News & Analysis as of

Department of Health and Human Services (HHS) Regulatory Agencies

Morrison & Foerster LLP

FDA and USDA Seek Comments on Defining Ultra-Processed Foods

On July 25, 2025, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) published a joint Request for Information (RFI) to solicit information and data to help the agencies develop a...more

Health Care Compliance Association (HCCA)

Amid Seeming Error, HHS Finalizes Klote’s Termination As Director of Crippled OHRP; She Issues a Warning

In the end, the final termination letter arrived in the mail on July 18. For nearly three months—about half of the length of time she was director of the HHS Office for Human Research Protections (OHRP)—Molly Klote, M.D.,...more

Cozen O'Connor

FDA’s New Measures to Eliminate All Petroleum-Based Synthetic Dyes from Food

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On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a plan to phase out all petroleum-based synthetic dyes from the nation’s food supply. The plan is...more

Bergeson & Campbell, P.C.

President’s FY 2026 Budget Requests Would Eliminate CSB, Reorganize CPSC

President Trump’s fiscal year (FY) 2026 budget request for the Chemical Safety and Hazard Investigation Board (CSB) states that the President’s budget proposes to eliminate funding for CSB as part of the Trump...more

Proskauer - Employee Benefits & Executive...

Departments Press Pause on Final Mental Health Parity Regulations

Yesterday, the Departments of Labor, Treasury, and Health and Human Services announced a non-enforcement policy with respect to final regulations issued under the Mental Health Parity and Addiction Equity Act of 2008...more

Venable LLP

Venable FDA Pulse: FDA at the 100-Day Mark of Trump Administration 2.0

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Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during...more

Foley & Lardner LLP

Leaked Budget Proposal Suggests Major Restructuring of Federal Health and Safety Agencies, Including the Consumer Product Safety...

Foley & Lardner LLP on

A recently leaked and apparently genuine Office of Management and Budget (OMB) Budget “Passback” memorandum—the OMB’s official feedback mechanism for budget submissions from federal agencies—signals major changes to the...more

Venable LLP

FDA to Phase Out Eight Artificial Dyes by 2026

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On April 22, 2025, the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration announced a series of new measures to quickly phase out all petroleum-based synthetic dyes from the nation’s food...more

Benesch

Dialysis & Nephrology Digest - April 2025

Benesch on

ESRD ETC among value-based care models being ended early by CMS - This decision to end the ESRD ETC payment model and several others on Dec. 31 aligns with CMS’ goal to focus on models that demonstrate potential for...more

King & Spalding

FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

King & Spalding on

A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more

King & Spalding

Lawmakers Armed with Loper are Preparing to Take Aim at HHS Policies

King & Spalding on

On July 10, 2024, HHS found itself a recipient of one of the dozens of letters sent to various federal agencies by Republican lawmakers. These letters task the federal agencies to themselves identify areas where the agencies...more

BakerHostetler

Federal Government Addresses AI Transparency and Safety in Healthcare

BakerHostetler on

On Oct. 30, President Biden signed an executive order calling for a coordinated government approach to establish new safeguards for AI safety and security in healthcare. In response to the executive order, on Dec. 14 the...more

Patrick Malone & Associates P.C. | DC Injury...

Big shakeups under way in much-criticized U.S. health agencies

While most regular folks wouldn’t give a hill of beans about the organization of bureaucracies in Washington, D.C., frustrated taxpayers should be taking note of seismic rumblings about restructurings that are shaking some of...more

Alston & Bird

Alston & Bird Health Care Week in Review - March 2022 #4

Alston & Bird on

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

Eversheds Sutherland (US) LLP

Overview of President Biden’s Non-Compete Agreement Executive Order 

On July 9, 2021, President Biden signed the Executive Order on Promoting Competition in the American Economy. The Order, breathtaking in scope, asserts as a key goal the desire to improve the lives of consumers through...more

Akin Gump Strauss Hauer & Feld LLP

HHS Proposes to Rein In Its Use of Regulatory “Dark Matter”

- HHS is overhauling its process for developing interpretive guidance documents under a new Proposed Rule. - HHS proposes to no longer use “guidance documents” to establish broadly applicable legal obligations on the...more

Foley & Lardner LLP

COVID-19: Resources for Oncology Providers (Medicaid, Grants, & Stark Law Waivers)

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The Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS), the Office for Civil Rights (OCR), the Office of the Inspector General (OIG), and other Federal and State agencies and...more

Foley & Lardner LLP

COVID-19: Resources for Oncology Providers (Telehealth, Clinical Trials, Reporting Deadlines)

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The Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS), the Office for Civil Rights (OCR), the Office of the Inspector General (OIG), and other Federal and State agencies and...more

Seyfarth Shaw LLP

HHS Issues Advisory Opinion on PREP Act: Immunity May Extend Beyond Actual Covered Persons and Approved Countermeasures

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With crisis comes uncertainty, and even the best-intentioned regulations can leave those combating the current COVID-19 public-health emergency out in the cold.  Many have asked whether the recent Declaration under the...more

Seyfarth Shaw LLP

Health CARES - Title III of the CARES Act Impact on Telehealth

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As we previously reported, Congress passed and the President signed the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-136) (“CARES Act”) on March 27, 2020. We recently provided guidance on how the CARES Act...more

Seyfarth Shaw LLP

CMS Announces New Priorities for Facility Surveys and Inspections

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In light of findings from the COVID-19 outbreak at a nursing home in Kirkland, Washington, the Centers for Medicare and Medicaid Services (CMS) has announced that it will suspend all routine facility inspections and surveys...more

Eversheds Sutherland (US) LLP

FDA issues status report on CBD enforcement policy - A potential path forward in spite of unanswered questions

The cannabis world is abuzz with news about the latest federal Food & Drug Administration (FDA) report regarding cannabidiol (CBD). We break down what it is, and what it means for the industry and the regulatory landscape for...more

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