Appeal type: Experimental/Investigational
Decision: Overturned

Diagnosis: Leiomyoma of uterus
Treatment: Radiofrequency surgery
The insurer denied Radiofrequency surgery.
The determination is overturned.

The patient presented to her gynecologist with uterine fibroids. Her bleeding was severe enough to cause anemia, and the fibroids also caused pelvic pain, pressure, and dyspareunia. The patient's extensive work-up showed benign pathology, and multiple fibroids - the most significant being a 5 centimeter (cm) fibroid with a submucosal component. The patient requested a minimally invasive treatment of the fibroid, and objected to the removal of her uterus. She requested the Sonata procedure for transcervical radiofrequency ablation of the fibroids. At issue is whether the proposed health service or treatment radiofrequency surgery is likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

The proposed health service has a high likelihood of benefiting the given condition, and likely imposes less risk than traditional alternatives. Reference 21 does explore success rates of radiofrequency ablation of fibroids for up to five years in a retrospective fashion. The reoperation rate that group reports is 19% at five years. That reoperation rate is comparable to reported five-year reoperation rates for putative alternatives in reference 22, such as myomectomy (19%), endometrial ablation (33%), and uterine artery embolization (24%). Although some of these references are looking at laparoscopic radiofrequency ablation, the technology is the same - Sonata represents a different route of delivery. Short-term studies referenced here (references 23, 24, and 25) specifically demonstrate the safety and efficacy of transcervical radiofrequency ablation as requested in this case. The literature clearly establishes that the Sonata procedure has benefit over traditional procedures (which are much more invasive and have abdominal surgical risks), and a high likelihood of providing this patient with resolution of her current symptoms. There is clearly appropriate data in place to support routine use of this procedure for appropriate candidates.
Multiple references below show that this Food and Drug Administration (FDA) approved procedure has had its safety and effectiveness established by multiple different investigating groups
A review of the literature finds feasibility and safety studies from the United States and abroad, but also several clinical trials that demonstrate safety and efficacy. A precursor to this technology was reported on in 2008 by Cho et al. where a transvaginal route was utilized with only a 4.3% reoperation rate. Reoperation rate is often a good measure of a minimally invasive technology, used in the literature and patient counseling where the question is asked "what are your chances of undergoing this procedure, and then being dissatisfied such that you return to have a hysterectomy?". A manufacturer-sponsored trial has published a 3 year prospective study of 104 patients, showing that there was a reoperation rate of only 11%. Quality of life improvement was also seen. Retrospective data for the Sonata procedure show a 96% satisfaction rate, and also establish safety. The Food and Drug Administration (FDA) demonstrates only three adverse events, all second degree skin burns from the same clinic, suspected to be from careless use of the electrodes. There are several after-market studies ongoing, as is customary for new medical technology. A recent meta-analysis (reference 20) shows the breadth of effectiveness data that is available at this time for radiofrequency ablation of fibroids.
The reviewed data is relatively new, but is more than sufficient to show a benefit to the patient without significant safety concerns. The reoperation rate of 4-19% should be looked at in comparison to the more established procedure of endometrial ablation (another minimally invasive technology that is used to treat specifically menstrual bleeding, not fibroids). The older versions of that technology (used primarily prior to 2010) carried putative reoperation rates of 25% or higher. Those numbers were considered entirely acceptable and those procedures became mainstream with improvements seen only in the third generation of devices. Of note, again in comparison to data used for endometrial ablation, a 10 year follow-up on endometrial ablation patients confirmed what most practicing gynecologists have seen anecdotally, where 73% of those who would undergo reoperation presented for reintervention in the first 2 years after the original procedure. This finding suggests that the early data is suggestive of who will do well in the long-term from minimally invasive procedures.
The American Medical Association has assigned a CPT code for the procedure (0336T). The FDA approval for the device came originally in November 2012 (Acessa). The transcervical device requested in this case was approved in 2018. Further, one can cite the wealth of evidence from the many years of use of this technology in the more hazardous areas of ablation of tumors in the kidney and liver.
The Sonata procedure would be beneficial for this patient, and she meets the established criteria for the procedure. This patient demonstrates classic symptoms of fibroids, including heavy menstrual bleeding. Her bleeding has been severe enough to compromise her daily activities. Her history fits the criteria used by both the manufacturer and the studies cited above, indicating she would have an excellent chance of success with this procedure. Hysterectomy and myomectomy remain her only remaining "traditional" options, which she has objected to out of a desire for a minimally invasive procedure. The FDA approved Sonata procedure provides a minimally invasive, safe alternative with a high likelihood (up to 96%) of reducing her symptoms to improve quality of life. The Sonata procedure does not carry the same abdominal surgical risks as myomectomy or hysterectomy (infection, abscess, organ injury, vascular injury), so there is no reason to suspect the Sonata procedure has a higher risk than those more traditional therapies. A recent American College of Obstetricians and Gynecologists (ACOG) bulletin about fibroids (reference #27) specifically states that this technology is appropriate. The patient's presentation completely fits the intended use of the product. Though relatively early in its adoption, there is sufficient evidence to support use of this technology as a safe, minimally invasive treatment for fibroids.