News & Analysis as of

Department of Health and Human Services (HHS)

Epstein Becker & Green

Vendor Fees Flagged as Kickback Risk in HHS OIG Advisory Opinion

On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging...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

Morgan Lewis

16 States Challenge Gender-Affirming Care EO as DOJ Scrutinizes Hospitals, Doctors, and Pharma Manufacturers

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On August 1, 2025, 16 state attorneys general filed a complaint in federal court in Massachusetts against the US administration seeking a declaratory judgment that President Trump’s January 28, 2025 Executive Order 14187,...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

Shipman & Goodwin LLP

340B Drug Pricing Program Is on a Slippery Slope

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On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more

Husch Blackwell LLP

Trump Executive Order Aligns with NCAA Policy Positions Post-House Settlement

Husch Blackwell LLP on

On July 24, 2025, President Donald Trump issued Executive Order 14322: Saving College Sports, which is largely focused on the state of NCAA Division I college sports and which aligns closely with positions taken by the NCAA. ...more

ArentFox Schiff

HHS Announces 340B Rebate Model Pilot Program

ArentFox Schiff on

On July 31, the US Department of Health and Human Services’ (HHS) Health Resources and Services Administration (HRSA) announced the availability of a new pilot program altering how pharmaceutical manufacturers can honor the...more

King & Spalding

Second Circuit Affirms Lower Court’s Ruling Rejecting Neurological Surgery Provider’s Challenge to the No Surprises Act

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On July 22, 2025, the United States Court of Appeals for the Second Circuit affirmed the judgment of the United States District Court for the Eastern District of New York, which dismissed an amended complaint brought by...more

King & Spalding

Congressional Crack Down on Hemp Loophole? Significant Changes Loom for Hemp Industry

King & Spalding on

The House Committee on Appropriations approved legislation that would prohibit the production, distribution, and sale of hemp-derived delta-9 tetrahydrocannabinol (“THC”) and related cannabinoids at the federal level. If the...more

Fisher Phillips

Nevada Limits FMLA Certification Fees Starting in 2026: What Employers Should Know About AB 305

Fisher Phillips on

Nevada will soon impose new limits on fees health care providers can charge employees for completing paperwork required under the federal Family and Medical Leave Act (FMLA). Assembly Bill 305, which was recently approved by...more

McDermott+

McDermott+ Check-Up – August 1, 2025

McDermott+ on

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

Wiley Rein LLP

UPDATE: Trump Administration Asks Supreme Court to Stay Order Blocking NIH Grant Cancellations

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On July 24, 2025, the Trump Administration turned to the U.S. Supreme Court to block U.S. District Judge Young’s preliminary injunction prohibiting the National Institutes of Health (NIH) from cutting hundreds of grant...more

Venable LLP

CBER Director Resigns from FDA, Commissioner Makary’s Recent Remarks on FDA Staffing Cuts, CBER Hiring Data, and Additional...

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Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency’s structure and stakeholder interactions. ...more

Goodwin

Health Headlines: July 2025

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Welcome to the sixth issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice....more

Venable LLP

HHS Finalizes Staffing Cuts, New CDER Director, CDER Hiring Data, and New AI Councils at FDA

Venable LLP on

Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions....more

Goodwin

CCPA Settlement Signals Focus on Web Tracking Health Data

Goodwin on

In June 2025, California Attorney General Rob Bonta filed a proposed settlement with Healthline, a health information website, for its handling of personal information under the California Consumer Privacy Act (CCPA)....more

Ropes & Gray LLP

HRSA Announces 340B Rebate Model Pilot Program

Ropes & Gray LLP on

On July 31, 2025, the Health Resources and Services Administration (“HRSA”) announced the availability of a voluntary 340B Rebate Model Pilot Program (the “340B Rebate Pilot” or the “Pilot”) that would test, for a limited...more

King & Spalding

The Fourth Circuit Rejects a Non-Delegation Doctrine Challenge to the Anti-Kickback Statute

King & Spalding on

On July 22, 2025, the Fourth Circuit published its opinion in United States v. Donald Booker, No. 23-461, affirming a 200-month prison sentence for the owner of United Youth Care Services, which billed North Carolina’s...more

Wilson Sonsini Goodrich & Rosati

CMS Announces Creation of Health Tech Ecosystem for Improving Access to Patient Data

During a “Make Health Tech Great Again” event on July 30, 2025 at the White House, the Centers for Medicare & Medicaid Services (CMS) announced its intent to create a digital health ecosystem, in partnership with private...more

Alston & Bird

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

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

Akin Gump Strauss Hauer & Feld LLP

President’s Council on Sports, Fitness, and Nutrition, and the Reestablishment of the Presidential Fitness Test (Trump EO Tracker)

Reestablishes the Presidential Fitness Test and revitalizes the President's Council on Sports, Fitness, and Nutrition to promote youth participation in sports, improve national health, and address rising rates of obesity and...more

Snell & Wilmer

Federal Court Vacates Key Provisions of HIPAA Privacy Rule on Reproductive Healthcare

Snell & Wilmer on

On June 18, 2025, the U.S. District Court for the Northern District of Texas issued a ruling in Purl v. United States Department of Health and Human Services, vacating most of the Health and Human Services (HHS) Office for...more

Cozen O'Connor

Democratic AGs Push Back Against USDA Demand for SNAP Recipient Data

Cozen O'Connor on

A group of 21 Democratic AGs and the Governor of Kentucky have filed a lawsuit challenging a directive by the U.S. Department of Agriculture requiring states to turn over the personal information of individuals who apply for...more

Stevens & Lee

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

Stevens & Lee on

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

Dinsmore & Shohl LLP

HRSA Announces Pilot Program for 340B Rebate Models

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On the heels of multiple lawsuits disrupting drug manufacturers’ efforts to convert the 340B Program into a rebate-based model, the Health Resources and Services Administration (HRSA) released a Notice[1] announcing the...more

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