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.
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.
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.
Sr. Director, Investor Relations & Corporate Strategy & Development