News & Analysis as of

Department of Health and Human Services (HHS) Health Care Providers

Alston & Bird

Health Care Week in Review | Draft MAHA Commission Strategy Document Circulated; President Trump Signs EO Aiming to Fill Drug...

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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

Baker Donelson

HRSA Announces 340B Rebate Pilot Program

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Structure & Timing of the Pilot Program - On August 1, 2025, the Health Resources and Services Administration (HRSA), administrator of the 340B Drug Pricing Program, announced its voluntary 340B Rebate Model Pilot Program in...more

Amundsen Davis LLC

Federal Public Benefits and Immigration Status: What HHS’s Guidance Means for Mental Health Providers

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Mental health services are often partially funded with federal money, whether through grants or federal health care plans. Recently, the Department of Health and Human Services (“HHS”) updated its guidance clarifying how...more

Davis Wright Tremaine LLP

Navigating Federal and State Oversight in Gender-Affirming Care

On August 1, Washington D.C. and 16 states sued the Department of Justice, U.S. Attorney General Pamela Bondi, and President Donald Trump, alleging that the Trump Administration unlawfully prevented transgender minors from...more

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

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

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On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

DLA Piper

Paying for Direct Primary Care Arrangements With HSAs is Now Permitted – With Caveats

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While proposed frequently in Congress over the past few years, the One Big Beautiful Bill Act (OBBBA) has succeeded in revising the rules governing health savings accounts (HSA) in key ways that allow them to be used to pay...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

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

Fisher Phillips

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

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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

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...

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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

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

Morgan Lewis - Health Law Scan

OIG’s Advisory Opinion No. 25-08: Negative Opinion Highlights Potential Broad Reach of AKS

In a relatively rare move, the US Department of Health and Human Services Office of Inspector General (OIG) recently issued an unfavorable Advisory Opinion (No. 25-08) (Opinion) reinforcing the agency’s expansive view of the...more

Epstein Becker & Green

Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast

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Can food really be the prescription for better health? Discover how the “Food as Medicine” movement is reshaping health care and what it means for patients, providers, and the future of wellness. On this episode, special...more

Husch Blackwell LLP

Federal Court Vacates 2024 HIPAA Reproductive Health Privacy Rule: Key Impacts for Covered Entities and NPP Compliance

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On June 18, 2025, the U.S. District Court for the Northern District of Texas issued a decision in Carmen Purl, et al. v. United States Department of Health and Human Services, et al., vacating nearly all of the 2024 HIPAA...more

Foley & Lardner LLP

HHS Guidance Excluding Non-Qualified Aliens from More Federal Programs Raises Questions for Providers and Grantees

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A Notice published on July 14, 2025 identifies 12 new Federal public benefit programs (see list below) for which non-qualified aliens are not eligible. Although it was published by the U.S. Department of Health and Human...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

Holland & Knight LLP

Holland & Knight Health Dose: July 29, 2025

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This week, the U.S. House of Representatives will be out of session, as the chamber has adjourned for the August 2025 district work period. The U.S. Senate remains in session and continues to consider nominations to lead...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

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

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon...

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This week on the podcast, Lynnsey and Lauren are joined by their colleague, Maynard Nexsen healthcare attorney Shannon Lipham, who helps healthcare providers and practices navigate complex federal and state regulations....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

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