CLIA Waived Tests and CPT Codes

1 DOH 681-018 April 2017 Page 1 of 47 Waived Tests and CPT Codes This list is for informational purposes only and may not accurately represent current CMS CPT Codes . Please verify your Tests Waived status and CPT code prior to implementing testing. Test Name/Specific Test System Manufacturer Approved CPT code (s) Adenovirus AdenoPlus (human eye fluid) Rapid Pathogen Screening, Inc. 87809QW Rapid Pathogen Screening RPS Adeno Detector Rapid Pathogen Screening, Inc. 87809QW Aerobic/Anaerobic Organisms - Vaginal Genzyme Diagnostics OSOM BVBLUE Test Gryphus Diagnostics, LLC 87905QW Gryphus Diagnostics BVBlue Gryphus Diagnostics, LLC 87905QW OBGYN-Vph Vaginal Ph Screening Kit Teco Diagnostics Pending Aerobic/Anaerobic/Viral Panel - Respiratory FilmArray Respiratory Panel EZ (RP EZ) (nasopharyngeal) Biofire Diagnostics, LLC Pending Albumin Abaxis Piccolo Blood Chem Analyzer WB (Chem 13, CMP, Renal) Abaxis, Inc 82040QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) Abaxis, Inc.

2 82040QW Abaxis Piccolo xpress Chem Analyzer WB (Chem 13, CMP, Liver Panel Plus, Renal) Abaxis, Inc 82040QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 82040QW Genzyme Diag OSOM ImmunoDip (urinary alb) Genzyme Diagnostics 82040QW HemoCue Albumin 201 System (urinary albumin) HemoCue AB 82040QW Alanine Aminotransferase (ALT) Abaxis Piccolo Blood Chem Analyzer WB (CMP, Chem 6, Chem 13) Abaxis, Inc 84460QW Abaxis Piccolo Point Of Care Chemistry Analyzer (Lipid Panel Reagent Disc) ALT Abaxis, Inc. 84460QW Abaxis Piccolo xpress Chem Analyzer WB(CMP, Lipid Panel Plus, Liver Panel Plus, Chem 6, Chem 13) Abaxis, Inc 84460QW Alere Cholestech LDX (ALT)(WB) Alere, Inc 84466QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Arkray, Inc. / Polymedco, Inc 84460QW Cholestech LDX Alanine Aminotransferase (ALT) Cholestech Corporation 84460QW Alkaline Phosphatase (ALP) Abaxis Piccolo Blood Chem Analyzer WB (CMP, Chem 13) Abaxis, Inc 84075QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) (WB) Abaxis, Inc.

3 84075QW Abaxis Piccolo xpress Chem Analyzer WB (CMP, Chem 13, Liver Panel Plus) Abaxis, Inc 84075QW Akray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 84075QW Amylase Abaxis Piccolo Blood Chem Analyzer WB (Chem 13) Abaxis, Inc 82150QW Abaxis Piccolo express Chemistry Analyzer WB (Liver Panel Plus, Chem 13) Abaxis, Inc 82150QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc)(WB) Abaxis, Inc. 82150QW Aspartate Aminotransferase (AST) Abaxis Piccolo Blood Chem Analyzer WB (Chem 6, Chem 13, CMP) Abaxis, Inc 84450QW DOH 681-018 April 2017 Page 2 of 47 Test Name/Specific Test System Manufacturer Approved CPT code (s) Abaxis Piccolo Point Of Care Chemistry Analyzer (Liver Panel Reagent Disc) AST (WB) Abaxis, Inc. 84450QW Abaxis Piccolo xpress Chem Analyzer WB(Chem 6, Chem 13, CMP, Liver Panel Plus, Lipid Panel Plus) Abaxis, Inc 84450QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Arkray, Inc.

4 / Polymedco, Inc 84450QW Cholestech LDX Aspartate Aminotransferase Cholestech Corporation 84450QW B-Type Natriuretic Peptide (BNP) Biosite Triage Meter (WB) (BNP) Biosite Incorporated 83880QW Biosite Triage Meter Plus (WB)(BNP) Biosite Incorporated 83880QW Biosite Triage Meterpro (WB)(BNP) Biosite Incorporated 83880QW Basic Metabolic Panel (Calcium, Ionized) Abbott i-STAT CHEM8+ Cartridge WB I-STAT Corporation 80047QW Basic Metabolic Panel (Calcium, Total) Abaxis Piccolo Blood Chemistry Analyzer WB (Basic Metabolic Reagent Disc) Abaxis, Inc 80048QW Abaxis Piccolo xpress Chemistry Analyzer WB (Basic Metabolic Reagent Disc) Abaxis, Inc 80048QW Bilirubin, Total Abaxis Piccolo Blood Chem Analyzer WB (Chem 13, CMP) Abaxis, Inc 82247QW Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc)(WB) Abaxis, Inc. 82247QW Abaxis Piccolo xpress Chem Analyzer WB(Chem 13, CMP, Liver Panel Plus) Abaxis, Inc 82247QW Akray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 82247QW Bladder Tumor Associated Antigen Alere NMP22 BladderChek Test Alere 86386QW BTA stat Test (for home use) Bion Diagnostic Sciences 86294QW LifeScan Status BTA Polymedco, Inc 86294QW Maritech BladderCheck Maritech, Inc.

