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CMS understands that statutory provisions at section 1860D-14B of the Act require that CMS establish the payment amount benchmark period at the dosage form and strength level, and that resetting the payment amount benchmark period for a new NDC-9 of an existing Part D rebatable drug may not fully align with this directive

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Subject to paragraph (b)(3) of this section, eligibility for a rebate reduction under this section is limited to Part B rebatable biosimilar biological products for which a manufacturer submits a rebate reduction request under this section

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