Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Uterine fibroids
Treatment: Acessa procedure
The insurer denied the Acessa procedure.
The denial is upheld. 

The patient is a female with a history of symptomatic uterine fibroids causing menorrhagia and pelvic pressure. She had failed oral contraceptive and non-steroidal anti-inflammatory drug (NSAID) treatments. She consulted her gynecologist and reported a desire for uterine preservation. A pelvic ultrasound performed prior to the visit revealed nine uterine fibroids ranging from two to five centimeters in size. Her gynecologist has recommended radiofrequency volumetric thermal ablation.

No, the proposed Acessa Procedure (58674) is not medically necessary.

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 (UAE). Other treatment options that are not currently considered a standard of care include MRgFUS (magnetic resonance-guided focused ultrasound surgery) and ultrasound-guided ablation. The Acessa device is a new Food and Drug Administration (FDA) 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 was first introduced approximately 20 years ago. 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 radiofrequency volumetric thermal ablation (RFVTA) 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 radiofrequency volumetric thermal ablation (RFVTA) with laparoscopic myomectomy reported that radiofrequency volumetric thermal ablation (RFVTA) resulted in shorter hospital stay and lower blood loss. However, long term data comparing treatment outcomes for symptoms and patient satisfaction were lacking.

There is no clear evidence in the peer reviewed literature supporting this technique as effective in maintaining future fertility and reproductive outcomes. Therefore this treatment has not been thoroughly evaluated for long-term clinical efficacy in a randomized study. It is not considered a standard of care and is therefore considered experimental/investigational. The American Association of Gynecologic Laparoscopists, in its Practice Guidelines, state: "The impact of leiomyoma ablation techniques on submucous leiomyomas and the overlying and nearby endometrium has not been established." "Recommendations for Future Research: Prospectively evaluate of the impact of selective leiomyoma ablation on submucous myomas, the molecular profile of the adjacent endometrium and the related symptoms of abnormal uterine bleeding or infertility".

Although initial data has already indicated that radiofrequency volumetric thermal ablation (RFVTA) is a promising minimally invasive treatment for symptomatic fibroids and adenomyomas, its clinical use still has not been standardized with protocols and uniform patient selection criteria. The treatment of uterine fibroids using radiofrequency volumetric thermal ablation (RFVTA) requires the insertion of coagulator into myometrium under the monitoring of ultrasound imaging; therefore, the operation is more difficult, and the accuracy of the insertion and successful thermal coagulation of various sizes of myomas directly affect its efficacy. Serious complications including organ perforation can occur. In addition, there is no uniform indication for the treatment of uterine fibroids using radiofrequency volumetric thermal ablation (RFVTA), which further limits its application. The excessive differences in the use of radiofrequency volumetric thermal ablation (RFVTA) amongst surgeons, both regarding indications and access, have led to discordant efficacy data with consequent controversy surrounding its application in gynecology. Therefore the service is not medically necessary. The health plan acted reasonably, with sound medical judgment and in the best interest of the patient.

No, the requested therapy is not likely to be more beneficial for the enrollee than any available standard therapy.