Regence Medicare Advantage Policy Manual TOPIC: Genetic and Molecular Diagnostics – Single Gene or Mutation Testing Section: Medicare Manual – Genetic Testing Approval Date: June 2015 Policy No: M-GT20 Published Date: 07/01/2015 IMPORTANT REMINDER: The health plan’s Medicare Advantage Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with the member Evidence of Coverage (EOC) booklet. Benefit determinations are based in all cases on any applicable EOC language and any applicable CMS policy. To the extent there may be any conflict, applicable EOC language or applicable CMS policy take precedence over the health plan’s Medicare Advantage Medical Policy. Important Notes Regarding Diagnostic Laboratory and Genetic Testing Services Description Genetic testing is testing performed to detect changes or mutations in DNA, RNA, chromosomes, proteins, or certain metabolites. Genetic testing may be performed for several different purposes, including, but not limited to, diagnosing or predicting susceptibility for inherited conditions, screening for common disorders, or selecting appropriate treatments (also known as pharmacogenetic testing). Medicare and Medical Necessity According to Medicare guidelines, Medicare coverage is contingent upon the services meeting certain requirements to determine medical necessity. In order to be considered a covered service, Medicare requires that the service in question: • • Fall within a defined Medicare benefit category,(1,2) Not be excluded from coverage by statute, regulation, National Coverage Determination, (NCD), or Local Coverage Determination (LCD)(2) 1 – M-GT20 • • • Be considered medically necessary, as required per the Social Security Act, §1862(a)(1)(A). This means the service must be considered reasonable and necessary in the diagnosis or treatment of an illness or injury, or to rule out or confirm a suspected diagnosis because the patient has a sign and/or symptoms.(3,4) This also means services that are determined to be not medically necessary for any reason (including lack of safety and efficacy because it is an investigational service) are non-covered.(5) Be ordered by a physician who is treating the beneficiary;(6,7) Provide data that would be directly used in the management of a beneficiary’s specific medical problem.(6,7) Services excluded from coverage “Screening services, such as pre-symptomatic genetic tests and services, are those used to detect an undiagnosed disease or disease predisposition, and as such are not a Medicare benefit and not covered by Medicare. Similarly, Medicare may not reimburse the costs of tests/examinations that assess the risk for and/or of a condition unless the risk assessment clearly and directly effects the management of the patient.”(8) In addition, tests performed in the absence of signs, symptoms, complaints, personal history of disease, or injury are not covered, except when there is a statutory provision that explicitly covers a specific screening test.(8-11) Molecular Diagnostic Services Program (MolDX) In addition to applicable NCDs and LCDs, the local Medicare contractor – Noridian Healthcare Solutions, LLC. – and the Medicare Advantage Organization (MAO) both apply coverage determinations made by the Medicare (CMS) Molecular Diagnostic Services Program (MolDX) contractor through the MolDX program, published by Palmetto GBA.(12,13) The MolDX program was developed in 2011 to identify and establish coverage and reimbursement for molecular diagnostic tests. Palmetto GBA evaluates genetic tests to determine analytical and clinical validity and clinical utility, as well as confirming that each test meets Medicare criteria (described below). Palmetto MolDX guidelines provide assessments and indicate coverage or non-coverage of each test. For testing performed by a laboratory outside of the MAO’s service area “A MAC outside of the plan’s service area sometimes has exclusive jurisdiction over a Medicare covered item or service. In some instances, one Medicare A/B MAC processes all of the claims for a particular Medicare-covered item or service for all Medicare beneficiaries around the country. This generally occurs when there is only one supplier of a particular item, 2 – M-GT20 medical device or diagnostic test (for example; certain pathology and lab tests furnished by independent laboratories). In this situation, MA plans must follow the coverage requirements or LCD of the MAC that enrolled the supplier and processes all of the Medicare claims for that item, test or service.”