Medical Policy Original Effective Date: 12-17-08

Revised Date: 05-20-20 Page 1 of 20

Genetic and Genomic Testing (Disease Specific) MPM 7.1

Disclaimer Refer to the member’s specific benefit plan and Schedule of Benefits to determine coverage. This may not be a benefit on all plans or the plan may have broader or more limited benefits than those listed in these criteria.

Based on the Medicare Benefit requirements, the following test types are examples of services that may not be considered a benefit (statutory excluded) and therefore would be denied as Medicare Excluded tests:

• Tests considered screening in the absence of clinical signs and symptoms of disease that are not specifically identified by the law

• Tests that confirm a diagnosis or known information

• Tests to determine risk for developing a disease or condition

• Tests performed to measure the quality of a process

• Tests without diagnosis specific indications

• Tests identified as investigational by available literature and/or the literature supplied by the developer, and are not a part of a clinical trial

• Tests typically performed on patients younger than 65 years of age and outside of the Medicare population

Tests performed on patients receiving Medicare benefits younger than 65 years will be reviewed on a case-by-case basis

Description Genetic testing is the use of specific assays to determine the genetic status of individuals already suspected to be at high risk for a particular inherited condition. High risk means that the individual has a known family history or classic symptoms of the disorder. Genetic testing includes a variety of techniques that test for genetic diseases and analyzes genetic risk factors that may contribute to disease. Techniques involve the examination of a blood sample, or other body fluid, or tissue to indicate the presence, absence, or alteration (mutation) of genes linked to specific diseases or conditions.

The main difference between genetic and genomic tests is that genetic tests look at sequence variants in single genes while genomic tests look at the expression of multiple genes in a single assay. Genetic testing typically refers to inherited disorders. Genomic testing usually refers to tests that look at expression profiles of multiple genes in a particular tissue affected by an acquired disease (e.g., a tumor), and in many cases, are cancer tests.

Recognizing the differences as described above, for the purposes of this Medical Policy, the term “genetic testing” is considered interchangeable with “genomic testing” and is used throughout.

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Genetic and Genomic Testing (Disease Specific) MPM 7.1

Coverage Determination

Prior Authorization is required for the following tests: Allomap, BRCA1, BRCA2, BART, Colaris®, Colaris AP®, Oncotype DX, EndoPredict, Prosigna, BCI, Mammaprint, DecisionDX-Melanoma, PathfinderTG and PancraGEN.

For Benefit Certification and billing purposes, S codes should be utilized (see coding section) with applicable CPT. Log on to Pres Online to submit a request: https://ds.phs.org/preslogin/index.jsp

Prior Authorization is not required for most of the testing listed under “Covered Diagnoses” except indicated. However, all claims are subject to retrospective review.

Genetic testing may not be a benefit on all plans. Refer to the member’s specific benefit plan and Schedule of Benefits to determine coverage

The following basic guidelines apply:

General population screening using genetic testing is not covered unless specified in this Policy or the member’s contract. If there is a conflict between this Policy and the member’s contract, the contract will govern.

Metabolic disease/Genetic inborn errors of metabolism testing are covered for newborn screening for genetic disorders as mandated by state guidelines.2

Presbyterian considers multigene cancer panels experimental and investigational because there is insufficient evidence of their clinical validity and utility. They therefore are not covered except those that are required by Medicare. Otherwise only individual tests that are medically necessary and prior authorized are covered.

Genetic testing is covered for certain diagnoses when all of the following criteria have been met. (See pages 5-10 for a list of diagnoses and the type of genetic testing covered.)

• Genetic testing should be ordered by specialized physicians and/or certified genetic counselor qualified to interpret the testing results. Appropriate documentation of patient consent should be obtained.

• After physical examination and routine testing, the diagnosis remains uncertain. The member is at risk for a genetic disease, either with a direct risk factor for the development of an inheritable disease (known family history) or demonstrating signs/symptoms of a genetic disease.

• The genetic test result has a potential to affect the course of treatment for the member.

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Genetic and Genomic Testing (Disease Specific) MPM 7.1

• Pharmacogenetics is a type of genetic testing that may help determine what medication and dosage will be most effective and beneficial for a particular health condition or disease.

• Consultations with qualified genetic counselors and physicians should be part of the treatment plan in order for the patient to receive the appropriate interpretation of the genetic testing. Unless otherwise stated, a printed three generation pedigree should be part of the genetic consultation and should be available for review.50

• The genetic test is considered a proven method to

1. identify or rule out an inheritable disease, or

2. to detect an inherited or acquired disease-related genotype, mutation, phenotype or karyotype for clinical purposes.

• Genetic testing for a specific disease is only covered once in a person’s lifetime. Coverage will be extended if additional tests are developed that expand the ability to find mutations in patients who have been previously tested, and if the test is considered a proven method.

• Carrier and predictive testing is covered for certain genetic diseases when there is an affected family member of first or second-degree relation who has an identified mutation or genetic disease, and the information will help with medical or reproductive decision-making. In some circumstances, testing may also be covered when the patient is the reproductive partner of a person with a positive genetic test and the couple intends to have a baby.

• Prenatal or preimplantation genetic testing is covered for certain genetic diseases if there is an increased risk (known family history) that an offspring will have a genetic or chromosomal disorder. (Please note: Preimplantation genetic testing, as part of assisted reproductive techniques such as in-vitro fertilization, may not be a covered benefit. Refer to the member’s specific benefit plan to determine coverage).

Exclusions

Genetic testing of PHP members is not covered when the test is performed primarily for the medical management of other family members.

Additional expenses for banking of genetic material is not covered.

The following testing are not covered by PHP:

• APOE testing for use as adjunct test in clinical evaluation of patients with dementia of unknown etiology or for risk assessment of Alzheimer Disease in asymptomatic individuals.79,88

• CDKN2A Testing for malignant melanoma (Melaris®) (test for

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Genetic and Genomic Testing (Disease Specific) MPM 7.1

familial melanoma).10

• CYP2D6 Genotyping (for dose management of Tamoxifen during treatment for breast cancer).60,61

• Cutaneous Melanoma – DecisionDX-Melanoma test is not covered for Centennial Care and Commercial. See Genetic Testing for Cutaneous Melanoma for Medicare, MPM 7.7 for coverage details.

