Laparoscopic, Percutaneous, and Transcervical Techniques for Uterine Fibroid Myolysis

POLICY NUMBER

A.4.01.19

DESCRIPTION

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.

Uterine Fibroids

Uterine fibroids, also known as leiomyomas, are among the most common conditions affecting women in their reproductive years; symptoms include menorrhagia, pelvic pressure, or pain. It is estimated that uterine fibroids occur in up to 70% of women by menopause, with approximately 25% of these being clinically significant and requiring intervention. The prevalence rate of uterine fibroids is 2 to 3 times higher among Black women compared with White women, and there are higher rates of hysterectomy and myomectomy compared with non-surgical therapy, potentially demonstrating a disparity in access to uterine-sparing interventions.

Treatment

Surgery, including hysterectomy and various myomectomy procedures, is considered the criterion standard for symptom resolution. However, there is the potential for surgical complications and, in the case of a hysterectomy, the uterus is not preserved. In addition, multiple myomectomies may be associated with longer operating time, postoperative febrile morbidity, and development of pelvic adhesions. There has been long-standing research interest in developing minimally invasive alternatives for treating uterine fibroids, including procedures that retain the uterus and permit future childbearing. Treatment options include uterine artery embolization and transcutaneous magnetic resonance imaging-guided focused ultrasound therapy (see the Magnetic Resonance-Guided Focused Ultrasound medical policy). Various techniques to induce myolysis have also been studied including Nd:YAG lasers, bipolar electrodes, cryomyolysis, and radiofrequency ablation. With these techniques, an energy source is used to create areas of necrosis within uterine fibroids, reducing their volume and thus relieving symptoms. Early methods involved multiple insertions of probes into the fibroid, performed without imaging guidance. There were concerns about serosal injury and abdominopelvic adhesions with these techniques, possibly due to the multiple passes through the serosa needed to treat a single fibroid. Newer systems using radiofrequency energy do not require repetitive insertions of needle electrodes. Ultrasonography is used laparoscopically or transcervically to determine the size and location of fibroids, to guide the probe, and to ensure the probe is in the correct location so that optimal energy is applied to the fibroid. Percutaneous approaches using magnetic resonance imaging guidance have also been reported.

In 2012, the Acessa™ System (Acessa Health, formerly Halt Medical) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for percutaneous laparoscopic coagulation and ablation of soft tissue and treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance (K121858). The technology was previously approved in 2010, at which time it was called the Halt 2000GI™ Electrosurgical Radiofrequency Ablation System. In 2014, the ultrasound guidance system received marketing clearance from the FDA (K132744). FDA product code: GEI. In 2018, the third-generation Acessa™ ProVu System® was cleared for marketing by the FDA through the 510(k) process for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. (K181124). Hologic acquired Accessa Health in 2020. FDA product code: HFG.

In 2018, the Sonata® Sonography-Guided Transcervical Fibroid Ablation System (Gynesonics) was cleared for marketing by the FDA through the 510(k) process for diagnostic intrauterine imaging and transcervical radiofrequency ablation as treatment of symptomatic uterine fibroids (K173703). The Sonata System 2.1 received marketing clearance in 2020 (K193516) and the Sonata System 2.2 received marketing clearance in 2021 (K211535). The Sonata system was previously known as Vizablate. FDA product codes: KNF, ITX, and IYO.

Cryoablation is a surgical procedure that uses previously approved and available cryoablation systems; and as a surgical procedure, it is not subject to regulation by the FDA. Other products addressed in this policy (eg, Nd:YAG lasers, bipolar electrodes) have long-standing FDA approval, and there are no products specifically approved for the treatment of uterine fibroids.

