DESCRIPTION
Hysteroscopic placement of micro-inserts in the fallopian tubes is a form of permanent sterilization. Micro-inserts are inserted bilaterally into the fallopian tubes. An example of the micro-inserts for sterilization is the Essure™ systems. Permanent scarring caused by the inserts occludes the fallopian tubes, rendering the individual infertile. Due to FDA requirements, the individual must undergo a hysterosalpingogram (HSG) at three months to confirm occlusion from the micro-inserts has occurred. If the tube(s) are not fully occluded at this time, the HSG is repeated at six months. Individuals must rely on alternate forms of birth control until complete occlusion is confirmed.
Hysteroscopic oviductal blocking (i.e., tubal occlusion) is also intended for the purpose of sterilization. Small silicone rubber plugs are injected into the fallopian tubes by means of a hysteroscope that is inserted into the uterine cavity. Once placed in the fallopian tubes the plugs are to purposely cause blockage and sterilization.
POLICY
Hysteroscopic micro-inserts for permanent sterilization are considered medically necessary.
Hysteroscopic micro-inserts for conditions other than permanent sterilization are considered investigational.
Hysteroscopic oviductal blocking (tubal occlusion via silicone plugs) is considered investigational.
Any micro-insert utilized for this procedure must have FDA approval specific to the indication, otherwise its use will be considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
The hysterosalpingogram (HSG) evaluation required at three months post micro-insert placement is part of the FDA approval labeling. An HSG is done to confirm satisfactory tubal occlusion and micro-insert location before an individual can be instructed to discontinue the use of alternative contraception methods.
SOURCES
American College of Obstetricians and Gynecologists. (2003, September). Clinical management guidelines for obstetrician-gynecologists: Benefits and risks of sterilization. ACOG Practice Bulletin, 46, 1-12.
American College of Obstetricians and Gynecologists. (2010, June). ACOG Committee Opinion No 458: Hysterosalpingography after tubal sterilization. Obstetrics and Gynecology, 115 (6), 1334 - 1335.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2005). Hysteroscopic placement of micro-inserts in the fallopian tubes as a form of permanent sterilization (4.01.13). Retrieved July 16, 2010 from BlueWeb.(4 articles and/or guidelines reviewed).
Complete Guide to Medicare Coverage Issues [Computer software]. (2010, April). Sterilization (NCD 230.3, p. 2-180). The Ingenix Complete Guide to Medicare Coverage Issues.
Cooper, J., Carignan, C., Cher, D., & Kerin, J. (2003). Microinsert nonincisional hysteroscopic sterilization. The Journal of Obstetrics and Gynecology, 102 (1), 59-67. (Level 2 Evidence)
Kerin, J., Cooper, J., Price, T., Van Herendael, B., Cayuela-Font, E., Cher, D. & Carignan, C. (2003). Hysteroscopic sterilization using a micro-insert device: Results of a multicentre Phase II study. Human Reproduction, 18 (6), 1223-1230. (Level 4 Evidence)
National Guideline Clearinghouse. American college of Obstetricians and Gynecologists (ACOG). (2003 September). Benefits and risks of sterilization . Retrieved July 20, 2010 from http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=10945&string=sterilization+AND+contraception.
National Guideline Clearinghouse. Journal of Family Planning Reproduction and Health Care. (2005 January). Contraception for women aged over 40 years. Retrieved July 20, 2010 from http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=7095&string=sterilization+AND+contraception.
National Institute for Health and Clinical Excellence. (2009, September). Hysteroscopic sterilization by tubal cannulation and placement of intrafallopian implants. Retrieved July 20, 2010 from http://www.nice.org.uk/nicemedia/live/11118/45506/45506.pdf.
Ogburn, T., & Espey, E. (2007). Transcervical sterilization: past, present, future. Obstetrics and Gynecology Clinics of North America, 34 (1), 57 - 72. (Level 5 Evidence)
Palmer, S., & Greenberg, J. (2009). Transcervical sterilization: a comparison of essure® permanent birth control system and adiana ® permanent contraception system. Reviews in Obstetrics and Gynecology, 2 (2), 84 - 92. (Level 5 Evidence)
Smith, R. (2010). Contemporary hysteroscopic methods for female sterilization. International Journal of Obstetrics, 108 (1), 79 - 84. (Level 5 Evidence)
U.S. Food and Drug Administration. (2002, July). Centers for Devices and Radiological Health. Summary of safety and effectiveness data P020014. Retrieved July 20, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020014b.pdf.
U.S. Food and Drug Administration. (2002, November). Center for Devices and Radiological Health. New device approval Essure™ System - P020014. Retrieved July 20, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020014a.pdf.
U.S. Food and Drug Administration. (2007, December). Centers for Devices and Radiological Health. Summary of safety and effectiveness data P070022. Retrieved July 20, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/P070022b.pdf.
U.S. Food and Drug Administration. (2009, July). Center for Devices and Radiological Health. New device approval Adiana Permanent Contraception System - P070022. Retrieved July 20, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/P070022A.pdf.
Winifred S. Hayes, Inc. Medical Technology Directory. (2006, June). Hysteroscopic tubal occlusion for permanent contraception. Retrieved July 20, 2010 from www.Hayesinc.com/subscribers (33 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 4/1981
MOST RECENT REVIEW DATE: 9/9/2010
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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