Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Uterine Fibroids.
Treatment: Surgery (ablation with imaging guidance), Pre-service.

The insurer denied the Surgery (ablation with imaging guidance), Pre-service.  The denial is upheld. 

The patient is a G4 (four pregnancies) P2 (two births) Ab2 (two abortions) female. She has a history of uterine fibroids and previous myomectomy. She presented to her gynecologist.  According to the medical records, the patient reported no abnormal bleeding, pain, or urinary symptoms. She had a Mirena IUD (intrauterine device). A pelvic ultrasound revealed that the IUD (intrauterine device) was not in a proper location. Intramural fibroids of four, three and two cm (centimeters), and a small left ovarian hemorrhagic cyst were noted. The IUD (intrauterine device) was removed. Transcervical radiofrequency fibroid ablation was recommended.

No, the health plan should not cover the requested ablation with imaging guidance.

The medical records and medical literature were thoroughly reviewed. Options for minimally invasive uterus-sparing alternatives for the treatment of uterine fibroids, within the standard of care include myomectomy and uterine artery embolization. 

The Acessa device is a new FDA (United State Food and Drug Administration)-approved minimally invasive treatment for uterine fibroids that uses radiofrequency energy to destroy fibroid tissue. The novel use of radiofrequency ablation under laparoscopic and intra-abdominal ultrasound guidance to treat patients with symptomatic myomas was first introduced approximately 20 years ago. This has prompted the development of the proposed procedure device (Acessa), which carries out laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of uterine myomas in symptomatic women.

Transcervical fibroid ablation (TFA) has certain advantages that might appeal to patients, including a noninvasive delivery method, uterine preservation, ability to treat a wide range of fibroid types, avoidance of general anesthesia, and rapid recovery and return to ADLs (activities of daily living) following the procedure. The procedure is incisionless and preserves the uterus. Unlike operative hysteroscopy, TFA (transcervical fibroid ablation) is designed for ablation of most nonpedunculated fibroid types.

This patient has a diagnosis of uterine fibroids, and TFA (transcervical fibroid ablation) was recommended. The American College of Obstetrics and Gynecology, in its Practice Bulletin, states, "Laparoscopic radiofrequency ablation can be considered as a minimally invasive treatment option for the management of symptomatic leiomyomas in patients who desire uterine preservation and are counseled about the limited available data on reproductive outcomes. Laparoscopic radiofrequency ablation can be considered as a minimally invasive treatment option for the management of symptomatic leiomyomas in patients who desire uterine preservation and are counseled about the limited available data on reproductive outcomes. Radiofrequency ablation (RFA) can be delivered by a laparoscopic, transvaginal, or transcervical approach, using ultrasound guidance to induce coagulative necrosis in targeted uterine leiomyomas. All of the approaches are similarly effective in reducing uterine leiomyoma volume and in improving quality of life metrics, but the laparoscopic approach has been studied the most rigorously."

According to the medical records, there is no evidence or confirmation that the patient has abnormal uterine bleeding, urinary frequency or pain. Her pelvic examination is normal, with documentation that confirms a normal sized and non-tender uterus. Therefore, there is no indication for treatment of the fibroids. Therefore the proposed procedure is not medically appropriate.

No, the requested health service or treatment is not more beneficial than any standard treatment for the insured's condition or disease.

According to the medical records, there is no evidence or confirmation that the patient has abnormal uterine bleeding, urinary frequency or pain. Her pelvic examination is normal, with documentation that confirms a normal sized and nontender uterus. Therefore, there is no indication for treatment of the fibroids. Therefore, the proposed procedure is not medically appropriate.