Medical Devices and Wearables

Federal and state enforcement activity involving pharmacy fraud tops the list of categories in this edition of Rivkin Rounds’ Fraud Week. We’ll list just a sampling of cases.

On October 19, the U.S. Department of Justice (DOJ) announced that Jerry May Keepers of Kingswood, Texas was sentenced to 36 months of supervised probation for writing

In a recent blog post, Fitbit unveiled three new devices in its product line. One of the newly debuted watches, the Sense 2, includes an atrial fibrillation (AFib) detection algorithm that recently received FDA clearance.

The AFib detection technology relies on a photoplethysmography (PPG) optical heart-rate sensor that reads the heart rhythm of its

If our most recent Fraud Week post (NY Chiropractor Billed for Non-Existent Acupuncture Services) didn’t already drive home the point, it is worth emphasizing that billing insurers for items or services that weren’t actually provided is always a bad idea.

On August 4, the U.S. Department of Justice (DOJ) announced that Ariel Madero

On September 28, Rivkin Radler’s Jeff Kaiser will be a panelist at the Practising Law Institute’s program, Life Sciences 2022: Navigating Legal Challenges in Drug and Device Industries. The program is designed for attorneys and allied professionals who counsel pharmaceutical and life sciences companies.

Entitled “Enforcement Trends Impacting the Drug and Device Industries,” Jeff’s

Healthcare fraud related to durable medical equipment (DME) is extremely costly to insurers, yet often continues without criminal or civil consequences. Rivkin Radler’s Michael Vanunu recently wrote an article on the topic for Law360.

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The U.S. Department of Justice (DOJ) recently announced that Reliance Medical Systems LLC, a Utah-based distributor of spinal implant devices, two of its individual owners, and two of its physician-owned distributorships (PODs) agreed to pay $1 million to resolve a lawsuit brought under the False Claims Act. Reliance allegedly operated the PODs as a vehicle

In a recent Advisory Opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined that an arrangement involving certain physicians who have an ownership interest in a medical device company that manufactures products that may be ordered by the physician owners (the “Company”) was not considered a suspect physician-owned

Rivkin Radler’s Shari Claire Lewis wrote an article, “FTC Appears Ready to Begin Enforcing Its Health Breach Notification Rule,” that was published in the New York Law Journal on April 18. The article discusses the Federal Trade Commission’s rule that requires manufacturers of connected medical devices, fitness trackers and other wearables, and health

The Federal Trade Commission (FTC) recently issued a policy statement confirming that vendors of apps and other connected devices that collect personal health information, such as glucose levels, heart rate, or fertility or sleep data, are subject to the FTC’s Health Breach Notification Rule. The rule, issued in 2009, requires vendors to notify consumers

The proposed 2022 Medicare Physician Fee Schedule released on July 13 by the Centers for Medicare & Medicaid Services (CMS) includes a new category of CPT codes for “remote therapeutic monitoring” (RTM). The new codes are in addition to the set of codes introduced in 2019 for remote physiological monitoring, usually called remote patient monitoring