Recently, the United States filed a Notice of Settlement in the Middle District of Florida seeking to resolve its allegations that a pharmacy and its owner violated the False Claims Act. Notably, this matter was originally filed as qui tam... 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
Last month, Philips RS North America, LLC (formerly Respironics, Inc.), a durable medical equipment manufacturer, agreed to pay $1.28 million to settle civil allegations that it unlawfully induced referrals for its equipment in violation of the... Read More
Last week, a federal jury convicted a podiatrist for his role in orchestrating and implementing a scheme to defraud Medicare. Dr. Kenneth Mitchell, who was terminated from participating in the Medicare program in 2015, sought an end-run around the... Read More
Earlier this week the Second Circuit affirmed a lower court’s holding which found that drug manufacturer Pfizer Inc.’s practice of providing copay assistance to Medicare beneficiaries violated the Federal Anti-Kickback Statute (“AKS”).... Read More
During the 2021 fiscal year, The U.S. Department of Justice (DOJ) recovered $5.6 billion in civil settlements and judgments involving fraud and violations of the False Claims Act; a record-breaking $5 billion of this recovery was derived from... Read More
On July 20, 2022, the Office of Inspector General (OIG) issued a Special Fraud Alert warning practitioners to exercise caution when entering into certain telehealth arrangements. The Alert references the many recent investigations of telemedicine... Read More
On June 29, 2022, the Department of Justice (“DOJ”) announced the formation of the New England Prescription Opioid (NEPO) Strike Force. This strike force will investigate and vigorously prosecute healthcare providers involved in healthcare fraud... Read More
According to the DOJ’s indictment, Ms. Lavache prescribed DME for Medicare beneficiaries without conducting any consultations with the said beneficiaries. As a result, she allegedly caused the submission of false claims to Medicare totaling... Read More
Earlier this week, the U.S. Supreme Court ruled that to secure convictions under the federal Controlled Substances Act (“CSA”) for excessive prescribing of controlled substances, including opioids, prosecutors must prove beyond a reasonable... Read More