• deCODE Prostate Cancer™ (for assessment of prostate cancer risk or prostate cancer aggressiveness). See Genetic Testing for Prostate Cancer Testing, MPM 7.8 for complete details.

• Epidermal Growth Factor Receptor (EGFR) Gene Amplification Analysis by FISH (for predicting response to non-small cell lung cancer drug therapy). 74 EGFR Sequence Variant Analysis is a covered benefit for this diagnosis (see covered section).

• eXagenBC™ (breast cancer prognostic test)

• eXagen/BD™ (inflammatory bowel disease expression profile)

• eXagen/BS™ (irritable bowel syndrome expression profile)

• Familion® (for Brugada syndrome, or catecholaminergic polymorphic ventricular tachycardia. Familion® is covered for long QT syndrome). 3,63 (See covered section)

• JAK2 testing (for chronic myeloproliferative disorders for children. JAK2 testing is covered for adults.)16

• Mammaprint® assay used for the prognosis of breast cancer recurrence. Not covered for Commercial or Centennial members. See Breast Cancer Recurrence and Predictive Genetic Testing, for Medicare, MPM 33.0

• Mammostrat® (used for breast cancer recurrence risk)32

• Methylenetetrahydrofolate reductase (MTHFR) C677T (used for risk assessment for venous thromboembolism or obstetric complications)19

• Methylenetetrahydrofolate reductase (MTHFR) (to predict response to anti-folate chemotherapy (includes Methotrexate)52

• Mitochondrial DNA (mtDNA) Whole Genome Scanning/Sequencing (See “Mitochondrial Disorders” under “Covered Diagnoses” for diagnoses covered) 89

• PreGen-Plus™ for early detection of colorectal cancer. 76

• ProOnc TumorSourceDX™ (to identify tissue or origin for metastatic

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Genetic and Genomic Testing (Disease Specific) MPM 7.1

tumor).77

• Caris Molecular Intelligence (MI), formerly Target Now® by Caris DX to identify biomarkers in an individual’s cancer to aid oncologist in personalizing cancer therapy. There are 2 tumor profiling, MI Profile Test and MI TumorSeek Test. 78

• TheraGuide 5-FU™ (used to determine risk of adverse reaction to 5-FU related chemotherapy)28,29

Covered Diagnoses and types of genetic testing covered for each diagnosis

Genetic testing may be covered when any of the following diagnoses are suspected, either because of symptomatology and/or family history. The basic guidelines on page 2 must be met. The results of the genetic testing must have potential to impact medical and reproductive decision making. Please see “Background” section on pages 10 and 11 for a list of the different types of genetic tests. In some instances, more specific criteria are required for coverage of a genetic test.

• Newborn Screening for genetic disorders, as mandated by state guidelines. Guidelines can be accessed at the following web site.2

https://www.nmlegis.gov/Sessions/05%20Regular/final/HB0479.pdf

• Adrenoleukodystrophy (ALD)X-linked disorders, includes adrenomyeloneuropathy (AMN) (diagnostic, carrier, prenatal or preimplantation).75

• AlloMap® (used to determine cardiac transplant rejection).53 To be used in lieu of endomyocardial biopsy. Prior Authorization is required for AlloMap.

AlloMap®is is a noninvasive option to monitor cardiac transplant rejection and is used in lieu of biopsy.53 AlloMap® testing protocols will vary with facilities. PHP covers AlloMap® when ALL of the following criteria are met.

o Member is age 15 years or older

o Member is >55 days post-cardiac transplant with stable allograft function and low probability of moderate/severe acute cellular rejection (ACR) at the time of testing.

• Angelman syndrome (diagnostic testing for children).54

• Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy (ARVD/C). Genetic testing for sequence variants (DSG2, DSP and PKP2) are covered for diagnostic and predictive purposes as stated below.31

o Members with confirmed diagnosis (using International Task Force diagnostic criteria) to facilitate genetic screening for ARVD/C in at-risk relatives; or

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Genetic and Genomic Testing (Disease Specific) MPM 7.1

o Members who are at-risk relatives (meaning first-degree or second-degree relative) or of a proband with a confirmed diagnosis of ARVD/C (as defined above).

• Azoospermia or severe oligozoospermia (Y chromosome microdeletions) (diagnostic).73

• Breast Cancer Recurrent Predictive Tests:

Prior Authorization is required. Generally, the tests listed below is covered only once in a lifetime; however, request submitted for consideration will be reviewed on a case-by-case basis.

See Breast Cancer Recurrence and Predictive Genetic Testing, for Medicare, MPM 33.0 for coverage details on Oncotype DX, Oncotype DX for DCIS, ENDOPredict, Mammaprint, Prosigna, and Breast Index (BCI).

BRCA1, BRCA2, and BART for breast or ovarian cancer: Prior Authorization is required. Basic guidelines for BRCA1 and BRCA2 testing are listed below.

o For commercial insurance refer to NCCN® Practice Guidelines in Oncology for Hereditary Breast and/or Ovarian Cancer for greater detail.44

o For Medicare refer to LCD (L36715), BRCA1 and BRCA2 Genetic Testing. Please review coverage indication and list of covered diagnosis for the listed CPT codes below.45,48

▪ See A56542 for covered CPT codes: 81162, 81163, 81164,

81165, 81166, 81167, 81212, 81215, 81216, 81217, 81432,

81433, 81445, 81455. NOTE: Do not report 81162 in

conjunction with 81163, 81164, 81165, 81166, 81167,81216,

81217, 81432)

• Canavan disease, Aspartoacyclase 2 Deficiency (ASPA) Test, (diagnostic, carrier, prenatal or preimplantation testing).90,95

• Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) (diagnostic, predictive, prenatal and preimplantation).56,90

• Charcot-Marie-Tooth, Type 1A (diagnostic, prenatal or preimplantation testing).9,90

• Chromosomal imbalances for patients, see Comparative Genomic Hybridization (CGH) Microarray Testing.90 specific guidelines.

