The initial guidance includes information regarding how CMS will calculate Inflation Rebate amounts. The initial guidance provides clarifications regarding (i) the process CMS will use to identify Medicare Part B and Part D rebate-eligible drugs, (ii) the rebate calculation timeline, (iii) manufacturer financial responsibility for inflation rebate amounts, and (iv) certain exclusions from rebate calculation.
Under the initial guidance, manufacturers subject to Inflation Rebates will receive their first invoices for applicable products no later than September 30, 2025 for Part B drugs and December 31, 2025 for Part D drugs, with payment due 30 days later.
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