Mayo Medical Laboratories



POLICY:Genetic Testing is required to be scheduled prior to patients presenting to the laboratory for collection. This process will allow the scheduler to obtain the prior pre-authorization if needed from the ordering provider. Genetic testing is typically an expensive test and many insurance companies require pre-authorization prior to performing. The physician ordering the test is required to obtain the authorization number from the insurance company or meet the requirements for medical necessity if no authorization is needed.The patient cannot have the testing performed without the information provided above. If the patient presents without the information the ordering physician will be contacted to provide the authorization or asked to complete an Advanced Beneficiary Notice (ABN) form. The signed ABN holds the patient responsible for charges if the insurance does not cover the testing. The following insurances and requirements are included in this policy:HighmarkUPMCCignaAetnaGatewayMedicareFirstCare PPOHealthAmerica CoventryTypes of Genetic Testing:Newborn ScreeningNewborn screening is used just after birth to identify genetic disorders that can be treated early in life. Diagnostic TestingDiagnostic testing is used to identify or rule out a specific genetic or chromosomal condition. In many cases, genetic testing is used to confirm a diagnosis when a particular condition is suspected based on physical signs and symptoms. Diagnostic testing can be performed before birth or at any time during a person’s life.Carrier TestingCarrier testing is used to identify people who carry one copy of a gene mutation that, when present in two copies, causes a genetic disorder. This type of testing is offered to individuals who have a family history of a genetic disorder and to people of certain ethnic groups with an increased risk of specific genetic conditions. Prenatal testingPrenatal testing is used to detect changes in the fetus’s genes or chromosomes before birth. This type of testing is offered during pregnancy if there is an increased risk that the baby will have a genetic or chromosomal disorder. In some cases, prenatal testing can lessen a couple’s uncertainty or help them make decisions about a pregnancy.Currently Available DNA-Based Gene Tests:Alpha-1-antitrypsin deficiency (AAT; emphysema and liver disease)Amyotrophic lateral sclerosis (ALS; Lou Gehrig’s Disease; progressive motor function loss leading to paralysis and death)Alzheimer’s disease (APOE; late-onset variety of senile dementia)Ataxia telangiectasia (AT; progressive brain disorder resulting in loss of muscle control and cancers)Gaucher disease (GD; enlarged liver and spleen, bone degeneration)Inherited breast or ovarian cancer (BRCA1/BRCA2; early onset tumors of breasts and ovaries)Hereditary nonpolyposis colon cancer (CA; early-onset tumors of colon and sometimes other organs)Central core disease (CCD; mild to severe muscle weakness)Charcot-Marie-Tooth (CMT; loss of feeling in ends of limbs)Congenital adrenal hyperplasia (CAH; hormone deficiency; ambiguous genitalia and male pseudohermaphroditism)Cystic fibrosis (CF; disease of lung and pancreas resulting in thick mucous accumulations and chronic infections)Duchenne muscular dystrophy/Becker muscular dystrophy (DMD, sever to mild muscle wasting, deterioration, weakness)Dystonia (DYT; muscle rigidity; repetitive twisting movements)Emanuel syndrome (severe mental retardation, abnormal development of the head, heart and kidney problem)Fanconi anemia, group C (FA; anemia, leukemia, skeletal deformities)Factor V Leiden (FVL; blood-clotting disorder)Fragile X Syndrome (FRAX; leading cause of inherited mental retardation)Galactosemia (GALT; metabolic disorder affects ability to metabolize galactose)Hemophilia A and B (HEMA and HEMB; bleeding disorders)Hereditary hemochromatosis (HFE; excess iron storage disorder)Huntington’s disease (HD, usually midlife onset; progressive, lethal, degenerative neurological disease)Marfan syndrome (FBNI; connective tissue disorder, tissues of ligaments, blood vessel walls, cartilage, heart valves and other structures abnormally weak)Mucoplysaccharidosis (MPS; deficiency of enzymes needed to break down long chain sugars called glycosaminoglycans; corneal clouding, joint stiffness, heart disease, mental retardation)Myotonic dystrophy (MD; progressive muscle weakness, most common form of adult muscular dystrophy)Neurofibromatosis type 1(NF1; multiple benign nervous system tumors that can be disfiguring; cancers)Phenylketonuria (PKU; progressive mental retardation due to missing enzyme; correctable by diet)Polycystic kidney disease (PKD1, PKD2; cysts in the kidneys and other organs)Adult polycystic kidney disease (APKD; kidney failure and liver disease)Prader Willi/Angleman syndromes (PW/A; decreased motor skills, cognitive impairment early death)Sickle cell disease (SS; blood cell disorder; chronic pain and infections)Spinocerebellar ataxia, type 1(SCA1; involuntary muscle movements, reflex disorders, explosive speech)Spinal muscular atrophy (SMA; severe, usually lethal progressive muscle-wasting disorder in children)Tay-Sachs disease (TS; fatal neurological disease of early childhood, seizures, paralysis)Thalassemias (THAL; anemias-reduced red blood cell levels)Timothy syndrome (CACNA1C; characterized by sever cardiac arrhythmia, webbing of the fingers and toes called