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CLIA Waived Tests for Manufacturers

Clinical Laboratory Improvement Amendment of 1988 (CLIA). The CLIA-waived status allows a broad base of physicians to perform a test at the point-of-care setting.
CPT CODE MEDICARE FEE CAP TEST NAME (SELECTED PRODUCTS/MANUFACTURERS)
82055QW$15.10Alcohol Saliva Test (STC Diagnostics, QED Diagnostics)
82120QW$5.25Amines and pH (Advance Amines and pH test, Quidel, BV Blue, Genzyme)
83986QW$5.00Amines and pH (Advance Amines and pH test, Quidel, BV Blue, Genzyme)
85576QW$30.01Aspirin resistance test (VerifyNow Accumetrics)
83518QW$11.85Bladder Cancer Antigen (BTA Stat Test Bion Diagnostics)
83880QW$47.43BNP test (Triage Meter, Biosite Corp)
VariesVariesChemistry Tests: Albumin, Alkaline Phosphatase, Amylase, GGT, Total Bilirubin, Total Protein (Abaxis Piccollo)
82465QW$6.08Cholesterol (Chemtrak, J & J, Roche, Actimed Labs, Lifestream Technologies)
82044QW$6.39Dipstick Albumin (Chemstrip Micral Roche Corp, Immunodip, DCL)
81002$3.57Dipstick/Tablet Urinalysis
81002$3.57Dipstick Urinalysis
82570QW$7.23Creatinine (Bayer Multistix Pro 11, 10LS, 7G)
81003QW
82570QW
$3.14
$7.23
Dipstick Urine Analyzer (Clinitek 50 Bayer Corp.; Urisys Roche Corp.)+ Creatinine (Bayer Status Analyzer)
80101QW$19.24Drugs of Abuse tests
82272$4.54FOB, Diagnostic (Hemoccult Beckman Coulter, Seroccult Propper)
82270$4.54FOB, Screening
G0394$4.54FOB, single test for colorectal neoplasm
82274QW or G0328$22.22FOB, Immunoassay (InSure Enterix, FOB Alfa Scientific, Hemoccult ICT Beckman Coulter, Instant Technologies, Immunostics)
83001QW$25.97FSH (Biotechnostics, Menocheck Pro FSH Menopause Test)
82273QW$4.54Gastric Occult Blood (Beckman Coulter)
82962$3.27Glucose Meters
82951QW$17.99Glucose Tolerance Test, 3 Specimens
82947QW$5.48Glucose (HemoCue Glucose 201 Analyzer)
83036QW$13.56Hemoglobin A1c (Axis-Shield Afinion, Bayer DCA 2000)
83037QW$21.06Hemoglobin A1c, approved for home use (Cholestech, Metrika, BioRad, Provalis)
85014QW$3.31Hematocrit (StatSpin)
85018QW$3.31Hemoglobin (Hemocue)
86318QW$18.09H. pylori test whole blood (Quidel, BD, Accutest, Instant Technologies)
87338QW$20.10H. pylori test, stool (Meridian Bioscience, Immunocard)
86703QW$19.17HIV Rapid Test (OraSure)
87804QW$16.76Influenza Rapid Test Kits (Quidel, Binax)
83655QW$16.91LeadCare II Blood Lead Test System (ESA Biosciences, Chelmsford, MA)
80061QW$18.72Lipid Panel (Cholestech, Abaxis, Cardiocheck) (Cholest, HDL, Triglycerides)
84460QW$7.40ALT (SGPT)
84450QW$7.40AST (SGOT)
83721QW$13.33LDL (Polymer Technology; Cardiocheck PA)
86618QW$23.80Lyme Disease Rapid Test Kit (Inverness)
82043QW$8.09Microalbumin, Urine Quantitative (Hemocue)
83518QW$11.85Microalbumin Immunoassay (ICON Beckman Coulter)
86308QW$7.23Mononucleosis Test Kits (Quidel, Inverness, Genzyme)
80101QW$19.24Nicotine Test (NicCheck, Dynagen)
84830$14.02Ovulation Test Kits (Instant Technologies)
81025$8.84Pregnancy Test Kits Urine, Qualitative (Beckman Coulter, Genzyme, Quidel, Inverness)
84703QW$10.49Pregnancy Test Urine Instrument (Clinitek Bayer Corp)
85610QW$5.49Prothrombin Time (Protime ITC Corp, CoaguChek Roche, Hemosense)
87807QW$16.76RSV Rapid Test Kit (Binax, Integrated Biotechnology)
85651$4.96Sedimentation Rate, Non-Automated
87880QW$16.76Strep Rapid Test Kits (Beckman Coulter, Genzyme, Quidel, BD, Inverness, etc.)
87808QW$16.76Trichomonas Rapid Test Kit (Genzyme)
84443QW$23.47TSH, qualitative (Thyrotech)
81007QW$3.59Urinary Tract Infections (Uriscreen Diatech Diagnostics)

This list omits certain waived tests that are typically not performed in physician office settings. For a complete listing of every waived test by brand name, go to:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm

Courtesy, Quality America, Inc. 4/20/2007