PHYSICIANS LABORATORY SERVICES

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www.physlab.com OMAHA4840 “F” STREET P.O. BOX 27999OMAHA, NE 68127-0999402-731-4145 800-642-1117FAX 402-731-8653LINCOLN7441 “O” STREET, SUITE 100LINCOLN, NE 68510402-488-7710FAX 402-488-6941PHYSICIANS LABORATORY SERVICESANNUAL NOTICE TO PROVIDERS2017The Office of Inspector General (OIG) requires all clinical laboratories to send an annual notice to physicians as partof their compliance program. Physicians Laboratory is dedicated to abide by all federal and state laws andregulations. As part of this commitment, the following information is provided for review.MEDICAL NECESSITYTitle XVIII of the Social Security Act section 1862(a) (1) (A) excludes payment for services “which are not reasonableand necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed bodymember”. Medicare provides specific policies regarding medical necessity via the National CoverageDeterminations (NCDs) and Local Coverage Determinations (LCDs). In order to meet Medicare guidelines theprovider must document medical necessity for each test in the patient’s medical record, as well as accuratelycomplete the test order requisition form including the appropriate third party billing information and diagnosiscode(s). The ordering provider must ensure that all tests ordered meet all Federal and State requirements,including that the attending provider has specifically ordered the test(s) and that the tests are medically necessaryand do not violate frequency limitations. All standing orders must be for a defined period of time and for amedical condition warranting a standing order. Providers may order any tests that they believe are appropriate fortreatment of their patients; however, Medicare will only pay for tests that meet medical necessity requirements.In the event that a provider would like to order testing that does not meet Medicare’s definition of “medicalnecessity”, the provider is responsible for having the patient sign a completed Advance Beneficiary Notice (ABN)prior to service. By signing this document, the patient assumes responsibility for the cost of any testing that isperformed.NATIONAL COVERAGE DETERMINATIONS:The National Coverage Determinations (NCDs) include specific Medicare policies for twenty-four frequentlyordered laboratory tests. The policy manual specifically dictates which ICD-10 codes support medical necessity, aswell as the CPT codes for each of these tests. These rules are binding on all Medicare carriers. The twenty-fourNCDs include:Urine CulturePTTGlucoseDigoxinCA-125GGTHIV (Prognosis)Protime (INR)Glycated HemoglobinAlpha-fetoproteinCA 15.3/CA 27.29Hepatitis PanelHIV (Diagnosis)Iron StudiesThyroid TestingCEACA 19-9Occult BloodBlood CountsCollagen CrosslinksLipid TestinghCGPSASTI ScreeningThe diagnosis provided by the physician will be compared to the ICD-10 codes listed in the NCD policies.ICD-10 codes that are not listed as covered codes in this manual will be denied for payment as they do not supportmedical necessity. In those instances in which a physician wants to order a test with an ICD-10 code that is notlisted, an Advanced Beneficiary Notice (ABN) must be signed by the patient.For the most recent version of the Medicare National Coverage Determinations (NCD) Coding Policy Manual andChange Report please refer to the website below:National Coverage /CoverageGenInfo/LabNCDsICD10.html

