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- Administration creates new initiative to manage chronic diseases
The FDA and CMS are partnering to launch a first-of-its-kind pilot program, the ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model.
This initiative aims to expand access to innovative care options for managing chronic diseases such as high blood pressure and diabetes, which affect over two-thirds of Medicare beneficiaries.
- The pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use to improve patient outcomes.
- The model emphasizes outcome-aligned payment approaches.
- It supports the use of digital technologies in health care.
- The pilot could significantly improve care for millions of Americans managing chronic diseases.
The initiative will also include a new digital health pilot program, the "Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot."
- Participating manufacturers may request that the FDA exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, while manufacturers collect and share real-world data demonstrating the device’s performance.
What they're saying: "We are piloting an approach to encourage the use of digital technologies that meet people where they are," said FDA Commissioner Marty Makary, MD, MPH.
The big picture: The program will run for 10 years starting July 1, 2026.
Go deeper: Read more about the voluntary model.