On August 4, the U.S. Food & Drug Administration will publish a draft guidance in the Federal Register, Insanitary Conditions at Compounding Facilities. Click here to view a pdf of the draft guidance. In the announcement, the FDA states: “FDA is issuing this guidance to assist compounding facility in identifying insanitary conditions so that they [...]
On August 1, five pharmacies joined together and filed a class action lawsuit against Express Scripts Inc. (ESI), alleging ESI systematically stole customers to boost its mail order business. Initiated by Trone Health Services, Inc. (Idaho), Reddish Pharmacy, Inc. (Idaho), Jabos Pharmacy, Inc. (Tennessee), Oak Tree Pharmacy (Oregon), and Amrut JAL, LLC (Indiana), the lawsuit [...]
The U.S. Department of Justice announced this week, the guilty plea of pharmacy owner and pharmacist, Rodney Dalton Logan, to obstructing a Medicare audit in 2012. In his plea agreement, Mr. Dalton agreed to pay a $2.5 million penalty and faces a maximum penalty of five years in prison. Under Title 18, United States Code, [...]
The Department of Justice has confirmed a dramatic increase in the civil monetary penalty (CMP) amount the government can levy per-claim for violations of the False Claims Act. As reported by Law360, the DOJ confirmed yesterday that the penalties are set to nearly double. On November 2, 2015, the President Obama signed into law the [...]
Yesterday the Department of Justice along with their multi-agency enforcement partners announced a massive coordinated takedown of individuals for their alleged participation in health care fraud schemes involving approximately $900 million in false billings to Medicare. Approximately 300 individuals, including doctors, nurses, pharmacists and other licensed medical professionals were swept up in the raids. This [...]
An indictment last week of the owner of a compounding pharmacy, its marketers and a physician in California serves as warning to all concerned, that the government has targeted its investigations on marketing and is dialed-in on conducting these type of complex investigations. The owner of Valley View Drugs, Inc., owners and marketers of its [...]
The U.S. Supreme Court ruled yesterday that corporations can face False Claims Act liability if they bill a federal payor while out of compliance with regulations even though said regulations were not explicit conditions of payment. The Court also clarified when non-compliance is or is not material to federal reimbursement. This ruling has implications for [...]
The FisherBroyles Pharmacy Law team has observed an increase in the Department of Justice and Department of Defense’s coordinated efforts to conduct investigations into alleged violations of the False Claims Act for claims submitted to TRICARE. Lately, the Department of Labor has joined the enforcement actions for what they perceive as alleged overbilling for compounded [...]
New York pharmacist, Andrew Barrett pled guilty last week to falsely billing Medicare and Medicaid more than $2.7 million for HIV medication refills never requested or received by patients and for filing false tax returns. Mr. Barrett faces up to 10 years in prison, restitution, criminal forfeiture and a fine. A sentencing date has not [...]
Since last September when Deputy Attorney General Sally Quillian Yates issued a memo to federal attorneys nationwide, directing the aggressive pursuit of individual corporate wrongdoers for fraud and other misconduct, the government has noticeably stepped up its investigation of corporate individuals. Two criminal trials of former healthcare executives are set to begin in U.S. District [...]