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HHS limits the use of guidance documents in civil enforcement actions

Lester J. Perling ( is a Partner in the Fort Lauderdale office, and Jamie Gelfman ( is a Partner in the Boca Ratan office of the Nelson Mullins Riley & Scarborough LLP law firm.

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”[1] 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.”[2] The rule became effective January 12, 2021, and applies to all HHS divisions, including Centers for Medicare & Medicaid Services (CMS).

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