1.9.2023 Board Book

(You will be able to include additional citations once you have completed the file upload and publication details matrix) Category III Literature Criteria For Category III codes, please reference studies or research performed by national organizations if available. The following is used as formalized criteria by the CPT Advisory Committee and the CPT Editorial Panel for evaluating Category III code applications and includes identification of the following elements as guidelines for establishment of a Category III code: • The procedure or service is currently or recently performed in humans; AND At least one of the following additional criteria has been met: • The application is supported by at least one CPT or HCPAC advisor representing practitioners who would use this procedure or service; OR • The actual or potential clinical efficacy of the specific procedure or service is supported by peer reviewed literature which is available in English for examination by the Editorial Panel; OR • There is a) at least one Institutional Review Board approved protocol of a study of the procedure or service being performed, b) a description of a current and ongoing United States trial outlining the efficacy of the procedure or service, or c) other evidence of evolving clinical utilization. Vaccine Code Literature Criteria Applications requesting establishment of CPT codes for vaccine products will not be considered until evidence substantiating completion of Phase III Clinical Trials and review of unblinded data is submitted to AMA. However, coding applications may be considered prior to submission of the Biologic License Application (BLA) to the FDA. The CPT Editorial Panel, in recognition of the public health interest in vaccine products, may publish new or revised vaccine product codes prior to approval by the US Food and Drug Administration (FDA). These new or revised vaccine product codes will be released in accordance with the semi-annual schedule with the FDA approval pending symbol ( ⚡ ). Applications for establishment of new or revised vaccine product CPT code(s) prior to approval by the FDA require submission of the following: • Evidence that Phase III Clinical Trials have been completed and submitted to the FDA (eg, letters submitted or received from FDA documenting completion of Phase III study); • Summary/synopsis of the final results of Phase III studies and unblinded data to

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Code Change Application-last updated Dec 29,2022 CPT is a registered trademark of the American Medical Association Copyright 2013-2021 American Medical Association. All rights reserved.