Humana Genetic Testing for Celiac Disease Form

. Celiac disease is an autoimmune disorder with gastrointestinal (eg, abdominal pain, bloating, diarrhea, malabsorption, vomiting, weight loss) and variable non- gastrointestinal symptoms (eg, chronic fatigue, dermatitis herpetiformis, joint pain, migraines, vitamin deficiencies) that are triggered by eating foods that contain gluten, a grain protein (eg, barley, rye, wheat) found in many foods and in other products such as medications, toothpastes and vitamin supplements. The diagnosis of celiac disease is based on celiac-specific serology (blood tests) and duodenal histopathology. HLA-DQ2 and HLA-DQ8 genetic testing is appropriate for certain clinical situations but should not be used routinely. A positive HLA-DQ2/DQ8 result is not diagnostic for celiac disease since approximately 40% of the population have these alleles but do not have the disease.14 However, a negative result essentially excludes the diagnosis. Genetic Testing for Celiac Disease Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0544-009 Page: 2 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Except for an individual diagnosed with Down syndrome, genetic testing may not be warranted prior to serology or histopathology nor is it appropriate to perform combined or simultaneous genetic testing and serology. Examples of these types of tests include, but may not be limited to: • Celiac HLA DQ Association with Reflex to Celiac Antibodies tTG IgA/IgG with DGP IgA/IgG Pos/Neg Combination Screen • Celiac HLA DQ Association with Reflex to Celiac Antibodies tTG IgA, tTG IgG, DGP IgA, DGP IgG and Total IgA • Prometheus Celiac PLUS For information regarding genetic testing for the following, please refer to Genetic Testing Medical Coverage Policy: • DNA banking or preservation • General population screening • Individual 17 years of age or younger for adult-onset conditions • Interpretation and reporting for molecular pathology procedure • Polygenic risk score (PRS) and single nucleotide polymorphisms (SNPs) • Repeat germline or somatic genetic testing • Retrieved archival tissue Humana recognizes that the field of genetic testing is rapidly changing and that other tests may become available. Coverage Determination Any state mandates for genetic testing for celiac disease take precedence over this medical coverage policy. Genetic testing may be excluded by certificate. Please consult the member’s individual certificate regarding Plan coverage. Apply General Criteria for Genetic and Pharmacogenomics Tests when disease- or gene-specific criteria are not available on a medical coverage policy. For information See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Genetic Testing for Celiac Disease Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0544-009 Page: 3 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. regarding general criteria for genetic tests, please refer to Genetic Testing Medical Coverage Policy. Celiac Disease (HLA-DQ2/HLA-DQ8) Humana members may be eligible under the Plan for HLA-DQ2/HLA-DQ8 testing to assist in diagnosing an individual with suspected celiac disease when the following criteria are met: • Pre- and post-test genetic counseling; AND o Individual currently on a gluten-free diet (GFD) and both celiac-specific serology* and duodenal histology were not performed prior to beginning GFD; OR o Individual with discordant celiac-specific serology* and duodenal histology results; OR o Individual unable to undergo upper endoscopy (eg, unable to cooperate with procedure, presence of a known or suspected perforated viscus); OR o Individual with Down syndrome regardless of celiac-specific serology* or duodenal histology *Celiac-specific serology includes: • Deamidated gliadin peptide antibody immunoglobulin A (DGP-IgA) • Deamidated gliadin peptide immunoglobulin G (DGP-IgG) • Endomysial antibody immunoglobulin A (EMA-IgA) • Tissue transglutaminase antibody immunoglobulin A (tTG-IgA) • Tissue transglutaminase antibody immunoglobulin G (tTG-IgG) • Total serum IgA Coverage Limitations Humana members may NOT be eligible under the Plan for genetic testing for celiac disease for genes, indications or tests other than those listed above including, but may not be limited to: See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Genetic Testing for Celiac Disease Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0544-009 Page: 4 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. • Performed prior to celiac-specific serology except for an individual diagnosed with Down syndrome including, but may not be limited to: o Celiac HLA DQ Association with Reflex to Celiac Antibodies tTG IgA/IgG with DGP IgA/IgG Pos/Neg Combination Screen o Celiac HLA DQ Association with Reflex to Celiac Antibodies tTG IgA, tTG IgG, DGP IgA, DGP IgG and Total IgA) • Performed prior to duodenal histology except for an individual diagnosed with Down syndrome or unable to undergo endoscopy (eg, unable to cooperate with procedure, presence of a known or suspected perforated viscus) • Performed simultaneously to or in combination with celiac-specific serology including, but may not be limited to, Prometheus Celiac PLUS • Unaffected (asymptomatic) individual These are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition. Background Additional information about celiac disease may be found from the following websites: • National Library of Medicine Medical Alternatives Physician consultation is advised to make an informed decision based on an individual’s health needs. Provider Claims Codes Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Genetic Testing for Celiac Disease Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0544-009 Page: 5 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. CPT® Code(s) 81376 81377 81382 81383 96040 Description Comments HLA Class II typing, low resolution (eg, antigen equivalents); one locus (eg, HLA-DRB1, -DRB3/4/5, -DQB1, -DQA1, -DPB1, or - DPA1), each HLA Class II typing, low resolution (eg, antigen equivalents); one antigen equivalent, each HLA Class II typing, high resolution (ie, alleles or allele groups); one locus (eg, HLA-DRB1, -DRB3/4/5, -DQB1, -DQA1, -DPB1, or - DPA1), each HLA Class II typing, high resolution (ie, alleles or allele groups); one allele or allele group (eg, HLA-DQB1*06:02P), each Medical genetics and genetic counseling services, each 30 minutes face-to-face with patient/family Not Covered if used to report any test outlined in Coverage Limitations section CPT® Category III Code(s) No code(s) identified Description Comments HCPCS Code(s) S0265 Description Comments Genetic counseling, under physician supervision, each 15 minutes References 1. Agency for Healthcare Research and Quality (AHRQ) (ARCHIVED). Comparative Effectiveness Review. Diagnosis of celiac disease. https://effectivehealthcare.ahrq.gov. Published January 28, 2016. Accessed December 5, 2022. 