Like other attorneys whose practice is dedicated to healthcare transactional and regulatory compliance matters, we genuinely appreciate the paradigm under which a client seeks our counsel prior to entering into an arrangement that potentially implicates the Physician Self-Referral Law1 (Stark Law) or the Medicare and Medicaid Anti-Kickback Statute2 (AKS). Without exception, a proactive approach to ensure that the contemplated arrangement is structurally and operationally defensible from a Stark Law and AKS perspective will always be preferable to post-transaction efforts to extricate the client from regulatory issues that might arise from a defectively established relationship. Nonetheless, clients often have a penchant towards consulting legal counsel primarily when dealing with complex, high-value transactions – and those arrangements that clients view as fitting within the ordinary course of business might be perceived as not rising to a level of sophistication that warrants engaging counsel. Therefore, it is incumbent upon us as healthcare counsel to keep our clients apprised of legal developments which illustrate how seemingly mundane transactions may implicate the Stark Law or AKS – and engender substantial legal risks for clients. One such case is Ameritox, Ltd. v. Millennium Laboratories, Inc.3 (Ameritox case), which is pending appeal in the 11th Circuit.
Premium Content For:
- Health Law Section