Genetic Testing Form

Important note: Unless otherwise indicated, medical policies will apply to all lines of business. Medical necessity as defined by this policy does not ensure the benefit is covered. This medical policy does not replace existing federal or state rules and regulations for the applicable service or supply. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan documents. See the member plan specific benefit plan document for a complete description of plan benefits, exclusions, limitations, and conditions of coverage. In the event of a discrepancy, the plan document always supersedes the information in this policy. SERVICE: Genetic (Genomic) Testing
PRIOR AUTHORIZATION: Required. POLICY: Please review the plan’s EOC (Evidence of Coverage) or Summary Plan Description (SPD) for coverage details. Not all Plans cover non-mandated genetic/genomic testing. Please check the Plan documents for coverage limitations. Note: Unless otherwise indicated (see below), this policy will apply to all lines of business. Where genetic/genomic testing is a benefit ... All genetic testing should be used for predictive, diagnostic or prognostic disease situations. Genetic testing for non-medical purposes, such as paternity, ancestry. genome-wide association studies (GWAS), and non-disease traits, such as baldness, eye color, are NOT medically necessary. Most genetic testing is once per lifetime or once per pregnancy (prenatal testing). When possible, testing should be performed at a contracted/network laboratory. If a non-contracted (out-of-network) laboratory is required, the member should be informed of difference in out-of-pocket charges. In addition, the provider should document the need for an out-of-network laboratory, e.g., targeted testing in another family member, gene not offered at contracted/network laboratory, etc. Finally, medical necessity must be documented for every request. For Medicare plans, please refer to appropriate Medicare NCD (National Coverage Determination) or LCD (Local Coverage Determination). If there are no applicable NCD or LCD criteria, use the criteria set forth below. For Medicaid plans, please confirm coverage as outlined in the Texas Medicaid Provider Procedures
Manual | TMHP (TMPPM). If there are no applicable criteria to guide medical necessity decision making in the TMPPM, use the criteria set forth below. For all other plans, please confirm coverage and then use InterQual® for further guidance. If an appropriate criterion set is not found in the resources above, the request will be processed using the overarching principles that follow. A. Coverage for genetic/genomic testing and/or screening may be medically necessary when ALL of the following criteria are met: MEDICAL COVERAGE POLICY SERVICE: Genetic Testing Policy Number: 037 Effective Date: 05/01/2026 Last Review: 04/23/2026 Next Review: 04/23/2027

1. Appropriate genetic counseling occurs before and after testing. Members must have genetic counseling by a practitioner who has expertise in the genetic aspects of the condition being evaluated and who will discuss the results of the test and their clinical implications. Documentation of the counseling will accompany the preauthorization request. Evidence of genetic counseling should include, but is not limited to the following: a. Discussion of the types of test results (positive, negative, uncertain findings) that could be obtained b. Identifying problems that are known to occur due to test methodology c. Evaluation of the members risk for the specific disorder, the differential diagnosis, inheritance patterns, penetrance, variable expressivity and genetic heterogeneity d. Evidence of informed consent e. A plan for posttest counseling Note: Genetic counseling must be performed by practitioners NOT employed by testing companies due to conflict of interest.
2. There must be a reasonable expectation, based on family history, pedigree analysis, risk factors, and/or symptomatology, that a genetically inherited or acquired condition exists and the member displays clinical features, or is at direct risk of inheriting the mutation in question (pre-symptomatic) or comes from the appropriate disease-specific population. A three-generation pedigree MUST accompany the request for testing, where appropriate, to aid in coverage determination.
3. Knowledge of the presence or absence of the condition would DIRECTLY affect medical care of the member. a. The disease must be treatable and/or preventable AND b. The test results will lead to a change in the intensity of surveillance frequency and /or treatment for that disease.
   4. There are often options for single gene testing, multiple gene testing and panel testing. a. If a single gene test meets other criteria and will answer the clinical question, SHWP will generally find such a test medically necessary. b. If a multigene panel is requested, there must be evidence that there are two or more genes responsible for a specific condition or that there is the possibility that several genes can cause multiple diseases within the family. Most of the genes on the panel should be plausible explanations for the disorder observed. c. The smallest plausible gene panel will be authorized, to decrease variants of unknown significance. Broad multi-gene-based panels are not medically necessary when a more focused study is available. d. If a panel is chosen, the list of genes should be on the request and in the accompanying documentation to explain why that particular panel was chosen. e. Multiple panels tested at the same time are not medically necessary. MEDICAL COVERAGE POLICY SERVICE: Genetic Testing Policy Number: 037 Effective Date: 05/01/2026 Last Review: 04/23/2026 Next Review: 04/23/2027

