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Regulatory Requirements Healthcare

NAVEX

AI in Healthcare: Why Compliance Can’t Afford to Fall Behind

NAVEX on

The healthcare sector is rapidly embracing artificial intelligence (AI), from predictive diagnostics and clinical decision support to patient engagement and operational automation. With this innovation comes an urgent...more

Buchalter

9th Circ. Decisions Help Clarify Scope Of Legal Lab Marketing

Buchalter on

The Eliminating Kickbacks in Recovery Act, enacted in 2018, was a bombshell for the addiction treatment and diagnostic laboratory industries. For the first time, paying commissions for sales and marketing services was...more

Polsinelli

Regulatory Trend: Safeguarding Mental Health in an AI-Enabled World

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Key Takeaways: New York is the first state to enact mental health-focused statutory provisions for “AI Companions,” requiring user disclosures and suicide prevention measures for emotionally interactive AI systems....more

BakerHostetler

In Case of First Impression, Looking to AKS Precedent, Ninth Circuit Affirms EKRA Conviction for Improper Payments to Marketers

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In one of the few prosecutions based on the Eliminating Kickbacks in Recovery Act (EKRA), and in an even rarer Court of Appeals opinion interpreting the statute, the Ninth Circuit in United States v. Schena, No. 23-2989, 2025...more

Benesch

Off-Cycle Medicare Revalidations for SNFs – Deadline Extended Again to January 1, 2026

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On July 17, 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced via a Medicare Learning Network (“MLN”) update that the deadline for submission of mandatory off-cycle Medicare revalidations...more

Sheppard Mullin Richter & Hampton LLP

Pulse Check: How is Your California Practice Leveraging “103 NPs” – and Preparing for the Arrival of “104 NPs” in 2026?

Nearly three years ago, the passage of California Bill AB 890, effective January 1, 2023, set in motion a future pathway for qualified nurse practitioners (“NPs”) to practice independently under a new category of licensure....more

DLA Piper

Proposed CY 2026 Medicare Physician Fee Schedule: Key Changes Impacting the Medicare Shared Savings Program

DLA Piper on

On July 14, 2025, the Centers for Medicare and Medicaid Services (CMS) released the 2026 calendar year (CY 2026) Medicare Physician Fee Schedule (Proposed Rule). Among the many changes proposed, the Proposed Rule includes...more

Stotler Hayes Group, LLC

Still Stuck in the (Utah) Gap: How the “Miller Trust” Punishes the Most Vulnerable

For those seeking Medicaid coverage to pay for their care in a skilled care setting, like a nursing home, the Medicaid process can be daunting. For institutional Medicaid approval, an applicant must prove that they are...more

McDermott+

CMS releases CY 2026 Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System proposed rule

McDermott+ on

On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Proposed Rule [CMS-1834-P],...more

Clark Hill PLC

Right To Know - July 2025, Vol. 31

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Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed. State Action: Texas Limits Punitive Damage Liability For Data Security Breach...more

Benesch

CMS’s CY 2026 Fee Schedule Proposal: MSSP Reforms Take Center Stage in Push Toward Value

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On July 14, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the proposed rule for the Calendar Year (“CY”) 2026 Medicare Physician Fee Schedule (“PFS”), formally titled CMS-1832-P....more

Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

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In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

Hogan Lovells

An evolving ‘nexus’: OIG approves sponsored testing program involving companion diagnostic

Hogan Lovells on

The U.S. Department of Health and Human Services Office of Inspector General (OIG) once again addressed an industry-sponsored genetic testing program, posting a favorable decision on July 2, 2025 in Advisory Opinion (AO)...more

Cozen O'Connor

Pennsylvania Legislature Revives Bill Scrutinizing Health Care Transactions

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Throughout the country, state governments have been introducing bills which grant state authorities the ability to closely scrutinize health care transactions – specifically, with an eye toward those involving private equity....more

Troutman Pepper Locke

CFPB Will Not Reissue Medical Debt Advisory Opinion

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On July 14, the Consumer Financial Protection Bureau (CFPB or Bureau) filed a status report announcing its decision not to reissue its Medical Debt Collection Advisory Opinion, which had been issued in 2024 to “remind debt...more

Polsinelli

CMS Proposes New Mandatory, Two-Sided Risk Model for Heart Failure and Low Back Pain

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Key Takeaways - CMS has proposed a mandatory two-sided risk model for specialists treating heart failure and low back pain in outpatient settings....more

Benesch

Dialysis & Nephrology Digest - July 2025

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CMS Releases Proposed Rule for 2026 ESRD PPS - As the nephrology organization representing the specialty on socioeconomic and physician practice issues, the Renal Physicians Association analyzes and disseminates...more

Gardner Law

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

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In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more

A&O Shearman

A new European strategy to foster life sciences innovation and market access

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On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy). ...more

Sheppard Mullin Richter & Hampton LLP

Countdown to 2026: What Will the Texas AI Law Mean for Businesses?

Texas is getting into the AI action, with a new law (the Texas Responsible Artificial Intelligence Governance Act) that will place restrictions not only on AI use by government agencies, but businesses as well. In particular,...more

McDermott+

Digesting a giant reg: the CY 2026 Medicare Physician Fee Schedule proposed rule

McDermott+ on

Earlier this week, the Centers for Medicare & Medicaid Services (CMS) issued the calendar year (CY) 2026 Medicare Physician Fee Schedule (PFS) proposed reg. Stakeholders have highly anticipated the release of this reg, as it...more

Mintz - Health Care Viewpoints

California’s Office of Health Care Affordability – First Ever Cost and Market Impact Review and Potential Expansion of Office’s...

Since April 2024, the California Department of Health Care Access and Information (HCAI), Office of Health Care Affordability (OHCA) has received twenty-six Material Change Transaction Notices (Notices) as part of its...more

Proskauer - Health Care Law Brief

DOJ Targets Gender‑Affirming Care under FDCA and FCA: Scrutinizes Off‑Label Drug Use and False Diagnosis Codes

Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more

Polsinelli

HCBS Update: Indiana Implements Home-Grown 70/30 Direct Caregiver Compensation Requirement

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Executive Summary: On July 10, 2025, Indiana Medicaid issued guidance to providers of attendant care and structured family caregiver services requiring providers to pass through a specific percentage of their Medicaid...more

Woods Rogers

Federal Court Strikes Down HIPAA Reproductive Health Privacy Rule Lifting Compliance Requirements for Regulated Entities

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In a sweeping decision published in June, a federal court in Texas struck down most of the HIPAA Rule to Support Reproductive Health Care Privacy (Reproductive Health Rule) enacted in 2024 under the Biden administration to...more

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