Publication of New Category I CPT Code is an Important Step in Establishing Access to Minimally Invasive Technology for Patients with Reflux

SAN MATEO, Calif.–EndoGastric Solutions (EGS), developer of an incisionless approach to treat Gastroesophageal Reflux Disease (GERD), announced today that the American Medical Association (AMA) has created a new Category I Current Procedural Terminology (CPT®) code with a procedure descriptor associated with the company’s Transoral Incisionless Fundoplication (TIF®) procedure for reflux.

The code, 432XX1, covers Esophagogastric Fundoplasty Trans-Orifice procedures, and will enable physicians to specifically communicate information to payers about the TIF procedure which is used to treat patients with chronic GERD.

The application for the new code was jointly sponsored by four key specialty medical societies: American Gastroenterological Association (AGA), American College of Gastroenterology (ACG), American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES); this application was reviewed during the recent public CPT panel February meeting held in San Diego, California.

“AMA’s CPT Editorial Panel’s decision to add this Category I code in 2016 is significant as it enables healthcare providers better access to coding and payment structures in the U.S. than are currently available. This not only increases procedure choice for physicians but expands patient access for new technology for GERD patients,” said Philip Macdonald, Vice President, Healthcare Economics, Policy, and Reimbursement at EndoGastric Solutions.

The Summary of Panel Actions is a preliminary step; new and revised code descriptions may be further refined prior to implementation, scheduled for January 1, 2016.

“The AMA’s decision to create a unique CPT code that describes the transoral reconstruction of a defective gastroesophageal valve to prevent reflux is a significant milestone for GERD patients. It will allow well-selected GERD patients to receive an appropriate solution tailored to their disease stage,” said Skip Baldino, President and CEO of EndoGastric Solutions. “By creating this new code, the AMA has acknowledged the significant clinical evidence, including data from two randomized trials, and that this procedure has reached broad acceptance across both the GI and Surgeon physician community.”

“We are very pleased that the surgical and gastroenterological societies united in their support of the new code consistent with their continued efforts in advocating for evidence-based medicine and appropriate coding,” continued Baldino. “We feel that this is another important step in the process to provide broad availability to the innovative treatment option for millions of GERD patients.”

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.

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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