5 86386QW BUN (Blood Urea Nitrogen) Abaxis Piccolo Blood Chemistry Analyzer (Chem 6 and 13 Panels, CMP, BMP, Metlyte 8, Renal) Abaxis, Inc. 84520QW Abaxis Piccolo xpress Chemistry Analyzer WB (Chem 6, 13, Kidney Panels, CMP, BMP, Metlyte 8, Renal) Abaxis, Inc. 84520QW Abbott i-STAT 6+ Cartridge (WB) i-STAT Corporation 84520QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 84520QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Arkray, Inc. 84520QW Calcium Abaxis Piccolo Blood Chemistry Analyzer WB (Chem 13 Panel, CMP, BMP, Renal) Abaxis, Inc. 82310QW Abaxis Piccolo xpress Chemistry Analyzer WB (Chem 13 Panel, CMP, BMP, Renal) Abaxis, Inc. 82310QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 82310QW Calcium Ionized Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 82330QW Carbon Dioxide (CO2) Abaxis Piccolo Blood Chemistry Analyzer (CMP, BMP, Electrolyte Discs, Metlyte 8, Renal) Abaxis, Inc 82374QW DOH 681-018 April 2017 Page 3 of 47 Test Name/Specific Test System Manufacturer Approved CPT code (s) Abaxis Piccolo xpress Chemistry Analyzer (CMP, BMP, Electrolyte Discs, Metlyte 8, Renal) Abaxis, Inc 82374QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 82374QW Catalase Accutest Uriscreen Rapid UTI Screen Savyon Diagnostics 81007QW Uriscreen (for OTC use), urine Diatech Diagnostics 81007QW Chloride Abaxis Piccolo Blood Chemistry Analyzer (CMP, BMP, Electrolyte, Metlyte 8, Renal) Abaxis, Inc 82435QW Abaxis Piccolo xpress Chemistry Analyzer (CMP, BMP, Electrolyte, Metlyte 8, Renal)

6 Abaxis, Inc 82435QW Abbott i-STAT 6+ Cartridge (WB) i-STAT Corporation 82435QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 82435QW Cholesterol Abaxis Piccolo xpress Chemistry Analyzer {capillary-finger stick} (Cholesterol) Abaxis, Inc 82465QW Abaxis Piccolo xpress Chemistry Analyzer WB (Lipid Panel, Lipid Panel Plus) Abaxis, Inc 82465QW Abaxis Piccolo Point of Care Chemistry Analyzer WB (Lipid Panel, Lipid Panel Plus) Abaxis, Inc 82465QW Accu-Check InstantPlus Cholesterol Test System Roche/Boehringer Mannheim 82465QW Accucheck Instant Plus Dual Testing System Roche Diagnostics 82465QW Advanced Care Cholesterol Measuring System Johnson & Johnson 82465QW Alere Cholestech LDX (cholesterol)(WB) Alere, Inc 84465QW Arkray SPOTCHEM EZ Chem Analyzer (WB) Polymedco, Inc 82465QW Biomedix Inc Q Steps Biometer G/C Dual Monitoring System Biomedix, Inc. 82465QW ChemTrak AccuMeter Cholesterol Test System ChemTrak 82465QW Cholestech LDX (Must have software version or above) Cholestech 82465QW Total Cholesterol & PDU ActiMed Laboratories, Inc 82465QW Infopia USA LipidPro Infopia Co Ltd 82465QW Infopia USA LipidPro Professional Lipid Profile and Glucose Measuring System Infopia Co Ltd 82465QW Jant Pharmacal LipidPlus Lipid Profile and Glucose Measuring System Infopia Co, Ltd 82465QW Lifestream Plus Cholesterol Monitor Lifestream Technologies 82465QW Lifestream Technologies Cholesterol Monitor Lifestream Technologies 82465QW Lifestream Technologies Personal Cholesterol Monitor for cholesterol Lifestream Technologies, Inc.

