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Endometrial ablation is a potential alternative to hysterectomy for menorrhagia. A variety of approaches are available; these are generally classified into hysteroscopic techniques (eg, Nd-YAG laser, electrosurgical rollerball) and nonhysteroscopic techniques (eg, cryosurgical, radiofrequency ablation).
Ablation 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. These include: neodymium-yttrium aluminum garnet (Nd-YAG) laser, a resecting loop using electric current, 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 and do not require hysteroscopic procedures. (Other terminology for these categories of techniques include first- generation versus second-generation procedures and resectoscopic versus nonresectoscopic endometrial ablation methods). 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). 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.
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 maternal and fetal morbidity and mortality associated with pregnancy after endometrial ablation. Thus, U.S. Food and Drug Administration (FDA) approval of endometrial ablation devices includes only women for whom childbearing is complete.
The FDA indicates that endometrial devices are for use in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. FDA has approved devices for endometrial ablation through the premarket approval process. 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. Examples of devices for endometrial ablation are:
FDA Product Code: HHR.
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.
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.
In February 2013, FDA downgraded its contraindication of NovaSure for women with Essure® contraceptive microinserts to a warning. The warning states that a health hazard may exist when a NovaSure procedure is performed in women with improperly positioned Essure® microinserts. To verify proper placement, a report of the Essure Confirmation Test should be obtained prior to performing the NovaSure procedure. The labeling change also includes the requirement for a post-approval study.
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 Nervous/Mental Conditions, 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 Medically Necessary, “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.
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.
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.
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.