Last month, the U.S. Supreme Court extended the time in which a private party may bring a suit under the False Claims Act (FCA). The decision – United States ex rel. Hunt v. Cochise Consultancy – extended the statute of limitation to bring an FCA action up to 10 years from the date of the alleged violation.  The FCA permits a private person to bring a civil action in the name of the federal…

    Despite many articles, seminars, and educational opinions written on compliance and legal implications of dispensing, ordering, and storing controlled substances, it still remains the number one reason for disciplinary actions across the nation. This article focuses on the most cited violations of state or federal laws pertaining to working with the controlled substances. Improperly performed inventories. It’s common for pharmacy inventory to omit Time of the date the inventory was taken (beginning or…

 In 2015, the owner and pharmacist-in-charge of Lane Pharmacy passed away. The Pharmacy, however, carried on as nothing had happened. Allegedly, the Pharmacy continued to operate without a pharmacist. This “unusual” Pharmacy operated until 2017, when the California Board of Pharmacy received a complaint that non-licensed individuals were dispensing medications. The Board investigation revealed that pharmacy technicians continued to operate the pharmacy after its owner’s death and that these non-pharmacists purchased and signed for drug…

   In 2018, CMS proposed a Medicare rule that would eliminate retroactive DIR fees. One of the rationales for the rule was a colossal growth of DIRs between 2010 and 2017. During this period of time, DIRs grew by 45,000%. As a result of this aggressive “performance enforcement” by PBMs, many pharmacies are reimbursed below cost and many have closed their doors. The American Medical Association has published a study showing that many patients with…

  This month, I will be presenting a series of webinars organized by Nova Biomedical aimed to educate healthcare practitioners on what constitutes off-label use of blood-glucose meters (BGM). My part of the presentation will focus on the risks associated with the off-label use of BMGs and the ways to avoid potential liabilities. Why did we choose this topic? According to the FDA’s statistics there were thousands of serious injuries in critically ill patients due…

More and more states are mandating e-prescribing. Some states require e-prescribing only for CII controlled substances, some for all controlled substances, and some require e-scripts for all medications. States with current e-Rx mandate laws are: Connecticut (e-prescribing for controlled substances only, no penalties for non-compliance) Maine (e-prescribing for controlled substances only, penalties provided) Minnesota (all prescriptions, no penalties) New York (all prescriptions, penalties) State with future e-Rx mandate laws are: Arkansas (e-prescribing for controlled substances…