News & Analysis as of

Transparency Department of Health and Human Services (HHS)

Akin Gump Strauss Hauer & Feld LLP

HHS, FDA Announce Multiple Initiatives on Food Safety, Quality and Compliance Fronts

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more

MoFo Life Sciences

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

MoFo Life Sciences on

On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more

Ice Miller

RFK Jr. Calls to End the Self-Affirming GRAS “Loophole”

Ice Miller on

Through an Order that the Secretary of the U.S. Department of Health and Human Services (HHS) Robert F. Kennedy Jr. (RFK) called an act of “radical transparency,” the U.S. Food and Drug Administration (FDA) has been directed...more

Akin Gump Strauss Hauer & Feld LLP

Is Self-Affirming GRAS Off the Menu?

United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing...more

McGuireWoods Consulting

Health Care Executive Orders And Legal Actions: Part Three

Public Health - Withdrawing from the World Health Organization (WHO)...more

Maynard Nexsen

HHS Abandons Public Comment Practices Under the Richardson Waiver

Maynard Nexsen on

On March 3, 2025, the Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., officially announced the rescission of the Richardson Waiver, a policy in place since 1971 that required public...more

Morgan Lewis - ML Benefits

US Administration’s Executive Orders and Actions’ Impact on Group Health Plans

Since taking office, President Donald Trump has issued several executive orders (EOs) and actions that may have an impact on group health plans. These EOs provide insight into the US administration’s policies and outline...more

McGuireWoods Consulting

Department Of Health And Human Services Proposes Ending Public Comment For Grants And Contracts

On Feb. 28, 2025, the Federal Register listed a proposal to end mandatory public comment periods for the Department of Health and Human Services (HHS). This specifically relates to “agency management or personnel or to public...more

Vedder Price

Trump Administration Issues Executive Order Mandating Implementation and Enforcement of Health Care Pricing Transparency

Vedder Price on

On February 25, 2025, President Donald J. Trump signed an executive order titled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” (the “2025 Order”)...more

Wiley Rein LLP

Trump Prioritizes Health Care Pricing Transparency in New Executive Order

Wiley Rein LLP on

On Tuesday, February 25, 2025, President Trump issued an Executive Order (EO), “Making America Healthy Again By Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information.” The EO aims to improve...more

McDermott+

McDermott+ Check-Up: January 31, 2025

McDermott+ on

Senate Finance, HELP Committees Hold RFK Jr. Nomination Hearings. RFK Jr., nominated for Secretary of Health and Human Services (HHS), testified before the Senate Finance Committee on January 29 and before the Senate Health,...more

Stevens & Lee

Higher Prices, Reduced Access, Lower Quality Care: HHS, FTC, DOJ Report Harshly Criticizes Provider Consolidation and Private...

Stevens & Lee on

In March 2024, the Federal Trade Commission (FTC), the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) (collectively, Agencies) issued a request for information (RFI) seeking public comment...more

Gardner Law

FDA Tightens Food Chemical Safety Rules

Gardner Law on

The FDA is strengthening its oversight of food chemicals, signaling a shift towards a more proactive and comprehensive approach to food safety. This move comes in the wake of increasing public concern over the long-term...more

Snell & Wilmer

2024 End-of-Year Plan Sponsor “To Do” List (Part 1) Health and Welfare

Snell & Wilmer on

We are pleased to present our annual End of Year Plan Sponsor “To Do” Lists. This year, we present our “To Do” Lists in four separate SW Benefits Updates. This Part 1 covers year-end health and welfare plan issues. Parts 2,...more

Gardner Law

OIG’s Perspective on Discount and Refund Programs

Gardner Law on

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more

BakerHostetler

What’s Hot in Healthcare: Digital Health Regulatory Update

BakerHostetler on

As the summer winds down, regulatory updates related to digital health services certainly do not appear to be showing any signs of cooling off. It has been a busy summer, and below we have summarized several key updates for...more

Husch Blackwell LLP

Healthcare Founders Face New Exit Considerations

Husch Blackwell LLP on

Exiting a business, whether you are a serial entrepreneur looking to move on to the next project or a healthcare provider like a physician or therapist who has nurtured your practice for decades, can be difficult. After all,...more

Ankura

Will Regulatory Scrutiny Impact Private Equity Investment in Healthcare?

Ankura on

Private Equity in Healthcare - Over the past decade, private equity investors have shown a particular interest in acquiring or investing in various healthcare providers and services. This includes physician practices across...more

McDermott+

Breaking Down Federal Policies to Address Drug Shortages

McDermott+ on

In the wake of persistent drug shortages that compromise patient care and safety, the Biden administration and Congress have proposed policies to strengthen the pharmaceutical supply chain. Using authorities under both...more

McCarter & English, LLP

New Jersey Regulatory Update Part II

Part II of our New Jersey Regulatory Update further identifies proposed and adopted regulations that may impact healthcare providers, from additional financial transparency rules impacting facilities to rules attempting to...more

Sheppard Mullin Richter & Hampton LLP

CMS Issues Final Rule on Medicaid and CHIP Managed Care Access, Finance, and Quality

On April 22, 2024, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule (CMS-2439-F), effective July 9, 2024, aimed at advancing healthcare access,...more

Dechert LLP

Dechert Cyber Bits - Issue 54

Dechert LLP on

European Data Protection Board Publishes Strategy for 2024-27 - The European Data Protection Board (“EDPB” - the EU body tasked with promoting consistency and cooperation in enforcement of the GDPR) has outlined its...more

King & Spalding

Senators Introduce New Bill for Transparency and Oversight in Health Care Transactions and Investment

King & Spalding on

On April 3, 2024, Senators Ed Markey (D-Mass) and Elizabeth Warren (D-Mass) released draft legislation titled the “Health Over Wealth Act” (the Proposed Bill). This Proposed Bill is another attempt to regulate private...more

Foley & Lardner LLP

Private Equity: Proposed Health Over Wealth Act -What This Means for You

Foley & Lardner LLP on

On April 3, 2024, Senators Edward Markey (D-Mass.) and Elizabeth Warren (D-Mass.), chaired a Senate Health, Education, Labor, and Pensions (HELP) Subcommittee on Primary Health and Retirement Security field hearing titled,...more

McDermott+

President Biden Releases FY 2025 Budget: What’s NOT in It?

McDermott+ on

Earlier this week, President Biden released his Fiscal Year (FY) 2025 President’s Budget. As a reminder, every year, the White House releases a budget that serves as its official funding request to Congress for the following...more

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