Subject:
Serologic Markers for the Diagnosis of Irritable Bowel Syndrome
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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According to the American College of Gastroenterology, irritable bowel syndrome (IBS) is a chronic illness of disordered bowel function and abdominal pain or discomfort over a period of at least 3 months that is distinguished by the absence of biochemical markers or structural abnormalities. As individual symptoms have imperfect accuracy in diagnosing IBS, criteria have been developed to identify a combination of symptoms to diagnose the condition. The initial criteria was developed by Manning et al and was evaluated to have a sensitivity of 78% and a specificity of 72%. Another set of criteria was developed by Kruis et al which was suggested to have an excellent positive predictive value with a sensitivity of 77% and a specificity of 89%. The Rome criteria was subsequently developed and have undergone three iterations. The Rome I criteria was determined to have a sensitivity of 71% and a specificity of 85%; Rome II and Rome III have not yet been evaluated. None of the symptom-based criteria has an ideal accuracy, and the Rome criteria, in particular, have been inadequately evaluated.
Patients with typical IBS symptoms also may exhibit so-called "alarm features" that increase concern for the presence of organic disease. They include rectal bleeding, weight loss, iron deficiency anemia, nocturnal symptoms, and a family history of selected organic diseases including colorectal cancer, inflammatory bowel disease (IBD), and celiac sprue. According to the American College of Gastroenterology, it is usually recommended that patients who exhibit alarm features undergo further investigation, particularly with colonoscopy to rule out organic disease, e.g., colorectal cancer. Furthermore, it states that routine diagnostic testing with complete blood count, serum chemistries, thyroid function studies, stool for ova and parasites, and abdominal imaging is not recommended in patients with typical IBS symptoms and no alarm features because of a low likelihood of uncovering organic disease. Routine serologic screening for celiac sprue should be pursued in patients with diarrhea-predominant IBS and mixed IBS. Lactose breath testing can be considered when lactose maldigestion remains a concern despite dietary modification.
An objective diagnostic test to confirm or rule out the presence of IBS could be useful in the diagnosis and management of patients with gastrointestinal signs and symptoms suggestive of IBS. One proposed way to diagnose IBS is to assess for the presence of biomarkers in the patient's serum.
One commercially available diagnostic test for IBS based on biomarkers is the Prometheus IBS Diagnostic test (Prometheus Laboratories Inc, San Diego, CA). Currently, FDA approval is not required for the Prometheus IBS Diagnostic test since it uses in-house reagents and methods. Laboratories that use their own tests but do not market the kits to others are subject to the standards of the Clinical Laboratory Improvement Amendments (CLIA, but not to FDA marketing regulations.
According to Prometheus Laboratories, a set of different biomarkers is used because there is no known single marker for IBS. The Prometheus test evaluates serum for the presence of the following markers:
- Interleukin-1B (IL-1B)
- Growth-related oncogene-a (GRO-a)
- Brain-derived neurotrophic factor (BDNF)
- Anti-saccharomyces cerevisiae antibody IgA (ASCA IgA)
- Antibody against CBir1 (anti-CBir1)
- Antihuman tissue transglutaminase (tTG)
- TNF-like weak inducer of apoptosis (TWEAK)
- Antineutrophil cytoplasmic antibody (ANCA)
- Tissue inhibitor of metalloproteinase (TIMP-1)
- Neutrophil gelatinase-associated lipocalin (NGAL)
Based on evaluation of 516 serum samples, Prometheus Laboratory reported a sensitivity of 50% and a specificity of 88% with an overall accuracy of 70%.
Policy:
(NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
Serologic Markers for the diagnosis of irritable bowel syndrome (IBS) is considered investigational.
Medicare Coverage:
There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.
Per Noridian Healthcare Solutions, LLC (Jurisdiction J - E) Local Coverage Determination (LCD):MolDX: Prometheus IBD sgi Diagnostic Policy (L37299), Prometheus IBD sgi Diagnostic test is noncovered.
PROPRIETARY LABS (Labs that are the sole source for the diagnostic lab test)
For labs which are proprietary (that is, the sole source for the diagnostic lab test involved), Medicare Advantage Products will follow the Medicare Local Coverage Determination of the State where the proprietary lab is located.
Medicaid Coverage:
For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.
