Commercial

Medical Policy

Title:

Uterine Artery Embolization

Policy #:

11.06.04k

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

Uterine artery embolization (UAE) is considered medically necessary and, therefore, covered as a treatment for individuals with uterine fibroids when EITHER of the following criteria is met:

The individual is experiencing symptoms, such as but not limited to:
- Menorrhagia (excessive menstrual bleeding) as a direct result of the fibroid (i.e., not resulting from hyperplasia, atypia, or cancer) that interferes with daily activities or causes anemia
- Pelvic pain or pressure as a direct result of the fibroid
- Lower back pain as a direct result of the fibroid
- Urinary symptoms related to compression of the bladder (e.g., urinary frequency, urgency)
- Gastrointestinal symptoms related to compression of the bowel (e.g., constipation, bloating) as a direct result of the fibroid
- Dyspareunia (painful or difficult sexual relations) as a direct result of the fibroid
The individual is asymptomatic with an abdominally palpable fibroid or significantly enlarged fibroid on abdominal/vaginal examination

UAE is considered medically necessary and, therefore, covered as a treatment for postpartum uterine hemorrhage.

Repeat UAE may be considered medically necessary and, therefore, covered to treat symptoms of uterine fibroids that persist after an initial UAE.

ABSOLUTE CONTRAINDICATIONS

UAE is considered not medically necessary and, therefore, not covered for individuals with ANY of the following absolute contraindications:

Cancers of the endometrium, cervix, or ovaries
Pregnancy
Active infection

EXPERIMENTAL/INVESTIGATIONAL

UAE is considered experimental/investigational and, therefore, not covered for ANY of the following because the safety and/or effectiveness of UAE for these individuals has not been established by a review of the available published peer-reviewed literature:

Treatment of an individual who may want to become pregnant. Please refer to the Guidelines section of this policy for further clarification.
Management of cervical ectopic pregnancy
Treatment of adenomyosis

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

Uterine artery embolization (UAE) is appropriate as a treatment for individuals with symptomatic uterine fibroids who meet any of the following criteria:

The use of anesthesia places the individual at high surgical risk.
The individual has medical contraindications to hysterectomy (e.g., morbid obesity).
The use of hormonal therapy is contraindicated, or the individual is intolerant to or has previously failed a course of hormone therapy.
The individual wishes to avoid hysterectomy.
The individual has hydronephrosis.

Individuals who have received a gonadotropin-releasing hormone (GnRH) agonist to shrink uterine fibroids should not receive treatment with UAE until 6 weeks post-GnRH agonist treatment. UAE performed earlier than 6 weeks after hormone therapy may not be effective.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, UAE for the treatment of uterine fibroids is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in the medical policy are met. However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company. Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

When UAE is performed on an individual who has any of the absolute contraindications listed in this policy, it is considered not medically necessary and, therefore, not covered.

DESIRED FERTILITY

UAE may be appropriate as a treatment for individuals who want to become pregnant or who desire fertility because these individuals may not be candidates for other treatment options such as hormonal therapy, myomectomy, or hysterectomy. However, studies have shown that individuals who are treated with UAE are at increased risk for complications and miscarriages in subsequent pregnancies. Diminished ovarian reserve and increased risk for complications such as postdelivery bleeding have been noted.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for UAE.

Description

Uterine fibroids (leiomyomas) are extremely common benign tumors that are located within the uterine cavity (submucosal fibroids), on the serosal surface of the uterus (subserosal), within the body of the uterine musculature (intramural fibroids), and on a stalk inside or outside the uterus (pedunculated).

Uterine fibroids may be asymptomatic but can cause menorrhagia (excessive menstrual bleeding), pelvic pain, dyspareunia (painful or difficult sexual relations), lower back pain, constipation, urinary frequency, or infertility. Although hysterectomy is considered the definitive treatment of uterine fibroids, it may not be a viable option for individuals who wish to maintain fertility or are at high risk for surgery.

