Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Uterine Fibroids

Treatment: removal of uterine fibroid tumors

The insurer denied coverage for removal of uterine fibroid tumors

The denial is overturned

The patient has a history of uterine fibroids and pelvic pain. She consulted her gynecologist and treatment options of uterine artery embolization, hysterectomy, myomectomy and laparoscopic radiofrequency ablation were discussed. The patient chose laparoscopic radiofrequency ablation.  The medical records and medical literature were thoroughly reviewed. The medical records reveal that the patient wishes to leave the option of maintaining fertility "open" and has chosen radiofrequency volumetric thermal ablation (RFVTA). 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 (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 introduced. 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. 

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...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". Therefore, the scientific evidence in the peer-reviewed literature supports a result of improvement in health outcome and has final approval from the appropriate regulatory bodies for this diagnosis. The patient is a good candidate for removal of the fibroids, which is the best treatment for the condition at this time. The adverse risks are not increased over standard treatment/services. This procedure is likely to be more beneficial than any standard treatments/procedures.

The carrier's denial of removal of uterine fibroid tumors should be overturned.