syndactyly, autism)PROCEDURE:Prior to genetic testing being performed the Physician’s office must contact the scheduling department at 724-357-7075. The scheduling staff will require the office to obtain the proper authorization if needed prior to calling. The authorization and ordering script must be faxed at the time of scheduling.The ordering script and authorization form will be scanned into Meditech for other departments to prepare for the patient arrival by the scheduling staff.Appointments will have a two-day lead time and will only be scheduled Monday –Thursday 0630 to 1600 at the IRMC OP Lab at 835 Hospital Road location. Laboratory staff will have ample time to determine specimen requirements based on the test ordered and provide specimen integrity for shipping to the appropriate reference lab.Meditech Scheduling Software is programmed to flag the scheduling staff with the following message:THIS PROCEDURE WILL MORE THAN LIKELY REQUIRE A PRE-AUTHORIZATION. OFFICES MUST CALL INSURANCE TO VERIFY PATIENT PLAN REQUIREMENTS PER CPT.Physician’s office will be required to provide one of the following upon scheduling:Authorization numberNo authorization needed as per insuranceName of the representative giving information from insurance providerInfo provided by representativeWho called (from Physician’s office)Date and time calledNo authorization and meeting medical necessity as per policy/procedureThe scheduler will place either the AUTHORIZATION # or NONE in the authorization field.Patient presents with authorization or verification:Testing can be ordered, collected and referred to the proper reference laboratory. Verify if multiple testing is ordered that all requiring authorizations are denoted on the authorization form. If not an additional authorization may need to be obtained. Patient presents without authorization:The genetic test listing below denotes requirements for pre-authorizations prior to collection. Contact the physician office and inform pre-authorization form must first be obtained prior to collection of specimen. The physician office can fax the form to the collection site Patient may need to return to have testing completed until authorization is receivedIf patient is unwilling to return, they can complete an ABN form with the understanding they are responsible financially for any charges to IRMCThe authorization or ABN must be scanned into the system along with the physician orderHighmark RequirementsGenetic testing performed on patients with no current evidence or manifestation of genetic disease (i.e., asymptomatic) is considered genetic screening and is non-covered except for those groups/programs that specifically identify coverage in benefits. This includes genetic testing performed to determine susceptibility or predisposition to diseases such as cancer and heart disease and genetic testing for carrier identification to determine if a person is a “carrier” of an abnormal gene.Highmark requires a pre-authorization form for the following tests:CYP2C19 (Drug Metabolism)CYP2D6 (Drug Metabolism)CYP2C9 (Drug Metabolism)CPT 81275 KRAS Gene MutationCPT 81280 Long QT Syndrome Full Gene SequenceCPT 81281 Long QT Syndrome Known Familial Sequence VariantCPT 81282 Long QT Syndrome Deletion/Duplication VariantsCPT 81401 TPMT GenotypingCPT 81403 Pancreatitis MutationCPT (Dependent on Agent) Infectious Agent GenotypeCPT 81479 Unlisted Pathology TestCPT 83520x5, 88347, 88347x2, 81401 Chrons PrognosticCPT 81257, 81401, 81403, 81404 Hgb Molecular Exam And Selection Of Retrieved ArchivalThe following testing is covered for symptomatic patients. The testing is only covered for asymptomatic patients when the patient’s contract covers genetic testing. This is not an all-inclusive list.CPT: 81292, 81293, 81294, 81295, 81296, 81298, 81299, 81300, 81301, 81317, 81318, 81319) Inherited susceptibility to colon cancerCPT: 81220, 81221, 81222, 81223, 81224 Cystic Fibrosis TestingCPT: 81256 HemochromatosisCPT: 81257 Alpha-ThalessemiaCPT: 81255 Tay-Sachs DiseaseCPT: 81251 Gaucher DiseaseCPT: 81330 Niemann-Pic DiseaseCPT: 81241 Factor V Leiden ThrombophiliaCPT: 81243, 81244 Fragile X SyndromeGenetic testing for prenatal and preconceptual carrier screening is considered medically necessary for individuals of Ashkenazi Jewish ancestry in accordance with the American College of Medical Genetics guidelines as follows:Bloom SyndromeCanavan DiseaseCystic FibrosisDihydrolipoamide Dehydrogenase Deficiency (DLD)Familial Dysautonomia (FD)Familial Hyperinsulinism (FHI)Fanconi Anemia Type CGaucher Disease Type 1Glycogen Storage Disease type 1AJoubert SyndromeMaple Syrup Urine DiseaseMucolipidosis IVNemaline Myopathy (NM)Niemann-Pic Disease Type ASpinal Muscular AtrophyUsher Syndrome Type III and Type 1FWalker-Warburg SyndromeUPMC Health Plan RequirementsUPMC Health Plan requires prior authorization for the following genetic testing. Authorization should be approved based on the following indications. However, if testing is being performed based on the limitations medical necessity may not be proven.CPT Code: 81280 Long QT Syndrome Full Gene Sequence 81281 Long QT Syndrome Known Familial Sequence Variant 81282 Long QT Syndrome Deletion/Duplication VariantsCPT Codes: Breast and Ovarian Cancer Testing81211BRCA1/BRCA2 Gene Analysis Common Variant81212BRCA1/BRCA2 185/5385/6174 Variants81213BRCA1/BRCA2 Uncommon Variant81214BRCA1 Gene Analysis Common Variants81215BRCA1 