Appeal type: Experimental/Investigational
Decision: Upheld

This is a patient with no prior pregnancies who complained of a long history of pelvic pain and menorrhagia. Her evaluation showed numerous uterine fibroids with imaging demonstrating as many as 25 fibroids, with some as large as 8 centimeter (cm) in diameter. She failed an appropriate trial of medical management (oral contraceptive pills) and a prior uterine artery embolization. The patient requested a minimally invasive treatment of the fibroids that would not involve removal of the uterus. She has been assessed as a poor candidate for myomectomy due to the number of fibroids. Her physicians have stated that an attempt at a myomectomy will likely end in a hysterectomy, which the patient objects to. Because of her job as a police officer, she is seeking the least invasive treatment possible so as to return to work quickly. At issue is whether ablation with imaging guidance 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 health plan's determination is overturned.
The Acessa procedure would be more beneficial for this patient than more traditional methods of treating fibroids. She has already failed medical management with hormonal therapy and a minimally invasive procedure of uterine artery embolization. She has been assessed as a poor candidate for myomectomy because of the number of fibroids and history of prior embolization. A hysterectomy remains her only remaining traditional option, which she clearly states in her appeal documentation would compromise her job as a police officer because of the lengthy recovery time. Again she also objects to removal of her uterus. The Food and Drug Administration (FDA) approved Acessa procedure provides a minimally invasive, safe alternative with a high likelihood (80-90%) of reducing her symptoms to improve quality of life.
The Acessa system is a radiofrequency ablation system used for minimally invasive treatment of uterine fibroids. Uterine fibroids are benign tumors of the uterus, found in over 50% of women, and are the most common indication for hysterectomy in the United States. Though medications may temporarily decrease the size of fibroids and may successfully control some symptoms, there is no medical management strategy that will permanently address large mass related effects of fibroids. The Acessa system utilizes an intra-abdominal ultrasound probe to localize the target fibroid, along with a handpiece that deploys a radiofrequency array directly into the fibroid. The ablation is performed by releasing energy into the fibroid sufficient to promote protein denaturation and necrosis of the fibroid over the course of 1-3 months, thus reducing the size and associated symptoms of the fibroid. This technology is rooted in well-established procedures utilized for ablation of renal and hepatic malignancies. The procedure is designed to be used as an outpatient procedure that allows for uterine preservation for women with symptomatic intramural and subserosal fibroids with undesired fertility. The procedure was FDA approved November 2, 2012, and use in US hospitals began shortly after.
A review of the literature finds feasibility and safety studies from the United States (US) 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% re-operation rate. Re-operation rate is often a good measure of an minimally invasive technology, used in the literature and in 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?". Most telling, a manufacturer-sponsored trial has published 3 year data showing for 104 patients there was a re-operation rate of only 11%. Quality of life improvement was also seen. A separate publication of the early data from 12 month follow-up of the same cohort suggests outcome at 12 months was consistent with outcome at 36 months. Of note, only 2 significant adverse events were reported in the cohort of 135 patients. The FDA shows one reported adverse event, which was a mechanical failure attributed to operator error (the patient was not harmed). There is also a retrospective study looking specifically at the ability of Acessa to treat the most common symptom of fibroids, abnormal uterine bleeding. The study by Galen et al. showed a 45% improvement in menstrual bleeding volumes with this technology. Finally, there is one German study of the device that is a true randomized controlled trial comparing this procedure to laparoscopic myomectomy. In that study, 51 patients were randomized at the time of surgery to one of the two procedures, and the patients in the Acessa group had shorter hospital stays and less intraoperative blood loss in comparison to the myomectomy group. There are several after-market studies ongoing, as is customary for new medical technology.
The reviewed data is relatively new, and with minimal study of long-term outcome, but is more than sufficient to show a benefit to the patient without significant safety concerns. The re-operation rate of 11% 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 re-operation 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 re-operation presented in the first 2 years. This finding again suggests that the early data is suggestive of who will do well in the long-term from minimally invasive procedures.
It is important in considering the above data, to consider it in the context of recent controversies in the treatment of fibroids. One reason this technology has likely not undergone widespread adoption yet is there were good alternatives used widely over the past 12 years for minimally invasive treatment of fibroids via laparoscopic hysterectomy (supra-cervical or total) and myomectomy (via straight stick or robot-assist). Since 2014, however, the device upon which all of these procedures rely, the laparoscopic morcellator (a device that digests the removed fibroid tissue for removal through small openings in the body cavity) has been removed from the market. The controversy surrounds the ability of the device to disseminate occult malignancy. The effect for most general gynecologists outside of academic centers has been a general avoidance of these procedures, and a return to open surgery. In light of that, the data presented above for the Acessa device is excellent and provides an alternative for patients who do not want major surgery for what can be highly disruptive symptoms from fibroids.
There is plenty of non-scientific evidence supporting use of Acessa as well. The American Medical Association has assigned a CPT code for the procedure (0336T). The FDA approval for the device came originally in November 2012. A second generation of the device was approved in 2018. Further, there is a 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. Overall, the procedure has been proven safe and effective, and would benefit this patient.