Aside from the ordinary business concerns that apply to all business and transactions, healthcare businesses and transactions are subject to additional scrutiny for their compliance with the tangled web of state and federal restrictions on self-referral and other prohibited economic relationships. For example, the federal Stark regulations and Anti-Kickback Statute (AKS) are implicated by any arrangement or relationship that involves any federal health care program (such as Medicare or Medicaid). In addition, California has additional, distinct, and broader statutory rules (including PORA) governing health care providers’ business relationships. The repercussions for violation of these statutes can include criminal and civil penalties, as well as exclusion from participation in federal health care programs. For these reasons, it is imperative that practitioners in the healthcare arena have a basic grasp of the Statute, its safe harbors, and its practical application.
We regularly advise healthcare providers on the legal permissibility of relationships with other providers, managers, marketers, and other business entities Nelson Hardiman advises clients on compliance with the Stark Laws, the Anti-Kickback Statute, and other state and federal prohibitions on self-referral.