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CMS, OIG Release Stark, AKS Final Rules

  • November 20, 2020

The Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued today two highly anticipated final rules to reform the Stark Law and Anti-Kickback Statute (AKS) regulations.

Efforts to modernize and clarify the fraud and abuse laws began in 2018 as part of the Regulatory Sprint to Coordinated Care Initiative. The initiative is aimed at removing regulatory barriers that may hamper innovative arrangements for coordinating care consistent with a shift to a value-based health care system.

The agencies emphasized that the final rules offer health care providers more flexibility to coordinate and improve care for patients, while maintaining important guardrails that prevent overutilization and fraud and abuse.

The Stark final rule creates new, permanent exceptions to the Stark Law for value-based arrangements, according to CMS. These exceptions will apply broadly to care provided to all patients, not just Medicare beneficiaries, CMS said.

The 627+ page final rule also includes additional clarifications and guidance on key issues in response to stakeholder comments. For example, the final rule provides guidance on how to determine if compensation meets the requirement that compensation provided to a physician by another health care provider generally must be at fair market value. The rule also provides clarity and guidance on a wide range of other technical compliance requirements intended to reduce administrative burden that drives up costs, an agency fact sheet said.

In addition, the final rule includes new exceptions to provide protection for non-abusive, beneficial arrangements between physicians and other health care providers. These finalized exceptions provide new flexibility for certain arrangements, such as donations of cybersecurity technology that safeguard the integrity of the health care ecosystem, regardless of whether the parties operate in a fee-for-service or value-based payment system, the fact sheet said.

The 1000+ page AKS final rule implements seven new safe harbors, modifies four existing safe harbors, and codifies one new exception under the Beneficiary Inducements CMP.

In addition, the final rule modifies and clarifies certain provisions in response to comments received on the proposed rule. For example, the rule clarifies how medical device manufacturers and durable medical equipment companies may participate in protected care coordination arrangements that involve digital health technology; lowers the level of “downside” financial risk parties must assume to qualify under the new safe harbor for value-based arrangements with substantial downside financial risk; and broadens the new safe harbor for cybersecurity technology and services to cover remuneration in the form of cybersecurity-related hardware, according to an agency fact sheet.

AHLA volunteers are analyzing the rule for AHLA members and others. Stay tuned by following AHLA on Twitter and visit our Stark + AKS Health Law Hub for the latest news and analysis.