CMS Announces New FDA-Approved Waived Tests

In a change request (CR 14025) released on May 9, the Centers for Medicare & Medicaid Services (CMS) announced six new waived tests, approved by the U.S. Food and Drug Administration under the Clinical Laboratory Improvement Amendments (CLIA).

Under CLIA, waived tests are determined “to be so simple that there is little risk of error” and are exempt from certain measures of oversight.

The newly approved waived tests include:

• G0567QW (effective June 27, 2024): infectious agent detection by nucleic acid (DNA or RNA); hepatitis C, screening, amplified probe technique
• 87563QW (effective Jan. 16, 2025): infectious agent detection by nucleic acid (DNA or RNA); Mycoplasma genitalium, amplified probe technique
• 87491QW (effective Jan. 16, 2025): infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, amplified probe technique
• 87591QW (effective Jan. 16, 2025): infectious agent detection by nucleic acid (DNA or RNA); Neisseria gonorrhoeae, amplified probe technique
• 0563UQW (effective July 1, 2025): infectious disease (bacterial and/or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 11 viral targets and four bacterial targets, qualitative RT-PCR, upper respiratory specimen, each pathogen reported as positive or negative
• 0564UQW (effective July 1, 2025): infectious disease (bacterial and/or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 10 viral targets and four bacterial targets, qualitative RT-PCR, upper respiratory specimen, each pathogen reported as positive or negative

The implementation date for the change request is July 7.

Sources:

https://www.cms.gov/files/document/mm14025-new-waived-tests.pdf

https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/cliaback.pdf