Capital Bluecross fecal testing Coverage Update | OpenPayer
CurrentCapital BluecrossPolicy AHS G2060
Fecal Analysis in the Diagnosis of Intestinal Dysbiosis and Fecal Microbiota Transplant Testing
Defines coverage criteria for fecal testing used to diagnose intestinal dysbiosis and for screening donor stool prior to fecal microbiota transplantation; applies to Capital BlueCross medical benefit determinations.
Policy Summary
PayerCapital Bluecross
PolicyFecal Analysis in the Diagnosis of Intestinal Dysbiosis and Fecal Microbiota Transplant Testing
Policy CodePolicy AHS G2060
Change TypeNo material change
Effective Date
Next Review Date
Key ActionRequest prior authorization for donor stool testing with indication 'donor screening for FMT' and document indication and specific assays requested.
No material clinical or coverage changes in this revision.
8culture-covered organisms
8NAAT-covered targets
manynon-covered fecal tests
MDRO requiredFDA MDRO requirement
~40
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procedure codes listed
Coverage Criteria for Fecal Testing and Donor Screening
inv-01: Donor stool culture coverage
Covered donor stool testing prior to FMT donation when performed as part of donor screening
Culture-based screening (MEETS COVERAGE): Prior to donation for an FMT, analysis by bacterial culture of the donor fecal sample for the following microorganisms: (a) Extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae; (b) Vancomycin-resistant Enterococci (VRE); (c) Carbapenem-resistant Enterobacteriaceae (CRE); (d) Methicillin-resistant Staphylococcus aureus (MRSA); (e) Campylobacter; (f) Shigella; (g) Salmonella.none specified
These culture targets are listed as meeting coverage criteria.
inv-02: Donor stool NAAT coverage
Covered NAAT-based donor stool testing prior to FMT donation when performed as part of donor screening
NAAT-based screening (MEETS COVERAGE): Prior to donation for an FMT, analysis by nucleic acid amplification testing (NAAT) of the donor fecal sample for the following organisms: (a) Clostridium difficile; (b) Campylobacter; (c) Salmonella; (d) Shigella; (e) Shiga toxin-producing Escherichia coli; (f) Norovirus; (g) Rotavirus; (h) SARS-CoV-2 (COVID-19).none specified
These NAAT targets are listed as meeting coverage criteria.
inv-03: NAAT not covered for certain MDROs
NAAT testing NOT covered when used as part of donor stool screening for specified organisms
NAAT listed as not meeting coverage: Prior to donation for an FMT, analysis by NAAT of the donor fecal sample for the following DOES NOT MEET COVERAGE: (a) Extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae; (b) Vancomycin-resistant Enterococci (VRE); (c) Carbapenem-resistant Enterobacteriaceae (CRE); (d) Methicillin-resistant Staphylococcus aureus (MRSA); (e) other microorganisms not listed as NAAT-covered above.none specified
Policy distinguishes culture-covered MDROs from NAAT-based MDRO testing, which does not meet coverage criteria.
inv-04: Diagnostic fecal analyses not covered
Tests listed as not meeting coverage when ordered as diagnostic evaluation for intestinal dysbiosis
Fecal biomarker/analysis NOT covered: As diagnostic tests for evaluation of intestinal dysbiosis, irritable bowel syndrome, malabsorption, or small intestinal bacterial overgrowth, the following fecal analyses DOES NOT MEET COVERAGE: triglycerides; chymotrypsin; iso-butyrate, iso-valerate, and n-valerate; meat and vegetable fibers; long chain fatty acids; cholesterol; total short chain fatty acids; quantification of Lactobacilli, bifidobacteria, E. coli and other potential pathogens (including Aeromonas, Bacillus cereus, Campylobacter, Citrobacter, Klebsiella, Proteus, Pseudomonas, Salmonella, Shigella, Staphylococcus aureus, Vibrio); identification/quantitation of fecal yeast (eg, Candida albicans, C. tropicalis, Rhodotorula, Geotrichum); N-butyrate; beta-glucuronidase; pH; short chain fatty acid distribution; fecal secretory IgA.none specified
The policy states these analyses lack published evidence of clinical benefit for diagnostic use.
inv-05: Indications and donor screening overview
Clinical indications and constraints discussed by professional societies
FMT for recurrent C. difficile: Consider fecal microbiota transplantation (FMT) for patients with recurrent Clostridioides difficile infection after completion of standard-of-care antibiotics; FMT may also be considered for severe, fulminant, or treatment-refractory CDI and select high-risk patients.