Known Familial Variant81216BRCA2 Gene Analysis Common Variants81217BRCA2 Known Familial VariantBRACAnalysis? Rearrangement Test (BART) (Myriad Genetic Laboratories, Inc., Salt Lake City, UT)Inherited Colorectal Cancers: (HPNCC, FAP and MAP testing)CPT Codes: Cystic Fibrosis Testing81220CFTR Gene Analysis Common Variants81221CFTR Known Familial Variants81222CFTR Dup/Del Variants81223 CFTR Full Gene SequenceGenetic Testing for Long QT Syndrome:In order for medical necessity to be established, adequate information must be furnished by the treating physician. Necessary information includes, but is not limited to:Physician’s letter of medical necessity which includes supporting documentation such as patient symptoms, QT interval per EKG and family history with clinical documentation validating diagnosis.The Medical Management staff assigned to review obtains the clinical information according to determine if there is adequate clinical information. If the case does not meet established criteria, it is referred to a Medical Director. The Medical Director will then determine if the request service is medically necessary and appropriate. The Medical Management staff completes the review process and communicates the review decision according to the Timeliness of UM Decisions policy for the member’s benefit plan.Indications:QTc interval >470 msec in males and >480 msec in femalesDocumented history of Torsades de pointesPresence of T-wave alternans AND notched T Waves in 3 leadsA first degree relative with a confirmed clinical diagnosis of LQTSMembers with a QTc>440 msec AND an episode of aborted sudden death without another cause (such as cardiomyopathy or MI)Unexplained syncope and either A QTc >450 msec for males or >460 msec for females ORA known family member (1st or 2nd degree relative) with genetically identified LQTSLimitations:Members with a known cause of acquired LQTS such as drug induced, intracranial bleed or acute MIGenetic screening for LQTS in the general populationGenetic screening to determine prognosis and/or direct therapy in patients with known LQTSFamily testing of members with genetically-proven LQTSMolecular Susceptibility Testing for Breast Cancer and/or Ovarian (BRCA and BART Testing):In order to assess medical necessity for BRCA testing, adequate information must be furnished by the treating physician. Necessary information includes, but is not limited to:Physician’s letter of medical necessity to includeThe physician’s evaluation of the member’s condition andDetailed personal and family history of Breast/Ovarian and other pertinent cancers among first and second degree relatives (when applicable)Additional information will be requested if necessaryBART test- BRCA test results in addition to the above informationThe Medical Management staff assigned to review obtains the clinical information according to determine if there is adequate clinical information. If the case does not meet established criteria, it is referred to a Medical Director. The Medical Director will then determine if the request service is medically necessary and appropriate. The Medical Management staff completes the review process and communicates the review decision according to the Timeliness of UM Decisions policy for the member’s benefit plan.Indications for BRCA1/BRAC2 TestBRCA testing is indicated in any ONE (1) of the following situations (1-8)Family history with known BRCA1/BRCA2 mutation (male or female)Personal history of breast cancer (including invasive and ductal carcinoma insitu breast cancers) and at least ONE (1) of the following:Diagnosed age ≤ 45 years oldDiagnosed age ≤ 50 years oldAND1 close blood relative with breast cancer ≤ 50 years oldOR1 close blood relative with epithelial ovarian cancer, fallopian cancer, or primary peritoneal cancerORLimited family history2 breast primaries when first breast cancer diagnosis occurred prior to age 50(2 breast primaries include bilateral diseases or cases where there are 2 or more separate ipsilateral primary tumors)Diagnosed age < 60 yrs with triple negative breast cancer (ER neg, PR neg, HER neg)Diagnosed at any ageAND 2 close blood relatives with breast cancer or epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer at any ageClose male blood relative with breast cancerPersonal history of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancerPersonal background of ethnicity that is associated with higher mutational frequency (e.g. founder populations of Ashkenazi Jewish, Swedish, Icelandic, Hungarian and Dutch)Note: Testing for founder mutation(s), if available, should be performed first. Full sequencing may be considered if other HBOC criteria are met.ORPersonal history of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancerORPersonal history of male breast cancer ORPersonal history of breast and/or ovarian cancer at any ageAND2 close blood relatives with pancreatic cancer at any ageORPersonal history of pancreatic adenocarcinoma at any ageAND2 close blood relatives with breast and/or ovarian and/or pancreatic cancer at any ageORFamily history onlyAND1st or 2nd degree relative who meets any of the above criteria (1-6)OR3rd degree blood relative with breast cancer and/or ovarian/fallopian tube/primary peritoneal cancerAND2 close blood relatives with breast cancer (at least one with breast cancer ≤ 50yr and/or ovarian cancer (at least 1 with breast cancer 50 yr)ORLimited family