Laparoscopic (58578) and percutaneous (58999) techniques for myolysis (e.g. laser and bipolar needles, cryomyolysis, laparoscopic radiofrequency ablation [HALT procedure]) in the treatment of uterine fibroids (218.0-218.9) are considered experimental/investigational.  The published data regarding techniques of myolysis are inadequate to permit scientific conclusions due to the lack of randomized trials.  Surgical myolysis, whether performed via laparoscope or percutaneously, is not covered and not eligible for payment.  A participating, preferred, or network provider can bill the member for such procedures.

Description

Uterine fibroids are the most common type of abnormal growth in the uterus and one of the most common conditions affecting women in the reproductive years.  Symptoms include menorrhagia (abnormally heavy bleeding), pelvic pressure, and pain.  Hysterectomy and various myomectomy procedures are considered the gold standard treatment.  However, there has been longstanding interest in developing minimally invasive alternatives that include endometrial ablation (for submucosal fibroids), uterine artery embolization, and various techniques to induce myolysis of fibroids.  A variety of energy sources have been used for myolysis, including Nd:YAG lasers, bipolar electrodes, cryotherapy, and radiofrequency ablation.  Typically, the patients are pretreated with a 2 to 6 month course of depot GnRH agonists to shrink fibroids prior to the procedure.  In general, the procedures involve the insertion of probes multiple times into the fibroid.  When activated, the various energy sources induce devascularization and ultimately ablation of the target tissue.

Myolysis is accomplished using the following techniques:

• Laser and bipolar needles - These procedures involve the insertion of an Nd: YAG laser or bipolar needle electrodes into uterine fibroids in order to cause coagulation and shrinkage.
  
• Cryomyolysis - This technique involves the insertion of a cryoprobe into the center of a uterine fibroid to cause freezing of tissue and resultant reduction in the size of the fibroid.
  
• Radiofrequency ablation myolysis of uterine fibroids (e.g., the HALT [hysterectomy alternative] procedure) involves MRI-guided Nd: YAG laser myolysis.

Myolysis is typically performed as a laparoscopic procedure, but more recently, percutaneous approaches using magnetic resonance imaging (MRI) guidance (77022) have been employed.  The MRI can provide both the guidance for insertion of the probe and real-time thermal imaging maps of the treated area.  It can also be used to carry out in vivo monitoring of thermal changes in the tissues.

MRI guidance performed in conjunction with percutaneous myolysis of uterine fibroids is considered experimental/investigational.  A participating, preferred, or network provider can bill the member for the denied service.

NOTE:

For additional guidelines on the treatment of uterine fibroids, see Medical Policy Bulletins S-77 (Endometrial Ablation) and S-114 (Uterine Artery Embolization for Uterine Fibroids).

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP.  Medical policy is not an authorization, certification, explanation of benefits or a contract.  Benefits are determined by the Federal Employee Program.

Laparoscopic and Percutaneous Techniques for the Myolysis of Uterine Fibroids, Medical Policy Reference manual, Policy 4.01.19, 07/15/04