Recommendation and context provided by AGA guidance (see cited society guidance).
Do not routinely use FMT for IBD or IBS: Professional societies recommend against routine use of FMT for ulcerative colitis, Crohn's disease, pouchitis, and irritable bowel syndrome outside of clinical trials.
AGA, BSG, and other society statements caution against routine FMT for these conditions.
Donor screening requirements: Donor screening must include testing for C. difficile toxin B and routine enteric pathogens; the FDA requires testing to exclude MDROs (at minimum ESBL-producing Enterobacteriaceae, VRE, CRE, and MRSA), and consideration of SARS-CoV-2 exposure/testing during the donation period. Bookend testing and sample quarantine practices are described by FDA guidance.
This policy excludes a broad set of fecal biomarker assays and microbial quantifications when ordered to diagnose intestinal dysbiosis because these tests lack established clinical utility and robust evidence of benefit. Examples explicitly listed as DOES NOT MEET COVERAGE CRITERIA include measurements such as triglycerides, chymotrypsin, iso-butyrate/iso-valerate/n‑valerate, meat and vegetable fibers, long‑chain fatty acids, cholesterol, total short‑chain fatty acids, quantification of specific bacterial genera (e.g., Lactobacilli, bifidobacteria, E. coli) and many named potential enteric pathogens, fecal yeast identification, N‑butyrate, beta‑glucuronidase, pH, short‑chain fatty acid distribution, and fecal secretory IgA.
Professional society guidance does not support routine use of fecal microbiota transplantation (FMT) to treat inflammatory bowel disease (IBD) outside of clinical trials. The British Society of Gastroenterology states that there is no place for FMT in management of IBD unless complicated by C. difficile infection, and ACG guidance notes that FMT requires further study and clarification before routine therapeutic use in ulcerative colitis or Crohn's disease.
Safety concerns about FMT are emphasized by regulatory agencies. The FDA has issued safety communications highlighting the risk of transmission of multi‑drug resistant organisms and other pathogenic organisms through FMT and has provided additional safety information regarding donor screening, including protections related to SARS‑CoV‑2 during the COVID‑19 pandemic.
Fecal analyses listed in this policy are considered not medically necessary when used to diagnose intestinal dysbiosis, irritable bowel syndrome, malabsorption, or small intestinal bacterial overgrowth. The listed assays lack validated clinical benefit and therefore do not meet medical necessity for these diagnostic indications.
Routine testing for certain broad or nonspecific investigations is not necessary to evaluate suspected dysbiosis. NICE guidance indicates that tests such as faecal ova and parasite testing and hydrogen breath testing are not required to confirm IBS in people meeting diagnostic criteria, and the policy also notes that extensive comprehensive pathogen PCR panels and other broad stool pathogen panels are not necessary to evaluate intestinal dysbiosis.
Applicable Procedure Codes and Coding References
Applicable CPT/HCPCS procedure codes and coding referencesmixed
No codes listed
Applicable CPT/HCPCS Procedure Codes (part 1)CPT
82542
Column chromatography, includes mass spectrometry, if performed (eg, HPLC, LC, LC-MS, GC, GC-MS), non-drug analyte(s) not elsewhere specified; qualitative or quantitative; each specimen.
82705
Fat or lipids, feces; qualitative.
82710
82715
Fat differential, feces, quantitative.
83986
pH; body fluid, not otherwise specified.
84311
Spectrophotometry analyte not elsewhere specified.
87045
Culture, bacterial; stool, aerobic, with isolation and preliminary examination (eg, Salmonella and Shigella species).
87046
Culture, bacterial; stool, aerobic, additional pathogens, isolation and presumptive identification of isolates, each plate.
Applicable CPT/HCPCS Procedure Codes (part 2)CPT
87075
Culture, bacterial; any source, except blood, anaerobic with isolation and presumptive identification of isolates.
