Utah Medicaid Provider Manual
Division of Health Care Financing
CLIA Certification for Laboratory Services Updated October 2008
NOTES: The types of CLIA certificate required to cover specific HCPCS procedure codes are listed in the colum ns below. The last colum n is a list of codes which do not require CLIA certification. 1. 2. 3. 4. 5. 6. Not all of the codes listed are covered by Medicaid. Refer to the Utah Medicaid Provider Manual for specific policy and lim itations. Many codes can only be billed by certain provider types identified by Medicaid. In the list of Codes Excluded from CLIA Requirements, som e codes have been om itted because they will never be approved as Medicaid payable codes. Codes without the QW m odifier in the Certificate of W aiver colum n are for tests, while the rem aining codes are for specific kits approved by the Center for Disease Control. Clinical Laboratory Im provem ent Am endm ents web site: http://cm s.hhs.gov/clia Code(s) added to this list are in bold print. Other text changes are m arked with vertical line in left m argin. See Medical and Surgical Procedures (CPT Code List) for codes requiring docum entation.
CLIA Certificates and Excluded Codes
Certificate of W aiver
80047QW 80051QW 80061QW 80178QW 81003QW 81025 82042QW 82055QW 82247QW 82271QW 82310QW 82374QW 82465QW 82565QW 82679QW 82950QW 82952QW 82977QW 83001QW 83026 83518QW 83655QW 83721QW 83986QW 84132QW 84295QW 84450QW 84478QW 84550QW 84830 85014QW 85651 85610QW 86618QW 86318QW 86703QW 87210QW 87804QW 87880QW 80048QW 80053QW 80101QW 81002 81007QW 82010QW 82044QW 82150QW 82270 82274QW 82330QW 82435QW 82523QW 82570QW 82947QW 82951QW 82962 82985QW 83002QW 83036QW 83605QW 83718QW 83880QW 84075QW 84157QW 84443QW 84460QW 84520QW 84703QW 85013 85018QW 85576QW 86294QW 86308QW 86701QW 87077QW 87449QW 87807QW 87899QW
Certificate of W aiver, continued
Certificate for Provider-Performed Microscopy Procedures (PPMP) Includes all codes listed under the column headed Certificate of Waiver, plus the following codes: Q0111 Q0112 Q0113 Q0114 Q0115 81000 81001 81015 81020 89190 G0027
Certificates of Com pliance, Accreditation, or Registration Includes all codes listed under the columns headed Certificate of Waiver and Certificate for ProviderPerformed Microscopy Procedures (PPMP), plus the following codes: 17311 17313 17315 G0123 G0141 G0144 G0147 G0306 P3000 P7001 0030T 78110 78120 78122 78191 78271 17312 17314 G0103 G0124 G0143 G0145 G0148 G0307 P3001 0026T 0041T 78111 78121 78130 78270 78272
Certificates of Com pliance, Accreditation, or Registration required w hen billing w ith a “26" modifier.
Codes Excluded from CLIA Requirements The following codes are not subject to CLIA requirements. 70000 series test codes with a 26 modifier plus the following codes: 80500 81050 84061 86078 86485 86490 86586 86923 86930 86932 86950 86965 86999 87900 88311 88313 88329 89049 88400 89105 89132 89136 80502 82075 86077 86079 86486 86510 86580 86891 86927 86931 86945 86960 86985 88304 88305 88312 88314 89100 89130 89135 89140 89141
And all 80000 codes, except those listed in the column titled Codes Excluded from CLIA Requirements.