history, such as fewer than 2- 1st or 2nd degree female relatives or female relatives surviving beyond 45 year in either linage. Note: When investigating limited family history, the maternal and paternal sides should be considered separately.Testing Family MembersOccasional, blood or tissue samples from other non-covered family members are required to provide the medical information necessary for the proper medical care of a member. Such molecular-based testing for BRCA and other specific heritable disorders in non-members will be reviewed for medical necessity when ALL of the flowing conditions are met:The information is needed to adequately assess risk in the memberANDThe information will be used in the immediate care plan of the memberANDThe non-covered family member’s benefit plan (if any) will not cover the test and the denial is based on specific plan exclusion.Indications for BRACAnalysis? Rearrangement Test (BART):BART testing is indicated when the member is BRCA1/BRCA2 negativeANDIn any ONE (1) of the following situations (1-5)Breast cancer before age 50ANDFamily history of 2 or more close blood relatives with a diagnoses of breast cancer before age 50 and/or ovarian cancer at any ageOvarian cancer at any ageANDFamily history of 2 or more close blood relatives with a diagnoses of breast cancer before age 50 and/or ovarian cancer at any ageMale breast cancer at an ageANDFamily history of 2 or more close blood relatives with a diagnoses of breast cancer before age 50 and/or ovarian cancer at any ageBreast cancer at or after age 50 and ovarian cancer at any ageANDFamily history of 1 or more close blood relatives with breast cancer before age 50 and/or ovarian cancer at any ageBreast cancer before age 50 and ovarian cancer at any ageANDNo additional relatives are requiredLimitations of BRCA1/BRCA2 and BART testingExperimental and Investigational and therefore not covered:BRCA testing for assessment of risk of cancers other than breast or ovarian cancersNot medically necessary and therefore not covered:Genetic testing in members less than 18 years old for BRCA1 and BRCA2 mutationsWhen BRCA testing is performed primarily for medical management of other family members that are not covered by UPMC Insurance Services DivisionMembers post bone marrow transplant (allogenic or autologous) should not have testing via blood or buccal samples (due to contamination of donor DNA). In these cases, DNA should be extracted from a fibroblast culture.Genetic Testing for Inherited Colorectal Cancers: (HPNCC, FAP and MAP testing)HPNCC indications:UPMC Insurance utilizes modified Bethesda criteria to determine Medical necessity. Individuals must meet one of the following for medical necessity of HPNCC testing.Diagnosed with colorectal cancer before the age of 50 yearsPresence of synchronous or metachronous colorectal or other HNPCC related tumors regardless of age.Colorectal cancer with the MSI-H histology diagnosed in individual before the age of 60 years.Individuals with colorectal cancer with one or more first-degree relatives with an HNPCC related tumor, with one of the cancers diagnosed before age 50 years.Colorectal cancer diagnosed in two or more first or second degree relatives with an HNPCC related tumor, regardless of age.An alternative indication for who should have genetic testing is to perform the MSI-H testing on colon cancer tissue of patients meeting any of the Bethesda modified criteria. It the MSI-H is positive, the one could proceed with genetic testing for HNPCC.Note: Genetic testing to determine the carrier status of the HNPCC gene may be considered medically necessary in patients without a history of colorectal cancer but who have a first- or second-degree relative with a known HNPCC mutation.FAP indications:Members with greater than 100 colonic polyps identified by colonoscopy:ORHistory of FAP in first degree relativesIndividuals with 10-100 adenomas may be considered for APC testing.MYH Associated Polyposis (MAP) indications:Individuals with personal history of adenomatous polyposis and a negative APC test and a negative family history for adenomatous polyposis.Individual with a personal history of AP and family history for recessive inheritance where only siblings are affected;ORAsymptomatic siblings of individuals with know MYH polyposisCystic Fibrosis Genetic Testing:Indications:Diagnostic purposeA clinical presentation of CF and a negative/equivocal sweat testInfants with meconium ileus or other symptoms indicative of CF who are too young to produce adequate amounts of sweat for a sweat chloride testCarrier Screening for any of the followingIndividuals with positive family history of CFAdults with partners with known CF mutation or family history of and planning a pregnancyWoman’s reproductive partner had CF or apparently isolated congenital bilateral absence of vas deferensPrenatal testing of fetus may be indicated for any of the followingEmbryo at risk when either a parent has a diagnosis of CF, is a known carrier of a CFTR mutation of has a family history of CFFetus with fetal echogenic bowel per ultrasound during 2nd trimesterLimitations:Carrier screening in the general populationIf a patient has been previously testing, results should be documented and the test not repeatedComplete gene sequencing (beyond the ACMG-23 standard mutation panel) is not appropriate for carrier screening because it may yield results that are