News & Analysis as of

Department of Health and Human Services (HHS) Healthcare

King & Spalding

OIG Issues Series of Reports on Patient Harm in Hospitals and Gaps in Reporting

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On July 24, 2025, the OIG released reports evaluating the prevalence of patient harm in hospitals and the extent to which hospitals detect and report such events. These evaluations follow up on OIG’s 2022 report and provide...more

Alston & Bird

Health Care Week in Review | HHS Cancels mRNA Vaccine Development Projects Under BARDA; President Trump Signs EO to Increase...

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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

McDermott+

Trump Administration Executive Order Tracker

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Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, V 2, Issue 8, July 2025

Welcome to our eighth issue of 2025 of The Health Record -- our healthcare law insights e-newsletter. In this edition, we look at the rural health "slush fund" included in the Federal budget bill, the effect of Medicaid...more

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

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The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

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

Alston & Bird

Health Care Week in Review | CMS Finalizes FY 2026 Medicare Payment Rules, Senate Appropriations Committee Advances Labor-HHS...

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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

Stevens & Lee

Budget Negotiations May Delay Payments from the PA Department of Aging, DDAP, DOH or DHS

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On July 29, 2025, Uri Monson, Secretary for the Pennsylvania Governor’s Office of the Budget issued a letter to its “partners in health and human services,” notifying them that since they work for a human services...more

McDermott Will & Schulte

DOJ-HHS False Claims Act Working Group will pursue healthcare, life sciences enforcement priorities

The US Department of Justice (DOJ) and the US Department of Health and Human Services (HHS) recently announced the relaunch of the DOJ-HHS False Claims Act Working Group, intended to “strengthen[] [the agencies’] ongoing...more

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

Troutman Pepper Locke

HHS Sets Its Sights on $50B in Cost Savings: Medicare Payments to Nonhospice Providers Potentially Under Fire

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In May 2025, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a review, titled “Potential Cost Savings HHS Programs – HHS Actions,” which provided some insight into the OIG’s...more

Sheppard Mullin Richter & Hampton LLP

Potential False Claims Act Liability for Providers of Gender-Affirming Care for Minors

On July 9, 2025, the U.S. Department of Justice (“DOJ”) announced it sent more than 20 subpoenas to physicians and clinics involved in providing gender-affirming care to minors, and that the subpoenas related to...more

Sheppard Mullin Richter & Hampton LLP

DOJ False Claims “Working Group” Update

ICYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human Services (HHS) to enforce the False Claims Act...more

McDermott+

Healthcare Preview for the Week of: July 28, 2025

McDermott+ on

Senate Steers Toward Summer Break - With the House already on August recess, the Senate will consider several of President Trump’s nominees, including Gustav Chiarello III to be an assistant secretary of the US Department of...more

Alston & Bird

Health Care Week in Review | House Ways & Means Committee Holds Hearing on Medicare Advantage; President Trump Signs Executive...

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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

Health Care Compliance Association (HCCA)

Amid Seeming Error, HHS Finalizes Klote’s Termination As Director of Crippled OHRP; She Issues a Warning

In the end, the final termination letter arrived in the mail on July 18. For nearly three months—about half of the length of time she was director of the HHS Office for Human Research Protections (OHRP)—Molly Klote, M.D.,...more

McDermott+

McDermott+ Check-Up – July 25, 2025

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CBO releases final scores for OBBBA. The Congressional Budget Office (CBO) estimates that the One Big Beautiful Bill Act (OBBBA) will increase the uninsurance rate by 10 million individuals over 10 years. House Energy and...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | June 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more

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

Hinshaw & Culbertson - Health Care

Emergency Alert! HHS Restricts Care for Immigrants—Health Centers Must Act Now

Overview of Key Changes and Immediate Impacts - Key Policy Shift: Section 330 Grants now treated as a “Federal Public Benefit” - The U.S. Department of Health and Human Services (HHS) now classifies the Health Center Program...more

Epstein Becker & Green

Texas Judge Strikes Down HIPAA’s Reproductive Health Amendment

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Last month, Judge Matthew Kaszmaryk of the U.S. District Court, Northern District of Texas, in Purl v. United Stated Department of Health and Human Services, No. 2:24-cv-00228-Z (N.D. Tex Jun. 18, 2025) struck down nearly all...more

Holland & Knight LLP

Holland & Knight Health Dose: July 22, 2025

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With the One Big Beautiful Bill Act (OBBB) passed by U.S. Congress and signed into law, Congress now has less than three weeks that it will be in session before government funding expires on Sept. 30, 2025. Appropriators will...more

McDermott+

Healthcare Preview for the Week of: July 21, 2025

McDermott+ on

Two long weeks until August recess - This is the last week with both chambers in session until September, and things are relatively slow as lawmakers count down the days to the month-long August recess. With reconciliation...more

Stevens & Lee

New Changes to Medicare and Private Prior Authorization Processes

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Both the Centers for Medicare & Medicaid Services (CMS) and dozens of the nation’s largest insurance companies have revealed upcoming changes to their prior authorization processes. These changes aim to reduce the prevalence...more

McDermott+

McDermott+ Check-Up – July 18, 2025

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THIS WEEK’S DOSE - - OBBBA implementation begins. While the administration focuses on implementing the new law, some lawmakers are already discussing adjustments to health provisions in the One Big Beautiful Bill Act...more

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