Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Abnormal uterine bleeding (AUB).
Treatment: Outpatient procedure 0404T, ablation of uterine fibroids.
The insurer denied coverage for outpatient procedure 0404T, ablation of uterine fibroids.
The denial is overturned.

The patient in this case is a female who has been diagnosed with a uterine fibroid that is causing excessive vaginal bleeding. She has been anemic, necessitating two blood transfusions. A trial of Aygestin was unsuccessful. An office hysteroscopy confirmed the presence of a 3 centimeters (cm) submucous fibroid. An endometrial biopsy showed benign endometrial tissue that was thickened, presumably due to progestin effect. 
The patient's treating provider is recommending a radiofrequency ablation of the fibroid. This has been denied on the basis of plan language, which considers this procedure to be experimental/investigational. 

"Laparoscopic, ultrasound-guided radiofrequency ablation (RFA) is a new, FDA (food and drug administration)-cleared uterine sparing, outpatient procedure for uterine fibroids. The procedure utilizes recent technological advancements in instrumentation and imaging, allowing surgeons to treat numerous fibroids of varying size and location in a minimally invasive fashion. Early and mid-term data from multi-center clinical trials have demonstrated safety and efficacy, with resolution or improvement of symptoms and significant volume reduction. Re-intervention rates for fibroid symptoms have been low. The procedure is well tolerated with a typically uneventful and rapid recovery requiring NSAIDs (non-steroidal anti-inflammatory drugs) only for postoperative pain" (Lee, B. B., & Yu, S. P. 2016).

"The use of thermal energy-based systems to treat uterine fibroids has resulted in a plethora of devices that are less invasive and potentially as effective in reducing symptoms as traditional options such as myomectomy. Most thermal ablation devices involve hyperthermia (heating of tissue), which entails the conversion of an external electromagnetic or ultrasound waves into intracellular mechanical energy, generating heat. What has emerged from two decades of peer-reviewed research is the concept that hyperthermic fibroid ablation, regardless of the thermal energy source, can create large areas of necrosis within fibroids resulting in reductions in fibroid volume, associated symptoms and the need for reintervention. When a greater percentage of a fibroid's volume is ablated, symptomatic relief is more pronounced, quality of life increases, and it is more likely that such improvements will be durable" (Jones, S. et al. 2012).

"RF can be applied for the majority of fibroids. As a noninvasive therapy, HIFU (high intensity focused ultrasound) could be the preferred method for the treatment of small, hypovascular fibroids" (Meng, X. et al. 2010).

"Radiofrequency ablation with the Sonata System represents a minimally invasive, organ-preserving treatment option in patients with symptomatic uterine myomas, associated with clinically meaningful improvement of myoma-related symptoms" (Arnreiter, C., & Oppelt, P. (2021).

The Sonata System (Gynesonics; Redwood City, CA), previously known as VizAblate, integrates radiofrequency ablation for the treatment of fibroids with intrauterine sonography for real-time imaging within a single medical device. It is CE-marked (Conformite Europeene) in the European Union and is currently under investigation in the USA (United States of America). Because it is placed transcervically, it is incisionless and does not require general anesthesia. In particular, Sonata enables the outpatient treatment of a wide range of uterine fibroid types. While Sonata can treat FIGO (Federation Internationale de Gynecologie et d'Obstetrique) type 1 and type 2 fibroids, it can also ablate fibroids that are not treatable with hysteroscopic methods (e.g., FIGO types 3, 4, 5, 6 and types 25 [transmural])" (Toub D. B. 2017).

The requested service of radiofrequency ablation (Sonata procedure) of this patient's fibroid is likely to be more beneficial that the alternative treatments for this patient.

The carrier's denial of the outpatient procedure 0404T, is overturned.