Monday, October 22, 2007

QW modifier - CLIA waived Test

All clinical laboratory improvement amendments (CLIA) of 1988 require all testing sites to have one of the following certificates to perform clinical laboratory testing:

  1. Certificate of Waiver
  2. Certificate of Accreditation
  3. Certificate of Registration
  4. Certificate of Physician-Performed Microscopy

Each CLIA certificate allows the lab to perform certain tests. Two CLIA certificates prevent holders to certain test proedures: Certificate of Waiver (1) and Certificate of Physician-Performed Microscopy (4).

If a service that is a performed by the Lab is not covered under your CLIA certificate you can not bill the patient for this service and these codes will be billed with Modifier QW. The claim must also have the correct CLIA number on the claim to be billed.

Current Waived Tests under CLIA

  • 83001QW Genosis Fertell Female Fertility Test
  • 84443QW Jant Pharmacal Accutest TSH {Whole Blood}
  • 86308QW Signify Mono Whole Blood
  • 86308QW Clearview MONO Whole Blood
  • 82465QW Cholestech LDX (Lipid Profile - ALT (GPT)){Whole Blood}
  • 83718QW Cholestech LDX (Lipid Profile - ALT (GPT)){Whole Blood}
  • 84460QW Cholestech LDX (Lipid Profile - ALT (GPT)){Whole Blood}
  • 80061QW Cholestech LDX (Lipid Profile - ALT (GPT)){Whole Blood}
  • 84478QW Cholestech LDX (Lipid Profile - ALT (GPT)){Whole Blood}
  • 86318QW Immunostics Detector H. Pylori WB (H. pyloi Antibody Test) {Whole Blood}
  • 86308QW Immuno Detector Mono {Whole Blood}
  • 80101QW Innovacon Multi-Clin Drug Screen Test Device
  • 80101QW Jant Pharmacal Accutest MultiDrug ER11 Drug Screen Test Device
  • 87880QW Cardinal Health SP Brand Rapid Test Strep A Dipstick(K010582/A028)
  • 86318QW Cardinal Health SP Brand Rapid Test H. pylori {Whole Blood}(K024350/A15
  • 82042QW Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 1) {Whole Blood}
  • 82310QW Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 1) {Whole Blood}
  • 82565QW Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 1) {Whole Blood}
  • 82947QW Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 1) {Whole Blood}
  • 82950QW Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 1) {Whole Blood}
  • 82951QW Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 1) {Whole Blood}
  • 82952QW Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 1) {Whole Blood}
  • 84520QW Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 1) {Whole Blood}
  • 86308QW Cardinal Health SP Brand Rapid Test Mono {Whole Blood}
  • 882247QW Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 2) {Whole Blood}
  • 84075QW Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 2) {Whole Blood}
  • 84157QW Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 2) {Whole Blood}
  • 84450QW Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 2) {Whole Blood}
  • 84460QW Arkay SPOTCHEM EZ Chemistry Analyer (Spotchem II Basicpanel 2) {Whole Blood}
  • 86318QW Fisher Healthcare Sure-Vue H. pylori Test {Whole Blood}
  • 89321QW Fertell Male Fertility Test

Medicare will identify this list of codes as waived tests and they do not require a QW modifier: 81002, 81025, 82270, 82272, G0394, 82962, 83026, 84830, 85013, and 85651

For a complete detailed list please copy this link and add it to the google toolbar:

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  1. Our organization has developed a new diagnostic test that is under review for CLIA waived status. There is already a lab code that can be used for billing. Once our test is CLIA waived, will physicians bee be able to use the CPTcode plus the QW?

  2. Hi Megan,

    I have been out of town a lot consulting so I feel bad for not getting to this question sooner.

    I would recommend using the QW modifier when billing the CPT code after it's waived.

  3. What box on the CMS1500 form do you input the CLIA waiver number?


  4. Hello,

    As you are probably aware Medicare and Medicaid want electronic claims whenever possible.

    If you are receiving MA120 denial: Missing/incomplete/invalid CLIA certification number
    or MA130: Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information.

    You are getting these rejections because the CLIA is not on the claim form which is most likely why you are asking your above question.

    1. Entities that perform clinical laboratory tests (CLIA) must first obtain certification through the State Health Department (please verify this has been done).

    2. The CLIA number has to be submitted on the CMS-1500 claim in box 23 Prior Authorization Number field.
    (For those tranmitting claims electronically on a 837 format it's the equivilant to Loop 2300 or 2400 REF/X4.

    3. Some Clinical Laboratory tests must be submitted using the HCPCS modifier QW and please verify the Procedure codes because not all require the QW modifier only some.

    I would suggest submitting a corrected claim with a note that the CLIA Waiver is attached in box 23.

    Please let me know if you have problems processing your claim for payment!

    Have a wonderful week :).


  5. Please let me know that modifier QW is only added for Medicare or Medicaid or is it added for all insurance.

  6. Hi Neha,

    Let me begin by explaining that the QW modifier is a CLIA (Clinical Laboratory Improvement Amendments) requirement for specific procedure codes and to not include the QW modifier will result in a denial claim.

    On a more generic guideline Medicare makes the guidelines for the medical industry and all insurance carriers will normally follow. Some carriers like Auto and Workers Compensation are usually the last to ever update the way they accept claims (this means they will sometimes accept deleted procedure or Diagnosis codes or accept outdated billing rules because they haven't updated their claim guidelines).

    Health Insurance Carriers like Aetna, United Health Care, Blue Cross Blue Shield, Medicaid, Medi-Cal, Humana, Champus, Tricare etc follow Medicare's guidelines.

    So, what you do for Medicare you will most likely do for these other insurance carriers however; all insurance carriers have the right to make their own coding rules so you need to be ready to bill all carriers one way and single out another insurance carrier and bill it their own special way.

