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New Rules Prohibiting the Government s Use of Certain ‘Guidance Documents May Reduce False Claims Liability for Health Care Providers Wednesday, February 17, 2021
Health care providers and others in the health sector have long complained at the unfairness of facing enforcement actions – and the fines and penalties that accompany them – for failure to follow a poorly publicized or otherwise obscure agency guidance such as a local coverage determination (LCD). In 2019, the United States Supreme Court provided significant relief when it held in
Azar v. Allina Health Services, 139 S. Ct. 1804 (2019), that an agency guidance that established or changed a “substantive legal standard” had to undergo a notice-and-comment process before adoption and enforcement. On Dec. 3, 2020, the Office of General Counsel for the Department of Health and Human Services (HHS-OGC) issued an Advisory Opinion and two final rules that provide a roadmap as to how the ag