difficult to interpret, hence it is not covered and requests for exceptions will be reviewed on a case by case basis.Cigna RequirementsGenetic Disease Screening Panels: Cigna covers genetic testing for specific diseases and disorders as medically necessary when established criteria for that specific genetically transmitted disease are met. For specific criteria, please refer to the following related disease specific indications and limitations. CPT Code: Cystic Fibrosis Testing81220 CFTR Gene Analysis Common 81221 CFTR Known Familial Variant 81223 CFTR Full Gene Sequence (NOT COVERED)CPT Code: Hemochromatosis82156 Hemochromatosis HFE Gene AnalysisCPT Code: Hereditary Hypercoagulability81241 Factor V Leiden Variant 81240 Prothrombin G20210A Gene Analysis81479 Unlisted Molecular Pathology Procedure (NOT COVERED)CPT Code: Hemoglobin Molecular consisting of:81257 HBA1/HBA2 Gene Analysis Common Variant 81401 Molecular Procedure Level 281403 Molecular Procedure Level 481404 Molecular Procedure Level 5CPT Code: Long QT Syndrome81280 Long QT Syndrome Gene Analysis, full sequence81281 Long QT Syndrome Gene Analysis, known familial sequence variant 81282 Long QT Syndrome Gene Analysis, duplication/deletion variantsCPT Code: Breast Cancer and Ovarian Cancer Testing81211BRCA1/BRCA2 Gene Analysis Common Variant81212BRCA1/BRCA2 185/5385/6174 Variants81213 BRCA1/BRCA2 Uncommon Variant 81214BRCA1 Gene Analysis Common Variant81215BRCA1 Known Familial Variant 81216BRCA2 Gene Analysis Common Variant81217BRCA2 Known Familial VariantBRACAnalysis? Rearrangement Test (BART)(Myriad Genetic Laboratories, Inc., Salt Lake City, UT)CPT Code: TPMT Genotyping81401 Molecular Procedure Level 2Cystic Fibrosis: Cigna covers genetic testing for cystic fibrosis (CF) using the American College of Medical Genetics (ACMG) mutation core panel (ACMG-23) as medically necessary of any of the following:Confirmatory testingExhibition of symptoms of CF but has a negative sweat testInfant with other symptoms of CF but is too young to produce adequate volumes for sweat test.Infant with an elevated immunoreactive tyrpsinogen(IRT) with no suspicion of CFPreconception or prenatal carrier testing of an individual who is pregnant or a prospective biologic parentPrenatal testing of fetus (amniocentesis or chorionic villus sampling)Parent has a diagnosis of CF or a known carrier of mutation Fetal echogenic bowl has been identified on ultrasoundICD-9-CM Diagnosis Codes: 277.00 CF without mention of meconium ileus277.01 CF with mention of meconium ileus277.02 CF with pulmonary manifestations277.03 CF with gastrointestinal manifestations277.09 CF with other manifestationsV82.71 Screening for genetic disease carrier statusCigna Does Not Cover for:Carrier Screening in general populationRoutine genetic mutation screening in newbornsExtended mutation panelsCPT: 81223 CFTR Full Gene Sequence Genetic Testing for Hereditary Hemochromatosis: Cigna covers genetic testing to confirm a diagnosis of HFE-HHC as medically necessary without a requirement for pre- and post-test genetic counseling when an individual has findings consistent with hemochromatosis and a serum transferrin iron saturation greater than or equal to 45%, but the diagnosis remains uncertain after completion of conventional testing. ICD-9-CM Diagnosis Code: 275.01 Hereditary hemochromatosisGenetic Testing for Hereditary Hypercoagulability Disorders: Cigna covers genetic testing with targeted mutation analysis for coagulation Factor V Leiden and coagulation factor II (20210G) as medically necessary for either of the following indications:Confirmatory testing in ANY Of the following situationsAge <50 with history of unexplained venous thrombosisAge <50 with unexplained arterial thrombosis in the absence of other risk factors for atherosclerotic vascular diseaseVenous thrombosis in an unusual siteRecurrent venous thrombosisVenous thrombosis and a strong family history of thrombotic diseaseVenous thrombosis in a pregnant woman or a woman taking oral contraceptivesMI in female smoker age <50Predictive testing in a woman of childbearing age with intent/ability to conceive who has first-degree relative with history of high-risk thrombophiliaICD-9-CM Diagnosis Codes:2869Other and unspecified coagulation defects28981Primary hypercoagulable state410.00-410.92 Acute Myocardial Infarction444.0-444.9 Arterial embolism and thrombosis452 Portal vein thrombosis453.0-453.9 Other venous embolism and thrombosis557.0 Acute vascular insufficiency of intestine634.00-634.92 Spontaneous abortion646.30Habitual aborter, unspecified as to episode of care or not applicable646.33Habitual aborter, antepartum condition or complication671.50-671.54 Other phlebitis and thrombosis in pregnancy and the puerperiumV12.51 Personal history of venous thrombosis and embolismCigna DOES NOT COVER for the following indications because they are not considered medically necessary:General population screeningRoutine screening during pregnancy or prior to the use of oral contraceptives, HRT or SERMsNewborn or routine testing on asymptomatic childRoutine initial testing in an individual with arterial thrombosisAdverse pregnancy outcomes such as recurrent pregnancy loss, preeclampsia, intrauterine growth restriction or placental abruptionTesting of an asymptomatic first-degree relative of an individual with proven symptomatic thromboembolism and a proven factor V Leiden of factor II