• Chromosome 22q11.2 deletion syndrome (diagnostic, prenatal and preimplantation).59

• Chronic myelogenous leukemia (CML), BCR-ABL Testing

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Genetic and Genomic Testing (Disease Specific) MPM 7.1

(Diagnostic and monitoring response to therapy).1,97,98

• Chronic Myeloproliferative Disorders: polycythemia vera (PV), essential thrombocytopenia (ET) and primary Myelofibrosis (PMF), (diagnostic testing).15 See LCD-L36815 for diagnostic workup and coverage and limitation information17. The World Health Organization (WHO) further classifies PV, ET, PMF as Philadelphia chromosome negative myeloproliferative neoplasm (MPNs) for useful resource tables on the 2016 WHO diagnostic criteria.

• Colorectal Cancer Drug Therapy (KRAS Sequence Variant Analysis) (predictive).66

• Comparative Genomic Hybridization (CGH) Microarray Testing for Chromosomal Imbalances is covered as an adjunct to a conventional karyotype analysis for members suspected of having a genetic syndrome (i.e., have congenital anomalies, dysmorphic features, mental retardation, developmental delays or disabilities), when the test results will impact medical or reproductive decision making.90,80

• Cystic Fibrosis or Mucoviscidosis, (diagnostic, carrier, prenatal or preimplantation testing).5,8

• Cutaneous Melanoma – DecisionDX-Melanoma test is covered for Medicare only. Prior Authorization is required. See Genetic Testing for Cutaneous Melanoma for Medicare, MPM 7.7. for coverage details.

• Deafness (Congenital) (diagnostic, carrier or prenatal testing).33,57

• Ehlers-Danlos syndrome (diagnostic, predictive, prenatal or preimplantation testing).30

• Familial adenomatous polyposis (diagnostic, predictive, prenatal or preimplantation testing).6

• Familial dysautonomia (diagnostic, carrier, prenatal or preimplantation).90

• Fanconi’s anemia (diagnostic testing).47

• Fragile X syndrome (diagnostic, carrier, prenatal or preimplantation testing).12

• Gaucher disease (carrier, prenatal or preimplantation testing).90

• HLA-B*5701 Screening for Abacavir associated diseases (diagnostic).65,46

• Hemochromatosis, hereditary (diagnostic or carrier testing).13,35

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Genetic and Genomic Testing (Disease Specific) MPM 7.1

• Hemoglobinopathy (thalassemias and sickle cell anemia) (diagnostic or carrier testing).44,42

• Hemophilias (diagnostic, carrier, prenatal or preimplantation testing).36,37

• Hereditary non-polyposis colorectal cancer (HNPCC) or Lynch syndrome – Colaris Test for colorectal cancer (CRC). See Genetic Testing for Lynch Syndrome, MPM 7.5. Prior Authorization is required.

• Huntington Chorea/Disease (diagnostic, predictive, prenatal or preimplantation testing).14,90

• Interstitial Lung Disease, Envisia/Veracyte, (diagnostic) to determine Idiopathic Pulmonary Fibrosis (IPF). For Medicare only.91, 92

• Long QT syndrome (Familion®) (diagnostic or predictive testing).3

• Lung cancer, non-small cell. Epidermal Growth Factor Receptor (EGFR) Sequence Variant Analysis and KRAS Sequence Variant Analysis (for predicting response to non-small cell lung cancer drug therapy) (predictive).62,74 See Genetic Testing, InvisionFirst Liquid Biopsy for Lung Cancer, MPM 37.0 for coverage details if the tissue is unavailable due to insufficient and/or unobtainable material for tissue-based. Prior Authorization is required for Liquid Biopsy.

• Mammaprint assay used for the prognosis of breast cancer is for Medicare only. Prior Authorization is required. See Breast Cancer Recurrence and Predictive Genetic Testing for Medicare, MPM 33.0 for coverage details

• MUTYH or (MYH) associated polyposis (MAP) (diagnostic, predictive, prenatal or preimplantation testing).80

• Mitochondrial disorders: Leber hereditary optic neuropathy (LHON), Leigh syndrome, neurogenic muscle weakness with ataxia and retinitis pigmentosa (NARP), mitochondrial encephalomyopathy with lactic acidosis (MELAS and stroke-like episodes, myoclonic epilepsy with ragged-red fibers (MERRF) (diagnostic, prenatal or preimplantation testing).18,89

• Myotonic dystrophy (diagnostic, predictive, prenatal or preimplantation testing)26,67,90

• Niemann-Pick disease (diagnostic, carrier, prenatal or preimplantation testing).40

• Neurofibromatosis (diagnostic, prenatal and preimplantation testing)49,80

• Osteogenesis Imperfecta Types 1 to IV (diagnostic, prenatal, preimplantation testing).58

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Genetic and Genomic Testing (Disease Specific) MPM 7.1

• Pancreatic Cyst, (diagnostic), see Genetic Testing for Pancreatic Cyst PathfinderTG®/PancraGEN™ MPM 7.6 for coverage details. Prior Authorization is required.

• PTEN hamartoma tumor syndrome (diagnostic, predictive, prenatal or preimplantation testing) for patients at high risk of breast, thyroid, endometrial and renal cancers.64

• Prader-Willi syndrome (diagnostic, prenatal and preimplantation testing).20

• Primary dystonia Type 1 (diagnostic, prenatal or preimplantation testing)21,90

• Prostate Cancer (diagnostic) using Progensa®, BRCA1/2, ConfirmMDx; OR Treatment management testing using Decipher®, Oncotype DX AR-V7, Oncotype DX, Prolaris™, Promark. See Genetic Testing for Prostate Cancer Testing MPM 7.8 for coverage details).

