The United States has filed an amicus curiae (friend of the court) brief that urges the Eleventh Circuit Court of Appeals to reject the appeal filed by Millennium Health (MH) in a case in which a jury found MH violated both the Stark Law and the federal Anti-Kickback Statute (AKS) by providing free point-of-care urine drug testing (POCT) cups to physicians.
I am writing about this brief because it is my understanding (although I could be wrong) this is very unusual and may be the first instance in which the US has filed an amicus brief in a civil case involving Stark and AKS issues in which it was not a party.
This suit was originally filed by MH’s main competitor, Ameritox, in April 2011. Ameritox claimed MH (Millennium Laboratories at that time) violated the Lanham Act (false advertising), the Stark Law and the AKS, and engaged in unfair competition and tortious interference in multiple states by providing physicians with free POCT cups (urine cups which contain immunoassay strips for qualitative drug testing) in exchange for referrals.
A judge ruled in May 2014 that MH violated the Stark Law and AKS when it provided free POCT cups to physicians who then billed for chemical analysis, but allowed a jury to decide whether MH violated the Stark Law and the AKS by providing free POCT cups to physicians who could have billed for POCT but agreed not to do so.
In June 2014, the jury determined MH did indeed violate the Stark Law and AKS and ordered MH to pay Ameritox $14.8 million. That amount was later reduced to $11.26 million in September 2014. At some point (I do not know precisely when), MH appealed the decision, arguing, among other things, the provision of POCT cups to physicians did not violate Stark and the AKS.