First Takes
CMS and FDA Align on New Approaches to Drive Digital Health Adoption
The two agencies are launching allied programs next year to jumpstart market access for digital tools addressing chronic conditions. The nascent CMS ACCESS Model seeks to bypass Medicare barriers for digital health by offering outcome-aligned payments to technology-oriented clinics and companies. Meanwhile, FDA’s TEMPO pilot will grant regulatory enforcement discretion to some technologies used in the Medicare model. But implementation questions remain.
