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Frier Levitt Successfully Reduces PBM Audit Recoupments by Nearly $130k for New York-based Pharmacy

Frier Levitt recently assisted a New York-based pharmacy with multiple audits after a PBM alleged inventory shortages and compounding related issues. These alleged discrepancies racked up significant audit fines and the pharmacy reached out to Frier Levitt's attorneys to help assist the pharmacy in challenging and appealing the audit results. Frier Levitt reviewed the inventory documents and submitted the appeals to the PBM on the pharmacy's behalf. As a result,...

CLIENT ALERT: FDA Issues 2018 Compounding Policy Priorities Plan

On January 18, 2018 the U.S. Food and Drug Administration (FDA) issued its 2018 Compounding Policy Priorities Plan, which outlines how the agency will implement certain key aspects of the Drug Quality and Security Act (DQSA) and other provisions of the law relevant to compounders. DQSA put in place more robust oversight of compounders and enabled closer federal and state collaboration. It also established a clear legal framework that provides for...

Pharmacy Guide: Meeting Controlled Substance Regulatory Requirements

Due to the country's opioid crisis, it has become commonplace to read reports which show government enforcement actions asserted against pharmacies and their owners for both substantive and administrative violations of the Controlled Substances Act (CSA). Similarly, manufacturers and wholesale drug distributors can also implement restrictions on pharmacies, by way of Pharmacy Restriction Letters, that can impact a pharmacy's ability to purchase controlled substances which can be detrimental to a...

503B Outsourcing Facilities Exposed to Civil Liability for Allegedly Compounding “Essential Copies” of Commercially Available Drugs

On Sept. 7, 2017, Allergan filed two lawsuits in the US District Court for the Central District of California against Imprimis Pharmaceuticals and Sincerus Florida, two US FDA-registered 503B outsourcing facilities, and Prescriber's Choice, a management company that assists physicians, claiming they are illegally selling unapproved new drugs under the guise of lawful compounding. Additionally, Allergan claims the three companies are engaging in false and misleading advertising and promotion of...

PROVIDER ALERT: Medicare Advantage Organizations Have Been Wrongfully Terminating Physicians with Little to No Notice and Little to No Cause

In recent months, Medicare Advantage Organizations (MA Organizations) across the country have been on a network termination binge – often terminating physicians without sufficient (or sometimes any) notice and opportunity to appeal. These terminations have been effectuated by, among other means, denying physicians' recredentialing applications, with MA Organizations offering very little in the way of legal justification.  The Centers for Medicare and Medicaid Services (CMS) have promulgated regulations specific to...