Home 5 Articles 5 Ensure Proper Billing of New FDA-Approved CLIA-Waived Tests

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

by | Jun 28, 2021 | Articles, CLIA-nir, Essential, National Lab Reporter, Reimbursement-nir

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. […]

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 CodeName Use
81002Dipstick or tablet reagent urinalysis—non-automated for bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogenScreening of urine to monitor/diagnose various diseases/conditions, such as diabetes, the state of the kidney or urinary tract, and urinary tract infections
81025Urine pregnancy tests by visual color comparisonDiagnosis of pregnancy
82270 82272 (Contact your Medicare carrier for claims instructions)Fecal occult bloodDetection of blood in feces from whatever cause, benign or malignant (colorectal cancer screening)
82962Blood glucose by glucose monitoring devices cleared by FDA for home useVarious Monitoring of blood glucose levels  
83026Hemoglobin by copper sulfate – nonautomatedMonitor hemoglobin level in blood  
84830Ovulation tests by visual color comparison for human luteinizing hormoneDetection of ovulation (optimal for conception)  
85013Blood count; spun microhematocritScreen for anemia
85651Erythrocyte sedimentation rate – nonautomatedNonspecific screening test for inflammatory activity, increased for majority of infections, and most cases of carcinoma and leukemia

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