Johnson & Johnson Next Major Drugmaker to Require 340B Claims Data

As the greater pharmaceutical industry moves toward more transparency in 340B drug pricing, Johnson & Johnson was the most recent manufacturer to announce claims data requirements for participating pharmacies in the 340B Drug Pricing Program, according to the Healthcare Financial Management Association.¹

With debates ongoing regarding the true value of the 340B program, the manufacturer side of the initiative has made swift moves throughout 2026, forcing covered entities to follow suit with proper reporting if they would still like to be included in the program.²

“While manufacturers have demanded claims data as a condition for contract pharmacy access for several years, Exelixis was among the first manufacturers to condition 340B pricing for in-house pharmacy dispensing on the submission of claims data,” wrote Frier Levitt.² “Eli Lilly followed with an expanded policy in January 2026 that reached beyond contract pharmacy activity to cover in-house dispensing and provider-administered drugs across its full portfolio, requiring claims data to be submitted through its 340B ESP platform within 45 days of dispensing, or 60 days for certain specialty and provider-administered products, and taking the step of threatening to terminate access if such data was not supplied.”

READ MORE: The 3 Perspectives of 340B: Legal, Safety-Net, and Purchaser

Similar to Eli Lilly, under the new policy that took effect on September 15, 2026, Johnson & Johnson now mandates that covered entities submit claims data for in-house pharmacy dispensing within 45 days, extended to 60 days for specific oncology and autoimmune products. The company stated that the limited claims data requested is already maintained in auditable records and is necessary to protect program integrity.^1,3

However, this policy represents a significant expansion of compliance obligations for health-system pharmacists who must now navigate a rapidly shifting environment.¹

The details of Johnson & Johnson's mandate require health systems to report comprehensive pharmacy or medical claims elements to the 340B ESP platform. Covered entities that fail to submit timely and accurate data face at least 2 notices of noncompliance followed by a suspension of 340B pricing on all company products within 5 business days.^1,3

Manufacturer Justifications and Counterarguments From Providers

Johnson & Johnson defended its decision by pointing to persistent duplicate discounts in Medicaid managed care, which covers roughly 80% of Medicaid beneficiaries, as well as duplication risks under the Medicare Inflation Reduction Act Maximum Fair Price provisions. The manufacturer also highlighted instances of diversion, such as unregistered dispensing sites or duplicate replenishment claims across multiple entities.³

This dispute occurs as the program expanded from fewer than 30,000 registered sites in 2014 to over 60,000 by 2025, with annual purchases reaching $100 billion.

READ MORE: The Great 340B Debate: What Pharmacists Need to Know

Hospital groups have strongly contested the assertion that these reporting requirements create minimal administrative burdens.^1,4

According to the American Hospital Association, data for in-house dispensing resides across disparate electronic health record and billing systems, making reconciliation extremely costly and forcing entities to divert financial resources away from direct patient care. The hospital association emphasized that federal audit data shows Medicaid duplicate discount findings dropped 57% and drug diversion dropped 73% between 2018 and 2022.

Rather than managing fragmented manufacturer platforms, hospital leaders advocate for a neutral third-party clearinghouse overseen by federal regulators to handle data exchange and maintain program integrity.⁴

Operational Strategies for Health-System Pharmacists

Pharmacy administrators must also prepare for parallel federal reporting changes, including the launch of the centralized Medicare Part D repository by the Centers for Medicare and Medicaid Services (CMS), which transitions from voluntary testing to mandatory reporting in October, where noncompliance could jeopardize Medicare enrollment.¹

Legal analysts at Frier Levitt warn covered entities against waiting until wholesalers cut off discounted pricing, noting that Eli Lilly suspended 340B pricing for noncompliant hospitals in June 2026, leading to litigation in cases like Tampa General Hospital v Eli Lilly.^1,2

Although 72 bipartisan members of Congress have called on federal agencies to intervene, pharmacists must implement proactive operational protocols immediately.²

To safeguard 340B eligibility and maintain financial stability, pharmacy leaders should engage early with manufacturers to establish documented phased compliance plans where technical infrastructure requires extra development time. When a health system determines that a manufacturer mandate exceeds statutory authority, administrators should submit formal written legal objections prior to pricing cutoffs to preserve legal rights for administrative dispute resolution or court proceedings.

READ MORE: Health System Pharmacy Resource Center

REFERENCES

1. Hut N. J&J adds 340B claims data requirements amid growing manufacturer restrictions. Healthcare Financial Management Association. September 15, 2026. Accessed September 17, 2026. https://www.hfma.org/operations-management/340b-claims-data-requirements-jj-policy/

2. Bariso V. What covered entities can do right now about manufacturer 340B data mandates. Frier Levitt. September 4, 2026. Accessed September 17, 2026. https://www.frierlevitt.com/articles/manufacturer-340b-data-mandates-covered-entities/

3. Notice to 340B covered entities regarding 340B claims data submission policy. Johnson & Johnson. September 4, 2026. Accessed September 17, 2026. https://www.documentcloud.org/documents/28621100-johnson-johnson-notice-to-covered-entities-regarding-340b-claims-data-submission-policy-effective-09-15-2026/?_sp=b6699467-74ba-4f53-8a1d-cc838b591cca.1789662074912

4. Recent 340B data policy changes: separating the myths from the facts. American Hospital Association. August 11, 2026. Accessed September 17, 2026. https://www.aha.org/2026-08-11-recent-340b-data-policy-changes-separating-myths-facts