Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Uterine Fibroids
Treatment: Surgery (ablation with imaging guidance (0404T)
The insurer denied the Surgery (ablation with imaging guidance (0404T).
The denial is overturned. 

The patient is a female with a history of symptomatic uterine fibroids and anemia. According to the physician progress notes, there are two intramural fibroids on pelvic ultrasound imaging. According to the ultrasound report, there are two intramural fibroids with submucosal components and one submucosal fibroid seen. A sonohysterogram reported no submucosal components.

Transcervical radiofrequency fibroid ablation has been recommended by the patient's gynecologist. Mirena placement, uterine artery embolization, myomectomy and hysterectomy were also discussed. The patient has selected transcervical radiofrequency ablation.

Yes, the health plan should cover the requested health service.

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 (United State 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 was first introduced nearly two decades 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.

The patient has symptomatic uterine fibroids, and TFA (transcervical fibroid ablation) was 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."

Therefore, given the above, the procedure meets the standard of care, and it is medically appropriate. Therefore, the health plan should cover the requested health service.