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FDA codifies requirements for the medical device De Novo classification process

USA - October 14 2021 On October 5, 2021, the U.S. Food and Drug Administration (“FDA”) published a final rule to establish requirements for the medical device De Novo…

Title CMS again postpones the effective date of Medicare coverage pathway to access “breakthrough” medical technologies, regulatory standard for determining whether an item or service furnished under Medicare is “reasonable and necessary”

USA - May 17 2021 On May 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released a new final rule that further delays until December 15, 2021, the…

James Segroves

What happens when the clock strikes midnight: A Primer on “Midnight Regulations”

USA - February 10 2021 With another presidential transition in the history books, you may find it unsurprising to hear that many of us at Reed Smith are continuing to…

Open for business in 2021

USA - December 11 2020 With 2020 coming to a close, businesses are looking ahead to 2021 and evaluating how they can stay open while keeping their employees and patrons…

Kelly J. Kearney

The wait is over: The final rules to modernize Stark Law and Anti-Kickback Statute are here

USA - November 23 2020 On Friday, November 20, 2020, the Department of Health and Human Services (HHS) gave everyone an early holiday present when it released complementary…

Selina P. Coleman, Nicole J. Aiken-Shaban, James F. Hennessy, Katie C. Pawlitz, James Segroves