87076
Culture; bacterial; anaerobic isolate, additional methods required for definitive identification, each isolate.
87077
Culture, bacterial; aerobic isolate, additional methods required for definitive identification, each isolate.
87102
Culture, fungi (mold or yeast) isolation, with presumptive identification of isolates; other source except blood.
87493
Infectious agent detection by nucleic acid (DNA or RNA); Clostridium difficile, toxin gene(s), amplified probe technique.
87500
Infectious agent detection by nucleic acid (DNA or RNA); vancomycin resistance (eg, enterococcus vanA, vanB) amplified probe technique.
87641
Infectious agent detection by nucleic acid (DNA or RNA); Staphylococcus aureus, methicillin resistant, amplified probe technique.
87798
Infectious agent detection by nucleic acid (DNA or RNA), not otherwise specified; amplified probe technique, each organism.
89160
Meat fibers, feces.
S3708
Gastrointestinal fat absorption study.
Provider Requirements, Prior Authorization, and Documentation
Prior Authorization
Provider Requirements, Prior Authorization, and Documentation
Prior authorization is required for donor stool testing and related fecal analyses when member benefits indicate coverage; authorization may be contingent on documented donor screening, negative MDRO results, and adherence to current FDA and specialty-society guidance. Providers must document the clinical indication for testing, prior antibiotic and treatment history when FMT is being considered, and specific pathogens/tests ordered.
Applicable procedure codes (see code list in policy): 82542, 82705, 82710, 82715, 83986, 84311, 87045, 87046, 87075, 87076, 87077, 87102, 87493, 87500, 87641, 87798, 89160, S3708.
Prior authorization may be conditioned on documentation that donor stool testing includes MDRO screening (at minimum ESBL-producing Enterobacteriaceae, VRE, CRE, MRSA) and that stool samples are quarantined pending post-donation confirmatory testing ("bookend testing" no more than 60 days apart) per FDA recommendations.
Testing listed as "DOES NOT MEET COVERAGE CRITERIA" (see non-covered fecal component analyses and certain NAATs) will be denied as not covered.
Donor stool that tests positive for multi-drug resistant organisms (MDROs) — including ESBL, VRE, CRE, or MRSA — must be excluded from use; positive MDRO results will preclude authorization.
FDA safety communications and updates (including 2019 MDRO guidance and 2020 COVID-19 donor protections) may change prior authorization requirements or documentation expectations and can affect coverage determinations.
Background and Context
Intestinal dysbiosis refers to a disruption or imbalance of the gut microbial ecology and has been proposed as a factor in multiple gastrointestinal and systemic conditions. Proposed diagnostic approaches include direct microbiome profiling (for example, nucleic acid sequencing and NAAT) and indirect fecal biomarkers (such as short‑chain fatty acids, pH, and enzymes). However, many of these biomarkers and commercial panels have not demonstrated sufficient analytic and clinical validity or clinical utility to support routine diagnostic use. By contrast, fecal microbiota transplantation (FMT) is an established therapy for recurrent Clostridioides difficile infection when performed following accepted donor screening practices; FMT requires careful donor history and laboratory screening to mitigate infectious risk.
Definitions
Intestinal dysbiosis
DefinitionA disruption or imbalance of the intestinal microbial ecology.
Associated conditionsLinked with IBS, inflammatory bowel disease (IBD), celiac disease, and other systemic disorders.
Clinical implicationProposed diagnostic fecal biomarkers and microbiome profiling lack established clinical utility for routine diagnosis of dysbiosis per policy exclusions.
Fecal microbiota transplant (FMT)
DefinitionFecal microbiota transplant (FMT) — transfer/infusion of stool from a screened donor to a recipient to restore gut microbiota.
Primary indicationEstablished therapy for recurrent Clostridioides difficile infection after standard-of-care antibiotics; use for IBD/IBS generally not recommended outside trials.
Policy Summary
PayerCapital Bluecross
PolicyFecal Analysis in the Diagnosis of Intestinal Dysbiosis and Fecal Microbiota Transplant Testing
Policy CodePolicy AHS G2060
Change TypeNo material change
Effective Date
Next Review Date
Key ActionRequest prior authorization for donor stool testing with indication 'donor screening for FMT' and document indication and specific assays requested.
