On December 27, 2022, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule that would, among other things, amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for an "identified overpayment" and the requirement to report and return overpayments within 60 days (the 60-day Rule).
If finalized, the rule change would revise the meaning of "identification" in 42 C.F.R. §§ 401.305(a)(2), 422.326(c), and 423.360(c) of the Affordable Care Act (ACA) to remove the "reasonable diligence" standard and replace it with the False Claims Act's (FCA's) "knowing" standard. Under the proposed rule, providers, suppliers, Medicare Advantage Organizations (MAOs), and Part D sponsors will be deemed to have identified an overpayment if they have "actual knowledge of the existence of the overpayment or act in reckless disregard or deliberate ignorance of the overpayment." CMS is seeking comments on or before February 13, 2023.
Under the current 60-day Rule, an overpayment must be reported and returned within 60 days of identification to the Secretary, the state, an intermediary, a carrier, or a contractor, as appropriate, and must also notify that entity in writing of the reason for the overpayment. The current rule defines identification to include when the provider or supplier determined or should have determined through the exercise of reasonable diligence that they have received and retained an overpayment. In...
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