Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Fibroids. 
Treatment: Sonata system - radiofrequency ablation (to remove growths) - outpatient procedure (0404T x 1). 

The insurer denied: Sonata system - radiofrequency ablation (to remove growths) - outpatient procedure (0404T x 1). 
The denial is Upheld. 

The patient is an adult female with pelvic pressure, pain, and abnormal bleeding in the setting of a known fibroid uterus. Her largest fibroid is 3.7 centimeters (cm). She has had a prior myomectomy. The plan is for the Sonata procedure. This has been denied as investigational/experimental. This is being appealed. 

The health plan should not cover the proposed treatment. 

According to the American College of Obstetrics and Gynecology (ACOG), "There are a variety of treatment options for leiomyomas, including expectant, medical, interventional, and surgical therapies. Although evidence exists regarding outcomes with specific therapies, comparative effectiveness data are lacking for leiomyoma management options. 

The American College of Obstetrics and Gynecology reports that "Radiofrequency ablation (RFA) can be delivered by a laparoscopic, transvaginal, or transcervical approach, using ultrasound guidance to induce coagulative necrosis in targeted uterine leiomyomas. All of the approaches are similarly effective in reducing uterine leiomyoma volume and in improving quality of life metrics, but the laparoscopic approach has been studied the most rigorously. Although RFA is a reasonable option to consider for the treatment of symptomatic uterine leiomyomas, access to this technology is currently limited." The American College of Obstetrics and Gynecology states that "Focused ultrasound surgery, guided by diagnostic ultrasound or magnetic resonance, is a noninvasive treatment modality that uses multiple high-intensity ultrasound waves to cause coagulative necrosis of uterine leiomyomas. Currently only magnetic resonance-guided focused ultrasound is Food and Drug Administration (FDA) approved for the treatment of uterine leiomyomas. 

Per Toub et al (2017): "This article provides the current evidence related to transcervical radiofrequency ablation of uterine fibroids under integrated intrauterine sonography guidance (the Sonata System). A clinical trial under an FDA Investigational Device Exemption is in progress. The Sonata System is a promising treatment modality for uterine fibroids is an incisionless, minimally invasive treatment that does not require general anesthesia or hospitalization, it has the potential for redefining the current paradigm for management of symptomatic fibroids." 

Per Garza-Leal et al (2019): "Objective: The aim of this research was to learn the long-term (> [greater than] 5 years) clinical outcomes of transcervical radiofrequency ablation of uterine fibroids. Conclusions: Transcervical radiofrequency ablation with the Sonata System produced substantial durable clinical benefits beyond 5 years with a low reintervention rate." 

Per Miller et al (2019): "Objective: To report 2-year results of sonography-guided transcervical fibroid ablation (TFA) using the Sonata system in women with symptomatic uterine fibroids. 

Conclusions: TFA treatment with the Sonata system provides significant clinical improvement through 2 years postablation, with a low incidence of surgical reintervention. " 

Per Hudgens et al (2019): "The analysis of US patients in the SONATA pivotal IDE trial demonstrates results consistent with those in the full cohort. TFA with Sonata significantly reduced fibroid symptoms with a low surgical reintervention rate through 12 months. These results support the efficacy and safety of the Sonata system as a first-line treatment for women affected by symptomatic uterine fibroids." 
In summary, there are not any large randomized controlled trials or large observational trials that provide evidence that this procedure is better than the alternative options. There are also no data to support use of this procedure as being effective and safe long term in patients with symptomatic uterine myomas as compared to other alternatives. This procedure is also not endorsed by the American College of Obstetrics and Gynecology who provides the guidelines for obstetricians and gynecologists (OB/GYNs) in the United States. Therefore, this is not considered a standard of medical practice at this time. The plan does not cover procedures that are considered experimental, investigational or unproven.