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DLA Piper

Tracking the 2025 US Government Shutdown (Updated)

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Read our latest updates on the US Government shutdown. Previous insights - Government Shutdown Update: Thursday, November 6, 2025 - Senate Majority Leader John Thune (R-SD) has indicated that a vote aimed at ending...more

DLA Piper

Government Shutdown Update: Thursday, November 6, 2025

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Senate Majority Leader John Thune (R-SD) has indicated that a vote aimed at ending the government shutdown will take place Friday. In a private lunch with Republicans, Senator Thune discussed reintroducing the House-passed...more

Sheppard Mullin Richter & Hampton LLP

Delaware Bans Medical Debt from Consumer Credit Reports

On October 27, 2025, amendments to Delaware’s Medical Debt Protection Act took effect, establishing a total ban on the inclusion of medical debt in consumer credit reports. The amendments, enacted through Senate Substitute 1...more

Perkins Coie

California Governor Newsom Signs Several AI Bills but Vetoes Three

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Key Takeaways - The California legislature sent a range of AI bills to Governor Newsom’s desk in the legislative session that just concluded. The governor signed several into law and vetoed three....more

Epstein Becker & Green

OIRA Memo on Agency Deregulation: Implications for Health Care

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On October 21, 2025, the acting administrator of the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget issued Memorandum M-25-36, which contains guidance for federal agencies on “how...more

Hall Benefits Law

Survey Shows CEOs Acknowledge Benefits of Wellness Programs

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According to Wellhub, a New York-based corporate wellness platform, a survey involving 1,500 CEOs earlier this year found that most CEOs recognized the benefits of workplace wellness programs. The survey respondents found the...more

Hall Benefits Law

11th Circuit Rules Health Plan’s Gender Care Exclusions Not Discriminatory

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The U.S. Court of Appeals for the Eleventh Circuit recently overturned the rulings of a federal district court and an Eleventh Circuit panel, finding that a Georgia health plan’s exclusion of coverage for gender-affirming...more

Dorsey & Whitney LLP

SuperValu: Relators’ SCOTUS Victory Turns Pyrrhic After Jury’s Defense Verdict and Denial of Post-Trial Motions

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After fourteen years of litigation, United States ex rel. Schutte v. SuperValu, Inc. arrived at its likely end after the U.S. District Court for the Central District of Illinois rejected relators’ bid for a new trial after a...more

Fenwick & West LLP

What California’s AB 1415 Means for Healthcare Company Transactions

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In October 2025, California enacted significant legislative reforms that directly impact healthcare companies involved in private equity (PE) sales, hedge fund investments, and certain transactions involving management...more

Parker Poe Adams & Bernstein LLP

New National Guidance Lays Out 'Responsible Use of AI' for Healthcare Industry

As artificial intelligence (AI) becomes increasingly embedded in processes and systems across healthcare organizations, clinicians and administrators face an intensifying challenge to adapt their organizations to the rapidly...more

Goodwin

Hikma Launches Ustekinumab Biosimilar STARJEMZA

Goodwin on

On November 6, 2025, Hikma Pharmaceuticals PLC, and its subsidiary Hikma Pharmaceuticals USA Inc., announced the launch of STARJEMZA (ustekinumab-hmny).  STARJEMZA references Janssen’s STELARA, and is indicated for the...more

Goodwin

CMS Finalizes Changes to Bona Fide Service Fee Requirements, Alongside Other Adjustments to Medicare Part B Drug Reimbursement...