Transcatheter uterine artery embolization (UAE), also known as uterine fibroid embolization (UFE), is a minimally invasive, uterine-sparing treatment option for individuals with uterine fibroids. UAE has several advantages over conventional hormonal suppression and surgical procedures, including avoiding the side effects of drug therapy and the trauma of surgery; lower rate of morbidity; and shorter recovery time. Along with hysteroscopic resection, myolysis, and laparoscopic myomectomy, UAE widens the treatment options for individuals requiring treatment without hysterectomy.

During UAE, the uterine fibroid tumor is selectively devascularized by an injection of embolic agents (e.g., Embosphere® Microspheres) into the vessels that provide the blood supply to the tumor. While the individual is under sedation, a catheter is guided, under fluoroscopy, from the femoral artery (accessed through a percutaneous puncture site in the groin) to the uterine artery that supplies blood to the fibroid. When the catheter reaches the uterine artery, the embolic material is slowly released into the artery. The particles flow to the fibroids, wedge into the vessel, and block the blood flow, causing the fibroids to shrink while sparing surrounding uterine structures. As the fibroids shrink, the

preprocedure symptoms are relieved or reduced.

In most cases, UAE is performed bilaterally and requires overnight hospitalization. During or following the procedure, angiography is performed to assess the effectiveness of the procedure. A radiopaque contrast medium is injected through the catheter used during the procedure, and fluoroscopic images of the vessel are recorded. The images are interpreted to evaluate the status of the blood vessel and the effectiveness of the treatment.

UAE is also used as a treatment of postpartum hemorrhage. Per the American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin #183 (2017), candidates for UAE typically are hemodynamically stable, appear to have persistent slow bleeding, and less-invasive therapy has failed (e.g., uterotonic agents, uterine massage, uterine compression, and manual removal of any clots).

The ACOG issued a Practice Bulletin on Alternatives to Hysterectomy in the Management of Leiomyomas in 2008 (Reaffirmed in 2016). The concerns identified for individuals intending to become pregnant after UAE include age-related impairment of ovarian function and placentation problems caused by a potential compromise of the blood supply to the ovary and endometrium, which can lead to diminished ovarian reserve and abnormal placentation, respectively, even in individuals who are otherwise not at risk for these problems. Therefore, UAE in an individual wishing to become pregnant

postprocedure should be approached with caution; these potential risks must be fully disclosed.

The effect of UAE on pregnancy remains understudied. Although systematic reviews of fertility and pregnancy outcomes after UAE suggest that successful pregnancy is possible, there are higher rates of miscarriage and postpartum hemorrhage compared to individuals with intramural fibroids treated with myomectomy. There are limited data on pregnancy outcomes in individuals who became pregnant following UAE for treatment of postpartum hemorrhage.

A retrospective study published by

Pisco et al. (2017) examining pregnancy rates post-UAE in 359 individuals (mean age, 35.9 years) with uterine fibroids and/or

adenomyosis reported spontaneous pregnancy rates of 29.5 percent and 40.1 percent, at 1 and 2 years post-UAE, respectively. Conventional UAE, involving bilateral artery embolization, was performed in the majority of patients, while 160 received partial UAE, which treated only the small arteries feeding the fibroids. This was done to preserve fertility, with the idea that inducing a lower degree of ischemia to the endometrium may aid in ease of conception. Using Kaplan-Meier estimation, this research group found the overall probability of successful pregnancy with live birth 1 year following surgery was 24.4 percent, and after 2 years was 36.7 percent. Cox proportional hazards modeling showed there to be no significant difference in spontaneous pregnancy 1 year after partial or conventional UAE (hazard ratio, 1.27; 95 percent confidence interval [CI], 0.92–1.75; P=0.14), and no difference between groups for successful pregnancy ending in live birth (hazard ratio, 1.25; 95 percent CI, 0.87–1.80; P=0.21). Notably, adverse events were not worse in the partial UAE group relative to the conventional group: 14.6 percent vs. 23.1 percent; P=0.04. These data suggest that UAE may show itself to be a safe and effective approach towards fibroids in individuals who desire to retain their fertility.

