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Aetna Aetna
Clinical Policy Bulletin:
Female Sexual Dysfunction (FSD)
Number: 0574


Policy

Aetna considers biothesiometry experimental and investigational for the diagnosis of female sexual dysfunction (FSD).

Aetna considers female erectile devices (e.g., Eros clitoral stimulation device) experimental and investigational for the treatment of FSD and all other indications because there is a lack of data on the clinical value of clitoral stimulation devices in the treatment of FSD and other indications.

Aetna considers mindfulness meditation training for the treatment of FSD experimental and investigational becasue of insufficient evidence of its effectiveness for this indication.

Aetna considers radiofrequency thermal therapy (Viveve procedure) for the treatment of FSD experimental and investigational becasue of insufficient evidence.

Note: Aetna does not cover vibrators, which have been used in the treatment of FSD because vibrators do not meet Aetna’s contractual definition of covered durable medical equipment (DME).  Please check benefit plan descriptions.  Coverage of DME is limited to devices that are not normally of use in the absence of illness or injury.  Vibrators are not primarily a medical device, and may be of use in the absence of illness and injury.



Background

Female sexual dysfunction (FSD) entails many facets in the sexual process in women including vaginal dryness, arousal disorder, painful intercourse, an inability to achieve orgasm, and lack of clitoral sensation.

Despite significant anatomical and embryological parallels between women and men, the multi-faceted nature of FSD clearly is different from that of the man.  Clinicians can not approach female patients or their sexual function problems in the same fashion as in male patients.  The context in which a woman experiences her sexuality is equally if not more important than the physiological outcome she experiences, and these issues should be determined before beginning medical therapy or determining treatment effectiveness.

Biothesiometry is a technique that can be used for evaluating genital neurological function in women.  It entails the use of a small cylindrical instrument employed to evaluate the sensitivity of the clitoris and labia to pressure and temperature.  However, there is insufficient evidnce regarding its clinical use for the diagnosis of FSD.

Erol et al (2003) evaluated genital and extra-genital somatic sensory system in diabetic women using biothesiometry and investigated the relation with sexual dysfunction.  A total of 30 diabetic women and 20 normal sexually active women as a control group were evaluated with a detailed medical and sexual history including Index of Female Sexual Function (IFSF) questionnaire.  Somatic sensory system of all women enrolled to the study was assessed by biothesiometry and threshold sensory values of 9 genital sites and 14 extra-genital sites were analyzed.  The IFSF score in diabetic women was 23.6 while it was 38.3 in the control group (p < 0.0005).  For each genital as well as extra-genital sites, the mean biothesiometric values were significantly higher in diabetics.  The sensation of introitus vagina, labium minora and clitoris were found to be the most deteriorated genital sites in diabetic women.  The difference between diabetic women with or without FSD was not significant for biothesiometric values.  These findings indicate that, somatic sensory system is affected by diabetes however sexual dysfunction does not always manifest.

If a specific etiology for FSD is discovered on history, physical, and laboratory examination, the suspected etiology may be treated.  If no specific etiology for FSD is discovered, basic treatment strategies are applied.  These include educational interventions, enhancement of stimulation and elimination of routine (e.g., use of erotic books or videos, varying positions, use of vibrators, etc.), provision of distraction techniques (e.g., background music, encourage fantasies, etc.), encouragement of non-coital behaviors (e.g., sensate focus exercises, sensual massage), and techniques to minimize dyspareunia (e.g., change in position, topical lidocaine, lubricants, etc.).

Female erectile devices such as the Eros clitoral stimulation device (UroMetrics, Inc., St. Paul, MN) are used to obtain greater clitoral engorgement, which increases lubrication, and enhances the ability to achieve an orgasm.  However, more studies are needed to ascertain the medical necessity and long-term effects of clitoral stimulation devices as compared with established approaches such as lubricants, manual stimulation, and over-the-counter devices.

In a pilot study, Schroder et al (2005) assessed the effectiveness of Eros therapy in alleviating sexual dysfunction in irradiated cervical cancer patients.  A total of 15 women were enrolled and 13 completed the study.  The median patient age and radiotherapy-enrollment interval was 43.5 years and 2 years, respectively.  These investigators concluded that the clitoral stimulation device may alleviate sexual dysfunction in irradiated cervical cancer patients; and a randomized, controlled study is needed to evaluate the full benefits of this approach.

An UpToDate review on “Sexual dysfunction in women: Management” (Shifren, 2014) states that “A clitoral suction vacuum device, EROS-Clitoral Therapy Device, is approved by the US Food and Drug Association (FDA) for female sexual dysfunction.  Its design is similar to vacuum devices used for male erectile dysfunction.  It may improve local arousal and response by improving clitoral blood flow.  The device is expensive and likely no more effective than less costly devices available without a prescription, such as vibrators”.

