Appeal type: Experimental/Investigational
Decision: Overturned

 The enrollee requested reimbursement for laparoscopic ablation of uterine fibroids procedure (CPT code 58674). The enrollee has a history of intramural fibroids with abnormal uterine bleeding. An office visit revealed uterine fibroids, enlarged (16-week size), contour irregular and midline, mobile, and non-tender. The provider also noted leiomyoma and a pelvic mass. Pelvic ultrasound showed an anteverted, enlarged uterus. Also noted on the scan was a large, hypoechoic mass, indicative of a uterine fibroid and measuring 6.9 x 8.2 x 7.4 centimeters. The provider discussed a laparoscopic procedure, which uses radiofrequency energy to destroy the fibroid. Risks, benefits, and alternatives to the procedure were also discussed with the enrollee. The enrollee underwent the laparoscopic  ablation procedure for abnormal uterine bleeding. The laparoscopic ablation procedure has been approved and is recognized as a safe and effective alternative treatment for uterine fibroids compared to treatment options such as uterine artery embolization (UAE), myomectomy or hysterectomy.  It is associated with a lower complication rate compared to these treatments. The benefits of the laparoscopic ablation include: a short operative time of 60 - 90 minutes, minimal post-operative pain with a quick recovery to normal activity within three to five days, treatment of multiple fibroids, despite size and location, a minimally-invasive surgery with same-day discharge, allows for retention of the uterus, negligible intraoperative blood loss compared to myomectomy or hysterectomy and  permanent fibroid removal. The treated fibroids do not grow back. Additionally, the laparoscopic ablation procedure has the capability to treat fibroids located in positions traditionally regarded as high-risk; such as cervical, broad ligament, and round ligament fibroids. This is one of the most significant advantages of the laparoscopic ablation procedure. For this enrollee, the fibroid was very close to the cervix, which is considered one of the high-risk locations due to its proximity to the uterine arteries and ureters. This carries an increased risk of hemorrhage and increased risk of injury to the ureters. There is little to no post-operative pain after the laparoscopic ablation procedure, with most patients discharging with non-steroidal anti-inflammatories for pain management. Patients undergoing UAE, myomectomy, or hysterectomy usually require opiate pain medication during their recovery.  Patients who have had the laparoscopic ablation procedure have the quickest recovery time compared to UAE, myomectomy, or hysterectomy patients. Laparoscopic ablation patients typically return to work and regular physical activity in three to five days. UAE patients usually require at least 10 days before resuming work/normal activity. Patients who have undergone a myomectomy or hysterectomy typically need two to eight weeks to resume normal physical activity, depending upon the surgical approach, such as laparoscopic versus open. Clinical study results with the laparoscopic system have all been favorable. Primary outcome measures include the reductions in both fibroid and uterine volume, the frequency of adverse events, the re-intervention rate due to fibroid symptoms, and improvement in symptoms and quality of life.  RFA of uterine fibroids has been shown to be safe and successful in improving or resolving symptoms associated with fibroids. While the maximum size of the fibroids included in clinical studies was 10 centimeters, the laparoscopic ablation procedure has been used effectively to treat fibroids up to 16 centimeters in diameter. Because of the precise placement of the radiofrequency probe into the targeted fibroid, confirmed by laparoscopic ultrasound prior to ablation, there is minimal disruption of normal myometrium and ovarian function. This leads to a very low complication rate and low re-intervention rate. These results are demonstrated in systemic reviews and meta-analyses of published clinical studies.  In conclusion, this enrollee was an excellent candidate for the laparoscopic ablation of uterine fibroids procedure due to the location of her primary fibroid being located near her cervix. The high-risk location of the large fibroid is associated with an increased risk of complications, such as hemorrhage and ureteral injury. The physician reviewer found that the procedure is more beneficial to patients compared to the standard treatments because it is an outpatient, minimally-invasive surgery associated with the least post-operative pain, fastest recovery, minimal blood loss, and is also uterine-sparing. Final Result: Two of the three reviewers determined that the requested services were likely to have been more beneficial than any available standard therapy for treatment of the enrollees medical condition.