Ambulatory Payment Classification Assignment Also Included In The Federal Register

 REDMOND, Washington – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced the Federal Register has posted coding and payment information specific to the new Current Procedural Terminology (CPT)® code covering the Transoral Incisionless Fundoplication (TIF®) procedure.

Physician payment for CPT 43210 EGD esophagogastric fundoplasty has been given 12.43 relative value units (RVU); using the established Centers for Medicare and Medicaid (CMS) CY2016 conversion factor, 35.8279, this translates to a national unadjusted payment amount of $445.34.

For hospital outpatient payment, CPT 43210 has been grouped to APC 5331 Complex GI Procedures. This has a national unadjusted payment amount of $3,613.57. APCs are the federal government’s facility payments for outpatient Medicare services.

Physicians and hospitals will be able to reference CPT Code 43210 EGD esophagogastric fundoplasty and APC 5331 Complex GI Procedures for TIF procedures on or after January 1, 2016.

“Now that RVU and APC assignments for the new Category 1 CPT code 43210 have been finalized for use, healthcare providers should have a more effective pathway to appropriately receive reimbursement,” said Philip Macdonald, Vice President, Healthcare Economics, Policy and Reimbursement. “A larger percentage of GERD sufferers will have access to the TIF procedure as an option to resolve their chronic symptoms and help improve their quality of life.”

The relative value unit (RVU) assignment is based on the amount of the physician’s work, practice expense and malpractice expense associated with the procedure. The AMA formed the AMA/Specialty Society Relative Value Scale Update Committee (RUC) to act as an expert panel in developing relative value recommendations to the Centers for Medicare & Medicaid Services (CMS). The purpose of the RUC process is to provide recommendations to CMS for use in annual updates to the new Medicare RVS. Manufacturers have no impact or input into the assignment of RVUs.

“EGS invested in obtaining Level 1 evidence from randomized controlled trials to prove that the TIF procedure is an effective option to treat chronic acid reflux,” said Skip Baldino, President and CEO of EGS. “The CPT application was supported by four key surgical and gastroenterology societies—American Gastroenterological Association, American College of Gastroenterology, American Society for Gastrointestinal Endoscopy and the Society of American Gastrointestinal and Endoscopic Surgeon—who recognized the body of clinical evidence supported a dedicated CPT code.”

All outpatient services grouped under a specific APC are annually updated by the Centers for Medicare & Medicaid Services (CMS). Each APC is composed of services that are similar in clinical intensity, resource utilization and cost. Many service codes are derived directly from the American Medical Association’s CPT®.

“The APC classification assignment is also a significant step in the reimbursement process for the TIF procedure. We look forward to the increased economic value of the procedure for healthcare systems to provide chronic GERD patients this treatment option,” concluded Baldino.

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