CurrentCentenePolicy CP.PMN.47

Rifaximin (Xifaxan) (PDF)

Defines medical necessity criteria, initial and continuation approval criteria, dosing limits, covered indications (HE, IBS-D, travelers' diarrhea, SIBO off-label), approval durations, and required documentation for Centene lines of business (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyRifaximin (Xifaxan) (PDF)

Policy CodePolicy CP.PMN.47

Change TypeMaterial updates and annual reviews (step therapy bypass, duration and criteria revisions)

Effective Date11.01.11

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395 (effective 2026-01-01).

Updated initial approval duration for HE from 6 to 12 months for Medicaid/HIM line of business.

Added requirement for concurrent lactulose and rifaximin to initial criteria for HE per guidelines (4Q2022).

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.

Annual reviews with no significant changes and reference updates occurred in 4Q2021, 4Q2023, 4Q2024.

4Covered Indications (HE, IBS-D, TD, SIBO off-label)

1Off-label Indication (SIBO)

3Approval durations (varies by indication)

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2026-01-01IL HIM step therapy bypass effective date

Coverage Summary

Coverage stance: covered with criteria for rifaximin (Xifaxan) for Hepatic Encephalopathy (HE), Irritable Bowel Syndrome with Diarrhea (IBS-D), Travelers' Diarrhea (TD), and Small Intestinal Bacterial Overgrowth (SIBO) as an off-label indication. This policy defines medical necessity criteria, initial and continuation approval criteria, dosing limits, covered indications (HE, IBS-D, TD, SIBO off-label), approval durations, and required documentation for Centene lines of business (Commercial, HIM, Medicaid) as summarized in the scope. Approval durations overview: HE — HIM/Medicaid 12 months and Commercial 12 months or duration of request (whichever is less); IBS-D — 14 days; TD — 3 days (no re-authorization); SIBO (off-label) — up to 14 days. Detailed provider action and documentation/authorization requirements are provided in the Provider Actions section and the Initial/Continuation criteria sections of the policy. Policy number: CP.PMN.47; payer: Centene.

Rifaximin (Xifaxan) age and maximum dose thresholds

Hepatic Encephalopathy (HE) — age≥ 18 years

Hepatic Encephalopathy (HE) — maximum daily dose≤ 1,100 mg/day (2 tablets)

Irritable Bowel Syndrome with Diarrhea (IBS-D) — age≥ 18 years

Irritable Bowel Syndrome with Diarrhea (IBS-D) — maximum daily dose≤ 1,650 mg/day (3 tablets)

Travelers' Diarrhea (TD) — age≥ 12 years

Travelers' Diarrhea (TD) — maximum daily dose≤ 600 mg/day (3 tablets)

Small Intestinal Bacterial Overgrowth (SIBO) — age≥ 12 years

Small Intestinal Bacterial Overgrowth (SIBO) — maximum daily dose≤ 1,650 mg/day (3 tablets)

Initial Therapy Criteria

Initial Approval Criteria

Xifaxan is medically necessary when the following criteria are met:

Other diagnoses/indications

Label change: If drug has recently (within last 6 months) undergone a label change not reflected in this policy, follow formulary/no coverage or non-formulary policies referenced (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16) as applicable
Off-label referral: If requested use is NOT specifically listed under section III and criterion 1 above does not apply, refer to off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) for respective lines of business

Continuation Therapy Criteria

Continuation (Re-authorization) Criteria

Continued therapy is authorized when the following are met for each indication:

HE continued therapy

Continuation eligibility: Member is currently receiving medication via Centene benefit or previously met initial approval criteria
Concurrent therapy: Xifaxan is prescribed concurrently with lactulose, unless contraindicated or clinically significant adverse effects are experienced
Response: Member is responding positively to therapy

Diagnoses / Indications Not Authorized

Diagnoses/Indications Not Authorized

Coverage is not authorized for the following unless off-label criteria/policies are met:

Non-FDA approved indications that are not addressed in this policy, unless sufficient documentation of efficacy and safety per off-label use policies or evidence of coverage documents is provided

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Xifaxan requires prior authorization and must meet the specified initial or continuation criteria for the requested indication. Note: Re-authorization is not permitted for travelers' diarrhea (members must meet initial criteria for new TD cases).

