Endometrial Ablation

POLICY NUMBER

L.4.01.403

DESCRIPTION

Endometrial ablation is a potential alternative to hysterectomy for treatment of abnormal uterine bleeding. When considering treatment, two techniques present themselves: the hysteroscopic technique (eg, Nd-YAG laser, electrosurgical rollerball) and nonhysteroscopic techniques (eg, cryosurgical, radiofrequency ablation).

Abnormal Uterine Bleeding

A number of conditions cause abnormal uterine bleeding, including fibroids, polyps, and endometrial hyperplasia. Prevalence estimates for abnormal uterine bleeding range between 10% and 30%, varying by population and condition definition.

TreatmentAblation or destruction of the endometrium is used to treat abnormal uterine bleeding in women who have failed standard therapy. It is considered a less invasive alternative to hysterectomy; however, as with hysterectomy, the procedure is not recommended for women who want to preserve fertility.

Multiple energy sources have been used, which include: an neodymium-yttrium aluminum garnet (Nd-YAG) laser, a resecting loop using electric current, an electric rollerball, and thermal ablation devices. Endometrial ablation is typically preceded by hormonal treatment to thin the endometrium. 

Techniques for endometrial ablation are generally divided into two categories: those that do require hysteroscopic procedures and those that do not (other terminology for these categories of techniques includes first-generation versus second-generation procedures and resectoscopic versus nonresectoscopic endometrial ablation methods). Hysteroscopic techniques were developed first; the initial technique was photo-vaporization of the endometrium using an Nd-YAG laser, and this was followed by electrosurgical ablation using an electrical rollerball or electrical wire loop (the latter technique is also known as transcervical resection of the endometrium). Hydrothermal ablation also involves hysteroscopy. Hysteroscopic techniques require skilled surgeons and, due to the requirement for cervical dilation, the use of general or regional anesthesia. In addition, the need for the instillation of hypotonic distension media creates a risk of pulmonary edema and hyponatremia, which requires very accurate fluid monitoring.

Non-hysteroscopic techniques can be performed without general anesthesia and do not involve use of a fluid distention medium. Techniques include thermal fluid-filled balloon, cryosurgical endometrial ablation, instillation of heated saline, and radiofrequency ablation.

There are concerns about morbidity and mortality for both the mother and the fetus when becoming pregnant after endometrial ablation. Thus, U.S. Food and Drug Administration (FDA) approval of endometrial ablation devices includes only women for whom childbearing is complete.

Endometrial devices have been approved by the U.S. Food and Drug Administration through the premarket approval process for use in premenopausal women who are no longer bearing children and experiencing abnormal uterine bleeding due to benign causes. These devices include, but may not be limited to, laser therapy, electrical wire loop, rollerball using electric current, and thermal ablation using a liquid-filled balloon, microwave, electrode array, or a cryosurgical device. The table below provides examples of devices for endometrial ablation.

Endometrial Ablation Devices Approved by the Food and Drug Administration

Heated Fluid Devices:

• The ThermaChoice® device ablates endometrial tissue by thermal energy heating of sterile injectable fluid within a silicone balloon. Endometrial ablation will only work when there is direct contact between the endometrial wall and the fluid-filled balloon. Therefore, patients with uteri of abnormal shape, resulting from tumors such as myomas, polyps, or large size, due to fibroids, are generally not considered candidates for this procedure.

• The Genesys HTA™ System involves the instillation and circulation of heated saline into the uterus using hysteroscopic guidanceand includes features such as a smaller console and simplified set-up requirements.

Cryoablation Devices:

• Her Option™ Uterine Cryoablation Therapy system consists of, in part, a cryoprobe that is inserted through the cervix into the endometrial cavity. When cooled, an ice ball forms around the probe, which permanently destroys the endometrial tissue. Cryoablation is typically monitored by abdominal ultrasound.

Radiofrequency Devices:

• The Microwave Endometrial Ablation (MEA) System delivers fixed-frequency microwave energy, may be performed in a physician’s office, and requires use of the hysteroscope.

• The NovaSure™ Impedance Controlled Endometrial Ablation System consists of an electrode array on a stretchable porous fabric that conforms to the endometrial surface.

FDA Product Code: MNB.

POLICY

Endometrial ablation, with or without hysteroscopic guidance, using an FDA-approved device may be considered medically necessary in women with abnormal uterine bleeding who are not candidates for, or who are unresponsive to, hormone therapy and would otherwise be considered candidates for hysterectomy.

