News & Analysis as of

Secretary of HHS

Dorsey & Whitney LLP

The Supreme Court Update - April 30, 2025

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On Tuesday, April 29, the Supreme Court of the United States issued one decision: Advocate Christ Medical Center v. Kennedy, No. 23-715: This case addresses the proper method for calculating the “disproportionate share...more

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

Better Health Care Newsletter - April 2025

Plutocrats reigned. The gulf between rich and poor was huge. Nativist extremists, populist politicians, and major elements of the media clamored about the waves of immigrants flooding into America. And health challenges...more

Venable LLP

Exploring the Future of GRAS: HHS’s Recent Directive and Its Potential Impact on the Food Industry

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On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that HHS Secretary Robert F. Kennedy has directed the Food and Drug Administration (FDA or Agency) “to take steps to explore potential...more

Health Care Compliance Association (HCCA)

‘Waking Up With Panic Attacks’: NIH 15% Plan Caps Tumultuous Weeks Under New Administration

If NIH succeeds in imposing an across-the-board indirect cost rate of 15%, rough estimates indicate the University of Michigan could lose $119 million a year. Emory University could be down $75 million. For the University of...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing and Health Care Fraud Remain Key Issues

Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more

Health Care Compliance Association (HCCA)

Tackling Review of ‘Uninformative’ Studies, SACHRP Joins Quest to Boost Research Caliber

In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...more

ArentFox Schiff

Post-Chevron Health Care Regulations: Using Loper Bright as a Shield in Stark Law Litigation

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Previously, we discussed how the US Supreme Court’s opinion in Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce could create opportunities for private litigants to challenge health...more

Holland & Knight LLP

HHS Is Primed to Enforce Information Blocking Conduct

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The U.S. Department of Health and Human Services (HHS) continued its commitment to timely and full access to health records on June 24, 2024, through the finalization of its information blocking disincentives rule for...more

Holland & Knight LLP

Holland & Knight Health Dose: April 16, 2024

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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

Jackson Lewis P.C.

Puerto Rico Special Paid Leave Activated for Dengue Fever State of Emergency

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The Puerto Rico Secretary of Health issued Administrative Order No. 2024-589, declaring a public health emergency due to the prevalence of cases of dengue fever on the Island. Administrative Order No. 2024-589, signed on...more

Holland & Knight LLP

Holland & Knight Health Dose: March 19, 2024

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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

King & Spalding

CMS Issues Final Rule Changing Medicaid DSH Third-Party Payor Rule

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On February 23, 2024, CMS published a final rule updating the regulatory requirements of the Medicaid disproportionate share hospital (DSH) program in response to the Consolidated Appropriations Act (CAA) of 2021. The final...more

Goodwin

Court Dismisses PhRMA Lawsuit Challenging IRA

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Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation...more

Vicente LLP

The DEA’s Scheduling of Marijuana: What Happens After the DEA Publishes Its Rule?

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On August 29, 2023, the Department of Health and Human Services (“HHS”) sent the Drug Enforcement Administration (“DEA”) its recommendation to move marijuana from Schedule I to Schedule III of the Controlled Substances Act...more

McGlinchey Stafford

DEA Likely to Reschedule Marijuana Based on Congressional Report

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According to a report from the Congressional Research Service (the Report), the Drug Enforcement Administration (DEA) is likely to follow the Department of Health and Human Services (HHS) and the Food and Drug...more

Sands Anderson PC

COVID-19: Vaccine Injury Compensation Status

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On May 5, 2023, the World Health Organization declared an end to the global health emergency caused by the SARS-CoV-2 virus, known as COVID-19. While the emergency has, in many ways, waned, the virus and the need for COVID-19...more

Eversheds Sutherland (US) LLP

Preparing employee benefit plans for the emergency exit

The end of an era looms for employee benefits plans, as the Biden administration has announced the end of both the Public Health Emergency and the National Emergency periods on May 11, 2023. The two emergency periods were...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

New Guidance Helps Employers Navigate End of the COVID-19 Emergency Orders

As employers plan for the impact of the anticipated May 11, 2023, end of the two federal COVID-19 emergency orders, they have some important new clarity on test and vaccine coverage and on how to unwind COVID-19–era extended...more

Holland & Knight LLP

Holland & Knight Health Dose: March 28, 2023

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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

Hendershot Cowart P.C.

DEA Proposes Rules for Permanent Pandemic Telehealth Flexibilities

Hendershot Cowart P.C. on

Meta description: With the federal public health emergency (PHE) ending in May, changes to telehealth prescription rules are set to change. Read on to learn about proposed permanent changes. DEA Proposes Rules for...more

Foley Hoag LLP

Preparing for Impact: The Mifepristone Case in Texas Nears a Decision

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The legal status of mifepristone and misoprostol, drugs legally prescribed by physicians since 2000 for the medical termination of early pregnancy, may soon be decided by a federal court in Texas in a lawsuit known as...more

Venable LLP

Return to "Normalcy" - Bracing for the End of the Public Health Emergency

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In January 2020, Alex M. Azar, II, then secretary of the U.S. Department of Health and Human Services (HHS), signed a nationwide declaration of a Public Health Emergency (PHE) that would largely shape the response of public...more

Goodwin

Request for Comments on USPTO-FDA Collaboration Initiatives to Promote Generic Drug and Biosimilar Competition

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​​​​​​​On November 7, the U.S. Patent and Trademark Office (USPTO) published a request for comments on areas for USPTO-FDA collaboration and engagement. The USPTO also announced a related public listening session to be held...more

Bradley Arant Boult Cummings LLP

Editors’ Roundtable: A New Biden Doctrine?

Welcome to the third installment of the Editors’ Roundtable, in which our editors – Whitt Steineker, Jay Wright, Hunter Robinson, and Slates Veazey – discuss cannabis issues in the news and take a stab at where the cannabis...more

Foley Hoag LLP - Medicaid and the Law

Medicaid and the LawFoley Hoag LLP CMS Approves Two New Medicaid Waivers to Expand Coverage, Provide Flexibilities

On September 28, 2022, the Centers for Medicare & Medicaid Services (CMS) issued approval letters for Section 1115 Medicaid demonstration applications previously submitted by Oregon and Massachusetts. Section 1115 waivers...more

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