(14) In addition, “Jurisdiction of claims for laboratory services furnished by an independent laboratory normally lies with the carrier serving the area in which the laboratory test is performed. However, there are some situations where a regional or national lab chain jurisdiction is with a single carrier.”(15) Required Clinical Documentation The following information is required in order to determine medical necessity and potential Medicare coverage for a genetic or molecular diagnostic test. [See Title XVIII of the Social Security Act, §1833(e), which states no payment may be made unless information necessary to determine payment has been submitted)] 1. The specific name of the genetic or molecular diagnostic test; 2. Name of the performing laboratory; 3. The exact gene(s) and/or mutations being tested: 4. Applicable CPT and/or HCPCS code(s) 5. Brief explanation of how the results of genetic testing are necessary to guide treatment decisions relevant to the member’s personal medical history. Tests performed for the following purposes are a few examples: o Diagnose an illness when signs/symptoms are displayed; or, o Rule out a diagnosis when signs/symptoms are displayed; or o Guide treatment planning for a previously diagnosed illness (i.e., whether to perform surgery, determine chemotherapy treatment, choose between medication options, etc.). 6. Medical records relevant to the testing being performed. This includes: o History and physical examinations, o Conventional testing and outcomes, o Conservative treatment provided, if any, and o Documentation of pre-test genetic testing counseling, provided by a qualified and appropriately trained practitioner, and an informed consent form signed by the patient prior to testing which includes a statement that he/she agree to post-test counseling. 3 – M-GT20 MEDICARE MEDICAL POLICY CRITERIA Genetic or Molecular Diagnostic Test Criteria Source/Reference The following is a list of single gene tests with an available Medicare, Noridian, Palmetto MolDX coverage guideline, or other Medicare-based reference. In the absence of a guideline specific to the test, gene(s) and/or mutation(s) in question, for services rendered by a laboratory within the MAO service area, defer to the final two (2) paragraphs under the “TherapyDirecting testing” subheading within the Noridian LCD for Genetic Testing [L24308] (Idaho, Oregon, Utah, Washington). The term “therapy-directing testing” refers to laboratory testing performed when the results are anticipated to impact or direct further therapy and treatment decisions. 4q25-AF Risk Genotype MolDX: 4q25-AF Risk Genotype Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) 9p21 Genotype Test MolDX: 9p21 Genotype Test Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) Afirma™ Assay (Veracyte®) MolDX: Afirma Assay by Veracyte Coding and Billing Guidelines (Published by Palmetto GBA, and applies to all states covered by the MAO) ApoE Genotype MolDX: ApoE Genotype Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy (ARVD/C) Testing MolDX: Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy (ARVD/C) Testing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) Aspartoacyclase 2 Deficiency (ASPA) Testing MolDX: Aspartoacyclase 2 Deficiency(ASPA) Testing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) ATP7B Gene Tests MolDX: ATP7B Gene Tests Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) Avise PG Assay (Exagen MolDX: Avise PG Assay Coding and Billing Guidelines (Published by Palmetto GBA, and used 4 – M-GT20 MEDICARE MEDICAL POLICY CRITERIA Genetic or Molecular Diagnostic Test Criteria Source/Reference Diagnostics) for all states covered by the MAO) BCKDHB Gene Test MolDX: BCKDHB Gene Test Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) BCR/ABL Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for BCR/ABL fusion testing in the LCD. Bladder Tumor Marker FISH MolDX: Bladder Tumor Marker FISH Coding and Coding Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) BLM Gene Analysis MolDX: BLM Gene Analysis Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) BRAF See cobas® 4800 BRAF V600 and ThxID™ BRAF V600/K below BRCA1 and BRCA2 (hereditary breast cancer) When the member has a personal history of cancer relevant to the test performed, as