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January 25, 2018

Four Tests Added to List of CLIA Waived Tests

In early January, the Centers for Medicare and Medicaid Services (CMS) announced new waived tests... Learn More

New and Revised Vaccine Codes Added to 2018 CPT Code Book

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OIG Recommends Measures for Curbing Opioid Misuse and Fraud

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Medical Coding News


Four Tests Added to List of CLIA Waived Tests

January 25, 2018

In early January, the Centers for Medicare and Medicaid Services (CMS) announced new waived tests approved by the Food and Drug Administration under the Clinical Laboratory Improvement Amendments (CLIA). All of the latest waived tests must be reported with codes that include modifier QW so that the Medicaid and Medicare programs can recognize them as waived.

Labs that perform only waived tests can apply for a certificate of waiver and not be subject to the inspections that labs performing nonwaived tests undergo.

Additions to List of CLIA Waived Tests, Effective April 1, 2018

  • InflammaDry (Quidel Corporation): Multiple-step-method immunoassay for analyte (83516)
  • AdenoPlus Test tear fluid (Quidel Corporation): Immunoassay adenovirus detection (87809)
  • Insure One one-day test (Enterix Inc.): Fecal occult blood detection by immunoassay (82274 and G0328)
  • XW-100 (Sysmex): Complete automated blood count (85025)

Note also that new code 87634 (Infectious agent detection by nucleic acid [DNA or RNA]; respiratory syncytial virus, amplified probe technique), which was effective January 1, 2018, is now to be reported for the Alere i System Respiratory Syncytial Virus (previously reported with 87801).

For a full list of all CLIA waived tests, consult CMS Change Request 10418 at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R3945CP.pdf.

CPT © 2017 American Medical Association. All rights reserved.


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