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New Waived Tests for Labs - Modifier QW Updates

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require a facility to be appropriately certified for each test performed. 

To ensure that Medicare & Medicaid only pay for laboratory tests categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver.

The listed below are the latest tests approved by the Food and Drug Administration (FDA) as waived tests under CLIA. 

The Current Procedural Terminology (CPT) codes for the following new tests must have the modifier QW to be recognized as a waived test. 

However, the below-mentioned tests did not require a QW modifier to be recognized as a waived test.

Example (i.e., CPT codes: 81002, 81025, 82270, 82272, 82962, 83026, 84830, 85013, and 85651) 

  • 81002 - Dipstick or tablet reagent urinalysis – non-automated for bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen.
  • 81025 - Urine pregnancy tests by visual color comparison.
  • 82270 & 82272 - Fecal occult blood.
  • 82962 - Blood glucose by glucose monitoring devices cleared by the FDA for home use.
  • 83026 - Hemoglobin by copper sulfate – nonautomated.
  • 84830 - Ovulation tests by visual color comparison for human luteinizing hormone.
  • 85013 - Blood count; spun microhematocrit.
  • 85651 - Erythrocyte sedimentation rate – nonautomated. 

The CPT code 80305 is required modifier QW, effective date, and description for the latest tests approved by the FDA as waived tests under CLIA is the following,

  • August 25, 2020, Verify Diagnostics Inc. VeriCheck Drug Test Cup;
  • August 25, 2020, Verify Diagnostics Inc. VeriCheck Drug Test Dip;
  • September 23, 2020, Axium BioResearchInc.DrugExam Multi-Drug Screen Test;
  • October 9, 2020, American Screening LLC Discover Panel Dip Card Tests MOR 300;
  • October 9, 2020, American Screening LLC Discover Quick Cup Tests MOR 300;
  • October 9, 2020, American Screening LLC Discover Quick Cup Tests MOR 2000;
  • October 9, 2020, American Screening LLC Discover Plus Panel Dip Card Tests MOR 300;
  • October 9, 2020, American Screening LLC Discover Plus Panel Dip Card Tests MOR 2000;
  • October 9, 2020, American Screening LLC Discover Plus Quick Cup Tests MOR 300;
  • October 9, 2020, American Screening LLC Discover Plus Quick Cup Tests MOR 2000;
  • October 9, 2020, American Screening LLC OneScreen Plus Quick Cup Tests MOR300
  • October 9, 2020, American Screening LLC OneScreen Plus Quick Cup Tests MOR2000;
  • October 9, 2020, American Screening LLC Reveal Panel Dip Card Tests MOR2000;
  • October 9, 2020, American Screening LLC Reveal Quick Cup Tests MOR300; and
  • October 9, 2020, American Screening LLC Reveal Quick Cup Tests MOR2000.

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