Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Uterine Fibroids
Treatment: Radiofrequency Ablation of Symptomatic Uterine Fibroids (0404T)
The insurer denied Radiofrequency Ablation of Symptomatic Uterine Fibroids (0404T).
The denial is upheld.

The patient is an adult female with two known fibroids. She has heavy menses, painful menses, pelvic pressure, and urinary symptoms. She desires preservation of her uterus. The plan is for the Sonata procedure. This is denied as not experimental/investigational (unproven). 

The health plan should not cover the proposed treatment.
According to the American College of Obstetrics and Gynecology, "There are a variety of treatment options for leiomyomas, including expectant, medical, interventional, and surgical therapies." 

The American College of Obstetrics and Gynecology (ACOG) 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." "Currently only magnetic resonance-guided focused ultrasound is FDA (Food and Drug Administration) approved for the treatment of uterine leiomyomas. Limited, low-quality data suggest that magnetic resonance-guided focused ultrasound and high-intensity focused ultrasound are associated with a reduction in leiomyoma and uterine size. However, small randomized comparative trial data suggest that compared with UAE, magnetic resonance-guided focused ultrasound is associated with less improvement in symptoms and quality-of-life measures and a higher risk of reintervention. Additional data are needed before recommendations can be made regarding the use of this treatment for uterine leiomyomas." 

Per Toub et al (2017), "The Sonata System is a promising treatment modality for uterine fibroids. As 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): "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): "To report 2-year results of sonography-guided transcervical fibroid ablation (TFA) using the Sonata system in women with symptomatic uterine fibroids. This is a prospective multicenter single-arm interventional trial. 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): "This 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. This procedure is not endorsed by the American College of Obstetrics and Gynecology. Therefore this is not considered a standard of medical practice at this time. The plan does not cover procedures that are not considered medically necessary. The plan does not cover procedures that are experimental/investigational.
The requested health service or treatment is not more beneficial than any standard treatment for the insured's condition or disease.