Few studies have been reported that focus specifically on repeat UAE in individuals whose symptoms have either responded incompletely or recurred after the initial UAE. Although there is a lack of controlled studies on repeat UAE, several case series have reported a high success rate after a second UAE for recurrent or persistent symptoms.

There are other indications that may potentially be aided by use of UAE, including

adenomyosis.

Adenomyosis, also called uterine endometriosis, occurs when the lining of the uterus (endometrium) grows into the muscular wall of the uterus. The displaced tissue thickens, breaks down, and bleeds during each menstrual cycle. This condition is associated with cramps, heavy bleeding, and discomfort that impacts quality of life.

Several studies conducted on the efficacy of UAE in symptomatic

adenomyosis have shown sustained clinical and symptomatic improvements. A 2011 systematic review by

Popovic et al. of 15 studies including 511 individuals with

adenomyosis found statistically significant clinical improvement in 75 percent of subjects at short- and long-term follow-up. In 2016, a retrospective observational study examining treatment of

adenomyosis with UAE reported improvement in dysmenorrhea and menorrhagia in patients with vascular lesions (n=252; Zhou et al.). Other studies (Kitamura et al., 2006; Kim et al., 2007; de

Bruijn et al., 2017) also reported positive outcomes in the use of UAE for this indication. However, none of these studies were controlled or randomized. As such, the efficacy of UAE in

adenomyosis remains unclear, due to a lack of high-quality data. Larger scale, randomized controlled studies with longer follow-up times are mandatory to determine the efficacy of UAE in the treatment of

adenomyosis.

Additionally, the current available ACOG Committee Opinion regarding

adenomyosis and other causes of abnormal uterine bleeding (“Management of Acute Abnormal Uterine Bleeding in

Nonpregnant Reproductive Aged Women”, Committee Opinion 557) allows physicians to use discretion in the treatment of abnormal uterine bleeding, depending on clinical circumstances and patient desire for future fertility. Although the organization does not specifically rule out the use of UAE for

adenomyosis, it is also not explicitly recommended.

Available studies have demonstrated improved conditions after treatment for some individuals; however, there is overall insufficient evidence to support its use. In consideration of available evidence and professional society guidelines, use of UAE cannot be established as medically necessary for this indication.

In addition to

adenomyosis, UAE has been proposed for management of cervical ectopic pregnancy and uterine arteriovenous malformations; however, there are no controlled studies evaluating UAE for management of cervical ectopic pregnancy or uterine arteriovenous malformations.

References

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Coding

CPT Procedure Code Number(s)

36245, 36246, 36247, 36248, 37243

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

D25.0 Submucous leiomyoma of uterus

D25.1 Intramural leiomyoma of uterus

D25.2 Subserosal leiomyoma of uterus

D25.9 Leiomyoma of uterus, unspecified

O72.0 Third-stage hemorrhage

O72.1 Other immediate postpartum hemorrhage

O72.2 Delayed and secondary postpartum hemorrhage

HCPCS Level II Code Number(s)

N/A

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 11.06.04k:

06/24/2026	The policy has been reviewed and reissued to communicate the Company's continuing position on uterine artery embolization.
03/05/2025	The policy has been reviewed and reissued to communicate the Company's continuing position on uterine artery embolization.
03/20/2024	The policy has been reviewed and reissued to communicate the Company's continuing position on Uterine Artery Embolization.
06/28/2023	The policy has been reviewed and reissued to communicate the Company's continuing position on Uterine Artery Embolization.
06/29/2022	The policy has been reviewed and reissued to communicate the Company's continuing position on Uterine Artery Embolization.
06/02/2021	The policy has been reviewed and reissued to communicate the Company's continuing position on Uterine Artery Embolization.
04/08/2020	This policy has been reissued in accordance with the Company's annual review process.
05/20/2019	This version of the policy will become effective 05/20/2019. The intent of this policy remains unchanged, but the policy has been updated to provide additional clinical research information.

Revisions From 11.06.04j:

04/11/2018

This policy has undergone routine review, and no revisions have been made.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

5/20/2019

Version Issued Date: