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Fecal Microbiota Transplantation

Policy Number: MP-584

Latest Review Date: November 2024

Category: Laboratory                                                             

POLICY:

Effective for dates of service on and after December 22, 2020:

The use of fecal microbiota transplantation for treatment of individuals with recurrent Clostridium difficile infection may be considered medically necessary when:

  • There have been at least 2 recurrences that are refractory to standard antibiotic treatment.

The use of fecal microbiota transplantation is considered investigational in the absence of the conditions listed above.

Effective for dates of service prior to December 22, 2020:

The use of fecal microbiota transplantation for treatment of patients with recurrent Clostridium difficile infection may be considered medically necessary when:

  • There have been at least three episodes of recurrent infection; AND
  • Episodes are refractory to appropriate antibiotic regimens, including at least one regimen of pulsed vancomycin.

The use of fecal microbiota transplantation is considered investigational in the absence of the conditions listed above.

DESCRIPTION OF PROCEDURE OR SERVICE:

Fecal microbiota transplantation (FMT) involves the administration of intestinal microorganisms via the transfer of stool from a healthy person into a diseased individual, with the intent of restoring normal intestinal flora. Fecal transplant is proposed for treatment-refractory Clostridioides (formerly Clostridium) difficile infection (CDI) and other conditions, including inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), pouchitis, constipation, multi-drug resistant organism (MDRO) infection, or metabolic syndrome.

Fecal Microbiota

Fecal microbiota transplantation (FMT), also called donor feces infusion, intestinal microbiota transplantation, and fecal bacteriotherapy, involves the duodenal infusion of intestinal microorganisms via the transfer of stool from a healthy individual into a diseased individual to restore normal intestinal flora. The stool can be infused as a liquid suspension into a patient’s upper gastrointestinal tract though a nasogastric tube or gastroscopy, or into the colon through a colonoscope or rectal catheter.

The goal of FMT is to replace damaged and/or disordered native microbiota with a stable community of donor microorganisms. The treatment is based on the premise that an imbalance in the community of microorganisms residing in the gastrointestinal tract (i.e., dysbiosis) is associated with specific disease states, including susceptibility to infection.

The human microbiota, defined as the aggregate of microorganisms (bacteria, fungi, archaea) on and in the human body, is believed to consist of approximately 10 to 100 trillion cells, approximately ten times the number of human cells. Most human microbes reside in the intestinal tract, and most of these are bacteria. In its healthy state, intestinal microbiota perform a variety of useful functions including aiding in the digestion of carbohydrates, mediating the synthesis of certain vitamins, repressing growth of pathogenic microbes, and stimulating the lymphoid tissue to produce antibodies to pathogens.

Applications

Clostridioides Difficile Infection

To date, the major potential clinical application of fecal microbiota transplantation is in the treatment of Clostridioides difficile infection (CDI). Infection of the colon with C difficile is a major cause of colitis and can cause life-threatening conditions including colonic perforation and toxic megacolon. C difficile occurs naturally in the intestinal flora. According to the 2019

Centers for Disease Control and Prevention (CDC) report, Antibiotic Resistance Threats in the United States, CDI continues to be an urgent threat. In 2017, there were an estimated 223,900 cases of CDI in hospitalized patients and an estimated 12,900 CDI-associated deaths. Interestingly, the overall number of cases of healthcare-associated CDI cases has been trending down since 2012 when the number of cases was estimated at 251,400.

It is unclear what causes C difficile overgrowth, but disruption of the normal colonic flora and colonization by C difficile are major components. Disruption of the normal colonic flora occurs most commonly following the administration of oral, parenteral or topical antibiotics. Standard treatment for CDI is antibiotic therapy. However, symptoms recur in up to 35% of patients and up to 65% of patients with recurrences develop a chronic recurrent pattern of CDI.

Other Applications

Other potential uses of fecal microbiota transplant include the treatment of conditions in which altered colonic flora may play a role: inflammatory bowel disease, irritable bowel syndrome, idiopathic constipation and non-gastrointestinal diseases 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.

There is interest in alternatives to human feces that might have the same beneficial effects on intestinal microbiota without the risks of disease transmission. A proof of principle study, Perof et al (2013) evaluated a synthetic stool product in two patients with recurrent CDI. The product is made from 33 bacterial isolates developed from culturing stool from a healthy donor.

