Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Coverage Policy Manual
Policy #:	2003020
Category:	Surgery
Initiated:	June 2003
Last Review:	August 2023

Hysteroscopic Placement of Micro-Inserts in the Fallopian Tubes as a Form of Permanent Sterilization

Description:

Permanent forms of elective sterilization include vasectomy or tubal ligation. Tubal ligation is a surgical procedure, typically performed laparoscopically, but requiring general anesthesia. The Essure System for permanent sterilization involves a hysteroscopic approach and the insertion of micro-inserts bilaterally into the Fallopian tubes. The resulting scarring permanently occludes the fallopian tubes, rendering the patient infertile. To confirm occlusion, the patient typically undergoes a hysterosalpingogram (HSG) at 3 months; if the tube(s) are still patent the HSG is repeated at 6 months. Patients must rely on alternate forms of birth control until complete occlusion is confirmed.

The FDA labeled indication for the Essure System states, “The Essure System is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.

After approval in 2002, the U.S. Food and Drug Administration (FDA) began receiving reports of adverse events. In February 2016, the FDA ordered Bayer to conduct a post-marketing study to evaluate the safety profile of the device and also required Bayer to add a boxed warning to the Essure label about the possible adverse events. Despite the post-marketing study and boxed warning to the Essure label, the FDA determined that some women are still not receiving information regarding the known risks of Essure. The FDA issued an order on April 9, 2018, to restrict the sale and distribution of the Essure device to ensure all women considering use of the permanent contraception device are provided with adequate risk information so that they can make informed decisions. On July 20, 2018 Bayer announced it would discontinue sales of the Essure permanent birth control implant in the United States at the end of 2018.

Policy/
Coverage:

Effective August 2018

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Bilateral occlusion of the fallopian tubes using the Essure System as a technique for permanent sterilization does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, bilateral occlusion of the fallopian tubes using the Essure System as a technique for permanent sterilization is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective Prior to August 2018

Bilateral occlusion of the fallopian tubes meets primary coverage criteria for effectiveness and is covered as a technique for permanent sterilization.

Rationale:

Data regarding the safety and effectiveness of the Essure System is based on information contained in the package insert and 1 published clinical trial. The pivotal trial that formed the basis of the FDA approval included 518 women who underwent placement of the micro-inserts. Bilateral micro-inserts were successfully placed in 86% of patients, and in 90% of patients with 2 attempts. All patients were evaluated with a hysterosalpingogram (HSG) at 3 months, which was repeated at 6 months if the initial HSG did not document occlusion. The effectiveness rate after 2 years of follow-up was 99.8%. Adverse events that prevented reliance on the device for contraception included failure to place 2 micro-inserts at the first procedure (14%), initial tubal patency (3.5%), expulsion (2.2%), perforation (1.5%) or other unsatisfactory device location (0.6%).

The Adiana Permanent Contraception System, indicated for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes was granted FDA approval July 6, 2009 (P070722)

The Adiana method of permanent sterilization consists of four steps:

Step 1: Delivery of bipolar radiofrequency energy to create a superficial lesion within the fallopian tube. The creation of this lesion will initiate an acute wound healing response.

Step 2: Deployment of a matrix within the area of the superficial lesion. The tissue in-growth response will lead to occlusion of the fallopian tube along the length of the matrix.

Step 3: Patient must use a reliable form of contraception until bilateral tubal occlusion is confirmed by the Adiana HSG three months after placement of the Adiana matrices.

Step 4: Bilateral tubal occlusion must be confirmed by the Adiana HSG before the patient can be advised that she can rely on Adiana Permanent Contraception for pregnancy prevention.

Anderson and Vancaillie, in 2011, reported efficacy of the Adiana System for preventing pregnancy in women desiring permanent sterilization. Data demonstrated that efficacy of the Adiana System for pregnancy preventions was similar to other permanent sterilization methods.

2014 Update

A search of the MEDLINE database conducted through April 2014 did not reveal any new information that would prompt a change in the coverage statement.

In response to reports of pain and other health problems from patients after using Essure, the FDA conducted a review of the available information on the use of Essure since the initial FDA approval. The results of this review were published on the FDA website (FDA, 2014). The review included a search of the Manufacturer and User Facility Device Experience (MAUDE) database. From Nov. 4, 2002, Essure's approval date, through Oct. 25, 2013. The FDA has received over 900 reports of adverse events related to Essure including reports of pain, hemorrhage, headache, menstrual irregularities, fatigue, and weight fluctuations. The most frequent device problems reported were the migration of the device or device component, patient device incompatibility (e.g., possible nickel allergy), device operating differently than expected, malposition of the device, and device breakage. Also reviewed, were the results from a five-year study conducted by Conceptus. According to the FDA, “Although there is evidence of complications, as there are with all medical devices, overall results from this study did not demonstrate any new safety problems or an increased incidence of problems already known” (FDA, 2014). At present, the FDA did not make any rulings based on this review but will continue to monitor the safety of Essure (FDA, 2014).

