Lexology January 18, 2023
Ropes & Gray LLP

Introduction

On December 27, 2022, the Centers for Medicare & Medicaid Services (“CMS”) released proposed changes and clarifications concerning the Medicare Advantage (“MA”) and the Medicare Prescription Drug (“Part D”) programs through a Notice of Proposed Rulemaking (the “Proposed Rule”). The Proposed Rule focuses on changes designed to improve beneficiary transparency around prior authorization, offer additional formulary flexibility, increase health equity, and clarify CMS’s position on when an overpayment is “identified” by an MA Organization (“MAOs”) for purposes of triggering the False Claims Act’s (“FCA”) “60 day rule.”

In particular, the Proposed Rule includes a new requirement that prior authorization approvals by MAOs remain valid for the duration of a beneficiary’s course of treatment; introduction of a health equity index...

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