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President Biden’s Buy American Executive Order Signals Possible Heightened False Claims Act Risk for Government Contractors

USA - February 11 2021 On January 25th, 2021, President Biden signed Executive Order 14005, entitled “Ensuring the Future Is Made in All of America by All of America’s…

John P. Bueker, Joshua S. Levy, Kirsten Mayer, Michael R. Littenberg.

Medicare Expands Coverage of “Breakthrough” Medical Devices and Codifies “Reasonable and Necessary” Standard

USA - January 21 2021 On January 14, 2021, the Centers for Medicare and Medicaid Services (“CMS”) published a final rule that significantly alters the Medicare…

Gregory H. Levine, Mara Sanders, William Hudson.

Rutledge vs. PCMA: SCOTUS Greenlights State Regulation of Pharmacy Benefit Manager Drug Reimbursement

USA - January 13 2021 On December 10, 2020, the Supreme Court, in a unanimous opinion, held that the Employee Retirement Income Security Act ("ERISA") does not…

Christopher M. Gillis, Harvey D. Cotton, Margaux J. Hall, Samuel Perrone.

Rutledge vs. PCMA: SCOTUS Greenlights State Regulation of Pharmacy Benefit Manager Drug Reimbursement

USA - January 13 2021 On December 10, 2020, the Supreme Court, in a unanimous opinion, held that the Employee Retirement Income Security Act (“ERISA”) does not preempt an…

Christopher M. Gillis, Harvey D. Cotton, Margaux J. Hall, Samuel Perrone.

Midnight Changes to the Medicaid Drug Rebate Program Regulations

USA - December 23 2020 On December 21, 2020, the Center for Medicare & Medicaid Services ("CMS") issued a Final Rule that makes significant modifications to the Medicaid…

Kelly Hamachi, Margaux J. Hall, Meredythe Ryan.