CurrentCentenePolicy CP.PMN.196

Clinical Policy: Rifamycin (Aemcolo)

Defines medical necessity criteria, prior authorization requirements, dosing limits, and exclusions for oral rifamycin (Aemcolo) for treatment of travelers' diarrhea and guidance for other/ off-label indications across Centene lines of business (Commercial, HIM/ICHRA, Medicaid).

Policy Summary

PayerCentene

PolicyClinical Policy: Rifamycin (Aemcolo)

Policy CodePolicy CP.PMN.196

Change TypeAdded requirementsline of business update

Effective Date06.01.19

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added requirement that member must use Xifaxan before Aemcolo (2Q 2024 annual review).

Added step therapy bypass for Illinois HIM per IL HB 5395 (added 07.14.25).

Added ICHRA (health insurance marketplace/ICHRA) line of business (2Q 2026 annual review).

2Q 2026 annual review: no significant clinical changes; references reviewed and updated.

1Covered Indication (FDA-approved)

3Maximum treatment duration (days)

≥18Minimum age (years)

≤776 mg/dayMaximum daily dose

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Coverage Summary

Aemcolo (rifamycin) is covered with criteria for treatment of travelers' diarrhea (TD) in adults. Coverage is limited to the FDA‑approved indication and authorized uses in this policy, with prior authorization required and specific criteria to minimize antibacterial resistance and restrict use to supported indications (e.g., age ≥18, prior therapy requirements, and dose ≤ 776 mg/day).

Key limits

Minimum age≥ 18

Maximum daily dose≤ 776 mg/day (4 tablets)

Maximum treatment duration3 days

Initial Therapy Criteria

Initial Approval Criteria

Aemcolo is medically necessary when the following criteria are met:

ALL of the following

Diagnosis of travelers' diarrhea (TD)
Age ≥ 18 years
Azithromycin failure: Failure of azithromycin 1,000 mg as a single dose, unless contraindicated or clinically significant adverse effects are experienced
Step therapy requirement is bypassed for Illinois HIM requests per IL HB 5395 (effective 1/1/2026)
Rifaximin trial: Member must use Xifaxan (rifaximin), unless contraindicated or clinically significant adverse effects are experienced
Added requirement in 2Q 2024 annual review; step therapy bypass for Illinois HIM per IL HB 5395 (1/1/2026)
Dose limit: Dose does not exceed 776 mg (4 tablets) per day

Step Therapy

Step therapy requirements

Step therapy requiring prior failure of azithromycin and use of Xifaxan applies for Aemcolo except that this step therapy requirement does not apply for Illinois HIM requests per IL HB 5395 effective 2026-01-01.

Prior Authorization

Prior authorization required with criteria

Aemcolo requires prior authorization and will be approved only when the initial approval criteria are met (diagnosis of TD, age ≥18, prior azithromycin and Xifaxan use or documented contraindication, dose ≤776 mg/day).

Other Indications / Off‑Label Guidance

Other diagnoses/indications — Initial Approval

If use is not for TD or recent label change not yet reflected, submit per referenced policies:

ANY of the following

Recent label change: If drug has recently (within last 6 months) undergone a label change not yet reflected in this policy, refer to no coverage or non-formulary policy for relevant line of business (listed references)
Other uses: If requested use is not listed under section III and criterion above does not apply, refer to off-label use policy for relevant line of business (listed references)

CDC Yellow Book 2026 and the FDA prescribing information are used as referenced guidance for TD treatment. Requests for off‑label uses or indications not listed in this policy should follow the referenced off‑label use policies for the relevant line of business and provide supporting documentation per policy criteria.

Not Authorized / Exclusions

Not Authorized Diagnoses/Indications

Coverage is not authorized for:

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

Provider Actions

Documentation Required

Support approval criteria

Provider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

Billing Rule

Treatment duration limit

Maximum allowed treatment duration for travelers' diarrhea is 3 days (may not be renewed).

Applicable Codes

NDC / drug productNDC

Delayed-release tablet: 194 mg (Aemcolo) -- specific NDC not provided in policy

Clinical Evidence & References

Evidence references:

• Aemcolo Prescribing Information, Aries Pharmaceuticals, November 2018.

• CDC Yellow Book 2026: Travelers' diarrhea.

Background

Aemcolo is an oral rifamycin that is FDA‑approved for treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. It is not indicated for diarrhea with fever or bloody stool or for infections due to pathogens other than noninvasive E. coli. The policy aligns use with the label to minimize development of drug‑resistant bacteria and restricts coverage to supported indications and dosing limits.

Definitions:

• TD: Travelers' diarrhea

Revision History

2Q 2024 (Date = 01.10.24; P&T Approval Date = 05.24)added

Added requirement that member must use Xifaxan before Aemcolo; references reviewed and updated. (2Q 2024 annual review)

07.14.25added

Added step therapy bypass for Illinois HIM per IL HB 5395 (step therapy requirements do not apply for Illinois HIM requests effective 1/1/2026).

2Q 2026 (Date = 03.26.26; P&T Approval Date = 05.26)addedLatest