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.
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