Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Fecal Microbiota Transplantation (FMT)

Policy #:07.05.08a

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Fecal microbiota transplantation (FMT) is considered medically necessary and, therefore, covered for treatment of individuals with recurrent Clostridium difficile infection (CDI) when all of the following criteria are met:
  • Infection confirmed by a positive stool test for C. difficile toxin;
  • There have been at least 3 episodes of recurrent infection;
  • Episodes are refractory to appropriate antibiotic regimens, including at least one regimen of pulsed Vancomycin.

All other uses for fecal microbiota transplantation are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, fecal microbiota transplantation is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

In July 2013, the U.S. Food and Drug Administration (FDA) issued guidance regarding investigational new drug requirements for use of FMT to treat CDI not responsive to standard therapies. The FDA has not issued its final regulatory approval and labeling of fecal microbiota transplantation. If FDA approval is granted, further review regarding the safety and/or effectiveness of this therapy may be conducted.

Description

Fecal microbiota transplantation (FMT, also known as fecal bacteriotherapy, fecal transfusion, intestinal microbiota transplantation, probiotic infusion, and donor feces infusion) involves the infusion of a liquid suspension of fecal matter from a healthy donor into an individual with a specific disease. The purpose of this procedure is to re-establish the normal composition of the intestinal flora. FMT is proposed for the treatment of treatment-refractory Clostridium difficile infection (CDI), which can result in mild diarrhea to life-threatening fulminant pseudomembraneous colitis.

The major potential clinical application of FMT is the treatment of CDI. Other potential uses of FMT include treatment of conditions in which altered colonic flora may play a role. These include inflammatory bowel disease (IBD), irritable bowel syndrome, idiopathic constipation, and nongastrointestinal disease such as multiple sclerosis, obesity, autism, and chronic fatigue syndrome. However, for these conditions, the contribution of alterations in colonic flora to the disorder is uncertain or controversial.

Although the efficacy and safety profiles of FMT have not yet been fully evaluated in controlled clinical trials, published data suggest that the use of fecal microbiota to restore intestinal flora may be an effective therapy in the management of refractory Clostridium difficile infection.

In July 2013, the U.S. Food and Drug Administration (FDA) issued guidance regarding investigational new drug requirements for use of FMT to treat CDI not responsive to standard therapies. The document states that the FDA is continuing to consider how to regulate FMT and that, during this interim period, the agency will use enforcement discretion regarding use of FMT to treat treatment-resistant CDI infections. The FDA requires that providers obtain adequate informed consent from patients or their legal representative before performing the intervention. The document also states that selective enforcement does not apply to other uses of FMT, and that data regarding the use of FMT to treat conditions other than treatment-resistant Clostridium difficile are limited. Furthermore, the study of FMT for these other uses is not included in the FDA enforcement policy.
References


American College of Gastroenterology (ACG). Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections. [Gastroenterology Web site]. 02/26/2013. Available at: http://gi.org/guideline/diagnosis-and-management-of-c-difficile-associated-diarrhea-and-colitis/. Accessed June 15, 2018.

Anderson JL, Edney RJ, Whelan K. Systematic review: faecal microbiota transplantation in the management of inflammatory bowel disease. Aliment Pharmacol Ther. 2012; 36(6):503-16.

Baddour LM. Donor feces for recurrent Clostridium difficile infection. J Watch Infect Dis. 2013 Jan 16.

Bakken JS. Fecal bacteriotherapy for recurrent Clostridium difficile infection. Anaerobe. 2009;15(6):285-289.

Brandt LJ, Reddy SS. Fecal microbiota transplantation for recurrent clostridium difficile infection. J Clin Gastroenterol. 2011;45 Suppl:S159-S167.

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.

Drekonja D, Reich J, Gezahegn S, et al. Fecal Microbiota Transplantation for Clostridium difficile Infection: A Systematic Review. Ann Intern Med. 2015;162(9):630-638.

Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011; 53(10):994-1002.

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):865-75.

Kachrimanidou M, Malisiovas N. Clostridium difficile infection: a comprehensive review. Crit Rev Microbiol. 2011; 37(3):178-87.

Kelly CP. Fecal microbiota transplantation - An old therapy comes of age. N Engl J Med. 2013; 368(5):474-5.

Lee CH, Belanger JE, Kassam Z, et al. The outcome and long-term follow-up of 94 patients with recurrent and refractory Clostridium difficile infection using single to multiple fecal microbiota transplantation via retention enema. Eur J Clin Microbiol Infect Dis. 2014; 33(8):1425-8.

Moayyedi P, Surette MG, Kim PT, et al. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015;149(1):102-109 e106.

Nelson RL, Kelsey P, Leeman H, et al. Antibiotic treatment for Clostridium difficile-associated diarrhea in adults. Cochrane Database Syst Rev. 2011; (9):CD004610.

Petrof EO, Gloor GB, Vanner SJ, et al. Stool substitute transplant therapy for the eradication of Clostridium difficile infection: 'RePOOPulating' the gut. Microbiome. 2013; 1(1):3.

Rossen NG, Fuentes S, van der Spek MJ, et al. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015;149(1):110-118 e114.

Rossen NG, MacDonald JK, de Vries EM, et al. Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. World J Gastroenterol. 2015;21(17):5359-5371.

Sha S, Liang J, Chen M, et al. Systematic review: faecal microbiota transplantation therapy for digestive and nondigestive disorders in adults and children. Aliment Pharmacol Ther. 2014;39(10):1003-1032.

Sofi AA, Silverman AL, Khuder S, et al. Relationship of symptom duration and fecal bacteriotherapy in Clostridium difficile infection-pooled data analysis and a systematic review. Scand J Gastroenterol. 2013; 48(3):266-73.

U.S. Food and Drug Administration (FDA). Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies. July 2013. Available online at:
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformtion/Guidances/Vaccines/UCM361393.pdf. Accessed June 15, 2018.

van Nood E, Vrieze A, Nieuwdorp M et al. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013; 368(5):407-15.

Vrieze A, Van Nood E, Holleman F, et al. Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome. Gastroenterology. 2012;143(4):913-916 e917.

You DM, Franzos MA, Holman RP. Successful treatment of fulminant Clostridium difficile infection with fecal bacteriotherapy. Ann Intern Med. 2008;148(8):632-633.

Youngster I, Sauk J, Pindar C, et al. Fecal microbiota transplant for relapsing Clostridium difficile infection using a frozen inoculum from unrelated donors: a randomized, open-label, controlled pilot study. Clin Infect Dis. 2014; 58(11):1515-22.




Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

THE FOLLOWING CODE IS USED TO REPRESENT THE PREPARATION OF FECAL MICROBIOTA FOR INSTILLATION:

44705

THE FOLLOWING CODE IS USED TO REPRESENT THE INSTILLATION OF FECAL MICROBIOTA BY ORO-NASOGASTRIC TUBE OR ENEMA:

44799


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

A04.71 Enterocolitis due to Clostridium difficile, recurrent


HCPCS Level II Code Number(s)



G0455 Preparation with instillation of fecal microbiota by any method, including assessment of donor specimen


Revenue Code Number(s)

N/A

Coding and Billing Requirements



Policy History

Effective 10/05/2017 this policy has been updated to the new policy template
format.



07/18/2018As of 07/18/2018, this policy has been reviewed and reissued to communicate the Company’s continuing position on fecal microbiota transplantation (FMT)
Version Effective Date: 10/01/2017
Version Issued Date: 09/29/2017
Version Reissued Date: 07/18/2018

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2017 Independence Blue Cross.
Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.