Eight New CLIA-Waived Tests Your Lab Staff Need to Know About
CMS has instructed its MACs to recognize eight new CLIA-waived complexity tests for which labs will be allowed to bill, effective Oct. 1.
On Aug. 4, the Centers for Medicare and Medicaid Services (CMS) instructed its Medicare Administrative Contractors (MACs) to recognize eight new CLIA-waived complexity tests for which labs will be allowed to bill, effective October 1, 2022. Here’s a briefing of what your lab billing staff needs to know about the changes to ensure proper billing and coding of the newly waived tests.
Billing of New CLIA-Waived Tests
Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations require labs to be appropriately certified for each test they perform. CMS edits lab claims at the CLIA certificate level to ensure that Medicare pays only for lab tests that the FDA approves as waived complexity under CLIA in facilities with a CLIA certificate of waiver. Since such tests are marketed immediately after approval, CMS has to notify its MACs about the new tests to ensure they can process claims accurately.
The New QW Modifier CLIA-Waived Tests
In its Aug. 4 transmittal (Pub. 100-04/Transmittal: 11547/Change Request: 12841), CMS lists the Healthcare Common Procedure Coding System (HCPCS) codes for eight new tests that must be recognized as CLIA-waived tests, provided that they list the QW modifier:
| HCPCS Code | Effective Date | Description |
|---|---|---|
| 87651QW | November 9, 2020 | Mesa Biotech Accula {Accula Strep A Test} |
| G0475QW | February 7, 2022 | Abbott Diagnostics Determine HIV-1/2 Ag/Ab Combo {Fingerstick whole blood} |
| 80305QW | March 1, 2022 | Noble Medical Inc. Noble Dip Card/Drug Test Cup |
| 82465QW | March 25, 2022 | PTS Panels Cholesterol Test Strips, Polymer Technology Systems Inc. CardioChek Plus Test System {PTS Panels Cholesterol Test Strips} |
| 82010QW, 82962 | April 7, 2022 | Apex Biotechnology Corp. MTM301 Blood Glucose and Ketone Monitoring System |
| 80305QW | May 9, 2022 | T&D Diagnostics Canada Pvt. Ltd. Sienna Multi-Drug Test (Cup and Dip Card) |
| 80305QW | June 1, 2022 | NexScreen Gen2 Multi-Drug Urine Test Cup |
| 80305QW | June 1, 2022 | NexScreen Gen2 Multi-Drug Urine Test Dip Card |
New Non-QW Modifier CLIA-Waived Tests
Also be aware that there are CLIA-waived tests that will be recognized without the QW modifier, all of which are produced by various manufacturers (and thus have a CPT rather than a proprietary HCPCS code associated with a single producer):
| CPT Code | Name | Use |
|---|---|---|
| 81002 | Dipstick or tablet reagent urinalysis—non-automated for bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen | Screening of urine to monitor/diagnose various diseases/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infections |
| 81025 | Urine pregnancy tests by visual color comparison | Diagnosis of pregnancy |
| 82270 82272 (Contact your MAC for claims instructions) | Fecal occult blood | Detection of blood in feces from whatever cause, benign or malignant (colorectal cancer screening) |
| 82962 | Blood glucose by glucose monitoring devices cleared by FDA for home use | Monitoring of blood glucose levels |
| 83026 | Hemoglobin by copper sulfate—nonautomated | Monitor hemoglobin level in blood |
| 84830 | Ovulation tests by visual color comparison for human luteinizing hormone | Detection of ovulation (optimal for conception) |
| 85013 | Blood count; spun microhematocrit | Screen for anemia |
| 85651 | Erythrocyte sedimentation rate—nonautomated | Nonspecific screening test for inflammatory activity, increased for majority of infections, and most cases of carcinoma and leukemia |
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