Clinical Policy: Rifamycin (Aemcolo)
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Defines medical necessity and prior authorization criteria for Aemcolo (rifamycin) use, primarily for treatment of travelers' diarrhea in adults, and applies to Ambetter Georgia lines of business including Commercial, HIM/ICHRA, and Medicaid.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Approval Criteria — Travelers' Diarrhea
Covered when ALL of the following are met
See Appendix B therapeutic alternatives for dosing.
Step therapy requirement does not apply for Illinois HIM requests per IL HB 5395 effective 1/1/2026.
Dosage regimen for TD: 388 mg PO twice daily for 3 days (maximum 776 mg/day).
Initial Therapy
Initial therapy — covered when ALL of the following are met
Refer to Appendix B for therapeutic alternatives and dosing.
If contraindicated to rifaximin or azithromycin, document rationale.
Approved TD dosing: 388 mg PO BID for 3 days (see dosage and administration).
Continuation Therapy
Continued therapy rules
Review initial approval criteria for new, unrelated TD episodes.
Continuation Therapy — Travelers' Diarrhea
Continued therapy for travelers' diarrhea
Initial approval criteria must be met for any new TD episode unrelated to the original request.
Other Diagnoses/Indications
Other diagnoses / off-label uses
See policy references (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16) in the source policy.
Refer to CP.CPA.09 (commercial), HIM.PA.154 (HIM/ICHRA), or CP.PMN.53 (Medicaid).
Non-FDA approved indications are not authorized unless sufficient documentation of efficacy and safety is provided per off-label use policies.
Non‑FDA approved indications for Aemcolo are not authorized under this policy unless the request includes sufficient documentation of efficacy and safety and is processed according to the applicable off‑label use policy for the member’s line of business. Refer to the referenced off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for HIM/ICHRA, and CP.PMN.53 for Medicaid) or other applicable evidence of coverage documentation when evaluating off‑label requests.
Aemcolo is not indicated for treatment of diarrhea that is complicated by fever and/or bloody stool, or when diarrhea is due to pathogens other than noninvasive strains of Escherichia coli. Such uses fall outside the FDA‑approved indication and are not covered under the criteria in this policy unless specifically addressed via an off‑label authorization per the referenced policies.
Coding
Provider Actions & Requirements
Prior authorization required
Prior authorization is required; Aemcolo (rifamycin) will be considered medically necessary only when the policy's approval criteria for travelers' diarrhea are met.
Step therapy required; IL HIM bypass noted
Step therapy is required: the member must have failed azithromycin 1,000 mg as a single dose and must use Xifaxan (rifaximin) unless contraindicated or clinically significant adverse effects occur. For Illinois HIM requests, the step therapy requirement does not apply per IL HB 5395 effective 1/1/2026.
- Failure of azithromycin 1,000 mg single dose is required prior to Aemcolo.
- Member must use Xifaxan (rifaximin) unless contraindicated.
- IL HIM bypass: step therapy requirement waived effective 1/1/2026 per IL HB 5395.
Submit supporting clinical documentation
Provider must submit supporting clinical documentation (such as office chart notes, laboratory results, or other clinical information) demonstrating the member meets all approval criteria.
- Include documentation of diagnosis, age, prior azithromycin therapy, and any contraindications to alternatives when applicable.
Lack of required documentation may trigger denial
Insufficient or missing documentation that demonstrates all approval criteria (for example diagnosis, age, or prior therapy failure) may result in denial of the request.
- Denial risk includes failure to document prior azithromycin 1,000 mg single-dose therapy or contraindications to alternatives.
Definitions
Background
Aemcolo (generic: rifamycin) is an oral rifamycin antibacterial formulated as delayed‑release tablets. It is FDA‑approved for the treatment of travelers' diarrhea (TD) caused by noninvasive strains of Escherichia coli in adults. The FDA limitation states Aemcolo should not be used for diarrhea complicated by fever and/or bloody stool or caused by pathogens other than noninvasive E. coli, and it should be reserved for infections that are proven or strongly suspected to be bacterial to help limit development of resistance.
Step Therapy
| Step | Requirement | Notes |
|---|---|---|
| 1 | Member must have failed azithromycin 1,000 mg as a single dose (unless contraindicated or clinically significant adverse effects). | Failure of azithromycin is required before Aemcolo for travelers' diarrhea per Initial Approval Criteria. |
| 2 | Member must use Xifaxan (rifaximin) unless contraindicated or clinically significant adverse effects are experienced. | Xifaxan (rifaximin) dosing referenced in Appendix B: 200 mg PO TID for 3 days (600 mg/day). |
| 3 | For Illinois HIM requests, the step therapy requirement does not apply (bypass) effective 1/1/2026 per IL HB 5395. | Policy notes IL HIM bypass for step therapy per IL HB 5395 effective 01/01/2026. |
Quantity Limits
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