Phexxi / Phexx (lactic acid, citric acid, potassium bitartrate) vaginal gel — Prior Authorization Medical Necessity Criteria
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Prior authorization medical necessity criteria for coverage of Phexxi/Phexx vaginal gel as an on‑demand contraceptive for females of reproductive potential; affects providers seeking coverage for this medication under UnitedHealthcare clinical pharmacy programs.
Added the product Phexx to the criteria.
Coverage Criteria
Initial Therapy — Covered when ALL of the following are met:
Covered when ALL of the following are met:
Authorization issued for 12 months.
Phexxi/Phexx is not effective for prevention of pregnancy when administered after intercourse. This limitation should be documented in the patient record and considered when assessing clinical appropriateness for use.
Initial Therapy
Initial Therapy — Initial authorization requirements
Initial authorization requirements
Authorization issued for 12 months. State mandates, federal requirements, and member benefit plan coverage may affect coverage.
Continuation and Re-authorization
Continuation Therapy — Re-authorization/continuation criteria
Re-authorization/continuation
Automated approval processes may vary by program/therapeutic class.
Provider Actions and Requirements
Prior authorization required; 12‑month approval when criteria met
Prior authorization is required for Phexxi/Phexx. Approval is issued when the medication is used for prevention of pregnancy and all criteria are met; authorization will be issued for 12 months.
Requirement to demonstrate inability to use other contraceptive methods
Not a formal step‑therapy medication, but the request must document inability to use other contraceptive methods due to failure, contraindication, intolerance, or refusal — examples listed include injection, oral contraceptive, transdermal patch, vaginal ring, diaphragm, sponge, cervical cap, and female condom. A history of failure/contraindication/intolerance to nonoxynol‑9 spermicide is also required.
- Examples of other methods that must be unable to be used: injection (Depo‑Provera), oral contraceptives (e.g., norethindrone, Yaz), transdermal patch (Twirla, Xulane), vaginal ring (Annovera, NuvaRing), diaphragm, sponge (Today), cervical cap (FemCap), female condom
- Prior history of failure/contraindication/intolerance to nonoxynol‑9 spermicide is required
Provider attestation and documentation of counseling and inability to use other methods
Provider must attest in the medical record that they have counseled the patient that other contraceptive methods provide a higher rate of pregnancy prevention compared to Phexxi/Phexx. Documentation should also support inability to use other methods (failure, contraindication, intolerance, or refusal).
- Attestation that counseling occurred regarding higher effectiveness of other methods (e.g., injection, oral contraception, transdermal patch, vaginal ring)
- Documentation of failure, contraindication, intolerance, or patient refusal for other listed contraceptive methods
Denial likely when indication, documentation, or required attestation are missing
Requests may be denied if the medication is not being requested for prevention of pregnancy, if there is no documentation that the member is unable to use other contraceptive methods (no documented failure/contraindication/intolerance/refusal), or if there is no history of failure/contraindication/intolerance to nonoxynol‑9 spermicide or missing provider attestation of counseling.
- Denial risk if indication is not prevention of pregnancy
- Denial risk if documentation does not show failure/contraindication/intolerance/refusal of other methods
- Denial risk if no documented history of failure/contraindication/intolerance to nonoxynol‑9 spermicide
- Denial risk if provider attestation of counseling is not present
Step Therapy / Alternative Method Requirement
| Step | Requirement | Notes |
|---|---|---|
| 1 | Must document inability to use other listed contraceptive methods due to failure, contraindication, intolerance, or refusal | Examples to document include: injection (e.g., Depo‑Provera); oral contraceptive (e.g., norethindrone, Yaz); transdermal patch (e.g., Twirla, Xulane); vaginal ring (e.g., Annovera, NuvaRing); diaphragm; sponge (e.g., Today); cervical cap (e.g., FemCap); female condom |
| 1a | History of failure, contraindication, or intolerance to nonoxynol‑9 based spermicide must be documented | This is required in addition to inability to use other contraceptive methods |
| 1b | Provider must attest that they counseled the patient regarding higher pregnancy prevention rates with other contraceptive methods compared to Phexxi/Phexx | Examples of methods to counsel about include injection, oral contraception, transdermal patch, and vaginal ring |
Definitions
Background
Phexxi/Phexx is a vaginal gel formulation containing lactic acid, citric acid, and potassium bitartrate that is indicated as an on‑demand contraceptive for the prevention of pregnancy in females of reproductive potential. It is intended for use immediately before intercourse and is an alternative option when other contraceptive methods cannot be used.
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