83020 84165 84182 86255 86320 86327 87164 88104 88107 88112 88161 88172 88182 88300 88304 88307 88312 88314 88319 88331 88342 88347 88349 88356 88362 88371 88399
83912 84181 85390 86256 86325 86334 87207 88106 88108 88160 88162 88173 88199 88302 88305 88309 88313 88318 88323 88332 88346 88348 88355 88358 88365 88372 89060
Manuals: Physician Services, Lab & X-ray
Key to code changes, page 1, item 5
page 1 of 9
Utah Medicaid Provider Manual
Division of Health Care Financing
CLIA Certification for Laboratory Services Updated October 2008
CLIA Waiver Kits
The following test kits are approved by the Center for Disease Control. W hen one of these kits is used, bill the HCPCS code with a ‘QW ’ m odifier. Code 80047QW 80048QW Manufacturer i-STAT Corporation Abaxis, Inc. Test Name (in order of CPT code) Abbott i-STAT Chen 8+ Cartridge {W hole Blood}* 1. Abaxis Piccolo Blood Chemistry Analyzer (Basic Metabolic Reagent Disc) {W hole Blood} 2. Abaxis Piccolo xpress Chemistry Analyzer (Basic Metabolic Reagent Disc) {W hole Blood} 1. Abaxis Piccolo Blood Chemistry Analyzer (Electrolyte Metabolic Reagent Disc) {W hole Blood} 2. Abaxis Piccolo xpress Chemistry Analyzer (Electrolyte Metabolic Reagent Disc) {W hole Blood} 1. Abaxis Piccolo Blood Chemistry Analyzer (Comprehensive Metabolic Reagent Disc) {W hole Blood} 2. Abaxis Piccolo xpress Chemistry Analyzer (Comprehensive Metabolic Reagent Disc) {W hole Blood} Piccolo Point of Care Chemistry Analyzer (Lipid Panel Reagent Disc) Cholestech LDX Cardio-Chek PA Analyzer (PTS Panels Lipid Panel Test Strips)
80051QW
Abaxis, Inc.
80053QW
Abaxis, Inc.
80061QW 80061QW 80061QW 80101QW 80101QW 80101QW 80101QW 80101QW 80101QW 80101QW 80101QW 80101QW
Abaxis, Inc. Cholestech Polymer Technology
Advantage Diag Corp (ADC) Alatex Scientific Peace of Mind Multiple Drugs of Abuse Test Forefront Diagnostics, Inc. Drugfree at Home THC/COC Test Kit
Advantage Diag Corp (ADC) ADC Multiple Drug Test Card Advantage Diag Corp (ADC) ADC CLIA W aived Multiple Drug Test Card Advantage Diag Corp (ADC) ADC CLIA W aived Marijuana (THC) and Cocaine Test Advantage Diag Corp (ADC) ADC Marijuana (THC) and Cocaine Home Drug Test Advantage Diag Corp (ADC) ADC CLIA W aived Marijuana (THC) Test Dynagen, Inc Pharmatech DynaGen NicCheck 1 Test Strips Pharmatech At Home Drug Test (Model 9150T)
80101QW
Pharmatech
Pharmatech At Home Drug Test (Model 9078T)
80101QW
Pharmatech
Phamatech At Home Drug Test (Model 9063) (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions Phamatech At Home Drug Test (Model 9068) (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions Phamatech At Home Drug Test (Model 9073) (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions Phamatech At Home Drug Test (Model 9078) (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions Phamatech At Home Drug Test (Model 9083) (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions
80101QW
Pharmatech
80101QW
Pharmatech
80101QW
Pharmatech
80101QW
Pharmatech
page 2 of 9
Key to code changes, page 1, item 5
Manuals: Physician Services, Lab & X-ray
Utah Medicaid Provider Manual
Division of Health Care Financing
Code 80101QW 80101QW 80101QW Manufacturer Accu-Stat Diagnostics, Inc. Accu-Stat Diagnostics, Inc. Pharmatech
CLIA Certification for Laboratory Services Updated October 2008
