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OIG Finds Physician-Owned Medical Device Innovator Not a Suspect “POD”

USA - April 25 2022 On April 18, 2022, the Centers for Medicare & Medicaid Services ("CMS") published its annual proposed rule for the federal fiscal year ("FY") 2023…

Alison Fethke, Michael B. Lampert

CMS Proposes Revised Definition of Medicare Part D Drug “Negotiated Prices”: Rule Could Increase Predictability for Pharmacies and Lower Medicare Enrollee Drug Cost-Sharing but Increase Premiums

USA - January 18 2022 On January 6, 2022, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule entitled “Medicare Program; Contract Year 2023 Policy…

Chandler Gray, Margaux J. Hall, Gregory F. Malloy, Stephanie A. Webster

A New Year for Drug Pricing and Price Reporting? What’s Happening Now and What’s New for 2022

USA - December 14 2021 The past two years have featured a flurry of legislative action, agency rulemaking and Executive Orders targeting the pricing of pharmaceutical and…

Scott Falin, Margaux J. Hall, Emma Kaufman, Ryan B. Marcus

CMS Finalizes Repeal of Medicare “Breakthrough” Device Coverage Rule, Pledges to Invite Further Industry Input

USA - November 24 2021 On November 15, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued a final rule1 implementing, without substantial modification, its…

Austin D. Laroche, Gregory H. Levine

Podcast: Non-binding Guidance: Rolling Back the Medicare Coverage of Innovative Technology (MCIT) Rule

USA - November 8 2021 This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on the Biden administration's recent proposal to repeal the Medicare…

Gregory H. Levine