Female Sexual Dysfunction (FSD)
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Clinical policy governing diagnostic and therapeutic interventions for female sexual dysfunction, including coverage stance on specific devices, procedures, and drugs; applies to Aetna plans and providers evaluating or requesting coverage for treatments for FSD.
No material clinical or coverage changes in this revision.
Coverage stance and evidence summaries
Covered vs Experimental/Investigational and DME stance
Summary coverage stance and key medical necessity points from this part of the policy:
See specific contraindications and boxed warnings in the background section.
Listed as experimental/investigational due to insufficient evidence.
Coverage may vary by plan.
Evidence summaries and implied coverage stance
Summaries of evidence and regulatory positions for selected FSD interventions in these document chunks:
FDA communications and review of adverse events cited.
Multiple systematic reviews and small studies reported; benefit not consistently proven.
Indicated for acquired generalized HSDD in pre-menopausal women only.
Potential alternative for women who cannot use hormonal therapy.
Evidence promising but limited.
Further high-quality trials needed.
Evidence Summary
Evidence summary relevant to coverage consideration:
Authors conclude data are insufficient and large randomized placebo-controlled trials are needed before standard therapy adoption.
Aetna does not cover vibrators as durable medical equipment because they do not meet the plan’s contractual definition of DME; vibrators are not primarily medical devices and may be of use in the absence of illness or injury. Check applicable benefit plan descriptions for any additional exclusions of drugs or supplies for sexual dysfunction.
The FDA has raised concerns about the use of lasers and other energy-based devices marketed for “vaginal rejuvenation” to treat gynecologic conditions, menopause-related symptoms, urinary incontinence, or sexual function, noting these uses lack adequate evidence and have been associated with serious harms (for example, vaginal burns, scarring, chronic pain).
Use of laser and other energy-based devices for vaginal “rejuvenation” or to treat sexual function or menopause-related gynecologic conditions is discouraged outside FDA‑cleared indications because safety and effectiveness for these indications have not been established.
Systematic reviews and small trials of topical agents such as hyaluronic acid and vaginal suppositories report potential benefit for symptoms (eg, dyspareunia, dryness, mucosal inflammation) in select populations, but study heterogeneity and small sample sizes limit definitive conclusions; authors state larger randomized, placebo‑controlled trials are needed before these interventions can be considered standard therapy.
Several interventions included in this policy (for example, biothesiometry, botulinum toxin, hyaluronic acid, radiofrequency procedures, laser therapy, sacral neuromodulation, stem-cell and regenerative approaches, and various topical or device-based therapies) are classified as experimental and investigational due to insufficient evidence and are therefore not established as covered treatments.
Published studies of radiofrequency procedures (eg, ThermiVa, Viveve) include methodological limitations (small or selective samples, post-hoc analyses, lack of blinding) and investigators note a lack of evidence regarding effectiveness for vaginal rejuvenation, FSD, and other gynecologic disorders.
Procedures using energy-based devices marketed for “vaginal rejuvenation” to treat sexual dysfunction or related gynecologic conditions lack adequate evidence of safety and effectiveness; the FDA has warned clinicians and patients about deceptive marketing and documented adverse events for these off‑label uses.
Although some small studies report symptom improvement with interventions such as hyaluronic acid suppositories, the policy notes there is insufficient evidence to support routine adoption of these therapies and calls for larger randomized, placebo‑controlled trials.
Codes referenced by the policy
| 0552T | Low-level laser therapy, dynamic photonic and dynamic thermokinetic energies, provided by a physician or other qualified health care professional. |
| 0672T | Endovaginal cryogen-cooled, monopolar radiofrequency remodeling of the tissues surrounding the female bladder neck and proximal urethra for urinary incontinence. |
| 17110 | Destruction (eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical curettement), of benign lesions other than skin tags or cutaneous vascular proliferative lesions; up to 14 lesions [micro-ablative carbon dioxide laser]. |
| 17111 | Destruction ... 15 or more lesions [micro-ablative carbon dioxide laser]. |
| 64566 | Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming. |
| 11980 | Subcutaneous hormone pellet implantation (implantation of estradiol and/or testosterone pellets beneath the skin). |
| 96372 | Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular. |
| J0585 | Injection, onabotulinumtoxinA, 1 unit. |
| J0586 | Injection, abobotulinumtoxinA, 5 units. |
| J0587 | Injection, rimabotulinumtoxinB, 100 units. |
| N90.5 | Atrophy of vulva. |
| N94.10 | Dyspareunia. |
| N94.11 | Dyspareunia (other specified). |
| N94.19 | Dyspareunia (other specified). |
| N95.2 | Postmenopausal atrophic vaginitis. |
| F52.0 | Sexual dysfunction not due to a substance or known physiological condition, female. |
| F52.1 | Sexual dysfunction not due to a substance or known physiological condition, female (additional codes range). |
| F52.22 | Sexual dysfunction not due to a substance or known physiological condition, female (range). |
| F52.31 | Sexual dysfunction not due to a substance or known physiological condition, female (range). |
| F52.5 | Sexual dysfunction not due to a substance or known physiological condition, female (range). |
Prior authorization, documentation, and prescribing guidance
Codes identified for review/prior authorization
Codes listed in the coding section may require review and/or prior authorization depending on the plan. Providers should verify billing codes and check plan-specific prior authorization requirements before submitting services.
