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New Dawn for PBM Regulation? - Supreme Court Determines ERISA Does Not Pre-empt State PBM Law

USA - December 17 2020 On December 10, 2020, the Supreme Court of the United States issued a decision in Rutledge v. Pharmaceutical Care Management Association holding that…

Molly Ramsden, Rujul Desai, Anna Kraus, Kendra L Roberson

Trump Administration Releases "Most Favored Nation" Interim Final Rule

OECD, USA - November 23 2020 On November 20, 2020, the Centers for Medicare & Medicaid Services ("CMS") issued an interim final rule ("IFR") implementing President Trump's Most…

Beth Braiterman, Rujul Desai, Anna Kraus, Olivia Vega

FDA Issues New Guidance for Development of COVID-19 Drugs and Biological Products

USA - May 18 2020 On May 11, 2020, the U.S. Food and Drug Administration (“FDA”) issued new guidance on the development of drugs and biologics to treat or prevent…

Denise Esposito, Allison M. Whelan

CMS Finalizes Rule Expressly Permitting Copay Accumulator Programs

USA - May 15 2020 On May 7, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced that it had finalized the Notice of Benefit and Payment Parameters for…

Tara Carrier, Rujul Desai, Stefanie Doebler, Paige M. Jennings, Anna Kraus, Kendra L Roberson