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[673] We proposed at 427.402(c)(2), for a natural disaster or other unique or unexpected event occurring on or after August 2, 2024, that the manufacturer believes caused a severe supply chain disruption, the manufacturer must submit the rebate reduction request within 60 calendar days from the first day that the natural disaster or other unique or unexpected event occurred or began in order for CMS to consider a rebate reduction

Clinical data, though somewhat limited, are promising

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The intricate HBV replication cycle, the persistent presence of cccDNA within the host cell nucleus, and the continuous synthesis of HBsAg from the integrated HBV DNA in the host genome present formidable challenges to attaining a functional cure for CHB