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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
Newsletters
6.03.26
The Life Sciences Report – June 2026
This latest edition features articles on accelerating new therapies under the new FDA administration, cash-pay healthcare companies possibly facing kickback and fee-splitting risk under federal and state laws, building in-house legal teams for biotech, digital health, and medical devices companies, and life sciences venture financings for firm clients across 1H2025 and 2H2025.
News Articles
4.10.26
Jodi Daniel Quoted by KFF Health News and CNN on Healthcare Privacy Concerns
Wilson Sonsini partner Jodi Daniel was recently quoted in a KFF Health News article, which was also featured by CNN. The piece, titled "Trump’s Personnel Agency Is Asking for Federal Workers’ Medical Records," explores the Trump administration's notice regarding access to medical records of federal workers, retirees, and their families. The proposal has raised concerns about whether the collection meets requirements under the HIPAA privacy rules, which only allows health plans to disclose individually identifiable health information for limited purposes and even then only the minimum necessary. Concerns have also been raised about the Office of Personnel Management (OPM) having access to large amounts of health information, which would no longer be subject to HIPAA. Jodi, who played a pivotal role in shaping the legal framework for the HIPAA privacy rules over 20 years ago, commented, “The language in it [the OPM notice] seems quite broad and encompasses potentially a lot of information and data and is light on justification."
Alerts
4.06.26
FTC Announcement of Healthcare Task Force Coincides with Joint DOJ/FTC Appearance at ONC Annual Meeting
Two recent developments suggest that enforcers are poised to grapple with antitrust concerns in health tech, signaling an escalation of scrutiny into Information Blocking1 tactics that have persisted despite U.S. Department of Health and Human Services (HHS) rules and regulations designed to curtail such practices. Stakeholders and industry participants should be prepared for potential outreach.
Alerts
1.22.26
2026 Antitrust Year in Preview
Last year was a landmark in the development of antitrust law. Enforcers, legislators, and private parties grappled with the fundamental shift represented by artificial intelligence (AI) technologies, the resolution of important digital technology antitrust cases, and significant divergence in policy across a presidential administration transition. The changes will not stop in 2026. In this preview, we focus on several economic sectors that were most impacted by developments in antitrust law in 2025 to identify the trends that will drive governmental and private activity in antitrust in 2026.
News Articles
1.06.26
Wilson Sonsini Lawyer Andrea Linna Quoted by Inside Health Policy on State Laws Regulating AI in Mental Health Care in 2026
Wilson Sonsini partner Andrea Linna was quoted in an Inside Health Policy article titled “State Legislatures to Weigh AI Mental Health, Transparency and Sandbox Bills In 2026,” providing insight on state-level regulatory oversight of AI in mental health care. Andrea described how AI in the context of mental health remains top of mind for state legislatures “with states such as Illinois restricting how AI can be used in counseling services.”