4 Important Things You Need to Know About CLIA

Posted on 27 May, 2019 |comments_icon 0|By Bruce Pegg

If your practice conducts, or is considering conducting, simple in-house laboratory tests for such common medical conditions as pregnancy, diabetes, or drug dependency, then more than likely you have heard of CLIA.

But if you don’t know what a CLIA-waived test is, or if your knowledge of the program only extends to knowing that you should append HCPCS modifier QW (CLIA waived test) to a CPT® lab code, then you’re only getting part of the story.

If you want to know the rest, all you need to do is read the answers to the following four questions.

What Is a CLIA Waiver?

The Clinical Laboratory Improvement Amendments (CLIA) project is a Centers for Medicare and Medicaid Services (CMS)-administered program that issues waivers for any laboratory that performs “testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of, human beings.” In other words, if your practice performs basic laboratory tests, you need “a CLIA certificate regardless of how many tests you perform and even if you do not charge the patient or bill Medicare or other insurances.”

With a CLIA Certificate of Waiver, your practice can administer in-house any test that “the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have determined to be so simple that there is little risk of error,” according to CMS. This includes numerous basic laboratory tests, including lipid profiles, drug tests, pregnancy tests, and urine tests for many common conditions.

How Do I Obtain a CLIA Waiver?

Simply complete a CMS-116 application form and return it to the State Agency for the state in which your laboratory is located. Once the application is accepted, and after you have paid the appropriate fee, CMS will grant your laboratory the waiver.

Note: You’ll find more information about the application process on the CMS website.

How Do I Document a CLIA-Waived Test?

Reporting a CLIA-waived test is a simple, four-step process.

  1. Report the appropriate CPT®test code.
  2. Append the procedure code with modifier QW when needed. (The list of waived tests below indicates which tests require the modifier.)
  3. Link the CPT®code to an ICD-10 diagnosis code. In the case of pregnancy testing, for example, this would mean using Z32.00 (Encounter for pregnancy test, result unknown), Z32.01 (Encounter for pregnancy test, result positive), or Z32.02 (Encounter for pregnancy test, result negative).
  4. Record your CLIA number on the claim form.

What Tests Are on the CLIA List?

The list of waived tests that currently appears on the Categorization of Tests page on the CLIA site includes all quarterly additions up to Transmittal 4169, which was published on November 15, 2018 and became effective on January 1, 2019. (CMS lists tests that don’t require the QW modifier at the beginning of the list.)

Since then, CMS has made two more additions to the list, which appear in Transmittal 4195 (published January 11, 2019 and effective April 1, 2019) and Transmittal 4277 (published April 12, 2019 and effective July 1, 2019).

While CMS has not added any new CPT® tests so far this year, there have been significant additions to the list for tests produced by individual manufacturers. So, for example, Transmittals 4195 and 4277 include the following tests that meet the criteria for CPT®  80305 (Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; capable of being read by direct optical observation only (eg, utilizing immunoassay [eg, dipsticks, cups, cards, or cartridges]), includes sample validation when performed, per date of service):

  • Precision DX Panel Dip M300, Precision DX Panel Dip M2000, Precision DX Quick Cup M300, Precision DX Quick Cup M2000, manufactured by American Screening Corporation (addition effective May 25, 2018);
  • Confirm Biosciences Equate Multi Drug of Abuse Test Cup, manufactured by Walmart Stores (addition effective September 14, 2018);
  • Accutest VALUPAK Drug Screen Cup, manufactured by Jant Pharmacal Corp. (addition effective October 4, 2018);
  • McKesson Drugs of Abuse PPX Test Cup, manufactured by McKesson Medical-Surgical (addition effective October 2, 2018);
  • McKesson Multi Panel Drugs of Abuse Test Cup, manufactured by McKesson Medical-Surgical (addition effective October 9, 2018);
  • Precision Plus Quick Cup Tests and Precision DX Quick Cup Tests, manufactured by American Screening Corporation (addition effective November 2, 2018);
  • CAREONE Drug Screen Tests Home Test Kit (OTC Use), manufactured by Foodhold USA (addition effective November 29, 2018);
  • Easy@Home Single Drug Screen Test (THC), manufactured by Easy Healthcare Corporation (addition effective January 3, 2019); and
  • Q-Cup Multi-Drug Urine Test Cup, manufactured by Wondfo USA (addition effective February 13, 2019).

Tip: You can stay ahead of the game each quarter and find the transmittal containing the most recent CLIA-waived tests by going to the CMS Transmittals page and typing “New Waived Tests” into the search box for the year in question.

Learn More

Find the help you need to secure optimum reimbursement with your monthly subscription to Pathology/Lab Coding Alert. Every issue of this indispensable resource delivers high-impact tips and guidance — and answers to reader questions like these — as our experts tackle the revenue-risking challenges that threaten your claims and compliance success.

The Coders’ Specialty Guide 2019: Pathology/ Laboratory includes all CPT® and HCPCS codes relevant to pathology, simple descriptions that explain each code, expert advice for assigning codes, Medicare reimbursement details, diagnosis codes crosswalk, applicable modifiers, CCI edits, global days, code index, hundreds of anatomical illustrations, and more.


Bruce Pegg
Editor, Newsletters

An experienced teacher and published author, Bruce is TCI’s new voice of primary care, delivering advice and insights every month for coders in the fields of family, internal, and pediatric medicine through Primary Care Coding Alert and Pediatric Coding Alert. Additionally, he is the current editor of E/M Coding Alert. Bruce has a Bachelor of Arts degree from Loughborough University in England and a Master of Arts degree from The College at Brockport, State University of New York. He recently became a Certified Professional Coder (CPC®), credentialed through AAPC.

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