Silverstein et al (2011) stated that treatments of FSD have been largely unsuccessful because they do not address the psychological factors that underlie female sexuality.  Negative self-evaluative processes interfere with the ability to attend and register physiological changes (interoceptive awareness).  These researchers examined the effect of mindfulness meditation training on interoceptive awareness and the 3 categories of known barriers to healthy sexual functioning: attention, self-judgment, and clinical symptoms.  A total of 44 college students (30 women) participated in either a 12-week course containing a "meditation laboratory" or an active control course with similar content or laboratory format.  Interoceptive awareness was measured by reaction time in rating physiological response to sexual stimuli.  Psychological barriers were assessed with self-reported measures of mindfulness and psychological well-being.  Women who participated in the meditation training became significantly faster at registering their physiological responses (interoceptive awareness) to sexual stimuli compared with active controls (F(1,28) = 5.45, p = 0.03, η(p)(2) = 0.15).  Female meditators also improved their scores on attention (t = 4.42, df = 11, p = 0.001), self-judgment, (t = 3.1, df = 11, p = 0.01), and symptoms of anxiety (t = -3.17, df = 11, p = 0.009) and depression (t = -2.13, df = 11, p < 0.05).  Improvements in interoceptive awareness were correlated with improvements in the psychological barriers to healthy sexual functioning (r = -0.44 for attention, r = -0.42 for self-judgment, and r = 0.49 for anxiety; all p < 0.05).  The authors concluded that mindfulness-based improvements in interoceptive awareness highlight the potential of mindfulness training as a treatment of FSD.

In a pilot study, Millheiser et al (2010) evaluated the safety and tolerability of non-surgical radiofrequency (RF) thermal therapy for treatment of laxity of the vaginal introitus after vaginal delivery.  They also explored the utility of self-report questionnaires in assessing subjective effectiveness of this device.  A total of 24 women (25 to 44 years) once using reverse gradient RF energy (75 to 90 joules/cm(2) ), delivered through the vaginal mucosa were include in this study.  Post-treatment assessments were at 10 days, 1, 3, and 6 months.  Main outcome measures included pelvic examinations and adverse event reports to assess safety.  The author modified Female Sexual Function Index (mv-FSFI) and Female Sexual Distress Scale-Revised (FSDS-R), Vaginal Laxity and Sexual Satisfaction Questionnaires (designed for this study) to evaluate both safety and effectiveness, and the Global Response Assessment to assess treatment responses.  No adverse events were reported; no topical anesthetics were required.  Self-reported vaginal tightness improved in 67 % of subjects at 1 month post-treatment; in 87 % at 6 months (p < 0.001).  Mean sexual function scores improved: mv-FSFI total score before treatment was 27.6 +/- 3.6, increasing to 32.0 +/- 3.0 at 6 months (p < 0.001); FSDS-R score before treatment was 13.6 +/- 8.7, declining to 4.3 +/- 5.0 at month 6 post-treatment (p < 0.001).  Twelve of 24 women who expressed diminished sexual satisfaction following their delivery; all reported sustained improvements on SSQ at 6 months after treatment (p = 0.002).  The authors concluded that the RF treatment was well-tolerated and showed an excellent 6-month safety profile in this pilot study.  Responses to the questionnaires suggested subjective improvement in self-reported vaginal tightness, sexual function and decreased sexual distress.  They stated that these findings warrant further study.

In a review on “Female sexual disorders: Treatment options in the pipeline”, Krychman (2013) noted that Viveve (Sunnyvale, CA) has developed a monopolar RF thermal therapy to improve laxity of the vaginal introitus and sexual satisfaction in women after vaginal deliveries.  In a pilot study in 24 women aged 25 to 44 years, reverse-gradient RF (energy range of 60 joules [n = 3], 75 joules [n = 3], and 90 joules [n = 18]) was delivered through the vaginal mucosa.  No adverse events were reported, and no topical anesthetics were required.  Self-reported vaginal tightness improved in 67 % of patients at 1 month post-treatment and in 87 % at 6 months (p < 0.001).  Mean sexual function scores improved, and FSDS-R score before treatment was 13.6 +/- 8.7, declining to 4.3 +/- 5.0 at month 6 post-treatment (p < 0.001).  The author concluded that this office-based procedure is well-tolerated and has shown excellent preliminary results.  These findings need to be validated by well-designed studies.

