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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
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.
News Articles
6.04.26
Wilson Sonsini Practices, Attorneys Recognized in 2026 Chambers USA Guide
The 2026 Chambers USA guide has recognized Wilson Sonsini Goodrich & Rosati as a leading law firm in 44 geography-specific practice categories and named 87 Wilson Sonsini attorneys among the best in their fields. This year, the firm received four new practice area rankings, including in the nationwide National Security and Capital Markets: Convertible Debt categories, and three improved practice area rankings.
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
1.13.26
2026 Year in Preview: AI Regulatory Developments for Companies to Watch Out For
In 2026, businesses will face an increasingly complex regulatory environment for Artificial Intelligence (AI). With new state laws and various federal action on the horizon, here’s our top 10 list of what businesses should watch out for in the AI regulatory space in 2026:
Alerts
12.19.25
ASTP/ONC Issues an RFI Seeking Input on How HHS Can Accelerate Adoption and Use of AI in Clinical Care
On December 19, 2025, the Office of the Deputy Secretary and Assistant Secretary for Technology Policy (ASTP) and Office of the National Coordinator for Health Information Technology (ONC) (ASTP/ONC) announced the release of a Request for Information (RFI) seeking broad public input on questions for how the U.S. Department of Health and Human Services (HHS) can accelerate the adoption and use of artificial intelligence (AI) as part of clinical care.
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.
News Articles
12.18.25
Wilson Sonsini Named Among Global Elite in Lexology 100: Data 2026
On December 18, 2025, Lexology published the 2026 edition of the Lexology 100: Data 2026 (formerly GDR 100), a global ranking that captures the capabilities, track record, and market reputation of the top 100 leading law firms in the field. Wilson Sonsini Goodrich & Rosati has been ranked No. 13 overall among the “Global Elite,” a shortlist of the top 25 firms recognized for market-leading expertise. Wilson Sonsini also placed No. 2 for advisory work, No. 4 for investigations, and No. 10 for litigation.
Alerts
12.16.25
Trump Administration Issues Executive Order on National AI Policy and Deregulation
On December 11, 2025, the White House issued an Executive Order (EO), “Ensuring a National Policy Framework for Artificial Intelligence,” that establishes a new federal policy on artificial intelligence (AI). The EO states that it is “the policy of the United States to sustain and enhance the United States’ global AI dominance through a minimally burdensome national policy framework for AI.” The EO asserts that leadership in AI is critical to U.S. national and economic security and dominance and that “AI companies must be free to innovate without cumbersome regulation.” To accomplish this, the EO seeks to challenge “onerous” state AI laws through various federal actions.
Client Highlights
12.03.25
Wilson Sonsini Advises Serent Capital on Recapitalization and Exit from Axiom Medical
On December 3, 2025, Serent Capital, a growth-focused private equity firm, announced the successful recapitalization of Axiom Medical, a leading provider of technology-enabled workplace injury management and employee health solutions. After a seven-year partnership with Serent Capital, Axiom Medical has received a strategic growth investment from NMS Capital to support its next phase of expansion. Wilson Sonsini Goodrich & Rosati advised Serent Capital on the transaction.
The Wilson Sonsini team that advised Serent Capital on the transaction included:
M&A
Rob Ishii
Catherine Riley Tzipori
David Adler
Elia Perez Villamarin
Yifeng Li
Eric Conner
Tax
Jonathan Zhu
Derek Wallace
Han Shen
Antitrust and Competition
Ben Labow
Kimberley Biagioli
Julio Albornoz
Technology Transactions
Barath Chari
Morgan Kasenchak
Brittany Von Rueden
Stephanie Stark
Employee Benefits and Compensation
Sriram Krishnamurthy
Matthew Norgard
Madeleine Boshart
Jason Chan
Laura Yun
Employment
Nedim Novakovic
Data, Privacy, and Cybersecurity
Matt Staples
Daniel Chen
Chany Kim
Regulatory
Jodi Daniel
Andrea Linna
Nawa Lodin
For more information, please see Serent’s news release.
The Wilson Sonsini team that advised Serent Capital on the transaction included:
M&A
Rob Ishii
Catherine Riley Tzipori
David Adler
Elia Perez Villamarin
Yifeng Li
Eric Conner
Tax
Jonathan Zhu
Derek Wallace
Han Shen
Antitrust and Competition
Ben Labow
Kimberley Biagioli
Julio Albornoz
Technology Transactions
Barath Chari
Morgan Kasenchak
Brittany Von Rueden
Stephanie Stark
Employee Benefits and Compensation
Sriram Krishnamurthy
Matthew Norgard
Madeleine Boshart
Jason Chan
Laura Yun
Employment
Nedim Novakovic
Data, Privacy, and Cybersecurity
Matt Staples
Daniel Chen
Chany Kim
Regulatory
Jodi Daniel
Andrea Linna
Nawa Lodin
For more information, please see Serent’s news release.