KEY POINTS:

The most recent literature review was updated through October 8, 2024.

Summary of Evidence

For individuals who have recurrent Clostridioides difficile infection (CDI) refractory to antibiotic therapy who receive fecal microbiota transplantation (FMT) with a product that is not commercially available, the evidence includes systematic reviews with meta-analyses and observational studies. Relevant outcomes are symptoms, change in disease status, and treatment-related morbidity. Meta-analyses have found that FMT is more effective than standard treatment or placebo for patients with recurrent CDI. A long-term prospective study found that FMT for recurrent or refractory CDI appears to be durable at 4 to 8 years following treatment, even for patients who had subsequently received non-CDI antibiotic therapy. A meta-analysis comparing several routes of FMT delivery for the treatment of recurrent CDI found that cure rates were significantly higher with colonoscopy or oral capsules versus nasogastric tube or enema, while colonoscopy and capsules were equally effective. Similar success rates have been demonstrated with FMT using fresh versus frozen feces. Conversely, data regarding the superiority of FMT using donor versus autologous feces are conflicting. Few treatment-related adverse events have been reported. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have recurrent Clostridioides difficile infection (CDI) refractory to antibiotic therapy who receive fecal microbiota transplantation (FMT) with a commercially available Food and Drug Administration (FDA)-approved product, the evidence includes randomized controlled trials (RCTs) and open-label studies. Relevant outcomes are symptoms, change in disease status, and treatment-related morbidity. The efficacy of a commercially available rectally administered suspension containing live fecal microbiota spores was evaluated in a phase 3 double-blind, placebo-controlled RCT (PUNCH CD3; N=289), with analysis conducted using a Bayesian hierarchical model that borrowed data from a preceding phase 2b trial (PUNCH CD2; N=134). Both trials included adults with recurrent CDI (1 or more recurrences in PUNCH CD3, and 2 or more recurrences in PUNCH CD2) or a minimum of 2 CDI episodes within the preceding year that led to hospitalization, who received at least 10 consecutive days of standard antibiotic therapy and displayed improvement in CDI symptoms. The rate of treatment success, defined as the absence of CDI within 8 weeks of study treatment, was significantly higher in the group of patients who received rectally administered live fecal microbiota spores as compared to placebo (70.6% vs 57.5%). Additionally, among those patients who achieved treatment success at 8 weeks, more than 90% remained free of CDI recurrence through 6 months. In a single-arm, open-label trial evaluating FDA-approved rectal suspension containing live fecal microbiota spores, 91% of responders remained CDI free through 6 months. A phase 3, double-blind, placebo-controlled RCT (N=182) evaluated the efficacy of commercially available oral capsules containing live fecal microbiota spores in patients who had at least 2 recurrences within 12 months and who received 10 to 21 consecutive days of standard antibiotic therapy and displayed improvement in CDI symptoms. Results demonstrated that a 3-day course of oral live fecal microbiota spores was more effective than placebo at preventing CDI recurrence within 8 weeks of treatment (12% vs 40%, respectively). In a single-arm, open-label trial evaluating commercially available oral capsules containing live fecal microbiota spores, the CDI recurrence rate at 24 weeks follow-up was 13.7%. Both commercially available therapies were well-tolerated, with the majority of adverse events being mild-to-moderate in severity. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have inflammatory bowel disease (IBD) who receive FMT, the evidence includes systematic reviews and RCTs. Relevant outcomes are symptoms, change in disease status, and treatment-related morbidity. Systematic reviews have generally shown favorable clinical remission and response with FMT in patients with IBD while acknowledging that further RCTs and long-term follow-ups are needed to assess long-term effectiveness and safety. A 48-week RCT in patients with UC in clinical remission after prior FMTs found conflicting results for remission outcomes with additional courses of FMT. Another RCT in patients with recurrent active UC found a median remission time of 24 months in both FMT and standard of care treatment groups. A 12-month RCT evaluating FMT for the maintenance of remission in patients with UC did not find a statistically significant difference between single-dose FMT and control groups. This current evidence is not sufficient to permit conclusions on the efficacy of FMT for UC. Additionally, questions remain about the optimal route of administration, donor characteristics, and the number of transplants. A small RCT in patients with Crohn disease (CD) failed to find a difference in the achievement of remission with FMT versus placebo. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have irritable bowel syndrome (IBS) who receive fecal microbiota transplantation (FMT), the evidence includes systematic reviews and RCTs. Relevant outcomes are symptoms, change in disease status, and treatment-related morbidity. For individuals who have IBS who receive FMT, the evidence includes systematic reviews and RCTs. Systematic reviews with meta-analyses have been inconsistent in finding improvements in clinical response, IBS Severity Scoring System, or IBS Quality of Life scores with FMT compared to placebo. Two additional RCTs also utilized autologous FMT as a placebo, and did not find a significant reduction in symptoms of IBS using donor FMT; both trials also found reduced durability of response 1 year following donor FMT. An additional placebo-controlled RCT used FMT delivered via oral capsules and found no improvement in abdominal pain scores, stool frequency, or stool form in a mixed population of patients with IBS. Few treatment-related adverse events have been reported. Data are limited by heterogeneity in utilized outcome measurement scales and definitions of treatment response. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have pouchitis, constipation, multi-drug resistant organism (MDRO) infection, or metabolic syndrome who receive fecal microbiota transplantation (FMT), the evidence includes systematic reviews, RCTs, and prospective cohort studies. Relevant outcomes are symptoms, change in disease status, and treatment-related morbidity. Systematic reviews of data from patients who received FMT for constipation, pouchitis, MDRO infections, and metabolic syndrome have all concluded that more data are needed before FMT can be applied in clinical practice for these populations. In a meta-analysis assessing the use of FMT in obese and metabolic syndrome patients, the initial improvements of several metabolic parameters failed to demonstrate sustained durability at 12 weeks after treatment. While cohort studies have demonstrated FMT to be fairly effective in eradicating MDRO colonization, an RCT comparing FMT to no intervention in patients with MDROs failed to demonstrate improved rates of decolonization with treatment. An additional RCT in patients with chronic pouchitis concluded that the FMT regimen evaluated was not effective. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Gastroenterological Association