5. The test is performed in a CLIA certified laboratory, AND is FDA approved, AND is
   recommended by recognized, national guidelines.
6. The request MUST be submitted with the SWHP “Statement of Medical Necessity for Genetic Testing” located at the end of this policy, OR other documentation such as clinical documentation that addresses all of the questions in that document. In particular, there must be a clear statement that explains how the test results will improve the medical management of the patient’s condition. The statement “... is medically necessary” does NOT meet the criteria since it does not explain the change in management or surveillance that would take place if the test is positive and if it were negative. Note: Genetic/genomic testing for specific germline conditions or mutations is limited to once per lifetime for the specific mutation or panel. Exceptions may be considered if there is a change in guidelines for genes that have not been tested or need reinterpretation of results. B. Tests with specific policy guidance
7. Cell-free DNA screening tests for microdeletions (CPT 81422) have NOT been validated and are not deemed medically necessary.
8. Whole Genome Sequencing may be medically necessary to identify or confirm the genetic etiology of a known or unknown disorder in clinically affected neonatal and pediatric patients. In most cases whole genome sequencing will not be found medically necessary unless more targeted studies have failed to identify a mutation. C. Exclusions (The following are examples of services that are not covered)
9. Routine, ongoing, or long-term genetic counseling.
10. Genetic testing to determine the paternity of a child.
11. Genetic testing to determine the sex of the child.
12. General population screening for genetic disorders (e.g., cystic fibrosis). D. Genetic Test codes with Prior Authorization (PA) diagnosis specifications 81161 DMD (dystrophin) (eg, Duchenne/Becker muscular dystrophy) deletion analysis, and duplication analysis, if performed No PA if Prenatal Dx present 81220 CFTR (cystic fibrosis transmembrane conductance regulator) (eg, cystic fibrosis) gene analysis; common variants (eg, ACMG/ACOG No PA if Prenatal Dx present 81221 guidelines) CFTR (cystic fibrosis transmembrane conductance regulator) (eg, cystic fibrosis) gene analysis; known familial variants No PA if Prenatal Dx present 81222 CFTR (cystic fibrosis transmembrane conductance regulator) (eg, cystic fibrosis) gene analysis; duplication/deletion variants No PA if Prenatal Dx present 81223 CFTR (cystic fibrosis transmembrane conductance regulator) (eg, cystic fibrosis) gene analysis; full gene sequence No PA if Prenatal Dx present MEDICAL COVERAGE POLICY SERVICE: Genetic Testing Policy Number: 037 Effective Date: 05/01/2026 Last Review: 04/23/2026 Next Review: 04/23/2027

