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DESCRIPTIONAblation or destruction of the endometrium is used to treat menorrhagia in women who failed standard therapy. It is considered a less invasive alternative to hysterectomy however as with hysterectomy, the procedure is not recommended for women who wish to preserve their fertility.
Multiple energy sources have been used: (1) the neodymium-yttrium aluminum garnet (Nd-YAG) laser; (2) a resecting loop using electric current; (3) electric rollerball; and (4) thermal ablation devices, including high-frequency radio frequency (RF) probes, cryoprobes, liquid-filled balloons, multi-electrode balloons, microwave energy, and installation of heated saline. 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 and do not require hysteroscopic procedures. Hysteroscopic techniques were developed first; the initial technique was photovaporization of the endometrium using a 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 or TCRE). Hydrothermal ablation also involves hysteroscopy. Hysteroscopic techniques require skilled surgeons and, due to the requirement for cervical dilation, 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 such that very accurate monitoring of fluids is required.
The ThermaChoice® device has been approved by the U.S. Food and Drug Administration (FDA) as a technique for endometrial ablation; this 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, such as myomas, polyps, or large size due to fibroids, are generally not considered candidates for this procedure.
Her OptionTM Uterine Cryoablation TherapyTM System is an FDA-approved device consisting in part of 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.
The Hydro ThermAblator® System, another FDA approved device for endometrial ablation, involves the instillation and circulation of heated saline into the uterus using hysteroscopic guidance. The Genesys HTA System, a newer version of this technology including features such as a smaller console and simplified set-up requirements, was approved by the FDA in May 2010.
The NovaSureTM impedance controlled endometrial ablation system delivers radiofrequency energy to the endometrial surface. This FDA-approved device consists of an electrode array on a stretchable porous fabric that conforms to the endometrial surface.
The MEA System from Microsulis Medical, which delivers fixed-frequency microwave energy, has also received FDA approval for endometrial ablation.
POLICYEndometrial 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 and would otherwise be considered a candidate 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:
Endometrial ablation is considered investigational for all other indications.
POLICY GUIDELINESMicrowave ablation, thermal ablation and cryoablation may be performed in an office setting.
Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/1992: 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.
SOURCE(S)Blue Cross Blue Shield Association policy # 4.01.04
CODE REFERENCEThis 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.
This may not be a comprehensive list of procedure codes applicable to this policy.