• Retinoblastoma (diagnostic, predictive and prenatal testing).39

• RET Proto-Oncogene Point Mutations (MEN2), (diagnostic or predictive testing).40

• Rett syndrome (diagnostic, prenatal or preimplantation)5.0,90

• Spinal Muscular Atrophy (diagnostic, carrier, prenatal or preimplantation).27,68,90

• Spinocerebellar Ataxia (diagnosis, predictive).6,24,69,70,71, 82-87

• Tay-Sachs disease (diagnostic, carrier, prenatal or preimplantation testing).7,55,90

• Thrombosis panel for risk assessment for venous thromboembolism (VTE) or obstetric complications.11,23,25 Factor V Leiden and Prothrombin G20210A are covered in the following circumstances:

o Patients with obstetric complications of abnormal placenta vasculature

o Patients with VTE with a personal or family history of recurrent VTE.11,23,25

• Thyroid nodules, Afirma Thyroid FNA Analysis (Veracyte), (diagnostic).93, 94

• von Hippel-Lindau disease (diagnostic, predictive, prenatal or preimplantation testing)43,80

• Uniparental disomy (UPD) for Chromosomes 7,11,14 or 15 (diagnostic, prenatal or preimplantation).72,34

o For neonates, infants, children or adults symptomatic for

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Beckwith-Wiedermann syndrome for UPD for chromosome 11

o For prenatal testing among fetuses with inherited Robertsonian translocations, supernumerary marker chromosomes, or level III mosaicism involving chromosomes 7, 14 or 15 for UPD for chromosomes 7, 14 or 15.

• Uveal Melanoma, DecisionDX-UM© test is used to determine risk for metastasis within 5 years in patients with diagnosis of Uveal Melanoma). Prior Authorization is required. See Genetic Testing for Uveal Melanoma, MPM 7.9 for complete details

• Warfarin, Pharmacogenetic Testing: This test has been reviewed by the Technology Assessment Committee and the Medical Policy Committee. The practical value of this testing is limited or yet to be determined; therefore, the TAC and MPC do not endorse this testing for widespread use. A small volume of clinically appropriate testing is already occurring and will be continue to be covered.4

Background Genetics refers to the study of genes and their role in inheritance – the way certain traits or conditions are passed down from one generation to another. Genetics involves scientific studies of single genes and their effects. Genes (units of heredity) carry the instructions for making proteins, which direct the activities of cells and functions of the body. Genes influence traits such as hair and eye color as well as health and disease development. Genetics determines much (but not all) of a person’s health status; environmental differences also play a part.81

A genome is defined as all the genetic material in the chromosomes of a particular organism. Genomics is a relatively new term describing the study of multiple genes from the same person, including interactions of those genes with each other and the person’s environment. Genomics involves the scientific study of complex diseases such as heart disease, asthma, diabetes and cancer because they are caused more by a combination of genetic and environmental factors. Genomics is offering new possibilities for therapies and treatment of some diseases, as well as new diagnostic methods. The major tools and methods related to genomics studies are bioinformatics, genetic analysis, measurement of gene expression, and determination of gene function.81

Types of genetic tests:

• Newborn screening: Used just after birth to identify genetic disorders that can be treated early in life.

• Diagnostic testing: 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, but is not

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Genetic and Genomic Testing (Disease Specific) MPM 7.1

available for all genes or all genetic conditions. The results of a diagnostic test can influence a person’s choices about health care and the management of the disorder.

• Carrier testing: 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 in certain ethnic groups with an increased risk of specific genetic conditions. If both parents are tested, the test can provide information about a couple’s risk of having a child with a genetic condition.

• Prenatal testing: Used to detect changes in a fetus’ 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. It cannot identify all possible inherited disorders and birth defects.

• Preimplantation testing: A specialized technique that can reduce the risk of having a child with a particular genetic or chromosomal disorder. It is used to detect genetic changes in embryos created using assisted reproductive techniques such as in-vitro fertilization. Only embryos without certain genetic changes are implanted in the uterus to initiate a pregnancy.

• Predictive and presymptomatic testing: Used to detect gene mutations associated with disorders that appear after birth, often later in life. These tests can be helpful to people who have a family member with a genetic disorder, but who have no features of the disorder themselves at the time of testing. The results of the testing can provide information about a person’s risk of developing a specific disorder and help with making decisions about medical care.

Medical Terms Assay: A laboratory test to find and measure the amount of a specific substance.

First-degree relative: Parents, children, siblings (blood relatives).

Gene expression: The process by which proteins are made from the instructions encoded in DNA.

Second-degree relative: Grandparents, aunts and uncles, nieces and nephews, grandchildren, half-sibling (blood relatives)

Third-degree relative: Great-grandparents, great-aunts, great-uncles, and first cousins (blood relatives)

Three-Generation Pedigree: A pictorial representation of diseases within a family to assess hereditary influences on disease or to help identify relatively rare conditions that may not be considered in a differential diagnosis.

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The coding listed in this medical policy is for reference only. Covered and non-covered codes are within this list.

81105 81213 81251 81292 81328 81401 81442 81539 0002M 0161U

81106 81215 81252 81293 81329 81402 81443 81540 0003M 0162U

81107 81216 81253 81294 81330 81403 81445 81541 0004M 0170U

81108 81217 81254 81295 81331 81404 81448 81542 0006M 0171U

81109 81218 81255 81296 81332 81405 81450 81545 0007M 0159U

81110 81219 81256 81297 81334 81406 81455 81551 0011M G9143

81111 81220 81257 81298 81335 81407 81460 81552 0012M S0265

81112 81221 81258 81299 81340 81408 81465 81595 0013M S3800

81120 81222 81259 81300 81341 81410 81470 81599 0014M S3840

81121 81223 81260 81301 81342 81411 81471 83520 0008U S3841

81161 81224 81261 81302 81346 81412 81479 84311 0010U S3842

81162 81225 81262 81303 81350 81413 81490 86152 0019U S3844

81163 81226 81263 81304 81355 81414 81493 86153 0029U S3845

81164 81227 81264 81305 81361 81415 81500 88245 0030U S3846

81165 81228 81265 81308 81362 81416 81503 88248 0033U S3849

81166 81229 81266 81310 81363 81417 81504 88249 0050U S3850

81167 81230 81267 81311 81364 81420 81506 88261 0101U S3852

81170 81231 81268 81312 81370 81422 81507 88262 0102U S3853

81175 81232 81270 81313 81371 81425 81508 88263 0103U S3854

81176 81235 81271 81314 81372 81426 81509 88264 0129U S3861

81200 81238 81272 81315 81373 81427 81510 88271 0130U S3865

81201 81240 81273 81316 81374 81430 81511 88272 0131U S3866

81202 81241 81275 81317 81375 81431 81512 88273 0132U S3870

81203 81242 81276 81318 81376 81432 81518 88274 0133U 81205 81243 81280 81319 81377 81433 81519 88275 0134U 81206 81244 81281 81321 81378 81434 81520 88280 0135U 81207 81245 81282 81322 81379 81435 81521 88283 0136U 81208 81246 81283 81323 81380 81436 81525 88285 0137U 81209 81247 81287 81324 81381 81437 81528 88289 0138U 81210 81248 81288 81325 81382 81438 81535 88291 0157U 81211 81249 81290 81326 81383 81439 81536 88299 0158U 81212 81250 81291 81327 81400 81440 81538 88380 0160U

