News & Analysis as of

Department of Health and Human Services (HHS) Biden Administration

McDermott+

McDermott+ Check-Up – August 1, 2025

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Senate HELP Committee advances legislation, examines healthcare affordability. The legislation would reauthorize expiring programs, including the Over-the-Counter Monograph Drug User Fee Program. Senate Appropriations...more

Epstein Becker & Green

CMS’s Rescission of 2022 EMTALA Guidance Presents New Considerations for Hospitals, Post-Dobbs

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The Centers for Medicare & Medicaid Services (CMS) recently rescinded its July 2022 guidance titled “Reinforcement of EMTALA Obligations specific to Patients who are Pregnant or are Experiencing Pregnancy Loss” (“2022...more

King & Spalding

Texas Court Overturns Biden Administration’s Expansion of Abortion Privacy

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On June 18, 2025, Judge Matthew Kacsmaryk of the Northern District of Texas vacated the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to Support Reproductive Health Care Privacy (the Rule). The...more

Holland & Hart - Health Law Blog

Federal Court Vacates HIPAA Reproductive Health Rule

As anticipated, a Texas federal district court has vacated the HIPAA Reproductive Health Rule (the “Rule”) nationwide. (Memorandum Opinion and Order, Purl v. HHS, 2:24-CV-228-Z (N. Dist. Tex (Jun. 18, 2025), available here)....more

Saul Ewing LLP

Federal District Court Issues Opinion Vacating HHS Rule Protecting Reproductive Health Information

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On June 18, 2025, U.S. District Judge Matthew Kacsmaryk of the Northern District of Texas (the “District Court”) vacated a 2024 final rule issued by the U.S. Department of Health and Human Services (“HHS”) under the Biden...more

Ballard Spahr LLP

Court Vacates HIPAA Reproductive Information Privacy Regulations

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A federal district court has vacated a federal regulation under HIPAA that provided special restrictions on the disclosure of reproductive health information....more

Foley Hoag LLP

CMS Rescinds Post-Dobbs EMTALA Guidance, Raising New Questions for Emergency Departments

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I. Key Takeaways - Federal enforcement under the Emergency Medical Treatment and Labor Act (EMTALA) may be changing after the Centers for Medicare & Medicaid Services (CMS) rescinded guidance issued under the Biden...more

Morgan Lewis

On the Basis of Sex: HHS Rescinds Prior Section 1557 Guidance Interpreting Sex-Based Discrimination

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The US Department of Health and Human Services (HHS) has rescinded several pieces of informal guidance, including its 2021 interpretation of Section 1557 of the Affordable Care Act (Section 1557), in response to executive...more

McDermott+

McDermott+ Check-Up: June 13, 2025

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THIS WEEK’S DOSE - - Reconciliation Moves Forward. Senate committees continue to release their reconciliation provisions. - NIH Director Testifies on FY 2026 Budget. National Institutes of Health (NIH) Director Bhattacharya...more

Holland & Knight LLP

Holland & Knight Health Dose: June 10, 2025

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The U.S. Senate will likely release additional sections of the reconciliation package this week. It is unlikely the Senate Committee on Finance, which has jurisdiction over Medicaid, will hold a markup on its portion of the...more

Alston & Bird

Health Care Week in Review | CMS Rescinds Biden-Era EMTALA Abortion Guidance; CBO Projects 16 Million Could Lose Coverage Under...

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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

Maynard Nexsen

In Surprise Move, DHHS Appeals District Court Decision to Strike Down Long Term Care Staffing Mandates

Maynard Nexsen on

On April 7, 2025, U.S. District Judge Matthew J. Kacsmaryk of the Northern District of Texas struck down the Biden administration’s final rule related to federally imposed minimum staffing requirements for long term care...more

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

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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

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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

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