Harvard Pilgrim HealthCare Medical Policy

Fecal Microbial Transplant (FMT) For Clostridium Difficile Infection

Subject: Fecal Microbial Transplant (FMT) for Clostridium Difficile Infection

Background: Fecal microbiota transplantation (FMT) involves the infusion of intestinal microorganisms via transfer of stool from a healthy person into a diseased patient. The intent is to restore normal intestinal flora. For the purposes of this coverage guideline, fecal transplant may be covered for the treatment of clostridium difficile infection (CDI) that has not responded to standard therapies.

Policy and Coverage Criteria:

Harvard Pilgrim Health Care (HPHC) considers fecal microbial transplant (FMT) as reasonable and medically necessary for the treatment of members with Clostridium Difficile Infection (CDI) when documentation confirms ANY of the following conditions:

• There have been at least 3 episodes (one initial and at least 2 recurrences) of infection confirmed by positive stool cultures; OR
• A persistent episode that is refractory to appropriate antibiotic treatment protocol, including one of the following:
  • At least one regiment of tapered or pulsed vancomycin
  • Vancomycin followed by Rifaximin
  • A regimen of Fidaxomicin (standard or extended-pulsed)

Documentation should include the following:

• If requested for review, the submitted medical record should support the use of the selected ICD-CM and CPT/HCPCS code(s) used to describe the service performed.
• Documentation maintained by the ordering physician/treating physician must indicate the medical necessity for performing this procedure. Informed consent should include, at a minimum, a statement that the use of FMT products to treat C. difficile is investigational with a discussion of its potential risks, per FDA suggested guidance.

FMT is considered medically necessary for recurrent CDI only.

Exclusions:

Harvard Pilgrim Health Care (HPHC) considers urine drug testing as not medically necessary for all other indications.