DESCRIPTION
Vulvovaginal atrophy, also known as vaginal atrophy, atrophic vaginitis, and/or urogenital atrophy, is a condition that causes the vagina and tissue near the vagina to become dry, thin and inflamed. Vaginal atrophy is often caused by lack of a woman’s ability to produce estrogen due to any of the following:
Menopause, perimenopause
Radiation treatments for ovarian cancer
Certain medications such as Tamoxifen or prolonged use of birth control
Vaginal dryness and/or atrophy stemming from prolonged breast feeding
Fractional carbon dioxide (CO2) lasers (e.g., MonaLisa Touch®, CO2RE Intima) are traditionally used to treat skin wrinkles or acne scarring and are being marketed as a non-surgical treatment for vulvovaginal atrophy. The safety and effectiveness of this procedure has not been documented. This micro-ablative procedure is performed in the physician’s office with local anesthetic.
POLICY
Fractional laser or fractional carbon dioxide (CO2) laser treatment(s) for vulvovaginal atrophy is considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
The safety and effectiveness of energy-based medical devices for the treatment of vulvovaginal atrophy has not been established.
SOURCES
Alexiades, M.R. (2021). Fractional Co2 laser treatment of the vulva and vagina and the effect of postmenopausal duration on efficacy. Lasers In Surgery and Medicine, 53 (2), 185-198. (Level 4 evidence)
American College of Obstetricians and Gynecologists. (2020). Committee opinion (#795).Elective female genital cosmetic surgery. Retrieved April 15, 2021 from https://www.acog.org.
American College of Obstetricians and Gynecologists. (2021). Clinical Consensus (#2). Treatment of urogenital symptoms in individuals with a history of estrogen-dependent breast cancer. Retrieved May 12, 2023 from https://www.acog.org.
Arroyo, C. (2017). Fractional CO2 laser treatment for vulvovaginal atrophy symptoms and vaginal rejuvenation in perimenopausal women. International Journal of Women’s Health, (9), 591-595. (Level 4 evidence)
Behnia-Willison, F., Sarraf, S., Miller, J., Mohamadi, B., Care, A., Lam, A., et al. (2017). Safety and long-term efficacy of fractional CO2 laser treatment in women suffering from genitourinary syndrome of menopause. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 213, 39-44. Abstract retrieved September 26, 2018 from PubMed database.
Gittens, P., & Mullen, G. (2019). The effects of fractional microablative CO2 laser therapy on sexual function in postmenopausal women and women with a history of breast cancer treated with endocrine therapy. Journal of Cosmetic and Laser Therapy, 21 (3), 127-131. Abstract retrieved September 16, 2019 from PubMed database.
Li, F., Maheux-Lacroix, S., Deans, R., Nesbitt-Hawes, E., Budden, A., Nguyen, K., et al. (2021). Effect of fractional carbon dioxide laser vs sham treatment on symptom severity in women with postmenopausal vaginal symptoms: A randomized clinical trial. JAMA, 326 (14), 1381–1389. (Level 2 evidence)
Pearson, A., Booker, A., Tio, M., & Marx, G. (2019). Vaginal CO 2 laser for the treatment of vulvovaginal atrophy in women with breast cancer: LAAVA pilot study. Breast Cancer Research and Treatment, 178 (1), 135-140. Abstract retrieved July 22, 2020 from PubMed database.
Perino, A., Calligaro, A., Forlani, F., Tiberio, C., Cucinella, G., Svelato, A., et al. (2015). Vulvo-vaginal atrophy: a new treatment modality using thermo-ablative fractional CO2 laser. Maturitas, 80 (3), 296-301. Abstract retrieved August 26, 2016 from PubMed database.
Salvatore. S., Nappi, R., Zerbinati, N., Calligaro, A., Ferrero, S., Origoni. M., et al. (2014). A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric, 17 (4), 363-369. Abstract retrieved August 26, 2016 from PubMed database.
Sokol, E.R. & Karram, M.M. (2016). An assessment of the safety and efficacy of a fractional CO2 laser system for the treatment of vulvovaginal atrophy. Menopause, 23 (10), 1102-1107. Abstract retrieved September 26, 2018 from PubMed database.
ORIGINAL EFFECTIVE DATE: 1/14/2017
MOST RECENT REVIEW DATE: 7/13/2023
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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