www.physlab.com OMAHA4840 “F” STREET P.O. BOX 27999OMAHA, NE 68127-0999402-731-4145 800-642-1117FAX 402-731-8653LINCOLN7441 “O” STREET, SUITE 100LINCOLN, NE 68510402-488-7710FAX 402-488-6941LOCAL COVERAGE DETERMINATIONMedicare contractors can establish additional policies pursuant to their areas of jurisdiction. These policies arecalled Local Coverage Determinations (LCDs) and also have specific ICD-10 codes that are required for payment.Currently, these include:Allergy TestingCirculating Tumor AssaysDrug TestingFlow CytometryGenetic Testing for CYP2C19, CYP2D6, CYP2C9 & VKORC1Genetic Testing for Hypercoagulability/Thrombophilia (Factor V Leiden, Factor II Prothrombin, & MTHFR)Molecular Diagnostic TestingVitamin D AssayFor the most recent list of Local Coverage Determinations for the states of Nebraska, Iowa, Kansas and Missouri,please refer to the website below:Local Coverage Determinations (WPS Health Insurance Medicare J5 MAC Part tionsADVANCE BENEFICIARY NOTICE (ABN)The Advance Beneficiary Notice (ABN) is provided to Medicare beneficiaries to inform the patient that Medicaremay not pay for specific services. The provider is required to document the specific tests, the reason Medicaremay not pay and the estimated cost of each test. By signing, the patient then assumes responsibility for paymentof the tests in the event Medicare denies payment. The ABN must be completed prior to services beingperformed. Common reasons for Medicare denials include: The diagnosis code provided does not support medical necessity. Testing exceeded Medicare’s frequency limitations. Testing is considered experimental or for research use. Testing is for screening purposes only.CUSTOM PANELSPhysicians Laboratory does not encourage the use of custom profiles; however, in those instances in which aprovider requests customization they will be required to date and sign a form acknowledging the following: The provider requested the custom test order profile. The provider has been informed of the Medicare reimbursable amount and CPT codes for thecustom panel and its components. The provider is aware that the use of customized panels may result in Medicare denyingreimbursement. The provider must order individualized tests or a less inclusive profile when all of the tests inthe custom panel are not medically necessary. The provider recognizes that the “Office of Inspector General (OIG) takes the position that anindividual who knowingly causes a false claim to be submitted may be subject to sanctions orremedies available under civil, criminal and administrative law” (Federal Register, p. 45080). The provider is aware that the laboratory makes available the services of a Clinical Consultantto assist in ensuring that appropriate tests are ordered.The Provider Acknowledgement Form must be signed annually.

www.physlab.com OMAHA4840 “F” STREET P.O. BOX 27999OMAHA, NE 68127-0999402-731-4145 800-642-1117FAX 402-731-8653LINCOLN7441 “O” STREET, SUITE 100LINCOLN, NE 68510402-488-7710FAX 402-488-6941REFLEX TESTINGPhysicians Laboratory utilizes reflex testing to validate primary test results or add additional testing whenmedically appropriate. A list is provided below that details all reflex testing that is performed at PhysiciansLaboratory, as well as all reference laboratories.PERFORMED AT PHYSICIANS LABORATORYINITIAL TESTREFLEX CRITERIAREFLEX TESTING (WHEN NECESSARY)ANA, IgG Screen w/ Reflex to Titer ANA 20 UnitsIFA Titer(CPT -------ANA, IgG Screen w/ Reflex toANA 20 UnitsdsDNA IgG(CPT 86225)Connective Tissue Disease ProfileSmith ENA IgG (CPT 86235)SSA IgG(CPT 86235)SSB IgG(CPT 86235)SCL-70 IgG(CPT 86235)Chromatin(CPT 86235)Centromere(CPT 86235)RNP IgG(CPT -------Antibody ScreenPositiveAntibody ID(CPT 86780)(Reflex requires Provider’s Approval)Antibody Titer (CPT 86886)**If the antibody cannot be identified at PLS, the specimen will be forwarded to a referral laboratory for additionaltesting (additional CPT Codes will --------Beta StrepPositive Group B Strep w/Sensitivity(CPT 87186)(Genital)Penicillin --------Culture, AFB & SmearPositive growthSensitivity(CPT 87186)ID(CPT 87118)ID by Probe(CPT 87149)ID by Sequencing (CPT 87153)Respiratory SourceConcentration (CPT -------Culture, AerobicPositive growth w/Sensitivity(CPT 87186)(Urine, Genital, Fluid, Wound &Clinical RelevanceID(CPT 87077)Respiratory)Typing(CPT -------------------------------------------- -------------Culture, AnaerobicPositive growthID(CPT -------Culture, FungusPositive growthID (Yeast)(CPT 87106)ID (Mold)(CPT -------Culture, TissueHomogenizationHomogenization (CPT 87176)Positive growthSensitivity(CPT 87186)Typing(CPT 87147)ID(CPT 87077)

