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Arnall Golden Gregory LLP

Not a Second Time: FDA’s Office of Prescription Drug Promotion Issues a Warning Letter to a Company for Unlawful Promotion

The authors were thinking of the Beatles’ 1963 song, “Not a Second Time,” when we read the latest Warning Letter from the Food and Drug Administration’s Office of Prescription Drug Promotion. The company received a Warning...more

Hall Benefits Law

PBM Contracts Could Expose Plan Sponsors to Fiduciary Liability

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A plan sponsor’s fiduciary duty to be transparent in Pharmacy Benefit Manager contracts safeguards plan participants’ interests and mitigates the risk of litigation, regulatory penalties, and reputational harm, say Hall...more

Epstein Becker & Green

DOJ Civil Division Announces 2025 Priorities: Promises “Aggressive” False Claims Act Enforcement of Civil Rights Violations and...

Epstein Becker & Green on

On June 11, 2025, Assistant Attorney General Brett A. Shumate issued an internal memorandum (the “Shumate memo”) to all Civil Division employees of the U.S. Department of Justice (“DOJ”), describing the Division’s enforcement...more

Mayer Brown

Big Firms, Be Careful What You Say: First UK Competition Disparagement Decision Puts Large Companies On Notice

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OVERVIEW - The UK Competition and Markets Authority (“CMA”) has recently published a decision accepting commitments from Vifor Pharma (“Vifor”). This brings to a close an unprecedented abuse of dominance investigation...more

Epstein Becker & Green

A Headliner Upholding a State Ban on Transition Care for Transgender Minors Leads the Latest Five Decisions - SCOTUS Today

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To anyone who has followed the case of United States v. Skrmetti, especially those who attended or listened to the oral argument, the U.S. Supreme Court’s 6–3 holding that a Tennessee law prohibiting certain medical...more

Dentons

Ep. 66 – Mid-year Compliance Check-in: Three New Enforcement Priorities to Add to Your 2025 Work Plan

Dentons on

As we hit the halfway point of 2025, now is the perfect time to revisit your compliance work plan. While it’s always good practice to assess whether your organization is meeting its compliance goals, this year presents a...more

Littler

Policy Week in Review – June 2025 #3

Littler on

Senate HELP Committee Holds Hearing on Labor Nominees; Announces Committee Votes - On June 18, 2025, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on four nominees for a number of...more

Alston & Bird

Health Care Week in Review | Senate Finance Committee Releases Budget Reconciliation Text; SCOTUS Upholds TN Ban on...

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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

Holland & Knight LLP

HIPAA's Reproductive Health Rule Is Vacated Nationally

Holland & Knight LLP on

The U.S. District Court for the Northern District of Texas on June 18, 2025, issued an order vacating the HIPAA Privacy Rule to Support Reproductive Health Care Privacy, published on April 26, 2024, which amended the Health...more

Rivkin Radler LLP

The Latest Refinements to DOJ’s White Collar Enforcement Policy

Rivkin Radler LLP on

Last month, the head of the Criminal Division of the U.S. Department of Justice (DOJ), Matthew R. Galeotti, issued a Memorandum outlining DOJ’s enforcement priorities and policies for prosecuting white-collar crime,...more

Knobbe Martens

Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth

Knobbe Martens on

The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...more

Stark & Stark

Guide to Ozempic/Wegovy Vision Loss Lawsuits and Settlements

Stark & Stark on

What types of eye injuries does Ozempic/Wegovy cause? Ozempic/Wegovy are two of the most common weight-loss medications known as GLP-1 drugs. Other  GLP-1 drugs include Mounjaro, Rybelsus, Saxenda, Victoza, Trulicity, and...more

Offit Kurman

The Heat Is On: OSHA’s Proposed Heat Safety Rule Advances with June 16 Hearing

Offit Kurman on

As summer temperatures soar, so does the urgency for workplace safety measures to protect employees from heat-related illnesses. On July 2, 2024, the Occupational Safety and Health Administration (OSHA) unveiled its proposed...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Can Your Therapist Opine About Your Custody Case?

Parents often tell me that their individual therapist, former marriage counselor, or even their child’s therapist should have an opinion about the outcome of their custody case. They’ll ask why the judge cannot just speak to...more

Arnall Golden Gregory LLP

Landmark $9.25M AGG Class Action Settlement Against UnitedHealthcare Receives Preliminary Approval, Class Claim Submission Process...

AGG Healthcare Litigation attorneys Rich Collins and Landen Benson represent two of the three named plaintiffs in an ERISA class action against UnitedHealthcare (“United”), involving the insurer’s denial of access to proton...more

TNG Consulting

Mandated Risk Assessment of Students: Part Two – Higher Education 

TNG Consulting on

The first Tip of the Week in this series explored how the authority to mandate a risk assessment is established and communicated within any educational community. In this second installment, we focus on the steps to take once...more

Arnall Golden Gregory LLP

Federal Court Permits MultiPlan Antitrust MDL to Proceed: Court Upholds Federal and State Antitrust and Consumer Protection...

On June 3, 2025, Judge Matthew F. Kennelly of the U.S. District Court for the Northern District of Illinois issued a sweeping ruling in In re MultiPlan Health Insurance Provider Litigation, largely denying motions to dismiss...more

DLA Piper

OIG Issues Favorable Advisory Opinion on Telehealth Marketplace MSO-PC Arrangement

DLA Piper on

The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a favorable advisory opinion under the federal Anti-Kickback Statute (AKS), wading into the world of not only telehealth but also...more

McDermott+

McDermott+ Check-Up – June 18, 2025

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THIS WEEK’S DOSE - - Senate Finance Committee Releases Reconciliation Text. The language is subject to change as negotiations continue and the Byrd rule process plays out. - CMS Releases MA Risk Adjustment Audit Methodology...more

Sheppard Mullin Richter & Hampton LLP

Understanding the Federal Reconciliation Bill’s Implications for MCO Tax Structure

New York’s Medicaid financing strategy—particularly its use of a managed care organization (MCO) tax—has come under renewed federal scrutiny amid recent legislative proposals and regulatory developments. The federal...more

Sheppard Mullin Richter & Hampton LLP

Maine Enacts Ban on Reporting Medical Debt to Credit Bureaus

On June 9, Maine Governor Janet Mills signed into law LD558, which prohibits the reporting of medical debt to consumer reporting agencies. The law bars medical creditors, debt collectors, and debt buyers from furnishing...more

Woods Rogers

Supreme Court’s Skrmetti Decision Redefines Legal Landscape for Gender-Affirming Care for Youth

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On Wednesday, June 18, 2025, the Supreme Court of the United States issued a landmark 6-3 decision in United States v. Skrmetti, directly addressing the constitutionality of state laws banning gender-affirming care for...more

Holland & Knight LLP

Another Change to NIH Grant Civil Rights Terms and Conditions

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The National Institutes of Health (NIH) issued a notice on June 12, 2025, rescinding recent civil rights–related changes to the terms and conditions governing federally funded research (the Rescission). Effective immediately,...more

J.S. Held

The Classification of Gasoline & Gasoline Fumes as a Carcinogen: Considerations for Corporate Executives & Attorneys

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The International Agency for Research on Cancer (IARC) recently re-evaluated the carcinogenicity of automotive gasoline and several gasoline additives, such as MTBE and ETBE, and have now classified automotive gasoline as a...more

Hogan Lovells

New MDCG guidance clarifies rules for medical device software available on online platforms

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The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more

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