Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under Which Homeopathic Drugs May Be Marketed, and, concurrently, published revised draft guidance titled Drug Products Labeled as Homeopathic (the “Revised

The Federal Trade Commission’s (“FTC”) recently submitted Congressional Budget Justification and Annual Performance Plan and Report contains helpful insight into the FTC’s focus and expectations for the coming fiscal year.  Of particular note, is a slight shift of funds from activities designed to “protect consumers” to activities intended to “promote competition.”  High on the FTC’s

The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”), has made pursuing fraud in the personal care services (“PCS”) sector a top priority, including making it a focus of their FY2017 workplan.

Last week, OIG released a report, Medicaid Fraud Control Units Fiscal Year 2016 Annual Report,  which set

The federal government continues to secure significant recoveries through settlements and court awards related to its enforcement of the False Claims Act (FCA), particularly resulting from actions brought by qui tam relators. In fiscal year (FY) 2016, the federal government reported that it recovered $2.5 billion from the health care industry. Of that $2.5 billion,

By Adam Solander, Ali Lakhani and Wenxi Li

The increasing prevalence of mobile technology in the healthcare sector continues to create compliance concerns for physician practices and other health care entities.  While the Office of Civil Rights (OCR) of the Department of Health and Human Services, has traditionally focused on technology breaches within larger

According to a new report released in December 2011 by the Office of Inspector General (“OIG”), more than 25 percent of all durable medical equipment (“DME”) suppliers faced enforcement actions by the Centers for Medicare & Medicaid Services during their first year of participation in the Medicare program. In its report, the OIG reviewed a