CLIA categorization of lab tests

Since November 13, 2003, the Food and Drug Administration (FDA) has had the authority to implement the Clinical Laboratory Improvement Amendments (CLIA) test complexity categorization provisions, which includes, but is not limited to the following:

(a)   Interpreting the CLIA provisions related to complexity categorization;

(b)   Holding public workshops and meetings on CLIA complexity categorization; and,

(c)   Developing and issuing implementing rules and guidance for CLIA complexity categorization.

Refer to the link below to access the FDA CLIA database containing the commercially marketed in vitro test systems categorized by the FDA since January 31, 2000 and the tests categorized by the Centers for Disease Control and Prevention prior to that date.

The following information appears in the download: 

1. A current list of waived tests, including the HCPCS/CPT code;
2. A list of tests categorized as provider-performed microscopy procedures (PPMP), including the HCPCS/CPT code;
3. A list of tests (CPT-4 and HCPCS codes) subject to CLIA Edits that includes non-waived and non-PPMP tests;
4. A list of laboratory certification (LC) codes [CLIA specialty and subspecialty information] that is for information purposes only; and
5. A list of tests (CPT-4 codes) excluded from CLIA edits within the 80000 series.

https://www.cms.gov/CLIA/10_Categorization_of_Tests.asp

About the Author

Reed Tinsley CPA

This article is written by Reed Tinsley, a Houston, TX-based CPA with over 30 years of experience advising physicians and medical practices across Texas and the United States. Reed holds certifications as a Certified Valuation Analyst (CVA), Certified Healthcare Business Consultant (CHBC), and Certified Financial Planner (CFP), specializing exclusively in the healthcare sector. He is a published author, nationally recognized speaker, and trusted advisor to physicians on accounting & tax, practice management, and financial planning. Schedule a Free Consultation.