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Genetic and Genomic Testing (Disease Specific) MPM 7.1

References:

1. Hayes 2020 TractManager, Comparative Effectiveness Review Of The Influence Of Stem Cell Source On Allogeneic Stem Cell Transplant Effectiveness For Treatment Of Chronic Myelogenous Leukemia, Annual review, Aug 20, 2019. [Cited 06/01/2020]

2. Section 24-1-6 NMSA 1978, Chapter 359, Section 6. Tests Required for Newborn Infants. Accessed on 01-28-10 at: http://www.nmlegis.gov/Sessions/05%20Regular/final/HB0479.pdf

3. MCG, Health Ambulatory Care 24th Edition, Long QT Syndrome (Hereditary) – Gen Panel (ACG: A-0918 (AC), Last Update: 04/29/2020. [Cited 06/02/2020]

4. CMS, NCD for Pharmacogenomic Testing for WARFARIN Response (90.1), Effective: 08/03/2009, Version#1. [Cited 06/02/2020]

5. Hayes 2020 TractManager, Genetic Carrier Testing for Cystic Fibrosis. June 7, 2004. Update Search: August 1, 2008. Archived July 7, 2009. [Cited 06/01/2020].

6. UpToDate, Puneet Opal, MD, PhDHuda Y Zoghbi, MD, The spinocerebellar atxias, Literature review current through:May 2020.|This topic last updated:Mar 18, 2020. [Cited 06/02/2020]

7. MCG 24th Edition, Tay-Sachs Disease and Variants – HEXA Gene, (ACG: A-06140, last updated 04-29-2020. [Cited 06/02/2020]

8. Hayes 2020 TractManager, Cystic Fibrosis Transmembrane Regulator (CFTR) Testing For Cystic Fibrosis, ARCHIVED Jun 29, 2018. [Cited 06/01/2020]

9. Hayes, 2020 TractManager, Charcot-Marie-Tooth Type 1A (PMP22). ARCHIVED Sep 4, 2013. [Cited 06/01/2020]

10. MCG Health Ambulatory Care 23rd Edition, Malignant Melanoma (Cutaneous) – BAP1, CDK4, and CDKN2A Genes, (ACG: A-0601 (AC), Last Update: 02/11/2019. (for CDKN2A Testing for Malignant Melanoma).[Cited 11/13/2019]

11. Hayes, 2020 TractManager, Thrombosis Panel for Risk Assessment for Venous Thromboembolism (VTE) or Obstetric Complication, ARCHIVED 10-31-2013. [Cited 06/02/2020]

12. Hayes, 2020 TractManager, Genetic Testing For Fragile X Syndrome, Annual review Jan 26, 2020. [Cited 06/01/2020].

13. Hayes, 2020 TractManager, Genetic Testing Hereditary Hemochromatosis (HFE-HHC) in Patients with Iron Overload, Annual Review: Oct 21, 2019. Update Search: June 02, 2020.

14. Hayes, 2020 TractManager, Huntington Chorea/Disease (HD) for Diagnostic, Predictive, and Prenatal or Preimplantation Genetic Diagnosis Purposes. ARCHIVED May 28, 2013. [Cited 06/02/2020]

15. Hayes, 2020TractManager, Genetic Test for the Diagnosis and

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Treatment of Polycythemia Vera (PV), Clinical Utility Evaluation, Apr 2, 2018. (Note: PV is a chronic myeloproliferative disease). [Cited 11/13/2019]

16. MCG Health Ambulatory Care 23rd Edition, Myeloproliferative Neoplasms – JAK2 Gene, (ACG: A-0669 AC), Last Update: 02/11/2019. [Cited 11/18/2019]

17. CMS MolDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease (L36815), Effective Date 02/16/2017, Revision Date: 11/01/2019, R7. [Cited 06/01/2020]

18. Hayes, TractManager, LHON (Leber Hereditary Optic Neuropathy) for Diagnosis and Risk of Transmission. ARCHIVED: 04/29/2013. Update Search: 06/02/2020.

19. MCG, Hyperhomocysteinemia – MTHFR Gen (ACG: A-0629 (AC), Ambulatory Care 24rd Edition, Copyright 2019 MCG Health, LLC. [Cited 11/13/2019].

20. MCG, 24th Edition, Prader-Willi Syndrome DNA Methylation Testing, (ACG: A-0707), last updated 04-29-2020. [Cited 06/02/2020]

21. Hayes, 2020 TractManager, Molecular Test Assessment, Primary Dystonia Type 1 (DYT1/TOR1A), ARCHIVED Aug 06, 2013. Update Search: June 02, 2020

22. Hayes, 2020 TractManager, Molecular Assessment, Prothrombin G20210A for Risk Assessment for Venous Thromboembolism (VTE) or Obstetric Complications, ARCHIVED 11-01-2013. [Cited 06/02/2020]

23. MCG, 24th Edition, Factor V Leiden Thrombophilia – F5 Gene, (ACG: A-0600), last updated 04-29-2020. [Cited 06/02/2020]

24. MCG, 24th Edition, Spinocerebellar Ataxia - ATXN1, ATXN2, ATXN3, ATXN7, and CACNA1A Genes and Gene Panels, (ACG: A-0908), last update 04-29-2020. [Cited 06/02/2020]

25. Hayes, Molecular Test Assessment, Thrombosis Panel for Risk Assessment for Venous Thromboembolism (VTE) or Obstetric Complications. ARCHIVED 10-31-2013. [Cited 06/02/2020]