POLICY

Laparoscopic or transcervical radiofrequency ablation (RFA) as a treatment of symptomatic uterine fibroids is considered medically necessary in individuals 18 years and older when ALL of the following conditions are met:

• Evidence of uterine fibroids via ultrasound that are less than 10 cm in diameter for laparoscopic RFA with Acessa or 7 cm for transcervical RFA with Sonata; AND

• Individual desires a uterine-sparing treatment approach or is ineligible for hysterectomy or other uterine-sparing alternatives to RFA (e.g., laparoscopic myomectomy, uterine artery embolization [UAE]) (see Policy Guidelines); AND

• Individual has experienced at least 1 of the following symptoms that are a direct result of the fibroid(s):

  • Menorrhagia or other abnormal uterine bleeding that interferes with daily activities or causes anemia (see Policy Guidelines);

  • Pelvic pain or pressure;

  • Urinary symptoms (e.g., urinary frequency, urgency) related to bulk compression of the bladder;

  • Gastrointestinal symptoms related to bulk compression of the bowel (e.g., constipation, bloating);

  • Dyspareunia (painful or difficult sexual relations).

Other laparoscopic, transcervical, or percutaneous techniques for myolysis of uterine fibroids, including use of laser or bipolar needles, cryomyolysis, and magnetic resonance imaging-guided laser ablation, are considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Eligibility Considerations

Abnormal uterine bleeding refers to uterine bleeding of abnormal frequency, duration, and volume that interferes with an individual's quality of life. Individuals with abnormal uterine bleeding with an inadequate response to appropriately selected medical therapy may be considered for alternate uterine-sparing interventions. In individuals >45 years of age with menorrhagia or other abnormal bleeding, endometrial biopsy is recommended prior to treatment to rule out endometrial malignancy and/or additional assessment to rule out a risk for uterine leiomyosarcoma.

Clinical trial experience with radiofrequency ablation (RFA) has been limited to patients with overall uterine size ≤16 gestational weeks size based on pelvic examination. In individuals where fibroids cannot be distinguished from adenomyosis on ultrasound, advanced imaging (e.g., magnetic resonance imaging [MRI]) may be required. For individuals with pelvic pain, alternative causes such as endometritis and active pelvic inflammatory disease should be excluded prior to treatment with RFA.

Treatment Approach Considerations for Radiofrequency Ablation

Uterine fibroids are categorized according to the International Federation of Gynaecology and Obstetrics (FIGO) leiomyoma subclassification system (see the table below). Choice of laparoscopic versus transcervical RFA treatment is dependent on fibroid number, size, type and location, and patient preferences. For example, predominantly lower uterine segment or cervical leiomyomata, or those with a predominant submucosal location or intramural FIGO type 2 or 3 fibroids, may suggest a transcervical approach, whereas fibroids with largely fundal or extramural components may suggest a laparoscopic approach. Individuals aiming to avoid future deliveries via obligate cesarean section may prefer a transcervical approach. Select individuals with numerous fibroids may benefit from combined laparoscopic RFA and laparoscopic myomectomy. Individuals with intramural fibroids, intra-abdominal adhesions, or medical contraindications may not be candidates for alternative uterine-sparing interventions.

International Federation of Gynaecology and Obstetrics (FIGO) Leiomyoma Subclassification System

Table adapted from Gomez et al (2021). MRI-based pictorial review of the FIGO classification system for uterine fibroids. Abdom Radiol. 46(5): 2146-2155. PMID: 33385249.

Reinterventions

Reintervention with RFA may be considered for individuals meeting policy criteria with documentation of new or recurrent fibroid development following a partial response with the initial procedure. However, data on reinterventions for new or recurrent fibroids is limited and documentation procedures for repeat anatomic mapping of fibroids are not standardized.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

04/01/2023: New policy added. Approved by the Medical Policy Advisory Committee.

12/21/2023: Code Reference section updated to add new 2024 CPT code 58580, effective 01/01/2024.

03/19/2024: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "patients" to "individuals" and to remove information regarding devices.

04/10/2025: Policy reviewed. Policy statements unchanged. Code Reference section updated to remove deleted CPT code 0404T.

SOURCE(S)

Blue Cross Blue Shield Association policy # 4.01.19

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

Investigational Codes

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