mutations for the purpose of considering primary prophylactic anticoagulationPrenatal testing of fetusCigna DOES NOT COVER genetic testing for ANY of the following indications because it is considered experimental, investigational or unproven:F2 (coagulation factor II) 1199G<A VariantF5 (coagulation factor V) HR2 VariantF7 (coagulation factor VII) R353Q VariantF13B (factor XIII, B polypeptide), V34L variantICD-9-CM Diagnosis Codes: Not coveredV78.8 Special Screening for other disorders of blood and blood-forming organsV78.9Special screening for unspecified disorder of blood and blood forming organsV82.71 Screening for genetic disease carrier statusV82.79 Other genetic screening2869Other and unspecified coagulation defects28981 Primary hypercoagulable state 410.00-410.92 Acute Myocardial Infarction444.0-444.9 Arterial embolism and thrombosisGenetic Testing for Hemoglobinopathies: Cigna covers genetic testing for hemoglobinopathies (i.e. thalassmemias and sickle cell disease) as medically necessary for ANY of the following indications:Confirmatory testing with targeted mutation analysis for common deletions or variants in gene HBB, HBA1 or HBA2 in the following situation Symptomatic individual with clinical features suggestive of a hemoglobinopathy, results by conventional studies yield equivocal results and a definitive diagnosis remains uncertain Infant with a newborn screening test positive for hemoglobinopathyConfirmatory testing with sequence analysis when targeted mutation analysis is negative and the clinical suspicion of hemoglobinopathy remains highPreconception or prenatal genetic testing to determine carrier status of a prospective biological parent with the capacity and desire to reproduce when ANY of the following appliesAn affected family member (first- or second-degree relative) who has thalassemia or sickle cell diseaseThe individual is the reproductive partner of a known carrierThe individual is of African, Asian, Mediterranean, Middle Easter or Caribbean descent and result of testing by conventional studies yield equivocal results and a definitive diagnosis remains uncertainPrenatal testing of a fetus in either of the following situations:Testing targeted mutational analysis of the known mutation when both parents are known carriers for the disorderOne parent is a known carrier and the mutation status of the other parent is not known and can’t be determinedICD-9-CM:282.41-282.49 Thalassemias282.5 Sickle Cell Trait282.60-282.69 Sickle Cell Disease282.7 Other hemoglobinopathiesV18.9 Family history of genetic disease carrierV82.71 Screening for genetic disease carrier statusGenetic Testing for Long QT Syndrome (LQTS):Cigna covers genetic testing for the long QT syndrome as medically necessary for ANY of the following indications:Confirmatory testing with full sequent analysis when there is confirmed prolonged QT interval on electrocardiogram or Holter monitor and an acquired cause has been ruled outPredictive testing with full sequence analysis when there is evidence in a first-degree relative of a history of prolonged QT interval on ECG or Holter monitor , sudden death or near sudden death and a genetic syndrome is suspectedPredictive testing for the known familial sequence variant when there is a positive genetic test for LQTS in a first-degree relative.Prenatal testing of a fetus for known familial sequence variant when the disease-causing mutation has been identified in an affected biologic parentCigna covers genetic testing for LQTS with deletion and duplication analysis as medically necessary when sequence analysis is negative and the clinical suspicion of LQTS remains high.Cigna DOES NOT COVER genetic screening for LQTS if the general population, because such screening is considered not medically necessary or of unproven benefit.ICD-9-CM:426.82 Long QT Syndrome427.0-427.69 Cardiac Dysrhythmias780.2Syncope and collapse780.4Dizziness and giddinessV12.53Personal history of sudden cardiac arrestV17.41Family history of sudden cardiac death (SCD)V17.49Family history of other cardiovascular diseasesV18.9Family history of genetic disease carrierNot covered: V82.79Other genetic screeningGenetic Testing for Susceptibility to Breast and Ovarian Cancer (BRCA1 and BRCA2):Cigna covers BRCA1 and BRCA2 genetic testing for susceptibility to breast or ovarian cancer in adults as medically necessary for ANY of the following indications:Biologically-related individual from a family with a known BRCA1 or BRCA2 mutationPersonal history of breast cancer and ANY of the following:Diagnosed at age 45 or youngerDiagnosed at age 50 or younger with EITHER of the following:At least one close blood relative with breast cancer at age 50 or lessAt least one close blood relative with epithelial ovarian, fallopian tube or primary peritoneal cancerDiagnosed with two breast primaries (includes bilateral disease or cases where there are two or more clearly separate ipsilateral primary tumors) when the first breast cancer diagnosis occurred prior to age 50Diagnoses at age 60 or younger with a triple negative breast cancerDiagnosed at age 50 or younger with a limited family historyDiagnosed at any age and there are at least two close blood relatives with breast cancer or epithelial ovarian, fallopian tube or primary peritoneal cancer at any ageClose male blood relative with breast cancerPersonal history of epithelial ovarian, fallopian tube or primary peritoneal