In a prospective single-arm study, Sekiguchi and colleagues (2103) reported the long-term effectiveness of a single non-surgical procedure with RF energy for laxity at the vaginal introitus.  A total of 30 pre-menopausal women (age of 21 to 52 years) with one 30-min office procedure using RF applied to the vaginal introitus; 12-month outcome assessments included the linguistic validated Japanese versions of the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) and the Vaginal Laxity and Sexual Satisfaction Questionnaires.  Sexual function improved significantly throughout 6 months (30 subjects); mean FSFI total score was 22.4 ± 6.7 before treatment and then improved to mean 26.0 ± 5.8 at month 6 (p = 0.002), inclusive of improved scores in 5 of 6 FSFI domains except desire (p < 0.001 - <0.01).  In the 22 of 30 subjects remaining evaluable at 12 months, the mean was 26.0 ± 5.2 (p = 0.08).  Distress related to sexual activity decreased significantly; baseline FSDS-R mean score of 15.8 ± 11.7 improved to 9.8 ± 8.0 at 1 month and was sustained throughout 12 months (p <0.001 - 0.002).  Subjects reported decreased vaginal laxity within the 1st month after the procedure (p < 0.001); responses peaked, and effectiveness was sustained through 12 months (p < 0.001).  The authors concluded that a single non-surgical office-based RF procedure for vaginal introital laxity achieved significant and sustainable 12-month effectiveness with respect to improved integrity at the vaginal introitus and improved sexual satisfaction.  Treatment was well-tolerated with no adverse events.  The main drawbacks of this study were the lack of a control group, small sample size and relatively short follow-up.  These preliminary findings need to be validated by well-designed studies.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
There are no specific codes for female erectile devices, biothesiometry, mindfulness meditation training or the Viveve Procedure:
ICD-9 codes not covered for indications listed in the CPB:
302.7 - 302.73 Psychosexual dysfunction, female orgasmic disorder
302.76 - 302.79 Dyspareunia, psychogenic, with other specified psychosexual dysfunctions
629.8 Other specified disorders of female genital organs


The above policy is based on the following references:
  1. Berman JR, Goldstein I. Female sexual dysfunction. Urol Clin North Am. 2001;28(2):405-416.
  2. Goldstein I. Female sexual arousal disorder: New insights. Int J Impot Res. 2000;12(Suppl 4):S152-S157.
  3. Kohn I, Kaplan S. Female sexual dysfunction, what is known and what remains to be determined. Contemporary Urol. 1999;11( 9):54-72.
  4. Phillips NA. Female sexual dysfunction: Evaluation and treatment. Am Fam Physician. 2000;62(1);127-136, 141-142.
  5. Wilson SK, Delk JR 2nd, Billups KL. Treating symptoms of female sexual arousal disorder with the Eros-Clitoral Therapy Device. J Gend Specif Med. 2001;4(2):54-58.
  6. Billups KL. The role of mechanical devices in treating female sexual dysfunction and enhancing the female sexual response. World J Urol. 2002;20(2):137-141.
  7. Billups KL, Berman L, Berman J, et al. A new non-pharmacological vacuum therapy for female sexual dysfunction. J Sex Marital Ther. 2001;27(5):435-441.
  8. Berman LA, Berman JR, Werbin T, et al. The use of the Female Intervention Efficacy Index (FIEI) as an immediate outcome measure of medical intervention to treat female sexual dysfunction. J Sex Marital Ther. 2001;27(5):427-433.
  9. Munarriz R, Maitland S, Garcia SP, et aI. A prospective duplex Doppler ultrasonographic study in women with sexual arousal disorder to objectively assess genital engorgement induced by EROS therapy. J Sex Marital Ther. 2003;29 Suppl 1:85-94.
  10. Schroder M, Mell LK, Hurteau JA, et al. Clitoral therapy device for treatment of sexual dysfunction in irradiated cervical cancer patients. Int J Radiat Oncol Biol Phys. 2005;61(4):1078-1086.
  11. Pauls RN, Kleeman SD, Karram MM. Female sexual dysfunction: Principles of diagnosis and therapy. Obstet Gynecol Surv. 2005;60(3):196-205.
  12. Verit FF, Yeni E, Kafali H. Progress in female sexual dysfunction. Urol Int. 2006;76(1):1-10.
  13. Brotto LA, Bitzer J, Laan E, et al. Women's sexual desire and arousal disorders. J Sex Med. 2010;7(1 Pt 2):586-614.
  14. Al-Azzawi F, Bitzer J, Brandenburg U, et al. Therapeutic options for postmenopausal female sexual dysfunction. Climacteric. 2010;13(2):103-120.
  15. Silverstein RG, Brown AC, Roth HD, Britton WB. Effects of mindfulness training on body awareness to sexual stimuli: Implications for female sexual dysfunction. Psychosom Med. 2011;73(9):817-825.
  16. American College of Obstetricians and Gynecologists (ACOG). Female sexual dysfunction. ACOG Practice Bulletin No. 119. Washington, DC: ACOG; April 2011.
  17. Millheiser LS, Pauls RN, Herbst SJ, Chen BH. Radiofrequency treatment of vaginal laxity after vaginal delivery: Nonsurgical vaginal tightening. J Sex Med. 2010;;7(9):3088-3095.
  18. Krychman ML. Female sexual disorders: Treatment options in the pipeline. Formulary. February 28, 2013. Available at: http://formularyjournal.modernmedicine.com/formulary-journal/news/clinical/clinical-pharmacology/female-sexual-disorders-treatment-options-pipe. Accessed June 3, 2013.
  19. Sekiguchi Y, Utsugisawa Y, Azekosi Y, et al. Laxity of the vaginal introitus after childbirth: Nonsurgical outpatient procedure for vaginal tissue restoration and improved sexual satisfaction using low-energy radiofrequency thermal therapy. J Womens Health (Larchmt). 2013;22(9):775-781.
  20. Shifren JL. Sexual dysfunction in women: Management. UpToDate [serial online]. Waltham, MA; UpToDate; reviewed April 2014.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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