In 2024, the American Gastroenterological Association (AGA) released guidelines for fecal microbiota-based therapies including recommendations for the use of FMT in several gastrointestinal (GI) diseases including CDI, UC, Crohn disease (CD), pouchitis, and IBS. The AGA recommends the following:

  • "In immunocompetent adults with recurrent C difficile infection, the AGA suggests the use of fecal microbiota–based therapies upon completion of standard of care antibiotics over no fecal microbiota–based therapies. (Conditional recommendation, low certainty evidence)". The recommendations further specify that conventional (compounded, donor), fecal microbiota live-jslm, and fecal microbiota spores live-brpk are all included in this recommendation.
  • "In mildly or moderately immunocompromised adults with recurrent C difficile infection, the AGA suggests the use of conventional fecal microbiota transplant upon completion of standard of care antibiotics over no fecal microbiota transplant. (Conditional recommendation, very low certainty of evidence) In severely immunocompromised adults with recurrent C difficile infection, the AGA suggests against the use of fecal microbiota based therapies upon completion of standard of care antibiotics over no fecal microbiota–based therapies. (Conditional recommendation, very low certainty of evidence)". Severely immunocompromised individuals include "patients receiving active cytotoxic therapy for solid tumors and hematologic malignancies, patients who have received chimeric antigen receptor T-cell therapy or hematopoietic cell transplant (only when neutropenic), any neutropenia, patients with severe primary immunodeficiency, patients with advanced or untreated HIV infection (CD4 counts <200/mm3, AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)." All other immunocompromised patients are considered to be mild or moderate when they do not meet the definition of severe immunocompromise.
  • "In adults hospitalized with severe or fulminant C difficile infection not responding to antimicrobial therapy, the AGA suggests the use of conventional fecal microbiota transplant over no fecal microbiota transplant. (Conditional recommendation, very low certainty of evidence)". Severe CDI includes individuals with a leukocyte count of 15 x 109 cells/L or more and/or creatinine of 1.5 mg/dL or more. Fulminant CDI is severe CDI with shock, ileus, or megacolon. The AGA also states, "FMT should be performed with appropriately screened donor stool. There is no evidence for using the FDA-approved fecal microbiota based therapies as adjuvant treatment in severe or fulminant CDI."

The AGA "suggests against the use of conventional fecal microbiota transplant, except in the context of clinical trials" for adults with UC, CD, pouchitis, or IBS.

