Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Fibroids.
Treatment: Radiofrequency Ablation (0404Tx1).

The insurer denied: Radiofrequency Ablation (0404Tx1).  The denial is upheld.

The patient is an adult female with a 12.5 by 10.4 by 10.3-centimeter (cm) uterus with 36 fibroids. She has pelvic pressure, heavy menses, painful intercourse, backache, urinary frequency, and painful menses. The information provided does not report that she has tried any medications.

The health plan should not cover the proposed treatment.

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 FDA 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."

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 a Food and Drug Administration (FDA) Investigational Device Exemption is in progress. 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): "TFA treatment with the Sonata system provides significant clinical improvement through 2 years post ablation, with a low incidence of surgical reintervention. Other favorable outcomes included a rapid return to work and
substantial improvements in quality of life, symptom severity, work productivity, and activity levels."

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."

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 also not endorsed by the American College of Obstetrics and Gynecology who provides the guidelines for obstetricians/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 not considered medically necessary. 

There are not any large randomized controlled trials or large observational trials that provide evidence that this procedure is better than the alternative options.