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Consistent with the policy established in section 50.12 of the revised Medicare Part B Drug Inflation Rebate Guidance, we proposed at 427.402(c)(5) that a manufacturer may receive only one extension of the rebate reduction per Part B rebatable biosimilar biological product per CMS determination of a severe supply chain disruption

This approach makes intuitive sense because the amount of incretin stimulation needed to maintain a lower weight is probably less than the amount needed to achieve that lower weight in the first place

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