American College of Gastroenterology

In 2019, the American College of Gastroenterology (ACG) published guidelines on the management of adults with ulcerative colitis (UC). The guidelines noted "fecal microbiota transplantation (FMT) requires more study and clarification of treatment before use as therapy for UC."

In 2021, the ACG published a guideline on the management of Clostridioides difficile infection (CDI). This guideline makes the following recommendations:

  • "We suggest fecal microbiota transplantation (FMT) be considered for patients with severe and fulminant CDI refractory to antibiotic therapy, particularly, when patients are deemed poor surgical candidates (strong recommendation, low quality of evidence)."
  • "We recommend patients experiencing their second or further recurrence of CDI be treated with FMT to prevent further recurrences (strong recommendation, moderate quality of evidence)."
  • "We recommend FMT be delivered through colonoscopy (strong recommendation, moderate quality of evidence) or capsules (strong recommendation, moderate quality of evidence) for treatment of CDI; we suggest delivery by enema if other methods are unavailable (conditional recommendation, low quality of evidence)."
  • "We suggest repeat FMT for patients experiencing a recurrence of CDI within 8 weeks of an initial FMT (conditional recommendation, very low quality of evidence)."
  • "FMT should be considered for recurrent CDI in patients with IBD (strong recommendation, very low quality of evidence)."

In 2021, the ACG also published a guideline on the management of irritable bowel syndrome (IBS). This guideline recommended against the use of fecal transplant for the treatment of global IBS symptoms (strong recommendation; very low quality of evidence).

American Society of Colon and Rectal Surgeons

In 2021, the American Society of Colon and Rectal Surgeons (ASCRS) published a guideline on the management of CDI. This guideline states that:

  • "Patients with recurrent or refractory CDI should typically be considered for fecal bacteriotherapy (eg, intestinal microbiota transplantation) if conventional measures, including appropriate antibiotic treatment, have failed (Grade of recommendation: Strong recommendation based on moderate-quality evidence, 1B)."
  • "Patients with 3 or more CDI episodes can be managed with a vancomycin tapered and pulsed course or fidaxomicin followed by a microbiome-based therapy such as fecal microbiota transplantation."
  • "In general, conventional antibiotic treatment should be used for at least 2 recurrences (ie, 3 CDI episodes) before offering fecal microbiota transplantation."

Per Table 3 in this guideline: for "Third or Subsequent” CDI episode: “If FMT is available, then 10-day course of vancomycin followed by FMT.”

Infection Diseases Society of America

The Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) updated clinical practice guidelines (2019) for the diagnosis and treatment of CDI in children and adults. Recommendations were summarized as follows:

  • "Consider fecal microbiota transplantation for pediatric patients with multiple recurrences of CDI following standard antibiotic treatments. (Weak recommendation, very low quality of evidence)"
  • "Fecal microbiota transplantation is recommended for patients with multiple recurrences of CDI who have failed appropriate antibiotic treatments. (Strong recommendation, moderate quality of evidence)"
  • "Potential candidates for FMT include patients with multiple recurrences of CDI who have failed to resolve their infection despite treatment attempts with antibiotic agents targeting CDI. Although there are no data to indicate how many antibiotic treatments should be attempted before referral for FMT, the opinion of the panel is that appropriate antibiotic treatments for at least 2 recurrences (ie, 3 CDI episodes) should be tried."

A 2021 focused update of this guideline echoes the previous recommendations for FMT by stating: "FMT is recommended only for patients with multiple recurrences of CDI who have failed appropriate antibiotic treatments and where appropriate screening of donor and donor fecal specimens have been performed, in accordance with these newer FDA recommendations."

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Fecal microbiota transplant, Donor feces infusion, Intestinal microbiota transplantation, Fecal bacteriotherapy, Fecal transplant, Rebyota, Vowst

APPROVED BY GOVERNING BODIES:

In 2022, the U.S. Food and Drug Administration (FDA) issued updated draft guidance on investigational new drug requirements for the use of FMT to treat CDI not responsive to medication therapy. The draft guidance is similar to the 2013 guidance and states that the Food and Drug Administration is continuing to consider how to regulate FMT and that, during this interim period, the agency will use enforcement discretion regarding the use of fecal transplant to treat treatment-resistant CDI. The Food and Drug Administration requires that physicians obtain adequate informed consent from patients or their legal representative before performing the intervention. The document also noted that selective enforcement does not apply to the use of fecal transplant for treating conditions other than treatment-resistant CDI.

