MARLBOROUGH, Mass.,
Aug. 2, 2021 /PRNewswire/
-- Boston Scientific (NYSE: BSX) announced that the U.S.
Centers for Medicare & Medicaid Services (CMS) granted a New
Technology Add-on Payment (NTAP) for single-use duodenoscopes,
applicable to the EXALT™ Model D Single-Use Duodenoscope, as part
of its Fiscal Year 2022 Hospital Inpatient Prospective Payment
System. NTAP was created to facilitate patient access for
qualifying new medical technologies that substantially improve the
diagnosis or treatment of Medicare beneficiaries. Beginning
October 1, 2021, CMS will provide
hospitals with additional device reimbursement when the EXALT Model
D Single-Use Duodenoscope is used for eligible cases in the
hospital inpatient setting.
The EXALT Model D Single-Use Duodenoscope is designed to
eliminate the risk of infection due to ineffective
reprocessing of traditional reusable duodenoscopes. Duodenoscopes
are used to diagnose and treat various pancreatic and biliary
conditions during endoscopic retrograde cholangiopancreatography
(ERCP) procedures. Every year, more than 700,000 ERCP procedures
are performed in the U.S. and approximately 1.5 million are
completed worldwide.i In 2019 the U.S. Food and Drug
Administration (FDA) recommended that providers utilize
duodenoscopes with disposable components or fully disposable
devices, when available.ii
The EXALT Model D Single-Use Duodenoscope previously received
Breakthrough Device Designation from the FDA as well as
transitional pass-through (TPT) payment by CMS, the latter of which
allows for incremental device reimbursement for Medicare cases
performed in the hospital outpatient setting. Further, in response
to a Boston Scientific request, CMS created two unique ICD-10
procedure codes for hospitals to facilitate reporting the use of
single-use duodenoscopes when used in the hospital inpatient
setting beginning October 1,
2021.
"Securing NTAP, in addition to TPT, for the EXALT Model D
Duodenoscope will support health care providers in accessing this
device for Medicare patients – a group that represents over 40% of
all ERCPs performed in the U.S. each year," said Dave Pierce, executive vice president and
president, MedSurg and president, Endoscopy, Boston Scientific.
"Adequate reimbursement is key for the adoption of any new
technology, and this decision from CMS will help provide hospitals
with the means to treat Medicare patients with this device."
The EXALT Model D Duodenoscope is part of the Boston Scientific
single-use device portfolio, which includes technologies within the
gastrointestinal, pancreaticobiliary, surgical, urological and
airway spaces such as the LithoVue™ Digital Flexible
Ureteroscope, SpyGlass™ DS Direct Visualization
System, SpyGlass™ Discover Digital Catheter, and EXALT™
Model B Single-Use Bronchoscope.iii
For additional information, please visit the EXALT Model D
Single-Use Duodenoscope page on the Boston Scientific
website.
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 more than 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
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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 business plans, clinical trials and product
performance and impact. If our underlying assumptions turn out
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actual results could vary materially from the expectations and
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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
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Factors that may cause such differences include, among other
things: future economic, political, competitive, reimbursement and
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trends; 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 IA - 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
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conditions, or circumstances on which those expectations may be
based, or that may affect the likelihood that actual results will
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statements. This cautionary statement is applicable to all
forward-looking statements contained in this press release.
CONTACTS:
Nate Illsley
Media Relations
(508) 269-4607 (office)
Nathan.Illsley@bsci.com
Lauren Tengler
Investor Relations
508-683-4479
BSXInvestorRelations@bsci.com
i Internal estimate
ii 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
iii The EXALT Model B Single-Use Bronchoscope is
currently pending FDA 510(k) review and is not yet available for
sale in the United States
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SOURCE Boston Scientific Corporation