Item 7.01. Regulation FD Disclosure.
On July 19, 2021, the Centers for Medicare & Medicaid Services (CMS) proposed
Medicare payment rates for services furnished in both the hospital outpatient
(HOPD) and Ambulatory Surgical Center (ASC) settings. The Calendar Year (CY)
2022 Hospital Outpatient Prospective Payment System (OPPS) and ASC Payment
System Proposed Rule is published annually and is followed by a 60-day public
comment period closing on September 17, 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 is in addition to the CMS Calendar Year 2022 Medicare
Physician Fee Schedule Proposed Rule released by CMS on July 13, 2021, as
discussed in a press release issued by Glaukos Corporation (Glaukos) on July 14,
2021.
The Proposed Rule and accompanying Addenda include facility fee 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 code 0191T as the primary code
that hospitals and ASCs 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. The Proposed Rule
includes a 2022 ASC facility fee payment rate for CPT codes 669X2 and 669X1 of
$2,516, compared to the current payment rate under the Category III code of
$3,353. 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 Proposed Rule includes a 2022 HOPD facility fee payment rate for
CPT codes 669X2 and 669X1 of $4,019, compared to the current payment rate under
the Category III code of $3,918. Additionally, the Proposed Rule includes a 2022
ASC facility fee payment rate for CPT code 01X2T, for standalone insertion of an
aqueous drainage device, of $2,516 in the ASC setting and $2,131 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 Proposed Rule and
accompanying Addenda, including these proposed payment rates, can be accessed on
the CMS website at www.cms.gov.
Glaukos Corporation plans to engage with CMS during the public comment period in
hopes that medical facilities across its network are paid appropriately for
conducting these types of procedures.
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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