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With respect to invoicing manufacturers for the rebate amount owed, under section 1847A(i)(1) of the Act, CMS must report rebate amounts to each manufacturer of a Part B rebatable drug no later than 6 months after the end of each calendar quarter, except that for calendar quarters beginning in 2023 and 2024, CMS has until September 30, 2025, to invoice manufacturer for rebates

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The dosage of AOD9604 used in this study or 0.25 mg per injection, was carefully calculated to be molar equivalent to doses of full-length GH shown to be effective in prior rabbit OA studies