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We explained that we inadvertently did not modify the monitoring portion of the regulation, § 425.316(c), when we established the alternative quality performance standard in the CY 2023 PFS final rule, and stated our belief that it would be appropriate to revise the regulation at § 425.316(c) to be consistent with our longstanding practice to monitor ACOs for their compliance with our quality reporting and quality performance standard requirements

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Use of this product outside of a licensed laboratory or clinical research setting, or without valid medical prescription and supervision, is strongly discouraged and done entirely at your own risk