Item 7.01. Regulation FD Disclosure.
On November 2, 2021, the Centers for Medicare & Medicaid Services (CMS)
published its Final Rules for 2022 Medicare physician fee payment rates and 2022
Medicare facility fee payment rates for services furnished in both the hospital
outpatient (HOPD) and Ambulatory Surgical Center (ASC) settings. These Final
Rules supercede the proposed rates that were issued in July 2021, and are
subject to the issuance of any updates or corrections by CMS prior to or around
January 1, 2022, the date these Final Rules take effect. Glaukos Corporation
("Glaukos") issued a press release announcing the proposed 2022 physician fee
payment rates on July 14, 2021, and filed a Current Report on Form 8-K
announcing the proposed 2022 facility fee payment rates with the U.S. Securities
and Exchange Commission on July 20, 2021.
In the Final Rules, CMS established payments for new Category I Current
Procedural Terminology (CPT) codes 66991 for cataract extraction in combination
with the insertion of an aqueous drainage device, and 66989 for complex cataract
extraction in combination with the insertion of an aqueous drainage device.
Category I CPT Codes 66991 and 66989 will replace Category III codes 0191T and
0376T as the primary codes that physicians, hospitals and ASCs will use to seek
reimbursement utilizing Glaukos' trabecular micro-bypass technologies (iStent®,
iStent inject®, and iStent inject W) when used as approved in combination with
cataract surgery. The Calendar Year 2022 Medicare Physician Fee Schedule Final
Rule and accompanying Addenda include a 2022 physician fee payment rate for CPT
code 66991 of approximately $663.57, representing incremental physician fee
payment for the insertion of an aqueous draining device of approximately
$134.73, and a 2022 physician fee payment rate for CPT code 66989 of
approximately $831.56, representing incremental physician fee payment for the
insertion of an aqueous draining device of approximately $107.18.
The Final Rule with respect to facility fee payment rates, and accompanying
Addenda, include a 2022 ASC facility fee payment rate for CPT codes 66991 and
66989 of $3,245.55. Glaukos estimates that approximately 80% of procedures
utilizing its trabecular micro-bypass technologies in the U.S. are performed in
the ASC setting. For the remaining estimated 20% of procedures performed in the
HOPD setting, the Final Rule includes a 2022 HOPD facility fee payment rate for
CPT codes 66991 and 66989 of $4,250.50. Additionally, the Final Rule includes a
2022 ASC facility fee payment rate for CPT code 0671T, for standalone insertion
of an aqueous drainage device, of $1,601.18 in the ASC setting and $2,120.86 in
the HOPD setting, which would be the primary code that hospitals and ASCs will
use to seek reimbursement utilizing Glaukos' iStent® infinite product, which is
not yet approved by the U.S. Food & Drug Administration.
The Final Rules and accompanying Addenda, including these final payment rates,
can be accessed on the CMS website at www.cms.gov. All website references herein
are provided for convenience only and the content of the website does not
constitute a part of this Current Report on Form 8-K. Further, the information
contained herein shall not be deemed filed for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise
subject to the liabilities of that section, or incorporated by reference in any
filing under the Exchange Act or the Securities Act of 1933, as amended, except
as shall be expressly set forth by specific reference in such filing.
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