CLIA (Clinical Laboratory Improvement Amendments)

• The Clinical Laboratory Improvement Amendments (CLIA) was passed by Congress in 1988 to establish quality standards for all laboratory testing. These standards are applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. CLIA ensures the accuracy, reliability, and timeliness of patient test results, wherever a test is performed. CLIA is user-fee funded. Therefore, all costs of administering the program are covered by the regulated facilities. 

• CLIA applies to all providers rendering clinical laboratory and certain other diagnostic services, whether or not claims are filed to Medicare.

• CLIA number is necessary to bill along with the Lab code (8 series code). If it is missing then the claim will deny for missing the CLIA number.

• CLIA certification number is billed on box 23 of the CMS-1500 Claim Form.

• CLIA numbers are 10 characters in length and contain both letters & numbers. 3rd character is always the letter "D".

• CLIA number needs to be billed with the valid qualifier "X4". It must be at the start of the 10-character CLIA number.

• CLIA number can be found on below 2 websites. On the CDC portal, you can search for CLIA by CLIA number or Laboratory Name (Facility or Group Name) and on the CMS portal, CLIA number can be searched using CLIA number, Facility Name, or Facility Address. 

• CDC Portal: https://www.cdc.gov/clia/LabSearch.html

• CMS Portal: https://qcor.cms.gov/advanced_find_provider.jsp?which=4&backReport=active_CLIA.jsp

• There are 2 types of CLIA tests:

       1) CLIA Waived Test

       2) CLIA Non-Waived Test

• CLIA Waived Test - These are simple tests with a low risk of an incorrect result. They include:

• Certain tests listed in the CLIA regulations

• Tests cleared by the FDA for home use

• Tests that the manufacturer applies to the FDA for waived status by providing scientific data that verifies that the CLIA waiver criteria have been met

• Sites that perform only waived testing must have a CLIA certificate and follow the manufacturer’s instructions

• CLIA Non-Waived Test - This term is used to refer collectively to moderate and high complexity testing. Laboratories or sites that perform these tests need to have a CLIA certificate, be inspected, and must meet the CLIA quality standards.

• CLIA Waived test CPTs must be billed with the QW modifier along with the CLIA number.

• On below CMS portal link, you can find out the list of CPTs that need to be billed with the QW modifier. In the list, if the QW modifier is not attached to the CPTs, it means the QW modifier is not required for that particular CPT.

• https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/waivetbl.pdf