26. Hayes, 2020 TractManager, Myotonic Dystrophy Types 1 and 2. ARCHIVED Nov 15, 2017. [Cited 06/02/2020]

27. MCG, 24th Edition, Spinal Muscular Atrophy - SMN1 and SMN2 Genes, last updated 04-29-20. [Cited 06/02/20]

28. MCG, Health Ambulatory Care 23rd Edition, 5-Fluorouracil Pharmocogenetics – DPYD, MTHFR, and TYMS Genes, (ACG: A-0665 AC), Last Updated 02/11/2019. [Cited 11/18/2019]

29. Hayes, 2020 TractManager, TheraGuide 5-FU™ (Myriad Genetic Laboratories Inc.) For Predicting Toxicity To 5-Fluorouracil (5-FU) / Capecitabine-Based Chemotherapy, ARCHIVED Jun 4, 2014. [Cited 06/01/2020]

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Genetic and Genomic Testing (Disease Specific) MPM 7.1

30. Hayes, 2020TractManager, Whole Genome Sequencing (WGS) In Neonatal And Pediatric Patients (for Ehlers-Danlos Syndrome), Annual review Aug 12, 2019. [Cited 06/01/2020]

31. MCG Health Ambulatory Care 23rd Edition, Arrhythmogenic Right Ventricular Cardiomyopathy – ARVC Genes (ACG: A-0627-AC), Last Update 02/11/2019, [Cited 11/19/2019]

32. Hayes, 2020 TractManager, Mammostrat® for Prognosis of Breast Cancer Recurrence, ARCHIVED Sep 28, 2015 (Rating D2). [Cited 06/01/2020]

33. Hayes, 2020 TractManager, Genetic Screening of Newborns for Risk of Hearing Loss, Clinical Utility Evaluation, Nov 22, 2019. [Cited 06/01/2020]

34. UpToDate, Carlos A Bacino, MD, FACMG, Genomic disorders: An overview, (see section on Uniparental disomy), Literature review current through: May 2020. | This topic last updated: 02-05-2019. [Cited 06/20/2020]

35. UpToDate, B Bacon, MD, C Camaschella MD, HFE and other Hemochromatosis Genes, Review current through May 2020. [Cited 06/02/2020]

36. Hayes, 2020 TractManager, Hemophilia A (Factor VII Deficiency), ARCHIVED Jul 12, 2016. [Cited 06/02/2020]

37. UpToDate, W Keith Hoots, MD, Amy D Shapiro, MD, M Heiman, MS, LCGC, CCRC, Genetics of hemophilia A and B, Topic last updated: Oct 16, 2019. [Cited 06/02/2020]

38. MCG, 24th Edition, Niemann-Pick Disease (Acid Sphingomyelinase Deficiency) – NPC1, NPC2, and SMPD1 Genes, Last Update: 04/29/2020. [Cited 06/02/2020]

39. MCG, 24th Edition, Retinoblastoma -RB1 Gene, (ACG: A-0586), last updated 04/29/2020. [Cited 06/02/2020]

40. MCG, 24th Edition, Multiple Endocrine Neoplasia (MEN) Syndrome, Type 2 - RET Gene, (ACG: A-0842), last update: 04/29/2020. [Cited 06/02/2020]

41. CMS, Local Coverage Determination MolDX: Molecular Diagnostic Tests (MDT) (LCD L36807), Revision date: 01/01/2020, R13, (for Hemoglobinopathy) [Cited 06/02/2020]

42. CMS, Local Coverage Article, Billing and Coding: MolDX: HBB Gene Tests (A55166), Revision date: 11/01/2019, R6 (for Hemoglobinopathy). [Cited 06/02/2020]

43. MCG, 24th Edition, Von Hippel-Lindau Syndrome – VHL Gene, (ACG: A- 0583), last update 04-29-2020. [Cited 06/02/2020]

44. NCCN Guidelines Version 1.2020, Breast and/or Ovarian Cancer Genetic Assessment, BR/OV-1. Accessed 06-20-2020.

45. CMS, Local Coverage Article, Billing and Coding: BRCA1 and

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Genetic and Genomic Testing (Disease Specific) MPM 7.1

BRCA2 Genetic Testing (A56542), R1, Effective Date 11/07/2019. [Cited 06/02/2020]

46. Medscape Genomic Medicine, A Torkamani, PhD; KarlS Roth, MD, Abacavir and HLA-B*5701, Updated: Dec 07, 2018. [Cited 06/02/2020]

47. MCG, 24th Edition, Fanconi Anemia, FANC Genes and Gene Panel Testing, (ACG: A-0683), Last Updated: 04/29/2020. [Cited 06/01/2020]

48. CMS, Local Coverage Determination (LCD) BRCA1 and BRCA2 Genetic Testing (L36715), Revision Date 11/07/2019, R5. [Accessed 06/02/2020]

49. MCG, 24th Edition, Neurofibromatosis NF1 Gene (ACG: A-0581) and Neurofibromatosis – NF2 Gene (ACG: A-0846), both last updated: 04/29/20. [Cited 06/02/2020]

50. MCG, 24th Edition, Rett Syndrome – CDKL5, FOXG1, and MECP2 Genes, (ACG: A-0687). Last updated 04-29-20. [Cited 06/02/2020]

51. NCCN® Clinical Practice Guidelines in Oncology. Genetic/Familial High-Risk Assessment: Breast and/or Ovarian Cancer, v.1.2020. [Cited 06/02/2020] http://www.nccn.org/professionals/physician_gls/PDF/genetics_screening.pdf

52. Hayes, a Division of TractManager, MTHFR Pharmacogenetic Genotyping For Altering Drug Treatment, Date 02-25-2019 (Rating D2). Copyright 2019 TractManager [Cited 11-06-2019].