In 2019, the FDA issued a safety alert regarding the use of FMT due to the potential risk of serious or life-threatening infections caused by the transmission of multi-drug resistant organisms (MDROs). Two immunocompromised individuals received investigational FMT and developed invasive infections caused by the transmission of extended-spectrum beta-lactamase-producing Escherichia coli. One of the affected individuals died. The donor stool used in each patient's FMT procedures had not been tested for extended-spectrum beta-lactamase-producing gram-negative organisms prior to use. Follow-up testing verified donor stool was positive for MDROs identical to the organisms isolated from the two patients. Due to these events, the FDA has determined that the following additional protections are required for any investigational use of FMT:

  • Donor screening that specifically addresses risk factors for colonization with MDROs and exclusion of individuals at higher risk of colonization with MDROs (eg, health care workers, persons who have recently been hospitalized or discharged from long-term care facilities, persons who regularly attend outpatient medical or surgical clinics, and persons who have recently engaged in medical tourism).
  • MDRO testing of donor stool and exclusion of stool testing positive for MDROs. At a minimum, tests should include:
    • extended-spectrum beta-lactamase-producing Enterobacteriaceae
    • vancomycin-resistant enterococci
    • carbapenem-resistant Enterobacteriaceae
    • methicillin-resistant Staphylococcus aureus
  • All FMT products currently in storage for future use must be quarantined until donor MDRO carriage risk can be assessed and FMT products are tested and found negative for MDROs.
  • The informed consent process for FMT treatment subjects should describe the risk of MDRO transmission and infection and the measures being implemented for donor screening and stool testing.

On April 9, 2020, the FDA published additional safety information regarding the potential risk of transmission of SARS-CoV-2 via FMT. 

On August 20, 2022, the FDA also published a safety alert regarding the use of FMT and additional safety protections pertaining to the monkeypox virus.

In 2022, the FDA approved the first fecal microbiota product, RebyotaTM (fecal microbiota, live-jslm). Rebyota is approved for the prevention of recurrence of CDI in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI. Importantly, the drug is not approved for the treatment of CDI. Rebyota is supplied as a 150 mL suspension for rectal administration as a single dose, 24 to 72 hours after the last dose of antibiotics for CDI.

In 2023, the FDA approved the first orally administered fecal microbiota product, VowstTM (fecal microbiota spores, live–brpk). Similar to Rebyota, Vowst is approved for the prevention of recurrence of CDI in individuals 18 years of age and older following antibiotic treatment for recurrent CDI, and is not approved for the treatment of CDI. The drug is administered as 4 capsules by mouth once daily for 3 consecutive days.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  

CURRENT CODING: 

CPT Codes:

44705

Preparation of fecal microbiota for installation, including assessment of donor specimen                       
0780T Instillation of fecal microbiota suspension via rectal enema into lower gastrointestinal tract

HCPCS Codes:

G0455

Preparation with instillation of fecal microbiota by any method, including assessment of donor specimen
J1440 Fecal microbiota, live - jslm, 1 ml

       

