FDA Creates Pathway for Unauthorized Digital Health Devices to Access Medicare Payment Option

Overview of New Policy

The Food and Drug Administration (FDA) has established a new pathway allowing unauthorized digital health devices to access a Medicare payment option. A policy published last week indicates that the FDA will consider waiving standard market access regulations for companies interested in participating in a new program initiated by the Centers for Medicare and Medicaid Services (CMS). This initiative could facilitate device developers in gathering data through real-world usage within the CMS’ Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) program.

Insights into the ACCESS Program

The ACCESS program aims to tackle barriers to care that arise from Medicare’s traditional fee-for-service payment model. Instead of reimbursing for individual services, Medicare will provide ongoing payments to healthcare facilities managing patients with qualifying conditions. Full payment will be granted to sites that achieve measurable health outcomes. This model encourages clinicians to adopt technology-supported care approaches.

Collaboration Between FDA and CMS

In conjunction with the CMS initiative, the FDA has launched the Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot for Digital Health Devices. This pilot allows companies to request waivers for premarket authorization and investigational device requirements while they gather real-world data through the ACCESS program. According to Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, the agency aims to align its regulatory framework with the rapid advancements in digital technologies that are transforming chronic condition management.

Focus Areas of the CMS Program

The CMS program prioritizes four specific areas: early cardio-kidney-metabolic health, cardio-kidney-metabolic health, musculoskeletal health, and behavioral health. These categories encompass conditions such as high blood pressure, obesity, diabetes, and depression. The FDA plans to accept around 10 U.S.-based manufacturers in each of these areas, welcoming manufacturers of all sizes and types.

Application Process for Manufacturers

Manufacturers can utilize off-the-shelf technologies, including unregulated general-purpose computing platforms or wearables. The FDA will assess whether a digital health device poses significant risks to patient health, safety, or welfare. Companies interested in participating in the pilot can submit statements of interest starting January 2. Applicants will be required to provide safety data, risk-mitigation strategies, and timelines for formal marketing submissions. The FDA anticipates issuing follow-up requests beginning in early March.

Timeline for the ACCESS Program

The ACCESS program is scheduled to commence on July 1 and will run for a duration of 10 years.