indicated by the LCD: Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for BRCA1 and/or BRCA2 testing in multiple sections of LCD. Testing performed with no personal history of cancer relevant to the testing, testing for familial mutation (CPT codes 81215 and 81217): Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for BRCA1 and/or BRCA2 testing in multiple sections of LCD. Note Medicare does not cover genetic tests based on family history alone CDH1 Genetic Testing MolDX: CDH1 Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) CFTR Gene Analysis MolDX: CFTR Gene Analysis Coding and Billing Guidelines (Published by Palmetto GBA, and 5 – M-GT20 MEDICARE MEDICAL POLICY CRITERIA Genetic or Molecular Diagnostic Test Criteria Source/Reference used for all states covered by the MAO) CHD7 Gene Analysis MolDX: CHD7 Gene Analysis Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) Chimerism Testing MolDX: Chimerism Testing Billing and Coding Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) cobas® 4800 BRAF V600 Test FDA-Approved BRAF Tests (Published by Palmetto GBA, and used for all states covered by the MAO) cobas EGFR Mutation Test MolDX: cobas EGFR Mutation Test Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) Cologuard™ Colorectal Screening (Exact Sciences Laboratories) Until NCD 210.3 is revised regarding Cologuard™ coverage, see CMS Decision Memo (CAG00440N) (For all other screening DNA stool tests, see applicable guideline below) Corus® CAD MolDX: Corus CAD Test Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) Cytochrome p450 Genotyping See individual genome below (i.e., CYP2B6, CYP2D6, etc) CYP2B6 MolDX: CYP2B6 Test Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) CYP2C9 CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing (L35472) (Idaho, Oregon, Utah, 6 – M-GT20 MEDICARE MEDICAL POLICY CRITERIA Genetic or Molecular Diagnostic Test Criteria Source/Reference Washington) (See also Warfarin Response Testing guidelines below) CYP2C19 CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing (L35472) (Idaho, Oregon, Utah, Washington) CYP2D6 CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing (L35472) (Idaho, Oregon, Utah, Washington) Cytogenomic Constitutional Microarray Analysis MolDX: Cytogenomic Constitutional Microarray Analysis Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) DPYD Gene Analysis See Medicare Advantage medical policy for Laboratory and Genetic Testing for Use of 5Fluorouracil (5-FU) in Patients with Cancer, Laboratory, Policy No. M-64 (see Cross References) ENG and ACVRL1 Gene Tests MolDX: ENG and ACVRL1 Gene Tests Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) Familial Adenomatous Polyposis (FAP) (includes Attenuated FAP [AFAP]) Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for FAP and/or AFAP testing in multiple sections of LCD. FANCC Genetic Testing MolDX: FANCC Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) Fragile X Testing MolDX: Fragile X Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) FSHD Southern Blot Test (Athena Diagnostics, Molecular Pathology Procedures (L34506)(15) (Published by National Government Services, and used for all states covered by the MAO) 7 – M-GT20 MEDICARE MEDICAL POLICY CRITERIA Genetic or Molecular Diagnostic Test Criteria Source/Reference Worcester, MA) Glucosidase, Beta, Acid (GBA) Genetic Testing MolDX: GBA Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) HAX1 Gene Sequencing MolDX: HAX1 Gene Sequencing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) HBB Full Gene Sequencing MolDX: HBB Full Gene Sequencing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) HEXA Gene Analysis MolDX: HEXA Gene Analysis Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) HLA-B*5701 Testing Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for HLAB*5701 testing in multiple sections of LCD. HTTLPR Gene Testing MolDX: HTTLPR Gene Testing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) IKBKAP Genetic Testing MolDX: IKBKAP Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) JAK2 Testing Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for JAK2 testing in multiple sections of LCD. KIF6 Genotype MolDX: KIF6 Genotype Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) know error® DNA Specimen Provenance Assay (Strand Diagnostics, Indianapolis, IN) Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states " ...no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis and treatment of illness or injury..." The know error® system is a test performed to confirm a surgical biopsy sample belongs to the patient evaluated for treatment. Test results measure the 8 – M-GT20 MEDICARE MEDICAL POLICY CRITERIA Genetic or Molecular Diagnostic Test Criteria Source/Reference quality of a process, rather than providing information to diagnose or treat a patient. Therefore, this test is not medically necessary based on Medicare guidelines. See also MolDX: know error Coding and Billing Guidelines See also the “Specimen Validity Testing” guideline below KRAS Testing Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for KRAS testing in multiple sections of LCD. L1CAM Gene Sequencing MolDX: L1CAM Gene Sequencing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) LPA-Aspirin Genotype MolDX: LPA-Aspirin Genotype Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) LPA-Intron 25 Genotype MolDX: LPA-Intron 25 Genotype Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) Lynch Syndrome (hMLH1, hMSH2, hMSH6, PMS2 and EPCAM gene testing) Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for Lynch Syndrome gene testing in multiple sections of LCD. MCOLN1 Genetic Testing MolDX: MCOLN1 Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) MECP2 Genetic Testing MolDX: MECP2 Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) MGMT Gene Promoter MolDX: MGMT Gene Promoter Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) 9 – M-GT20 MEDICARE MEDICAL POLICY CRITERIA Genetic or Molecular Diagnostic Test Criteria Source/Reference Mitochondrial Nuclear Gene Tests MolDX: Mitochondrial Nuclear Gene Tests Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) MMACHC Testing MolDX: MMACHC Test Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) MPL Gene Tests MolDX: MPL Gene Tests Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) MYH-associated polyposis (MAP) Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) Criteria for MAP testing in multiple sections of LCD. myPAP™ DNA test MolDX: myPap Billing and Coding Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) NSD1 Gene Tests MolDX: NSD1 Gene Tests Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) PathFinderTG® Molecular Testing Loss-of-Heterozygosity Based Topographic Genotyping with PathfinderTG® (L31144)(15-17) (Published by Novitas, and applies to all states covered by the health care plan) PAX6 Gene Sequencing MolDX: PAX6 Gene Sequencing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) Pervenio Lung RS Assay MolDX: Pervenio Lung RS Assay Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) PIK3CA MolDX: PIK3CA Gene Tests Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) PTCH1 Gene Testing MolDX: PTCH1 Gene Testing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) RPS19 Gene Tests MolDX: RPS19 Gene Tests Coding and Billing Guidelines (Published by Palmetto GBA, and 10 – M-GT20 MEDICARE MEDICAL POLICY CRITERIA Genetic or Molecular Diagnostic Test Criteria Source/Reference used for all states covered by the MAO) Screening DNA (Deoxyribonucleic acid) stool tests • ColoSure™ • PreGen-PlusTM NCD for Colorectal Cancer Screening Tests (210.3) SEPT9 Gene Test MolDX: SEPT9 Gene Test Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) Short Tandem Repeat (STR) Markers MolDX: Short Tandem Repeat (STR) Markers Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) SLCO1B1 Genotype MolDX: SLCO1B1 Genotype Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) SMPD1 Genetic Testing MolDX: SMPD1 Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) Specimen Validity Testing MolDX: Specimen Validity Testing (Published by Palmetto GBA, and used for all states covered by the MAO) STAT3 Gene Testing MolDX: STAT3 Gene Testing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) SULT4A1 Genetic Testing MolDX: SULT4A1 Genetic Testing Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) TERC Gene Tests MolDX: TERC Gene Tests Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) therascreen® EGFR RGQ MolDX: therascreen EGFR RGQ PCR Kit Coding and Billing Guidelines (Published by Palmetto 11 – M-GT20 MEDICARE MEDICAL POLICY CRITERIA Genetic or Molecular Diagnostic Test Criteria Source/Reference PCR Kit GBA, and used for all states covered by the MAO) ® therascreen KRAS PCR Kit MolDX: therascreen KRAS PCR