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Quantity Limit Exception Criteria Medicare Part D

Medicare Drug Policy
Version Date: 01/01/2025

Quantity Limit Exception Criteria for Approval

The requested medication will be approved when BOTH of the following are met: 

  1. The patient has an FDA labeled indication or an indication that is supported in CMS approved compendia for the requested medication AND
  2. ONE of the following: 
    1. The requested quantity (dose) does NOT exceed the program quantity limit OR 
    2. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit AND
      2. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit AND
      3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months