Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals.

There are no NCDs and/or LCDs for uterine fibroid surgical treatments.

Description

Uterine Fibroid Surgical Treatments

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Uterine fibroids (also referred to as leiomyomas or myomas) are noncancerous growths of the uterus that often develop during childbearing years. The size and growth pattern of uterine fibroids vary; some may be undetectable to the human eye while others are bulky masses that can distort the uterine cavity.

Many fibroids, even large ones, do not produce symptoms. However, when symptoms do occur (eg, excessive bleeding, pain, pressure), medical or surgical treatment may be warranted.

The surgical options for symptomatic fibroids that have not responded to medical treatment include, but may not be limited to:

• A hysterectomy is the surgical removal of the uterus. During the procedure, a surgeon detaches the uterus from the ovaries, fallopian tubes and upper vagina, as well as from the blood vessels and connective tissue that support it. The uterus is then removed through the vagina or abdomen depending on which approach is utilized. Vaginal hysterectomy is the preferred surgical approach when hysterectomy is used to treat fibroids.
• A myomectomy is the surgical removal of fibroids from the wall of the uterus via hysteroscopy, laparoscopy or laparotomy. The surgeon's goal during the procedure is to take out symptom-causing fibroids and reconstruct the uterus. Unlike a hysterectomy, which removes the entire uterus, a myomectomy removes only the fibroids and leaves the uterus intact. This makes it the preferred treatment for individuals interested in preserving fertility.
• Uterine artery embolization (UAE) is a minimally invasive treatment for uterine fibroids. During this percutaneous procedure, a doctor uses a slender, flexible tube to inject embolic agents into the uterine arteries, which supply blood to the fibroids and uterus. The goal is to block the fibroid blood vessels, which will cause them to shrink and die. UAE also can be referred to as uterine fibroid embolization (UFE).
• Performed by a board-certified radiologist, magnetic resonance-guided focused ultrasound (MRgFUS) is a minimally invasive alternative to open surgery. The combination of high intensity focused ultrasound (HIFU) with MRI guidance purportedly enables accuracy for tissue targeting, as well as real-time, thermal monitoring of the treatment effect. When high intensity focused ultrasound waves converge, they heat and ablate the targeted tissue. The Exablate Body System is an example of a device that uses MRgFUS.
• Radiofrequency ablation (RFA) is also a proposed treatment for uterine fibroids. Ultrasound probes are used to determine the location and size of the fibroids. An electrode array then delivers alternating radiofrequency energy to drive a current through the tissue. Purportedly, this allows for controlled, local heating and results in targeted tissue destruction. There are a few approaches and devices utilized for fibroid RFA; some have been more rigorously studied than others.

Examples of RFA devices include, but may not be limited to:

• Acessa ProVu System – Performs radiofrequency volumetric thermal ablation (RFVTA) laparoscopically to cause coagulative necrosis of fibroid tissue
• MYOBLATE RFA – Consists of the Mygen M-3004 RF Generator and MYOBLATE electrodes that coagulate and ablate symptomatic fibroids via a transcervical or transvaginal approach
• Sonata System – Utilizes real-time intrauterine ultrasound guidance with targeted RFA via a transcervical approach to destroy symptomatic fibroids

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Another type of procedure that has been explored for freezing fibroids is known as cryoablation.

With this technology, freezing temperatures are delivered to the endometrium via a cryoprobe during laparoscopy or hysteroscopy. An example of such a device used for this purpose includes, but may not be limited to, the Cerene Cryotherapy Device.

Uterine artery ligation/occlusion

is a doppler-guided procedure in which the uterine arteries are temporarily clamped to stop the flow of blood to the fibroids in order to remove excess fibroid tissue.

Coverage Determination

Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.

In interpreting or supplementing the criteria above and in order to determine medical necessity consistently,

Humana may consider the following criteria:

Uterine Fibroid Surgical Treatments

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.

Coverage Limitations

US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage