The brief was submitted Feb. 28 by the American Hospital Association, the Children’s Hospital Association, the Association of American Medical Colleges and America’s Essential Hospitals with respect to a lawsuit before the U.S. District Court for the District of Columbia.
The 340B program requires drug manufacturers to provide discounts to hospitals that serve underserved populations. J&J’s rebate model, however, seeks to impose additional conditions on these discounts, potentially delaying or reducing financial relief for hospitals, the brief said.
The development comes after J&J received federal pushback on the rebate plan and the HRSA warned the drugmaker could face significant fines or lose eligibility for Medicare or Medicare Part B participation if it were to proceed.
As a result, J&J filed a lawsuit against HHS and HRSA in November, requesting that a federal judge declare its rebate plan legal and block federal authorities from taking any enforcement action against the implementation.
The AHA and other healthcare groups argue that the approach is illegal and would force hospitals to advance millions of dollars to drug manufacturers, leading to financial strain.
