3 Feb 2016


Modifier "QW" - CLIA waived test


Use QW modifier to the Lab/Pathology services that are on the CLIA waived test list provided by the CMS. QW modifier is only for 8xxxx series codes found in CPT book.  

CLIA - Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. (CMS)


CLIA requires a facility to be appropriately certified for each test it performs. To make sure that Medicare / Medicaid only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver, laboratory claims are currently edited at the CLIA certificate level.


CMS identifies CLIA waived tests by providing an updated list of waived tests to the Medicare contractors on a quarterly basis via a Recurring Update Notification.


To be recognized as a waived test, some CLIA waived tests have unique HCPCS procedure codes and some must have a QW modifier included with the HCPCS code. 


In total, CLIA covers approximately 251,000 laboratory entities as per CMS.


Waived Test - As defined by CLIA waived tests are categorized as simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.”The Food and Drug Administration (FDA) determines the criteria for tests being simple with a low risk of error and approves manufacturer’s applications for test system waiver- (CMS)


The CLIA requires all laboratory testing sites to have one of the following certificates to legally perform clinical laboratory testing,

            ·        Certificate of Waiver

            ·        Certificate of Registration

            ·        Certificate of Accreditation

            ·        Certificate for Physician-Performed Microscopy


The below given two types of CLIA certificates that limit holders to perform only certain test procedures:

            ·        Certificate of Waiver

            ·        Certificate of Physician Performed Microscopy Procedures (PPMP)


Note: Laboratories can only perform tests that are CLIA waived with a certificate of waiver. They cannot perform other than waived tests even though they have a certificate of waiver.


If any lab service is denied as non covered under your CLIA certificate, then you should not bill the beneficiary for that particular service.


If the provider has 2 offices then the provider required 2 CLIA certificate for each office to avoid rejections. 


The provider should use the CLIA numbers that specifically represents the site where the test was performed.


While submitting the claim we must consider all the below points to get the payment,

     *  All clinical diagnostic laboratories must include their CLIA numbers on all claims to avoid rejection. 


    *  The CLIA number must be placed in Item 23 of the CMS-1500 claim form. Electronic submitters using the ANSI X12 4010 version should use segment 2-180-REF02 (X4).


    *  CLIA Waived Test still requires the provider to include their CLIA number on the claim.


    *  To be recognized as a waived test, some CLIA waived tests have unique HCPCS procedure codes (*No need of QW modifier when filing the claim) and some must have a QW modifier included with the HCPCS code (* With these CPT's Submit the claim with QW modifier).