The United States Department of Health & Human Services (HHS) has issued a regulation modifying certain practices with respect to civil enforcement actions, intended to promote “transparency and fairness” in such proceedings (the rule). HHS states that the rule is “designed to ensure accountability, fairness of how [HHS] uses guidance, proper use of guidance documents, and opportunities for third parties to be heard.” The rule became effective January 12, 2021, and applies to all HHS divisions, including Centers for Medicare & Medicaid Services (CMS).
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