Dan Kagan

Morrison & Foerster LLP

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Latest Posts › Medicare

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CMS Proposes To Repeal MCIT Final Rule

Last week, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule (the “Proposed...more

9/22/2021 / Centers for Medicare & Medicaid Services (CMS) , Final Rules , Food and Drug Administration (FDA) , Innovative Technology , Medical Devices , Medicare , Medicare Beneficiaries , Public Comment

Ninth Circuit Weighs In On Fraud-On-The-FDA Theory, Marketing Devices For Off-Label Use, And Kickbacks

The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtronic, Inc.: (1) Engaged in “fraud-on-the-FDA” when obtaining...more

5/5/2021 / Anti-Kickback Statute , False Claims Act (FCA) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Health Care Providers , Medical Devices , Medicare , Pharmaceutical Industry , Popular , Rebates

Do You Have The COVID-19 Blues? Don’t Forget About Sunshine!

While the Centers for Medicare and Medicaid Services (CMS) acknowledges the impact COVID-19 has had on the healthcare industry, CMS does not have the authority to postpone the deadline for Sunshine Act reporting. Accordingly,...more

3/1/2021 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Justice (DOJ) , False Claims Act (FCA) , Health Care Providers , Medicaid , Medicare , Open Payments , Sunshine Act

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