Specific criteria for Category I codes

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.