February 25, 2015 - Revised: 07.20.18
Fecal Microbiota Transfer
CGS has received inquiries into the coverage of fecal microbiota transfer (FMT) for the treatment of Clostridium difficile infection (CDI). After review of current literature, CGS has determined the following:
Effective for dates of service BEFORE January 1, 2015:
FMT is a non-covered service at this time as a statutorily excluded service. Any other services performed that are related to the FMT procedure will also be denied as non-covered, including but not limited to anoscopy and donor specimen.
Health care providers are not required to submit claims to Medicare for statutorily non-covered services; however, you may choose to submit claims (e.g., at the patient's request). Claims for FMT must include:
- CPT code 44799
- HCPCS modifier GY (statutorily non-covered service)
- The appropriate ICD-9-CM code(s)
- The name of the test, "FMT"
- Electronic Claims: Loop 2400, NTE02, or SV101-7 field
- Paper Claims: Block 19
Effective for dates of service ON or AFTER January 1, 2015:
Fecal bacteriotherapy or fecal microbiota transplant (FMT) may be considered medically necessary as a treatment for recurrent or relapsing Clostridium difficile infection (CDI) as indicated by a positive C. difficile toxin stool test and defined as one of the following:
- At least 3 episodes of mild to moderate CDI and failure of a 6-8 week taper with vancomycin with or without an alternative antibiotic (e.g., rifaximin, nitazoxanide), or
- At least two episodes of severe CDI resulting in hospitalization and associated significant morbidity, or
- Moderate CDI not responding to standard therapy (vancomycin) for at least a week, or
- Severe fulminant C. difficile colitis with no response to standard therapy after 48 hours.
CGS considers FMT investigational for any other indication (e.g., Crohn's disease or inflammatory bowel disease, irritable bowel syndrome, and intestinal dysbiosis).
Claims for FMT must include:
- The appropriate ICD-9/ICD10 code. At this time, ICD-9 code 008.45 (intestinal infections due to clostridium difficile) ICD10 A04.71 (Enterocolitis due to Clostridium difficile, recurrent) or A04.72 (Enterocolitis due to Clostridium difficile, not specified as recurrent) are the only diagnosis code that will be considered for coverage; all other indications for these procedures will be denied as investigational.
- HCPCS code G0455 (Preparation with instillation of fecal microbiota by any method, including assessment of donor specimen)
Reference:
- Definition of "reasonable and medically necessary": Social Security Act, section 1862(a)(1)(A)
- Exception to mandatory claim submission for "statutorily excluded services": CMS MLN Matters article SE0908, "Mandatory Claims Submission and Its Enforcement"