| On July 24, 2024, two hospital-covered entities sued the Health Resources and Services Administration (“HRSA”), arguing that HRSA’s approval of J&J’s 340B audit request against them was unlawful and premature. The two hospitals, Oregon Health & Science University (“OHSU”) and Maine General Medical Center (“MaineGeneral”), filed their lawsuits in the District Court for the District of Columbia.
J&J Failed to Follow Procedure – HRSA Audit Premature: OHSU and MaineGeneral both argue that because J&J did not 1) notify them in writing that J&J suspected a 340B breach and 2) work with the hospitals in good faith for 30 days to resolve the issue, HRSA prematurely granted J&J’s request to audit the hospitals. The 1996 Manufacturer Audit Guidelines prohibit HRSA from granting a manufacturer request to perform an audit until after the manufacturer takes the above steps. Before filing lawsuits, HRSA denied both hospitals’ requests to reverse its decision to approve J&J’s audit request.
Relief Sought: OHSU and MaineGeneral seek a declaration from the court that HRSA must abide by the 1996 Manufacturer Audit Guidelines. Additionally, both seek an injunction that would 1) prohibit HRSA from moving forward with its audits and 2) prevent HRSA from applying sanctions to either hospital for their failure to respond to J&J’s audit demands.
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