Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Uterine fibroids.
Treatment: Acessa procedure.
The insurer denied the Acessa procedure.
The denial is upheld. 

The patient is a female with an enlarged multifibroid uterus measuring 14 centimeters.  There are nine fibroids measuring from 2.4 to 5.0 centimeters.  She has bloating, pressure, and abnormal bleeding.  She desires preservation of her uterus.

No the health plan should not cover the proposed Acessa procedure.

Galen et al (2014) performed a retrospective, multicenter clinical analysis of 206 consecutive cases of ultrasound-guided laparoscopic radiofrequency volumetric thermal ablation (RFVTA) of symptomatic myomas conducted on an outpatient basis under two phase II studies at two sites (n = 69) and one phase III study at 11 sites (n = 137). Descriptive and exploratory, general trend, and matched-pair analyses were applied.

Results:  From baseline to 12 months in the phase II study, the mean transformed symptom severity scores improved from 53.9 to 8.8, health-related quality-of-life scores improved from 48.5 to 92.0, and mean uterine volume decreased from 204.4 cm3 to 151.4 cm3. Patients missed a median of four days of work (range, 210 days). The rate of possible device-related adverse events was 1.4% (1 of 69). In the phase III study, approximately 98% of patients were assessed at 12 months, and their transformed symptom severity scores, health-related quality-of-life scores, mean decrease in uterine volume, and mean menstrual bleeding reduction were also significant. Patients in phase III missed a median of five days of work (range, 129 days). The rate of periprocedural device-related adverse events was 3.5% (5 of 137). Despite the enrollment requirement for patients in both phases to have completed childbearing, four pregnancies occurred within the first year after treatment.

According to Brucker et al:
Laparoscopic radiofrequency volumetric thermal ablation of fibroids versus laparoscopic myomectomy.

OBJECTIVE:
To compare the mean hospital discharge times and perioperative outcomes for radiofrequency volumetric thermal ablation (RFVTA) of fibroids and laparoscopic myomectomy (LM).

METHODS:
The present postmarket, randomized, prospective, single-center, longitudinal, comparative study, conducted in Tubingen, Germany, evaluated the outcomes of radiofrequency volumetric thermal ablation (RFVTA) and the current standard of care (laparoscopic myomectomy [LM]) for symptomatic uterine fibroids in women who desired uterine conservation. The surgeons were blinded to the treatment until all fibroids had been mapped by laparoscopic ultrasound.

RESULTS:
The mean hospitalization times were 10.0  5.5 (median 7.8 [range 4.2-25.5]) hours for the radiofrequency volumetric thermal ablation (RFVTA) group and 29.9  14.2 (median 22.6 [range 16.1-68.1]) hours for the laparoscopic myomectomy (LM) group (P < 0.001, Wilcoxon test). Intraoperative blood loss was 16  9 (median 20 [range: 0-30]) mL for the radiofrequency volumetric thermal ablation (RFVTA) procedures and 51  57 (median 35 [range 10-300]) mL for the laparoscopic myomectomy (LM) procedures. The percentage of fibroids imaged by laparoscopic ultrasound that were treated/excised was 98.6% for radiofrequency volumetric thermal ablation (RFVTA) and 80.3% for laparoscopic myomectomy (LM). Two complications were reported: vertigo (n = 1; radiofrequency volumetric thermal ablation [RFVTA]) and port site hematoma (n = 1; laparoscopic myomectomy [LM]).

CONCLUSION:
Radiofrequency volumetric thermal ablation resulted in the treatment of more fibroids, a significantly shorter hospital stay, and less intraoperative blood loss than laparoscopic myomectomy.

According to Hahn et al:
Radiofrequency Volumetric Thermal Ablation of Fibroids and Laparoscopic Myomectomy: Long-Term Follow-up From a Randomized Trial.

Laparoscopic myomectomy (LM) has been the gold standard treatment for uterine fibroids in women desiring uterine conservation. To evaluate a new fibroid treatment modality - radiofrequency volumetric thermal ablation (RFVTA) - we compare 12-month results in women who had symptomatic uterine fibroids and who were randomized to laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation (RFVTA) or laparoscopic myomectomy (LM). Materials and Methods: Our study is a 1:1 parallel, randomized, prospective, single-center, longitudinal, comparative analysis of radiofrequency volumetric thermal ablation (RFVTA) to laparoscopic myomectomy (LM) for fibroid treatment in women = 18 years of age who desired uterine conservation. Fifty women were randomized intraoperatively to radiofrequency volumetric thermal ablation (RFVTA) (n [number] = 25) or to laparoscopic myomectomy (LM) (n [number] = 25) after laparoscopic ultrasound mapping of the uterus. Results: Post surgery, ablation and myomectomy subjects took pain medications for four days (range: 1-46) and seven days (range: 1-83 days) respectively. Ablation and myomectomy subjects missed 10.0 workdays (range: 2-86 days) and 17.0 workdays (range: 7-30 days), resumed normal activities in 20.5 days (range: 5-103 days) versus 28.0 days (range: 10-42 days) respectively. Mean symptom severity scores decreased (improved) by -7.8 for the ablation subjects and by -17.9 for the myomectomy subjects. Health-related quality of life improved (increased) by 7.5 and 13.1, respectively, for the two groups. Two myomectomy subjects had pregnancies that ended in a Cesarean delivery and a vaginal delivery of healthy infants. Two pregnancies in the radiofrequency volumetric thermal ablation (RFVTA) group ended in full-term vaginal deliveries of healthy infants.
Conclusions: Early postoperative recovery and twelve-month results attest to similar clinical benefits from radiofrequency volumetric thermal ablation (RFVTA) and laparoscopic myomectomy (LM).

In summary, there are no long term data to support use of this procedure as being effective and safe long term in patients with symptomatic uterine myomas.  This procedure is also not endorsed by the American College of Obstetrics and Gynecology who provides the guidelines for OB/GYNs in the United States.  Therefore this is not considered a standard of medical practice at this time.  The plan does not cover procedures that aren't considered medically necessary.

No, the requested therapy is not likely to be more beneficial for the patient than any available standard therapy.  There are alternative options that have been better evaluated that would treat the patient's medical condition.