Ensure Proper Billing of New FDA-Approved CLIA-Waived Tests

Reminder: Effective July 1, labs can bill Medicare for a number of new CLIA-waived tests approved by the FDA. 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:

• 80305QW, Aug. 25, 2020, Verify Diagnostics Inc. VeriCheck Drug Test Cup
• 80305QW, Aug. 25, 2020, Verify Diagnostics Inc. VeriCheck Drug Test Dip
• 80305QW, Sept. 23, 2020, Axium BioResearch Inc. DrugExam Multi Drug Screen

Test

• 80305QW, Oct. 9, 2020, American Screening LLC Discover Panel Dip Card Tests

MOR 300

• 80305QW, Oct. 9, 2020, American Screening LLC Discover Quick Cup Tests MOR 300
• 80305QW, Oct. 9, 2020, American Screening LLC Discover Quick Cup Tests MOR 2000
• 80305QW, Oct. 9, 2020, American Screening LLC Discover Plus Panel Dip Card Tests MOR 300
• 80305QW, Oct. 9, 2020, American Screening LLC Discover Plus Panel Dip Card Tests MOR 2000
• 80305QW, Oct. 9, 2020, American Screening LLC Discover Plus Quick Cup Tests MOR 300
• 80305QW, Oct. 9, 2020, American Screening LLC Discover Plus Quick Cup Tests MOR 2000
• 80305QW, Oct. 9, 2020, American Screening LLC OneScreen Plus Quick Cup Tests MOR300
• 80305QW, Oct. 9, 2020, American Screening LLC OneScreen Plus Quick Cup Tests

MOR2000

• 80305QW, Oct. 9, 2020, American Screening LLC Reveal Panel Dip Card Tests MOR2000
• 80305QW, Oct. 9, 2020, American Screening LLC Reveal Quick Cup Tests MOR300
• 80305QW, Oct. 9, 2020, American Screening LLC Reveal Quick Cup Tests MOR2000

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	Various 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