News & Analysis as of

Department of Health and Human Services (HHS) Biden Administration

Health Care Compliance Association (HCCA)

‘I Really Wanted to Stay’: Amid Success, Regrets, OHRP’s Kaneshiro Hopes Agency Will Be Rebuilt

When Jerry Menikoff retired at the end of 2022 after leading the HHS Office for Human Research Protections (OHRP) for 14 years, he left behind an agency limping along with 20 employees, less than half of what it needed. For...more

Hogan Lovells

FDA Announces Plans for Post-Market Chemical Review Program

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The U.S. Food and Drug Administration (FDA) recently announced plans to update its post-market food chemical review program. In its announcement, FDA explained that its forthcoming plans will take a proactive approach to...more

Bass, Berry & Sims PLC

Healthcare Regulatory & Compliance Summit 2025 Recap

Health Policy Fireside Chat: What to Expect from the New Administration - Bill Mathias, Member at Bass, Berry & Sims, engaged in a fireside chat with Colin Roskey, Principal at FHP Strategies, former Deputy Assistant...more

McDermott+

The Missing Puzzle Pieces of the FY 2026 “Skinny” President’s Budget

McDermott+ on

Last week, the White House Office of Management and Budget (OMB) released its fiscal year (FY) 2026 discretionary funding request to Congress on its President’s Budget webpage. The administration released a “skinny” FY 2026...more

McDermott+

The First 100 Days: By the Numbers

McDermott+ on

To state the obvious, a lot has happened in healthcare over the first 100 days of President Trump’s second term. But how much? ...more

McDermott+

The Leaked OMB Passback Document: What It Is and Isn’t

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Last week, a sensitive internal government document was leaked to the public: the White House Office of Management and Budget’s (OMB’s) passback to the US Department of Health and Human Services (HHS) laying out proposed...more

Epstein Becker & Green

Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast

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Important changes are unfolding in the vaccine space. How have vaccine exemptions posed a significant risk to populations across the country? What are the long-lasting effects of the new administration's federal health...more

Ballard Spahr LLP

Section 1557: Deadlines Approach, But Long-Term Prognosis Unclear Under Executive Orders

Ballard Spahr LLP on

Section 1557 of the Affordable Care Act mandates nondiscrimination in health care programs managed or funded by the Department of Health and Human Services (HHS), with upcoming deadlines for compliance set for May and July...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

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

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No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more

McGuireWoods Consulting

Health Care Executive Orders And Legal Actions: Part Five

This is part five in a series of executive orders related to health care. Trump Recission of Biden Administration Executive Orders - Medicaid and the Affordable Care Act (ACA)...more

Mintz - Health Care Viewpoints

CMS’s ACA Marketplace Integrity and Affordability Proposed Rule – What it may mean for Health Plans

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2025 Marketplace Integrity and Affordability Proposed Rule (Proposed Rule), proposing a number of enrollment and eligibility policies...more

Holland & Knight LLP

Holland & Knight Health Dose: February 11, 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

McDermott+

To Comment or Not to Comment: Looking at the Biden Administration’s HIPAA Cybersecurity Proposed Reg

McDermott+ on

One of the Biden Administration’s last healthcare regs was a proposed rule that, if finalized, would make significant changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule to...more

BakerHostetler

FDA Advances Proposal To Lower Nicotine in Cigarettes

BakerHostetler on

In the final days of the Biden administration, the Food and Drug Administration (FDA) has taken a significant step toward reducing nicotine levels in cigarettes by submitting a proposed rule to the Office of Management and...more

McDermott+

Healthcare Preview for the Week of: January 27, 2025

McDermott+ on

RFK Nomination Hearing Week - Robert F. Kennedy Jr. (RFK), nominated for Secretary of Health and Human Services (HHS), has a busy week with two Senate nomination hearings. He will testify in front of the Senate Finance...more

McDermott+

Regs on the Menu for Rescission Under Budget Reconciliation

McDermott+ on

Over the next several weeks, both the Trump Administration and the 119th Congress will review the “menu” of Biden-era regulations that they may want to rescind or modify. In one of his first orders, President Trump (like...more

McDermott+

Healthcare Preview for the Week of: January 13, 2025

McDermott+ on

During the Biden Administration’s final week, congressional Republicans are moving full steam ahead with Senate confirmation hearings for Trump-nominated officials and with ongoing budget reconciliation discussions....more

Kilpatrick

Recent Changes in Appropriations Legislation May Have Given "Baby False Claims Act" New Teeth

Kilpatrick on

On December 23, 2024, President Biden signed into law H.R. 5009 - “Servicemember Quality of Life Improvement and National Defense Authorization Act for Fiscal Year 2025.” (2025 NDAA). First passed in 1961, the NDAA is a...more

Sheppard Mullin Richter & Hampton LLP

Healthy AI: 2024 Year in Review

On October 30, 2023, President Biden signed Executive Order 14110, laying the groundwork for the ethical and secure deployment of AI across industries, including healthcare. This comprehensive directive outlines policy goals...more

Ropes & Gray LLP

Biden Administration Finalizes Its Last Changes To Health Data Interoperability and Information Blocking Regulations

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In December 2024, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (“ASTP/ONC”) within the U.S. Department of Health and Human Services (“HHS”) published two...more

Holland & Knight LLP

OCR Shores Up Access to Healthcare with Nondiscrimination Protections

Holland & Knight LLP on

Access to quality healthcare services has long been a priority of the U.S. Department of Health and Human Services (HHS), and through its Office for Civil Rights (OCR) this agency has, since at least 2001, sought to provide...more

Alston & Bird

Health Care Week in Review: Biden Administration Submits Disaster Aid Request; Senators Propose New Health Care Cybersecurity...

Alston & Bird on

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

McDermott+

McDermott+ Check-Up: November 15, 2024

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Congress Returns for Lame Duck Session. The House and Senate returned this week, kicking off the post-election lame duck session. The focus this week was not on legislating, but on organizing for the upcoming 119th Congress,...more

Holland & Knight LLP

Regulation of AI in Healthcare Utilization Management and Prior Authorization Increases

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Over the past two years, federal and state government agencies have moved to regulate the deployment of artificial intelligence (AI) in the healthcare setting, including in the utilization management (UM) and prior...more

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