Kit Billing/Coding Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) ThxID™ BRAF V600/K FDA-Approved BRAF Tests (Published by Palmetto GBA, and used for all states covered by the MAO) TP53 Gene Test MolDX: TP53 Gene Test Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) TYMS Gene Analysis See Medicare Advantage medical policy for Laboratory and Genetic Testing for Use of 5Fluorouracil (5-FU) in Patients with Cancer, Laboratory, Policy No. M-64 (see Cross References) UGT1A1 Gene Analysis MolDX: UGT1A1 Gene Analysis Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) VEGFR2 Tests MolDX: VEGFR2 Tests Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) VKORC1 See Warfarin Response Testing guidelines below Warfarin Response Testing • CYP2C9 • VKORC1 Pharmacogenomic Testing for Warfarin Response (90.1) YouScript Plavix (Genelex, Seattle, WA) The YouScript Plavix test analyzes only the CYP2C19 gene. Therefore, see Noridian LCD for CYP2C19, CYP2D6, CYP2C9, and VKORC1 Genetic Testing (L35472) (Washington) The same coverage information is published in multiple locations for CYP2C9 and VKORC1. See the row for “Cytochrome p450 Genotyping” above and additional “References” below.(18) **Scroll to the “All Versions” section at the bottom of the LCD or LCA to access prior versions. 12 – M-GT20 REFERENCES 1. Medicare Coverage Determination Process 2. Medicare Managed Care Manual, Ch. 4 - Benefits and Beneficiary Protections, §10.2 Basic Rule 3. Title XVIII of the Social Security Act, §1862(a)(1)(A) 4. Medicare Benefit Policy Manual, Chapter 16 - General Exclusions From Coverage, §20 - Services Not Reasonable and Necessary 5. Medicare Claims Processing Manual, Chapter 23 - Fee Schedule Administration and Coding Requirements, §30 - Services Paid Under the Medicare Physician’s Fee Schedule, Subsection A 6. 42 CFR §410.32(a) 7. Medicare Benefit Policy Manual, Ch. 15 – Covered Medical and Other Health Services, §80.1 - Clinical Laboratory Services 8. Noridian LCD for Genetic Testing (L24308) (Idaho, Oregon, Utah, Washington) (Scroll to the “All Versions” section at the bottom of the LCD or LCA to access prior versions.) 9. Federal Register / Vol. 66, No. 226 / Friday, November 23, 2001 10. Medicare Claims Processing Manual, Chapter 16 – Laboratory Services, §120.1, Negotiated Rulemaking Implementation, see section regarding “Clarification of the Use of the Term ‘Screening’ or ‘Screen’” 11. Medicare National Coverage Determinations (NCD) Coding Policy Manual and Change Report January 2013 12. Noridian Healthcare Solutions - Palmetto GBA MolDX Program for Jurisdiction F 13. Noridian LCA for MolDX Excluded Tests (A54013) (Idaho, Oregon, Utah, Washington) 14. Medicare Managed Care Manual, Ch. 4 - Benefits and Beneficiary Protections, §90.2.1 MACS with Exclusive Jurisdiction over a Medicare Item or Service 15. Medicare Claims Processing Manual, Chapter 1 - General Billing Requirements, §10.1.5.4 - Independent Laboratories 16. Novitas LCA for Biomarkers for Oncology (A52317) 17. Novitas LCA for RedPath - PathFinderTG - Provider Bulletin (A51681) 18. MolDX: CYP2C9 and/or VKORC1 Gene Testing for Warfarin Response Coding and Billing Guidelines (Published by Palmetto GBA, and used for all states covered by the MAO) 19. Noridian LCA for Molecular Genetic testing (A52164) (Idaho, Oregon, Utah, Washington) (Scroll to the “All Versions” section at the bottom of the LCD or LCA to access prior versions.) CROSS REFERENCES Genetic and Molecular Diagnostics – Next Generation Sequencing and Genetic Panel Testing, Genetic Testing, Policy No. M-64 13 – M-GT20 Chemoresistance and Chemosensitivity Assays, Laboratory, Policy No. M-06 Laboratory and Genetic Testing for Use of 5-Fluorouracil (5-FU) in Patients with Cancer, Laboratory, Policy No. M-64 Vectra™ DA Test for Monitoring Disease Activity in Rheumatoid Arthritis, Laboratory, Policy No. M-67 CODES NUMBER DESCRIPTION Note: The newly added (2013) CPT® codes for molecular genetic testing are often nonspecific as evidenced by the CPT range 81400-81408. Many of the tests listed for these codes are not covered by Medicare. In order to properly adjudicate claims for molecular genetic testing, the actual test name being performed must be included in the narrative section of the claim.