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Across several votes, the panelists voted 8-6, with one abstention, in favor of putting the peptides on FDAs list of substances considered safe for pharmacy compounding

Consistent with CMS' statements in the CY 2025 PFS proposed rule regarding the potential alternative of requiring manufacturers to report AMP, the use of base date AMP described herein is consistent with CMS' understanding of the provisions of section 1860D-14B of the Act requiring CMS to establish the payment amount benchmark period at the dosage form and strength level and with CMS' authority under sections 1102(a) and 1871(a)(1) of the Act to make rules and regulations as necessary for the efficient administration of programs, including the Medicare Part D Drug Inflation Rebate Program

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Comment: One commenter urged CMS to clarify that there is an exception to the eligibility of the furnishing fee for when a patient needs a blood clotting factor for hemophilia and surgery while in the hospital, contending that absent the recommendation, there could be a significant impact on hospitals due to lack of payment