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Client Advisories
9.22.26
Evolving Expectations for AI in Mental Health
Artificial intelligence (AI)-enabled mental health products are becoming more ubiquitous with many individuals turning to chatbots, digital companions, coaching tools, and other AI systems for mental health support. They are also attracting increased attention from regulators, policymakers, and courts. As discussed in our previous client alert, Legal Framework for AI in Mental Healthcare, these products already fall within a patchwork of federal and state regulatory frameworks. Recent developments suggest government scrutiny of the sector is likely to continue increasing, including recent actions by agencies, state laws, and emerging litigation. For companies developing AI-enabled mental health products, key considerations may include medical device regulation, emerging state AI laws, Federal Trade Commission (FTC) oversight of health-related claims, privacy, transparency and health data use, and potential liability theories, including the unauthorized practice of medicine or psychology.
Alerts
8.18.26
CMS Proposes Changes to Incentivize FHIR-enabled Electronic Prior Authorization Use
On July 14, 2026, the Centers for Medicare & Medicaid Services (CMS) announced the CY 2027 Physician Fee Schedule (PFS) proposed rule. The proposed rule includes modifications to further incentivize the use of electronic prior authorization in Medicare Ambulatory Specialty Models (ASMs) and the Merit-based Incentive Payment System (MIPS) by health care providers. This builds on prior CMS regulations related to prior authorization which imposed requirements on certain health plans, but not on health care providers (see 2024 CMS Interoperability and Prior Authorization final rule). These changes are not “PFS” in the technical sense of altering relative value unit (RVU) or conversion-factor payment calculations, but rather are Quality Payment Program (QPP) and Center for Medicare and Medicaid Innovation (CMMI) policy changes that are included in the same omnibus annual rulemaking package. For CMS’s proposed PFS and Hospital Outpatient Prospective Payment System (OPPS) payment changes, see our previous client alert, “Health Reimbursement Signals: CMS Proposes Payment Frameworks for ‘Software as a Medical Service.’”1
Alerts
8.13.26
New Oregon HCMO Rules Bring Higher Fees, New Penalties, and Deal Timing Requirements
On July 1, 2026, Oregon’s significant amendments to the regulations implementing its Health Care Market Oversight (HCMO) program, one of the country’s most comprehensive state healthcare transaction review regimes, took effect. Unlike many state transaction notice laws, Oregon’s program gives the Oregon Health Authority (OHA) power to substantively review and approve, condition, or disapprove covered healthcare transactions.
Alerts
7.23.26
Health Reimbursement Signals: 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