In 2010, a review was published comparing the clinical trial data for the Essure Permanent Birth Control System and Adiana Permanent Contraception (Basinski, 2010). The author notes that the Essure and Adiana procedures both have high patient satisfaction and tolerability. The major strength of the Essure procedure is the high efficacy rate (0% failure rate in clinical trials) compared to a more frequent risk of pregnancy, including tubal pregnancy, associated with the use of Adiana. The author states the major advantage of Adiana is the ability to cannulate fallopian tubes with distal blockage or spasm which would inhibit the placement of an Essure device. Additionally, the Adiana offers an alternative to patients with a nickel allergy. The author concludes both the Adiana and Essure device offer advantages over laparoscopic sterilization including the reduced need for anesthesia and decreased risk for injury to intraabdominal organs.

2015 Update

A literature search conducted through May 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.

Lorente and colleagues published an article for Essure, a permanent birth control device that is inserted through the cervix by hysteroscopy (Lorente, 2015).. The device is placed in the fallopian tubes, where it causes occlusion by stimulating fibrosis. Patients can be followed up with plain-film X-rays, hysterosalpingography, and ultrasonography, although the devices can also be identified incidentally on CT and MRI. The follow-up of Essure is based on checking the criteria for appropriate positioning and correct functioning (tubal occlusion) and on diagnosing complications. The most common complications are perforation, migration (toward the uterine or peritoneal cavity), and occlusion failure. In hysterosalpingography, vascular intravasation is the most common cause of diagnostic error. Radiologists need to know how to recognize the device on different imaging techniques, how to check that it is correctly placed and functioning, and how to diagnose complications.

2017 Update

A literature search conducted through April 2017 did not reveal any new information that would prompt a change in the coverage statement.

2018 Update

Annual policy review completed with a literature search using the MEDLINE database through May 2018. No new literature was identified that would prompt a change in the coverage statement.

2018 August Update

This policy is being updated based on a recent decision by Bayer to discontinue sales of the Essure permanent birth control implant in the United States.

The coverage statement has been revised to that of non-coverage for the Essure System for permanent sterilization.

2019 Update

Annual policy review completed with a literature search using the MEDLINE database through July 2019. No new literature was identified that would prompt a change in the coverage statement.

2020 Update

Annual policy review completed with a literature search using the MEDLINE database through July 2020. No new literature was identified that would prompt a change in the coverage statement.

2021 Update

Annual policy review completed with a literature search using the MEDLINE database through July 2021. No new literature was identified that would prompt a change in the coverage statement.

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through July 2022. No new literature was identified that would prompt a change in the coverage statement.

2023 Update

Annual policy review completed with a literature search using the MEDLINE database through July 2023. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:

References:

Anderson TL, Vancaillie TG.(2011) The Adiana System for permanent contraception: safety and efficacy at 3 years. J Minim Invasive Gynecol, 2011; 18:612-6.

Basinski CM.(2010) A review of clinical data for currently approved hysteroscopic sterilization procedures. Rev Obstet. Gynecol. 2010;3(3):101-110.

Brooks, M.(2018) Bayer to halt US sales for essure permanent contraceptive. Medscape Medscape. Jul 20, 2018. Accessed at https://www.medscape.com/viewarticle/899624?nlid=123935_3901&src=wnl_newsalrt_180720_MSCPEDIT&uac=253050EN&impID=1690548&faf=1. Last accessed 03 Aug 2018.

FDA’s Review of Reported Problems. U.S. Food and Drug Administration. Accessed at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/ucm371014.htm. Last accessed May 23, 2014.

Kerin JF, Carignan CS, Cher D.(2001) The safety and effectiveness of a new hysteroscopic method for permanent birth control: Results of the first Essure PBC clinical study. Aust NZ J Ob Gyn 2001;41:364-70.

Lorente Ramos RM, Azpeitia Armán J, Aparicio Rodríguez-Miñón P et al.(2015) Radiological assessment of placement of the hysteroscopically inserted Essure permanent birth control device. Radiologia. 2015 May-Jun;57(3):193-200. doi: 10.1016/j.rx.2014.12.006. Epub 2015 Feb 3.

www.essure.com.

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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