Appeal type: Experimental/Investigational
Decision: Upheld

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

The patient is a female with complaint of symptomatic fibroids (pelvic pressure and heavy menses). Ultrasound showed multiple fibroids averaging four to six centimeters in size.  The patient is requesting coverage for Acessa radiofrequency ablation of uterine fibroids.

Yes, the health plan should cover the proposed Acessa procedure.
The health plan has denied the requested procedure because, "this treatment is not approvable under the plan clinical criteria because there is no proof or not enough proof it improves health outcomes. For this reason, the request is denied as investigational"

The requested outpatient surgery services (code 58674 Laparoscopy, surgical, ablation of uterine fibroid(s) including intraoperative ultrasound guidance and monitoring, radiofrequency) is medically necessary in this case.

Minimally invasive therapies to treat symptoms of uterine myomas can be effective alternatives to major surgery. Such modalities include pharmacologic agents, uterine artery embolization, magnetic resonance-guided focused ultrasound, and laparoscopic radiofrequency ablation, known as the Acessa procedure. Acessa is used to treat women with symptomatic myomas and was approved by the US Food and Drug Administration.

The Society of Obstetricians and Gynaecologists of Canada (SOGC)'s guideline on "Abnormal uterine bleeding in pre-menopausal women'' states that radiofrequency ablation devices have a large reported clinical experience.  One of the main advantages of this technique is its successful implementation in a surgical suite or clinic setting, which avoids the use of operating room resources and general anaesthetic".

Based on a randomized, prospective study, compared to myomectomy, lap-radiofrequency ablation (RFA) is associated with significantly lesser intraoperative blood loss, shorter procedure and hospitalization times, lesser consumption/use of disposable and reusable surgery equipment, reduced health care resource utilization, and faster return to work through three months posttreatment.

In an analysis of a randomized controlled trial comparing laparoscopic radiofrequency volumetric thermal ablation of uterine fibroids with laparoscopic myomectomy a 24-month data suggest equivalence in safety and patient-reported efficacy of radiofrequency volumetric thermal ablation (RFVTA) and laparoscopic myomectomy.

A meta-analysis of eight studies showed that all subscales of quality of life improved significantly, and most of the changes remained stable in long-term follow-up. The overall reintervention rate was 4.39% and the median uterine volume reduction was 69.17 centimeters3. The overall procedure-related adverse events rate was 1.78% and patients missed an average of 4.35 days of work.

In conclusion, laparoscopic radiofrequency ablation therapy is an efficacious way to treat small-sized and nonpedunculated symptomatic uterine fibroids, providing stable long-term symptom relief and quality of life improvement with a low risk of adverse events and reintervention and just a few days of missed work.

Yes, the requested therapy is likely to be more beneficial for the enrollee than any available standard therapy.