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( 21 ) GCDRA and GCDRM (codes for cardiovascular risk assessment and risk management services)

(1) Section 1847A(i)(8) of the Act precludes administrative or judicial review on the determination of units as set forth in 427.303, the determination of whether a drug is a Part B rebatable drug as set forth in 427.101, and the calculation of the rebate amount as set forth in 427.301, inclusive of any reconciled rebate amount

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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