Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Uterine myomas
Treatment: Laparoscopic Ablation of Uterine Fibroids
The insurer denied the Laparoscopic Ablation of Uterine Fibroids
The denial is upheld.

The patient is a woman with a diagnosis of uterine myomas, menorrhagia and pelvic pain. She consulted her gynecologist who recommended laparoscopic radiofrequency ablation treatment. The Health Plan has denied coverage on the basis of experimental/investigational.

No, the health plan should not cover the Laparoscopic Ablation of Uterine Fibroids.
The medical records and medical literature were thoroughly reviewed. Options for minimally invasive uterus-sparing alternatives for the treatment of uterine fibroids, within the standard of care include myomectomy and uterine artery embolization. The Acessa device is a new FDA (United States Food and Drug Administration)-approved minimally invasive treatment for uterine fibroids that uses radiofrequency energy to destroy fibroid tissue.

The novel use of radiofrequency ablation under laparoscopic and intra-abdominal ultrasound guidance to treat patients with symptomatic myomas. This has prompted the development of the proposed procedure device (Acessa) which carries out laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of uterine myomas in symptomatic women. The key feature to using laparoscopic ultrasound lies in the inherent and immediate proximity of the transducer to the target (fibroid), allowing the use of higher frequencies with significantly increased resolution. In addition, the versatility and mobility of laparoscopic ultrasound permits direct imaging from multiple directions and angles.

Based on a recent study, radiofrequency volumetric thermal ablation (RFVTA) of uterine myomas safely achieved a high rate of patient satisfaction, a low re-intervention rate, and significant improvements in menstrual blood loss, symptom severity, and quality of life through 12 months of follow-up. A prospective follow-up of patients for 36 months after treatment in a multicenter international trial of outpatient, laparoscopic ultrasound-guided RFVTA (radiofrequency volumetric thermal ablation) of symptomatic uterine myomas has been published. One hundred thirty-five premenopausal women with symptomatic uterine myomas and objectively confirmed heavy menstrual bleeding from uterine myomas resulted in sustained relief from myoma symptoms and continued improvement in health-related quality of life through 36 months after ablation.

A recent, small randomized study comparing RFVTA (radiofrequency volumetric thermal ablation) with laparoscopic myomectomy reported that RFVTA (radiofrequency volumetric thermal ablation) resulted in shorter hospital stay and lower blood loss. A recent parallel, randomized, prospective, single-center, longitudinal, comparative analysis of RFVTA (radiofrequency volumetric thermal ablation) to laparoscopic myomectomy for fibroid treatment in women 18 years of age who desired uterine conservation. Fifty women were randomized intraoperatively to RFVTA (radiofrequency volumetric thermal ablation) or to laparoscopic myomectomy after laparoscopic ultrasound mapping of the uterus. Post-surgery, ablation and myomectomy subjects took pain medications for 4 days (range: 1-46) and 7 days (range: 1-83 days) respectively. Ablation and myomectomy subjects missed 10.0 workdays (range: 2-86 days) and 17.0 workdays (range: 7-30 days), resumed normal activities in 20.5 days (range: 5-103 days) versus 28.0 days (range: 10-42 days) respectively. Mean symptom severity scores decreased (improved) by 7.8 for the ablation subjects and by 17.9 for the myomectomy subjects. Health-related quality of life improved (increased) by 7.5 and 13.1, respectively, for the two groups. It was concluded that early postoperative recovery and twelve-month results attest to similar clinical benefits from RFVTA (radiofrequency volumetric thermal ablation) and laparoscopic myomectomy.

The American College of Obstetrics and Gynecology, in its Practice Bulletin, states, "Laparoscopic radiofrequency ablation can be considered as a minimally invasive treatment option for the management of symptomatic leiomyomas in patients who desire uterine preservation and are counseled about the limited available data on reproductive outcomes."

The patient has a diagnosis of symptomatic fibroids. There is no evidence in the medical records that the patient was seeking uterine conservation and was not counseled on reproductive outcomes following the procedure. Therefore the proposed procedure is not within the standard of care for the proposed indication, and is experimental/investigational.

No, the Laparoscopic Ablation of Uterine Fibroids is not more beneficial.