Strict Compliance with Safe Harbor Requirements is Key to Avoiding Anti-Kickback Violations

Office of Inspector General (“OIG”) Advisory Opinion 25-09 [1] addresses an inquiry from a company that develops, manufactures and sells medical devices used in emergency stroke treatment and provides commentary for similarly situated business looking to navigate potentially complicated investor situations. The company in question requested this opinion to determine whether the below-described arrangement would be grounds for sanctions under federal anti-kickback statutes. After an extensive, fact-based analysis, OIG determined that the company was not subject to sanctions as the arrangement d