Clinical Coverage Policy (CCP) 1A-39 Routine Costs in Clinical Trial Services for Life Threatening Conditions

<p>To align with children&rsquo;s health quality measure reporting, NC Medicaid has added diagnosis code Z71.82 (Exercise Counseling) to NCTracks as an acceptable secondary diagnosis effective Oct. 1, 2017.</p>

Author: GDIT, (800) 688-6696

Clinical Policy, Routine Costs in Clinical Trial Services for Life Threatening Conditions, 1A-39 has been revised. The revisions, which will become effective July 1, 2019, provide clearer explanations and definitions regarding coverage for routine costs in clinical trial services for life-threatening conditions. Descriptions will be added for the following:

  • Clinical trial phases 0-IV
  • Investigational Device Exemption (IDE)
  • Humanitarian Use Device (HUD)
  • Humanitarian Device Exemption (HDE)
  • Investigational New Drug (IND)

Definitions will be revised or added for the following:

  • Qualifying clinical trial
  • Routine costs
  • Life-threatening condition
  • Informed consent
  • ClinicalTrials.gov Identifier (NCT number)
  • Institutional Review Boards (IRB)

Prior approval requirements will be clarified for clinical trials in which the underlying service, product or procedure requires prior approval.

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