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Opioids ER Prior Authorization (with Quantity Limit) Criteria - Medicare Part D

Medicare Policy
Version Date: 01/01/2025

The following products are included in this PA program (formulary specific):

MAPD Stars formularies: Belbuca, buprenorphine TD patch, fentanyl TD patch 12, 25, 37.5, 50, 62.5, 75, 87.5, 100 mcg/hr, morphine sulfate ER tablet, Oxycontin ER, tramadol ER

Enhanced: fentanyl TD patch 12, 25, 50, 75,100 mcg/hr, morphine sulfate ER tablet, tramadol ER

Basic formulary: fentanyl TD patch 12, 25, 50, 75,100 mcg/hr, morphine sulfate ER tablet, tramadol ER

PA applies to new starts only

Prior Authorization and Quantity Limit Criteria for Approval

Formulary ER Opioids will be approved when BOTH of the following are met:

  1. ONE of the following:
    1. The patient has a diagnosis of chronic cancer-related pain
      OR
    2. The patient has a diagnosis of pain due to sickle cell disease
      OR
    3. The patient is undergoing treatment of chronic non-cancer pain AND ONE of the following:
      1. There is evidence of a claim that the patient has been treated with the requested medication within the past 90 days
        OR
      2. The prescriber states the patient has been treated with the requested medication within the past 90 days
        OR
      3. ALL of the following:
        1. The prescriber has completed a formal, consultative evaluation including BOTH of the following:
          1. Diagnosis
            AND
          2. A medical history which includes previous and current pharmacological and non-pharmacological therapy for the requested diagnosis
            AND
        2. The requested medication is NOT prescribed as an as-needed (prn) analgesic
          AND
        3. The prescriber has confirmed that a patient-specific pain management plan is on file for the patient
          AND
        4. ONE of the following:
          1. The patient’s medication history includes use of an immediate-acting opioid
            OR
          2. The patient has an intolerance or hypersensitivity to an immediate-acting opioid
            OR
          3. The patient has an FDA labeled contraindication to an immediate-acting opioid
            AND
        5. The prescriber has reviewed the patient’s records in the state’s prescription drug monitoring program (PDMP) AND has determined that the opioid dosages and combinations of opioids and other controlled substances within the patient’s records do NOT indicate the patient is at high risk for overdose
          AND
        6. The patient does NOT have any FDA labeled contraindications to 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