FDA and society guidance detail these donor screening and safety requirements.
Required documentation when requesting prior authorization: clinical indication for testing or FMT, documentation of prior standard-of-care therapy (e.g., appropriate antibiotic treatment for CDI), documentation of recurrent CDI episodes if applicable, donor screening questionnaire completion, specific tests ordered and results, and evidence of stool quarantine and postdonation testing as applicable.
Donor screening and quarantine documentation must include evidence of pre-donation and post-donation laboratory screening for specified pathogens, completion of a donor health questionnaire, and confirmation that stool samples were quarantined until postdonation MDRO tests were confirmed negative.
Donor screening documentation should follow consensus guidance (e.g., BSG/HIS, AGA) and FDA recommendations: include listed stool assays (C. difficile PCR; Shiga toxin-producing E. coli PCR; Campylobacter/Salmonella/Shigella culture or PCR; MDRO testing; norovirus/rotavirus; ova/parasite and protozoa testing) and appropriate serum screening per guidelines.
Step therapy/therapy sequencing considerations: FMT is generally reserved for recurrent C. difficile infection after appropriate antibiotic therapy and documented recurrence; prior authorization will usually require documentation of antibiotic treatment and recurrence history.
Society guidelines (AGA, BSG/HIS and others) recommend FMT primarily for multiply recurrent CDI (after at least two recurrences or per guideline thresholds) and advise against routine use for other indications (e.g., IBS, IBD) outside clinical trials; prior authorization will reflect these guideline-informed sequencing recommendations.
Safety noteSubject to donor screening and FDA safety communications due to risk of transmission of pathogenic organisms and MDROs.
NAAT (Nucleic acid amplification testing)
DefinitionNucleic acid amplification testing (NAAT) — molecular methods that detect specific organism nucleic acids.
Role in policyNAAT is an accepted method for detecting certain enteric pathogens (e.g., C. difficile, Campylobacter, Salmonella, Shigella, STEC, norovirus, rotavirus, SARS‑CoV‑2) for donor screening when listed as meeting coverage.
LimitationNAAT is NOT covered for screening donor stool for certain MDROs (ESBL, VRE, CRE, MRSA); culture is the covered modality for those MDROs per policy distinction.
C. difficile toxin B testing
DefinitionC. difficile toxin B testing — molecular (PCR) or, if unavailable, enzyme immunoassay for toxins A and B to detect toxigenic C. difficile.
Role in donor screeningRecommended analyte in donor stool screening prior to FMT (workgroup guidance lists toxin B by PCR; EIA if PCR unavailable).
Role in recipient evaluationUsed for recipient evaluation prior to FMT to confirm active C. difficile infection as indication for transplantation.
Multi‑drug resistant organisms (MDROs)
DefinitionMulti-drug resistant organisms (MDROs) — organisms resistant to multiple antibiotic classes; policy-relevant examples include ESBL-producing Enterobacteriaceae, vancomycin-resistant enterococci (VRE), carbapenem-resistant Enterobacteriaceae (CRE), and methicillin-resistant Staphylococcus aureus (MRSA).
FDA requirementFDA requires MDRO testing to exclude donor stool that tests positive for ESBL, VRE, CRE, and MRSA prior to FMT donation; nasal or peri-rectal swab culture acceptable alternative for MRSA only.
Operational noteBookend testing (pre- and post-donation within 60 days) with quarantine of stool until postdonation MDRO results are negative is acceptable per FDA guidance.
Fecal Microbiota Transplantation (FMT) — definition and safety screening note
DefinitionFecal Microbiota Transplantation (FMT) — transfer/infusion of screened donor fecal material to a recipient to restore gut microbiota.
Donor screening requirementDonor screening should include C. difficile toxin B (PCR or EIA), routine enteric pathogen testing, ova/parasites, and MDRO testing (ESBL, VRE, CRE, MRSA) per workgroup and FDA guidance.
Safety considerationsFDA safety communications highlight risk of transmission of MDROs and other pathogens; adherence to recommended donor screening, testing, and quarantine procedures is required to mitigate risk.