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Clinical Policy Bulletin:
Hysteroscopic Tubal Sterilization
Number: 0657


Policy

Aetna considers hysteroscopic tubal sterilization (e.g., the Essure Micro-Insert and the Adiana Permanent Contraception System) medically necessary for women who desire permanent birth control by bilateral occlusion of the fallopian tubes.

Aetna considers hysteroscopic tubal sterilization (e.g., the Essure Micro-Insert and the Adiana Permanent Contraception System) experimental and investigational for all other indications.

Contraindications to hysteroscopic tubal sterilization are presented as an appendix to the background section.



Background

The Essure Miro-Insert System is an 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.

In an observational, multi-center, 6-month study, Panel and Grosdemouge (2008) evaluated a new hysteroscopic method of tubal sterilization; specifically, to examine the factors associated with placement failure of Essure implants.  A total of 7 gynecology clinics, including 5 public hospitals and 2 private clinics; and a total of 495 women who provided informed consent were included in this study.  All procedures were done by a vaginoscopic approach with a 5-mm operating hysteroscope.  Data collected were age, parity, type of anesthesia, pre-medication, endometrial aspect, ostia visualization, duration of the procedure, pain during the procedure, and associated procedures.  Unilateral and bilateral placement rates were assessed.  Adverse events at 3 months (e.g., expulsion, migration, perforation) were also recorded.  Mean parity was 2.45; 20 women were nulliparous.  In 56.3 % of cases (n = 277), none or local anesthesia was used for the placement procedure.  Overall, 86 % of the women (n = 423) had non-steroidal anti-inflammatory drug (NSAID) pre-medication, and 8.1 % (n = 40) had another intra-uterine surgical procedure performed at the same time.  In 24 cases, at least one of the tubal ostia could not be visualized well during hysteroscopy.  The authors concluded that the failure rate for Essure micro-insert placement was 6 % at first attempt and 3.3 % after two attempts.  Success rate was not significantly associated with parity, mode of analgesia, NSAID pre-medication, or combination with another procedure.  The only factor significantly associated with the failure rate was poor visualization of the tubal ostia.

An assessment by the National Institute for Health and Clinical Excellence (NICE, 2009) concluded that current evidence on the safety and efficacy of hysteroscopic sterilization by tubal cannulation and placement of intrafallopian implants is adequate to support the use of this procedure.

Vancaillie and colleagues (2008) evaluated placement efficacy and reliability of a an intra-tubal occlusion device, the Adiana System for Transcervical Sterilization, for permanent contraception and assessed tolerability and overall satisfaction.  A total of 770 women with known parity were recruited to participate in a prospective, multi-center study.  Bipolar, low-level radiofrequency energy delivery and porous silicon inserts were used.  Inserts were placed bilaterally in the fallopian tube lumen.  Subsequent bilateral occlusion was assessed with hysterosalpingography.  Overall, bilateral placement success was achieved in 611 of 645 women (95 %).  Bilateral occlusion was confirmed in 570 of 645 (88.4 %).  The 1-year pregnancy prevention rate as derived with life-table methods was 98.9 %.  The authors concluded that this transcervical sterilization system offers an effective contraceptive method, which was well-tolerated and had a high satisfaction rate.

Palmer and Greenberg (2009) compared the available data on transcervical sterilization procedures (Essure and Adiana) to study the strengths and weakness of each system.  The authors reported that the Essure implants have been offered to women in the U.S. for 7 years and have proved to be safe, effective, and well-tolerated.  On the other hand, the experience with the Adiana system is limited (with only 12-month data).  However, results from the pivotal study provided important clinical information.  As with the Essure implants, the Adiana system appears to be well-tolerated with low rates of side effects, although more data are clearly needed.  The overall bilateral placement rates for both systems are similar (94 % to 95 %), and the rates of tubal occlusion following hysterosalpingography are comparable.  There have been no reported pregnancies after Essure implantation from the phase II and pivotal clinical trials. 

Results from the Evaluation of the Adiana System for Transcervical Sterilization study (Vancaillie et al, 2008) indicated that the cumulative failure rate of the Adiana system using life-table methods was 1.07 % at the primary endpoint of 1 year, which falls within the range of other sterilization methods (0 to 2.4 %).

On July 6, 2009, the FDA approved the Adiana Permanent Contraception System for women who desire permanent birth control by occlusion of the fallopian tubes.

 

Appendix

Hysteroscopic tubal sterilization is contraindicated in any woman who:

  • Is uncertain about her desire to end fertility; or
  • Can have only occlusion device placed (including members with apparent contralateral proximal tubal occlusion and members with a suspected unicornuate uterus); or
  • Has previously undergone a tubal ligation.

Hysteroscopic tubal sterilization 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 occlusion device 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:
  1. 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.
  2. 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.
  3. Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Selective tubal occlusion procedure. Emerging Device List No. 5. Ottawa, ON: CCOHTA; June 2001.
  4. National Horizon Scanning Centre (NHSC). Selective tubal occlusion (Essure) for female sterilisation - horizon scanning review. Birmingham, UK: NHSC; 2002.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. Connor VF. Contrast infusion sonography to assess microinsert placement and tubal occlusion after Essure. Fertil Steril. 2006;85(6):1791-1793.
  12. Alberta Heritage Foundation for Medical Research (AHFMR). Hysteroscopic tubal sterilization (Essure (TM) system). Technote TN 57. Edmonton, AB: AHFMR; 2006.
  13. 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.
  14. Hopkins MR, Creedon DJ, Wagie AE, et al. Retrospective cost analysis comparing Essure hysteroscopic sterilization and laparoscopic bilateral tubal coagulation. J Minim Invasive Gynecol. 2007;14(1):97-102.
  15. 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.
  16. 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.
  17. Vancaillie TG, Anderson TL, Johns DA. A 12-month prospective evaluation of transcervical sterilization using implantable polymer matrices. Obstet Gynecol. 2008;112(6):1270-1277.
  18. Podolsky ML, Desai NA, Waters TP, Nyirjesy P. Hysteroscopic tubal occlusion: Sterilization after failed laparoscopic or abdominal approaches. Obstet Gynecol. 2008;111(2 Pt 2):513-515.
  19. Thiel JA, Carson GD. Cost-effectiveness analysis comparing the Essure tubal sterilization procedure and laparoscopic tubal sterilization. J Obstet Gynaecol Can. 2008;30(7):581-585.
  20. Panel P, Grosdemouge I. Predictive factors of Essure implant placement failure: Prospective, multicenter study of 495 patients. Fertil Steril. 2008 Nov 18. [Epub ahead of print].
  21. Palmer SN, Greenberg JA. Transcervical sterilization: A comparison of Essure(r) permanent birth control system and Adiana(r) permanent contraception system. Rev Obstet Gynecol. 2009;2(2):84-92.
  22. U.S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health. Approval letter for the Adiana Permanent Contraception System. Rockville, MD: FDA; July 6, 2009. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf7/P070022a.pdf. Accessed August 28, 2009.
  23. National Institute for Health and Clinical Excellence (NICE). Hysteroscopic sterilisation by tubal cannulation and placement of intrafallopian implants. Interventional Procedure Guidance 315. London, UK: NICE; September 2009.


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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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