Diagnosis: Uterine Fibroids.
Treatment: Radiofrequency ablation.
The insurer denied radiofrequency ablation.
The health plan's determination is upheld.

The patient is a female. The patient was seen in the office regarding bladder pressure. The patient noted heavy menstrual bleeding as well as a history of a fibroid measuring 9.3 centimeters (cm) in the largest dimension on ultrasound. Her past medical history is also remarkable for degenerative spine arthritis, a history of cataracts, latent tuberculosis, obesity, PCOS (polycystic ovary syndrome), and psoriasis. The plan is for magnetic resonance imaging (MRI) of the pelvis and the patient was educated regarding transcervical radiofrequency ablation.

No data is demonstrating that the requested radiofrequency ablation is likely to be more beneficial than the standard of care options.
This technology, while FDA-approved, has not been evaluated in prospective, comparative clinical trials. There are single-arm trials (which are essentially case series) demonstrating the technology to be tolerable and to have myoma volume reductions, and even improve symptoms. There is also cost data comparing it to other standard-of-care options. However, no trial data is comparing this technology to standard-of-care options such as medications or other conservative procedural options, such as uterine artery embolization or myomectomy.
For transcervical radiofrequency ablation of fibroids, there is simply no comparative data upon which to conclude that it is comparable to the standard of care options. A key passage from the pivotal trial data is this: "However, randomized controlled trials, as well as comparative studies, are still lacking. Randomized controlled trials comparing the Sonata System with the already established treatment methods could help to define the future value of the Sonata System as a therapy alternative for uterine myomas." It is noted that in the latest update of the American College of Obstetricians and Gynecologists (ACOG) guidelines regarding symptomatically fibroids, radiofrequency ablation, in general, is noted to be an option. However, the guidelines go on to discuss how laparoscopically-guided ablation has the most data and does not mention transcervical delivery as a reasonable option. Additionally, this patient's childbearing desires are not addressed in the progress note, which is a key counseling point for this technology per ACOG guidelines.