Test Name (in order of CPT code) Accu-Stat Drugs of Abuse Home Test for Marijuana (THC) and Cocaine (COC) Accu-Stat Drugs of Abuse Home Test for Marijuana (THC-COC) Phamatech At Home Drug Test (Model 9133) (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions W orldwide Medical Corp, First Check at Home Drug Test (THC) First Check Home Drug Test Panel 4 (THC-COC-OPI-MET) W orldwide Medical Corp, First Check at Home Drug Test (THC) Bayer Clinitek 50 Urine Chemistry Analyzer - qualitative dipstick for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrate, leukocytes - automated Biosys Laboratories Optima Urine Anlayzer Chemstrip Mini UA - qualitative dipstick for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, leukocytes automated Roche Diagnostics Urisys 1100 Urine Analyzer Roche Diagnostics/Boehringer Mannheim Chemstrip 101 urine analyzer Teco Diagnostics URITEK TC-101 ThermoBiostar PocketChem UA Hypoguard Diascreen Urine Chemistry Analyzer Diatech Diagnostics Uriscreen (for OTC use) Medisense Precision Xtra Advanced Diabetes Mngmt (K040814) Medisense Products Precision Xtra Advanced Diabetes Mngmt (K983504) PTS Bioscanner (for OTC use) - for blood ketones Arkay SPOTCHEM EZ Chemistry Analyzer (Spotchem II Basicpanel 1) {W hole Blood} Bayer Clinitek 50 Urine Chemistry Analyzer-microalbumin, creatinine OraSure Technologies Q.E. D. A-150 Saliva Alcohol Inc.Test OraSure Technologies Q.E. D. A-350 Saliva Alcohol Inc.Test STC Diagnostics Q.E.D. A150 Saliva Alcohol Test (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions) STC Diagnostics Q.E.D. A350 Saliva Alcohol Test (This test may not be covered in all instances. Contact your Medicare carrier for claims instructions) Litmus Concepts FemExam TestCard Quidel Quick Vue Advance ph and Amines Test Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) {W hole Blood} Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) {W hole Blood} Primary Care Diagnostics Gastrocult Aerscher Hemaprompt FG SmithKline Gastroccult Beckman Coulter Hemoccult ICT Key to code changes, page 1, item 5 page 3 of 9
80101QW 80101QW 80101QW 81003QW
W orldwide Medical Corp W orldwide Medical Corp W orldwide Medical Corp Bayer
81003QW 81003QW
Biosys Laboratories Boehringer Mannheim
81003QW 81003QW 81003QW 81003QW 81003QW 81007QW 82010QW 82010QW 82010QW 82042QW 82044QW 82055QW 82055QW 82055QW
Roche Diagnostics Roche Diagnostics Teco Diagnostics ThermoBiostar Hypoguard USA, Inc Savyon/USA Abbott Laboratories, Inc Abbott Laboratories, Inc Polymer Technology Systems, Inc. Polymedco, Inc. Bayer OraSure Technologies OraSure Technologies STC Technologies Inc.
82055QW
STC Technologies Inc.
82120QW 82120QW 82150QW 82247QW 82273QW 82273QW 82273QW
Litmus Concepts, Inc Quidel Corporation Abaxis, Inc. Abaxis, Inc. Beckman Coulter, Inc Aerscher Diagnostics SmithKline
82274QW Beckman Coulter, Inc Manuals: Physician Services, Lab & X-ray
Utah Medicaid Provider Manual
Division of Health Care Financing
Code 82274QW 82273QW 82310QW 82330QW 82374QW 82435QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82465QW 82523QW 82565QW 82570QW 82570QW 82570QW 82570QW 82570QW 82679QW Manufacturer Enterix, Inc SmithKline Polymedco, Inc. i-STAT Corporation i-STAT Corporation i-STAT Corporation Abaxis, Inc ActiMed Labs, Inc ActiMed Laboratories, Inc Boehringer Mannheim ChemTrak Cholestech Johnson & Johnson Lifestream Technologies
CLIA Certification for Laboratory Services Updated October 2008
Test Name (in order of CPT code) Enterix Insure Fecal Occult Blood Test SmithKline Gastroccult Arkay SPOTCHEM EZ Chemistry Analyzer (Spotchem II Basicpanel 1) {W hole Blood} Abbott i-STAT Chen 8+ Cartridge {W hole Blood}* Abbott i-STAT Chen 8+ Cartridge {W hole Blood}* Abbott i-STAT Chen 8+ Cartridge {W hole Blood}* Piccolo Point of Care Chemistry Analyzer (Lipid Panel Reagent Disc) ActiMed Laboratories ENA.C.T Total Cholesterol Test (PDU) ActiMed Laboratories ENA.C.T Total Cholesterol Test (PDU) Boehringer Mannheim Accu-Chek Instant Plus Cholesterol Chemtrak Accumeter Cholestech LDX Advanced Care Lifestream Technologies Cholesterol Monitor
