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When Your Medicare Privileges Are On the Line – Don’t Ignore Emergency Judicial Measures

While always a gamble, when a provider is faced with the prospect of losing their Medicare privileges based on allegations of fraud, waste or abuse, filing for a Temporary Restraining Order (TRO) against the government to halt termination may pay substantial dividends.  Recently, Frier Levitt was retained by a large laboratory that had received notice from the Centers for Medicare & Medicaid Services (CMS) that its Medicare billing privileges would...

Telehealth Expands to Medicare Advantage Plans

Last month, a federal bill was introduced and passed by the Senate that enables Medicare Advantage (MA) plans to reimburse for telehealth services at comparable rates to in-person services beginning in 2020. Currently, MA plans offer telehealth coverage for an additional premium; a supplemental benefit. The new bill requires Medicare Advantage plans to reimburse for telehealth services at the same rate as Medicare fee-for-service. While the adoption of this bill...

Pharmacy Owner and Director of Compliance Charged with Defrauding United States and Distributing Adulterated Products

On Tuesday, June 20, 2017, Paul J. Elmer, pharmacist and owner of Pharmakon Pharmaceuticals Inc. (a 503B Outsourcing Facility), and Caprice R. Bearden, Pharmakon's Director of Compliance, were arrested and later indicted by a Federal Grand Jury in Indiana, charged with one count of conspiracy to defraud the United States and three counts of distributing adulterated products. According to FDA requirements, 503B Outsourcing Facilities must comply with current Good Manufacturing...

NY Hospital Management Company Settles for $4 Million for Alleged FCA Violations Arising from Failure to Document Physician Arrangements in Writing

On September 13, 2017, the U.S. Department of Justice (DOJ) announced that MediSys Health Network Inc. (MediSys), a New York management company that owns and operates Jamaica Hospital Medical Center and Flushing Hospital and Medical Center, agreed to pay $4 million to settle allegations that it violated the False Claims Act (FCA) by engaging in improper financial relationships with referring physicians. The underlying lawsuit was filed by Dr. Satish Deshpande...

Need for Heightened Vigilance Illustrated by Pharmaceutical Manufacturer Mallinckrodt’s Settlement with DEA for $35 Million Based on Suspicious Orders

In an unprecedented settlement, Mallinckrodt, LLC, one of the largest pharmaceutical manufacturers of generic oxycodone, has agreed to pay Federal Drug Enforcement Agency (DEA) $35 million to settle allegations that they violated certain provisions of the Controlled Substance Act (CSA). The allegations included that Mallinckrodt failed to meet its obligations to detect and notify the DEA of suspicious orders of controlled substances, such as oxycodone, (a drug at the height...