(19) In addition, HCPCS S-codes are not payable by Medicare, and therefore, are not payable for the health plan’s Medicare Advantage members. CPT 81161, Molecular pathology code range 81200 – 81479 81504 Oncology (tissue of origin), microarray gene expression profiling of > 2000 genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as tissue similarity scores 81507 Fetal aneuploidy (trisomy 21, 18, and 13) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy 81519 Oncology (breast), mRNA, gene expression profiling by real-time RT-PCR of 21 genes, utilizing formalin-fixed paraffin embedded tissue, algorithm reported as recurrence score 81599 84999 88299 88363 Unlisted multianalyte assay with algorithmic analysis Unlisted chemistry procedure Unlisted cytogenetic study Examination and selection of retrieved archival (ie, previously diagnosed) tissue(s) for molecular analysis (eg, KRAS mutational analysis) Scoliosis, DNA analysis of 53 single nucleotide polymorphisms (SNPs), using saliva, prognostic algorithm reported as a risk score Oncology (hepatic), mRNA expression levels of 161 genes, utilizing fresh hepatocellular carcinoma tumor tissue, with alpha-fetoprotein 0004M 0006M 14 – M-GT20 CODES NUMBER DESCRIPTION 0007M 0008M 0009M 0010M HCPCS G0452 G0464 G9143 S3721 S3800 S3840 S3841 S3842 S3844 S3845 S3846 S3849 S3850 level, algorithm reported as a risk classifier Oncology (gastrointestinal neuroendocrine tumors), real-time PCR expression analysis of 51 genes, utilizing whole peripheral blood, algorithm reported as a nomogram of tumor disease index Oncology (breast), mRNA analysis of 58 genes using hybrid capture, on formalin-fixed paraffin-embedded (FFPE) tissue, prognostic algorithm reported as a risk score Fetal aneuploidy (trisomy 21, and 18) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy Oncology (High-Grade Prostate Cancer), biochemical assay of four proteins (Total PSA, Free PSA, Intact PSA and human kallikrein 2 [hK2]) plus patient age, digital rectal examination status, and no history of positive prostate biopsy, utilizing plasma, prognostic algorithm reported as a probability score Molecular pathology procedure; physician interpretation and report Colorectal cancer screening; stool-based DNA and fecal occult hemoglobin (e.g., KRAS, NDRG4 and BMP3) Warfarin responsiveness testing by genetic technique using any method, any number of specimen(s) Prostate cancer antigen 3 (PCA3) testing (Not valid for Medicare purposes) Genetic testing for amyotrophic lateral sclerosis (ALS) (Not valid for Medicare purposes) DNA analysis for germline mutations of the RET proto-oncogene for susceptibility to multiple endocrine neoplasia type 2 (Not valid for Medicare purposes) Genetic testing for retinoblastoma (Not valid for Medicare purposes) Genetic testing for Von Hippel-Lindau disease (Not valid for Medicare purposes) DNA analysis of the connexin 26 gene (GJB2) for susceptibility to congenital, profound deafness (Not valid for Medicare purposes) Genetic testing for alpha thalassemia (Not valid for Medicare purposes) Genetic testing for hemoglobin E beta-thalassemia (Not valid for Medicare purposes) Genetic testing for Niemann-Pick disease (Not valid for Medicare purposes) Genetic testing for sickle cell anemia (Not valid for Medicare purposes) 15 – M-GT20 CODES NUMBER DESCRIPTION S3852 S3853 S3854 S3855 S3861 S3865 S3866 S3870 S3890 DNA analysis for APOE epsilon 4 allele for susceptibility to Alzheimer’s disease (Not valid for Medicare purposes) Genetic testing for muscular dystrophy (Not valid for Medicare purposes) Gene expression profiling panel for use in the management of breast cancer treatment (Not valid for Medicare purposes) Genetic testing for detection of mutations in the presenilin-1 gene (Not valid for Medicare purposes) Genetic testing, sodium channel, voltage-gated, type V, alpha subunit (SCN5A) and variants for suspected Brugada syndrome (Not valid for Medicare purposes) Comprehensive gene sequence analysis for hypertrophic cardiomyopathy (Not valid for Medicare purposes) Genetic analysis for a specific gene mutation for hypertrophic cardiomyopathy (HCM) in an individual with a known HCM mutation in the family (Not valid for Medicare purposes) Comparative genomic hybridization (CGH) microarray testing for developmental delay, autism spectrum disorder and/or intellectual disability (Not valid for Medicare purposes) DNA analysis, fecal, for colorectal cancer screening (Not valid for Medicare purposes) 16 – M-GT20
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