Pathology/Lab Coding Alert

Question: We are a physician office lab and are performing some COVID-19 rapid lab tests, reporting U0002 or 87635, but we’re getting denials. What could be the problem?

Texas Subscriber

Answer: As a physician office lab, you’re probably operating with a certificate of waiver under the Clinical Laboratory Improvement Amendments (CLIA). If that’s the case, your problem might be that you need a modifier.

Effective March 20, CMS issued the following statement related to codes U0002 (2019-ncov coronavirus, sars-cov- 2/2019-ncov (covid-19), any technique, multiple types or subtypes (includes all targets), non-cdc) and 87635 (Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique):

“Those tests listed on the FDA’s Emergency Use Authorizations for COVID-19 website under the Test Kit Manufacturers and Commercial Laboratories Table that include the terms ‘patient care settings outside of the clinical laboratory environment,’ ‘near patient testing,’ or ‘point of care’ in the EUA can be used by facilities having a current CLIA certificate of waiver. On March 20, 2020, FDA issued the first EUA containing the previous terms. HCPCS code U0002 and 87635 must have the modifier QW [CLIA waived test] to be recognized as a test that can be performed in a facility having a CLIA certificate of waiver.”