On December 7, 2016, the HHS Office of the Inspector General (“OIG”) approved new safe harbors to the federal anti-kickback statute (“AKS”) and amendments to the civil monetary penalty (“CMP”) rules, including recognizing new statutory exceptions, seeking to alleviate blanket prohibitions, and regulatory measures to promote access to care. In doing so, the OIG is ushering in a new era for compliance and providing life science companies some refuge from the regulatory storm.
Dating back to 1972, the Anti-Kickback Statute (“AKS”) is a legal requirement whose “main purpose is to protect patients and the federal health care programs from fraud and abuse by curtailing the corrupting influence of money on health care decisions.” At the time the AKS was implemented, various “concerns arose among health care providers that some relatively innocuous, and in some cases even beneficial, commercial arrangements are prohibited by the anti-kickback law.” This was a result of the fact that in an effort to combat all types of fraud and abuse, the AKS’s reach is incredibly broad.