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As explained in the CY 2025 final rule (FR 98307), the Suggestion of Error process is limited to mathematical steps involved in determining the rebate amount and the elements precluded from administrative or judicial review will not be considered in-scope for the Suggestion of Error process

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enforcement discretion has ended, and the FDA has proposed permanently excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list

To maximize the benefits of Dihexa, we recommend maintaining a healthy lifestyle, including regular exercise, a balanced diet, adequate sleep, and stress management techniques