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Therefore, we are continuing our currently approved per response time estimates for submitting the MVP quality performance category data due to this proposal

Reducing the Rebate Amount for Part B Rebatable Biosimilar Biological Products When There Is a Severe Supply Chain Disruption In 427.402 of this proposed rule, CMS proposes to codify the policy established in section 50.12 of the revised Medicare Part B Drug Inflation Rebate Guidance for rebate reductions when CMS determines there is a severe supply chain disruption during a calendar quarter

Alternatively, chewing tobacco packaging that has already been opened may last less than a year

We propose to use the update based on the most recent historical data available at the time of publication of the final rule

CMS continues to be interested in comments on this topic and welcomes additional comments on this approach and alternative approachesspecifically, how CMS should address the situations in which the manufacturer of a Part D rebatable drug does not have an MDRP agreement in effect for any part of the applicable period or when a Part D rebatable drug may be excluded from the definition of a COD and manufacturers may not be required to report pricing and drug product information under section 1927(b)(3) of the Act