As healthcare AI continues to evolve, reimbursement is emerging as a critical factor in commercialization. Building on our previous research into Software as a Medical Device, this whitepaper examines CMS’s proposed 2027 Medicare reimbursement changes and the introduction of Software as a Medical Service.

These proposals mark an important step toward establishing a more comprehensive Medicare reimbursement framework for software-based clinical services. Our team explores how new payment pathways under the Hospital Outpatient Prospective Payment System and Physician Fee Schedule could reshape the market for AI-enabled technologies, while highlighting the uncertainties that remain around coding, coverage, and payment rates.

For HealthTech developers and investors, these developments reinforce the importance of aligning FDA regulatory strategy, clinical evidence, reimbursement planning, and provider workflows early in the commercialization process. We examine the potential implications across key therapeutic areas and the policy developments that could shape market access, adoption, and long-term commercial success.