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  45. Lahtinen P, Jalanka J, Hartikainen A, et al. Randomised clinical trial: faecal microbiota transplantation versus autologous placebo administered via colonoscopy in irritable bowel syndrome. Aliment Pharmacol Ther. Jun 2020; 51(12): 1321-1331.
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  48. Lee CH, Chai J, Hammond K, et al. Long-term durability and safety of fecal microbiota transplantation for recurrent or refractory Clostridioides difficile infection with or without antibiotic exposure.. Eur. J. Clin. Microbiol. Infect. Dis., Sep 2019; 38(9): 1731-1735.
  49. Lee CH, Steiner T, Petrof EO, et al. Frozen vs fresh fecal microbiota transplantation and clinical resolution of diarrhea in patients with recurrent Clostridium difficile Infection: a randomized clinical trial. JAMA. Jan 12 2016; 315(2):142-149.
  50. Li Q, Ding X, Liu K, et al. Fecal Microbiota Transplantation for Ulcerative Colitis: The Optimum Timing and Gut Microbiota as Predictors for Long-Term Clinical Outcomes. Clin Transl Gastroenterol. Aug 2020; 11(8): e00224.
  51. Lichtenstein GR, Loftus EV, Isaacs KL, et al. ACG Clinical Guideline: Management of Crohn's Disease in Adults. Am J Gastroenterol. Apr 2018; 113(4): 481-517.
  52. Madsen AMA, Halkjaer SI, Christensen AH, et al. The effect of faecal microbiota transplantation on abdominal pain, stool frequency, and stool form in patients with moderate-to-severe irritable bowel syndrome: results from a randomised, double-blind, placebo-controlled study. Scand J Gastroenterol. Jul 2021; 56(7): 761-769.
  53. Mamo Y, Woodworth MH, Wang T, et al. Durability and long-term clinical outcomes of fecal microbiota transplant treatment in patients with recurrent Clostridium difficile infection. Clin Infect Dis. May 17 2018;66(11):1705-1711.
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  56. Meighani A, Hart BR, Bourgi K, et al. Outcomes of fecal microbiota transplantation for Clostridium difficile infection in patients with inflammatory bowel disease. Dig Dis Sci. Oct 2017;62(10):2870-2875.
  57. Minkoff NZ, Aslam S, Medina M, et al. Fecal microbiota transplantation for the treatment of recurrent Clostridioides difficile (Clostridium difficile). Cochrane Database Syst Rev. Apr 25 2023; 4(4): CD013871.
  58. 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. Jul 2015; 149(1):102-109 e106.
  59. Paramsothy S, Paramsothy R, Rubin DT, et al. Faecal microbiota transplantation for inflammatory bowel disease: a systematic review and meta-analysis. J Crohns Colitis. Oct 1 2017;11(10):1180-1199.
  60. Peery AF, Kelly CR, Kao D, et al. AGA Clinical Practice Guideline on Fecal Microbiota-Based Therapies for Select Gastrointestinal Diseases. Gastroenterology. Mar 2024; 166(3): 409-434.
  61. Petrof EO, Gloor GB, Vanner SJ et al. Stool substitute transplant therapy for the eradication of Clostridium difficile infection: 'RePOOPulating' the gut. Microbiome Jan 09 2013; 1(1):3.
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POLICY HISTORY:

Medical Policy Panel, February 2014

Medical Policy Group, February 2015 (3):  Newly adopted policy

Medical Policy Administration Committee, March 2015

Medical Policy Panel, April 2015

Medical Policy Group, May 2015 (3): 2015 Updates to Key Points & References; no change in policy statement.

Medical Policy Panel, November 2015

Medical Policy Group, December 2015 (3): 2015 Updates to Key Points and References; no change in policy statement.

Medical Policy Panel, November 2016

Medical Policy Group, November 2016 (3): 2016 Updates to Key Points and References; no change in policy statement.

Medical Policy Panel, November 2017

Medical Policy Group, November 2017 (3): 2017 Updates to Description, Key Points & References; no change in policy statement.

Medical Policy Panel, November 2018

Medical Policy Group, December 2018 (4): Updates to Key Points, Approved by Governing Bodies, and References.  No change to policy statement.

Medical Policy Panel, November 2019

Medical Policy Group, November 2019 (5): Updates to Description, Key Points, Practice Guidelines, Approved by Governing Bodies, and References. No change to Policy Statement.

Medical Policy Panel, December 2020

Medical Policy Group, December 2020 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy Statement updated to the following: There have been at least 2 recurrences that are refractory to standard antibiotic treatment. Available for comment December 22, 2020 through February 5, 2021.

Medical Policy Panel, November 2021

Medical Policy Group, November 2021 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, November 2022

Medical Policy Group, November 2022 (5): Updates to Description, Key Points, and References. Policy Statement updated to replace the word “patients” with the word “individuals.” No change to policy intent.

Medical Policy Group, December 2022: 2023 Annual Coding Update: Added CPT code 0780T to Current Coding section. Key Words updated to include: Rebyota. No change to Policy Statement.

Medical Policy Panel, November 2023

Medical Policy Group, November 2023 (11): Updates to Key Points, Key Words, Approved by Governing Bodies, Benefit Application, Current Coding and References.

Medical Policy Panel, November 2024

Medical Policy Group, November 2024 (11): Updates to Description, Key Points, Approved by Governing Bodies, and References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.