Lifestream Technologies, Inc Lifestream Technologies Personal Cholesterol Monitor Polymer Technology Systems, Inc Polymer Technology Systems, Inc Ostex International Inc i-STAT Corporation Bayer Inc. Bayer Diagnostics Bayer Diagnostics Bayer Diagnostics Bayer Corp Unipath Limited Polymer Technology Systems, (PTS) MTM Bioscanner 1000 (for OTC use) for cholesterol (Contact your Medicare carrier for claims instructions) (PTS) Bioscanner test strips Cholesterol (Contact your Medicare carrier for claims instructions) Ostex International Osteomark NTX Point of Care Prescription Home Use Abbott i-STAT Chem8+ Cartridge {W hole Blood}* Bayer Diagnostics/MICROALBUSTIX Reagent Strip Bayer Multistick Pro 10LS Reagent Strips Bayer Multistick Pro 11 Reagent Strips Bayer Multistick Pro 7G Reagent Strips Bayer Clinitek 50 Urine Chemistry Analyzer-for microlabumin, creatinine Clearplan Easy Fertility Monitor (for luteinizing hormone and estrone 3 glucuronide) This test may not be covered in all instances. Contact your Medicare Carrier for claims instructions Cholestech LDX HemcoCue Glucose 201 Microcuvettes and Glucose 201 Analyzer HemoCue B-Glucose Photometer Cholestech LDX HemoCue B-Glucose Photometer HemcoCue Glucose 201 Microcuvettes and Glucose 201 Analyzer Cholestech LDX HemoCue B-Glucose Photometer HemcoCue Glucose 201 Microcuvettes and Glucose 201 Analyzer Cholestech LDX
82947QW 82947QW 82947QW 82950QW 82950QW 82950QW 82951QW 82951QW 82951QW 82952QW
Cholestech HemoCue, Inc HemoCue Cholestech HemoCue HemoCue, Inc Cholestech HemoCue HemoCue, Inc Cholestech
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Key to code changes, page 1, item 5
Manuals: Physician Services, Lab & X-ray
Utah Medicaid Provider Manual
Division of Health Care Financing
Code 82952QW 82952QW 82977QW 82985QW 82985QW 82985QW 83001QW 83001QW 83001QW 83002QW Manufacturer HemoCue HemoCue, Inc Abaxis, Inc. LXN Corporation LXN Corporation LXN Corporation Acon Laboratories Genua 1944 Inc. Applied Biotech, Inc Unipath Limited
CLIA Certification for Laboratory Services Updated October 2008
Test Name (in order of CPT code) HemoCue B-Glucose Photometer HemcoCue Glucose 201 Microcuvettes and Glucose 201 Analyzer Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) {whole blood} LXN Fructosamine Test System LXN Duet Glucose Control Monitoring System LXN IN CHARGE Diabetes Control System Acon Laboratories, Inc. FSH Menopause Predictor Test Genua Menopause Monitor Test Applied Biotech, Inc. RU25 Plus FSH Menopause Test Clearplan Easy Fertility Monitor (for luteinizing hormone and estrone 3 glucuronide) This test may not be covered in all instances. Contact your Medicare Carrier for claims instructions Bayer DCA 2000 (& 2000+) glycosylated hemoglobin (Hgb Alc) Metrika DRxâ HbA1c (Professional Use Test System) Bayer DCA 2000+ - Glycosylated Hemoglobin (Hgb A1c) Bio-Rad Micromat II Hemoglobin A1c Prescription Home Use Test Cholestech GDX A1C Test (Prescription Home Use) Metrika A1c Now - Professional Use (K000887) Metrika A1c Now for Prescription Home Use (K020234) Metrika A1c Now for Professional Use (K020235) Provalis Diagnostics Glycosal HbA1c Test
83036QW 83036QW 83036QW 83036QW 83036QW 83036QW 83036QW 83036QW 83036QW 83518QW 83518QW 83518QW 83518QW 83518QW 83518QW 83605 QW 83718QW 83718QW 83718QW 83986QW 83986QW 83986QW 83986QW 83986QW 84075QW
Bayer Metrika, Inc. Bayer Corp Bio-Rad Laboratories Cholestech Corporation Metrika, Inc Metrika, Inc Metrika, Inc Provalis Diagnostics Ltd
Beckman Coulter Boehringer Mannheim Diagnostic Chemicals Limit Diagnostic Chemicals Limit (USA) Roche Diagnostics Corp KDK Corporation Abaxis, Inc Cholestech Polymer Technology Systems, Inc. Litmus Concepts, Inc various Quidel Corporation Beckman Coulter, Inc FemTek, LLC Abaxis, Inc.
