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Health Government Contracting

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
Venable LLP

Dr. Tidmarsh Resigns as Director of CDER, Leadership Developments in Key FDA Offices, and FDA Announces Reforms to Accelerate...

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Through our Venable FDA Pulse series, we provide insight into key developments within the Food and Drug Administration (FDA or the Agency), emerging trends, enforcement activity, and other topics impacting stakeholders. ...more

Maynard Nexsen

Alabama Supreme Court Appellate Alert: Decision from November 7, 2025

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The Alabama Supreme Court issued its weekly release list on Friday, November 7, which included one opinion of interest to the Alabama business community...more

Groom Law Group, Chartered

This Week From the Hill (November 9 – 15, 2025)

Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing,...more

Blank Rome LLP

A New Deal For GLP-1s

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The Trump Administration recently announced a multi-pronged deal with Eli Lilly and Novo Nordisk aimed at lowering the cost of GLP-1 medications used for weight loss and diabetes. While many details remain in flux, the...more

Foley & Lardner LLP

FDA Considers Drug Pricing: Leadership Cites Consumer Cost as a Driver for Changes to Biosimilar Recommendations

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“By streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions...more

Mintz - Health Care Viewpoints

Health Law Diagnosed – What California’s New Laws Mean for Health Care Investors

In this episode of Health Law Diagnosed, Of Counsel Bridgette Keller welcomes Mintz Members Daniel Cody and Deborah Daccord to unpack the latest legislative developments reshaping health care transactions in California,...more

Sheppard Mullin Richter & Hampton LLP

Patients Over Profit Act: A Federal Inflection Point on Insurer-Provider Integration and What Comes Next

For years, the conversation around health insurer consolidation and vertical integration has simmered through antitrust inquiries, oversight hearings, and policy papers. The Patients Over Profit Act (the “POP Act”),...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - December 5th, San Francisco, CA

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

Polsinelli

CMS Finalizes Sweeping Reforms to Skin Substitute Payments Amid Rising Costs and Enforcement Activity

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Key Takeaways: Major Financial and Operational Impact: On Nov. 5, 2025, CMS finalized a rule that fundamentally changes Medicare payment methodology for a broad range of skin substitute products used for wound care....more

Foley Hoag LLP - Security, Privacy and the...

Changes in the Rules for Disclosure for Substance Use Disorder Treatment Records: 42 CFR Part 2: What Changed, Why It Matters, and...

42 CFR Part 2: What Changed, Why It Matters, and What to Do Now - On November, 7, 2025, I spoke to the Massachusetts Health Information Management Association about the federal government’s sweeping updates to 42 CFR Part...more

Mintz

[Podcast] Health Law Diagnosed – What California’s New Laws Mean for Health Care Investors

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In this episode of Health Law Diagnosed, Of Counsel Bridgette Keller welcomes Mintz Members Daniel Cody and Deborah Daccord to unpack the latest legislative developments reshaping health care transactions in California,...more

Epstein Becker & Green

Outside Counsel’s Internal Investigations—Including Those Relating to Health Care—Are Privileged and Protected from Disclosure

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In Summer 2025, the U.S. Court of Appeals for the Sixth Circuit issued a strongly worded decision in In Re: FirstEnergy Corporation (No. 24-3654)—confirming the core concept that internal investigations conducted by counsel...more

Alston & Bird

Comparative Efficacy Studies Are No Longer the Default Requirement for Biosimilars

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Our FDA: Drug & Device Team examines the FDA’s new draft guidance that allows biosimilar developers to rely more on analytical and pharmacokinetic data, reducing the need for costly and time-consuming comparative efficacy...more

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

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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

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