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).