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SOURCE Halt Medical, Inc.
LIVERMORE, Calif., June 3, 2014 /PRNewswire/ -- Halt Medical, Inc., today announced that Aetna US Healthcare and Coventry Health Care have published updates to their Fibroid Treatment Clinical Policy and are now providing benefits for Halt Medical's Acessa™ Procedure as a treatment option for women with symptomatic uterine fibroids.
Aetna US Healthcare is the third largest national commercial insurer in the United States with over 21 million covered lives and one of the top five insurers in most states. Coventry Health Care, Aetna's national managed health care company, serves an additional approximately five million members.
"These decisions from leading insurers are a welcome recognition of the demonstrated clinical benefits and cost effectiveness of the Acessa Procedure, a minimally invasive treatment for women with symptomatic uterine fibroids," said Jeff Cohen, chief executive officer for Halt Medical, Inc. "Over the past several months, most major insurers have provided benefits for Acessa on a case-by-case basis. However, these individual processes have made it difficult for physicians to continue to offer this procedure. By formalizing favorable coverage policies, Aetna and Coventry have made access to Acessa a timely and viable option."
The Center for Medicare and Medicaid Services (CMS) has provided coverage for the Acessa Procedure since July 2013, and updated the Ambulatory Payment Classification (APC) schedule to include coverage and payment for Acessa services reported under CPT 0336T. This change occurred pursuant to the recommendations of the American Medical Association's development of separate and unique reporting for the Acessa Procedure, which went into effect on January 1, 2014.
In an effort to continue to build support for additional coverage by insurers, Halt Medical is conducting independent post-market studies of the Acessa Procedure including randomized controlled trials and registry data collection. The Company has recently concluded a three-year follow up on patients treated with Acessa during the pivotal trial.
About the Acessa Procedure
The Acessa Procedure is a minimally invasive laparoscopic procedure that delivers radiofrequency energy to destroy the fibroids. After treatment, the fibroid is re-absorbed by the surrounding tissue. Acessa allows the surgeon to treat only the fibroids, while preserving normal function of the uterus. Patients typically go home the same day with little pain, and enjoy a rapid return to normal activities. The Acessa System is FDA-cleared for the treatment of symptomatic uterine fibroids and is now available at leading medical centers throughout the U.S.
About Uterine Fibroids
Fibroids are benign, non-cancerous tumors in a woman's uterus that often appear during childbearing years. Also called leiomyomas, fibroids are made up of muscle and connective tissue and may range in size from microscopic to larger than a grapefruit. The rate at which they grow is unpredictable, and a woman may have more than one fibroid at a time. While some fibroids are asymptomatic, others can be very painful and cause heavy bleeding, pressure on the bladder or rectum, a distended abdomen, and a lack of energy stemming from anemia. The majority of American women will develop fibroids at some point in their lives. According to the National Institutes of Health (NIH), at least 70 percent of women in the U.S. will develop fibroids by age 50, and the prevalence is even higher among African American women.
About Halt Medical, Inc.
Founded in 2004, Halt Medical is a medical device innovator focused on establishing a new standard of care for women with symptomatic uterine fibroids. The Company has developed and launched the Acessa System and Procedure, using radiofrequency energy to destroy uterine fibroids. The results of both U.S. and international trials have led to the clearance of the product by the FDA for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance. The Acessa System also has regulatory approval to treat symptomatic uterine fibroids in the European Union, Canada, Mexico and Israel. The Company is located in Brentwood, CA. For information about the Acessa Procedure, please visit www.haltmedical.com.
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