Johnson & Johnson will require 340B covered entities to submit claims-level data for its covered outpatient drugs starting Sept. 15, according to a notice the drugmaker sent to providers Sept. 4.
Covered entities that don’t submit will receive at least two noncompliance notices and a notice of pricing suspension, with suspension beginning at least five business days after the final notice. J&J said 340B pricing will be restored within 10 business days once a covered entity submits compliant data.
The policy applies to all covered entity types regardless of dispensing or administration location, inventory management system or payer coverage. J&J said it will continue to offer 340B pricing upfront at the time of purchase rather than moving to a rebate model, and that the policy supersedes claims-data provisions in a prior notice from February 2023.
Covered entities must submit data within 45 days of a drug’s dispensation; a list of oncology, autoimmune and other specialty drugs, including Stelara, Darzalex and Tremfya, carries a 60-day window.
J&J also issued a companion notice Sept. 4 limiting 340B covered entities to a single contract pharmacy location within 40 miles of their parent site, effective Sept. 15 for hospitals and Nov. 3 for grantees.
“Johnson & Johnson is updating its 340B claims data policy to help guard against prohibited duplicate discounts and other non-compliance and to help promote the long-term sustainability of the 340B program,” a J&J spokesperson told Becker’s. “J&J is strongly committed to the original intent of the 340B program in service of improving affordable access to innovative medicines for low-income and vulnerable patients.”
The claims-data mandate is the latest expansion of manufacturer-imposed reporting requirements across the drug industry. Eli Lilly began requiring in-house pharmacy claims data earlier this year and started suspending 340B pricing for hospitals that didn’t comply, prompting pushback from hospital associations and a lawsuit from Tampa (Fla.) General Hospital. Novo Nordisk has imposed a similar in-house claims-data requirement.
J&J itself has tried to reshape 340B pricing before. In 2024 it moved to end upfront discounts on Xarelto and Stelara in favor of a rebate model, then paused the effort after HRSA warned that rebate-based models are illegal under the 340B statute. J&J later sued HHS and HRSA over the issue, part of a broader legal fight over drugmakers’ rebate models that a federal judge largely upheld HRSA’s authority to block.
Hospital and provider groups have argued that claims-data mandates, alongside proposed rebate pilots and other manufacturer policies, threaten to squeeze already-strained safety-net providers.
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