REDMOND, Wash.--(BUSINESS WIRE)--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.
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. In the U.S., GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Pain and discomfort from acid reflux impact more than 80 million Americans at least once a month according to estimates. The first treatment recommendations for GERD patients is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Patients are instructed to take prescription medications; unfortunately, it is a common practice to increase medication doses and, over time, become dependent on these medications to control symptoms. A variety of other health complications are linked to the long-term, maximum-dose usage of prescription medications.
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 an effective treatment option to correct the underlying cause of GERD. Most patients stopped using daily medications to control symptoms and had their esophageal inflammation (esophagitis) eliminated up to three years after the TIF procedure based on studies.
There are more than 20,000 TIF patients treated worldwide since the EsophyX® device launched. In the past ten years, over 60 centers published more than 80 peer-reviewed papers. These studies document consistent outcomes on over 1,300 unique study patients. For more information, visit www.GERDHelp.com.
About EsophyX® technology
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. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. EndoGastric Solutions® launched the third generation EsophyX device, the EsophyX Z model, in 2015. The evolving EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes to treat the underlying anatomical cause of GERD. These options include low profile and larger high-definition models.
Indications
The EsophyX device with SerosaFuse® fasteners and accessories are indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. They are 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 ≤ 2cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.
About EndoGastric Solutions®
Based in Redmond, WA, 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 the Transoral Incisionless Fundoplication (TIF®) 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelp and Google+: GERDHelp.
