Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Fibroids
Treatment: Sonata System (radiofrequency ablation) Outpatient Procedure (0404T x1)
The insurer denied sonata system outpatient procedure.
The denial is upheld.

The patient is an adult female G4P3 (4 pregnancies, 3 births) with a history of migraines, subclinical hypothyroidism, melanoma, anemia, pulmonary embolism, and fibroid uterus. She has abnormal bleeding. She has had a hysteroscopy and endometrial biopsy 3 years ago. Ultrasound revealed five fibroids with submucosal component. She had blood work, which revealed anemia and low thyroid function. She was counseled about options including Mirena, progestins, depo provera, uterine artery embolization, hysteroscopic myomectomy, and sonata. She elected for the sonata procedure.

The request was denied coverage by the health plan as not medically necessary. This denial is being appealed.

The sonata system (radiofrequency ablation) outpatient procedure (0404T x1) is not medically necessary.

ACOG (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."

ACOG 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 [United States Food and Drug Administration] 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."

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 (transcervical fibroid ablation) treatment with the Sonata system provides significant clinical improvement through 2 years postablation, 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 (Investigational Device Exemption) 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. Therefore, this is not considered a standard of medical practice at this time. This procedure does not meet the definition of medical necessity.