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.–(BUSINESS WIRE)–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)
[email protected]
or
Lazar
Partners, LTD
Dawn Fallon, 646-871-8481 (direct)
[email protected]
or
Twitter:
@GERDHelp
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GERDHelpcom
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