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Former Dentist Pleads Guilty to $16.6M Medical Device Fraud Scheme

Former South Dakota dentist Robert "Larry" Lytle pled guilty last week to an enterprise that involved the marketing of a laser treatment known as the Qlaser System to treat more than 200 serious conditions, including autism, sciatica, HIV/AIDS, emphysema and cancer.   Prosecutors asserted that Lytle promoted the Qlaser System without scientific evidence or FDA approval, and in defiance of 2015 injunction from a federal court directing him to stop selling...

Opioid Indictment Underscores Importance of Vigilant Compliance

Frier Levitt's regulatory, transactional and criminal defense attorneys begin each day reviewing Department of Justice (DOJ) news bulletins regarding its successful enforcement activity. Later in the day, an interdepartmental meeting occurs and we analyze the potential impact of the DOJ's investigations, indictments and convictions on our clients' transactional documents, operations and/or regulatory analyses. Our mission is to inform our healthcare and life sciences provider clients with updates on prosecutorial investigations...

The Opioid Epidemic: Protecting Your Patients, the Public and Your License

Earlier this year, at the prompting of Governor Christie, New Jersey's Attorney General Chris Porrino invoked his emergency powers to impose limitations on opioid prescribing, a measure aimed at reducing the risk of opioid addiction and restricting the number of pills available for diversion. The "Emergency Rule" mandates include: (i) initial opioid prescriptions for acute pain must be limited to 5 days; (ii) prescribers must query the Prescription Monitoring Program...

Why HIPAA Compliance Should Be a Priority

On April 24, 2017, the United States Department of Health and Human Services (HHS) through its Office of Civil Rights (OCR) announced a $2.5 Million settlement that should get the attention of every Covered Entity that lacks a formal HIPAA Compliance Plan. CardioNet, a wholly owned subsidiary of BioTelemetry, is a cardiac monitoring service headquartered in Malvern, PA. It is a "Covered Entity" as defined by 45 C.F.R. §160.103, and...

Qui Tam Case Against Physicians and Hospital Advances on What May Have Been a Technical Oversight

A U.S. District Judge found that two agreements between a set of doctors and a University of Pittsburgh Medical Center-owned hospital ran afoul of the Stark Law and the False Claims Act, the former of which prohibits a physician from referring Medicare patients for designated health services to an entity with which the physician (or immediate family member) has a financial relationship, and the latter of which prohibits the filing of...