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As described in the example in the CY 2025 PFS proposed rule (89 FR 61977), if a generic Part D rebatable drug is currently in shortage during the applicable period beginning October 1, 2023 because the manufacturer had trouble meeting demand for the drug and then in August 2024, the manufacturer faces difficulties securing the API for such drug and believes this may worsen the shortage situation and result in the generic Part D rebatable drug being currently in shortage in the next applicable period, the manufacturer may submit a likely to be in shortage rebate reduction request to CMS providing information on the severity of the likely shortage

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Luba Lee, FNP-BC is a Board-Certified Family Nurse Practitioner (FNP) and educator based in Tennessee

Because AOD9604 does not stimulate IGF-1 production and lacks strong GH receptor agonism, it may present a safer alternative for long-term OA treatment [1]