ModifiedCignaPolicy IP0556

Prevention of recurrent Clostridioides difficile infection (CDI)

Defines updated criteria and documentation for prevention of recurrence of CDI, including positive stool test requirements for the current episode; applies to Cigna members and providers submitting requests for therapies related to CDI recurrence prevention.

Policy Summary

PayerCigna

PolicyPrevention of recurrent Clostridioides difficile infection (CDI)

Policy CodePolicy IP0556

Change TypePositive stool test criteria reviseddocumentation requirements removed

Effective Date

Next Review Date

Key ActionUpdate prior authorization workflows to require a positive stool test 'for current episode' and note that prior operational documentation requirements were removed.

SourceLink

POLICY UPDATE CHANGES

Updated positive stool test criteria with addition of 'for current episode' and removed 'within the previous 30 days'.

Removed documentation requirements.

1Selected Revision entry in Revision Details

IP0556Coverage Policy Number

2025-08-01Selected Revision Date

Coverage Criteria

This policy incorporates safety communications from the U.S. Food and Drug Administration regarding fecal microbiota transplantation and microbiota‑based therapies. The FDA has issued alerts noting a risk of serious adverse reactions due to transmission of multi‑drug‑resistant organisms and additional safety alerts describing risk of serious adverse events likely due to transmission of pathogenic organisms, as well as updates addressing additional protections for SARS‑CoV‑2 (COVID‑19) and monkeypox. These safety concerns inform coverage restrictions and exclusions for fecal microbiota transplantation and related therapies in this policy.

Provider Actions and Operational Impact

Prior Authorization

Positive stool test requirement updated

Positive stool test requirement updated: a positive stool test for the current episode is now required to support coverage decisions for prevention of recurrent Clostridioides difficile infection (CDI). Prior positive tests that are not for the current episode do not meet this requirement and may not support prior authorization or coverage.

Positive stool test must be for the current episode (not prior unrelated episodes)
Previous wording referencing 'within the previous 30 days' has been removed

Policy Summary

PayerCigna

PolicyPrevention of recurrent Clostridioides difficile infection (CDI)

Policy CodePolicy IP0556

Change TypePositive stool test criteria reviseddocumentation requirements removed

Effective Date

Next Review Date

Key ActionUpdate prior authorization workflows to require a positive stool test 'for current episode' and note that prior operational documentation requirements were removed.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Denial Risk

Removal of documentation requirements may increase denial risk if supporting records are not provided

Operational denial risk: removal of documentation requirements in the policy does not eliminate denial risk if prior authorization or claims adjudication relies on supporting records that are not submitted. Providers should still submit relevant clinical documentation at the time of prior authorization to avoid processing delays or denials.

If prior authorization workflows or adjudication systems expect supporting documentation, failure to provide available clinical records may result in denials
When submitting prior authorization requests, include documentation demonstrating the positive stool test for the current episode and any other clinical information the payer requests operationally

Background and Clinical Sources

Clinical references supporting this policy include practice guidelines and regulatory guidance on management and safety of Clostridioides difficile infection and fecal microbiota transplantation. Key sources cited are the IDSA/SHEA 2021 focused update on CDI management, the ACG 2021 clinical guidelines for prevention, diagnosis, and treatment of CDI, the ASCRS 2021 clinical practice guidelines, and FDA safety communications and alerts regarding FMT safety, including updates addressing SARS‑CoV‑2 and monkeypox. Prescribing information for approved microbiota‑based therapies (for example, Rebyota and RBX2660) and the NCCN guidance on prevention and treatment of cancer‑related infections are also referenced for clinical context.

Definitions

FMT / Microbiota-based therapy — definitions and key distinctions

TermFecal microbiota transplantation (FMT) / microbiota-based therapy

DefinitionTransfer or administration of stool-derived microbiota or standardized microbiota-based products (e.g., Rebyota, RBX2660) to restore gut microbial balance for prevention or treatment of Clostridioides difficile infection (CDI)

Safety considerationsFDA safety communications note risk of serious adverse reactions from transmission of multi‑drug‑resistant organisms and pathogenic organisms; additional FDA alerts describe protections for SARS‑CoV‑2 and monkeypox

Regulatory contextFDA has issued multiple safety alerts and updates regarding FMT use and safeguards; professional society guidance (IDSA/SHEA, ACG, ASCRS) and product prescribing information are referenced for clinical use

Examples of microbiota-based therapiesRebyota (fecal microbiota suspension) and RBX2660 (product dossier referenced) cited in prescribing information and product data