    I hope this helps!


  7. Does anyone know what the acronym "QW" stand for? I know that software developers sometime use to mean "Quick Reference" but I think that CMS have a different meaning for this?


  8. Hi Arnol,

    The Modifier QW actually stands for CLIA waived test.

    Some other Q modifiers:
    QK: Medical direction of two, three or four concurrent anesthesia procedures involving qualified individuals.

    QW: CLIA Waived Test

    QX: CRNA Service: with medical direction by a physician

    QY: Medical direction of one Certified Registered Nurse Anesthetist by an anesthesiologist.

    QZ: CRNA service: without medical direction by a physician.

    I hope this helps answer your billing question.


  9. I was told the only time you use the QW modifier is when the lab is done in the doctors office as opposed to our laboratory. Is this correct?

  10. Hello,

    I hope to supply you with the information required to answer your question:

    Each physical location (even those with no intention of billing Medicare or Medicaid/Medi-Cal) that tests human specimens to diagnose, treat or monitor patients is required to sign up with the CLIA certificate for the level of testing the facility performs.

    Many tests have different ways of performing them like quantitative, qualitative, via an assay, via a culture, or via a test kit that changes color.

    Tests by Test Kit which do not require a Lab Technician's clinical skills can be performed in the doctors office and is billed using the CLIA-waived procedure code.

    In short check the CLIA-waived test list and make sure the test or manufacturers information is on the list and always check your CPT manual to make sure that you have selected the correct Procedure code for the test.

    Based on the way you are performing the test you will indicate the correct procedure code you used and if the procedure code that best describes your services require a QW modifier you will bill as such.

    I hope this answers your question...

  11. Our clinical staff changed to a CLIA waived urine drug screen without telling the billing staff. All of the UDS have been billed without the QW modifier for the past 2 months. Do I need to go back and correct these claims? Is reimbursement affected in anyway if you do/don't use the QW modifier? Or should I just start using the QW modifier on all future UDS claims? Thanks!

  12. Hello,

    Yes, you would be required to identify all claims billed without the QW modifier and resubmit corrected claims.

    The carriers will notify you after processing the corrected claims what steps they will require of you to resolve any outstanding balance issues.

    Future claims should have the QW modifier.

    Have a great day!


  13. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research)

    CLIA program is to ensure quality, accuracy and Timliness laboratory testing.

    CLIA program is to ensure quality, accuracy and Timliness laboratory testing.

    medical coding training

  14. If a laboratory is CLIA licensed for the 8000 CPT code range and they bill a "CLIA waived test" is the modifier QW necessary? My understanding is that the QW is for CLIA waived labs only??

    Truly confused! Any info would be greatly appreciated.

  15. Thanks so much for this post!!! It contains the exact info I was looking for. You rock! :)

  16. I got a denial from medicare stating that CPT 85610-QW requires clia certification...can anyone please let me know about it. our facility is CLIA certified. is it require CLIA certification...really?

  17. Hello Anonymous (April 26),

    When you are submitting medical insurance claims by Paper you will need to indicate in HCFA (CMS-1500) box 23 the CLIA number of the billing laboratory that is performing the testing. (These steps should be taken when the Billing Laboratory performs all laboratory testing)

    Paper option if Billing Laboratory performs some laboratory testing; some testing is referred to another laboratory:
    If a billing laboratory performs some testing and refers the remaining tests to another (referral) laboratory to perform, the facility must split the claim and submit two separate claims. Paper claims will be returned as unprocessable if billing providers combine clinical lab services performed themselves and any referred to another lab on the same CMS 1500 form. On each claim, the CLIA number of the laboratory that is actually performing the testing must be reported in Item 23 on the CMS-1500 form. Referral laboratory claims are permitted only for independently billing clinical laboratories, specialty code 69.

    Ansi or eClaims options below:

    If Billing Laboratory performs all Laboratory testing:
    If you are submitting your medical claims electronically through the ANSI 837 4010A1 format than your CLIA number will need to populate in Loop 2300, in the REF02 and REF01=X4 segments.

    If Billing Laboratory performs some laboratory testing; some testing is referred to another laboratory then you will need to submit the CLIA number in Loop 2400, in the REF02 and REF01=F4 Segments.

    I hope this helps you out -


  18. This is really helpful information. thanks Jennifer

  19. CPT 82692 is a clia waived CPT code? Please confirm.

  20. To further comment on the questions regarding the usage of the QW modifier on tests, there are some test that can be either waived or not depending on the way the test is performed. If the test for 80061 (for example) is performed/resulted using a "CLIA-waived test kit" a QW should be used when submitting to Medicare. If it is not then no modifier should be used. The reimbursement is not different for using the CLIA-waived test kits.

    If you are performing or resulting the test in the clinical setting, you are more then likely using the CLIA-waive test kists.

  21. In the state of Maryland, may a POL direct bill private pay and insurance companies for laboratory tests performed by outside lab?

  22. If a hospital is billing for a routine pap/thin prep that is being performed by a independent laboratory and a interpretation is performed by the pathologist with the independent laboratory, is the independent laboratory allowed to bill Medicare for the abnormal interpretation since the hospital is not? The hospital is billing the pap/thin prep only and has a client bill arrangement with the independent laboratory but no one is billing the interpretation that is on the physician fee schedule.

  23. Hi All,
    I need to know the billing procedure for CLIA waived tests...... What i understand is :

    1. If a test is CLIA Waived, send a 'QW' modifier in CMS-1500 claim form under field #24D.
    2. Send 10 Digits CLIA # in CMS-1500 claim form under field #23

    Is that Correct?