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Such information and supporting documentation include the following: (i) Evidence that demonstrates a generic Part D rebatable drug is likely to be in shortage, including anticipated cause(s) of the shortage and information about why the manufacturer believes ( the generic Part D rebatable drug is likely to be in shortage

CPI-U means the monthly Consumer Price Index for All Urban Consumers (United States city average) index level for all items from the Bureau of Labor Statistics

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In the CY 2023 PFS final rule (87 FR 69960 through 69963), CMS noted that the follow up communication promotes transparency and empowers beneficiaries to make an informed decision in choosing a primary care physician and how they share their health data

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J3380: Vedolizumab (Entyvio) for Crohn's, Ulcerative Colitis