CLIA-Waived Tests, Effective April 2018

CLIA-Waived Tests, Effective April 2018

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) requires that only certified labs may bill for laboratory services, unless the test in question has been granted a waiver. The Centers for Medicare & Medicaid Services (CMS) has announced several new laboratory services, recently approved by the Food and Drug Administration (FDA), which qualify for a CLIA waiver:

83516 Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method
87809 Infectious agent antigen detection by immunoassay with direct optical observation; adenovirus
82274 Blood, occult, by fecal hemoglobin determination by immunoassay, qualitative, feces, 1-3 simultaneous determinations
G0328 Colorectal cancer screening; fecal occult blood test, immunoassay, 1-3 simultaneous
85025 Blood count; complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet count) and automated differential WBC count

Additionally, note that 87634 Infectious agent detection by nucleic acid (DNA or RNA); respiratory syncytial virus, amplified probe technique, introduced in CPT® 2018, now describes testing previously assigned using 87801.
When reporting any of the above codes, you must append modifier QW when billing services to Medicare, to indicate a CLIA waived test.

John Verhovshek
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About Has 569 Posts

John Verhovshek, MA, CPC, is a contributing editor at AAPC. He has been covering medical coding and billing, healthcare policy, and the business of medicine since 1999. He is an alumnus of York College of Pennsylvania and Clemson University.

2 Responses to “CLIA-Waived Tests, Effective April 2018”

  1. Sylvia Ficklin says:

    I have been billing cpt 99213 and 81003 QW together to Medicare. Medicare used to pay for them both but now they only pay for the 99213 and they are saying that the 81003 QW the provider was not certified or eligible to be paid for procedure or services on this date. What am I doing wrong. Medicare used to pay for both code together. What can I do to get this paid. Thanks.

  2. Michelle - NM says:

    You should make sure your test was CLIA waived on the billing date. If it fell off of the list, you will want to remove the QW modifier, as it is no longer a waived test.