www.physlab.comREFLEX TESTING - PERFORMED AT PHYSICIANS LABORATORYINITIAL TESTREFLEX CRITERIACytopathology FluidsPer Pathologist Request OMAHA4840 “F” STREET P.O. BOX 27999OMAHA, NE 68127-0999402-731-4145 800-642-1117FAX 402-731-8653LINCOLN7441 “O” STREET, SUITE 100LINCOLN, NE 68510402-488-7710FAX 402-488-6941REFLEX TESTING (WHEN NECESSARY)Histologic StainsImmunopathologic StainsFlow CytometryElectron -----------DNA Double Stranded (dsDNA)dsDNA 200 IU/mLIFA Titer(CPT 86256)IgG w/ Reflex to IFA ------Drug ScreensPositiveConfirmation(CPT -------Female Infertility PanelEIA PositiveRPR(CPT 86592)EIA Positive & RPR NegativeTP-PA(CPT -------HIV 1/2 AntibodyPositiveConfirmation(CPT 86701)(CPT -------Hepatitis Bs AntigenPositiveConfirmation(CPT 87341)Hepatitis Bs Ag -------------HSV Culture w/ Typing 1 & 2PositiveTyping(CPT -------HPV High Risk w/ Reflex toPositive for High Risk HPV16/18 Genotype (CPT 87625)16/18 ---------OB Panel IEIA PositiveRPR(CPT 86592)EIA Positive & RPR NegativeTP-PA(CPT -------OB Profile IVEIA PositiveRPR(CPT 86592)EIA Positive & RPR NegativeTP-PA(CPT -------OB Profile IV Hep CEIA PositiveRPR(CPT 86592)EIA Positive & RPR NegativeTP-PA(CPT -------------------------- -------------------------------OB Profile VIEIA PositiveRPR(CPT 86592)EIA Positive & RPR NegativeTP-PA(CPT ---------------------------- -----------------------------Pap, SurePath w/ Reflex toAge 21 or 65 No HPVHPV (ACOG Guidelines)Age 21–29 HPV High Risk Screen if ASCUS HPV High Risk(CPT 87624)Age 30–65 Pap & HPV Any Dx (Co-Testing) HPV High Risk(CPT 87624)Age 30-65 Pap (Neg) HPV Screen (Pos)HPV 16/18(CPT --------

www.physlab.com OMAHA4840 “F” STREET P.O. BOX 27999OMAHA, NE 68127-0999402-731-4145 800-642-1117FAX 402-731-8653LINCOLN7441 “O” STREET, SUITE 100LINCOLN, NE 68510402-488-7710FAX 402-488-6941REFLEX TESTING - PERFORMED AT PHYSICIANS LABORATORYINITIAL TESTREFLEX CRITERIAREFLEX TESTING (WHEN NECESSARY)Pap, ThinPrep w/ Reflex toHPV (ACOG Guidelines)Age 21–29 HPV High Risk Screen if ASCUS HPV High Risk(CPT 87624)Age 30–65 Pap & HPV Any Dx (Co-Testing) HPV High Risk(CPT 87624)Age 30-65 Pap (Neg) HPV Screen (Pos)HPV 16/18(CPT -------Pap, ThinPrep Imaged w/ Reflexto HPV (ACOG Guidelines)Age 21–29 HPV High Risk Screen if ASCUS HPV High Risk(CPT 87624)Age 30–65 Pap & HPV Any Dx (Co-Testing) HPV High Risk(CPT 87624)Age 30-65 Pap (Neg) HPV Screen (Pos)HPV 16/18(CPT -------Partner Infertility PanelEIA PositiveRPR(CPT 86592)EIA Positive & RPR NegativeTP-PA(CPT -------Semen Analysis, FertilityAbsence of SpermSemen Fructose (CPT -------Surgical PathologyPer Pathologist RequestHistologic StainsImmunopathologic StainsFlow CytometryElectron MicroscopyMolecular ----------TrepSureEIA PositiveRPR(CPT 86592)(Anti-treponemal EIA Assay)EIA Positive & RPR NegativeTP-PA(CPT -------TSH w/ Reflex to Free T40.5 uIU/mL TSH 5.0 uIU/mLFree T4(CPT -------UrinalysisPositive blood, protein, nitrites,Microscopic Examor leukocyte esterase and/or(Replace CPT 81003 w/cloudy appearanceCPT -------Urinalysis w/ Reflex to CultureWBC 5Urine Culture(CPT -------Urine TestingAny timed urine sample thatUrine Volume(CPT 81050)(Timed Samples)requires a volume -------------

