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  • Washington Highlights

    AAMC Files 340B Lawsuit that Challenges the Delay in the Ceiling Price Rule

    Ivy Baer, Senior Director and Regulatory Counsel

    The AAMC, American Hospital Association, America’s Essential Hospitals, and 340B Health filed a lawsuit Sept. 11 in U.S. District Court that challenges the years-long delay by Department of Health and Human Services (HHS) to issue the ceiling price and civil monetary penalties (CMP) final rule [see Washington Highlights, June 8].

    The rule requires HHS to develop a system to verify that drug manufacturers disclose the ceiling price that can be charged to providers for outpatient drugs under the 340B Drug Pricing Program. Such verification is the only way that 340B covered entities can know if drug manufacturers are providing the correct prices, as required by law. The suit further challenges the delay to give the government the ability to levy CMPs against drug companies that knowingly and intentionally overcharge 340B providers.

    In a joint press release from the hospital associations, AAMC President and CEO Darrell G. Kirch stated, “The final regulation provides important transparency for this vital program. Delaying implementation of that rule ultimately harms vulnerable patients and the teaching hospitals they rely on for care.”

    The associations are joined in the suit by three hospital plaintiffs: Rutland Regional Medical Center, Genesis HealthCare System, and Kearny County Hospital.