Important Safety Information

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device. Continue reading below

Ordering and Reimbursement

Order Essure®

Essure can be ordered by phone, email, or fax.

call
Call 855-406-2861 8 AM – 8 PM ET,
Monday through Friday
fax
Fax 888-281-8199

To place an order, please provide

  • Name of certified/trained Essure provider(s) and date(s) of certification or scheduled training
  • Facility license, in-house pharmacy license, or provider license
  • Signed Essure Physician Distribution Agreement (EPDA) for active Essure user(s), within the account stating that they will use the Patient -Doctor Discussion Checklist with all patients prior to the procedure.
  • Facility Confirmation Form from the user facility to confirm that the purchased product will only be distributed to a physician within the account that has a signed EPDA on file.
  • Shipping/billing address (including facility name)
  • Letter of Affiliation
  • Copy of resale certificate or Department of Revenue letter proving tax exemption (if applicable)

Shipping and delivery is easy

  • All shipping is FREE
  • SAME DAY shipping for orders received before 3:30 PM ET
  • Standard delivery is 2 business days

*Once the license is on file, it is not necessary to provide another copy until the license has expired.

For all states except Florida, a Letter of Affiliation is needed if there is not an address on the license or if the address on the license does not match the shipping location. Please note that some offices are slow to return this document. Due to the E-Pedigree law in the state of Florida, Florida customers must submit their HCCE permit of the Declaration of Intent Letter before orders can be released.

Coding Information

Accurate diagnosis, procedure, and product coding are essential to help ensure prompt Essure claims processing and reimbursement. Coding for Essure can include CPT codes, HCPCS codes, ICD-10 codes, and modifiers, and may include no-cost coverage.

The following CPT Fourth Edition codes may be used to report procedures associated with Essure:

Product/Service Code Description
Essure procedure 58565 Hysteroscopy, surgical; with bilateral fallopian tube cannulation to induce occlusion by placement of permanent implants
Modified HSG 58340 Catheterization and introduction of saline or contrast material for saline infusion sonohysterography (SIS) or HSG
Modified HSG, interpretation and supervision 74740 HSG, radiologic supervision and interpretation
Modified HSG, interpretation 74740-26 HSG, radiologic supervision and interpretation, professional component only
Modified HSG, supervision 74740-TC HSG, radiologic supervision and interpretation, technical component only
TVU 76830 Ultrasound: Transvaginal

*CPT codes, descriptions, and other data are copyright 2010 American Medical Association (AMA). All rights reserved. CPT is a registered trademark of the AMA.

The following HCPCS code may
be used (in addition to the CPT
code) for selected payers that, including some state Medicaid programs, allow for separate payment. Please check with the payer to confirm whether
payment is separate or bundled.

Product/Service Code Description
Essure procedure A4264 Permanent implantable contraceptive intratubal occlusion device(s) and delivery system

Please note that Medicare does not allow for separate reporting and billing of permanent implantable contraception. Private payers and Medicaid will make their own determination on whether or not to use the HCPCS code. Please confirm with your payer that A4264 is allowed for billing and will be paid.

For many payers, the following codes from the International Classification of Diseases, 10th edition, may be used to identify the Essure Confirmation Test with modified HSG/TVU as a preventive service:

Product/Service Code Description
Essure procedure Z30.2 Encounter for sterilization
Essure Confirmation Test Z98.51 Tubal ligation status
Essure Confirmation Test (identified as a preventive service) Z30.8 Other specified contraceptive management
Essure Confirmation Test Z30.49 Surveillance of other contraceptive management

CPT Modifier 33 is applicable for the identification of preventive services without cost sharing and may be added to the following CPT codes:

Product/Service Code Description
Essure procedure 58565-33 Hysteroscopy, surgical; with bilateral fallopian tube cannulation to induce occlusion by placement of permanent implants
Modified HSG 58340-33 Catheterization and introduction of saline or contrast material for SIS or HSG
TVU 76830-33 Ultrasound, transvaginal

Not all commercial payers will require the use of Modifier 33. Some will automatically process Essure and the Essure Confirmation Test without patient cost sharing.

For all codes and more information about reimbursement, download the guide below.

Essure Reimbursement
Guide

Pursuant to the Affordable Care Act (ACA), the Essure Confirmation Test with TVU or modified HSG may be available to most patients at low or no cost

The ACA has helped make health insurance and healthcare services more affordable and accessible for millions of people who previously did not have coverage.1 The ACA generally requires health plans to cover FDA-approved contraceptive methods as a preventative service at low or no cost to the patient (eg, copayment, coinsurance). However, depending on the specific insurance plan, the patient may still be responsible for the cost of the product and/or product-related costs, such as insertion or removal procedure fees.1

Multiple necessary services are performed by a healthcare provider during a procedure. These services are said to be billed/paid “globally”—sometimes referred to as the global/surgical package. The global/surgical package also includes a global period: a set number of days during the postoperative period. The global period is usually 90 days for major procedures and 0 to 10 days for minor procedures. Therefore, all follow‑up care, including the treatment of complications, is included in the global period and cannot be billed separately.

Because the Essure Instructions for Use states than an Essure Confirmation Test with TVU/modified HSG is a required part of the Essure procedure, it is considered typical and usual, and will not be paid separately if it is performed within the 90-day global period of the Essure procedure.

