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CMS would identify the months for which a beneficiary has Medicaid coverage with cost-sharing assistance using available information (for example the State MMA File of dually eligible beneficiaries) at the time the rebate amount is being calculated for a calendar quarter

Consequently, we are not proposing any changes to the burden for the OAuth credentialing and token request process under that control number

For example, if CMS grants a severe supply chain disruption rebate reduction request for a generic Part D rebatable drug or biosimilar that was submitted on November 15, 2024, and that generic Part D rebatable drug or biosimilar is currently in shortage from September 15, 2025, until May 15, 2026, CMS would apply a 75 percent reduction in the total rebate amount for the duration of the applicable period for which the severe supply chain disruption rebate reduction request was granted (that is, October 1, 2024, to September 30, 2025), and then would apply the shortages reduction as proposed in 428.301, beginning with a reduction of 25 percent for a biosimilar or 75 percent for a generic Part D rebatable drug or plasma-derived product that is a biosimilar for the applicable period beginning October 1, 2025

[231] Autoimmune diseases are continuously affecting more people

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