CMS Recognizes 3 New CLIA-Waived (CW) Tests
CMS announced three new CLIA-waived complexity tests that labs will be allowed to bill to Medicare, effective January 3, 2022. Here are the key details you need to know to ensure maximum reimbursement and proper billing. Billing of New CLIA-Waived Tests 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 categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver. QW Modifier Tests: The CPT codes for the following new tests, 80305, must have the modifier QW to be recognized as a waived test: 87801QW, March 30, 2021, binx health io Instrument (for use with female vaginal swabs and male urine) 86308QW, August 9, 2021, Cardinal Health MONO Rapid Test (whole blood) 87801QW, August 26, 2021, Visby Medical Sexual Health Click Test (for use with self-collected vaginal swabs). Non-QW Modifier Tests: The CPT codes for the following new tests, all of which are produced by various manufacturers, don’t need a QW modifier to be recognized as a waived test: CPT Code Name Use 81002 Dipstick or tablet reagent urinalysis—non-automated for bilirubin, glucose, hemoglobin, ketone, […]
CMS announced three new CLIA-waived complexity tests that labs will be allowed to bill to Medicare, effective January 3, 2022. Here are the key details you need to know to ensure maximum reimbursement and proper billing.
Billing of New CLIA-Waived Tests
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 categorized as waived complexity under CLIA in facilities with a CLIA certificate of waiver.
QW Modifier Tests: The CPT codes for the following new tests, 80305, must have the modifier QW to be recognized as a waived test:
- 87801QW, March 30, 2021, binx health io Instrument (for use with female vaginal swabs and male urine)
- 86308QW, August 9, 2021, Cardinal Health MONO Rapid Test (whole blood)
- 87801QW, August 26, 2021, Visby Medical Sexual Health Click Test (for use with self-collected vaginal swabs).
Non-QW Modifier Tests: The CPT codes for the following new tests, all of which are produced by various manufacturers, don’t need a QW modifier to be recognized as a waived test:
| 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 Medicare carrier 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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