For example, each new exception includes the requirements that (1) remuneration is not an inducement to reduce or limit medically necessary items or services to any patient and (2) if a patient expresses a preference for a provider, such preference supersedes any referral conditions. Instead of requiring adherence to requirements that arose in a fee-based environment, the definitions and requirements of 42 CFR § 422.357(aa) provide criteria specific to a value-based environment to guard against program or patient abuse. These exceptions differ from the prior Stark exceptions, which require that compensation be set at fair market value, and not determined in a manner that takes into account the volume or value of referrals. Three new exceptions have been added for value-based compensation arrangements.

The final rule establishes new exceptions to Stark for value-based arrangements. These regulations are effective on January 19, 2021, except for the amendment regarding group practice compensation methodologies, which is effective January 1, 2022.Ī. The final rule includes: three new value-based exceptions and relevant defined terms guidance and clarification on several key definitions and requirements clarification regarding group practice profit shares and productivity bonuses and new exceptions for non-abusive arrangements for which there is currently no applicable exception. The Stark final rule aims to build a successful value-based system by encouraging innovative new models in Medicare and Medicaid and removing regulatory barriers that impede care coordination. These new final rules aim to alleviate those concerns and advance the transition to value-based care and encourage the coordination of care among providers, while continuing to provide important safeguards to protect against fraud, abuse, and overutilization.

Over time, and with the rise of data that could be used by providers and payers to better anticipate patient needs and payment for them, concern arose that the existing regulations and policies would potentially inhibit the innovation necessary for moving toward a value-based system of care and payment. The prior Stark and AKS regulations were developed in a volume-based health care delivery and payment system. These new final rules generally take effect on January 19, 2021. On Novemthe Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of the Inspector General (OIG) issued two final rules to modernize and clarify the Physician Self-Referral regulations (the Stark Law, or Stark) and the Anti-Kickback Statute (AKS) safe harbor regulations.

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