Humana Serological and Fecal Testing for Inflammatory Bowel Disease Form

. Serological testing is proposed as an adjunctive test for the diagnosis and management of inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). Serologic testing for IBD involves obtaining a blood sample for analysis to determine the presence of autoantibodies such as antisaccharomyces cerevisiae antibodies (ASCA), perinuclear antineutrophil cytoplasmic antibodies (pANCA) and antibodies directed against the porin protein C of Escherichia coli (AntiOmp C). (Refer to Coverage Limitations section) Fecal testing may include fecal calprotectin and fecal lactoferrin. (Refer to Coverage Limitations section) Both are noninvasive markers designed to determine the presence of intestinal inflammation. They have also been utilized to differentiate CD from UC. Fecal calprotectin is a calcium binding protein and fecal lactoferrin is an Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 2 of 20 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. iron binding protein and both are released by neutrophils (a type of white blood cell). When there is inflammation in the gastrointestinal (GI) tract, fecal calprotectin and fecal lactoferrin levels are purportedly increased in the stool; thereby indicating intestinal inflammation.35,36 Another method of fecal testing includes, but may not be limited to, Genova’s GI Effects Comprehensive Profile. This test analyzes biomarkers for absorption, digestion, inflammation, immunology and gut microbiome purported to reveal information about the root cause of GI symptoms such as abdominal pain, bloating, constipation, diarrhea, gas and indigestion. (Refer to Coverage Limitations section) Antiglycan antibodies are serological markers that are reportedly being utilized for testing in IBD. These markers are directed against microbial carbohydrate antigens and it is purported that these markers are useful in the differentiation of CD versus UC. Antiglycan antibodies include, but may not be limited to the following (Refer to Coverage Limitations section): • Antichitin (AntiC) • Antichitobioside (ACCA) • Antilaminaribioside (ALCA) • Antilaminarin (AntiL) • Antimannobioside (AMCA) • Antismooth muscle antibody (ASMA), which detects autoantibodies directed against smooth muscle The pANCA antibodies are more common in UC, but seldom found in CD, whereas ASCA are often found in CD but rarely found in UC. It is purported that as a first screen, these antibodies may help identify an individual with IBD. As a second screen, they may help differentiate UC from CD in cases of indeterminate colitis (IC). AntiOmp C antibodies are supposedly associated with rapidly progressing Crohn’s disease. (Refer to Coverage Limitations section) 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. Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 3 of 20 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. Combined serological testing has been proposed to diagnose and assist in treatment planning. Examples of these tests include, but may not be limited to the following (Refer to Coverage Limitations section): • PredictSURE IBD is a blood-based, prognostic biomarker test that uses mRNA gene expression profiling of 17 genes which is reported as a continuous risk score and classification system for IBD aggressiveness • PROMETHEUS Crohn’s Prognostic test combines proprietary serologic (antiCBir1, antiOMPC, DNAse sensitive pANCA) and genetic (NOD2 variants single nucleotide polymorphisms [SNPs] 8, 12, 13) markers to provide probabilities for developing disease complications after diagnosis and assist in treatment planning • PROMETHEUS IBD sgi Diagnostic is a commercially available diagnostic test that uses pattern recognition to assess 17 assay results, including proprietary biomarkers antiCBir1, antiA4-Fla2, antiFlaX, antiOmpC and DNAse-sensitive pANCA to aid in the diagnosis of IBD • PROMETHEUS Monitr Crohn’s Disease is a laboratory-developed test that evaluates 13 markers of mucosal damage and repair processes, regardless of disease location. It applies a proprietary algorithm to produce a quantitative endoscopic healing index (EHI) score, ranging from 0 to 100, to purportedly aid in distinguishing endoscopic remission from active disease in an adult individual with CD The measurement of antibodies to adalimumab, infliximab, infliximab biosimilar, ustekinumab or vedolizumab have been proposed to determine whether an individual with IBD/Crohn’s have antibodies and/or sufficient drug concentrations. Examples of these tests include, but may not be limited to, the following (Refer to Coverage Limitations section): • Anser ADA • Anser IFX • Anser UST • Anser VDZ • Electrochemiluminescence immunoassay (ECLIA) 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. Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 4 of 20 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. Genetic testing has been proposed to play a role in the determination of susceptibility, disease severity and treatment response of CD. It has been suggested that NOD2 (also known as CARD15) may indicate an increased risk for CD in some populations. (Refer to Coverage Limitations section) A test for the measurement of 2 biomarkers has been developed to reportedly aid in the diagnosis of diarrhea-predominant IBS. The test measures anticytolethal distending toxin B (CdtB) and antivinculin. CdtB is a toxin released by the 4 main bacteria known to cause gastroenteritis and vinculin is a protein released as a result of nerve and intestinal tissue damage. The test results may indicate the presence of IBS as opposed to IBD or celiac disease. Examples of these tests include, but may not be limited to, IBSDetex, IBSchek and ibs-smart. (Refer to Coverage Limitations section) Bile acid malabsorption (BAM) has been suggested as a test to determine the cause of chronic diarrhea in an individual with IBD. Excess bile acids entering the colon may cause symptoms such as watery stool, urgency and fecal incontinence. There are various conditions that may contribute to this condition including, but may not be limited to, ileal resection (eg, surgical treatment for CD), small intestinal bacterial overgrowth (SIBO) or pancreatitis. An example of this test includes, but may not be limited to, PROMETHEUS 7C4 Diagnostic test. (Refer to Coverage Limitations section) For information regarding thiopurine s-methyltransferase (TPMT) genotyping assays or TPMT phenotypic assays, please refer to Pharmacogenomics – Noncancer Indications Medical Coverage Policy. Coverage Determination Humana members may be eligible under the Plan for fecal calprotectin testing (83993) to assist in the detection of IBD in an individual with chronic diarrhea (eg, loose or watery stools that last for greater than 4 weeks) of unknown etiology. Coverage Limitations Humana members may NOT be eligible under the Plan for fecal calprotectin testing for any indications other than those listed above. This is considered experimental/ investigational as it is not identified as widely used and generally accepted for any 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. Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 5 of 20 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. other proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. Humana members may NOT be eligible under the Plan for the following serological and fecal tests for IBD: • ACCA; OR • ALCA; OR • AMCA; OR • ANCA; OR • AntiA4-Fla2; OR • AntiCBir1; OR • AntiFlaX; OR • AntiL; OR • AntiOmpC; OR • ASCA; OR • ASMA; OR • DNAse-sensitive pANCA; OR • Fecal lactoferrin testing (83630, 83631); OR • GI Effects Comprehensive Profile; OR • Measurement of antibodies to adalimumab, infliximab, infliximab biosimilar, ustekinumab or vedolizumab when performed individually or as part of a panel (eg, Anser ADA, Anser IFX, Anser UST and Anser VDZ, ECLIA); OR 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. Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 6 of 20 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. • Measurement of biomarkers CdtB and antivinculin (eg, IBSchek [0176U], IBDetex, ibs-smart [0164U]) to aid in the diagnosis of diarrhea-predominate IBS; OR • NOD2 (CARD15) gene testing to determine susceptibility, disease severity or response to treatment of CD; OR • pANCA; OR • PredictSURE IBD (0203U); OR • PROMETHEUS 7C4 Diagnostic Test for BAM; OR • PROMETHEUS Crohn’s Prognostic; OR • PROMETHEUS IBD sgi Diagnostic; OR • PROMETHEUS Monitr Crohn’s Disease These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language. Background Additional information about IBD may be found from the following websites: • American College of Gastroenterology • American Gastroenterological Association • National Library of Medicine Medical Alternatives Alternatives to fecal and serological testing for IBD include, but may not be limited to, the following: • Biopsy and microscopic examination • Colonoscopy 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. Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 7 of 20 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. Physician consultation is advised to make an informed decision based on an individual’s health needs. Humana may offer a disease management program for this condition. The member may call the number on his/her identification card to ask about our programs to help manage his/her care. 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. Description Comments CPT® Code(s) 80145 Adalimumab 80230 Infliximab 80280 Vedolizumab 80299 Quantitation of therapeutic drug, not elsewhere specified 81401 MOLECULAR PATHOLOGY PROCEDURE LEVEL 2 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. Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 8 of 20 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. 82239 Bile acids; total 82240 Bile acids; cholylglycine 82271 Blood, occult, by peroxidase activity (eg, guaiac), qualitative; other sources 82272 82274 Blood, occult, by peroxidase activity (eg, guaiac), qualitative, feces, 1-3 simultaneous determinations, performed for other than colorectal neoplasm screening Blood, occult, by fecal hemoglobin determination by immunoassay, qualitative, feces, 1-3 simultaneous determinations 82397 Chemiluminescent assay Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section 82542 Column chromatography, includes mass spectrometry, if performed (eg, HPLC, LC, LC/MS, LC/MS-MS, GC, GC/MS-MS, GC/MS, HPLC/MS), non-drug analyte(s) not elsewhere specified, qualitative or quantitative, each specimen Not Covered if used to report any test outlined in Coverage Limitations section 82656 Elastase, pancreatic (EL-1), fecal; qualitative or semi- quantitative Not Covered if used to report any test outlined in Coverage Limitations section 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. Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 9 of 20 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. 82710 Fat or lipids, feces; quantitative 82715 Fat differential, feces, quantitative 82725 Fatty acids, nonesterified 82784 Gammaglobulin (immunoglobulin); IgA, IgD, IgG, IgM, each 83516 83520 Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified 83630 83631 Lactoferrin, fecal; qualitative Lactoferrin, fecal; quantitative 83986 pH; body fluid, not otherwise specified 83993 Calprotectin, fecal Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered Not Covered Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section 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. Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 10 of 20 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. 84311 Spectrophotometry, analyte not elsewhere specified 84999 Unlisted chemistry procedure 86021 Antibody identification; leukocyte antibodies 86140 C-reactive protein; 86141 C-reactive protein; high sensitivity (hsCRP) 86255 Fluorescent noninfectious agent antibody; screen, each antibody 86256 Fluorescent noninfectious agent antibody; titer, each antibody 86625 Antibody; Campylobacter Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section 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. Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 11 of 20 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. 86671 Antibody; fungus, not elsewhere specified 87045 Culture, bacterial; stool, aerobic, with isolation and preliminary examination (eg, KIA, LIA), Salmonella and Shigella species 87046 Culture, bacterial; stool, aerobic, additional pathogens, isolation and presumptive identification of isolates, each plate 87075 Culture, bacterial; any source, except blood, anaerobic with isolation and presumptive identification of isolates 87102 Culture, fungi (mold or yeast) isolation, with presumptive identification of isolates; other source (except blood) 87177 Ova and parasites, direct smears, concentration and identification 87209 Smear, primary source with interpretation; complex special stain (egtrichrome, iron hemotoxylin) for ova and parasites 87324 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Clostridium difficile toxin(s) Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section 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. Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 12 of 20 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. 