cancerPersonal history of epithelial ovarian fallopian tube or primary peritoneal cancerPersonal history of male breast cancerPersonal history of breast, ovarian or pancreatic cancer at any age with two or more close blood relatives with breast, ovarian or pancreatic cancer at any ageNo personal history of breast or ovarian cancer and a family history of first- or second-degree blood relative meeting any of the above criteriaNo personal history of breast or ovarian cancer and a family history of a third-degree blood relative with breast and/or epithelial ovarian/fallopian tube/primary peritoneal cancer with two or more close blood relatives with breast and/or ovarian cancerCigna covers BRACAnalysis? Rearrangement Test (BART)(Myriad Genetic Laboratories, Inc., Salt Lake City, UT) as medically necessary when conventional BRCA1/BRAC2 testing is negative and for ANY of the following indication:Breast Cancer diagnosed before age 50 and a family history of EITHER of the following orOvarian Cancer diagnosed at an age and a family history of EITHER of the following orMale breast cancer diagnosed at any age and a family history of EITHER of the following orBreast cancer diagnosed at or after age 50 and ovarian cancer at an age and a family history of EITHER of the followingTwo or more diagnoses of breast cancer before age 50 (male breast at any age)Ovarian cancer at any ageDiagnosed with both breast cancer before age 50 and ovarian cancer at any ageCigna DOES NOT COVER BRCA1/BRCA2 genetic testing for susceptibility to breast cancer for the following because it is not considered medically necessary:Genetic screening for general populationTesting of individuals with no personal history of breast or ovarian cancer except as noted aboveTesting of individuals under 18 years of ageCigna DOES NOT COVER other genetic tests for susceptibility to breast and ovarian cancer because they are considered experimental, investigational or unproven.(e.g.Candidate breast cancer susceptibility genes and single nucleotide polymorphisms (SNPs)ICD-9-CM Diagnosis Codes:158.8Malignant neoplasm of specified parts of peritoneum158.9Malignant neoplasm of peritoneum, unspecified174.0-174.9Malignant neoplasm of female breast175.0-175.9Malignant neoplasm of male breast183.0Malignant neoplasm of ovary198.6Secondary malignant neoplasm of ovary198.81Secondary malignant neoplasm of breast233.0Carcinoma in situ of breast238.3Neoplasm of uncertain behavior of breastV10.3Personal history of malignant neoplasm of breastV10.41Personal history of malignant neoplasm of cervix uteriV10.43Personal history of malignant neoplasm of ovaryV10.44Personal history of malignant neoplasm of other female genital organsV10.88Personal history of malignant neoplasm of other endocrine glands and related structuresV16.0Family history of malignant neoplasm of gastrointestinal tractV16.3Family history of malignant neoplasm, breastV16.41Family history of malignant neoplasm, ovaryV84.01Genetic susceptibility to malignant neoplasm of breastV84.02Genetic susceptibility to malignant neoplasm of ovaryNot medically covered: V82.79 Other genetic screeningGenotyping for Thiopurine Methyltranferase (TPMT) Deficiency in Individuals with Inflammatory Bowel Disease (IBD):Cigna covers genotyping for thiopurine methyltransferase (TPMT) deficiency as medically necessary for the management of inflammatory bowel disease (IBD) for either of the following:Prior to the initiation of azathioprine (AZA) or 6-mercaptopurine (6-MP) therapyWhen standard dosing of AZA/6-MP fails to produce a therapeutic responseICD-9-CM Diagnosis Codes:555.0-555.9 Regional enteritis, Crohn’s disease556.0-556.9 Ulcerative colitisGateway Health Plan RequirementsGateway has contracted with many participating hospitals and laboratory facilities for outpatient laboratory services. Gateway members are required to have all of their outpatient laboratory work completed through the appropriate contracted lab. Currently IRMC Lab is not a contracted laboratory with Gateway Medicaid or Medicare Assured.If IRMC is designated as a lab for any reason please contact Provider Services at 1-800-685-5205 for further explanation of what services require an authorization. Authorizations are the responsibility of the ordering provider. STAT laboratory services must only be utilized in urgent cases. If a lab other than the member’s designated lab is to be used, a referral form is required. Every effort should be made to direct the member to his/her designated lab.Unusual circumstances arise where it is impossible to follow the laboratory procedures outlined above, please contact Gateway’s Utilization Management Dept at 1-800-392-1146 for assistance.AETNA RequirementsAetna requires precertification for the following genetic testing:BRCA Genetic Testing: 1-877-794-8720CPT Codes: 81211BRCA1/BRCA2 Gene Analysis Common Variant81212BRCA1/BRCA2 185/5385/6174 Variants81213 BRCA1/BRCA2 Uncommon Variant81214BRCA1 Gene Analysis Common Variants81215BRCA1 Known Familial Variant81216BRCA2 Gene Analysis Common Variants81217BRCA2 Known Familial VariantMaternity genetic testing through the Beginning Right? Maternity Program: 1-800-272-3531CPT Code: Hemoglobin Molecular consisting of:81257 HBA1/HBA2 Gene Analysis Common Variant81401 Molecular Procedure Level 281403 Molecular Procedure Level 481404 Molecular Procedure Level 5CPT Codes: 81280 Long QT Syndrome Gene Analysis, full sequence81281 