Dive Brief:

• The Food and Drug Administration has created a pathway for unauthorized digital health devices to access a new Medicare payment option.
• In a policy published last week, the FDA said it will consider waiving typical market access rules for companies that want to join a new Centers for Medicare and Medicaid Services program.
• The pathway could enable device developers to collect data through real-world use in the CMS’ Advancing Chronic Care with Effective, Scalable Solutions, or ACCESS, program.

Dive Insight:

The CMS created ACCESS to address barriers to care stemming from Medicare’s fee-for-service payment model. Rather than pay for specific services, Medicare will make recurring payments to healthcare sites that manage patients’ qualifying conditions. Sites will receive full payment if they achieve measurable health outcomes. The model is designed to allow clinicians to adopt technology-supported care options.

In conjunction with the CMS program, the FDA has created the Technology-Enabled Meaningful Patient Outcomes, or TEMPO, for Digital Health Devices Pilot. Through the pilot, companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect real-world data in the ACCESS program.

Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said in a statement that the agency wants to ensure its regulatory approach keeps pace with digital technologies that “are rapidly transforming how people manage chronic conditions.” TEMPO is designed to meet that goal by showing how devices perform for patients in their everyday lives.

The CMS program is focused on four areas: early cardio-kidney-metabolic, cardio-kidney-metabolic, musculoskeletal and behavioral health. The categories cover conditions including high blood pressure, obesity, diabetes and depression. The FDA plans to accept up to about 10 manufacturers based in the U.S. in each of the four areas. Officials are seeking “manufacturers of all sizes, types and maturities.”

Applicants can use off-the-shelf technologies such as unregulated general-purpose computing platforms or wearables. The FDA will evaluate whether the digital health device could pose a serious risk to the health, safety or welfare of patients.

Companies that want to participate in the pilot can submit statements of interest from Jan. 2. The FDA has asked applicants to provide information including safety data, risk-mitigation plans and timelines for submitting a formal marketing submission. FDA officials expect to start sending follow-up requests in early March. The ACCESS program is set to start on July 1 and run for 10 years.