Connecticut Leads the Way in Refusing to Cover Essure Sterilization
On April 9, 2018, the FDA mandated new labeling and sales requirements for the Essure sterilization device. The new Essure labeling, now legally required, restricts the sale and distribution of the device to only health care providers and facilites who provide the mandated information to patients about the risk and benefits of the device, "in the form and manner specified in approved labeling." This information must be signed by both the patient and the physician, and Bayer is required to ensure provider compliance. The FDA will enforce these requirements and will take appropriate actions, including civil and criminal penalties if necessary.
As a result of this action, healthcare facilites are rethinking the advisibility of continuing to provide this service to women. Connecticut's Department of Social Services has taken the innovative and appropriate action and announced that effective July 1, 2018, it will no longer cover the costs of implanting the Essure sterilization device. The Connecticut Medical Assistance Program's announcement provides:
"Effective for dates of service July 1, 2018 and forward, the permanent implantable contraceptive intratubal occulsion device and delivery system that is used as part of bilateral fallopian tube cannulation to induce occlusion by placement of permanent implants procedure will no longer be coverd under the Healthcare Common Procedure Coding System (HCPCS) code A4264-Intratubal occlusion device. Other birth control devices such as the Falope ring and filshie clips remain covered and should continue to be billed under HCPCS code A4264.
Additionally, Current Procedure Terminology (CPT) code 58565-Hysteroscopy sterilization will be end-dated for dates of service July 1, 2018 and forward on the following fee schedules: physician-surgical, ambulatory surgical centers, and family planning clinics. The CPT code will be changed to a "no" under the payment type column on the Connecticut Medical Assistance Program Addendum B for outpatient hospitals.
This is a major step forward for Connecticut and it is hoped and anticipated that most, if not all states will soon follow suit. This action appears to be as a direct result of the FDA's April 9, 2018 mandate regarding the sale of the Essure device, which was brought about after years of lobbying by the tenancious Essure Problems Group. As more states follow Conneticut's lead, fewer women will be implanted with the device and it will hopefully be removed from the market entirely. The full announcement can be found here. https://www.ctdssmap.com/CTPortal/Information/Get%20Download%20File/tabid/44/Default.aspx?Filename=PB18_26.pdf&URI=Bulletins%2FPB18_26.pdf
Kudos to Connecticut.
If you or a loved one has been injured by the Essure device or have questions concerning Conneticut's actions, contact Holly Ennis at Ennis & Ennis, P.A. at Holly@Ennislaw.com or visit us online at www.EnnisLaw.com.