EndoGastric Solutions Announces Assignment of Relative Value Units for New CPT Code Covering TIF Procedure

Ambulatory Payment Classification Assignment Also Included in the Federal Register

REDMOND, Wash.--()--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 total 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.

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 17,000 TIF patients have been treated worldwide since EsophyX® device clearance in 2007. More than 50 peer-review papers from over 40 centers have been published documenting consistent outcomes on over 800 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 gastroesophageal reflux disease (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 gastroesophageal reflux disease 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 gastroesophageal reflux disease.

Contacts

EndoGastric Solutions, Inc.
Debbie Donovan, 408-621-0126 (cell)
ddonovan@endogastricsolutions.com
or
Lazar Partners, LTD
Dawn Fallon, 646-871-8481 (direct)
dfallon@lazarpartners.com
or
Twitter: @GERDHelp
Facebook: GERDHelpcom
Google+: GERDHelp

Release Summary

EndoGastric Solutions Announces Assignment of Relative Value Units For New CPT Code Covering TIF Procedure

Contacts

EndoGastric Solutions, Inc.
Debbie Donovan, 408-621-0126 (cell)
ddonovan@endogastricsolutions.com
or
Lazar Partners, LTD
Dawn Fallon, 646-871-8481 (direct)
dfallon@lazarpartners.com
or
Twitter: @GERDHelp
Facebook: GERDHelpcom
Google+: GERDHelp