FDA Pilots Allow Digital Health Devices to Access Medicare Payments

The FDA has announced a new pathway for digital health devices, enabling them to access Medicare payment options without the usual premarket authorization and investigational requirements. This initiative, developed in collaboration with CMS, is part of the ACCESS program, which seeks to provide stable funding for healthcare sites managing chronic conditions in exchange for achieving specific health outcomes. By facilitating real-world data collection, this policy aims to support the integration of technology into chronic care management, ultimately improving patient outcomes and transforming healthcare delivery models. The accompanying TEMPO pilot further aids manufacturers in navigating regulatory hurdles, encouraging innovation in digital health solutions.

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