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109-171) (DRA) amended section 1848(b)(4) of the Act to require that, for imaging services, if(i) The TC (including the TC portion of a global fee) of the service established for a year under the fee schedule without ( application of the geographic adjustment factor, exceeds (ii) The Medicare OPD fee schedule amount established under the prospective payment system (PPS) for HOPD services under section 1833(t)(3)(D) of the Act for such service for such year, determined without regard to geographic adjustment under section 1833(t)(2)(D), the Secretary shall substitute the amount described in clause (ii), adjusted by the geographic adjustment factor under the PFS, for the fee schedule amount for such TC for such year

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Consistent with the policy established in section 40.5.2 of the revised Medicare Part D Drug Inflation Rebate Guidance, we proposed at 428.302(c)(5) that a manufacturer may receive only one extension of the rebate reduction per generic Part D rebatable drug or biosimilar per CMS determination of a severe supply chain disruption

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Patients should follow the dosing instructions provided by their healthcare professional or as indicated on the product label