Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Fibroid Tumors.
Treatment: Transcervical Radiofrequency Ablation.
The insurer denied: Transcervical Radiofrequency Ablation.
The denial is upheld.

The patient is an adult female with abnormal irregular menstrual cycles. She has a history of interstitial cystitis. She has pelvic pressure, urinary frequency and urgency. She also has a history of vulvodynia. The patient had an exam revealing and enlarged uterus 14-16 weeks. Imaging with an ultrasound revealed seven fibroids that are intramural and subserosal. The largest measured 6 by 6 by 8 centimeters. The plan is for the Sonata procedure. This has been denied as not medically necessary and is being appealed.

The proposed treatment is not medically necessary.

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. 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." 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. 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%. Additional data are needed before recommendations can be made regarding the use of this treatment for uterine leiomyomas."

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 and is not medically necessary.