Aetna considers implantation of the Essure Micro-Insert medically necessary for women who desire permanent birth control by bilateral occlusion of the fallopian tubes.
Aetna considers the Essure Micro-Insert experimental and investigational for all other indications.
Contraindications to use of the Essure Micro-Insert are presented as an appendix to the background section.
Background
The Essure Miro-Insert System is the first FDA-approved hysteroscopic approach to tubal sterilization. The primary advantages of the Essure System over other techniques of female sterilization are that the Essure System is non-incisional and sterilization can be performed without general anesthesia.
Using a hysteroscopic approach, one Essure micro-insert is placed in the proximal section of each fallopian tube lumen. The micro-insert expands upon release, acutely anchoring itself in the fallopian tube. The micro-insert subsequently elicits a benign tissue response. Tissue in-growth into the micro-insert anchors the device and occludes the fallopian tube, resulting in sterilization.
FDA approval of the Essure System was based on the results of a Phase III clinical trial involving 518 sexually active reproductive-age women who underwent a placement procedure. The Essure System was reported to be 98 percent effective in preventing pregnancy after two years follow up.
The primary endpoints of the Phase III study of Essure were pregnancy prevention, safety of the placement procedure, and safety of long-term use. Secondary endpoints included patient satisfaction and bilateral placement rate. Bilateral placement rate was 86% on 1st attempt and 90% on 2nd attempt. Average hysteroscopy time was 13 minutes, and average procedure time was 35 minutes.
Nichols et al (2006) compared hysteroscopic female sterilization with the Essure system performed in-office versus a hospital operating room (OR) among newly trained physicians. Procedure time (scope in/scope out time), device placement rates, and incidence of complications and adverse events were compared. There was no significant difference in scope time between the 2 settings. There was no significant difference in placement rates, although the placement rate was somewhat higher in-office (91 % versus 88 %). There were no complications among any of the procedures, and the incidence of minor adverse events was extremely low in both settings (OR = 2 %, in-office = 1 %). The authors concluded that thereis no clear advantage to performing hysteroscopic sterilization with the Essure system in a hospital operating room. Hysteroscopic sterilization can be performed safely and efficiently in an office setting.
Appendix
According to the FDA-approved labeling, the Essure System is contraindicated in any woman who:
Is uncertain about her desire to end fertility; or
Can have only 1 micro-insert placed (including members with apparent contralateral proximal tubal occlusion and members with a suspected unicornuate uterus); or
Has previously undergone a tubal ligation.
The Essure System is also contraindicated for women with any of the following conditions:
Pregnancy or suspected pregnancy; or
Delivery or termination of a pregnancy less than 6 weeks before Essure micro-insert placement; or
Active or recent upper or lower pelvic infection; or
Known allergy to contrast media or known hypersensitivity to nickel confirmed by skin test.
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
58565
58615
ICD-9 codes covered if selection criteria are met:
V25.2
Encounter for sterilization
ICD-9 codes contraindicated for this CPB:
614.3, 614.4, 614.9
Acute, chronic, or unspecified pelvic infection
630 - 677
Complications of pregnancy, childbirth, and the puerperium
752.19
Other anomaly of fallopian tubes
752.3
Other anomalies of uterus
V22.0 - V23.9
Supervision of pregnancy
V24.0
Postpartum care and examination immediately after delivery
V26.51
Tubal ligation status
The above policy is based on the following references:
Conceptus, Inc. Essure Microinsert System. Prescribing information. Document No. CC-0366. San Carlos, CA: Conceptus; July 16, 2004. Available at: http://www.essure.com/static/hcp/prescribing.pdf. Accessed October 13, 2005.
Kerin JF, Carignan CS, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: Results of the first Essure pbc clinical study. Aust N Z J Obstet Gynaecol. 2001;41(4):364-370.
Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Selective tubal occlusion procedure. Emerging Device List No. 5. Ottawa, ON: CCOHTA; June 2001.
National Horizon Scanning Centre (NHSC). Selective tubal occlusion (Essure) for female sterilisation - horizon scanning review. Birmingham, UK: NHSC; 2002.
National Institute for Clinical Excellence (NICE). Hysteroscopic sterilisation by tubal cannulation and placement of intrafallopian implant. Interventional Procedure Guidance 44. London, UK: NICE; February 2004. Available at: http://www.nice.org.uk/page.aspx?o=104525. Accessed October 13, 2005.
Ubeda A, Labastida R, Dexeus S. Essure: A new device for hysteroscopic tubal sterilization in an outpatient setting. Fertil Steril. 2004;82(1):196-199.
Medical Services Advisory Committee (MSAC). Hysteroscopic sterilisation by tubal cannulation and placement of intrafallopian implant. Assessment Report. MSAC Application 1055. Canberra, ACT: MSAC; November 2003. Available at: http://www.msac.gov.au/reports.htm#1055. Accessed October 13, 2005.
McSwain H, Shaw C, Hall LD. Placement of the Essure permanent birth control device with fluoroscopic guidance: A novel method for tubal sterilization. J Vasc Interv Radiol. 2005;16(7):1007-1012.
Kerin JF, Levy BS. Ultrasound: an effective method for localization of the echogenic Essure sterilization micro-insert: correlation with radiologic evaluations. J Minim Invasive Gynecol. 2005;12(1):50-54.
Weston G, Bowditch J. Office ultrasound should be the first-line investigation for confirmation of correct ESSURE placement. Aust N Z J Obstet Gynaecol. 2005;45(4):312-315.
Thiel JA, Suchet IB, Lortie K. Confirmation of Essure microinsert tubal coil placement with conventional and volume-contrast imaging three-dimensional ultrasound. Fertil Steril. 2005;84(2):504-508.
Connor VF. Contrast infusion sonography to assess microinsert placement and tubal occlusion after Essure. Fertil Steril. 2006;85(6):1791-1793.
Alberta Heritage Foundation for Medical Research (AHFMR). Hysteroscopic tubal sterilization (Essure (TM) system). Technote TN 57. Edmonton, AB: AHFMR; 2006.
Nichols M, Carter JF, Fylstra DL, Childers M; Essure System U.S. Post-Approval Study Group. A comparative study of hysteroscopic sterilization performed in-office versus a hospital operating room. J Minim Invasive Gynecol. 2006;13(5):447-450.
Sinha D, Kalathy V, Gupta JK, Clark TJ. The feasibility, success and patient satisfaction associated with outpatient hysteroscopic sterilisation. BJOG. 2007;114(6):676-683.
Scarabin C, Dhainaut C. The ESTHYME study. Women's satisfaction after hysteroscopic sterilization (Essure micro-insert). A retrospective multicenter survey. Gynecol Obstet Fertil. 2007;35(11):1123-1128.
Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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