Utilization Management by Managed Care Plans Aligned with Food and Drug Administration Labeling

This bulletin applies to NC Medicaid Managed Care.

Overview 

NC Medicaid Managed Care plans are authorized to apply utilization management (UM) strategies such as prior authorization based on Food and Drug Administration (FDA)-approved indications and usage when the State has not established specific clinical criteria and state policy does not prohibit clinical criteria for a drug or class of drugs. This policy applies to drugs in both the outpatient pharmacy and outpatient hospital settings. 

Outpatient Pharmacy

NC Medicaid Managed Care Plans may implement UM aligned with the FDA label in the following scenarios in outpatient pharmacy: 

• Preferred Drug List
  • Beginning Jan. 1, 2026, to support current policy, each drug category on the NC Medicaid Preferred Drug List (PDL) will include a notation in red text when additional UM or prior authorization may not be applied by NC Medicaid Managed Care plans.
    • The red text will indicate the following: Plans may not apply additional utilization management or prior authorization criteria to this category.
  • If no such red text appears, plans may apply UM consistent with FDA labeling.
• Non-PDL Drugs
  • Per Clinical Coverage Policy 9, drugs not listed on the PDL may be subject to UM based on FDA labeling only if there are no posted clinical criteria in NCTracks and state policy does not prohibit clinical criteria for a drug or class of drugs.
  • If clinical criteria are posted in NCTracks, plans must not apply additional UM beyond what is specified.
  • NCTracks Pharmacy Clinical Criteria is located here: https://www.nctracks.nc.gov/content/public/providers/pharmacy/pa-drugs-criteria-new-format.html 

Accessing Clinical Criteria

Providers should consult NCTracks for NC Medicaid Direct or the respective NC Medicaid Managed Care plan’s website for posted clinical criteria. For NC Medicaid Managed Care plans, refer to Health Plan Contacts and Resources. For Healthy Blue Care Together, visit https://provider.healthybluenc.com/north-carolina-provider/pharmacy. 

Outpatient Hospital 

Drugs administered in outpatient hospital settings may also be subject to UM based on the FDA label, when the state does not have posted clinical criteria in NCTracks and state policy does not prohibit clinical criteria for a drug or class of drugs. 

Accessing Clinical Criteria 

Providers should consult NCTracks for NC Medicaid Direct or the respective NC Medicaid Managed Care plan’s website for posted clinical criteria.   

Physician Administered Drug Program 

Per Clinical Coverage Policy 1B, Managed Care plans are not permitted to apply UM to the Physician Administration Drug Program (PADP).