Healthcare Regulatory Check-Up Newsletter | October 2025 Recap

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Healthcare Regulatory Check-Up Newsletter | October 2025 Recap

November 2025

Read time: 4 min

Overview

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for October 2025, which was relatively quiet due to the federal government shutdown. This month’s summary discusses revisions to the US Department of Health and Human Services (HHS) grants policy statement, the US Department of Education (DOE) public service loan forgiveness (PSLF) final rule, enforcement efforts and guidance from the US Food and Drug Administration (FDA) regarding biosimilars and weight loss drugs. We also review an Office of Inspector General (OIG) report regarding improper durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) payments, and the latest developments in judicial invalidation of Biden-era nondiscrimination rules under Section 1557 of the Affordable Care Act (ACA). This issue examines the calendar year (CY) 2026 Physician Fee Schedule (PFS) from the Centers for Medicare & Medicaid Services (CMS), and CMS’s decision to lift claim holds that were in place during the shutdown because of expired Medicare payment provisions. We also discuss updates to the Advanced Medical Technology Association (AdvaMed) Code of Ethics, a recent California law regulating pharmacy benefit managers, and a HIPAA security risk assessment tool published by HHS.

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In depth

Click each heading below for a sneak peek of related content.

Notable agency activity

HHS implements updated grants policies statement

Effective October 1, 2025, HHS implemented its grants policy statement v2.0, consistent with its prior adoption of 2 CFR part 200 with HHS-specific provisions at 2 CFR part 300.

DOE will exclude employers engaged in “substantially illegal” activities from public service loan forgiveness

On October 30, 2025, the DOE released a final rule addressing employer eligibility for the PSLF program by excluding employers that engage in activities that have a “substantial illegal purpose.”

FDA proposes methods to accelerate approval of biosimilar drugs

On October 29, 2025, FDA released draft guidance with proposals intended to make development of biosimilar medicines faster and less costly.

FDA issues warning letters on compounded weight loss drug advertising

Following US President Donald Trump’s September 9, 2025, memorandum on prescription drug advertisements that called on the FDA commissioner and the HHS secretary to take actions to enforce prescription drug advertising laws and regulations, FDA recently issued warning letters to more than 40 compounding pharmacies, demanding that they cease certain advertising practices for a variety of compounded drug products, including GLP-1 medications.

Medicare improperly paid suppliers $22.7M for inpatient DMEPOS

On October 24, 2025, OIG released the results of an audit analyzing Medicare payments to suppliers for DMEPOS items provided to Medicare enrollees during inpatient stays from 2018 through 2024.

Judge voids HHS rule banning gender identity discrimination

A federal judge voided parts of the Biden administration’s Section 1557 final rule that prohibited gender identity discrimination under the ACA.

CMS regulatory updates

CMS releases CY 2026 Physician Fee Schedule final rule

On October 31, 2025, CMS released the CY 2026 Medicare PFS final rule, which will take effect on January 1, 2026. The final rule largely tracks the policies of the July 14, 2025, proposed rule.

Other notable developments

AdvaMed modernizes its Code of Ethics for the digital era

On October 6, 2025, AdvaMed announced its updated Code of Ethics on Interactions with US Health Care Professionals.

California enacts SB 41 to regulate operations of pharmacy benefit managers

On October 11, 2025, California enacted Senate Bill (SB) 41, effective January 1, 2026, to extensively regulate pharmacy benefit managers (PBMs).

HHS releases updated HIPAA security risk assessment tool

The Office of the National Coordinator for Health Information Technology and the HHS Office for Civil Rights released an updated security risk assessment tool to assist small and medium-sized practices in complying with the Health Insurance Portability and Accountability Act security rule.

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