www.physlab.comREFLEX TESTING - PERFORMED AT REFERENCE LABORATORIESINITIAL TESTREFLEX CRITERIA OMAHA4840 “F” STREET P.O. BOX 27999OMAHA, NE 68127-0999402-731-4145 800-642-1117FAX 402-731-8653LINCOLN7441 “O” STREET, SUITE 100LINCOLN, NE 68510402-488-7710FAX 402-488-6941REFLEX TESTING (WHEN NECESSARY)Anabolic Steroids, Urine ScreenPositive for any anabolic steroidConfirmation(CPT 80328)w/ Reflex to -------------ANCA, IgGANCA screen detects antibodies at aEnd point titer (CPT 86256)1:20 dilution or greater, then a titer toend point will be ------------------------------------- -------------------Arsenic, Urine with ReflexIf total arsenic concentrationArsenic(CPT 82175)to Fractionationis between 35-2000 -----------------BCR-ABL1, Qualitative w/BCR-ABL1 Fusion Form UnknownBCR-ABL1 (p210) (CPT 81206)Reflex to BCR-ABL 1 Quantitative Reflex detects the presence of p210BCR-ABL1 (p190) (CPT 81207)or p190 and then -------------------------- ------------------------------------Bordetella pertussis CultureB. pertussis pathogen definitivelyAerobic Isolate (CPT -----------------Bordetella pertussis IgG by ElisaB Pertussis IgG 1.0 U/mL or IgG Immunoblot (CPT 86615)w/ Reflex to -----------Bordetella pertussis AntibodiesB Pertussis IgA 1.2 U/mL or IgA Immunoblot (CPT 86615)IgA, IgG, and IgM by Elisa w/B Pertussis IgG 1.0 U/mL or IgG Immunoblot (CPT 86615)Reflex to ImmunoblotB Pertussis IgM 1.2 U/mL or IgM Immunoblot (CPT -------Clostridium difficile CultureC. difficile culture is PositiveCytotoxin Cell(CPT 87230)w/ Reflex to Cytotoxin ---------------Dilantin Total w/ Reflex to FreeDilantin 0.5 ug/mLDilantin Free(CPT -------GHB, SerumPositiveConfirmation(CPT -------Hantavirus Ab IgG & IgMPositiveConfirmation(CPT 86790)w/ Reflex to ConfirmationEach ----------Heavy Metals Panel 3 w/If total arsenic concentrationArsenic(CPT 82175)Reflex to Arsenic Fractionatedis between 35-2000 ------------------Heparin InducedPositive Heparin PF4 ScreenHeparin PF4 IgG (CPT 86022)Thrombocytopenia AntibodyPositive Heparin PF4 IgGHeparin(CPT -----------------------------

