CurrentUnitedHealthcarePolicy 2025 P 2030-16

Xifaxan (rifaximin) prior authorization/medical necessity

UnitedHealthcare prior authorization program defining coverage criteria, initial and reauthorization rules, and supply/authorization durations for Xifaxan (rifaximin) for travelers' diarrhea, hepatic encephalopathy recurrence prevention, and irritable bowel syndrome with diarrhea (IBS-D). Applies to members subject to plan and state mandates; automated approval based on claims history may be used.

Policy Summary

PayerUnitedHealthcare

PolicyXifaxan (rifaximin) prior authorization/medical necessity

Policy CodePolicy 2025 P 2030-16

Change TypeAnnual review; clinical and administrative updates

Effective DateOct 1, 2025

Next Review Date

Key ActionProviders must obtain prior authorization and document history of failure, contraindication, or intolerance to specified step agents as applicable to the indication.

POLICY UPDATE CHANGES

Annual review July 2025; removed inflammatory bowel disease due to limited data available and updated references.

Program effective date updated to 10/1/2025 and P&T approval dates listed through 7/2025.

3Covered Indications

1m/12m/14dAuth durations (TD/HE/IBS-D)

3IBS-D reauth limit (6 mo)

9-tab one-timeTD automatic approval

Coverage Summary

UnitedHealthcare prior authorization program covers Xifaxan (rifaximin) with criteria for travelers' diarrhea, hepatic encephalopathy recurrence prevention, and irritable bowel syndrome with diarrhea (IBS-D). Coverage and authorization durations are specified per indication (TD: 1 month; HE: 12 months; IBS-D: 14 days). The policy applies to members subject to plan and state mandates, and UnitedHealthcare may use automated approval/re-approval based on claims/medication history, diagnosis codes, and claim logic.

Key coverage facts

Covered indicationsTravelers' diarrhea (≥12 years); hepatic encephalopathy recurrence prevention (adults); IBS‑D

Authorization durationsTD: 1 month; HE: 12 months; IBS‑D: 14 days

IBS‑D reauthorization limitMax 3 treatment courses in prior 6 months

TD automatic approvalOne‑time 9‑tablet dose of Xifaxan 200 mg automatically approved

Effective date2025-10-01

Last review2025-07-01

Policy number2025 P 2030-16

Initial Therapy Criteria

Travelers' Diarrhea — Automatic One‑Time Approval

Billing Rule

TD One-time Dose Automatic Approval

Members utilizing Xifaxan 200 mg for travelers' diarrhea will automatically be approved when prescribed as a one-time dose of 9 tablets. UnitedHealthcare may grant approvals via automated claim/medication history or claim logic per the program's billing rules.

Xifaxan 200 mg one-time dose: 9 tablets (automatic approval)
Approvals may be granted via claim logic / previous claim or medication history per provider_actions.billing_rule

Continuation / Reauthorization Criteria

Authorization Durations

Provider Actions

Prior Authorization

Prior authorization required

Xifaxan requires prior authorization/medical necessity review. Approvals are issued per the program criteria and differ by indication.

Travelers' diarrhea: Authorization issued for 1 month
Hepatic encephalopathy: Authorization issued for 12 months
IBS-D: Authorization issued for 14 days

Documentation Required

Document failure/intolerance/contraindication

Providers must document history of failure, contraindication, or intolerance to the specified step agents as applicable to the indication.

Travelers' diarrhea: antibiotics (e.g., azithromycin, ciprofloxacin, levofloxacin, ofloxacin)

Applicable Codes

Referenced diagnosis codesICD-10

Diagnosis codes (ICD-10) may be used by UnitedHealthcare for automated approval/re-approval; specific ICD-10 codes not listed in policy text

Background & Clinical Evidence

Xifaxan is indicated for travelers' diarrhea in patients aged ≥12 years, for reduction of hepatic encephalopathy recurrence in adults, and for treatment of IBS-D. The program requires trial or documented failure, contraindication, or intolerance to lower-cost or step therapies before approval. For travelers' diarrhea, patients must have tried one of: azithromycin, ciprofloxacin, levofloxacin, or ofloxacin (except a one-time 9-tablet 200 mg dose may be automatically approved). For hepatic encephalopathy, Xifaxan should be used as add-on to lactulose if the patient does not achieve optimal response to lactulose alone, or lactulose is contraindicated/intolerant; consideration of prior Viberzi failure or substance abuse risk is included. For IBS-D, patients must have had failure, contraindication, or intolerance to a tricyclic antidepressant (e.g., amitriptyline).

The program's P&T approval history spans 8/2014 through 7/2025 (annual reviews and updates). Referenced clinical information includes the Xifaxan package insert (October 2023).

Definitions

Automatic approval (TD one-time dose)Applies when Xifaxan 200 mg is prescribed as a single one-time dose of 9 tablets for travelers' diarrhea.

Revision History

2025-07-01clinical_changeLatest

Annual review July 2025: removed inflammatory bowel disease (IBD) indication due to limited data and updated references.

2025-07-01references_updateLatest

Updated references as part of the July 2025 annual review.

2025-10-01administrative_update