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On December 7, 2020, the Department of Health and Human Services (“HHS”) published the Good Guidance Practices final rule (“Rule”), which limits HHS’s ability to issue and rely upon sub-regulatory guidance documents in enforcement actions, investigations, and audits, including actions relating to coverage and reimbursement for items and services under Medicare and other federal health care programs.[1] In addition, the HHS Office of the General Counsel (“HHS-OGC”) released Advisory Opinion 20-05, which sets out HHS-OGC’s interpretation of
Azar v. Allina Health Services, 139 S. Ct. 1804 (2019) (“
Allina”), in which the U.S. Supreme Court held that HHS must use notice-and-comment rulemaking (as opposed to issuing guidance) when establishing or changing “substantive legal standards” that affect Medicare eligibility, benefits, or payments for services.[2] In Advisory Opinion 20-05, HHS-OGC defines its interpretation of the phrase “substantive legal standard,” and addresses