TIF procedure, GERD, acid reflux, insurance coverage, Medicare,EndoGastric Solutions® Provides Access to the TIF 2.0 procedure through Medicare Administrative Contractor Palmetto GBA

REDMOND, Washington 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 https://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.

NP02450-14A/-01D

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About GERD
Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease that affects nearly 20 percent of the U.S. population. It 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. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Some patients may have mild or moderate symptoms of GERD, while others have more severe manifestations causing chronic heartburn, asthma, chronic cough, and hoarse voice or chest pain. Left untreated, GERD can develop into a pre-cancerous condition called Barrett’s esophagus, which is a precursor for esophageal cancer. The first treatment recommendation for patients with GERD is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Proton pump inhibitor (PPI) medications are commonly used to treat GERD, but there are a variety of health complications associated with long-term dependency on PPIs, and more than 10 million Americans are refractory to PPI therapy and may opt for surgery.

About Transoral Incisionless Fundoplication (TIF® 2.0 procedure) for Reflux
The TIF 2.0 procedure enables an incisionless approach to fundoplication in which a device is inserted through the mouth, down the esophagus and into the upper portion of the stomach. This approach offers patients looking for an alternative to traditional surgery an effective treatment option to correct the underlying cause of GERD. Based on clinical studies, most patients stopped using daily medications to control their symptoms and had their esophageal inflammation (esophagitis) eliminated up to five years after the TIF 2.0 procedure. Additionally, clinical results have demonstrated that concomitant laparoscopic hiatal hernia repair (LHHR) immediately followed by TIF 2.0 procedure is safe and effective in patients requiring repair of both anatomical defects.

Over 25,000 TIF procedures have been performed worldwide. More than 140 peer-reviewed papers have consistently documented the sustained improved clinical outcomes and exemplary safety profile the TIF procedure provides to patients suffering from GERD. For more information, please visit www.GERDHelp.com.

About Reimbursement
With the support of clinical societies, commercial and federal insurance providers, representing more than 100 million lives, have recognized the value of the TIF 2.0 procedure through recently expanded coverage policies. The TIF 2.0 procedure is a covered benefit for all Medicare beneficiaries across the country.

For the TIF 2.0 procedure, physicians and hospitals can reference CPT Code 43210 EGD esophagogastric fundoplasty. CPT is a registered trademark of the American Medical Association.

About EsophyX® Technology
The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids from refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope, and enables creation of a 3 cm, 270° esophagogastric fundoplication. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. The evolving technology, including the latest iteration EsophyX Z+, launched in 2017, enables surgeons and gastroenterologists to use a wide selection of endoscopes to treat the underlying anatomical cause of GERD.

Indications
The EsophyX device, with SerosaFuse® fasteners and accessories, is indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. It is indicated for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacological therapy. The device is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2 cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2 cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2 cm or less.

About EndoGastric Solutions®
Based in Redmond, Washington, EndoGastric Solutions, Inc. (www.endogastricsolutions.com), is a medical device company 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 products and procedures to treat gastrointestinal diseases, including the TIF 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelp and LinkedIn: EndoGastric Solutions.

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Contact:
Ted Stephens
EndoGastric Solutions, Inc.
Phone: +1 513-312-9161
tstephens@endogastricsolutions.com

Erich Sandoval
Lazar Partners
Phone: +1 917-497-2867
esandoval@lazarpartners.com