Although this information should help make filing claims easier and help reduce claim rejection, its use does not guarantee payment. It is important to research coverage and payment for each patient since policies and guidelines vary by payer and plan. You are responsible for submitting accurate, complete, and appropriate claims to payers, and for compliance with any obligations you may have as required by law, contract, or otherwise.

For more information, call our reimbursement hotline at 1-877-ESSURE2 and press “#”.

Reference: 1. HRSA. Women's Preventative Services Guidelines. https://www.hrsa.gov/womens-guidelines/index.html. Accessed October 17, 2017.

Contact a Field Reimbursement Manager (FRM)

Request Bayer Representatives with one easy form.

Go to Form

Essure Physician Distribution Agreement (EPDA)

Starting on August 1st, 2018, a EPDA Form must be signed by active Essure user(s), within an account stating they will use the Checklist with all patients prior to the procedure.

Go to Form

Essure Facility Confirmation Form (EFCF)

Starting on August 1st, 2018, the user facility will need to submit an EFCF to confirm that the purchased product will only be distributed to a physician within the account that has a signed EPDA on file

Go to Form

INDICATION

Essure® is indicated for women who desire permanent birth control (female sterilization) by bilateral occlusion of the fallopian tubes.

IMPORTANT SAFETY INFORMATION

WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.

IMPORTANT

  • Caution: Federal law restricts this device to sale by or on the order of a physician. Device to be used only by physicians who are knowledgeable hysteroscopists; have read and understood the Instructions for Use and Physician Training Manual; and have successfully completed the Essure training program, including preceptoring in placement until competency is established, typically 5 cases.
  • The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer.

Contraindications

Essure is contraindicated in patients who are uncertain about ending fertility, can have only one insert placed (including contralateral proximal tubal occlusion or suspected unicornuate uterus), have a known abnormal uterine cavity that makes visualization of the tubal ostia impossible, and/or abnormal tubal anatomy or previous tubal ligation (including failed ligation), are pregnant or suspect pregnancy, delivered or terminated a pregnancy less than 6 weeks prior to the Essure procedure, have an active upper or lower genital tract infection, have unexplained vaginal bleeding, have a gynecological malignancy, or have a known allergy to contrast media.

General Warnings

  • The Essure procedure should be considered irreversible.
  • Pain (acute or persistent) of varying intensity and length of time may occur following Essure placement. This is also more likely to occur in individuals with a history of pain. If device removal is indicated, this will require surgery.
  • Patients with known hypersensitivity to nickel, titanium, platinum, stainless steel, and PET (polyethylene terephthalate) fiber or any of the components of the Essure system may experience an allergic reaction to the insert. In addition, some patients may develop an allergy to nickel or other components of the insert following placement. Symptoms reported for this device that may be associated with an allergic reaction include hives, urticaria, rash, angioedema, facial edema and pruritus. Patients should be counseled on the materials contained in the insert prior to the Essure procedure. Currently there is no test that reliably predicts who may develop a hypersensitivity reaction to the materials contained in the insert.
  • Patients on immunosuppressive therapy may experience delay or failure of the necessary tissue in-growth for tubal occlusion. For these patients, physicians must use the modified HSG as the Essure Confirmation Test. Transvaginal ultrasound (TVU) should not be used as the Essure Confirmation Test, as TVU cannot confirm tubal occlusion.

Pregnancy Risk

  • Pregnancies, including ectopic pregnancies, have been reported among women who have undergone the Essure procedure.
  • The patient must use alternative contraception until a satisfactory Essure Confirmation Test is documented. If the Essure inserts are not properly placed or are not in a satisfactory location, then the patient should be advised to not rely on Essure and use alternative contraception.
  • Counsel the patient on the need for the Essure Confirmation Test, the options for the confirmation test including their risks and benefits, and the possibility that the Essure Confirmation Test may be unsatisfactory.
  • Effectiveness rates for the Essure procedure are based on patients who had bilateral placement and a satisfactory Essure Confirmation Test.

Procedure Warnings

  • Never attempt to advance Essure insert(s) against excessive resistance. If a perforation occurs or is suspected, do not continue procedure and monitor the patient for signs and symptoms of possible complications related to perforation which may include unusual post-operative pain.
  • To reduce the risk of hypervolemia, terminate procedure if distension fluid deficit exceeds 1500cc or total hysteroscopic procedure time exceeds 20 minutes. Excess fluid deficit may signal uterine or tubal perforation. If noted, discontinue procedure and evaluate patient for possible perforation.
  • Do not attempt hysteroscopic Essure insert removal during the placement procedure unless 18 or more trailing coils are seen inside the uterine cavity due to risk of a fractured insert, fallopian tube perforation, or other injury.
  • DO NOT perform the Essure procedure concomitantly with endometrial ablation.

MRI Information

The Essure insert was determined to be MR-conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-05.

Adverse Events

The most common (≥10%) adverse events resulting from the placement procedure were cramping, pain, and nausea/vomiting. The most common adverse events (≥3%) in the first year of reliance were back pain, abdominal pain, and dyspareunia.

This product does not protect against HIV infection or other sexually transmitted diseases.

Prescription Only

Report any adverse events or product technical complaints involving Essure® immediately by calling 888-84-BAYER (888-842-2937).

You are also encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here.

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