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When to Use Modifier QW

When to Use Modifier QW

Know the rules for CLIA waived tests to ensure proper claims payment.

Modifier QW indicates a Clinical Laboratory Improvement Amendment (CLIA) waived test performed by a lab with a CLIA certificate. Appending modifier QW to a code indicates that the test was performed at a waived complexity level. Let’s make sure you understand what a CLIA waived test is so that you can use modifier QW appropriately to get claims paid.

What Is CLIA?

CLIA regulations include federal standards that are applicable to any U.S. facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for:

  • Diagnosis or treatment of disease or impairment
  • Health assessments

The objective of CLIA is to ensure the accuracy, reliability, and timeliness of test results regardless of where the test is performed.

CLIA Certifications

Every lab should have at least one of the five types of CLIA certifications to perform a lab test. These certifications include:

  • Certificate of Waiver – For performing simple laboratory examinations and procedures that have an insignificant risk of an erroneous result
  • Certificate of Provider Performed Microscopy Procedures (PPMP) – In addition to the waived tests, can perform an additional 12 microscopic tests
  • Certificate of Registration – Temporarily issued to a non-waivered lab until registration is completed
  • Certificate of Compliance – Can perform moderately and/or highly complex tests. This certificate is issued to a laboratory after an inspection that finds the laboratory to be in compliance with all applicable CLIA requirements. Compliance facilities are inspected by their CMS CLIA state agency.
  • Certificate of Accreditation – Can perform moderately and/or highly complex tests. This certificate is issued to a laboratory after an inspection by the laboratory’s accreditation organization to determine compliance with all applicable CLIA requirements. Accredited facilities are inspected by their accrediting agency. The accrediting agency must be approved by CMS.

The CLIA certificate number must appear on claims in Loop 2300 or 2400 REF/X4, 02 for electronic claims or Item 23 of the CMS-1500 for paper claims.

When to Code Modifier QW

If a lab has a certificate of waiver or certificate of PPMP, then modifier QW is mandatory for procedures included on the Centers for Medicare & Medicaid Services’ (CMS’) waived list, with a few exceptions. The following CPT® codes do not require modifier QW to be recognized as CLIA waived:

81002    Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; non-automated, without microscopy

81025    Urine pregnancy test, by visual color comparison methods

82270    Blood, occult, by peroxidase activity (eg, guaiac), qualitative; feces, consecutive collected specimens with single determination, for colorectal neoplasm screening (ie, patient was provided 3 cards or single triple card for consecutive collection)

82272    Blood, occult, by peroxidase activity (eg, guaiac), qualitative, feces, 1-3 simultaneous determinations, performed for other than colorectal neoplasm screening

82962    Glucose, blood by glucose monitoring device(s) cleared by the FDA specifically for home use

83026    Hemoglobin; by copper sulfate method, non-automated

84830    Ovulation tests, by visual color comparison methods for human luteinizing hormone

85013    Blood count; spun microhematocrit

85651    Sedimentation rate, erythrocyte; non-automated

PPMP Microscopic Procedures

In addition to waived tests, labs with a PPMP certification can perform an additional 12 microscopic tests. The 12 CPT® codes used to bill these tests do not require the addition of modifier QW.

Q0111   Wet mounts, including preparations of vaginal, cervical or skin specimens

Q0112   All potassium hydroxide (KOH) preparations

Q0113   Pinworm examinations

Q0114   Fern test

Q0115   Post-coital direct, qualitative examinations of vaginal or cervical mucous

81015    Urinalysis; microscopic only

81000    Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; non-automated, with microscopy

81001    Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; automated, with microscopy

81020    Urinalysis; 2 or 3 glass test

89055    Leukocyte assessment, fecal, qualitative or semiquantitative

G0027   Semen analysis; presence and/or motility of sperm excluding huhner

89190    Nasal smear for eosinophils

Test Your Knowledge

With the proper certifications, CLIA labs can perform tests at both waived and complex levels. Usually, the tests do not need modifier QW unless the documentation mentions the service was provided at a waived level. Only CPT® codes that need modifier QW to be recognized as waived need to be appended.

Here are some real-world examples for better understanding:

1. A patient came to a CLIA waived lab for a urinalysis test (Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; automated, without microscopy). Is it appropriate to use modifier QW for this test?

Answer: Yes. The CPT® code for this test is 81003 and the patient is in a CLIA waived lab. Per CMS, modifier QW is required to indicate the test was performed at a waived level.

2. A patient came to a CLIA compliance lab for a urinalysis test (Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; automated, without microscopy). Is it appropriate to use modifier QW for this test?

Answer: No. CLIA compliance does not require modifier QW unless the provider documented the service was performed at a waived level.

3. A patient came to a CLIA PPMP lab for a urinalysis test (Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; automated, without microscopy). Is it appropriate to use modifier QW for this test?

Answer: Yes. The CPT® code for this test is 81003 and CLIA PPMP labs perform waived tests only. Per CMS, modifier QW is required to indicate the test was performed at a waived level.

4. Does 87635 require modifier QW when performed in a CLIA waived lab?

Answer: Yes. CPT® 87635 was added to the code set in 2020 and must have modifier QW appended to be recognized as a test that can be performed in a facility with a CLIA certificate of waiver.

5. Is it appropriate to add modifier QW to 81001 when performed in a CLIA PPMP lab?

Answer: No. 81001 is one of the 12 microscopic procedures a PPMP lab is allowed to perform, making modifier QW unnecessary.

6. Is it appropriate to add modifier QW to 81000 or 81001 when performed in a CLIA waived lab?

Answer: No. 81000 and 81001 are not acceptable procedures to be performed in a CLIA waived lab (with or without QW); you cannot use these CPT® codes in a CLIA waived lab. If you receive a medical record coded with 81000 or 81001 under CLIA waived, query the physician for clarification. Note: In a CLIA PPMP lab, you can code 81001 but not 81000.

Remember: QW is a fee-affecting modifier and should be added as the first-listed modifier to a code. CMS updates its waived list every year, so make sure to check it annually to ensure billing accuracy.


Resources:

CDC: Tests Granted Waived Status Under CLIA

CMS: MLN Matters MM13253

U.S. FDA CLIA search database

CDC CLIA Law & Regulations

Archana Murali
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Archana Murali, CPC, has 14 years of experience in the healthcare industry, including coding for ambulatory and hospitals on the front end and in denial management and as a healthcare business analyst. Murali works at Athenahealth Technology Pvt Ltd as a team training manager, identifying training needs and designing and implementing training programs.

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