Changes/additions to CPT® Category I and Category III codes must meet both general criteria and specific criteria for each code.
- The proposed descriptor is unique, well-defined and describes a procedure or service which is clearly identified and distinguished from existing procedures and services already in CPT.
- The descriptor structure, guidelines and instructions are consistent with current editorial panel standards for maintenance of the code set.
- The proposed descriptor for the procedure or service is neither a fragmentation of an existing procedure or service nor currently reportable as a complete service by 1 or more existing codes (with the exclusion of unlisted codes). However, procedures and services frequently performed together may require new or revised codes.
- The structure and content of the proposed code descriptor accurately reflects the procedure or service as typically performed. If always or frequently performed with 1 or more other procedures or services, the descriptor structure and content will reflect the typical combination or complete procedure or service.
- The descriptor for the procedure or service is not proposed as a means to report extraordinary circumstances related to the performance of a procedure or service already described in the CPT code set.
- The procedure or service satisfies the category-specific criteria set forth below.
A proposal for a new or revised Category I code must satisfy all of the following criteria:
- All devices and drugs necessary for performance of the procedure or service have received FDA clearance or approval when such is required for performance of the procedure or service.
- The procedure or service is performed by many physicians or other qualified health care professionals across the United States.
- The procedure or service is performed with frequency consistent with the intended clinical use (i.e., a service for a common condition should have high volume).
- The procedure or service is consistent with current medical practice.
- The clinical efficacy of the procedure or service is documented in literature that meets the requirements set forth in the CPT code-change application.
The following criteria are used by the CPT/HCPAC Advisory Committee and the CPT Editorial Panel for evaluating Category III code applications:
- 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 1 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 CPT Editorial Panel (or)
- There is:
- At least 1 Institutional Review Board approved protocol of a study of the procedure or service being performed
- A description of a current and ongoing United States trial outlining the efficacy of the procedure or service or
- Other evidence of evolving clinical utilization
CPT® is a registered trademark of the American Medical Association.