On May 5, 2014, in Ameritox, Ltd. v. Millennium Labs., Inc., [No. 8:11-cv-775-T-24-TBM], 2014 WL 1779267 (M.D. Fla. May 5, 2014), the U.S. District Court for the Middle District of Florida granted in part and denied in part a motion for partial summary judgment as to the issue of whether the provision of free point-of-care (POC) testing cups to doctors constitutes remuneration under the Stark Law and anti-kickback statute (AKS).
The court, in granting the motion, determined that the free POC testing cups constituted remuneration to the doctors under the Stark Law and AKS when the POC testing cups were used to perform free preliminary test results that the doctors could not have obtained without purchasing the POC testing cups. The court rejected the argument that the free POC testing cups met an exception under the Stark Law. The court explained in such situation, the doctors obtained a preliminary test result without having to pay for the POC testing cups and without giving up the opportunity to bill for the POC testing by billing for a chemical analyzer test of the same specimen. The doctors, thus, were receiving a valuable benefit in the form of the free preliminary test results.
The court, in denying the motion, concluded that whether the provision of free POC testing cups constituted remuneration under the Stark Law and AKS to doctors who could bill for the POC testing using the free POC testing cups, but agreed to forego the opportunity to bill for it, was a genuine issue of material fact for the jury to determine. The court explained in such situation, it appears that the doctors were giving up the ability to bill for POC testing, which was approximately a net of $15 per specimen.
The specific facts of the arrangement determine whether the provision of free POC testing cups constitutes remuneration under the Stark Law and AKS. Therefore, it is important to analyze the details of your particular arrangement when free services or items are involved in order to determine whether it complies with the Stark Law and AKS.