WASHINGTON—AdvaMed, also known as the Advanced Medical Technology Association, has asked the United States District Court for the District of Massachusetts to rule as a matter of law that independent sales agent (ISA) arrangements do not—by themselves—violate the Anti-Kickback Statute (AKS) and, accordingly, grant summary judgment in the Langer v Zimmer Biomet case.
An ISA is a contract defining the professional relationship between a health care company and an independent sales representative who sells products and/or services on their behalf.
AdvaMed said in its brief that the use of ISAs is a practice that is widespread within, and vital to, the medical device industry and the patients it serves. They continued that this practice provides valuable benefits to health care companies, physicians and patients by increasing access to cutting-edge health care products and incentivizing health care companies to innovate and move health care forward.
"The regulatory scheme governing the health care and life sciences sectors is immensely complex," the company said. "Plaintiff-Relator’s misplaced legal theory that the practice of contracting with ISAs is a per se violation of the AKS both fundamentally misinterprets the AKS and vastly overstates the Office of Inspector General for the Department of Health and Human Services relevant guidance."
“ISAs are an integral part of the medical device industry, and a determination that they are per se illegal would have a significant harmful impact on the industry, the development of new medical technology and patients’ access to health care,” said Pat Fogarty, deputy general counsel and senior vice president of legal at AdvaMed. “ISAs are used in a lawful manner to help expand health care access and incentivize innovation.”