Schedule a Meeting

Coralville, Iowa, November 2, 2021 – Digital Diagnostics commends the Centers for Medicare & Medicaid Services (CMS) for recognizing that FDA-cleared, rigorously validated healthcare autonomous artificial intelligence (AI) can address health care disparities and drive health equity. CMS’ CY 2022 Medicare Physician Fee Schedule (MPFS) and CY 2022 Outpatient Prospective Payment System (OPPS) final regulations, published today, will help to create equitable access to the diabetic eye exam across the country.  Specifically, today’s rules mark the first national payment for the LumineticsCore™ (formerly known as IDx-DR) service in the physician office setting (CPT code 92229) and creates equitable access across the country. The ruling can be found on page 114 under the section titled “e. Establishment of Value for Remote Retinal Imaging (CPT Code 92229) of Federal Register Document [ ]. This also marks the first time that the agency has announced a national price for autonomous AI.

“We applaud the work of CMS in making this historic decision to support innovation in healthcare by creating a standard price for autonomous AI which leads to greater access to care and ultimately improves patient outcomes,” said Seth Rainford, president and COO of Digital Diagnostics. “We are proud to provide a solution that helps physicians deliver quality care to patients across the nation.”

“This historic moment is creating greater equity for patients,” said Juli Goldstein, vice president of government affairs and market access of Digital Diagnostics. “A national valuation is the beating heart of healthcare. It opens the door to equitable access and establishes transparency across the board.”

Digital Diagnostics created LumineticsCore (formerly known as IDx-DR), the autonomous AI diagnostic system for the detection of diabetic retinopathy (DR) and diabetic macular edema (DME) at the point-of-care. Only 15% of people with diabetes receive the recommended annual diabetic eye exam, and this lack of access is linked to widespread blindness, especially in Black and Hispanic populations. It leaves many with undiagnosed and untreated levels of disease, and a high risk of consequent visual loss and blindness.

“Supporting autonomous AI for the diagnosis of diabetic retinopathy and macular edema, which is proven to lack the racial or ethnic bias that plagues many other AI systems, allows for greater access regardless of race, ethnicity, geography, or lack of income,” said Michael D Abramoff, M.D., Ph.D., founder and chairman of Digital Diagnostics and chairman of the AI Healthcare Coalition. “These final regulations will allow eye exams to be administered at patients’ point-of-care where they receive diabetes management eliminating many barriers to care and increasing access.”

The leaders of Digital Diagnostics along with other specialty societies and healthcare trade associations have been at the forefront of delivering input and comments on the CMS rule for several years, with the focus of improving patient care and quality outcomes. A more detailed review of the final regulations is currently being conducted.

About Digital Diagnostics Inc.
Digital Diagnostics Inc. (formerly IDx) is a pioneering AI diagnostics company on a mission to transform the quality, accessibility, equity, and affordability of healthcare. It was founded by Michael D Abramoff, MD, PhD, a neuroscientist, practicing, fellowship-trained retina specialist ophthalmologist, and computer engineer. The platform includes two autonomous AI systems, LumineticsCore (formerly known as IDx-DR) and DermSpot. Digital Diagnostics is paving the way for autonomous AI diagnosis to become a new standard of care, contributing to democratizing healthcare and closing care gaps. The company works closely with patient advocacy groups, federal regulators, and other quality of care and ethics-focused stakeholders to enable adoption of autonomous AI. For more information and the latest news follow:

Media Contact:
Jacqueline Engle | 610.761.1886