New CMS & FDA Innovation Models: What ACCESS, TEMPO, and MAHA ELEVATE Mean for Digital Health Innovators
Leading up to the new year, CMS and FDA introduced ACCESS, TEMPO, and MAHA ELEVATE, three major innovation models that signal a shift in how federal agencies are thinking about digital health, care management, and reimbursement.
Together, these models create new pathways for digital health companies to support value-based care, generate real-world evidence, and shape future reimbursement frameworks.
In this webinar, Nixon Law Group’s attorneys break down what each model does, what types of entities can participate, and where we see concrete opportunities for digital health companies to engage.
This webinar covers:
The ACCESS Model and the new ACCESS Tools Directory, including what it means for digital health vendors
FDA’s TEMPO pathway and how it may accelerate evidence generation and FDA approval for digital health products
CMS’s MAHA ELEVATE Model and emerging opportunities around lifestyle, functional, and whole-person care
Practical takeaways for founders, executives, and investors who want to understand the potential opportunities these new models present