Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A57516 (Billing and Coding: MolDX: Prometheus® IBD sgi Diagnostic® Policy) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A57516: Billing and Coding: MolDX: Prometheus® IBD sgi Diagnostic® Policy (Billing and Coding, effective 2026-02-05)
- Covered ICD-10-CM codes
- 1
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 1
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| XX000 | — |
Procedure codes: 81479.
Coverage indications, limitations and medical necessity
This is a non-coverage policy for the Prometheus® IBD sgi Diagnostic® test. The intended use of this test is to aid healthcare providers in the differentiating inflammatory bowel disease (IBD) vs non-IBD, and Crohn’s disease (CD) vs Ulcerative Colitis (UC) in a comprehensive blood test. The test includes nine serological markers: ASCA IgA, ASCA IgG, anti-OmpC IgA, anti-CBir1 IgG, anti-A4 Fla2 IgG, anti-FlaX IgG, IBD-specific pANCA auto-antibody, IBD-specific pANCA IFA (perinuclear pattern), IBD-specific pANCA IFA DNAse Sensitivity; four genetic immune response markers (SNPs): ATG16L1, STAT3, NKX2-3, and ECM1; and five inflammatory biomarkers: ICAM-1, VCAM-1, VEGF, CRP and SSA. A proprietary Smart Diagnostic Algorithm interprets patterns among the multiple assay values to produce an IBD score. The test results are reported as “consistent with IBD” (consistent with UC; consistent with CD, or inconclusive for UC vs CD) or “not consistent with IBD”. In addition to the algorithmic test interpretation, the results of the 17 biomarkers are also individually reported.
Summary of evidence (opening)
CD and UC represent the two main forms of idiopathic chronic IBD. While the etiology remains idiopathic, evidence suggests that the ongoing inflammation in IBD results from persistent overly aggressive inflammatory responses to a subset of commensal microorganisms in a genetically susceptible host with exposure to environmental triggers. CD is characterized by discontinuous, transmural regions of intestinal inflammation most frequently involving the terminal ileum and colon, but can affect any part of the gastrointestinal tract, with symptoms of abdominal pain, weight loss and variable degrees of diarrhea, and complications of intestinal fibrosis, strictures and fistula formation. In contrast, UC is limited to the mucosa and submucosa of the colon, with particular involvement of the rectum. Classic symptoms of active UC include diarrhea, hematochezia, tenesmus and defecatory urgency. Extra intestinal manifestations of IBD occur in up to 25% of patients. Joints, skin and eyes may be affected. In both CD and UC, disease activity is typically relapsing and remitting, although the disease course of CD is typically progressive. Although UC and CD can usually be differentiated on the basis of clinical, radiographic, endoscopic, and histologic findings, these conditions can be difficult to distinguish in about 10% to 15% of IBD patients.
Evolution of IBD Testing
In the mid-2000s, two serologic markers – anti-Saccharomyces cerevisiae antibodies (ASCA) and perinuclear anti-neutrophil cytoplasmic antibodies (pANCA) – were used to diagnose IBD, and distinguish between UC and CD. Studies had shown that patients with CD had significantly higher ASCA antibodies than did controls or patients with UC. The reason CD patients have both IgA and IgG-ASCA is unclear. Overall, the sensitivity for either IgA or IgG-ASCA is in the range of 55% with specificity of about 90%. On the other hand, pANCA, a true autoantibody, was observed to be associated with colonic forms of IBD, particularly UC, with a sensitivity of approximately 60-70%. However, these pANCA–positive CD patients typically have a clinical phenotype resembling left-sided UC, so pANCA detection alone is of little value in distinguishing between UC and Crohn’s colitis.
A second generation IBD panel (IBD First Step®) was marketed by Prometheus Laboratories (2000) consisting of more sensitive ASCA and pANCA assays and the addition of a second microbial antigen, OmpC. Anti-OmpC was added to increase the sensitivity for CD. Subsequently, a third-generation serology panel (IBD Serology 7) was offered by Prometheus Laboratories in 2006. The panel is composed of the following markers: ASCA-IgA, ASCA-IgG, anti-OmpC-IgA, anti-CBir1-IgA, and three ANCA tests: pANCA, ANCA-IgG and DNAse-sensitive pANCA. The Smart Diagnostic Algorithm analyzes and correlated test results with patterns known to the database to be associated with IBD. It supposedly can predict an IBD diagnosis even when all 7 of the parameters of the IBD Serology 7 panel would be considered normal on the basis of the reference ranges provided. 1 It was reported to identify another 20% or more of otherwise seronegative CD patients. 2 The IBD Serology 7 panel has a sensitivity of 93%, specificity of 95% and positive predictive value of 96% in population prevalence of 59% according to Prometheus. A positive anti-CBir1 can additionally help distinguish between UC and CD in pANCA positive patients. However, in a comparison study evaluating the predictive IBD Serology 7 with routine blood test (IgA-ASCA, IgG-ASCA) in a pediatric population referred for initial evaluation of suspected IBD, the sensitivity, specificity, positive predictive value, negative predictive value, and k value for the serologic panel was 67%, 76%, 63%,79% and 47%. The antiflagellin antibody assay had sensitivity of 50% and specificity of 53%. Despite the inclusion of antiflagellin in the IBD7 panel, the IBD7 panel had lower predictive values compared with routine laboratory tests in pediatric screening for IBD. 3
The contractor cites 8 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2018-01-30
- Current revision effective
- 2026-02-05
- Last reviewed by the contractor
- 2025-03-03
- MCD version
- 30
Other related documents: A55778 (Response to Comments), A55779 (Response to Comments).
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Noridian Healthcare Solutions, LLC hub lists every other active policy from the same contractor.
The same policy title at other contractors
Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.
Frequently asked questions
What does LCD L37299 cover?
This is a non-coverage policy for the Prometheus® IBD sgi Diagnostic® test. The intended use of this test is to aid healthcare providers in the differentiating inflammatory bowel disease (IBD) vs non-IBD, and Crohn’s disease (CD) vs Ulcerative Colitis (UC) in a comprehensive blood test. The test includes nine serological markers: ASCA IgA, ASCA IgG, anti-OmpC IgA, anti-CBir1 IgG, anti-A4 Fla2 IgG, anti-FlaX IgG,… The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L37299 apply to?
Noridian Healthcare Solutions, LLC applies it to Medicare claims in AK, AS, AZ, CA, CNMI, GU, HI, ID, MT, ND, NF, NV, OR, SD, SF, UT, WA, WY. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L37299?
The companion billing and coding article A57516 lists 1 ICD-10-CM codes in 1 group that support medical necessity; the first 1 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L37299?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.