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As of writing, studies in laboratory animals have not identified significant safety concerns [3, 4]

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In a separate proposed rule entitled Medicare Program: Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023 (89 FR 55168, July 3, 2024) (referred to herein as the SAHS billing activity proposed rule), we proposed an approach to address the SAHS billing activity identified by CMS for CY 2023 to protect the accuracy, fairness, and integrity of Shared Savings Program financial calculations