REIMBURSEMENT

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

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