87328 87329 87336 87338 87427 87449 87505 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; cryptosporidium Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; giardia Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Entamoeba histolytica dispar group Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Helicobacter pylori, stool Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Shiga-like toxin Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; not otherwise specified, each organism Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (eg, Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 3-5 targets Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section 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. Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 13 of 20 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. 87507 Infectious agent detection by nucleic acid (DNA or RNA); gastrointestinal pathogen (eg, Clostridium difficile, E. coli, Salmonella, Shigella, norovirus, Giardia), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 12-25 targets 87798 Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; amplified probe technique, each organism 88346 Immunofluorescence, per specimen; initial single antibody stain procedure 88350 Immunofluorescence, per specimen; each additional single antibody stain procedure (List separately in addition to code for primary procedure) 89160 Meat fibers, feces 0164U Gastroenterology (irritable bowel syndrome [IBS]), immunoassay for anti-CdtB and anti-vinculin antibodies, utilizing plasma, algorithm for elevated or not elevated qualitative results Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered if used to report any test outlined in Coverage Limitations section Not Covered 0176U Cytolethal distending toxin B (CdtB) and vinculin IgG antibodies by immunoassay (ie, ELISA) Not Covered Autoimmune (inflammatory bowel disease), mRNA, gene expression profiling by quantitative RT-PCR, 17 genes (15 target and 2 reference genes), whole blood, reported as a continuous risk score and classification of inflammatory bowel disease aggressiveness Not Covered Description Comments 0203U CPT® Category III Code(s) 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. Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 14 of 20 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. No code(s) identified HCPCS Code(s) No code(s) identified Description Comments References 1. 2. 3. 4. 5. 6. 7. American College of Gastroenterology (ACG). ACG clinical guideline: management of Crohn’s disease in adults. https://www.gi.org. Published March 2018. Accessed June 8, 2023. American College of Gastroenterology (ACG). ACG clinical guideline: management of irritable bowel syndrome. https://www.gi.org. Published January 2021. Accessed June 8, 2023. American College of Gastroenterology (ACG). ACG clinical guideline: ulcerative colitis in adults. https://www.gi.org. Published March 2019. Accessed June 8, 2023. American Gastroenterological Association (AGA). AGA clinical practice guideline on the role of biomarkers for the management of ulcerative colitis. https://www.gastro.org. Published February 21, 2023. Accessed May 30, 2023. American Gastroenterological Association (AGA). AGA clinical practice guidelines on the laboratory evaluation of functional diarrhea and diarrhea- predominant irritable bowel syndrome in adults (IBS-D). https://www.gastro.org. Published July 2019. Accessed May 30, 2023. American Gastroenterological Association (AGA). AGA clinical practice guidelines on the management of mild-to-moderate ulcerative colitis. https://www.gastro.org. Published February 2019. Accessed May 30, 2023. American Gastroenterological Association (AGA). AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. https://www.gastro.org. Published January 2020. Updated April 2020. Accessed May 30, 2023. 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. Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 15 of 20 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. 8. 9. American Gastroenterological Association (AGA). AGA clinical practice update on diagnosis and management of small intestinal bacterial overgrowth (SIBO). https://www.gastro.org. Published July 14, 2020. Accessed May 30, 2023. American Gastroenterological Association (AGA). AGA clinical practice update on management of inflammatory bowel disease in elderly patients. https://www.gastro.org. Published September 30, 2020. Accessed May 30, 2023. 