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On October 31, 2025, the Centers for Medicare & Medicaid Services (CMS) released its Final Rule for the Calendar Year (CY) 2026 Physician Fee Schedule (PFS), detailing significant updates to Medicare Part B payment policies....more

Husch Blackwell LLP

340B Rebate Pilot Finalized: HRSA Approves Initial Manufacturer Plans, Clarifies Data and Operational Requirements

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The Health Resources and Services Administration (HRSA) finalized the 340B Rebate Model Pilot Program and published FAQs that supplement the August 7, 2025, Federal Register notice. The final materials confirm the pilot takes...more

Benesch

A $10 Million Warning Shot: State Attorney General Worker Misclassification Enforcement Puts Healthcare Industry on High Alert

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California’s Attorney General recently secured a $10 million judgment against a healthcare company for misclassifying in-home care workers as independent contractors, highlighting the serious risks of worker...more

Venable LLP

FDA Issues Complete Response Letter for Alvotech’s Simponi® (golimumab) Biosimilar AVT05

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On November 2, 2025, the FDA issued a complete response letter (CRL) for Alvotech’s abbreviated Biologics License Application (aBLA) for its proposed Simponi® (golimumab) biosimilar AVT05. ...more

Bergeson & Campbell, P.C.

EC Requests Scientific Opinion on the Safety of Hydrated Silica (Nano), Pyrogenic Silica (Nano), Silica Silylate (Nano), and...

The Scientific Committee on Consumer Safety (SCCS) announced on October 30, 2025, that the European Commission (EC) requested a scientific opinion on the safety of hydrated silica (nano), pyrogenic silica (nano), silica...more

Ropes & Gray LLP

Rare Disease Focus: FDA’s Trio of Cell and Gene Therapy Draft Guidances Highlight Expedited Programs, Innovative Trial Designs,...

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FDA’s Center for Biologics Evaluation and Research (“CBER”) recently issued a trio of new draft guidances to assist sponsors who are developing and conducting postapproval studies of cell and gene therapies (“CGTs”):...more

King & Spalding

OIG Audit Finds Medicare Improperly Paid DMEPOS Suppliers $22.7 Million Over 7 Years

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On October 28, 2025, HHS Office of Inspector General (OIG) posted an audit report finding that Medicare improperly paid suppliers $22.7 million over seven years for durable medical equipment, prosthetics, orthotics, and...more

Mintz - Health Care Viewpoints

Can You Keep a Secret? The Trade Secret Tightrope in FDA-Regulated MedTech

Trade secrets are a critical tool for protecting medical technology innovations. To that end, a robust trade secret management program is essential for safeguarding these valuable assets. To be effective in today’s legal...more

McDermott+

HHS GPS v2.0 + HRSA “strategic priority areas”: Impact on federal grant recipients engaged in pediatric gender-affirming care

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Effective October 1, 2025, the US Department of Health and Human Services (HHS) implemented grants policy statement (GPS) v2.0, consistent with its prior adoption of 2 CFR part 200 with HHS-specific provisions at 2 CFR part...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - November 14th, Nashville, TN

Benefit from compliance education and networking in your area! HCCA’s Regional Healthcare Compliance Conferences offer convenient, local compliance education in a variety of locations across the country, and feature...more

Littler

Rochester, NY Expands Protections for Immigrants, Reproductive Autonomy, and the LGBTQIA+ Community

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On August 26, 2025, the Rochester City Council voted unanimously to strengthen the city’s long-standing sanctuary city policy, adopting Ordinance No. 2025-283. The measure, formally adopted on August 27, 2025, amends the...more

Dentons

Ep. 86 – Preparing for ICE (Ep. 48 Replay)

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This year, immigration enforcement has been making headlines, with increased attention on workplace enforcement actions by U.S. Immigration and Customs Enforcement (ICE)....more

Hall Benefits Law

Trump Administration Targets PBM Reform to Lower Drug Prices

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Robert F. Kennedy, Jr. (RFK), secretary of the U.S. Department of Health and Human Services (HHS), appeared at a recent Senate Finance Committee hearing to review the current administration’s healthcare policy priorities....more

DLA Piper

Tracking the 2025 US Government Shutdown (Updated)

DLA Piper on

Read our latest updates on the US Government shutdown. Previous insights - Government Shutdown Update: Wednesday, November 5, 2025 - At 36 days, the government shutdown has now become the longest in U.S. history....more

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