Uterine fibroids, or leiomyomata, are benign growths (non-cancerous) in or around the uterus. Fibroids can range in size from a grape to larger than a grapefruit and may cause significant symptoms, including heavy menstrual bleeding, abdominal/pelvic pressure, subfertility, painful sex, constipation, and painful periods. These symptoms may worsen over time if the fibroids are left untreated.

Various minimally invasive treatments for uterine fibroids have been proposed as alternatives to surgery. Among these approaches are laparoscopic, percutaneous, and transcervical techniques to induce myolysis, which includes radiofrequency ablation (RFA), laser and bipolar needles, cryomyolysis, and magnetic resonance imaging-guided laser ablation. This policy applies specifically to transcervical radiofrequency ablation (RFA) with the SonataTM system.

Note: Counseling regarding risks and potential impact on future pregnancy should occur with members electing RFA with the SonataTM system.

Clinical Guideline Coverage Criteria

Point32Health companies6682744Transcervical Radiofrequency Ablation of Uterine Fibroids

The Plan may consider transcervical radiofrequency ablation (RFA) as a treatment of symptomatic uterine fibroids as reasonable and medically necessary in individuals 18 years and older when ALL of the following conditions are met:

1. There is evidence of uterine fibroids via ultrasound that are less than 7cm; and
2. Individual has experienced at least one of the following symptoms that are a direct result of the fibroid(s):
   • a. Menorrhagia or other abnormal uterine bleeding that interferes with daily activities or causes anemia; or
   • b. Pelvic pain or pressure; or
   • c. Lower back pain; or
   • d. Urinary symptoms (e.g., urinary frequency, urgency) related to bulk compression of the bladder; or
   • e. Gastrointestinal symptoms related to bulk compression of the bowel (e.g., constipation, bloating); or
   • f. Dyspareunia (painful or difficult sexual relations)

Limitations

The Plan will not cover transcervical radiofrequency ablation for members who have the following:

1. Acute pelvic inflammatory disease
2. Active pelvic infection
3. Unresolved abnormal pap smear test results
4. Suspected gynecologic malignancy/premalignancy requiring further workup
5. Current pregnancy
6. Any other medical contraindication to Transcervical RFA

Codes