Expanded Medicare coverage and update to facility reimbursement increases patient access to non-surgical alternative for long-term control of acid reflux symptoms

REDMOND, Wash. (November 14, 2017) – Medicare beneficiaries in 23 additional states have been granted reimbursed access to the Transoral Incisionless Fundoplication (TIF®) 2.0 procedure following positive coverage decisions by Medicare Administrative Contractors (MACs) Noridian Health Care Solutions (Noridian) and National Government Services, Inc. (NGS). These decisions benefit the growing number of gastroesophageal reflux (GERD) patients seeking a clinically proven treatment alternative with long-term symptom control and now make the TIF 2.0 procedure the only non-surgical treatment option for acid reflux available to these Medicare beneficiaries.

“The need exists for safe, dependable treatment options to address reflux beyond invasive surgical operations and proton pump inhibitor (PPI) dependence,” says gastroenterologist Kenneth Chang, M.D., UC Irvine Health. “The TIF 2.0 procedure provides a well-tested and proven therapeutic alternative to patients seeking lasting relief.”

The Noridian decision (effective October 27, 2017) provides coverage for more than 10.7 million Medicare patients in Alaska, Arizona, California, Hawaii, Idaho, Montana, North Dakota, Nevada, Oregon, South Dakota, Utah, Washington and Wyoming. Additionally, the NGS decision (effective December 1, 2017) will offer Part B coverage to approximately 10.1 million Medicare patients in Connecticut, Illinois, Maine, Massachusetts, Minnesota, New Hampshire, New York, Rhode Island, Vermont and Wisconsin.

By granting Medicare coverage for the TIF 2.0 procedure, Noridian and NGS join MACs Cahaba GBA, CGS Administration, Novitas and Palmetto, who already provide access to 23.9 million Medicare subscribers across an additional 20 states, including Washington, D.C. With the addition of Noridian and NGS, the total number of Medicare lives covered for the TIF 2.0 procedure will be approximately 44.8 million nationwide, representing 81 percent of 55.5 million total Medicare beneficiaries (and 43 states providing coverage).

“The robust body of clinical evidence which supports the TIF 2.0 procedure continues to demonstrate durable, positive outcomes for patients experiencing troublesome GERD symptoms,” says surgeon Kevin Reavis, M.D., FACS, The Oregon Clinic. “Now, patients who wish to avoid or discontinue PPI use and want a less invasive procedure than traditional surgery has access to sustained symptom relief with the TIF 2.0 alternative.”

These positive coverage decisions parallel a ruling from Centers for Medicare & Medicaid Services (CMS) to increase hospital reimbursement payments for the TIF 2.0 procedure. As a result, Medicare outpatient reimbursement payments to hospitals for the EsophyX TIF 2.0 procedure will increase by 93% starting January 1, 2018.

To date, the TIF 2.0 procedure has brought relief to more than 20,000 GERD patients worldwide, providing a safe and efficacious minimally invasive surgical solution for the millions of Americans suffering with persistent acid reflux.

“Further payer expansion of our TIF 2.0 procedure to more than 80% of Medicare lives, coupled with the 93% reimbursement increase from CMS, are testaments to the value proposition that our safe, minimally invasive, and highly effective long-term treatment option offer patients suffering from GERD,” said Skip Baldino, President and CEO of EndoGastric Solutions. “More than 94 million patients are now covered for the TIF 2.0 procedure following these coverage expansion decisions, further illustrating the need for safe and effective treatment options for patients suffering from GERD and the physicians who care for them.”

EndoGastric Solutions continues to work with other MACs and commercial payers to secure coverage for the TIF 2.0 procedure, ensuring GERD patients nationwide have access to this innovative, incisionless technology. Physicians assessing potential TIF 2.0 patients may call (860) 619-4133 to speak with a representative for information about appropriate coding, coverage and payment details.

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. The coding serves as an effective way to provide communication among 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