Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Uterine Fibroids
Treatment: Radiofrequency Ablation of Symptomatic Uterine Fibroids (0404T)
The insurer denied Radiofrequency Ablation of Symptomatic Uterine Fibroids (0404T).
The denial is upheld.

The patient is an adult female who consulted her gynecologist with complaints of fibroid uterus and menorrhagia. A pelvic ultrasound revealed two large fibroids of nine centimeters and six centimeters. Transcervical radiofrequency ablation was recommended and planned. The prior denial reason was on the basis of experimental/investigational. The reason for appeal is medical necessity.

The health plan should not cover the proposed treatment.
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 Sonata 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 in 2002. This has prompted the development of Sonata which carries out transcervical ultrasound-guided radiofrequency volumetric thermal ablation of uterine myomas in symptomatic women. The key feature lies in the inherent and immediate proximity of the transducer to the target (fibroid), allowing the use of higher frequencies with significantly increased resolution. Transcervical fibroid ablation (TFA) has certain advantages that might appeal to patients, including a noninvasive delivery method, uterine preservation, ability to treat a wide range of fibroid types, avoidance of general anesthesia, and rapid recovery and return to activities of daily living (ADLs) following the procedure. The procedure is incisionless and preserves the uterus. Unlike operative hysteroscopy, transcervical fibroid ablation is designed for ablation of most non-pedunculated fibroid types. This patient has symptomatic uterine fibroids and transcervical fibroid ablation is recommended. 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. 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". The American College of Obstetrics and Gynecology, in its Practice Bulletin, does not support transcervical radiofrequency ablation as an effective treatment for this condition. Therefore the procedure is considered experimental/investigational.
The requested health service or treatment is not more beneficial than any standard treatment for the insured's condition or disease.