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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…

Stephanie P. Hales, 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, Stephanie P. Hales, 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, Meghan Weinberg, Rebecca K. Wood, Stephanie P. Hales, 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, Megan Coggeshall, Stephanie P. Hales, Trevor L. Wear.

CMS Finalizes Medicaid Drug Rebate Changes Addressing PBM Accumulators, VBP Arrangements and Line Extensions

USA - December 29 2020 On December 21, 2020, the U.S. Centers for Medicare & Medicaid Services (CMS) issued a final rule implementing significant manufacturer price…

Corbin T. Santo, Elizabeth Hardcastle, Trevor L. Wear, William A. Sarraille.