53. Hayes, a Division of Tract Manager, Copyright 2019 TractManager, Molecular Test Assessment, AlloMap (CareDX), (formerly XDx), (AlloMap Molecular Expression Testing for Detection of Heart Transplant Rejection Annual Review: Sep 27, 2019. [Cited 11/19/2019]

54. MCG Health Ambulatory Care 23rd Edition, Angelman Syndrome _UBE3A Gen, (ACG: A-0708-AC), Last Update 02/11/2019. [Cited 11/19/2019]

55. UpToDate, Ashley S Roman, MD, MPH, Preconception and prenatal carrier screening for genetic disease more common in the Ashkenazi Jewish population and others with a family history of these disorders, Literature review current through: May 2020 | Last updated: Aug 01, 2019. [Cited 06/02/2020]

56. Hayes Genetic Test Evaluation Report. ©2008 Winifred S. Hayes, Inc. Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL). April 16, 2008.

57. Hereditary Hearing Loss and Deafness Overview, Eliot Shearer, MD, Michael S Hildebrand, PhD, and Richard JH Smith, MD, Last Update: July 27, 2017. [Cited 06/01/2020]

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Genetic and Genomic Testing (Disease Specific) MPM 7.1

58. MCG, 24th Edition, Osteogenesis Imperfecta - BMP1, COL1A1, COL1A2, CREB3L1, CRTAP, FKBP10, IFITM5, MBTPS2, P3H1, PLOD2, PPIB, SERPINF1, SERPINH1, SP7, SPARC, TENT5A, TMEM38B, and WNT1 Genes and Gene Panels, (A- 0796), last updated 04/29/2020. [Cited 06/02/2020]

59. Hayes, 2020 TractManager, Chromosome 22q11.2 Deletion Syndrome, ARCHIVED Dec 19, 2013. [Cited 06/01/2020]

60. MCG Health Ambulatory Care 23rd Edition, Tamoxifen Pharmacogenetics – CYP2D6 Gene, (ACG: A-0647-AC), Last Update: 02/11/2019,19 [Cited 11/13/2019].

61. NCCN Guidelines Version 3.2020, Breast Cancer, Invasive Breast Cancer section footnote: Footnote by NCCN: Based on current data NCCN panel does not support use of CYP2D6 gene testing for women being considered for tamoxifen therapy. Coadministration of strong inhibitors of CYP2D6 must be used with caution. [Cited 04-27-2020]

62. MCG Health Ambulatory Care 24th Edition, Non-Small Cell Lung Cancer – Gene Testing (Somatic or Therapeutic) (ACG: A-0795), Last Updated: 04-29-20. Update Search: 06/02/2020

63. Hayes, a Division of TractManager, Copyright 2019 TractManager, Genetic Testing for Individuals Clinically Diagnosed with Brugada Syndrome, Aug 30, 2019 or Genetic Testing for Family Members of Individuals with Brugada Syndrome, Aug 30, 2019.. Update Search 11/13/2019.

64. Hayes, 2020 TractManager, Clinical Utility, Genetic Testing For PTEN Hamartoma Tumor Syndrome (PHTS), Jan 23, 2020. [Cited 06/02/2020]

65. Hayes, 2020 TractManager, HLA-B*5701 Screening for Abacavir (Ziagen®) Hypersensitivity in HIV Patients. ARCHIVED 11/09/2013. [Cited 06/02/2020]

66. Hayes Genetic Test Evaluation Report. ©2008 Winifred S. Hayes, Inc. KRAS Sequence Variant Analysis for Predicting Response to Colorectal Cancer Drug Therapy. Annual Review: May 27, 2015, Archived (Jan 24, 2017). Update Search: 06-01-2020.

67. Hayes, 2020 TractManager, Myotonic Dystrophy Types 1 and 2, ARCHIVED 11/15/2017. [Cited 06/02/2020]

68. Hayes, 2020 TractManager, Spinal Muscular Atrophy, ARCHIVED 02-22-2014. [Cited 06/02/2020]

69. Hayes, 2020 TractManager, Molecular Test Assessment, Spinocerebellar Ataxia Type 1, ARCHIVED: 03-08-2014. [Cited 06/02/2020]

70. Hayes, 2020 TractManager, Molecular Test Assessment, Spinocerebellar Ataxia Type 2, ARCHIVED: 03-22-2014. [Cited

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06/02/2020]

71. Hayes, 2020 TractManager, Molecular Test Assessment, Spinocerebellar Ataxia Type 3/Machado-Joseph Disease, ARCHIVED: 03-25-2014. [Cited 06/02/2020]

72. Hayes, 2020 TractManager, Uniparental Disomy (UPD) for Chromosomes 6, 7, 11, 14, or 15. ARCHIVED 11-29-2013. Update Search:06/02/2020.

73. MCG Health Ambulatory Care 23rd Edition, Male Infertility – Y Chromosome Microdeletion Analysis, (ACG: A-0803-AC), Last Update: 02/11/2019, [Cited 11/19/2019]

74. NCCN® Clinical Practice Guidelines in Oncology – Version.5.2020 – May 27, 2020, Non-Small Cell Lung Cancer. [Cited 06/02/2020]

75. © 2019 UpToDate, Inc, Adrenoleukodystrophy, Authors: Ronald JA Wanders, PhD, Florian S Eichler, MD, topic 6200 Version 27.0. [Cited 11/19/2019]

76. Hayes 2020 TractManager, ColoSure™Colorectal Cancer Detection Test, ARCHIVED Nov 1, 2012. [Cited 06/01/2020]

77. Hayes 2020 TractManager ProOnc TumorSourceDX™ – MiRview™ Mets (Prometheus Laboratories; Rosetta Genomics) MicroRNA Analysis For Carcinoma Of Unknown Primary Origin (CUP), ARCHIVED 09-04-2014 [Cited 06/01/2020]

78. Hayes, 2020 TractManager, Molecular Test Assessment, MI Profile (Caris Life Sciences), (Formerly Target Now®), Rating is D2, updated Sep 27, 2019. [Cited 06/01/2020]

79. Hayes, Clinical Utility Evaluation, Genetic Testing for APOE Genetic Testing for Alzheimer Disease, Annual Review: Jun 17, 2019. [10-06-19]

80. Hayes, 2020 TractManager, Whole Genome Sequencing (WGS) In Neonatal And Pediatric Patients, Annual review: Aug 12, 2019. [Cited 06/02/2020]

81. National Human Genome Research Institute, National Institutes of Health. Frequently Asked Questions about Genetic and Genomic Science. Last Reviewed: March 27, 2008.

