EndoGastric Solutions Receives Positive Medical Coverage Policy By HCSC For TIF Procedure With Esophyx Device

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

REDMOND, Wash.--(BUSINESS WIRE)--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.

“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.”

HCSC 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.

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. 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 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 another 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 PPI medications to control symptoms.

Over 18,000 TIF patients have been treated worldwide since the EsophyX® device was launched. More than 70 peer-review 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 original EsophyX device was cleared by the FDA in 2007. EGS launched the third generation EsophyX device, the EsophyX Z, in 2015. The technology has continued to evolve and is a clinically-backed tool for physician use in the treatment of GERD. The 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. 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.

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®) procedure—a minimally invasive solution that addresses a significant unmet clinical need.

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.