FDA safety and marketing warning
The FDA has issued public safety statements warning about marketing of laser and other energy‑based devices for “vaginal rejuvenation” without adequate evidence of safety and effectiveness. Providers should be aware that FDA identified reports of burns, scarring, pain, and chronic symptoms and cautioned against off‑label promotional claims.
- FDA safety concern: vaginal burns, scarring, dyspareunia, recurring/chronic pain
- Devices may be cleared for other indications but not for vaginal rejuvenation
FDA warning on energy‑based devices
The FDA specifically cautions that lasers and other energy‑based devices have not been evaluated or confirmed as safe and effective for vaginal rejuvenation or treatment of gynecologic conditions beyond cleared indications. Use of these devices for vaginal rejuvenation is associated with possible serious harm and should be approached with caution; prior authorization is recommended where plan review is required.
- Avoid use of energy‑based vaginal therapies outside FDA‑cleared indications
- Document indication and informed consent if such therapies are considered
Ospemifene prescribing considerations
When prescribing ospemifene (Osphena), document the indication (moderate-to-severe dyspareunia due to vulvovaginal atrophy related to menopause), confirm dosing (60 mg daily with food), and consider uterine status and need for progestin in women with a uterus due to endometrial cancer risk; avoid use in contraindicated conditions.
- Indication: moderate-to-severe dyspareunia due to vulvovaginal atrophy (VVA) from menopause
- Dose: 60 mg orally once daily with food
- Contraindications/precautions: history of estrogen‑dependent neoplasia, abnormal genital bleeding, active or prior thromboembolic disease, severe hepatic impairment
- Consider progestin in women with a uterus; use shortest duration consistent with treatment goals
Trial outcome and safety documentation (ospemifene)
Clinical trials of ospemifene evaluated vaginal maturation index (parabasal and superficial cell percentages), vaginal pH, severity scores for dryness/dyspareunia, FSFI domain and total scores, and safety endpoints including endometrial assessments and laboratory monitoring. Document trial outcomes and safety monitoring when applicable.
- Co‑primary endpoints: maturation index components and vaginal pH; symptom severity (dryness/dyspareunia)
- FSFI improvements observed in trials (domains and total score)
- Safety monitoring included physical exam, Pap test, labs, endometrial thickness/histology
Bremelanotide (Vyleesi) prescribing limits
Bremelanotide (Vyleesi) prescribing limits must be followed: indicated only for pre‑menopausal women with acquired, generalized HSDD; limit dosing to no more than 1 dose in 24 hours and no more than 8 doses per month; discontinue if no benefit after 8 weeks.
- Indication: pre‑menopausal women with acquired, generalized HSDD causing marked distress
- Dosing limits: ≤1 dose per 24 hours; ≤8 doses per 30 days
- Discontinue after 8 weeks without benefit
Administrative documentation and policy history
Document prior authorization decisions, review dates, policy history, and plan‑specific administrative requirements. Providers should refer to the Aetna Clinical Policy Bulletin and the member's benefit plan for plan‑level prior authorization, coverage determinations, and exclusions.
- Effective date: 2001-11-09; Next review: 06/13/2024 (per policy header)
- Check member plan for exclusions of sexual dysfunction drugs or supplies
- Keep records of prior authorization submissions and rationale
Consider conservative therapy first
Conservative therapy should be attempted first in most cases of FSD when appropriate: education, lubricants, behavioral interventions (sensate focus), counseling, psychotherapy, and addressing contributing medical or medication causes are first‑line approaches prior to advanced or procedural therapies.
- First‑line: education, lubricants, topical measures to minimize dyspareunia, sensate focus exercises
- Address reversible contributors: medication review, psychiatric or relationship factors, medical conditions
Therapy sequencing observation
Therapy sequencing observations: across studies hormonal therapies showed the most consistent benefit for FSD symptoms; non‑hormonal and device‑based options often lack high‑quality evidence. Sequence therapies starting with conservative and hormonal options where appropriate, reserving experimental or device‑based interventions for selected cases with documented rationale.
- Hormonal therapies most consistently effective across studies
- Non‑hormonal options (e.g., HA, topical agents) have mixed/limited high‑quality evidence
- Device‑based therapies (lasers, RF) are considered experimental/investigational by Aetna
Step therapy — not specified
Step therapy is not specified in this policy. The policy notes adjunctive options (e.g., hyaluronic acid suppositories, topical agents) and highlights limited evidence for many interventions; follow plan‑specific utilization management for any step therapy requirements.
- No formal step‑therapy algorithm provided in this CPB
- Providers must follow any plan‑level step therapy or prior authorization rules
Clinical background and context
Female sexual dysfunction (FSD) encompasses a range of disorders affecting desire, arousal, orgasm and pain, including vaginal dryness, arousal disorders, dyspareunia (painful intercourse), inability to achieve orgasm, and loss of clitoral sensation. Evaluation should consider the psychosocial context and identify treatable etiologies first, with conservative non‑pharmacologic and standard hormonal therapies generally favored before experimental or device‑based interventions.
Key terms and definitions
Policy dates and document history
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