Lawmakers designed the federal Anti-Kickback Statute (AKS) to help better ensure medical professionals focus on the well-being of their patients. Lawmakers intended this piece of regulation to reduce the risk of medical decisions based on financial gain. But what happens when the government accuses a medical company or individual of an AKS violation? The following discussion provides a basic timeline.
Step one: Awareness and charges
First, the government must become aware of a potential violation. This generally occurs either through a government investigation after noticing a discrepancy in Medicare or Medicaid claims or from a tip given by a whistleblower. If substantiated, the government may move forward with criminal charges.
If the government pursues criminal charges, authorities will notify the individual or business. At this time, it is wise to begin building a defense.
Step two: Build a defense strategy
The defensive strategy may vary. One example may include a motion for summary judgment. This strategy was recently used by pharmaceutical company Teva after the government accused it of AKS violations. The pharmaceutical company filed for summary judgment arguing that it already had compliance materials in place to mitigate the risk of such a violation. Upon review of the motion, the judge dismissed the claim stating that although it had the needed documents it did not appear that the company had followed the regulations as outlined within the documents.
If the motion is not successful, as outlined in the case above, the accused is wise to implement another defensive strategy. This could include gathering evidence to establish that there was not a violation or to show that the alleged infraction falls within a safe harbor. Generally, those who are fighting against these claims will have multiple strategies working in conjunction to help better ensure success.
It is important to note that this example progression is relatively basic. The exact timeline will depend on the facts of each individual case. As a result, it is wise for those who faced such allegations to seek legal counsel experienced in this area of the law to better ensure a defensive strategy that is in line with their best interests.
