Dan Kagan at Morrison & Foerster LLP

New Jersey Court Affirms Prohibition Of Physician Practice From Opening And Operating In-Office Pharmacy

At the end of 2021, the Superior Court of New Jersey, Appellate Division upheld the decision by the New Jersey Board of Pharmacy (the “Board”) denying the application from a New Jersey oncology practice (the “Petitioner”) to...more

3/14/2022 / New Jersey , Pharmacies , Physicians , Prescription Drugs , Stark Law

FDA Releases Draft Guidance On Digital Health Technologies For Remote Data Acquisition In Clinical Investigations

In response to COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) continues to work in support of clinical investigation sponsors and an evolving environment in which they run their clinical trials while...more

2/18/2022 / Business Closures , Clinical Trials , Coronavirus/COVID-19 , Data Collection , Digital Health , Food and Drug Administration (FDA) , Public Health , Supply Chain , Technology Sector

FDA Oks Mail-Order Mifepristone: State Laws May Inhibit Its Use

In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and...more

1/27/2022 / Coronavirus/COVID-19 , Drug Distribution , Drug Treatment , Food and Drug Administration (FDA) , REMS , Telehealth , Telemedicine

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

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

EHR Vendor Settles Kickback Allegations To The Tune Of $18.25 Million

On January 28, 2021, the United States’ Department of Justice (DOJ) announced an $18.25 million settlement with athenahealth Inc. (“Athena”) to resolve allegations that Athena violated the False Claims Act by paying...more

2/5/2021 / Anti-Kickback Statute , Department of Justice (DOJ) , Electronic Medical Records , False Claims Act (FCA) , Marketing

Dan Kagan

Morrison & Foerster LLP

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