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7.23.26
CMS Proposes Payment Frameworks for “Software as a Medical Service”
On July 2, 2026, the Centers for Medicare and Medicaid Services (CMS) released the calendar year (CY) 2027 Hospital Outpatient Prospective Payment System (OPPS) proposed rule and on July 14, 2026, subsequently released the CY 2027 Physician Fee Schedule (PFS) proposed rule.1 These proposed rules establish a newly named Medicare payment category, Software as a Medical Service (SaMS), for software that supports clinical decision-making through algorithmic analysis.2 This is CMS’ first effort to pay for software-based clinical services in a structural way as their own category rather than as a cost buried inside reimbursement for another procedure. The consequential impact is that CMS would create a new reimbursement vehicle for software and AI-enabled products to be reimbursed as standalone services in the future. The proposal is worth close attention from stakeholders because Medicare reimbursement often determines the success of software or AI products intended for clinical purposes. Comments are due August 31, 2026, on the OPPS rule and September 14, 2026, on the PFS rule.
Press Releases
7.15.26
Wilson Sonsini Expands Healthcare Regulatory Practice with Brandon Ge and Ty Kayam
Contact:
Kimberly Brooks
212-453-2881
kbrooks@wsgr.com
Kimberly Brooks
212-453-2881
kbrooks@wsgr.com
Alerts
12.19.25
Navigating CMS’s ACCESS Model and FDA’s TEMPO Pilot: Opportunities for Digital Health Companies
Since the publication of this Alert, CMS has officially released the Request for Applications (RFA), which provides clarifications and significantly more detail on eligibility criteria, application timelines, requirements for each ACCESS Participant’s Medical Director, eligibility for inclusion in the Tools Directory, and the model’s financial structure. Interested organizations should carefully review the RFA for specific requirements that were not available at the time this Alert was published and may contact Wilson Sonsini’s Digital Health practice with any questions.
Alerts
12.05.25
FDA Issues Updated Guidance on Expanded Access to Investigational Drugs
The U.S. Food and Drug Administration (FDA) has issued updated guidance on Expanded Access to Investigational Drugs for Treatment Use, clarifying how drug developers, physicians, and patients can obtain investigational drugs outside traditional clinical trials.