Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Uterine fibroid tumors (bleeding and anemia)
Treatment: Transcervical Ablation Of Uterine Fibroids Using Ultrasound, Radiofrequency Using Sonata System, Pre-service
The insurer denied the Transcervical Ablation Of Uterine Fibroids Using Ultrasound, Radiofrequency Using Sonata System, Pre-service.
The denial is upheld. 

No, the transcervical ablation of uterine fibroids using ultrasound, radiofrequency, is not "medically necessary".

The patient is a woman with a history of uterine fibroids, menorraghia and anemia. She consulted her gynecologist requesting management of the fibroids with fertility preservation. Her gynecologist has recommended a Sonata procedure. 

Radiofrequency volumetric thermal ablation (RFVTA) is a nonexcisional uterine-sparing procedure that can be done either under laparoscopic guidance or using a transvaginal approach. The laparoscopic-guided procedure was FDA approved in the United States in 2012, whereas transvaginal approaches are under investigation. 
Radiofrequency energy is delivered to the myoma via a handpiece with a deployable electrode array. The laparoscopic approach includes identifying myomas with a laparoscopic ultrasound probe and ablating the myomas, under ultrasound guidance, with real-time thermal feedback. Symptom relief as demonstrated by a high decrease in symptom severity, and increase in quality of life scores are maintained out to 3 years. One randomized trial compared RFVTA with laparoscopic myomectomy and found that although treatment time was similar, women who underwent RFVTA had a higher proportion of myomas treated (98.6% vs 80.3%), less intraoperative blood loss, and shorter hospital stays. Overall reintervention rate at 3 years has been estimated at 11% in the initial trials. At this time no prospective studies have been published investigating fertility and pregnancy outcomes after RFVTA of myomas. However, there are case series of pregnancies after RFVTA treatment. There are a total of 20 reported cases. Seven were undesired pregnancies and thus underwent elective termination. Of the remaining 13, there was 1 spontaneous abortion and 12 full-term live births. Nine of the 12 pregnancies were delivered by cesarean section (75%). Cases reported by Bing-Song et al and Berman et al were RFVTA performed laparoscopically, whereas cases reported by Kim et al and Garza-Leal et al were transvaginal RFVTA procedures. Of the pregnancies reported after RFVTA, Berman et al described the size and location of the treated myomas. The cases reported show the ablation of myomas ranging from .9 cm to 7.6 cm and include single and multiple myomas located submucosally, intramurally, transmurally, and subserosally. Berman et al's series of patients had no reported uterine windows, abnormal placentation, uterine rupture, scarring, or uterine thinning. The one complication reported was in a 40-year-old woman, gravida 3 para 3, at 37 weeks' gestation who delivered a 2923-g baby by cesarean section. She previously had RFVTA of one fundal transmural myoma measuring 4.7 cm. Her delivery was complicated by expulsion of a degenerated myoma and a delayed postpartum hemorrhage of 1500 mL for which she received 6 units of blood. The concerns regarding pregnancy after myoma ablation are the effects of coagulative necrosis on the uterus. During myoma ablation, the integrity of the surrounding myometrium may be compromised. These techniques attempt to reduce uterine damage by directing the ablation to the myoma tissue only; however, there still may be an effect on the surrounding myometrium. Additionally, as opposed to myomectomy, the ablated myomas remain in the myometrium. The impact of this has on pregnancy and normal uterine physiology needs to be fully investigated. These changes may affect implantation, placentation, and uterine contractility during labor, thus increasing the risks of miscarriage, placenta accreta, placenta previa, uterine rupture, and postpartum hemorrhage. In the literature review we found complications related to uterine myomas that remained in situ that may have been avoided if the patient had a myomectomy instead. Additionally, it is unknown how the size and location of the treated myoma would affect reproductive outcomes. Another unknown is how myoma ablation affects one's ability to conceive. It is unknown how much myomas independently contribute to one's infertility. Although someone with infertility may be found to have myomas, the underlying cause of infertility may not be due to the patient's uterine myomas. Therefore, it is difficult to draw conclusions regarding the effects of myoma ablation on fertility outcomes without larger comparative trials. Therefore there is a need for a randomized control trial investigating fertility and pregnancy outcomes in all uterine-sparing myoma treatments, including transcervical RFVTA). Therefore the proposed treatment is not medically necessary. The health plan acted reasonably, with sound medical judgment and in the best interest of the patient.