State Boards of Pharmacy (“BOPs”) throughout the country are empowered through various laws, rules, and regulations governing administrative agencies, like BOPs, to handle issues with the licensees they regulate, including pharmacies and... Read More
Frier Levitt successfully assisted a Georgia-based pharmacy in securing reimbursement exceeding $1.2 million due and owed to the pharmacy from a major Pharmacy Benefit Manager (“PBM”). The PBM conducted multiple audits of the pharmacy including... Read More
State Boards of Pharmacy (“BOPs”) throughout the country rely on various types of proceedings, both formal and informal, to handle legal issues with licensees (pharmacies, pharmacists, etc.) conducting business in their state. Oftentimes, less... Read More
A New York-based pharmacy client was facing an audit conducted by a major pharmacy benefit manager (“PBM”). During the audit, the PBM conducted an invoice reconciliation, causing it to assert thousands of unsubstantiated claims. In fact, the PBM... Read More
Having served for nearly a decade as a federal prosecutor with the Department of Justice (“DOJ”), I always understood that whether a violation of the Anti-Kickback Statute (“AKS”) will result in criminal charges versus a civil lawsuit for... Read More
Compounding pharmacies should be Food and Drug Administration (“FDA”)-inspection ready and establish a plan to mitigate FDA inspection stress. As we approach the 10-year anniversary of passage of the Drug Quality and Security Act, the FDA... Read More
As the Pharmacy Benefit Managers (PBMs) prepare for the end-of-year “housekeeping”, pharmacies should be aware of the PBM audit trends and arm themselves with information necessary to preempt—and strategies to outright avoid—falling victim... Read More
In the course of pharmacy audits, PBMs are increasingly requesting from pharmacies copies of Drug Supply Chain Security Act (“DSCSA”) track and trace documents, commonly known as “T3” documentation. The T3, which consists of the Transaction... Read More
As a result of the increased marketing by payors of over-the-counter (“OTC”) cards to plan members, pharmacists are being placed in jeopardy by patients who do not know, or appreciate, the legal complexities around proper use of these cards. The... Read More
As we begin to enter the holiday season, pharmacies need to be cognizant that not everyone is eager to dive into the holiday spirit. Indeed, for pharmacy benefit managers (“PBMs”), the holiday season is merely the starting point of year-end... Read More