81224 CFTR (cystic fibrosis transmembrane conductance regulator) (eg, cystic fibrosis) gene analysis; intron 8 poly-T analysis (eg, male infertility) No PA if Prenatal Dx present 81229 Cytogenomic (genome-wide) analysis for constitutional chromosomal abnormalities; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants No PA if Prenatal Dx present 81238 F9 (coagulation factor IX) (eg, hemophilia B) No PA if Prenatal Dx 81243 FMR1 (fragile X mental retardation 1) (eg, fragile X mental retardation) gene analysis present No PA if Prenatal Dx present 81259 HBA1/HBA2 (alpha globin 1 and alpha globin 2) (eg, alpha thalassemia, Hb Bart hydrops fetalis syndrome, HbH disease), gene analysis, for common deletions or variant (eg, Southeast Asian, Thai, No PA if Prenatal Dx present 81302 MECP2 (methyl CpG binding protein 2) (eg, Rett syndrome) gene analysis; full sequence analysis No PA if Prenatal Dx present 81303 MECP2 (methyl CpG binding protein 2) (eg, Rett syndrome) gene analysis; known familial variant No PA if Prenatal Dx present 81304 MECP2 (methyl CpG binding protein 2) (eg, Rett syndrome) gene analysis; duplication/deletion variants No PA if Prenatal Dx present 81329 SMN1 (survival of motor neuron 1, telomeric) (eg, spinal muscular atrophy) gene analysis; dosage/deletion analysis (eg, carrier testing), includes SMN2 (survival of motor neuron 2, centromeric) analysi No PA if Prenatal Dx present 81336 SMN1 (survival of motor neuron 1, telomeric) (eg, spinal muscular atrophy) gene analysis; full gene sequence No PA if Prenatal Dx present 81337 SMN1 (survival of motor neuron 1, telomeric) (eg, spinal muscular atrophy) gene analysis; known familial sequence variant(s) No PA if Prenatal Dx present 81443 Genetic testing for severe inherited conditions (eg, cystic fibrosis, Ashkenazi Jewish-associated disorders Leg, Bloom syndrome, Canavan disease, Fanconi anemia type C, mucolipidosis type VI, Gaucher disease, Tay-Sachs disease], beta hemoglobinopathies, phenylketonuria, familial dysautonomia,Joubert syndrome,Maple syrup urine disease,Niemann-Pick disease,Nemaline myopathy,galactosemia No PA if Prenatal Dx present 88267 Chromosome analysis, amniotic fluid or chorionic villus, count 15 cells, 1 karyotype, with banding No PA if Prenatal Dx present 88269 Chromosome analysis, in situ for amniotic fluid cells, count cells from 6-12 colonies, 1 karyotype, with banding No PA if Prenatal Dx present E. Definitions:

1. First-degree relative – a blood relative with whom an individual shares approximately 50% of his or her genes, including parents, full siblings and children.
2. Second-degree relative – a blood relative with whom an individual shares approximately 25% of his/her genes, including grandparents, grandchildren, aunts, uncles, nephews, nieces and half-siblings MEDICAL COVERAGE POLICY SERVICE: Genetic Testing Policy Number: 037 Effective Date: 05/01/2026 Last Review: 04/23/2026 Next Review: 04/23/2027

MANDATES: None CODES: Important note: Due to the wide range of applicable diagnosis codes and potential changes to codes, an inclusive list may not be presented, but the following codes may apply. Inclusion of a code in this section does not guarantee that it will be reimbursed, and patient must meet the criteria set forth in the policy language. POLICY HISTORY: Status Date Action New 08/01/2010 New policy Reviewed 12/06/2011 Reviewed. Reviewed 12/06/2012 Revised. BRCA added. Criteria revised Reviewed 11/14/2013 BRCA criteria updated. Reviewed 04/24/2014 Minor updates made. Reviewed 07/02/2015 Extensively re-written Reviewed 09/08/2016 Clarified criteria; added pharmacogenetics section. Update 06/27/2017 Updated criteria for NIPT. Reviewed 08/22/2017 Set most testing limit to once per lifetime. Updated criteria. New request form. Minor correction 11/28/2017 Removed discussion regarding FIT-DNA stool testing Reviewed 06/26/2018 Significant revision of several coverage topics. Addition 02/12/2019 InterQual® to be used instead of policy for five codes. Major revision 09/26/2019 Policy re-written to direct reviews to InterQual® Reviewed 05/28/2020 Redesign incorporating LCD and Palmetto GBA MolDX Reviewed 04/22/2021 Reviewed 05/26/2022 Reviewed without changes Updated 07/27/2023 Re-wrote criteria referring primarily to IQ or Medicare/Medicaid guidelines Reviewed 08/12/2024 Formatting changes, added hyperlink to TMPPM resources, beginning and ending note sections updated to align with CMS requirements and business entity changes. Reviewed 03/10/2025 81443-Updated Description of Code, ending note section updated to align with business entity changes. Updated 08/11/2025 Removed “Medicare NCD or LCD specific InterQual criteria may be used when available.” Reviewed 04/26/2026 No changes MEDICAL COVERAGE POLICY SERVICE: Genetic Testing Policy Number: 037 Effective Date: 05/01/2026 Last Review: 04/23/2026 Next Review: 04/23/2027 CPT Codes HCPCS Codes ICD10 codes ICD10 Not covered