Note: Intrauterine ablation or resection of the endometrium should not be confused with laparoscopic laser ablation of intraperitoneal endometriosis. This policy does not address laparoscopic intraperitoneal ablation.

Contradictions for intrauterine ablation or resection of the endometrium include:

• Patient who is pregnant or desires pregnancy

• History of endometrial cancer or pre-cancerous histology

• Patient with an active genital or urinary tract infection at the time of the procedure

• Patient with active pelvic inflammatory disease

• Patient with an intrauterine device (IUD or Essure contraceptive micro-inserts) currently in place

• Patient with any anatomic or pathologic condition in which weakness of the of the myometrium could exist, such as history of previous classical cesarean sections or transmural myomectomy.

 Endometrial ablation is considered investigational for all other indications.

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.

Microwave ablation, thermal ablation and cryoablation may be performed in an office setting.

Other contraindications for microwave ablation include myometrial thickness less than 10 mm, and uterine sounding length less than 6 cm.

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

5/1992: Approved by Medical Policy Advisory Committee (MPAC).

2/1998: Reviewed with changes; new techniques described.

2/1999: Reviewed with changes; new device included.

2/15/2002: Investigational definition added.

3/13/2002: New 2002 code added, 4th digit added to 627.

4/26/2002: Type of Service and Place of Service deleted.

6/12/2002: ICD-9 diagnosis codes V10.42, 618.1-618.4 and 621.2 added.

7/2003: Reviewed by MPAC, "Description" section revised to be consistent with BCBSA, policy statement specifies any FDA-approved device instead of specific statements on individual devices, "Thermal fluid-filled balloon endometrial ablation can be performed without general anesthesia and can be performed in a physician's office. The entire procedure takes about 30 minutes. Unlike other endometrial ablation techniques, thermal balloon endometrial ablation does not require hysteroscopy for guidance." deleted from "Policy Guidelines," Sources updated.

3/10/2004: Code Reference section updated, CPT code 56356 deleted, ICD-9 diagnosis code 280.0 deleted.

3/22/2005: Code Reference section updated, CPT code 0009T deletion date of 12/31/2004 added, CPT code 58356 with effective date 1/1/2005 added covered codes, CPT code 0071T, 0072T with effective date 1/1/2005 added non-covered codes, ICD-9 diagnosis code 618.1, 618.2, 618.3, 618.4, 621.2, V10.42 deleted non-covered codes.

3/31/2005: Policy statement “Endometrial ablation, with or without hysteroscopic guidance using an FDA-approved device, may be considered medically necessary in women with menorrhagia who are not candidates for, or who are unresponsive to, hormone therapy or dilation and curettage.” changed to “Endometrial ablation, with or without hysteroscopic guidance, may be considered medically necessary in women with menorrhagia who are not candidates for, or who are unresponsive to, hormone therapy or dilation and curettage.”

3/16/2006: Policy reviewed, no changes.

08/14/2010: Policy description updated regarding treatment approaches and available devices. “Dilation and curettage” removed from policy statement and “would otherwise be considered a candidate for hysterectomy” added. Policy guidelines updated to indicate that microwave ablation, thermal ablation, and cryoablation may be performed in an office setting. 

08/11/2011: For clarity purposes, added a policy statement to indicate that endometrial ablation is considered investigational for all other indications. Deleted outdated references from the Sources section.

09/25/2012: Policy reviewed; no changes.

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

08/20/2014: Policy reviewed; description updated regarding devices. Policy statement unchanged.

08/18/2015: Medical policy revised for ICD-10.

10/27/2015: Policy description updated. Policy statements unchanged. Policy guidelines updated regarding contraindications for microwave ablation and NovaSure. Added medically necessary and investigative definitions.

05/27/2016: Policy number A.4.01.04 added.

09/22/2016: Policy description and policy statement updated to change "menorrhagia" to "abnormal uterine bleeding." Intent of policy statement unchanged.

08/31/2017: Policy description updated. Policy statements unchanged. Policy Guidelines updated to remove FDA contraindication for NovaSure.

08/21/2018: Policy description updated regarding abnormal uterine bleeding and devices. Policy statements unchanged.

03/27/2023: Policy reviewed. Policy statements unchanged. Medical policy number changed from "A.4.01.04" to "L.4.01.403." Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

04/29/2024: Policy reviewed; no changes.

03/28/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 4.01.04

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

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

Investigational Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.