Glaukos Comments on the Centers for Medicare and Medicaid Services 2022 Proposed Physician Fee Schedule
July 14 2021 - 2:00AM
Business Wire
Glaukos Corporation (NYSE: GKOS), an ophthalmic medical
technology and pharmaceutical company focused on novel therapies
for the treatment of glaucoma, corneal disorders and retinal
diseases, today commented on the recently released Centers for
Medicare and Medicaid Services (CMS) Calendar Year 2022 Medicare
Physician Fee Schedule Proposed Rule. The Proposed Rule was
released on July 13, 2021, and updates payment policies, payment
rates and other provisions for services furnished under the
Medicare Physician Fee Schedule on or after January 1, 2022. The
Proposed Rule release is followed by a 60-day public comment period
closing on September 13, 2021, which will culminate in CMS' release
of the Final Rule, which is expected to be announced by November
2021, for implementation on January 1, 2022. The Proposed Rule is
therefore subject to change.
The Proposed Rule and accompanying Addenda include payment rates
for two new Category I Current Procedural Terminology (CPT) codes,
including 669X2 for non-complex cataract extraction in combination
with the insertion of an aqueous drainage device and 669X1 for
complex cataract extraction in combination with the insertion of an
aqueous drainage device. Category I CPT Codes 669X2 and 669X1 will
replace Category III codes 0191T and 0376T as the primary codes
that physicians will use to seek reimbursement utilizing Glaukos’
trabecular micro-bypass technologies (iStent®, iStent inject®,
iStent inject W) when used as approved in combination with cataract
surgery.
Applying the CMS 2022 Proposed Rule’s assigned total facility
Relative Value Units (RVUs) and associated conversion factor,
Glaukos estimates a proposed 2022 physician fee for Category I CPT
Code 669X2 of approximately $565.23, representing incremental
physician fee payment for the insertion of an aqueous draining
device of approximately $34.25 versus the proposed 2022 physician
fee of approximately $530.98 for Category I CPT Code 66984
(non-complex cataract surgery alone).
“We are aware of and extremely disappointed with CMS’ proposed
2022 physician fees for the new Category I codes that cover our
sight-saving trabecular micro-bypass technologies used in
combination with cataract surgery,” said Thomas Burns, Glaukos
president and chief executive officer. “While this is unwelcomed
and unexpected news that we believe is unjustified, we are eager to
engage with our key ophthalmic societies and are committed to
exploring every option during the public comment period in hopes
that medical providers across our network are paid appropriately
for conducting these types of procedures. We remain steadfastly
dedicated to transform the treatment of chronic eye diseases for
the benefit of patients worldwide.”
This announcement does not include the Medicare Outpatient
Prospective Payment System (OPPS) Proposed Rule for Calendar Year
2022, which will include proposed facility fee payments for
services furnished in both the hospital outpatient department
(HOPD) and ambulatory surgical center (ASC) settings. Glaukos
expects the 2022 Medicare OPPS Proposed Rule to be released by CMS
over the coming days to weeks.
About Glaukos
Glaukos (www.glaukos.com) is an ophthalmic medical technology
and pharmaceutical company focused on novel therapies for the
treatment of glaucoma, corneal disorders and retinal diseases. The
company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to
revolutionize the traditional glaucoma treatment and management
paradigm. Glaukos launched the iStent®, its first MIGS device, in
the United States in 2012, its next-generation iStent inject®
device in the United States in 2018, and most recently, the iStent
inject W device in 2020. In corneal health, Glaukos’ proprietary
suite of single-use, bio-activated pharmaceuticals are designed to
strengthen, stabilize and reshape the cornea through a process
called corneal collagen cross-linking to treat corneal ectatic
disorders and correct refractive conditions. Glaukos is leveraging
its platform technology to build a comprehensive and proprietary
portfolio of micro-scale surgical and pharmaceutical therapies in
glaucoma, corneal health and retinal disease.
Forward-Looking Statements
All statements other than statements of historical facts
included in this press release that address activities, events or
developments that we expect, believe or anticipate will or may
occur in the future are forward-looking statements. Although we
believe that we have a reasonable basis for forward-looking
statements contained herein, we caution you that they are based on
current expectations about future events affecting us and are
subject to risks, uncertainties and factors relating to our
operations and business environment, all of which are difficult to
predict and many of which are beyond our control, that may cause
our actual results to differ materially from those expressed or
implied by forward-looking statements in this press release. These
potential risks and uncertainties include, without limitation, the
timing and extent to which obtain regulatory approval for
investigational products, our ability to successfully commercialize
such products, the ability to obtain and maintain adequate
financial coverage and reimbursement for our products, and the
continued efficacy and safety profile of our products. These and
other risks, uncertainties and factors related to Glaukos and our
business are described in detail under the caption “Risk Factors”
and elsewhere in our Quarterly Report on Form 10-Q for the quarter
ended March 31, 2021, which was filed with the Securities and
Exchange Commission (SEC) on May 6, 2021, and our Annual Report on
Form 10-K for the year ended December 31, 2020, which was filed
with the SEC on March 1, 2021. Our filings with the Securities and
Exchange Commission are available in the Investor Section of our
website at www.glaukos.com or at www.sec.gov. In addition,
information about the risks and benefits of our products is
available on our website at www.glaukos.com. All forward-looking
statements included in this press release are expressly qualified
in their entirety by the foregoing cautionary statements. You are
cautioned not to place undue reliance on the forward-looking
statements in this press release, which speak only as of the date
hereof. We do not undertake any obligation to update, amend or
clarify these forward-looking statements whether as a result of new
information, future events or otherwise, except as may be required
under applicable securities law.
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version on businesswire.com: https://www.businesswire.com/news/home/20210713006250/en/
Investor Contact: Chris Lewis Sr. Director, Investor Relations
& Corporate Strategy & Development (949) 481-0510
clewis@glaukos.com
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