FIDE-SNP Coverage:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
[INFORMATIONAL NOTE: There is insufficient scientific data to support the validity and utility of serologic markers in the diagnosis of irritable bowel syndrome. Published data currently available in the clinical literature are limited to case-control studies, case series and narrative reviews. Furthermore, the American College of Gastroenterology Evidence-Based Position Statement on the Management of Irritable Bowel Syndrome (IBS), British Society of Gastroenterology Guidelines on the Irritable Bowel Syndrome: Mechanisms and Practical Management, and the American Gastroenterological Association Medical Position Statement on Irritable Bowel Syndrome do not identify serologic markers for IBS as one of the appropriate and recommended tests in the diagnosis and management of the condition.]
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Serologic Markers for the Diagnosis of Irritable Bowel Syndrome
IBS, Serologic Markers
Irritable Bowel Syndrome, Serologic Markers
Markers, Serologic for Irritable Bowel Syndrome
References:
1. ECRI Institute. Health Technology Assessment Information Service (HTAIS). Hotline Response: Serologic Markers for Diagnosis of Irritable Bowel Syndrome.
2. The American College of Gastroenterology. Task Force on Irritable Bowel Syndrome. An Evidence-Based Systematic Review on the Management of Irritable Bowel Syndrome. The American Journal of Gastroenterology 2009 Jan 1;104(Suppl 1):S1-S7. Available at: http://www.tcgroup.it/attachFileMail/EmailAigo/AllegatiArticoli/1686-4120.pdf
3. Lembo AJ, Neri B, Tolley J, et al. Use of serum biomarkers in a diagnostic test for irritable bowel syndrome. Aliment Pharmacol Ther 2009 Apr 15;29(8):834-42.
4. Schoepfer AM, Trummler M, Seeholzer P, et al. Discriminating IBD from IBS: comparison of the test performance of fecal markers, blood leukocytes, CRP, and IBD antibodies. Inflamm Bowel Dis 2008 Jan;14(1):32-9.
5. Spiller R, Aziz Q, Creed F, et al. British Society of Gastroenterology. Guidelines on the irritable bowel syndrome: mechanisms and practical management. Gut 2007;56:1770-1798.
6. American Gastroenterological Association Medical Position Statement: Irritable Bowel Syndrome. Gastroenterology 2002;123:2105-2107. (current as of 07/01/2015)
7. Burbige EJ. Irritable bowel syndrome: diagnostic approaches in clinical practice. Clinical and Experimental Gastroenterology 2010 Sep; 2010(3):127-137.
8. UpToDate. Clinical manifestations and diagnosis of irritable bowel syndrome in adults. Literature review current through March 2016.
9. Ford AC, Moayyedi P, Lacy BE et al. American College of Gastroenterology monograph on the management of irritable bowel syndrome and chronic idiopathic constipation. Am J Gastroenterol. 2014 Aug;109 suppl 1:S2-26.
10. NICE Clinical Guideline 61: Irritable bowel syndrome in adults: diagnosis and management of irritable bowel syndrome in primary care. Issued: February 2015. Available at: http://www.nice.org.uk/guidance/cg61/resources/guidance-irritable-bowel-syndrome-in-adults-diagnosis-and-management-of-irritable-bowel-syndrome-in-primary-care-pdf
11. Sood R, Gracie DJ et al. Systematic review with meta-analysis: the accuracy of diagnosing irritable bowel syndrome with symptoms, biomarkers and/or psychological markers. Aliment Pharmacol Ther. 2015 Jun 15. doi: 10.1111/apt.13283. [Epub ahead of print]
12. Peppercorn MA, Kane SV. Clinical manifestations and diagnosis of irritable bowel syndrome in adults. In: UpToDate, Rutgeerts P, Robson KM (Eds), UpToDate, Waltham, MA. (Accessed on April 9, 2017.)
13. Peppercorn MA, Kane SV. Clinical manifestations and diagnosis of irritable bowel syndrome in adults. In: UpToDate, Robson KM (Eds), UpToDate, Waltham, MA. (Accessed on February 28, 2018.)
14. Wald A. Clinical manifestations and diagnosis of irritable bowel syndrome in adults. In: UpToDate, Talley NJ, Grover S (Eds), UpToDate, Waltham, MA. (Accessed on March 11, 2019.)
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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