EndoGastric Solutions Receives Positive Medical Coverage Policy by HCSC for TIF® Procedure with EsophyX® Device

REDMOND, Wash.–(BUSINESS WIRE)–EndoGastric Solutions® (EGS), a leader in incisionless procedural
therapy for gastroesophageal reflux disease (GERD), announced today that
Health Care Service Corporation (HCSC), a top commercial health insurer
in the U.S., has issued a medical coverage policy for Transoral
Incisionless Fundoplication (TIF®) procedures effective July 15, 2016.
HCSC will make the TIF procedure with EsophyX® device available
to its approximately 15 million members in the treatment of chronic
reflux. HCSC network includes its affiliates Blue Cross Blue Shield of
Illinois, Blue Cross Blue Shield of Montana, Blue Cross Blue Shield of
New Mexico, Blue Cross Blue Shield of Oklahoma and Blue Cross Blue
Shield of Texas.
HCSC’s coverage policy was based on multiple peer-reviewed, randomized
controlled trial evidence, including sham-control groups and long-term
outcome data, consistently demonstrating that the TIF procedure is a
safe, effective and durable treatment option for GERD.
Advocacy for this policy included a joint recommendation from the
American Gastroenterological Association (AGA) and The Society of
American Gastrointestinal and Endoscopic Surgeons (SAGES).
“On behalf of GERD sufferers, I would like to express our deep
appreciation to HCSC for being the first major commercial carrier to
give their patients access to our TIF procedure,” said Skip Baldino,
President and CEO of EndoGastric Solutions. “We are grateful to the
leading GI and surgical societies for the tangible actions to support
their members’ ability to offer a well-tested and proven therapeutic
intervention to their patients needing anatomical correction to control
GERD symptoms.”
This positive coverage decision expands on the American Medical
Association’s decision to create a new Category 1 Current Procedural
Terminology (CPT®) Code 43210: EGD Esophagogastric Fundoplasty, which
became effective in January 2016.
“CPT code 43210 was assigned a zero-day global period which means that
follow-up visits are billed separately,” said Philip Macdonald, Vice
President, Healthcare Economics, Policy & Reimbursement. “This is a
unique situation for a foregut surgery; typically, surgical procedures
are reimbursed with a payment covering care from procedure day plus up
to 90 days after. Patients are now able to follow-up with the healthcare
team members that have been most involved in their wellness management.”
To date, EGS has achieved other key reimbursement milestones. Cahaba
Government Benefit Administrators,® LLC (Cahaba GBA), a Medicare
Administrative Contractor (MAC), approved reimbursement of the TIF
procedure (since May 2015). Cahaba GBA administers benefit claims in
Alabama, Georgia and Tennessee for over three million members.
The TIF procedure with EsophyX device is also covered by Novitas
Solutions, a separate Medicare Administrative Contractor, which covers
over nine million members in Arkansas, Colorado, Louisiana Mississippi,
New Mexico, Oklahoma and Texas (since August 2012), and Delaware,
District of Columbia, Maryland, New Jersey and Pennsylvania (since April
2013).
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.
The Federal Register has posted coding and payment information specific
to the new CPT code, allowing patients to more easily receive access to
treatment for GERD. Physicians and hospitals can reference CPT Code
43210 EGD esophagogastric fundoplasty and APC 5331 Complex GI Procedures
for TIF procedures as of January 1, 2016.
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 18,000 TIF patients have been treated worldwide since the
EsophyX® device was launched. More than 70 peer-review papers
from over 50 centers have been published documenting consistent
outcomes on over 1,100 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 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
GERD 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 GERD.