DESCRIPTION
Uterine fibroids (i.e., uterine leiomyomas or uterine myomas) are one of the most common conditions affecting women in their reproductive years. Symptoms include heavy or prolonged menstrual bleeding, pelvic pressure or pain, urinary frequency, and reproductive dysfunction. Surgery, including hysterectomy and various myomectomy procedures, is considered the standard treatment. Because of the potential for surgical complications such as pelvic adhesions, and loss of the uterus with hysterectomy, minimally invasive laparoscopic, percutaneous and transcervical percutaneous techniques to induce myolysis (shrink or degenerate the tissue) have been proposed. These procedures include radiofrequency volumetric thermal ablation (e.g., Acessa™, Sonata®), laser and bipolar needles, cryomyolysis, and magnetic resonance imaging-guided laser ablation.
POLICY
Laparoscopic or transcervical radiofrequency ablation (RFA) may be considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Other laparoscopic, transcervical, or percutaneous techniques for myolysis of uterine fibroids, including use of laser or bipolar needles, cryomyolysis, and magnetic resonance imaging-guided laser ablation, is considered investigational.
MEDICAL APPROPRIATENESS
Laparoscopic or transcervical radiofrequency ablation (RFA) (i.e., Acessa™ system, Sonata System®) for the treatment of uterine fibroids is considered medically appropriate when ALL of the following are met:
Evidence of uterine fibroids documented by imaging study (e.g., ultrasound or hysteroscopy) and ANY ONE of the following:
Fibroid is less than 10 cm in diameter for laparoscopic radiofrequency ablation with Acessa
Fibroid is less than 7 cm in diameter for transcervical radiofrequency ablation with Sonata
Documentation of ANY ONE of the following:
Uterine conservation is desired
Individual is ineligible for hysterectomy or other uterine-sparing alternatives (e.g., myomectomy, uterine artery embolization)
Symptoms directly related to uterine fibroids as indicated by ANY ONE of the following:
Abnormal uterine bleeding not controlled by conservative treatment (e.g., hormonal therapy)
Bowel dysfunction (e.g., constipation, bloating)
Dyspareunia (painful intercourse)
Infertility
Iron deficiency anemia
Pelvic pain or pressure
Urinary dysfunction (e.g., urinary frequency, urgency)
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.
SOURCES
American College of Obstetricians and Gynecologists. (2021, June). Management of symptomatic uterine leiomyomas. ACOG Practice Bulletin Number 228. Retrieved July 6, 2021 from www.acog.org.
Arnreiter, C., & Oppelt, P. (2021). A systematic review of the treatment of uterine myomas using transcervical ultrasound-guided radiofrequency ablation with the sonata system. Journal of Minimally Invasive Gynecology, 28 (8), 1462–1469. Abstract retrieved September 19, 2023 from PubMed database.
BlueCross BlueShield Association. Evidence Positioning System. (2023, March). Laparoscopic and percutaneous techniques for the myolysis of uterine fibroids (4.01.19). Retrieved September 15, 2023 from http://www.evidencepositioningsystem.com. (39 articles and/or guidelines reviewed)
Bradley, L.D., Pasic, R.P., & Miller, L.E. (2019). Clinical performance of radiofrequency ablation for treatment of uterine fibroids: systematic review and meta-analysis of prospective studies.Journal of Laparoendoscopic & Advanced Surgical Techniques. Part A, 29 (12), 1507-1517. (Level 2 evidence)
Brucker, S., Hahn, M., Kraemer, D., Taran, F., Isaacson, K. & Krämer, B. (2014). Laparoscopic radiofrequency volumetric thermal ablation of fibroids versus laparoscopic myomectomy. International Journal of Gynecology and Obstetrics, 125 (2014), 261–265. (Level 2 evidence)
Hahn, M., Brucker, S., Kraemer, D., Wallwiener, M., Taran, F., Wallwiener, C., et al. (2015). Radiofrequency volumetric thermal ablation of fibroids and laparoscopic myomectomy: long-term follow-up from a randomized trial. Geburtshilfe Frauenheilkd, 75 (5), 442-449. (Level 2 evidence)
Havryliuk, Y., Setton, R., Carlow, J., & Shaktman, B. (2017). Symptomatic fibroid management: systematic review of the literature. Journal of the Society of Laparoendoscopic Surgeons, 21 (3), DOI: 10.4293/JSLS.2017.00041. (Level 2 evidence)
Hudgens, J., Johns, D.A., Lukes, A.S., Forstein, D.A., & Delvadia, D. (2019). 12-month outcomes of the US patient cohort in the SONATA pivotal IDE trial of transcervical ablation of uterine fibroids. International Journal of Women’s Health, 11, 387-394.(Level 4 evidence)
Lin, L., Ma, H., Wang, J., Quality of life, adverse events, and reintervention outcomes after laparoscopic radiofrequency ablation for symptomatic uterine fibroids: a meta-analysis Guan, H., Yang, M., Tong, X., & Zou, Y. (2019). Journal of Minimally Invasive Gynecology, 26 (3), 409-416. Abstract retrieved November 7, 2019 from PubMed database.
Lukes, A & Green, M.A. (2020). Three-year results of the SONATA pivotal trial of transcervical fibroid ablation for symptomatic uterine myomata. Journal of Gynecologic Surgery, DOI: 10.1089/gyn.2020.0021. (Level 3 evidence)
Miller, C.E & Osman, K.M. (2019). Transcervical radiofrequency ablation of symptomatic uterine fibroids: 2-year results of the SONATA pivotal trial. Journal of Gynecologic Surgery, 35 (6): 345-349. (Level 3 evidence)
National Institute for Health and Care Excellence (NICE). (2021, March). Transcervical ultrasound-guided radiofrequency ablation for symptomatic uterine fibroids. Retrieved June 15, 2022 from http://www.nice.org.uk.
Sandberg, E.M., Tummers, F.H.M.P., Cohen, S.L., van den Haak, L, Dekkers, OM., & Jansen, F.W. (2018). Reintervention risk and quality of life outcomes after uterine-sparing interventions for fibroids: a systematic review and meta-analysis. Fertility & Sterility, 109 (4), 698-707. (Level 1 evidence)
U. S. Food and Drug Administration. (2012, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K121858 (Acessa Guidance). Retrieved July 29, 2013 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2018, July). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K173703 (Sonata Guidance). Retrieved December 18, 2020 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Health Technology Assessment. (2020, September; last update search June 2023). Transcervical radiofrequency ablation with the sonata system for symptomatic uterine fibroids. Retrieved September 15, 2023 from www.Hayesinc.com/subscribers. (24 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Health Technology Brief. (2019, December; last update search February 2023). Laparoscopic radiofrequency volumetric thermal ablation (Acessa system; Halt Medical inc.) for treatment of uterine fibroids. Retrieved September 15, 2023 from www.Hayesinc.com/subscribers. (37 articles and/or guidelines reviewed)
Zhang, J., Go, V. A., Blanck, J. F., & Singh, B. (2022). A systematic review of minimally invasive treatments for uterine fibroid-related bleeding. Reproductive Sciences, 29 (10), 2786–2809. Abstract retrieved September 19, 2023 from PubMed database.
ORIGINAL EFFECTIVE DATE: 1/11/2014
MOST RECENT REVIEW DATE: 11/9/2023
ID_BA
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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