Beckman Coulter ICON Micralb Boehringer Mannheim Chemstrip Micral Diagnostic Chemicals ImmunoDip Urinary Albumin Test Diagnostic Chemicals ImmunoDip Urinary Albumin Screen (Urine Dipstick) Roche Diagnostics Chemstrip Micral (Urine Dipstick) Lactate Piccolo Point of Care Chemistry Analyzer (Lipid Panel Reagent Disc) Cholestech LDX PTS Bioscanner (for OTC use) - for HDL cholesterol Litmus Concepts FemExam TestCard (from vaginal swab) - pH All qualitative color comparison pH testing -body fluids (other than blood) Quidel Quick Vue Advance ph and Amines Test Beckman Coulter Primary Care Diagnostics Gastrocult FemTek pHEM-ALERT Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) {whole blood} Key to code changes, page 1, item 5 page 5 of 9
Manuals: Physician Services, Lab & X-ray
Utah Medicaid Provider Manual
Division of Health Care Financing
Code 84132QW 84157QW 84295QW 84450QW 84460QW 84478QW 84478QW 84478QW 84520QW 84550QW 84703QW 85014QW 85018QW 85018QW 85018QW 85018QW 85018QW 85018QW 85610QW 85610QW 85610QW 85610QW 85610QW 85610QW 85610QW 85610QW 85610QW 85610QW 85610QW 86294QW 86294QW 86308QW 86308QW Manufacturer i-STAT Corporation Abaxis, Inc. i-STAT Corporation Cholestech Corp Cholestech Corp Abaxis, Inc Cholestech Polymer Technology Systems, Inc. i-STAT Corporation Abaxis, Inc. Bayer W ampole Laboratories GDS Technology, Inc GDS Technology HemoCue HemoCue HemoCue HemoCue Avocet Medical, Inc. Avocet Medical, Inc Boehringer Mannheim HemoSense Inc. Intl Technidyne Corp (ITC) Roche Diag/ B Mannheim Intl Technidyne Corp Intl Technidyne Corp Lifescan, Inc Roche Diagnostics Roche Diagnostics Corp Bion Diagnostic Sciences Maritech, Inc Applied Biotech, Inc Applied Biotech, Inc
CLIA Certification for Laboratory Services Updated October 2008
Test Name (in order of CPT code) Abbot i-STAT Chem8+ Cartridge {W hole Blood}* Abaxis Piccolo Point of Care Chemistry Analyzer (Liver Panel Plus Reagent Disc) {whole blood} Abbot i-STAT Chem8+ Cartridge {W hole Blood}* Cholestech LDX Aspartate Aminotransferase (AST)(SGOT) Acholestech LDX Alanine Aminotransferase (ALT) Test Piccolo Point of Care Chemistry Analyzer (Lipid Panel Reagent Disc) Cholestech LDX PTS, Inc. Bioscanner 2000 for Triglycerides Abbot i-STAT Chem8+ Cartridge {W hole Blood}* Abaxis Piccolo Blood Chemistry Analyzer (General Chemistry 13 Panel) {W hole Blood}* Bayer Clinitek 50 Urine Chemistry Analyzer - for HCG, urine W ampole STAT-CRIT Hct GDS Diagnostics HemoSite Meter - for hemoglobin GDS Technology STAT-Site Mhgb Test System Hemoglobin 201+/HemoCue Hemoglobin Microcuvette System HemoCue Hemoglobin 201+ (Capillary, Venous, Arterial, W hole Blood) HemoCue Hemoglobin System HemoCue Donor Hemoglobin Checker System HemoCue AvoSure PT System (prescription home use) (Contact your Medicare Carrier for claims instructions) AvoSure Pro (professional use) (Contact your Medicare Carrier for claims instructions) CoaguChek PST for Prothrombin Time HemoSense INRatio System ITC Protime Microcoagulation System for Prothrombin Time Roche/Boehringer M CoaguChek System for Professional Use Intl Technidyne ProTime Microcoagulation Sys (Pro Time 3 Cuvette) Prescription Home Use Intl Technidyne ProTime Microcoagulation Sys (Pro Time 3 Cuvette) Professional Use Lifescan Harmony INR Monitoring System - Prescription Home Use and Professional Use Roche Diagnostics Coaguchek PST Roche Diagnostics Coagu Chek S Systems Test (for prothrombin time) Gion Diagnostic Sciences BTA stat Test (for home use) Matritech, Inc NMP22 BladderCheck Test for Professional and Prescription Home Use Applied Biotech SureStep Mono test (whole blood) Jant Accutest Infectious Mononucleosis Test (whole blood)
