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Executive Orders Proposed Rules Department of Health and Human Services (HHS)

Polsinelli

The Trump Administration Announces Price Targets as It Takes a Second Swing at “Most Favored Nation” Drug Pricing Model

Polsinelli on

At a Glance - MFN Pricing Returns: The EO revives effort to link U.S. drug prices to those in peer countries, calling for voluntary industry action. Aggressive Action on the Table: If progress on voluntary price cuts...more

McDermott+

McDermott+ Check-Up: May 16, 2025

McDermott+ on

THIS WEEK’S DOSE - - Key House Health Committees Advance Reconciliation, Bill Held Up in Budget Committee. The Energy and Commerce Committee and Ways and Means Committee passed their recommendations for reconciliation out of...more

Vedder Price

Trump Administration Issues Executive Order Aimed At Lowering Prescription Drug Pricing

Vedder Price on

On May 12, 2025, President Donald J. Trump signed an executive order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.” This executive order aims to lower the cost of prescription drugs...more

Hogan Lovells

White House raises more questions than answers in Executive Order directing Most Favored Nation drug pricing

Hogan Lovells on

On May 12, 2025, the White House issued an Executive Order (EO) entitled “Delivering Most Favored Nation Prescription Drug Pricing to American Patients.” The EO directs the Secretary of Health and Human Services (HHS) to...more

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

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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

King & Spalding

Executive Order to Deliver Lower Prescription Drug Prices

King & Spalding on

On April 15, 2025, President Trump issued an Executive Order (the EO) titled, “Lowering Drug Prices By Once Again Putting Americans First,” directing HHS to take action on a list of specific proposals with the goal of lower...more

Holland & Knight LLP

NIH Announces Significant Changes to Federal Grant Terms, Conditions on Civil Rights

Holland & Knight LLP on

The National Institutes of Health (NIH) announced on April 21, 2025, a significant change to the terms and conditions governing federal funding (the Notice) applicable to all NIH grants, cooperative agreements and other...more

Lathrop GPM

Flying Through the Whirlwind: Health Care Industry Continues To Be Buffeted as Administration Rolls Out New Initiatives

Lathrop GPM on

Health care providers and payers have been subject to a flurry of developments at the federal level in recent weeks. Considering that health care represents almost 18% of the U.S. gross domestic product, this was perhaps...more

Hogan Lovells

HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

Hogan Lovells on

The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more

DLA Piper

Food and Beverage News and Trends - March 2025 #2

DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. Secretary Kennedy takes first steps to eliminate GRAS exception. Health and...more

McDermott+

Regs & Eggs with a Side of DOGE

McDermott+ on

In the health policy world, nothing gets folks like me more “excited” than expecting and then seeing a new healthcare regulation pop up in the Federal Register. While the content of the reg is usually what public stakeholders...more

Mintz - Health Care Viewpoints

FDA Continues Push to Improve Food Labeling Practices in the United States

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more

McDermott+

Medicaid Cuts on the Menu: What Are the Options?

McDermott+ on

It’s been a busy week in the health policy world, and there are many topics that Regs & Eggs can (and probably will eventually) focus on, including the impact of the reductions in staff at the US Department of Health and...more

McDermott+

Regs and De-Regs: What to Watch Out for Next

McDermott+ on

It is relatively quiet on the healthcare regulatory front. The Trump administration is currently filling out its leadership team within the US Department of Health and Human Services (HHS), with the confirmation process of...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

Moore & Van Allen PLLC

The AI Executive Order: What’s Happened and What’s Coming Up… 

Last week, the White House issued an update on President Biden’s October 30, 2023 Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (the “AI EO” or “EO”). The update detailed...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Sheppard Mullin Richter & Hampton LLP

Proposed Rule Leverages Section 1557 for Healthcare Equity

On July 25, 2022, the U.S. Department of Health and Human Services (“HHS”) issued a proposed new rule that significantly expands the scope of protection available to vulnerable populations under Section 1557 of the Affordable...more

Sheppard Mullin Richter & Hampton LLP

The Biden Administration’s and HHS’s Plan to Advance Health Care Equity

President Biden issued Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (Executive Order) on inauguration day in 2021, signalizing the Administration’s...more

Sheppard Mullin Richter & Hampton LLP

Back to the Future: 2023 Payment Rule Would Revert Nondiscrimination and Guaranteed Availability Provisions to Pre-Trump Forms,...

Today HHS published the Notice of Benefit and Payment Parameters for 2023 proposed rule in the Federal Register. The annual rulemaking details changes to qualified health plans (“QHPs”), QHP issuers, and the ACA’s exchanges...more

Foley & Lardner LLP

OTC Hearing Aids: FDA Paves the Way in its Proposed Rule

Foley & Lardner LLP on

In response to President Biden’s Executive Order on Promoting Competition in the American Economy—which called for the Secretary of Health and Human Services to publish for notice and comment a proposed rule on...more

Sheppard Mullin Richter & Hampton LLP

Executive Order on Promoting Competition in the American Economy: The Biden Administration Considers Drug Pricing Strategies While...

On August 10, 2021, the Centers for Medicare and Medicaid (“CMS”) published a proposed rule (“Proposed Rule”) to rescind the Most Favored Nation Model (“MFN Model”) interim final rule that was published on November 26, 2020...more

ArentFox Schiff

What Should Pharma Companies Expect From the Biden Administration?

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With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway. What should...more

McDermott Will & Emery

CMS Takes a Preliminary Step to Make Certain COVID-19 Waivers Permanent

McDermott Will & Emery on

On August 4, 2020, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to update its payment policies under the Medicare Physician Fee Schedule (PFS) for calendar year 2021. The proposed rule was...more

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