On April 23, the OIG updated its FAQ webpage to reaffirm its long-stated position that although an arrangement might qualify for a Stark exception, it may nonetheless fail to meet the requirements of an applicable anti-kickback statute (AKS) exception or safe harbor (FAQ #4). Intent remains key in the OIG’s determination of whether an AKS violation exists, which is not an element of Stark’s strict liability prohibition. In addition, the OIG added a new FAQ #17, which reiterates its stance that fair market value (FMV) alone is not dispositive of whether an arrangement violates AKS. While FMV is an enumerated element of several safe harbors, the OIG emphasizes that all elements must be satisfied for a safe harbor’s protections to apply.
