate models as inconsistent with the 340B statute. J&J subsequently sued HHS and HRSA, and that litigation remains pending. Its decision to retain upfront pricing while adding a claims-data submission requirement is a calculated pivot designed to extract compliance data without reprising the rebate-model fight it already lost.
What J&J’s New 340B Claims-Data Policy Requires
Under its claims-data notice, covered entities must submit claims-level data for all J&J covered outpatient drugs within 45 days of dispensing or administration. A defined list of oncology, autoimmune, and specialty products, including Stelara (ustekinumab), Darzalex (daratumumab), and Tremfya (guselkumab), carries a 60-day submission window. The policy applies across all covered entity types, inventory management systems, and payer categories. J&J has stated that it will maintain upfront 340B pricing at the point of purchase rather than converting to a rebate model.
Covered entities that do not submit compliant data will receive at least two noncompliance notices and a pricing suspension notice, with suspension taking effect no sooner than five business days after the final notice. J&J has stated that 340B pricing will be restored within 10 business days of a compliant submission.
What 340B Covered Entities Should Do Now
Organizations that dispense or administer J&J covered outpatient drugs should confirm immediately whether their pharmacy and claims-processing information systems can generate and transmit the required data fields within J&J’s applicable submission windows. Covered entities with existing contract pharmacy arrangements beyond the 40-mile cap should assess whether those arrangements can be challenged on legal grounds consistent with prior HRSA and court analysis of manufacturer contract pharmacy restrictions.
Entities that cannot yet achieve full compliance should engage J&J in writing before the applicable compliance deadline, explaining their current data-capture limitations and propose a phased submission timeline. Documented early engagement may help create a record that matters both for any future HRSA administrative dispute resolution (ADR) filing and for a legal challenge to the policy itself. Any purchases made at above-ceiling prices following a suspension should be recorded as overcharges immediately, rather than discovered weeks later in a reconciliation report, to preserve the entity’s rights under the 340B ADR process.
How Frier Levitt Can Help
Frier Levitt represents hospitals, health systems, federally qualified health centers, disproportionate share hospitals, Ryan White grantees, and their affiliated pharmacies on the full range of 340B compliance and enforcement matters. We advise covered entities on manufacturer claims-data policies and contract pharmacy restrictions, evaluate their legal basis under the 340B statute and HRSA guidance, negotiate phased or partial compliance arrangements, and prepare the documentation needed to support HRSA ADR filings and litigation.
If your organization has received J&J’s notices, has contract pharmacy relationships affected by the 40-mile restriction, or has questions about how to respond to any manufacturer’s claims-data mandate, contact Frier Levitt to discuss the potential operational and legal implications for your 340B program.
