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CMS Proposes to Repeal Device Coverage Pathway and “Reasonable and Necessary” Regulations

USA - September 24 2021 On September 15, 2021, the Centers for Medicare & Medicaid Services (CMS) published a proposal (Proposed Rule) in the Federal Register that would…

Meenakshi Datta, Elizabeth Hardcastle, Brenna E. Jenny, Donielle McCutcheon, William A. Sarraille

Breakthrough Device Coverage Pathway and Reasonable and Necessary Regulations Delayed Until December

USA - June 11 2021 On May 18, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a final rule further delaying the effective date of…

Meenakshi Datta, Elizabeth Hardcastle, Brenna E. Jenny, William A. Sarraille, Trevor L. Wear

Drug Manufacturers Face Elimination of Medicaid Rebate Cap Beginning in 2024

USA - April 1 2021 Recently, President Joe Biden signed the American Rescue Plan Act of 2021 (the Rescue Plan), a $1.9 trillion COVID-19 relief package. We described a…

Meenakshi Datta, William A. Sarraille, Trevor L. Wear

CMS Delays and Reopens Comment Opportunity for Breakthrough Device Coverage Rule and Regulatory Definition of “Reasonable and Necessary”

USA - March 24 2021 On March 17, 2021, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule1 delaying the effective date of the final rule…

Meenakshi Datta, Elizabeth Hardcastle, Donielle McCutcheon, William A. Sarraille, Trevor L. Wear

American Rescue Plan - Key Provisions for Healthcare Providers and Manufacturers

USA - March 17 2021 Last week, President Joe Biden signed the American Rescue Plan Act of 2021 (American Rescue Plan), a $1.9 trillion COVID-19 relief package. The law…

Meenakshi Datta, Wandaly E. Fernandez, Brenna E. Jenny, Trevor L. Wear, Meghan Weinberg, Rebecca K. Wood