Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Multifibroid uterus
Treatment: Ambulatory surgery - radiofrequency ablation [0404T x (times) 1]
The insurer denied the Ambulatory surgery - radiofrequency ablation [0404Tx1].
The denial is upheld.

The patient is a female with a multifibroid uterus. She has heavy menstrual bleeding, dysmenorrhea, and pelvic pressure. She has had a prior dilation and curettage (D&C). She desires uterine preservation. The plan is for Sonata. This is denied as not medically necessary. This is being appealed.

No, the health plan should not cover the proposed treatment.

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 (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. 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." 


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 (Radiofrequency ablation) is a reasonable option to consider for the treatment of symptomatic uterine leiomyomas, access to this technology is currently limited."

Although there have been studies performed on the Sonata system, studies are still needed that compare this treatment to the standard treatments. 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 is 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 (ACOG), 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. The plan does not cover procedures that are not considered a standard of medical practice.

No, the requested health service or treatment is not more beneficial than any standard treatment for the insured's condition or disease.

Standard alternatives include hystereoscopic myomectomy, laparoscopic myomectomy, and Accessa.