Occlusion of Uterine Arteries Using Transcatheter Embolization

POLICY NUMBER

L.4.01.417

DESCRIPTION

Transcatheter uterine artery embolization (UAE) is a minimally invasive technique that involves the injection of small particles, gelfoam, coils, or glue into the uterine arteries to block the blood supply to the uterus and uterine fibroids. It potentially serves as an alternative to hysterectomy. UAE has also been used to treat postpartum hemorrhage, cervical ectopic pregnancy, uterine arteriovenous malformations, and adenomyosis.

Uterine Artery Embolization

There is interest in techniques that directly devascularize the uterine fibroid by interrupting the uterine arteries. One technique, uterine artery embolization, involves selective catheterization of the uterine arteries with injection of embolization material. Uterine artery embolization has also been used to control bleeding in situations such as severe postpartum hemorrhage, cervical ectopic pregnancy, bleeding uterine arteriovenous malformations (AVMs), and adenomyosis.

In April 2000, Embosphere® Microspheres (Merit Medical, formerly BioSphere Medical) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for hypervascularized tumors and arteriovenous malformations. In 2002, this product was cleared for marketing specifically for use in uterine fibroid embolization. Since then, several other devices have been cleared for marketing. In 2003, Coutour® Emboli PVA (Boston Scientific) was cleared for marketing by the FDA through the 510(k) process for the embolization of peripheral hypervascular tumors and peripheral arteriovenous malformations. In March 2004, the Contour SE™ (Boston Scientific) was cleared for marketing by the FDA through the 510(k) process for the treatment of uterine fibroids. In 2008, Polyvinyl Alcohol Foam Embolization Particles (Cook Inc.) was cleared for marketing by the FDA through the 510(k) process for use in uterine fibroid embolization. In 2016, Bead Block™ microspheres (Biocompatibles UK) were cleared for marketing by the FDA for embolization of uterine fibroids and AVMs. In 2020, Hydropearl® Microspheres (MicroVention, Inc.) was cleared for marketing by the FDA for the embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids.

POLICY

Transcatheter embolization of uterine arteries as a treatment of uterine fibroids or as a treatment of postpartum uterine hemorrhage may be considered medically necessary.

There are no specific criteria for uterine artery embolization regarding the size, location, or multiplicity of fibroid tumors. The American College of Obstetricians and Gynecologists has suggested the following general criteria for treatment of fibroid tumors:

• Asymptomatic fibroids of such size that they are palpable abdominally and are a concern to the patient; OR

• Excessive uterine bleeding as evidenced by either profuse bleeding lasting more than 8 days, or anemia due to acute or chronic blood loss; OR

• Pelvic discomfort caused by myomata, either acute severe pain, chronic lower abdominal pain, or low back pressure or bladder pressure with a urinary frequency not due to urinary tract infection.

One repeat transcatheter embolization of uterine arteries to treat persistent symptoms of uterine fibroids after an initial uterine artery embolization may be considered medically necessary (See Policy Guidelines).

Transcatheter embolization for the management of all other indications, including cervical ectopic pregnancy, uterine arteriovenous malformation, and adenomyosis is considered investigational.

POLICY EXCEPTIONS

None

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.

One repeat uterine artery embolization may be performed when there is documentation of continued symptoms such as bleeding or pain. Repeat procedures may be most appropriate when there are persistent symptoms in combination with findings on imaging of an incomplete initial procedure, as evidenced by continued blood flow to the treated regions. Limited data from case series have suggested a high rate of success following repeat procedures for this purpose, with most patients reporting relief of symptoms.

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

2/1999: Approved by Medical Policy Advisory Committee.

7/16/2001: Hayes report added to the Source(s) section.

2/14/2002: Investigational definition added.

4/22/2002: Type of Service and Place of Service deleted.

5/6/2002: Code Reference section updated.

5/2002: Reviewed by MPAC, investigational status remains.

8/2002: Reviewed by MPAC, investigational status changed to medically necessary.

12/16/2002: Code Reference section updated.

8/20/2003: ICD-9 diagnosis code range 218.0-218.9 listed separately.

11/5/2003: Code Reference section reviewed; no changes.

9/6/2006: Policy reviewed and policy section clarified.

3/5/2007: Code Reference section updated per quarterly HCPCS revisions. Added CPT code 37210.

1/14/2008: Policy reviewed, no changes.

7/18/2008: Anesthesia Coding Policy hyperlink added.

1/8/2009: Policy reviewed, no changes.

4/27/2010: Policy Description section revised to add laparoscopic bipolar coagulation of uterine vessels and FDA information. Code Reference section was revised to add the following language: "*Some covered procedure codes may have multiple descriptions. Coverage will only be made for covered codes when used for services outlined within the policy statement." Policy statement unchanged.

05/17/2011: Information regarding laparoscopic occlusion was removed from the policy description and policy statement. Policy statement regarding transcatheter uterine artery embolization unchanged. Policy titled changed from "Uterine Artery Embolization for Treatment of Fibroids" to "Occlusion of Uterine Arteries Using Transcatheter Embolization" to reflect the new scope of the policy. Outdated references removed from the Sources section.

09/25/2012: Added treatment of postpartum uterine hemorrhage to the medically necessary policy statement. Policy statement regarding repeat transcatheter embolization was changed from investigational to the following: One repeat transcatheter embolization of uterine arteries to treat persistent symptoms of uterine fibroids after an initial uterine artery embolization may be considered medically necessary with patient selection criteria added to the policy guidelines. Added the following policy statement: Transcatheter embolization for the management of cervical ectopic pregnancy is considered investigational. Added 666.00 - 666.24 to the Covered Codes table.

11/06/2013: Policy reviewed; no changes.

04/01/2014: Added the following new 2014 CPT code(s) to the Code Reference section: 37243.

09/11/2014: Policy reviewed; description updated. Investigational policy statement updated to state that transcatheter embolization for the management of all other indications, including cervical ectopic pregnancy and uterine arteriovenous malformation is considered investigational. It previously stated: Transcatheter embolization for the management of cervical ectopic pregnancy is considered investigational.

09/01/2015: Code Reference section updated for ICD-10. Added ICD-9 procedure codes 68.24 and 68.25.

11/02/2015: Policy description updated regarding devices. Policy statements unchanged. Policy guidelines section updated to add medically necessary and investigative definitions.

05/27/2016: Policy number A.4.01.11 added.

09/23/2016: Policy description updated to include adenomyosis. Policy statement updated to add adenomyosis as an investigational indication.

09/01/2017: Policy description updated regarding uterine fibroids and treatment of ectopic pregnancies, uterine arteriovenous malformations, and adenomyosis. Policy statements unchanged.

08/22/2018: Policy description updated regarding treatment of uterine fibroids. Policy statements unchanged.

09/10/2019: Policy description revised. Policy statements unchanged.

09/21/2020: Policy description updated regarding products. Policy statements unchanged.

07/24/2023: Policy updated to change the medical policy number from "A.4.01.11" to "L.4.01.417." Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

06/06/2024: Policy reviewed; no changes.

08/01/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 4.01.11

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.

Covered Codes

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