REFERENCES: The following scientific references were utilized in the formulation of this medical policy. SWHP will continue to review clinical evidence surrounding genetic testing and may modify this policy at a later date based upon the evolution of the published clinical evidence. Should additional scientific studies become available, and they are not included in the list, please forward the reference(s) to SWHP so the information can be reviewed by the Medical Coverage Policy Committee (MCPC) and the Quality Improvement Committee (QIC) to determine if a modification of the policy is in order.

1. Calderon-Margalit R, Paltiel O. Prevention of Breast Cancer in Women Who Carry BRCA1 or BRCA2 Mutations: A Critical Review of the Literature. Int J Cancer. 2004 Nov 10;112(3):357- 64.
2. National Comprehensive Cancer Network. Practice Guidelines in Oncology. Genetic/Familial High-Risk Assessment: Breast and Ovarian. Version 1. 2006. http://www.nccn.org/professionals/physiciangls/PDF/geneticsscreening.pdf
3. National Cancer Institute. Genetics of Colorectal Cancer (PDQ®). Last Modified 03/24/2006. http://nci.nih.gov/cancertopics/pdq/genetics/colorectal/healthprofessional.
4. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Colorectal Screening. Version 1. 2006.
5. http://www.nccn.org/professionals/physician gls/PDF/colorectal screening.pdf.
6. Croitoru ME, Cleary SP, Di Nicola N, Manno M, Selander T, Aronson M, Redston M, Cotterchio M, Knight J, Gryfe R, Gallinger S. Association between biallelic and monoallelic germline MYH gene mutations and colorectal cancer risk. J Natl Cancer Inst. 2004 Nov 3;96(21):1631-4.
7. Venesio T, Molatore S, Cattaneo F, Arrigoni A, Risio M, Ranzani GN.
8. High frequency of MYH gene mutations in a subset of patients with familial adenomatous polyposis. Gastroenterology. 2004 Jun; 126(7): 1681-5.
9. Sieber OM, Lipton L, Crabtree M, Heinimann K, Fidalgo P, Phillips RK, Bisgaard ML, Orntoft TF, Aaltonen LA, Hodgson SV, Thomas HJ, Tomlinson IP. Multiple colorectal adenomas, classic adenomatous polyposis, and germ-line mutations in MYH. N Engl J Med. 2003 Feb 27;348(9):791 -9.
10. Grosse SD, Boyle CA, Botkin JR et al. Newborn Screening for Cystic Fibrosis. CDC Recommendations and Reports. October 15, 2004. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5313a1.htm
11. Richards CS, Bradley LA, Amos J. et al. ACMG Technical Standards and Guidelines for CFTR Mutation Testing 2006 Edition. http://www.acmg.net/Pages/ACMG Activities/stds¬2002/cf.htm
12. Moskowitz SM, Gibson RL, Sternen DL, Cheng E, Cutting GR. CFTR-Related Disorders. August 2005. Available at: www.genetests.org.
13. ACOG Committee Opinion 690, March 2017: Carrier screening in the age of genomic medicine
14. ACOG Practice Bulletin 102, March 2017 (reaffirmed 2016): Management of stillbirth
15. American College of Obstetricians and Gynecologists Committee Opinion No 691: Carrier screening for genetic conditions carrier screening for genetic conditions 2017
16. American College of Medical Genetics, Points to consider in the clinical application of genomic sequencing Genet Med 2012 Aug 14(8):759-61 Policy statement whole exome and whole genome testing
17. American College of Medical Genetics and Genomics Practice Guidelines Genetic Testing Note: Health Maintenance Organization (HMO) products are offered through Scott and White Health Plan dba Baylor Scott & White Health Plan, and Scott & White Care Plans dba Baylor Scott & White Care Plan. Insured PPO and EPO products are offered through Baylor Scott & White Insurance Company. Scott and White Health Plan dba Baylor Scott & White Health Plan serves as a third-party administrator for self-funded employer-sponsored plans. Baylor Scott & White Care Plan and Baylor Scott & White Insurance Company are wholly owned subsidiaries of Scott and White Health Plan. These companies are referred to collectively in this document as Baylor Scott & White Health Plan. MEDICAL COVERAGE POLICY SERVICE: Genetic Testing Policy Number: 037 Effective Date: 05/01/2026 Last Review: 04/23/2026 Next Review: 04/23/2027

RightCare STAR Medicaid is offered through Scott and White Health Plan in the Central Texas Medicaid Rural Service Area (MRSA); FirstCare STAR is offered through SHA LLC dba FirstCare Health Plans (FirstCare) in the Lubbock and West MRSAs; and FirstCare CHIP is offered through FirstCare in the Lubbock Service Area SWHP Genetic Testing Prior Authorization Form 7/22/2024 version Date of Request: //__ Date, if procedure has been schedule: //__ Insured Member Information Name: ____ SWHP ID#:
Date of Birth: // Gender: M F Provider Information Requesting Provider Name: __ NPI#: _
Requesting Provider Address: ___
Office Contact Person: ____ Telephone #: ____ Fax #: Supplying Provider Information Supplying Provider Name: __ NPI#: __
Supplying Provider Address: ____
Office Contact Person: ____ Telephone #: ____ Fax #: Genetic Test Information
Requested Genetic Test BRCA 1 and 2, HBOC Breast expression RNA Hereditary Hemochromatosis Gene Analysis Colon Cancer Lynch Syndrome (list genes) Cystic Fibrosis Fragile X Syndrome Huntington’s Disease Janus Kinase 2(JAK2) Chromosomal Microarray Familial Adenomatous Polyposis /Assoc. Polyposis Conditions Cardiology Gene Expression (AlloMap) NIPS (non-invasive prenatal screen) MEDICAL COVERAGE POLICY SERVICE: Genetic Testing Policy Number: 037 Effective Date: 05/01/2026 Last Review: 04/23/2026 Next Review: 04/23/2027

Multigene panel: Please list genes requested Medical Information Provide information to justify each test requested. May attach clinical notes if they contain the requested information. 1) Why is the test appropriate for the patient? 2) Does the beneficiary exhibit clinical features of the mutation in question? If not, has a genetic variant been identified in a family member? 5) What is the validity of testing and is the testing scientifically sound? (reference or link) 6) Is the patient willing to undergo the increased interventions that may potentially be required because of 7) How will the results specifically impact or alter medical management of the patient? 8) What is the cost of the test? 9) Is multigene panel testing more cost efficient than the combined reimbursement for single codes? MEDICAL COVERAGE POLICY SERVICE: Genetic Testing Policy Number: 037 Effective Date: 05/01/2026 Last Review: 04/23/2026 Next Review: 04/23/2027 ICD-10 Codes: CPT Code Test CPT Code Test By whom?