MARLBOROUGH, Mass.,
June 8, 2020 /PRNewswire/ -- Boston
Scientific (NYSE: BSX) today announced that the Centers for
Medicare & Medicaid Services (CMS) has approved its application
for a transitional pass-through (TPT) payment category to describe
single-use endoscopes, including the EXALT™ Model D Single-Use
Duodenoscope, under the Medicare hospital outpatient prospective
payment system (OPPS). The intent of TPT payment is to facilitate
Medicare beneficiary access to the advantages of new and innovative
devices by allowing for adequate payment for these new devices
while the necessary cost data is collected to incorporate the costs
for these devices into the procedure
Ambulatory Payment Classifications (APC) rate.
The new device transitional pass-through code (C1748) may be
used to bill for EXALT Model D when it is used in treatment of
Medicare beneficiaries in the hospital outpatient setting starting
July 1, 2020.
The EXALT™ Model D Single-Use Duodenoscope is the world's first
and only single-use, flexible duodenoscope currently cleared by the
US. Food and Drug Administration (FDA). Duodenoscopes are used in
endoscopic retrograde cholangiopancreatography (ERCP) procedures to
diagnose and treat various pancreatic and biliary conditions. Every
year, more than 700,000 ERCP procedures are performed in the U.S.
and approximately 1.5 million are completed
worldwide.1
Notably, the FDA has recommended that providers transition to
duodenoscopes with disposable components or fully disposable
devices, when they are available.2
The FDA granted EXALT Model D its Breakthrough Devices
Designation through a program intended to expedite the development
and prioritize the review of certain medical devices that provide
for more effective treatment or diagnosis for life-threatening or
irreversibly debilitating diseases or conditions. Breakthrough
Device Designation provides patients more timely access to novel
medical devices such as Exalt Model D.
Since January 2020, CMS has
provided an alternative pathway for innovative technologies that
have received FDA marketing authorization and Breakthrough Devices
Designation to qualify for device pass-through payment. EXALT Model
D is among the first devices to receive TPT approval by CMS via
this pathway.
"The approval of this new payment category in the outpatient
setting will help ensure healthcare providers have access to EXALT
Model D at a time when there is heightened awareness of the need to
eliminate infection risk for patients, physicians, and hospital
staff. With EXALT Model D, physicians can use a new, sterile
duodenoscope for every procedure," said Brian Dunkin, M.D., chief medical officer,
Endoscopy, Boston Scientific. "Boston Scientific has been dedicated
to advancing the care of pancreaticobiliary diseases for over 30
years, and we are proud that the Centers for Medicare &
Medicaid Services, the country's largest payer for health care,
recognizes the importance of our technology to its
beneficiaries."
The EXALT™ Model D Single-Use Duodenoscope received FDA
clearance in December 2019 and has
been commercially launched as an alternative to reusable
duodenoscopes, eliminating the need for duodenoscope reprocessing
and repairs, and allowing physicians to use a new, sterile scope
for every procedure.
Please visit www.bostonscientific.com/EXALT for more information
about the EXALT Model D Single-Use Duodenoscope.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
solutions that improve the health of patients around the world. As
a global medical technology leader for 40 years, we advance science
for life by providing a broad range of high-performance solutions
that address unmet patient needs and reduce the cost of healthcare.
For more information, visit www.bostonscientific.com and connect on
Twitter and Facebook.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Forward-looking
statements may be identified by words like "anticipate," "expect,"
"project," "believe," "plan," "estimate," "intend" and similar
words. These forward-looking statements are based on our beliefs,
assumptions and estimates using information available to us at the
time and are not intended to be guarantees of future events or
performance. These forward-looking statements include, among other
things, statements regarding our product launches and product
performance and impact. If our underlying assumptions turn out to
be incorrect, or if certain risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections expressed or implied by our forward-looking statements.
These factors, in some cases, have affected and in the future
(together with other factors) could affect our ability to implement
our business strategy and may cause actual results to differ
materially from those contemplated by the statements expressed in
this press release. As a result, readers are cautioned not to place
undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other
things: future economic, competitive, reimbursement and regulatory
conditions; new product introductions; demographic trends; the
closing and integration of acquisitions; intellectual property;
litigation; financial market conditions; and future business
decisions made by us and our competitors. All of these factors are
difficult or impossible to predict accurately and many of them are
beyond our control. For a further list and description of these and
other important risks and uncertainties that may affect our future
operations, see Part I, Item 1A – Risk Factors in our most recent
Annual Report on Form 10-K filed with the Securities and Exchange
Commission, which we may update in Part II, Item 1A – Risk Factors
in Quarterly Reports on Form 10-Q we have filed or will file
hereafter. We disclaim any intention or obligation to publicly
update or revise any forward-looking statements to reflect any
change in our expectations or in events, conditions or
circumstances on which those expectations may be based, or that may
affect the likelihood that actual results will differ from those
contained in the forward-looking statements. This cautionary
statement is applicable to all forward-looking statements contained
in this document.
CONTACTS
Abhi Basu
Media Relations
(508) 683-4797 (Office)
Abhi.Basu@bsci.com
Susie Lisa, CFA
Investor Relations
508-683-5565 (office)
BSXInvestorRelations@bsci.com
- Internal Estimate
- United States Food and Drug Administration website: " The FDA
is Recommending Transition to Duodenoscopes with Innovative Designs
to Enhance Safety: FDA Safety Communication" April 10,
2020
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SOURCE Boston Scientific Corporation