New Rules on Physician Self-Referrals and Incentives Offer Clarity and Flexibility Amid Shift to Value-Based Care

November 24, 2020

The Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS) recently released two final rules aimed at modifying and clarifying existing regulations on physician self-referrals and safeguards against inappropriate incentives in federal health care plans.

CMS’ Modernizing and Clarifying the Physician Self-Referral Regulations final rule includes new exceptions designed to enable value-based care arrangements and proposes a long list of additional changes to Stark Law (the Medicare physician self-referral law) regulations intended to address many of the most challenging aspects of compliance with the law, including new exceptions for value-based care arrangements.

The final rule provides additional guidance on several key requirements that must often be met for physicians and health care providers to comply with the Stark Law. For example, compensation provided to a physician by another health care provider generally must be at fair market value—with the rule providing guidance on how to determine if compensation meets this requirement. 

The rule also provides clarity and guidance on a wide range of other technical compliance requirements intended to reduce administrative burden. Learn more.

HHS’ final rule, Fraud and Abuse; Revisions to Safe Harbors under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements, modifies existing Anti-Kickback Statute safe harbors and creates new safe harbors and Civil Monetary Penalty Law (CMPL) exceptions. It also adds three new safe harbors for certain value-based care arrangements, greater flexibility for part-time and outcomes-based arrangements, and a CMPL exception for furnishing telehealth technologies to certain in-home dialysis patients. Learn more.

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