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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…

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

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, Trevor L. Wear, William A. Sarraille.

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…

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

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…

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

New Drug Price Reporting and Transparency Measures Included in U.S. Coronavirus Relief Legislation

USA - January 6 2021 The $900 billion U.S. coronavirus relief and government appropriations legislation (the Act) contains several important new drug price reporting and…

Corbin T. Santo, Meenakshi Datta, Megan Coggeshall, Trevor L. Wear.