Description

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. (Refer to Coverage Limitations section)
• 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:

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Uterine Fibroid Surgical Treatments Effective Date: 06/22/2023
Revision Date: 06/22/2023
Review Date: 06/22/2023
Policy Number: HUM-0321-023
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• 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 (Refer to Coverage Limitations)
• Sonata System – Utilizes real-time intrauterine ultrasound guidance with targeted RFA via a transcervical approach to destroy symptomatic fibroids (Refer to Coverage Limitations)

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. (Refer to Coverage Limitations section)

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. (Refer to Coverage Limitations section)

For information regarding proposed treatments for indications not addressed in this policy, please see the following Medical Coverage Policies:

Treatments

Corresponding Medical Coverage Policy

1. Cryoablation for other indications
   • Cryoablation
2. High intensity focused ultrasound (HIFU) for other indications
   • Benign Prostatic Hyperplasia Treatment and Hyperthermia Treatment for Cancer (Local, Regional and Whole Body)
3. Surgical procedures
   • Infertility Evaluation and Treatment
4. to correct issues
5. that may hinder
6. fertility

Uterine Fibroid Surgical Treatments Effective Date: 06/22/2023
Revision Date: 06/22/2023
Review Date: 06/22/2023
Policy Number: HUM-0321-023
Page: 4 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Coverage Determination

Please refer to the member’s applicable pharmacy benefit to determine benefit availability and the terms and conditions of coverage for medication for the treatment of uterine fibroids.

Humana members may be eligible under the plan for hysterectomy when the following criteria are met:

• Imaging-confirmed presence of uterine fibroids; AND
• Persistent symptoms lasting 3 or more consecutive months despite medical management (eg, hormonal therapy, nonsteroidal anti-inflammatory drugs [NSAIDs]) if medically appropriate and not contraindicated

Humana members may be eligible under the plan for laparoscopic radiofrequency ablation (eg, Acessa ProVu System [58674]), myomectomy or uterine artery embolization/uterine fibroid embolization (UAE/UFE) when the following criteria are met:

• Imaging-confirmed presence of uterine fibroids; AND
• Individual desires uterine sparing procedure; AND
• Persistent symptoms lasting 3 or more consecutive months despite medical management (eg, hormonal therapy, NSAIDs) if medically appropriate and not contraindicated

Coverage Limitations

Humana members may NOT be eligible under the plan for any procedures other than those listed above including, but may not be limited to:

• Cryoablation of fibroids (eg, Cerene Cryotherapy Device) (58578, 58579, 58999); OR
• MRgFUS/HIFU (eg, Exablate Body) (0071T, 0072T); OR
• Transcervical or transvaginal radiofrequency ablation (eg, MYOBLATE RFA, Sonata System) (0404T); OR
• Uterine artery ligation/occlusion (37243)

These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Additional information about uterine fibroids may be found from the following websites:

Background

• American College of Obstetricians and Gynecologists
• National Institutes of Health
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual's health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

Uterine Fibroid Surgical Treatments Effective Date: 06/22/2023
Revision Date: 06/22/2023
Review Date: 06/22/2023
Policy Number: HUM-0321-023
Page: 5 of 12

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.