MOUNTAIN VIEW, Calif., Aug. 1, 2011 (GLOBE NEWSWIRE) -- Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure® procedure, the most effective non-surgical permanent birth control method available, today applauded the decision by the U.S. Department of Health and Human Services (HHS) to mandate that permanent birth control be a covered procedure under the Patient Protection and Affordable Care Act of 2010 (PPACA).
The decision follows a July 19, 2011 report from the Institute of Medicine (IOM) that recommended the coverage of additional preventive health services to promote women's health. Under the PPACA, health plans must cover services listed in the HHS comprehensive list of preventive services at no cost to patients. HHS adopted IOM's recommendation to add all eight preventive services to the current list of preventive services available to women without cost including medications, procedures, devices, tests, education and counseling shown to improve well-being, and/or decrease the likelihood or delay the onset of a targeted disease or condition.
The approved preventive services in the HHS guidelines anticipated to have the greatest impact on adoption of the Essure procedure include the following:
- All U.S. Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education and counseling for all women with reproductive capacity(1).
- Well-woman preventive care visit annually for adult women to obtain the recommended preventive services that are age and developmentally appropriate, including preconception and prenatal care.
New, non-grandfathered private health plans must cover the guidelines on women's preventive services with no cost sharing in plan years starting on or after August 1, 2012. Plans will retain the flexibility to control costs and promote efficient delivery of care.
"Removing what can often be a substantial cost barrier that women with private insurance now face will not only make it easier for them to afford contraception generally, but will allow them to be able to use the most effective methods that they might not otherwise be able to afford. This is a landmark development for women's health on the order of the invention of the contraceptive pill 50 years ago," said Susan A. Cohen, MPH, director of government affairs of the Guttmacher Institute.
"We have worked closely with a broad range of women's health and medical associations that have championed these new expanded guidelines for contraceptive services. Conceptus is committed to leadership in permanent contraception, and we are delighted that this determination by HHS will increase access and affordability for women nationwide. We fully expect this change to be a key inflection point as we look at our business in the future," said Mark Sieczkarek, president and chief executive officer of Conceptus.
About the Essure® Procedure
The Essure procedure, FDA approved since 2002, is the first permanent birth control method that can be performed in the comfort of a physician's office in less than 10 minutes (average hysteroscopic time) without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Soft, flexible inserts are placed in a woman's fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around and through the micro-inserts to prevent sperm from reaching the egg. Three months after the Essure procedure, a doctor is able to perform an Essure Confirmation Test to confirm that the inserts are properly placed and the fallopian tubes are fully blocked, giving the patient reliance on Essure for permanent birth control.
The Essure procedure is 99.95% effective based on one year of follow up with zero pregnancies reported in clinical trials, making it the most effective form of permanent birth control on the market. The procedure is covered by most insurance plans, and when it is performed in a doctor's office the cost to the patient may be as low as a simple co-pay. Essure has been proven and trusted by physicians since 2002, with more than 500,000 women worldwide having undergone the Essure procedure.
About Conceptus, Inc.
Conceptus, Inc. is a leader in the design, development, and marketing of innovative solutions in women's healthcare. The Company manufactures and markets the Essure procedure. The Essure procedure is available in the United States, Europe, Australia, New Zealand, Canada, Mexico, Central and South America and the Middle East. The Company also promotes the GYNECARE THERMACHOICE® Uterine Balloon Therapy System by ETHICON™ Women's Health & Urology, a division of Ethicon, Inc., in U.S. OB/GYN physician offices.
Please visit www.essure.com for more information on the Essure procedure. Patients may call the Essure Information Center at 1-877-ESSURE-1 with questions or to find a physician in their area.
The Conceptus, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7961
Forward Looking Statements
Except for the historical information contained herein, the matters discussed in this press release include forward-looking statements, the accuracy of which is subject to risks and uncertainties. These forward-looking statements include discussions regarding the effect of the expanded guidelines approved by the U.S. Department of Health and Human Services for additional preventive health services for women under the Patient Protection and Affordable Care Act of 2010 that will include permanent birth control, the effect of the economy and high deductible insurance plans on a patient's ability to pay out-of-pocket costs for the Essure procedure, and the expected attainment of strategic initiatives intended to grow the business. These discussions and other forward-looking statements included herein may differ significantly from actual results. Such differences may be based upon factors such as changes in strategic planning decisions by management, re-allocation of internal resources, changes in the impact of domestic and global macroeconomic pressures, reimbursement decisions by insurance companies and domestic and foreign governments, scientific advances by third parties, litigation risks, the effect of regulations promulgated pursuant to the Patient Protection and Affordable Care Act of 2010, and the introduction of competitive products, as well as those factors set forth in the Company's most recent Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q, and other filings with the Securities and Exchange Commission. These forward-looking statements speak only as to the date on which the statements were made. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.
(1) Group health plans sponsored by certain religious employers, and group health insurance coverage in connection with such plans, are exempt from the requirement to cover contraceptive services.
© 2011 Conceptus, Inc. – All rights reserved. Conceptus, Essure, Your Family is Complete, Your Choice is Clear are registered trademarks and service marks of Conceptus, Inc. Essure FlexPay and Essurance Promise are trademarks of Conceptus, Inc.
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