This is the eighth in our 2024 Year in Preview series examining important trends in white collar law and investigations in the coming year. It is not often that we can.
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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
HIPAA
Shannon B. Hartsfield
To date, there has been little consistency in how Health Insurance Portability and Accountability Act (HIPAA) requirements are enforced by the U.S. Department of Health and Human Services (HHS), or the amount of settlements or penalties. In
Univ. of Texas M.D. Anderson Cancer Ctr. v. U.S. Dept. of Health and Human Servs. No. 19-60226, 2021 WL 127819 (5th Cir. Jan. 14, 2021), the court vacated significant penalties against M.D. Anderson Cancer Center (M.D. Anderson) in a manner that could lead to changes to HIPAA enforcement in the future. The court found that HHS decision to fine M.D. Anderson $4,348,000 was arbitrary, capricious, and contrary to law.