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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

This novel pathway reinforces the recent evidence that lysosomes do not function solely as recycling bins but are involved in numerous regulatory processes, such as mTORC1-mediated nutrient sensing, orchestrating transcriptional programs that control various metabolic and cellular events (Saftig & Klumperman, 2009