www.physlab.comREFLEX TESTING - PERFORMED AT REFERENCE LABORATORIESINITIAL TESTREFLEX CRITERIA OMAHA4840 “F” STREET P.O. BOX 27999OMAHA, NE 68127-0999402-731-4145 800-642-1117FAX 402-731-8653LINCOLN7441 “O” STREET, SUITE 100LINCOLN, NE 68510402-488-7710FAX 402-488-6941REFLEX TESTING (WHEN NECESSARY)HCV PCR w/ Reflex to GenotypeHCV Viral Load 100 IU/mLHCV Genotype (CPT -------HSV Type 1 and/or 2 IgG and IgM HSV 1 and/or 2 IgG 1.10 IVHSV 1 gG Specific (CPT 86695)w/ Reflex to Type 1 & 2HSV 2 gG Specific (CPT 86696)Glycoprotein G-Specific Ab, ----Herpesvirus 6 Antibody, IgMHHV6 IgM is detected at 1:10HSV Titer(CPT 86790)w/ Reflex to Titer by ----HTLV I/II Antibodies w/ ReflexHTLV I/II screen is repeatedly reactiveHTLV I/II(CPT 86689)To HTLV I/II -------------------------Lupus Anticoagulant PanelPT 15.0PT, Pt/Ctrl Mix (CPT 85611)TCT 20TT, Pt/PSO4 Mix (CPT 85670)APTT 36aPTT, Pt/Ctrl Mix (CPT 85732)APTT Mix 5HPNT(CPT 85598)DRVVT 45.7dRVVT Mix Ratio (CPT 85613)DRVVT Ratio 1.2drVVT Confirm (CPT -------Motor & SensoryANNA screen is positive at 1:10 or greater ANNA Titer(CPT 86256)Neuropathy EvaluationWestern Blot(CPT 83516)w/ Immunofixation & -------Myasthenia GravisIf muscle AchR modulatingGAD65 Ab Assay (CPT 86341)Evaluation Adultantibody value is (or exceeds) 90%CRMP-5-IgG(CPT 84182)Acetylcholine receptor (AchR) lossNeuronal VGKC (CPT 83519-59)and Striational Ab 1:60AchR Ganglionic (CPT 83519-59)(All four codes listed to the right willNeuronal Abbe added if these conditions are ----- -Paraneoplastic AntibodiesIf IFA Screen is Positive at 1:10, thenTiter(CPT 86256)(PCCA-ANNA) by IFA w/ Reflexa specific titer and Western Blot willWestern Blot(CPT 83516)to Titer & Western Blotbe ------Paraneoplastic AutoantibodyIFA patterns indeterminateParaneoplasticEvaluationAutoantibody WB(CPT 84182)IFA patterns suggest CRMP-5-IgGCRMP-5-IgG WB (CPT 84182)IFA pattern suggests NMONMO IgG(CPT 86255)IFA pattern suggests Amphiphysin AbAmphiphysin WB (CPT 84182)IFA pattern suggest GAD65 AbGAD65 Ab(CPT 86341)If Ach Receptor Binding Ab 0.02 orAch Recep Mod (CPT 83519-59) &If striational ab are 1:60CRMP-5-IgG WB (CPT 84182)

www.physlab.comREFLEX TESTING - PERFORMED AT REFERENCE LABORATORIESINITIAL TESTREFLEX CRITERIA OMAHA4840 “F” STREET P.O. BOX 27999OMAHA, NE 68127-0999402-731-4145 800-642-1117FAX 402-731-8653LINCOLN7441 “O” STREET, SUITE 100LINCOLN, NE 68510402-488-7710FAX 402-488-6941REFLEX TESTING (WHEN NECESSARY)Phenytoin, Total w/ Reflex toPhenytoin 0.5 ug/mLPhenytoin Free (CPT 80186)Phenytoin, -----Respiratory Viral CultureIf definitive ID performedDefinitive ID(CPT -------Skeletal Muscle Antibody, IgGStriated Muscle Ab is 1:40Striated Muscle (CPT 86256)w/ Reflex to -----------Smooth Muscle Ab, IgGSmooth Muscle Ab IgG 20 UnitsSmooth Muscle (CPT 86256)w/ Reflex to TiterAb, IgG IFA ------Thyroglobulin EvaluationTgAb NegativeTg CIA(CPT 84432)w/ Reflex to LC-MS/MS or CIATgAb PositiveTg LC-MS/MS(CPT -------Viral CultureIf definitive ID performedDefinitive ID(CPT 87253)TECHNICAL CONSULTANTS & MARKETING PERSONNELPatti SeidelConsultantpseidel@physlab.comPhone: (402)690-9802Angie WilcoxsonConsultantEmail: awilcoxson@physlab.comPhone: (402)660-4858Bev RuchMarketing RepresentativeEmail: bruch@physlab.comPhone: (402)660-6760Vinny RallisMarketing RepresentativeEmail: vrallis@physlab.comPhone: (402)547-1294Kacey MorelandDirector of MarketingEmail: kmoreland@physlab.comPhone: (402)677-8872

INITIAL TEST REFLEX CRITERIA REFLEX TESTING (WHEN NECESSARY) ANA, IgG Screen w/ Reflex to Titer ANA 20 Units IFA Titer (CPT 86039) ----- ANA, IgG Screen w/ Reflex to ANA 20 Units dsDNA IgG (CPT 86225) Connective Tissue Disease Profile Smith ENA IgG (

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