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Comment: Many commenters supported or recommended CMS finalize its proposal to exclude billing units of a refundable drug subject to a discarded drug refunds from the calculation of Part B inflation rebate amounts during the reconciliation process, except for calendar quarters in calendar year 2023

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Here's the complete regulatory history: FDA Approval Timeline Date Event Details November 10, 2010 Original FDA Approval Egrifta approved for HIV-associated lipodystrophy (reduction of excess abdominal fat in HIV-infected patients with lipodystrophy) September 2019 Egrifta SV Approval Date Single-vial reformulation approved (simplified reconstitution vs

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FcRn antagonists represent an attractive way to minimize this hurdle, by increasing the catabolism of circulating neutralizing Abs prior to administration of the viral vector