Glaukos comments on the proposed physician fee schedule for the Centers for Medicare and Medicaid Services 2022



SAN CLEMENTE, Calif .– (COMMERCIAL THREAD) – Glaukos Corporation (NYSE: GKOS), an ophthalmic and pharmaceutical medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today commented on the recent schedule of the Centers for Medicare and Medicaid Services (CMS) Proposed rule for the Medicare physician fee schedule for the year 2022. The proposed rule was released on July 13, 2021 and updates payment policies, payment rates and other provisions for services provided under the Medicare Physician Fee Schedule effective January 1, 2022. The publication of the proposed rule is followed by a 60-day public comment. comment period ending on September 13, 2021, which will culminate with the publication by CMS 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 a 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 claim reimbursement using Glaukos’ micro-trabecular bypass technologies (iStent®, iStent inject®, iStent inject W) when used as approved in conjunction with cataract surgery.

Applying the total Relative Value Units (UVRs) assigned to the proposed CMS 2022 rule and the associated conversion factor, Glaukos estimates the proposed 2022 physician fees for CPT Category I code 669X2 to be approximately $ 565.23, this which represents the additional physician fee payment for the insertion of an aqueous drainage device of approximately $ 34.25 over the proposed 2022 physician fee of approximately $ 530.98 for Category I CPT code 66984 (non-complex cataract surgery alone).

“We are aware and extremely disappointed with the physician fees proposed by CMS for 2022 for the new Category I codes that cover our vision-saving micro-trabecular bypass technologies used in combination with cataract surgery,” said Thomas Burns, President and CEO of Glaukos. . “While this is unwanted and unexpected news that we believe is unwarranted, we look forward to engaging with our major ophthalmic companies and are committed to exploring all options during the public comment period in the hope that medical providers in our network are paid appropriately to carry them out. types of procedures. We remain committed to transforming the treatment of chronic eye disease for the benefit of patients around the world. ”

This announcement does not include the proposed Medicare Outpatient Prospective Payment System (OPPS) rule for calendar year 2022, which will include proposed facility fee payments for services provided in both the outpatient department. in the hospital (HOPD) and in the outpatient surgery center (ASC). Glaukos expects the proposed OPPS Medicare 2022 rule to be released by CMS in the next few days or weeks.

About Glaukos

Glaukos (www.glaukos.com) is an ophthalmic and pharmaceutical medical technology company specializing in 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 paradigm of glaucoma treatment and management. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012, its new generation iStent inject® in the United States in 2018, and more recently the iStent inject W in 2020. In corneal health, Glaukos’ exclusive line of single-use bio-activated pharmaceuticals are designed to strengthen, stabilize and reshape the cornea through a process called corneal collagen crosslinking to treat corneal ectatic disorders and correcting the refractive conditions. Glaukos leverages its technology platform to create a comprehensive and exclusive portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal diseases.

Forward-looking statements

All statements other than statements of historical fact included in this press release that deal with activities, events or developments that we expect, believe or anticipate will occur or may occur in the future are forward-looking statements. While we believe we have a reasonable basis for the forward-looking statements contained herein, we caution you that they are based on current expectations regarding future events affecting us and are subject to risks, uncertainties and factors. related to our operations and our business environment, many of which are beyond our control, which may cause our actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, but are not limited to, when and to what extent to obtain regulatory approval for investigational products, our ability to successfully commercialize such products, the ability to obtain and maintain financial coverage. and adequate reimbursement for our products, and the continued effectiveness and safety profile of our products. These and other risks, uncertainties and factors relating to Glaukos and our business are described in detail under the heading “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 Securities and Exchange Filings Commissions are available in the Investors section of our website at www.glaukos.com or at www.sec.gov. In addition, information on the risks and benefits of our products is available on our website 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 any forward-looking statements in this press release, which speak only as of the date hereof. We assume no obligation to update, modify or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under securities laws. applicable movable property.


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