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Clinical Policy Bulletin:
Fecal Microbiota Transplantation
Number: 0844


Policy

Aetna considers fecal bacteriotherapy medically necessary for persons with Clostridium difficile infection, with infection confirmed by a postive stool test for C. difficle toxin, that has recurred following at least one course of adequate antibiotic therapy (10 or more days of vancomycin at a dose of greater than or equal to 125 mg four times per day or 10 or more days of metronidazole at a dose of 500 mg three times per day). Aetna considers fecal bacteriotherapy experimental and investigational for all other indications.



Background

Fecal bacteriotherapy (FT, also known as fecal microbiota transplantation fecal transplant, fecal transfusion, and probiotic infusion) is the transfer of a liquid suspension of stool from a healthy donor to the patient and is proposed for the treatment of Clostridium difficile infection (CDI), which can result in mild diarrhea to life-threatening fulminant pseudomembraneous colitis.  Treatment involves discontinuation of the offending antibody and oral administration of metronidazole or vancomycin.  In some cases, patients non-responsive to medical management are treated by surgical colectomy which has a motality rate of 35 % to 57 %.  One of the risks with FT is the transfer of contagious agents (e.g., fungi, parasites, and viruses) from the donor (You et al, 2008; Bakken et al, 2009).

A randomized controlled clinical trial by van Nood, et al. (2013) found that infusion of donor feces was significantly more effective for the treatment of recurrent C. difficile infection than the use of vancomycin. Included in the study were patients who were at least 18 years of age and who had a life expectancy of at least 3 months and a relapse of C. difficile infection after at least one course of adequate antibiotic therapy (≥ 10 days of vancomycin at a dose of ≥ 125 mg four times per day or ≥ 10 days of metronidazole at a dose of 500 mg three times per day). C. difficile infection was defined as diarrhea (≥ 3 loose or watery stools per day for at least 2 consecutive days or ≥ 8 loose stools in 48 hours) and a positive stool test for C. difficile toxin. Available isolates were characterized by PCR. Investigators randomly assigned patients with recurrent C. difficle infection to receive one of three therapies: an initial vancomycin regimen (500 mg orally four times per day for 4 days), followed by bowel lavage and subsequent infusion of a solution of donor feces through a nasoduodenal tube; a standard vancomycin regimen (500 mg orally four times per day for 14 days); or a standard vancomycin regimen with bowel lavage. The primary end point was the resolution of diarrhea associated with C. difficile infection without relapse after 10 weeks. The study was stopped after an interim analysis. Of 16 patients in the infusion group, 13 (81%) had resolution of C. difficile-associated diarrhea after the first infusion. The 3 remaining patients received a second infusion with feces from a different donor, with resolution in 2 patients. The investigators reported that resolution of C. difficile infection occurred in 4 of 13 patients (31%) receiving vancomycin alone and in 3 of 13 patients (23%) receiving vancomycin with bowel lavage (p < 0.001 for both comparisons with the infusion group). No significant differences in adverse events among the three study groups were observed except for mild diarrhea and abdominal cramping in the infusion group on the infusion day. After donor-feces infusion, patients showed increased fecal bacterial diversity, similar to that in healthy donors, with an increase in Bacteroidetes species and clostridium clusters IV and XIVa and a decrease in Proteobacteria species. An accompanying editorial (Kelly, 2013) stated that the study by van Nood et al. is an important confirmation of the efficacy of fecal microbiota transplant for recurrent C. difficile infection.

Baddour (2013) commented that the findings of this study by van Nood, et al. will garner much attention and will likely increase the use of fecal transplantation (FT) in the treatment of recurrent C. difficle infection. These happenings, coupled with our increasing understanding of the gut microbiome, should markedly advance our understanding of the pathogenesis and treatment of C. difficile infection.

This clinical trial is consistent with the results of earlier studies of fecal bacteriotherapy. Guo et al (2012) critically appraised the clinical research evidence on the safety and effectiveness of FT compared with standard care in the treatment of patients with clostridium difficile-associated disease (CDAD).  A comprehensive literature search was conducted by a research librarian to identify relevant studies published between 2000 and 2011.  The Cochrane Library, PubMed, EMBASE, CINAHL, Biological Abstracts, BIOSIS Previews and Web of Science were searched.  Methodological quality of the included case series studies was assessed in terms of patient selection criteria, consecutive recruitment, prospective data collection, reporting of lost to follow-up, and follow-up rates.  No controlled studies were found.  Based on the weak evidence from 7 full-text case series studies of 124 patients with recurrent/refractory CDAD, FT appears to be a safe and effective procedure.  In most cases (83 %) symptoms improved immediately after the first FT procedure, and some patients stayed diarrhea-free for several months or years.  The authors concluded that although these results appear to be promising, the treatment effects of FT can not be determined definitively in the absence of a control group.  Results from RCTs that compare FT to oral vancomycin without or with a taper regimen will help to better define the role of FT in the management of recurrent CDAD.

Brandt and Reddy (2011) stated that with the increasing prevalence of recurrent/refractory CDI, alternative treatments to the standard antibiotic therapies are being sought.  One of the more controversial of such alternative treatments is fecal microbiota transplantation (FMT).  Although the notion of FMT is foreign -- even startling -- and not esthetic to most people, the concept has been around for many decades.  Its benefit and effectiveness dated back more than 50 years to its use for staphylococcal pseudomembranous colitis, and now FMT is showing a great promise as an inexpensive, safe, and highly efficient treatment for recurrent and refractory CDI.  Moreover, with a better understanding of the intricacies of the colonic microbiome and its role in colonic pathophysiology, FMT has the potential to become the standard of care for CDI treatment, and a potential answer to other intestinal disorders in years to come.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met :
44705
HCPCS codes covered if selection criteria are met:
G0455 Preparation with instillation of fecal microbiota by any method, including assessment of donor specimen
ICD-9 codes covered if selection criteria are met:
008.45 Intestinal infections due to clostridium difficile


The above policy is based on the following references:
  1. van Nood E, Vrieze A, Nieuwdorp M, et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 16. [Epub ahead of print]
  2. Kelly CP. Fecal microbiota transplantation - An old therapy comes of age. N Engl J Med. 2013 Jan 16. [Epub ahead of print]
  3. Baddour LM. Donor feces for recurrent Clostridium difficile infection. JWatch Infect Dis. 2013 Jan 16.
  4. Cohen SH, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol 2010;31(5):431-455.
  5. Brandt LJ, Reddy SS. Fecal microbiota transplantation for recurrent clostridium difficile infection. J Clin Gastroenterol. 2011;45 Suppl:S159-S167.
  6. Guo B, Harstall C, Louie T, et al. Systematic review: Faecal transplantation for the treatment of Clostridium difficile-associated disease. Aliment Pharmacol Ther. 2012;35(8):865-875.
  7. You DM, Franzos MA, Holman RP. Successful treatment of fulminant Clostridium difficile infection with fecal bacteriotherapy. Ann Intern Med. 2008;148(8):632-633.
  8. Bakken JS. Fecal bacteriotherapy for recurrent Clostridium difficile infection. Anaerobe. 2009;15(6):285-289.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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