CMS and the OIG Issue Final Rules Modernizing and Clarifying the Federal Stark and Anti-Kickback Laws

In a coordinated effort, on November 27, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) published final 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). Together, the final rules implement a framework to support transitions to value-based payment models and promote improvements in technology infrastructure. Perhaps most notable, however, are the strides CMS has taken toward adding flexibility and attempting to clarify the Stark regulations.

On the same day, in an effort to increase transparency in drug pricing and lower those prices, the OIG separately released a final rule to alter the way prescription drug discounts are handled and to protect certain drug-manufacturer payments to pharmacy benefit managers (PBMs).

Although the regulations remain complex, the healthcare industry should be pleased with the new flexibilities to support innovation, the avenues to protect financial relationships with referral sources, and the clarifications to help fend off frivolous whistleblower lawsuits...

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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