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Department of Health and Human Services (HHS) Regulatory Agenda Health Care Providers

Quarles & Brady LLP

DOJ and HHS Announce New False Claims Act Working Group

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On July 2, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) announced that they are forming the DOJ-HHS False Claims Act Working Group to further combat healthcare fraud—an...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

McDermott+

Price Transparency: A Regulatory Priority

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The Trump administration is beginning to lay out its regulatory (and deregulatory) priorities, and on February 25, 2025, the administration spotlighted one of those priorities in an executive order on price transparency....more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more

McCarter & English, LLP

DEA Telemedicine Update

The Drug Enforcement Administration (DEA), in concert with other federal agencies, has taken various steps in the past few months to strengthen a practitioner’s ability to prescribe controlled substances via telemedicine, a...more

Sheppard Mullin Richter & Hampton LLP

Updated: The Future of Gender-Affirming Care – New Legal and Regulatory Considerations for Hospitals Providing These Services

As legal and policy developments continue to evolve, hospitals and health care professionals that provide gender-affirming care face new uncertainties regarding federal funding, compliance, and patient access. While these...more

Holland & Knight LLP

Holland & Knight Health Dose: February 5, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Holland & Knight LLP

Holland & Knight Health Dose: January 29, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Stotler Hayes Group, LLC

Status of Nursing Home Staffing Standards Announced by Biden Administration and Orders Announced by Trump Administration

Attorneys General from 20 states asked a federal judge to grant a temporary injunction halting implementation of changes to new rules affecting minimum nursing home staffing requirements announced by the Centers for Medicare...more

Alston & Bird

Health Care Week in Review: President Trump Issues a Series of Executive Orders; Senate Committees Announce Hearing Dates for HHS...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Holland & Knight LLP

Holland & Knight Health Dose: What to Expect in the 119th Congress – January 16, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include ...more

Ropes & Gray LLP

FDA and OHRP Issue Draft Guidance on Including Biopsies in Clinical Trials

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On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more

Husch Blackwell LLP

New Legislation Revises Massachusetts' Determination of Need Statute

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On January 8, 2025, Massachusetts Governor Maura Healey signed into law “An Act Enhancing the Health Care Market Review Process.” Part of this sweeping healthcare oversight law includes changes to the Determination of Need...more

Troutman Pepper Locke

HIPAA Security Rule Revamp Is on the Horizon

Troutman Pepper Locke on

On January 6, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published significant proposed amendments (proposed rule) to the Security Rule under the Health Insurance Portability and...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | November 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2024. We discuss several US Department of Justice (DOJ) enforcement actions involving the False Claims Act (FCA) and the...more

Quarles & Brady LLP

Fresh From the Oven: OCR-HHS Issues a Notice of Proposed Rulemaking for the HIPAA Security Rule

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‘Tis the season for holiday baking and the elves at the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), have been diligently crafting their own holiday treat. On December 27,...more

McDermott+

McDermott+ Check-Up: December 20, 2024

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118th Congress Continues to Grapple with Contentious CR. With the collapse of Republican support for the negotiated continuing resolution (CR) package, as of the time of publication on Friday at 3:00 PM EST, Congress is still...more

McDermott+

No Surprises Act Implementation Under the Trump Administration

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The No Surprises Act, a law that ended the practice of “balance billing” by certain out-of-network providers, was enacted as part of the Consolidated Appropriations Act of 2021 on December 27, 2020. While the law passed...more

McDermott+

McDermott+ Check-Up: December 6, 2024

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Congress Negotiates Healthcare Extenders, Continues to Plan for 2025. Lawmakers continue negotiations to wrap up the 118th Congress and pass remaining must-do policies, including government funding, likely through a...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | October 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for October 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

Health Care Compliance Association (HCCA)

Recognized Security Practices ‘Saved’ Covered Entity $60K of $300K Fine, But Which Ones Remain a Mystery

Covered entities (CEs) and business associates (BAs) may receive a “discount” for having recognized security practices (RSPs) in place when the HHS Office for Civil Rights (OCR) calculates financial penalties for Security...more

Health Care Compliance Association (HCCA)

Privacy Briefs: November 2024

Change Healthcare Inc. has amended its initial breach report to the HHS Office for Civil Rights (OCR) to state that 100 million individuals were impacted by its mammoth ransomware attack and breach. However, as of Oct. 24,...more

McDermott+

Medicare FFS Regs: Thrills and Chills Under the Trump and Biden Administrations

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Happy Halloween! In the health policy world, there are two things on everyone’s mind this spooky season: the upcoming election and the major calendar year (CY) 2025 Medicare fee-for-service (FFS) final regs that should be...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | September 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2024. We discuss several enforcement actions pertaining to healthcare fraud, including alleged violations under the False...more

Bass, Berry & Sims PLC

HHS-OIG Set To Intensify Scrutiny of Grants and Contract Compliance: How to Prepare

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As we detailed in a previous blog, on October 3, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a strategic plan to “safeguard[] the integrity of HHS grants and contracts.” The...more

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