2. American Academy of Pediatrics (AAP). Clinical report - health supervision for children with Down syndrome. https://www.aap.org. Published 2011. Updated January 2018. Accessed December 5, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Genetic Testing for Celiac Disease Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0544-009 Page: 6 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 3. 4. 5. 6. 7. 8. 9. American College of Gastroenterology (ACG). Practice Guidelines. ACG clinical guidelines: diagnosis and management of celiac disease. https://gi.org. Published May 2013. Accessed December 2, 2022. American Gastroenterological Association (AGA). AGA clinical practice update on diagnosis and monitoring of celiac disease – changing utility of serology and histologic measures: expert review. https://gastro.org. Published December 19, 2018. Accessed December 2, 2022. American Gastroenterological Association (AGA). AGA clinical practice update on management of refractory celiac disease: expert review. https://gastro.org. Published September 19, 2022. Accessed December 2, 2022. ECRI Institute. ECRIgene. Celiac Genetics (Prometheus Laboratories Inc) for assessing risk of celiac disease. https://www.ecri.org. Published December 2019. Accessed December 1, 2022. ECRI Institute. ECRIgene. Seq2Know Celiac Disease (PreventionGenetics) for confirming and assessing risk of celiac disease. https://www.ecri.org. Published November 2019. Accessed December 1, 2022. Hayes, Inc. Clinical Utility Evaluation. HLA-DQ2/DQ8 genotyping for celiac disease in asymptomatic individuals with type 1 diabetes. https://evidence.hayesinc.com. Published June 15, 2018. Updated July 16, 2022. Accessed December 1, 2022. Hayes, Inc. Clinical Utility Evaluation. HLA-DQ2/DQ8 genotyping in asymptomatic relatives of individuals with celiac disease. https://evidence.hayesinc.com. Published June 15, 2018. Updated July 16, 2022. Accessed December 1, 2022. 10. Hayes, Inc. Clinical Utility Evaluation. HLA-DQ2/DQ8 genotyping to establish a non-biopsy diagnosis of celiac disease in symptomatic children. https://evidence.hayesinc.com. Published June 15, 2018. Updated July 16, 2022. Accessed December 1, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Genetic Testing for Celiac Disease Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0544-009 Page: 7 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 11. Hayes, Inc. Clinical Utility Evaluation. HLA-DQ2/DQ8 genotyping to rule out celiac disease in symptomatic individuals with an uncertain diagnosis. https://evidence.hayesinc.com. Published June 15, 2018. Updated July 16, 2022. Accessed December 1, 2022. 12. MCG Health. Celiac disease – HLA testing. 26th edition. https://www.mcg.com. Accessed December 1, 2022. 13. National Center for Biotechnology Information (NCBI). Genetic Testing Registry. Celiac disease. https://www.ncbi.nlm.nih.gov. Published July 3, 2008. Updated January 31, 2019. Accessed December 5, 2022. 14. National Institutes of Health (NIH). NIH Consensus and State-of-the-Science Statements (ARCHIVED). NIH consensus statement on celiac disease. https://www.nih.gov. Published June 2004. Accessed December 2, 2022. 15. North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHN). Clinical Guideline. Guideline for the diagnosis and treatment of celiac disease in children: recommendations of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition. https://www.naspghan.org. Published January 2005. Accessed December 2, 2022. 16. Testing.com: for health professionals. Celiac disease. https://www.testing.com. Updated December 3, 2021. Accessed December 5, 2022. 17. UpToDate, Inc. Diagnosis of celiac disease in adults. https://www.uptodate.com. Updated October 2022. Accessed December 1, 2022. 18. UpToDate, Inc. Diagnosis of celiac disease in children. https://www.uptodate.com. Updated October 2022. Accessed December 1, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Genetic Testing for Celiac Disease Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0544-009 Page: 8 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 19. UpToDate, Inc. Overview of upper gastrointestinal endoscopy (esophagogastroduodenoscopy). https://www.uptodate.com. Updated October 2022. Accessed December 1, 2022. 20. US Preventive Services Task Force (USPSTF). Recommendation Statement. Celiac disease: screening. https://www.uspreventiveservicestaskforce.org. Published March 2017. Accessed December 2, 2022. Appendix A See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Genetic Testing for Celiac Disease Effective Date: 02/02/2023 Revision Date: 02/02/2023 Review Date: 02/02/2023 Policy Number: HUM-0544-009 Page: 9 of 9 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Pre- and Post-Test Genetic Counseling Criteria Pre- and post-test genetic counseling performed by any of the following qualified medical professionals Genetic counselor who is board-certified or board-eligible by the American Board of Medical Genetics and Genomics (ABMGG) or American Board of Genetic Counseling, Inc (ABGC) and is not employed by a commercial genetic testing laboratory; OR Genetic clinical nurse (GCN) or advanced practice nurse in genetics (APNG) who is credentialed by the Genetic Nursing Credentialing Commission (GNCC) or the American of Nurses Credentialing Center (ANCC) and is not employed by a commercial genetic testing laboratory; OR Medical geneticist who is board-certified or board-eligible by ABMGG; OR Treating physician who has evaluated the individual to be tested and has completed a family history of three generations See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only.