Newly Issued Technology Coverage Statement on Minimally Invasive Surgical Options for GERD

REDMOND, Washington. – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), announced today that Health Care Service Corporation (HCSC), a top commercial health insurer in the U.S, has issued a medical coverage policy for Transoral Incisionless Fundoplication (TIF®) procedures effective July 15, 2016.

HCSC Blue Cross Blue Shield coverageHCSC will make the TIF procedure with EsophyX® device available to its approximately 15 million members in the treatment of chronic reflux. HCSC network includes 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.

HCSC’s coverage policy was based on multiple peer-reviewed, randomized controlled trial evidence, including sham-control groups and long-term outcome data, consistently demonstrating that the TIF procedure is a safe, effective and durable treatment option for GERD.

Advocacy for this policy included a joint recommendation from the American Gastroenterological Association (AGA) and The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).

“On behalf of GERD sufferers, I would like to express our deep appreciation to HCSC for being the first major commercial carrier to give their patients access to our TIF procedure,” said Skip Baldino, President and CEO of EndoGastric Solutions. “We are grateful to the leading GI and surgical societies for the tangible actions to support their members’ ability to offer a well-tested and proven therapeutic intervention to their patients needing anatomical correction to control GERD symptoms.”

This positive coverage decision expands on the American Medical Association’s decision to create a new Category 1 Current Procedural Terminology (CPT®) Code 43210: EGD Esophagogastric Fundoplasty, which became effective in January 2016.

“CPT code 43210 was assigned a zero-day global period which means that follow-up visits are billed separately,” said Philip Macdonald, Vice President, Healthcare Economics, Policy & Reimbursement. “This is a unique situation for a foregut surgery; typically, surgical procedures are reimbursed with a payment covering care from procedure day plus up to 90 days after. Patients are now able to follow-up with the healthcare team members that have been most involved in their wellness management.”

To date, EGS has achieved other key reimbursement milestones. Cahaba Government Benefit Administrators,® LLC (Cahaba GBA), a Medicare Administrative Contractor (MAC), approved reimbursement of the TIF procedure (since May 2015). Cahaba GBA administers benefit claims in Alabama, Georgia and Tennessee for over three million members.

The TIF procedure with EsophyX device is also covered by Novitas Solutions, a separate Medicare Administrative Contractor, which covers over nine million members in 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).

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 new 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 as of January 1, 2016.

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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