Johnson & Johnson will begin requiring 340B-covered entities, including community health centers, to submit claims-level data to maintain access to upfront 340B discounts. The new policy, which takes effect Sept. 15, requires detailed prescription, provider and pharmacy information generally within 45 days of dispensing. Providers that fail to submit timely and complete data could ultimately have access to J&J’s 340B pricing suspended.
The policy comes amid growing manufacturer restrictions on the 340B program and concerns from safety-net providers about the cumulative impact of data requirements, rebate models and other changes. ACH CEO Amanda Pears Kelly told Modern Healthcare that the nation’s primary care safety net is reaching a “dangerous tipping point,” warning that additional burdens on 340B could strain already limited health center resources and threaten patients’ access to care.