82. Hayes, 2020 TractManager, Molecular Test Assessment, Spinocerebellar Ataxia Type 6, ARCHIVED: 04-10-2014. [Cited 06/02/2020]

83. Hayes, 2020 TractManager, Molecular Test Assessment, Spinocerebellar Ataxia Type 7, ARCHIVED: 05-27-2014. [Cited 06/02/2020]

84. Hayes, 2020 TractManager, Molecular Test Assessment, Spinocerebellar Ataxia Type 8 (SCA8), ARCHIVED: 06-13-2014. [Cited 06/02/2020]

85. Hayes, 2020 TractManager, Molecular Test Assessment,

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Spinocerebellar Ataxia Type 10 (SCA10), ARCHIVED: 07-01-2014. [Cited 06/02/2020]

86. Hayes, 2020 TractManager, Molecular Test Assessment, Spinocerebellar Ataxia Type 12 (SCA12), ARCHIVED: 07-10-2014. [Cited 06/02/2020]

87. Hayes, 2020 TractManager, Molecular Test Assessment, Spinocerebellar Ataxia Type 17 (SCA17), ARCHIVED: 07-24-2014. [Cited 06/02/2020]

88. MCG Health Ambulatory Care 23rd Edition, Alzheimer Disease (Late Onset – APOE Genotyping, (ACG: A-0809 (AC), Last Update: 02/11/2019. [Cited 11/14/2019]

89. MCG Health, Whole Genome/Exome Sequencing-Mitochondrial Disorders (ACG: A-0869 (AC), Last Update: 04/29/2020, Ambulatory Care 24th Edition, Copyright 2020 MCG Health, LLC. [Cited 06/02/2020].

90. Hayes 2020 TractManager, Whole Exome Sequencing For Neurological Conditions In Pediatric Populations, Clinical Utility Evaluation, Jul 17, 2019. [Cited 06/01/2020]

91. CMS, Local Coverage Determination (LCD): MolDX: Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test (L37919), Effective Date: 11/01/2019, R1. [Cited 06/04/2020]

92. Hayes, TractManager, Envisia Genomic Classifier (Veracyte) Molecular Test Assessment, Mar 5, 2020, Rating of D2 [Cited 06/04/2020]

93. CMS, Local Coverage Article A55139 - Billing and Coding: MolDX: Afirma™ Assay by Veracyte Update (for Thyroid nodules); [related (LCD): MOLDX: Molecular Diagnostic Tests (MDT) (L36807)], revision date: 04/30/2020, R4. [Cited 06/04/2020]

94. Hayes, TractManager, Afirma Thyroid FNA Analysis (Veracyte), ARCHIVED Mar 25, 2019. [Cited 06/04/2020]

95. CMS, Local Coverage Article: Billing and Coding: MOLDX: Aspartoacyclase 2 Deficiency (ASPA) Testing (A55142) [related (LCD): MOLDX: Molecular Diagnostic Tests (MDT) (L36807)], revision date: 11/01/2019, R4. [Cited 06/04/2020]

96. CMS, Local Coverage Determination (LCD): MOLDX: Genetic Testing for BCR-ABL Negative Myeloproliferative Disease (L36815), Revision date: 11/01/2019, R7. [Cited 06/04/2020]

97. CMS, Local Coverage Article: Billing and Coding: MOLDX: BCR-ABL (A55233), revision date: 11/01/2019, R5 [ Cited 06/04/2020]

Reviewed by: 1. Michael Crossey, MD. Clinical Pathologist, TriCore Reference Labs. Albuquerque, NM. August 2008

2. Paul Duncan, MD. Hematology Oncology Associates. Albuquerque, NM. August, September, December 2008, November 2009

Medical Policy Original Effective Date: 12-17-08

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Genetic and Genomic Testing (Disease Specific) MPM 7.1

Approval Signatures: Clinical Quality Utilization Mgmt. Committee: Howard Epstein MD

Medical Director: Norman White MD

Approval Date: May 20, 2020

Publication History 12-17-08: Original Effective Date 03-25-09: Review and Revision 01-27-10: Review and Revision 01-19-11: Annual Review & Revision 02-22-12: Revision Updated BRCA1/BRCA2 guidelines 11-28-12: Revised BRCA1/BRCA2, BART guidelines 03-27-13: Revised added Decision Dx-UM for Uveal Melanoma,

Mammaprint and Chromosomal Microarray Analysis are not covered.

02-24-16: Language added re: Non coverage of multigene panels. 03-22-17: Annual Review. Removed repetitive language re:

Chromosomal Microarray Analysis and corrected page number from 8 to 10 for this testing.

02/11/19: Update on CPT codes and references links to BRCA1 & BRCA2 test for breast only

05-20-20 Annual review. Updated references. Noted in policy to see the newly created MPMs: • Breast Cancer Recurrent Predictive Genetic Testing,

MPM 33.0 • Genetic Testing for Lynch Syndrome, MPM 7.5 • Genetic Testing, InvisionFirst Liquid Biopsy for Lung

Cancer, MPM 37.0 • Genetic Testing for Pancreatic Cyst

(PathfinderTG/PancraGen), MPM 7.6 • Genetic Testing for Cutaneous Melanoma, MPM 7.7 • Genetic Testing for Prostate Cancer, MPM 7.8 Coverage diagnosis added are: Interstitial lung disease, Envisia/Veracyte, (diagnostic) and thyroid nodules, Afirma Thyroid FNA Analysis (Veracyte) (diagnostic).

This Medical Policy is intended to represent clinical guidelines describing medical appropriateness and is developed to assist Presbyterian Health Plan and Presbyterian Insurance Company, Inc. (Presbyterian) Health Services staff and Presbyterian medical directors in determination of coverage. The Medical Policy is not a treatment guide and should not be used as such.

For those instances where a member does not meet the criteria described in these guidelines, additional information supporting medical necessity is welcome and may be utilized by the medical director in reviewing the case. Please note that all Presbyterian Medical Policies are available on the Internet at: http://www.phs.org/phs/healthplans/providers/healthservices/Medical/index.htm