page 6 of 9
Key to code changes, page 1, item 5
Manuals: Physician Services, Lab & X-ray
Utah Medicaid Provider Manual
Division of Health Care Financing
Code 86308QW 86308QW 86308QW 86308QW 86308QW 86308QW 86308QW 86308QW 86308QW 86308QW 86308QW 86308QW 86308QW 86318QW 86318QW 86318QW 86318QW 86318QW 86318QW 86318QW 86318QW 86318QW 86318QW 86318QW 86318QW 86318QW 86318QW 86318QW 86618QW 86701QW 86701QW 87077QW 87077QW 87077QW 87077QW 87077QW 87077QW 87210QW 87210QW Manufacturer Applied Biotech, Inc Applied Biotech, Inc Applied Biotech, Inc Genzyme Diagnostics Genzyme Diagnostics
CLIA Certification for Laboratory Services Updated October 2008
Test Name (in order of CPT code) Meridian ImmunoCard Stat Mono (for whole blood) Polymedco, Inc. Poly Stat Mono Remel RIM A.R.C. Strep A Test Genzyme Contrast Mono (whole blood) Seradyn Color Q Mono (whole blood)
Princeton BioMeditech Corp LifeSign UniStep Mono Test (whole blood) Quidel Corp W ampole Laboratories W yntek Diag, Inc W yntek Diag, Inc W yntek Diag, Inc Quidel Corporation W yntek Diagnostics, Inc Abbott Laboratories ACON Laboratories, Inc Applied Biotech, Inc. Applied Biotech, Inc. Applied Biotech, Inc. Applied Biotech, Inc Quidel Cards O.S. Mono (for whole blood) W ampole Mono-Plus W B W yntek Signify Mono Test BioStar Acceava Mono Test (whole blood) W yntek Diagnostics OSOM Mono Test (whole blood) Quidel Quick Vue+ Infectious Mononucleosis (W hole Blood) W yntek Signify Mono Test Abbott TestPak Plus H. pylori (for whole blood) Acon H pylori Test Device Applied Biotech SureStep H. Pylori W B Test (whole blood) JANT Pharmacal Corp. H. Pylori W B Test Polymedco, Inc. Poly stat H. Pylori Meridian BioScience ImmunoCard STAT H.pylori W hole Blood Test
Cortecs Diagnostics Limited Becton Dickinson Link 2 H. pylori Rapid Test (for whole blood) Princeton BioMeditech Quidel Corp Quidel Corp Remel SmithKline Diag, Inc SmithKline Diag, Inc Trinity BioTech Beckman Coulter, Inc W ampole Laboratories OraSure Technologies, Inc OraSure Technologies, Inc Ballard Medical Products Delta W est Tri-Med Specialties Medical Instruments Mycoscience Labs, Inc. Serim GI Supply LEC Associates O2 Unlimited Corp LifeSign Status H. Pylori (for whole blood) QuickVue One-Step H. Pylori test for W hole Blood QuickVue One-Step H. Pylori II Test Remel RIM A.R.C. H. pylori Test SmithKline Diag FlexSure HP Test IgG Antibodies H. pylori whole blood Abbott FlexPak HP test for whole blood Trinity Uni-Gold H.pylori Beckman Coulter Primary Care Diag Flexsure HP Test for IgG Antibodies to H. Pylori in W hole Blood Borrelia burgdorferi OraSure OraQuick Rapid HIV-1 Antibody Test-fingerstick & venipuncture OraSure Technologies OraQuick Rapid HIV-1 Antibody Test Ballard Medical Products CLOtest Delta W est CLOtest Medical Instruments Corporation Pronto Dry H. Corporation phylori GI Supply HP-FAST Serim Pyloritek Test Kit GI Supply, Div. Chek-Med Systems HP One Stesans Maybe Mom Mini Ovulation Microscope Q2 Unlimited Donna Ovulation Tester Key to code changes, page 1, item 5 page 7 of 9
