Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Fibroids
Treatment: Radiofrequency Ablation of Uterine Fibroids
The insurer denied: Radiofrequency Ablation of Uterine Fibroids
The denial is upheld.

The patient is an adult female with ongoing abnormal vaginal bleeding with pain. She has a known fibroid uterus and has undergone a hysteroscopic myomectomy in the past and a uterine artery embolization. She had an ultrasound seven months ago revealing multiple fibroids. She also had an MRI (magnetic resonance imaging) confirming fibroids. She desires preservation of her uterus and declines hysterectomy. The request has been for the Sonata procedure.
The request was denied coverage by the health plan as an unproven and not medically necessary procedure. This is being appealed.

The Radiofrequency Ablation of Uterine Fibroids is not medically necessary.

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. Although evidence exists regarding outcomes with specific therapies, comparative effectiveness data are lacking for leiomyoma management options. When considering treatment options, patient-specific symptoms and severity should be addressed. If a patient describes symptoms that are neither 
severe, nor debilitating, expectant management may be appropriate. Medical treatments primarily address bleeding symptoms. Procedural interventions and surgical approaches treat bulk symptoms by decreasing uterine mass."
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. Although RFA [radiofrequency ablation] is a reasonable option to consider for the treatment of symptomatic uterine leiomyomas, access to this technology is currently limited."
ACOG (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 [United States 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 [uterine artery embolization], magnetic resonance-guided focused ultrasound is associated with less improvement in symptoms and quality-of-life measures and a higher risk of reintervention. In a recent meta-analysis, the rate of reintervention at 60 months was 53.9% (percent). Additional data are needed before recommendations can be made regarding the use of this treatment for uterine leiomyomas."
There are not any large randomized controlled trials or large observational tried 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 OB/GYNs (obstetrician/gynecologists) in the United States. Therefore, this is not considered a standard of medical practice at this time and does not follow the definition of medical necessity.