SAN MATEO, Calif.–EndoGastric Solutions® (EGS), a leader in advanced endoscopic reconstructive therapy for gastroesophageal reflux disease (GERD), announces Cahaba Government Benefit Administrators,® LLC (Cahaba GBA) has approved reimbursement of the company’s Transoral Incisionless Fundoplication (TIF®) procedure to treat underlying anatomical causes of GERD. Cahaba GBA is a Medicare Administrative Contractor (MAC), which administers benefit claims in Alabama, Georgia and Tennessee for over three million members.
“Formal recognition and expanded health care coverage of the TIF procedure validates its importance in meeting an unmet medical need,” said Mark Fox, MD, FACS, a leader in anti-reflux surgery at Tennessee Heartburn Clinic at Crossville Medical Group. “Since I have been fortunate enough to participate in the research and clinical care studies pertaining to the TIF procedure, I can offer it to my patients with complete confidence in the technique and its efficacy.”
Cahaba GBA approved coverage of the TIF procedure as a treatment for patients with symptomatic chronic GERD (present for more than six months) begins May 1, 2015.
“The company is grateful to Dr. Fox and our physician users who continue to support EGS and the TIF procedure,” said Skip Baldino, CEO, EndoGastric Solutions. “With Cahaba’s coverage decision, we are able to provide access to more patients with chronic GERD who seek a less invasive treatment with minimal side effects.”
The TIF procedure is also covered by Novitas Solutions—a separate Medicare Administrative Contractor—which covers over nine million members in two jurisdictions: Arkansas, Colorado, Louisiana Mississippi, New Mexico, Oklahoma, and Texas since August 2012 and Delaware, District of Columbia, Maryland, New Jersey, and Pennsylvania since April 2013.
Recently EGS announced that the American Medical Association (AMA) created a new Category I Current Procedural Terminology (CPT®) code with a procedure descriptor associated with the company’s Transoral Incisionless Fundoplication (TIF®) procedure which will be effective January 1, 2016.
About GERD
Gastroesophageal Reflux Disease (GERD) is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to wash back up into the esophagus, causing heartburn and possible injury to the esophageal lining. The stomach produces hydrochloric acid and other digestive enzymes after a meal to aid in the digestion of food. The cells that line the stomach are coated with a protective mucus that can withstand gastric contents, while the cells that line the esophagus lack the same protection.
GERD is the most common gastrointestinal-related diagnosis made by physicians during clinical visits in the U.S. It is estimated that pain and discomfort from acid reflux impacts over 23 million people two or more times per week in the U.S. The standard recommendations for symptomatic GERD patients include lifestyle changes (e.g., diet, scheduled eating times, and sleeping positions) and escalating doses of prescription medications for prolonged periods of time. Long-term, maximum-dose usage of prescription medications has been linked to a variety of other health complications.
About Transoral Incisionless Fundoplication (TIF®) procedure for reflux
Performed entirely through the mouth without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical change to correct the underlying cause of GERD, another treatment option beyond traditional surgery. Studies show that for up to three years after the TIF procedure esophageal inflammation (esophagitis) is eliminated and most patients are able to stop using daily PPI medications to control symptoms.
The TIF procedure has an established safety and efficacy profile with more than 16,700 patients treated worldwide. For more information, visit www.GERDHelp.com.
About the EsophyX® device
The EsophyX device was FDA cleared in 2007, and is commercially available in the United States. Inserted through the patient’s mouth with visual guidance from an endoscope, the EsophyX device is used to reconstruct the gastroesophageal valve (GEV) in order to restore its function as a barrier to prevent stomach acids from washing back up into the esophagus.
About EndoGastric Solutions®
EndoGastric Solutions, Inc. (www.endogastricsolutions.com), is a leader in the endoluminal treatment of digestive diseases. EGS’ mission is to combine the most advanced concepts in gastroenterology and surgery to develop products and procedures that address unmet needs in gastrointestinal diseases.
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Contacts:
Debbie Donovan
EndoGastric Solutions, Inc.
Phone: 650-578-5120
ddonovan[at]endogastricsolutions[dot]com
Dawn Fallon
Lazar Partners, LTD
Phone: 646-871-8481 (direct)
dfallon[at]lazarpartners[dot]com
Twitter: @GERDHelp
Facebook: GERDHelpcom
Google+: GERDHelp
The EsophyX device with SerosaFuse fasteners is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia <2 cm in size in patients with symptomatic chronic gastroesophageal reflux disease.
NP02440-01A