Manuals: Physician Services, Lab & X-ray
Utah Medicaid Provider Manual
Division of Health Care Financing
Code 87449QW 87804QW 87804QW 87804QW 87804QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW 87880QW Manufacturer Zymetx, Inc Quidel Corporation Quidel Corporation Binax, Inc Binax, Inc Applied Biotech, Inc Applied Biotech, Inc Applied Biotech, Inc Applied Biotech, Inc Applied Biotech, Inc Applied Biotech, Inc Applied Biotech, Inc Applied Biotech, Inc Binax Binax Germaine Laboratories Inc Germaine Laboratories Inc Genzyme General Genzyme Diag Genzyme Corporation Applied Biotech, Inc Princeton BioMeditech Quidel Corp Quidel Corporation Quidel Corporation W yntek Diag, Inc W yntek Diag, Inc W yntek Diag, Inc W yntek Diagnostics, Inc Stanbio Laboratory Acon Laboratories, Inc Acon Laboratories, Inc Acon Laboratories, Inc Acon Laboratories, Inc Acon Laboratories, Inc Acon Laboratories, Inc Acon Laboratories, Inc
CLIA Certification for Laboratory Services Updated October 2008
Test Name (in order of CPT code) ZymeTx Zstatflu Test Quidel Quickvue Influenza A+B test Quidel Quick Vue Influenza Test Binax Now Flue A Test Binax Now Blu B Test Applied Biotech SureStep Strep A (II) (direct from throat swab) Becton Dickinson LINK 2 Strep A Rapid Test (direct from throat swab) Fisher HealthCare Sure-Vue Strep A (Direct from throat swab) Jant Pharmacal AccuStrip Strep A (II) (direct from throat swab) Mainline Confirms Strep A Dots Test (direct from throat swab) Meridian Diag ImmunoCard STAT Strep A (direct from throat swab) Polymedco, Inc. Poly stat A (II) Remel RIMÒ A.R.C. Strep A Test Binax NOW Strep A Test SmithKline ICON Fx Strep A Test (from throat swab only) Germaine Laboratories Strep Aim Tower Germaine Laboratories Strep Aim Rapid Dipstick Test Genzyme OSOM Ultra Strep A Test Genzyme Contrast Strep A (direct from throat swab) Genzyme OSOM Strep A U Polymedco Poly Stat Strep A Liquid Test LifeSign LLC Status Strep A Quick Vue In-Line One-Step Strep A Test Quick Vue In-Line One-Strep Strep A Test (K934484) Quick Vue Dipstick Strep A Abbott Signify Strep A Test (from throat swab only) BioStar Acceava Strep A Test (direct specimen only) W yntek Diagnostics OSOM Strep A Test W yntek OSOM Ultra Strep A Test Stanbio QuStick Strep A DE Healthcare Products TruView Strep A Cassette Test Acon Strep A Rapid Strip Test Acon Strep A Twist Rapid Strip Test Beckman Coulter Primary Care Diagnostics ICON DS Strep A Beckman Coulter ICON SC Strep A Test Immunostics Immuno/Strep A Detector Instant Technologies iStrep Strep
page 8 of 9
Key to code changes, page 1, item 5
Manuals: Physician Services, Lab & X-ray
Utah Medicaid Provider Manual
Division of Health Care Financing
Code 87880QW 87880QW 87880QW 89300QW Manufacturer Beckman Coulter DE Healthcare Products Henry Schein Embryotech Laboratories
CLIA Certification for Laboratory Services Updated October 2008
Test Name (in order of CPT code) Beckman Coulter Primary Care Diag ICON FX Strep A Immunochemical Strep A Test DE Healthcare Products, TruView Strep A Test Henry Schein Inc, One Step+ Strep A Test Embryotech Laboratories FertilMARQ Home Diagnostic Screening Test for Male Infertility
Manuals: Physician Services, Lab & X-ray
Key to code changes, page 1, item 5
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