Medicare Patients in North Carolina, South Carolina, West Virginia and Virginia Now Have a New Minimally Invasive Treatment Option for Reflux Disease

EndoGastric Solutions® Provides Access to the TIF 2.0 Procedure through Medicare Administrative Contractor Palmetto GBA

REDMOND, Wash.--()--EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), is pleased to announce that Medicare Administrative contractor Palmetto GBA, LLC has approved reimbursement of the company’s Transoral Incisionless Fundoplication (TIF®) 2.0 procedure for Medicare patients across the Carolinas, Virginia and West Virginia. Palmetto GBA, based in Columbia, South Carolina, is one of the nation’s largest providers of high volume claims and transaction processing, contact center operations and technical services to the federal government and other commercial customers. This decision will affect approximately 4.4 million Medicare patients across the region.

“Patients suffering from chronic GERD need a third option other than medications, which mask the symptoms of the condition, and traditional surgery with its known side effects,” says Karim Trad, MD, Clinical Professor of Surgery at George Washington University School of Medicine and principal investigator in the TIF 2.0 clinical study. He further explains how the TIF 2.0 procedure works, “Utilizing the EsophyX® device, a tool designed to rebuild the antireflux valve and restore the body’s natural protection against acid reflux, the TIF 2.0 procedure offers patients durable relief from GERD symptoms.”

“Approximately one in four Americans suffer from GERD, and the TIF 2.0 procedure has already helped more than 18,000 patients worldwide treat their chronic GERD,” says Skip Baldino, CEO, EndoGastric Solutions. “We are grateful for partners like Palmetto, who are helping us address an unmet clinical need by making the TIF 2.0 procedure more accessible for Medicare patients.”

The TIF 2.0 procedure was made available with Palmetto on November 28, 2016, and patients and providers can reference Category 1 CPT® code 43210 for coverage opportunities. For more information on the TIF 2.0 procedure, please visit http://www.endogastricsolutions.com/tif-procedure/.

The positive coverage decision follows publication of three-year follow up data from TIF EsophyX vs Medical PPI Open Label (TEMPO), a prospective, randomized, multicenter clinical study, which demonstrated long-term control of chronic GERD after a TIF 2.0 procedure with the EsophyX® device. The study met its primary endpoint, with 83 percent of patients undergoing the TIF procedure experiencing elimination of regurgitation and all atypical GERD symptoms at three-years post-procedure. The Surgical Endoscopy open access paper is available here. The TIF 2.0 procedure has also been supported by over 70 additional published studies that consistently report positive clinical outcomes.

Additional Medicare Administrator Contractors with confirmed coverage for the TIF procedure include: Cahaba Government Benefit Administrators,® LLC for over three million members in Alabama, Georgia and Tennessee, CGS Administrators®, LLC which serves 2.7 million members in Kentucky and Ohio, and Novitas Solutions, Inc. which covers over nine million members in Arkansas, Colorado, Louisiana, Mississippi, New Mexico and Oklahoma.

Earlier this year, Health Care Service Corporation (HCSC) provided coverage for approximately 15 million members through its affiliates; Blue Cross Blue Shield of Illinois, Blue Cross Blue Shield of Montana, Blue Cross Blue Shield of New Mexico, Blue Cross Blue Shield of Oklahoma and Blue Cross Blue Shield of Texas.

About Current Procedural Terminology (CPT®)

CPT codes are a listing of descriptive terms and identifying codes for reporting medical services and procedures. The purpose of CPT is to provide a uniform language that accurately describes medical, surgical, and diagnostic services, and thereby serves as an effective means for reliable nationwide communication among physicians and other healthcare providers, patients and third parties. CPT is registered trademark of the American Medical Association.

The Federal Register has posted coding and payment information specific to the CPT code, allowing patients to more easily receive access to treatment for GERD. Physicians and hospitals can reference CPT Code 43210 EGD esophagogastric fundoplasty and APC 5331 Complex GI Procedures for TIF® procedures.

About GERD

Gastroesophageal reflux disease (GERD) is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to reflux (wash backwards) into the esophagus, causing heartburn and possible injury to the esophageal lining. 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 80 million people at least once per month 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 without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical repair an effective treatment option to correct the underlying cause of GERD. 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 medications to control symptoms.

Over 18,000 TIF patients have been treated worldwide since the EsophyX® device was launched. In the past ten years, more than 70 peer-reviewed papers from over 50 centers have been published documenting consistent outcomes on over 1,100 unique study patients. For more information, visit www.GERDHelp.com.

About EsophyX® technology

The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope. The original EsophyX device was cleared by the FDA in 2007. EndoGastric Solutions® launched the third generation EsophyX device, the EsophyX Z, in 2015. The evolving EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes – including low profile and larger high-definition models — to treat the underlying anatomical cause of GERD.

Indications

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 GERD in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic GERD.

About EndoGastric Solutions®

Based in Redmond, WA, EndoGastric Solutions, Inc. (www.endogastricsolutions.com), is a medical device company focused on developing and commercializing innovative, evidence-based, incisionless surgical technology for the treatment of GERD. EGS has combined the most advanced concepts in gastroenterology and surgery to develop the Transoral Incisionless Fundoplication (TIF®) 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need.

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Contacts

EndoGastric Solutions®, Inc.
Debbie Donovan, 408-621-0216
ddonovan@endogastricsolutions.com
or
Edelman
Amanda Hodge, 214-443-7565
Amanda.Hodge@edelman.com

Contacts

EndoGastric Solutions®, Inc.
Debbie Donovan, 408-621-0216
ddonovan@endogastricsolutions.com
or
Edelman
Amanda Hodge, 214-443-7565
Amanda.Hodge@edelman.com