Documentation Required

Submit supporting documentation

Provider must submit supporting documentation demonstrating that the member has met all approval criteria. Acceptable examples include office chart notes, laboratory results, or other clinical information relevant to the request.

Office notes / chart documentation
Laboratory results
Other clinical information (e.g., prior medication trials, adverse reactions)

Applicable Codes

No procedure/drug codes listed in policy bodymixed

No codes listed

Clinical Evidence

Evidence highlights: The 2014 AASLD hepatic encephalopathy guideline recommends rifaximin as an add-on to lactulose to prevent overt HE recurrence (AASLD guidance). For SIBO, a randomized dose-finding trial (Scarpellini et al. 2007) reported higher glucose breath test (GBT) normalization with 1,600 mg/day (80% normalization) versus 1,200 mg/day (58% normalization), P < 0.05. Note: SIBO use is considered off-label in this policy.

Background

Background: FDA-approved indications for Xifaxan include treatment of travelers' diarrhea in patients aged ≥ 12 years, reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults, and treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. Dosing for SIBO is described in the policy as off-label. The policy explicitly notes alignment with AASLD guidance recommending rifaximin as an add-on to lactulose for prevention of overt HE recurrence.

Revision History

2026-01-01IL HIM step therapy bypass (per IL HB 5395)Latest

Added step therapy bypass for Illinois HIM per IL HB 5395 (effective 2026-01-01).

4Q2025Updated initial approval duration for HE from 6 to 12 months (HIM/Medicaid)Latest

Updated initial approval duration for HE from 6 to 12 months for Medicaid/HIM line of business.

4Q2022

Policy Summary

PayerCentene

PolicyRifaximin (Xifaxan) (PDF)

Policy CodePolicy CP.PMN.47

Change TypeMaterial updates and annual reviews (step therapy bypass, duration and criteria revisions)

Effective Date11.01.11

Next Review Date

Key ActionProvider must submit documentation (office notes, labs, or other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

If request is for a dose increase, new dose does not exceed 1,100 mg (2 tablets) per day

Travelers' Diarrhea continued therapy

No re-authorization: Re-authorization is not permitted; members must meet initial approval criteria for new cases

SIBO continued therapy

Continuation eligibility: Member is currently receiving medication via Centene benefit or previously met initial approval criteria
Response: Member is responding positively to therapy
Dose limit: If request is for a dose increase, new dose does not exceed 1,650 mg (3 tablets) per day<= 1,650 mg/day

Other diagnoses/indications continued therapy

Policy referral: Follow formulary/no coverage or non-formulary and off-label policies as referenced in initial criteria when applicable (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53)

Step Therapy

Step therapy requirements for certain indications

Step therapy is required for certain indications unless the Illinois HIM step therapy bypass applies (effective 2026-01-01 per IL HB 5395). Per-indication step failures required for approval are listed below.

Hepatic Encephalopathy (HE): Failure of lactulose monotherapy in the past 30 days at up to maximally indicated doses (unless contraindicated).
IBS-D: Failure of an anti-diarrheal agent (e.g., loperamide) and failure of an antispasmodic (e.g., dicyclomine) at up to maximally indicated doses (unless contraindicated).
Travelers' Diarrhea (TD): Failure of azithromycin 1,000 mg as a single dose (unless contraindicated).
Illinois HIM: Step therapy requirements do not apply for Illinois HIM requests as of 1/1/2026 per IL HB 5395.

Billing Rule

Approval durations vary by line of business

Approval durations vary by indication and line of business as follows.

Hepatic Encephalopathy (HE): HIM/Medicaid — 12 months; Commercial — 12 months or duration of request, whichever is less.
IBS-D: 14 days.
Travelers' Diarrhea (TD): 3 days (re-authorization not permitted).
SIBO (off-label): Up to 14 days.

Concurrent lactulose requirement added to initial HE criteria

Added requirement for concurrent lactulose and rifaximin to initial criteria for HE per guidelines (4Q2022).

Jan/May 2022Commercial approval duration revised to 12 months or duration of request, whichever is less

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.

4Q2021, 4Q2023, 4Q2024Annual reviews; reference/template updates (non-material)

Annual reviews with no significant changes and reference updates occurred in 4Q2021, 4Q2023, 4Q2024.