Long QT Syndrome Gene Analysis, known familial sequence variant 81282 Long QT Syndrome Gene Analysis, duplication/deletion variantsCPT Codes: 81220 CFTR Gene Analysis Common Variants 81221 CFTR Known Familial VariantPre-implantation genetic testing: 1-800-575-5999Medicare RequirementsMedicare states genetic testing will be covered if medical necessity is met. FirstCare PPOThe services requiring preauthorization include, but are not limited to, those services listed below. This listing is subject to change. Please contact customer service 1-800-240-3270 (Commercial) or 1-800-249-7366 (Self-funded) for information on the most up-to-date listing. Payments will be reduced for covered services if a pre-authorization form is not completed.Genetic Testing of any type- Excludes prenatal genetic testingHealthAmerica CoventryGenetic studies are listed as possibly needing prior authorization, but no specific testing is listed. For specific authorization information, use the Authorization Procedure Code Lookup at or contact Customer Service at 1-800-735-4404 (Western PA) or 1-800-290-0190 (Advantra). Coverage is subject to all plan provisions, limitations and eligibility.CPT Information:DESCRIPTIONMCR ALT CODE/CPTIRMC LIS codeBCR/ABL1 Major BREAK QUAL/QUANT81206BCRABLFISHBCR/ABL1 Min Break Qual/Quant81207BCR/ABL1 Other BREAK QUAL/QUANT81208BRAF Gene Analysis V600e Variant81210BRAFBRCA1/BRCA2 GENE Analysis Common VARIANT81211BRCA1/BRCA2 185/5385/6174 Variants81212BRCA1/BRCA2 Uncommon Variant81213BRCA1 Gene Analysis Common Variants81214BRCA1 Known Familial Variant81215BRCA2 Gene Analysis Common Variants81216BRCA2 Known Familial Variant81217CFTR Gene Analysis Common Variants81220CYSFIBCFTR Known Familial Variant81221CFTR Dup/Del Variants81222CFTR Full Gene Sequence81223CFTR Intron 8 Poly-T Analy81224EGFR Gene Analysis Common Variant81235EGFRPROTHROMBIN G20210A Gene Analysis 81240PTGENEFACTOR V LEIDEN Variant Gene Analysis81241F5MUTHEMOCHROMATOSIS HFE Gene Analysis81256HEMOCHROMAHBA1/HBA2 Gene Analysis Common Variant81257JAK2 Gene Analysis V617F Variant81270JAK2KRAS Gene Analysis Codon 12/13 Variant81275KRASMTHFR Gene Analysis Common Variant81291MTHFRSERPIN PEPTIDASE INHIB Gene Analysis81332in A1APHENOHLA ONE LOCUS DQA1/DQB181376Molecular Procedure Level 2 81401Molecular Procedure Level 381402Molecular Procedure Level 4 81403Molecular Procedure Level 581404Unlisted Molecular Path Procedure81479CMV Gene Analysis By Nucleic Acid87910HBV Gene Analysis By Nucleic Acid87912DESCRIPTIONMCR ALT CODE/CPTIRMC LIS codePancreatitis Mutation?HERPANMUTMolecular Procedure Level 4 81403HGB Molecular?HBA1/HBA2 Gene Analysis Common Variant81257Molecular Procedure Level 2 81401Molecular Procedure Level 481403Molecular Procedure Level 581404Chrons Prognostic?CROHNPROGImmunoassay Quant #183520Immunoassay Quant #283520Transglutaminase Antibody88347ASIALOGM1 IGG83520ASIALOGM1 IGM83520 91GD1A IGG83520 91Immunofluorescent Indirect88347Molecular Procedure Level 2 81401TPMT Genotyping?TPMTGENOMolecular Procedure Level 2 81401REFERENCES:Aetna Participating Provider Precertification List; 23.03.858.1P,Effective 1/1/13Aetna Medical Precertification List, healthcare-professionals/policies-guidelines/precertification _policy, Obtained 2/4/13Cigna Medical Coverage Policy Number 0280: Genetic Disease Screening Panels Effective Date 2/15/12Cigna Medical Coverage Policy Number 0022: Genetic Testing for Cystic Fibrosis, Effective Date 1/15/13Cigna Medical Coverage Policy Number 0255: Genetic Testing for Hereditary Hypercoagulability Disorders, Effective Date 12/15/12Cigna Medical Coverage Policy Number 0192: Genetic Testing for Hemoglobinopathies,Effective Date 9/15/12Cigna Medical Coverage Policy Number 0193: Genetic Testing for Long QT Syndrome (LQTS), Effective Date 10/15/12Cigna Medical Coverage Policy Number 0001: Genetic Testing for Susceptibility to Breast and Ovarian Cancer (e.g.BRCA1 & BRAC2), Effective Date 3/15/12Cigna Medical Coverage Policy Number 0003: Genotyping for Thiopurine Methyltransferase (TPMT) Deficiency in Individuals with Inflammatory Bowel Disease (IBD), Effective Date 1/15/13FirstCare PPO Services Requiring Pre-AuthorizationGateway Health Plan?, Laboratory Services, 2012 Medicaid Provider Office Policy and Procedure Manual pp 51-52.Coventry HealthAmerica/Advantra; Prior Authorization ListHighmark Medical Policy Bulleting, Section Laboratory, Number L-34, Genetic Testing, Effective date 1/1/2013Highmark Special Bulletin for Network Providers,”Highmark to Update Its List of Outpatient Procedures/Services Requiring Authorization” Rev 10/12.Highmark’s List of Procedures/DME Requiring Authorization Rev. 10/12Medicare National Coverage Determinations Manual, Chapter 1, Part 3 (Sections 170-190.34) Coverage Determinations Rev. 131, 2-23-11UPMC Healthplan Physician Partner Update Technology Assessment Committee 4/2012UPMC Healthplan Quick Reference Guide Effective 2/1/2013UPMC Healthplan Policy:PAY.080, 3/2012 Genetic Testing UPMC Healthplan Policy:PAY.116, 6/2012 Genetic Testing for Cystic FibrosisUPMC Healthplan Policy:PAY.042, Rev 8/12 Genetic Testing for Inherited Colorectal CancersUPMC Healthplan Policy:MP.055, Rev 7/2012 Molecular Susceptibility Testing for Breast Cancer and/or Ovarian Cancer (BRCA and BART Testing)UPMC Healthplan Policy: MP.027, Rev 5/2012 Genetic Testing for Long QT Syndrome ................
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