10. American Gastroenterological Association (AGA). American Gastroenterological Association Institute guideline on therapeutic drug monitoring in inflammatory bowel disease. https://www.gastro.org. Published 2017. Accessed May 30, 2023. 11. American Society of Colon and Rectal Surgeons (ASCRS). American Society of Colon and Rectal Surgeons clinical practice guidelines for the surgical management of Crohn’s disease. https://www.fascrs.org. Published 2020. Accessed June 8, 2023. 12. Bertani L, Blandizzi C, Mumolo MG, et al. Fecal calprotectin predicts mucosal healing in patients with ulcerative colitis treated with biological therapies: a prospective study. Clin Transl Gastroenterol. 2020;11(5):e00174. https://www.ncbi.nlm.nih.gov. Accessed June 8, 2023. 13. ClinicalKey. Clinical Overview. Chronic diarrhea. https://www.clinicalkey.com. Updated May 6, 2023. Accessed June 6, 2023. 14. ClinicalKey. Clinical Overview. Crohn disease. https://www.clinicalkey.com. Updated February 23, 2023. Accessed June 6, 2023. 15. ClinicalKey. Clinical Overview. Ulcerative colitis. https://www.clinicalkey.com. Updated September 2, 2022. Accessed June 6, 2023. 16. ECRI Institute. Clinical Evidence Assessment. Fecal calprotectin for aiding diagnosis of inflammatory bowel disease. https://www.ecri.org. Published April 29, 2021. Accessed May 31, 2023. 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. Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 16 of 20 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. 17. ECRI Institute. Clinical Evidence Assessment. Fecal calprotectin for monitoring inflammatory bowel disease. https://www.ecri.org. Published May 5, 2021. Accessed May 31, 2023. 18. ECRI Institute. ECRIgene Genetic Test Assessment. Prometheus IBD sgi diagnostic (Prometheus Laboratories, Inc.) for differentiating inflammatory bowel disease from non-inflammatory bowel disease and Crohn’s disease from ulcerative colitis. https://www.ecri.org. Published April 1, 2016. Updated May 2021. Accessed May 31, 2023. 19. ECRI Institute. Product Brief (ARCHIVED). Anser ADA assay (Prometheus Laboratories, Inc.) for guiding treatment with adalimumab for inflammatory bowel disease. https://www.ecri.org. Published November 6, 2018. Accessed May 31, 2023. 20. ECRI Institute. Product Brief (ARCHIVED). Anser IFX assay (Prometheus Laboratories, Inc.) for guiding treatment with infliximab for inflammatory bowel disease. https://www.ecri.org. Published November 6, 2018. Accessed May 31, 2023. 21. ECRI Institute. Product Brief (ARCHIVED). Anser UST assay (Prometheus Laboratories, Inc.) for guiding treatment with ustekinumab for inflammatory bowel disease. https://www.ecri.org. Published November 6, 2018. Accessed May 31, 2023. 22. ECRI Institute. Product Brief (ARCHIVED). Anser VDZ assay (Prometheus Laboratories, Inc.) for guiding treatment with vedolizumab for inflammatory bowel disease. https://www.ecri.org. Published November 6, 2018. Accessed May 31, 2023. 23. Hayes, Inc. Clinical Utility Evaluation. Genetic testing for inflammatory bowel disease. https://evidence.hayesinc.com. Published June 20, 2018. Updated June 16, 2022. Accessed June 1, 2023. 24. Hayes, Inc. Health Technology Assessment. Fecal calprotectin for predicting clinical relapse or treatment response in adult patients with ulcerative colitis. https://evidence.hayesinc.com. Published August 17, 2021. Updated September 1, 2022. Accessed May 23, 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. Serological and Fecal Testing for Inflammatory Bowel Disease Effective Date: 06/22/2023 Revision Date: 06/22/2023 Review Date: 06/22/2023 Policy Number: HUM-0418-026 Page: 17 of 20 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. 25. Hayes, Inc. Health Technology Assessment (ARCHIVED). Serological assays for the diagnosis and management of inflammatory bowel disease: Crohn’s disease. https://evidence.hayesinc.com. Published March 12, 2013. Updated January 1, 2017. Accessed June 1, 2023. 26. Hayes, Inc. Health Technology Assessment (ARCHIVED). Serological assays for the diagnosis and management of inflammatory bowel disease: ulcerative colitis. https://evidence.hayesinc.com. Published April 4, 2013. Updated March 17, 2017. Accessed June 1, 2023. 27. Hayes, Inc. Molecular Test Assessment. Prometheus IBD sgi diagnostic (Prometheus Laboratories Inc.). https://evidence.hayesinc.com. Published November 4, 2019. Updated October 21, 2022. Accessed June 1, 2023. 28. Hayes, Inc. Molecular Test Assessment (ARCHIVED). 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