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Based on the design of the eligible studies, the methodological quality of the available data was low, and the risk of bias was high

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We further proposed that if a manufacturer submits a complete and timely extension request, and CMS determines that the information submitted warrants an extension of the rebate reduction, the total rebate amount would be reduced by 75 percent for the fifth through eighth calendar quarters for that manufacturer's Part B rebatable biosimilar biological product, in accordance with 427.402(b)(2)