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Shook, Hardy & Bacon L.L.P.

Health Care Fraud, Public Corruption in Focus in First Six Months of U.S. Attorney’s Service in Northern District of Illinois

Health care fraud, public corruption and other types of fraud have emerged as apparent top white collar enforcement priorities of the United States Attorney’s Office for the Northern District of Illinois under the leadership...more

McDermott+

McDermott+ Check-Up: November 7, 2025

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Government shutdown breaks record. As the shutdown passed the 35-day record, negotiations to reopen the government continued....more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | September 2025 Recap

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This issue of McDermott Will & Schulte’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2025, including an update on the Centers for Medicare & Medicaid Services (CMS) Rural Health Transformation...more

Holland & Knight LLP

Senate Advances Funding Bill to End Record Shutdown

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The U.S. Senate voted 60-40 on Nov. 9, 2025, in a procedural step to advance a U.S. House of Representatives-passed government funding bill that will be amended to extend federal funding through Jan. 30, 2026, and include a...more

Fox Rothschild LLP

Strict Compliance with Safe Harbor Requirements is Key to Avoiding Anti-Kickback Violations

Fox Rothschild LLP on

Office of Inspector General (“OIG”) Advisory Opinion 25-09[1] addresses an inquiry from a company that develops, manufactures and sells medical devices used in emergency stroke treatment and provides commentary for similarly...more

Bond Schoeneck & King PLLC

New York State OMIG Launches Provider Portal

The New York State Office of the Medicaid Inspector General (OMIG), in collaboration with Performant Healthcare Solutions, earlier this week announced the launch of its Recovery Audit Contractor (RAC) portal. Earlier this...more

Woods Rogers

Social Media Posts Create Risk, Can Require Discipline, Healthcare Risk Management

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Healthcare Risk Management recently interviewed Woods Rogers Principal Mike Gardner for its November issue cover story on recent disciplinary actions against healthcare workers for offensive social media posts. These...more

Fox Rothschild LLP

HIPAA, but for non-Covered Entities?

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New bill, proposed by Bill Cassidy (R-LA), Chair of the Senate Health, Education, Labor and Pensions Committee (HELP), purports to apply the privacy and security practices under the HITECH Act, to entities that process non...more

DLA Piper

Government Shutdown Update: Friday, November 7, 2025

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While negotiations appeared to ramp up yesterday, the discussions today, both across and within parties, indicate there is still much work to be done. The Senate was expected to vote on an amended continuing resolution (CR)...more

Rivkin Radler LLP

OIG Report Exposes “Ghost Networks” Across U.S.

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The New York Attorney General’s Office imposition of a $250,000 penalty on MVP Health Care for maintaining an inaccurate mental health provider directory riddled with “ghost” providers. The problem, however, extends beyond...more

McGuireWoods LLP

Healthcare & Life Sciences Private Equity Deal Tracker: Curewell Acquires Wilmington PharmaTech

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Curewell Capital has acquired Wilmington PharmaTech (WPT), according to a news release. WPT, founded in 2003 and based in Newark, Delaware, is a contract research, development and manufacturing organization focused on...more

Rothwell, Figg, Ernst & Manbeck, P.C.

FDA Proposes Sweeping Changes to Accelerate Biosimilar Development

On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS), announced a new strategy aimed...more

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

DLA Piper on

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

Perkins Coie on

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

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