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Eyenuk Applauds CMS CY 2022 Medicare Physician Fee Schedule Final Rule to Establish National Price for Autonomous AI Technology

 The CMS Final Rule establishes a national payment for CPT code 92229 that describes Eyenuk’s FDA-cleared EyeArt® AI system and confirms that AI can be used to close care gaps under the Merit-based Incentive Payment System (MIPS).

 Los Angeles, November 4, 2021 — Eyenuk, Inc., a global artificial intelligence (AI) medical technology and services company and the leader in real-world applications for AI Eye Screening, applauds the Center for Medicare & Medicaid Service (CMS) determination to set a national payment rate for autonomous AI diagnostic technology for the detection of diabetic retinopathy including Eyenuk’s EyeArt® AI technology. On November 2, CMS issued the CY 2022 Medicare Physician Fee Schedule (PFS) final rule and the CY 2022 Outpatient Prospective Payment System (OPPS) final rule that updated payment rates. The Final Rule (found in Federal Register Document pages 106-114) establishes a national payment amount for CPT code 92229 (Imaging of retina for detection or monitoring of disease; point-of-care automated analysis and report, unilateral or bilateral).

In the PFS final rule (Federal Register Document on page 2266), CMS noted that, “According to the AAO, it is estimated that 61 million adults in the United States are at high risk for vision loss although only half have visited an eye doctor sometime in the last 12 months. New technology, such as artificial intelligence, may be an important step to make initial screenings more convenient and accessible, reaching people who may have otherwise gone without. While it is not expected that artificial intelligence would replace physicians, it will increase efficiency. As artificial intelligence may be able to assist in the detection of diabetic retinopathy and macular degeneration, it may help to catch those patients that are currently being missed for this extremely important examination.”

Based on input from physicians, professional societies, and technology developers, CMS concluded that, “After consideration of the public comments, we are finalizing our proposal to establish values for CPT code 92229 based on a direct crosswalk to CPT code 92325.” Based on Relative Value Units (RVUs) published by CMS for CPT code 92229, together with the CY 2022 PFS conversation factor, it is estimated that national average physician fee for CPT 92229 will be approximately $45.69. Physician payment amounts varies across the country depends on the applicable Geographic Practice Cost Indices (GPCI) for a specific locality, and in the locality with the highest cost index the physician fee for CPT code 92229 is estimated to be $62.93.

The PFS Final Rule also confirmed that autonomous AI can be used to close care gaps (Quality #117) for the Merit-based Incentive Payment System (MIPS). Specifically, CMS revised its policy to read “The [diabetes] eye exam must be performed by an ophthalmologist or optometrist, or there must be evidence that fundus photography results were read by a system that provides an artificial intelligence (AI) interpretation.”

In the OPPS final rule (Federal Register Document), CMS assigned CPT code 92229 to APC 5733 (Level 3 Minor Procedures) with a payment rate of $57.12.

“Eyenuk appreciates CMS’ efforts to establish a national price for CPT code 92229 which will allow autonomous AI to close care gaps related to diabetes eye exam”, commented Kaushal Solanki, PhD, founder and CEO of Eyenuk. “This historical decision reflects the view of the broad stakeholders who support the use of AI diagnostic technology for their patients. The certainty and transparency of Medicare national pricing enables providers to make informed decisions about their adoption and provision of new technologies such as our EyeArt AI system for their patients, which can help improve access and equity and eliminate health disparity.”

About the EyeArt AI System

The EyeArt AI System provides fully autonomous diabetic retinopathy (DR) screening, including retinal imaging, DR detection based on international clinical standards and immediate reporting, in a single office visit during a diabetic patient’s regular exam. Once the patient’s fundus images have been captured and submitted to the EyeArt AI System, the DR detection results are available in a PDF report in less than 30 seconds.

The EyeArt AI System was developed with funding from the U.S. National Institutes of Health (NIH) and is validated by the U.K. National Health Service (NHS). In addition to U.S. Food and Drug Administration (FDA) 510(k) clearance, the EyeArt AI System has CE marking as a class 2a medical device in the European Union and a Health Canada license. It is designed to be General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant.

The EyeArt System is reimbursable by government and private payors in the U.S. under the newly created Category 1 Current Procedural Terminology (CPT) code 92229.

VIDEO: Learn more about the EyeArt AI System for Autonomous Detection of Diabetic Retinopathy

About Eyenuk, Inc.

Eyenuk, Inc. is a global artificial intelligence (AI) medical technology and services company and the leader in real-world AI Eye Screening for autonomous disease detection and AI Predictive Biomarkers™ for risk assessment and disease surveillance. Eyenuk is on a mission to screen every eye in the world to ensure timely diagnosis of life- and vision-threatening diseases, including diabetic retinopathy, glaucoma, age-related macular degeneration, stroke risk, cardiovascular risk, and Alzheimer’s disease. Find Eyenuk online on its website, Twitter, Facebook, and LinkedIn.

Eyenuk, Inc. Contact

Frank Cheng, President & CCO

+1 818 835 3585

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