CMS and the OIG Issue Far-Reaching Proposed Rules to the Federal Stark and Anti-Kickback Laws

In a coordinated effort, CMS and the Office of Inspector General (OIG) published proposed rules to modernize regulations implementing the federal physician-self referral law, commonly referred to as the “Stark Law” (Stark), the federal Anti-Kickback Statute (AKS) and the beneficiary inducement provisions of the Civil Monetary Penalties Law (CMP Law). The proposed rules take steps to create a framework to support value-based payment models and promote improvements in technology infrastructure.

Perhaps most notable, however, are the strides taken by CMS toward adding flexibility and attempting to clarify the Stark regulations. Those who were hoping for less complexity may be disappointed, but simplicity was likely an unrealistic expectation given the complexity of our healthcare system and the underlying statutory mandates. Nonetheless, the healthcare industry should be pleased with clarifications and changes that may allow them to avoid Stark self-disclosures in seemingly innocuous circumstances and defend against frivolous whistleblower lawsuits.

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