INSIGHTS
February 23, 2026

CMS math

For digital health operators waiting on regulatory clarity from CMS, the payment fine print finally dropped. CMS released detailed reimbursement parameters for the ACCESS model, giving operators their first look at outcome-aligned payment levels. Many questioned whether or not the rates would support a sustainable operations. CMS reportedly reviewed the business models of ~100 companies, and their resulting rates signal a push for automation over heavy clinician involvement. The concurrent TEMPO pilot reinforces that direction, creating a regulatory pathway for digital health devices to plug directly into ACCESS in exchange for real-world data collection obligations.

The agency is advancing modernization with constraints, where payments are increasingly outcomes-linked and new growth opportunities come alongside rising expectations for operational efficiency and patient outcomes. Industry players must determine which business models align with the latest “CMS math.”

Headlines

  FDA Taps AI Executive To Lead Digital Health Center
Leadership shift signals deeper federal push into AI oversight and software-based care regulation STAT

CHAI's AI Oversight Ambitions Falter With Scrapped AI Labs
The challenges faced by CHAI highlight the complexities of AI regulation Fierce Healthcare

Hims & Hers To Acquire Eucalyptus In $1.15B Deal
Australian telehealth startup acquisition expands Hims & Hers’ global footprint The Wall Street Journal

Lilly Appeals Ruling Over Retatrutide Classification
Drug-not-biologic fight threatens compounding loopholes for next-gen obesity therapies Endpoints News

Recent Funding