7 82465QW Polymer Technology Systems Bioscanner, Bioscanner Plus, and Bioscanner 2000 PTS Polymer Technology Systems, Inc 82465QW Polymer Technology Systems MTM BioScanner 1000 Polymer Technology Systems, Inc 82465QW Polymer Technology Systems Cardiochek Plus, Cardiochek Home Use, Home Test System, and Cardiochek PA Analyzer test strips. CardioChek Home Chol+HDL+Glu Test strips Polymer Technology Systems, Inc 82465QW -PTS Panels Lipid Panel test strips 82947QW -CardioChek Home Lipid Panel test strips 82947QW DOH 681-018 April 2017 Page 4 of 47 Test Name/Specific Test System Manufacturer Approved CPT code (s) Roche Diagnostics Accutrend Plus System WB Roche Diagnostics 82465QW Wako APOLOWAKO Analyzer Wako Chemicals USA 82465QW Comprehensive Metabolic Panel Abaxis Piccolo Blood Chemistry Analyzer WB (Comprehensive Metabolic Reagent Disc) Abaxis, Inc 80053QW Abaxis Piccolo xpress Chemistry Analyzer WB (Comprehensive Metabolic Reagent Disc) Abaxis, Inc 80053QW Creatine Kinase (CK) Abaxis Piccolo Blood Chemistry Analyzer WB (Metlyte 8 Disc) Abaxis, Inc 82550QW Abaxis Piccolo xpress Chemistry Analyzer WB (Metlyte 8 Disc)

8 Abaxis, Inc 82550QW Creatinine Abaxis Piccolo Blood Chem Analyzer WB (Chem 6 and 13 Panels, CMP, BMP, Metlyte 8, Renal) Abaxis, Inc. 82565QW Abaxis Piccolo xpress Chem Analyzer WB (Chem 6, 13, Kidney Panels, CMP, BMP, Metlyte 8, Renal) Abaxis, Inc. 82565QW Abbott i-STAT Crea Cartridge (WB) i-STAT Corporation 82565QW Abbott i-STAT CHEM8+ Cartridge (WB) i-STAT Corporation 82565QW Akray SPOTCHEM EX Chem Analyzer (WB) Polymedco, Inc 82565QW Siemens Clinitek 50 Urine Chemistry Analyzer (see also under Urinalysis) Bayer 82570QW Siemens MICROABLUSTIX Reagent Strips Bayer 82570QW Siemens MultiStix PRO 10LS, PRO 11 and PRO 7G Reagent Strips (urine dipstick and urine creatinine nonautomated) Bayer 82570QW Drugs of Abuse (Use G0477QW for visually read devices or G0478QW for instrument read devices) 1 Step Detect Associates DTX Drug Test Cup Integrated E-Z Split Key Cup II(amphetamines, cocaine metabolites, MDMA, methamphetamines, opiates, PCP, THC)

9 Biosite Inc 80305QW Abbott Diagnostics Signify ER Drug Screen Test(amphetamines, barbiturates, benzodiazepines,cocaine metabolites, MDMA, opiates, oxycodone, PCP, propoxyphene, THC, tricyclic antidepressants) Innovacon, Inc 80305QW Acon iCassette Multi-Drug, Multi-Line Screen Test Device (amphetamines, cocaine metabolites, methamphetamines, opiates , PCP, THC) Acon Laboratories, Inc. 80305QW Acon Multi-Drug, Multi-Line Screen Test Card with Integrated Cup {professional use}(amphetamines, cocaine metabolites, MDMA methamphetamines, opiates, PCP, THC) Acon Laboratories, Inc. 80305QW Acon On Call Multi Drug Home Test/Test Cup(amphetamines, cocaine metabolites, methamphetamines, opiates, PCP,THC) Acon Laboratories, Inc. 80305QW Acon One Step Multi-Drug, Multi-Line Screen Test Device P{professional use}(amphetamines, cocaine metabolites, methamphetamines, opiates, PCP, THC) Acon Laboratories, Inc. 80305QW Acon Redi-Test Cassette Multi-Drug, Multi-Line Screen Test Device (amphetamines, cocaine metabolites, methamphetamines, opiates, PCP, THC) Acon Laboratories, Inc.

10 80305QW Accu-Stat Drugs of abuse Home Test amphetamines, cocaine metabolites, methamphetamines, opiates, PCP,THC) Accu-Stat Diagnostics, Inc. 80305QW DOH 681-018 April 2017 Page 5 of 47 Test Name/Specific Test System Manufacturer Approved CPT code (s) Accu-Stat Home Drug Test -Cocaine -Marijuana -Marijuana and Cocaine -Marijuana, cocaine, amphetamine, -Methamphetamine, opiates, PCP -Marijuana, cocaine, amphetamine, -Methamphetamine, opiates, ecstasy, PCP Accu-Stat Diagnostics, Inc. 80305QW ACCU News Drug Screening Test Card/Urine Cup (Amphetamines, Methamphetamines, Opiates, Cocaine Metabolites, Cannabinoids) Coretests, Inc 80305QW ADC Multiple Drug Test Card (opiates, methamphetamines, cocaine metabolites, THC, PCP) Advantage Diagnostics Corp 80305QW Accutest Multi-Drug, Multi Line Screen Test Device (amphetamines, THC, cocaine metabolites, methamphetamines.