Research, page-1491

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 of 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.

Source: ama-assn.org