Dan Kagan

Morrison & Foerster LLP

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Latest Posts › Medical Devices

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Rescinding The MCIT/R&N Final Rule, CMS Seeks New Approaches For Innovative Technology Coverage

On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule (MCIT/R&N). As...more

11/30/2021 / 21st Century Cures Act , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Innovative Technology , Medical Devices

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

Is 2021 The Value-Based And Shared Savings Revolution?

By now you are likely aware of the new safe harbor provisions of the federal anti-kickback statute (AKS), which the U.S. Office of Inspector General (OIG) finalized as of January 19, 2021. Among other changes to the AKS...more

4/22/2021 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Health Care Providers , Healthcare Costs , Medical Devices , OIG , Safe Harbors , Software , Technology Sector , Value-Based Care

FDA Clinical Decision Support Software Vs. EU’s Medical Device Regulation

In follow-up to our colleagues recent post about the newly implemented Medical Device Regulation (“MDR”) in the European Union, this post will discuss some of the similarities between FDA’s Clinical Decision Support (“CDS”)...more

4/6/2021 / 21st Century Cures Act , Draft Guidance , EU , European Commission , Food and Drug Administration (FDA) , Health Care Providers , International Medical Device Regulators Forum (IMDRF) , Medical Devices , Software

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