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Administrative Procedure Act Department of Health and Human Services (HHS)

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check July 2025

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In the early days of the second Trump Administration, several federal funding agencies announced caps to indirect cost (“IDC”) rates for federally funded research awards. In many cases, these caps would substantially reduce...more

Holland & Knight LLP

Healthcare Coalition Sues HHS Secretary Kennedy Over Vaccine Policy Changes

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On July 7, 2025, a coalition of healthcare organizations – including the American Academy of Pediatrics, American College of Physicians and Infectious Diseases Society of America, along with a pregnant Massachusetts physician...more

King & Spalding

Texas Court Overturns Biden Administration’s Expansion of Abortion Privacy

King & Spalding on

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

Wilson Sonsini Goodrich & Rosati

Texas District Court Vacates 2024 HIPAA Rule Designed to Enhance Reproductive Healthcare Privacy, Effective Nationwide

On June 18, 2025, the United States District Court for the Northern District of Texas vacated most of the rules designed to enhance reproductive healthcare privacy promulgated by the U.S. Department of Health and Human...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

Katten Muchin Rosenman LLP

Texas Federal Court Vacates Most of 2024 HIPAA Rule on Reproductive Health Information

In 2024, the U.S. Department of Health and Human Services’ (“HHS”) implemented a new privacy rule under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) that applied specifically to reproductive...more

Warner Norcross + Judd

Federal Court Vacates HIPAA Rule on Reproductive Health Care Privacy

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Last year, the federal Office for Civil Rights (OCR) modified the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to strengthen protections for reproductive health care information (the “2024 Rule”)....more

Holland & Knight LLP

HHS Secretary Kennedy Dismisses Entire CDC Vaccine Advisory Panel

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In a surprising move, the U.S. Department of Health and Human Services (HHS) announced it is reconstituting the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP), removing...more

ArentFox Schiff

Federal Court Sides With Payers on No Surprises Act IDRE Selection Process: What Providers Need to Know Now

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A recent decision from the US District Court for the Eastern District of New York has significant implications for providers navigating the No Surprises Act (NSA) independent dispute resolution (IDR) process....more

Mintz - Health Care Viewpoints

Twenty States Sue the Trump Administration for HHS Program Eliminations and Staff Layoffs

Nineteen states plus the District of Columbia filed a federal Complaint in U.S. District Court for the District of Rhode Island on May 5, 2025 alleging that the Trump Administration’s recent activities to downsize and...more

Baker Donelson

HHS Previews Guidance Addressing Implementation of 340B Rebate System

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In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more

Orrick, Herrington & Sutcliffe LLP

District court partially grants defendants’ motions to dismiss, tosses Privacy Act claim

On April 16, the U.S. District Court for the District of Columbia granted in part and denied in part the defendants’ motion to dismiss a case involving claims that DOGE and several federal agencies (including the DOL, the...more

Ropes & Gray LLP

District Court Embraces Loper Bright and Overturns FDA Laboratory Developed Test Rule – What Lies Ahead?

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On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA (“ACLA v. FDA”), a closely watched case...more

Brownstein Hyatt Farber Schreck

Reactions in the Wake of HHS Funding Cuts

In just over two months since President Donald Trump assumed office, the Department of Health and Human Services (HHS), now under the leadership of Secretary Robert F. Kennedy Jr., has undergone a profound shift in its...more

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

Jones Day on

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

Baker Donelson

HHS and HRSA Defend 340B Discount Model Against Pharma Rebate Plan

Baker Donelson on

Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...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

Orrick, Herrington & Sutcliffe LLP

District court receives sparring requests to deny DOGE access

On February 28, the Department of Labor, the CFPB, and the DHHS (the defendants), filed a motion to dismiss in the U.S. District Court for the District of Columbia, and a week later, a coalition of labor unions (the...more

Blank Rome LLP

60-Second Sustains: TISTA Science and Technology Corporation

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Protest of: TISTA Science and Technology Corporation - B-422891.2; .3; .4 - TISTA challenged the issuance of a task order by the National Institutes of Health to Tantus Technologies, alleging the agency engaged in...more

Arnall Golden Gregory LLP

U.S. Department of Health and Human Services Rescinds "Richardson Waiver" Policy

On March 3, 2025, the U.S. Department of Health and Human Services (“HHS”) announced a new policy to reverse course on certain public notice and comment procedures. This marks a significant change to a process in place for...more

Proskauer - Health Care Law Brief

HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking

On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more

Akerman LLP - Health Law Rx

No (Public) Comment: HHS Rescinds Policy on Public Participation in Rulemaking

The Department of Health and Human Services (HHS) recently rescinded its policy dating back to 1971 to now allow its agencies and offices to quickly alter certain rules and regulations without public notice and comment. The...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

Foley Hoag LLP

Department of Health and Human Services Seeks to Revise Rulemaking Policies

Foley Hoag LLP on

On Friday, February 28, 2025, the Department of Health and Human Services (HHS) issued a policy statement announcing changes to rulemaking processes for agencies within HHS. According to the statement, HHS is rescinding a...more

McDermott Will & Emery

NIH’s Mandatory 15% Indirect Rate – Next Steps Following Preliminary Injunction

On March 5, 2025, a US district court in Massachusetts issued a preliminary injunction blocking the National Institutes of Health (NIH) from implementing a February 7, 2025, “Supplemental Guidance” notice that would establish...more

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