Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Uterine fibroids
Treatment: Transcervical uterine ablation of leiomyomas (use of ultrasound and heat to remove benign uterine tumors)
The insurer denied coverage for transcervical uterine ablation of leiomyomas (use of ultrasound and heat to remove benign uterine tumors)
The denial is overturned

This case involves an adult patient with a history of uterine fibroids, abnormal Pap (Papanicolaou) smear of the cervix, and polycystic ovarian syndrome who received a denial of coverage for transcervical uterine ablation of leiomyomas using ultrasound and heat to remove benign uterine tumors. The records provided for the review noted that a Magnetic Resonance Imaging (MRI) of the visceral pelvis with and without contrast identified a 10.5 centimeters (cm) x 8.3 cm x 9.2 cm anterior intramural fibroid with a lesion well-circumscribed, although it showed an increased diffusion signal and a marked increase in size from a previous MRI. A leiomyosarcoma was considered unlikely. The physician recommended transcervical uterine ablation to address the fibroid given the size of the fibroid and the patient reports of pressure on the bladder, difficulty urinating, and painful urination. The patient also endorses heavy menstrual cycles. The report noted that the patient also had a prior transvaginal ultrasound showing a myoma 9.3 cm x 11.3 cm x 8.1 cm. This review pertains to transcervical uterine ablation of leiomyomas.

Scientific evidence in peer-reviewed literature supports a result of improvement in health outcome.

Transcervical uterine ablation of leiomyomas (use of ultrasound and heat to remove benign uterine tumors) has final approval from the appropriate regulatory bodies for this diagnosis.

This patient is a good candidate for transcervical uterine ablation of leiomyomas.

Transcervical uterine ablation of leiomyomas is one of the best available treatments for this patient at this time.

The adverse risks are not increased over standard treatment/services.

The requested services are likely to be as or more beneficial than any of the standard treatments/procedures for this patient.

Current literature notes that radiofrequency ablation (RFA) has emerged as a safe and effective treatment option for women with symptomatic uterine fibroids and can be delivered by laparoscopic, transvaginal, or transcervical approaches. The Sonata System enables sonography-guided RFA of uterine fibroids using an incisionless, transcervical approach. The device design consists of a reusable curvilinear intrauterine ultrasound probe and a single-use RFA handpiece that combine into a single unit. While the patient's medical policy indicates that the safety and effectiveness with regard to fertility and fecundity after the use of the Sonata system have not been established, current medical literature has stated otherwise noting that the Sonata system has Food and Drug Administration (FDA) approval for radiofrequency ablation of fibroids. After a review of the provided documentation and in reference to current peer-reviewed medical literature, it was determined that the proposed treatment with transcervical uterine ablation of leiomyomas is safe and effective for the treatment of the patient's condition. The prior determination should be overturned as there is sufficient evidence to justify this treatment method. As such, transcervical uterine ablation of leiomyomas (use of ultrasound and heat to remove benign uterine tumors) is appropriate.

In summary, the denial of transcervical uterine ablation of leiomyomas (use of ultrasound and heat to remove benign uterine tumors) and coverage for the requested treatment should be overturned. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.