Dan Kagan

Morrison & Foerster LLP

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Is The Future Of Telehealth In OIG’s Hands?

Telehealth services may be at a crossroads. While the COVID-19 pandemic brought about widespread adoption of telehealth services, the Department of Justice and the U.S. Department of Health and Human Services Office of...more

9/15/2021 / Audits , Centers for Medicare & Medicaid Services (CMS) , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Department of Justice (DOJ) , Fraud , Health Care Providers , Inspector General , Telehealth

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4/6/2021 / 21st Century Cures Act , Draft Guidance , EU , European Commission , Food and Drug Administration (FDA) , Health Care Providers , International Medical Device Regulators Forum (IMDRF) , Medical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

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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