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Health Military

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

Amgen Plans At-Risk Launch of EYLEA® Biosimilar Pavblu™ After Federal Circuit Lifts Temporary Injunction

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On October 22, 2024, the Federal Circuit (CAFC Case No. 24-2351) denied Regeneron’s request for an injunction pending appeal for Amgen’s EYLEA® (aflibercept) biosimilar Pavblu™ (aflibercept-ayyh), concluding that “Regeneron...more

Robinson+Cole Data Privacy + Security Insider

Microsoft Report Highlights Attacks Against Healthcare Organizations

On October 22, 2024, Microsoft issued a threat trend research report entitled “US Healthcare at risk: Strengthening resilience against ransomware attacks.” In it, Microsoft declares that ransomware attacks against the...more

Goodwin

Federal Circuit Denies Injunction Pending Appeal After Amgen Beat Preliminary Injunction for Biosimilar Aflibercept

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As we previously reported, on September 24, 2024, the District Court for the Northern District of West Virginia denied Regeneron’s motion seeking a preliminary injunction preventing Amgen from launching its FDA-approved...more

Venable LLP

What Nonprofit Employers Need to Know about Mental Health Parity

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The government recently issued final rules on the Mental Health Parity and Addiction Equity Act (MHPAEA). The rules require most employers—including most nonprofits—to take action by January 1, 2025....more

Epstein Becker & Green

States Fill Gaps in Hospital Workplace Violence Laws—Requiring Law Enforcement Officers, Weapons Detection Screening Policies in...

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While we wait for long-anticipated federal regulations from the Occupational Safety and Health Administration (OSHA) addressing the issue of workplace violence in health care, activity continues at the state level....more

Latham & Watkins LLP

Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit

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Manufacturers, government officials, and other stakeholders recently convened in Chicago for the annual Medicaid Drug Rebate Program Summit. In this episode of Connected with Latham, Washington, D.C. associate Danny Machado...more

McDermott+

It’s the Final Countdown: Comparing the Last Regulatory Actions of the Biden and Trump Administrations

McDermott+ on

The election is approaching fast, and no matter who wins, there will be a change in administration come January 20, 2025. Thus, the Biden Administration is in the midst of making its final mark on priority healthcare...more

Bass, Berry & Sims PLC

HHS-OIG Set To Intensify Scrutiny of Grants and Contract Compliance: How to Prepare

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As we detailed in a previous blog, on October 3, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a strategic plan to “safeguard[] the integrity of HHS grants and contracts.” The...more

McDermott Will & Emery

This Week in 340B: October 15 – 21, 2024

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Emery

Illinois Passes New Physical Therapy Law HB 5087

McDermott Will & Emery on

KEY UPDATE - Illinois enacted HB 5087, which significantly limits physical therapists’ ability to provide telehealth services to patients in the state. As enacted, these new provisions become effective on January 1, 2025....more

McDonnell Boehnen Hulbert & Berghoff LLP

Teva v. Amneal -- Amneal's Responsive Brief & Teva's Reply Brief

The Federal Circuit has been petitioned by plaintiff Teva Branded Pharmaceutical Products R&D, Inc. to reverse a decision in favor of Defendant Amneal Pharmaceuticals wherein the District Court entered an injunction ordering...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces New Director of the Center for Devices and Radiological Health

Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological Health (CDRH). She has spent...more

Fisher Phillips

The Whistleblowing Just Got Louder: 8 Things Employers Should Do in Response to Feds’ New Whistleblower Awards Program

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A new initiative rolled out by federal officials this summer can reward corporate whistleblowers with up to $30 million – which means it is incumbent upon your organization to step up your game when it comes to corporate...more

Rivkin Radler LLP

CA Physician and Practice Resolve FCA Allegations for $3.8 Million

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The U.S. Attorney’s Office for the Southern District of California announced on October 11 that Dr. Janette Gray and her former medical practice, The Center for Health & Wellbeing in San Diego, resolved False Claims Act (FCA)...more

Foley & Lardner LLP

GLP-1 Drugs: FDA Sued Over Removing Tirzepatide from the Drug Shortage List

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Less than a week after the U.S. Food & Drug Administration (FDA) determined that the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved” and removed from the FDA’s shortage...more

Groom Law Group, Chartered

IRS Announces 2025 Health and Welfare Limits

On October 22, 2024, the IRS issued Rev. Proc. 2024-40, which announces the 2025 indexed limits for certain health and welfare benefits. This is in addition to the limits that the IRS announced on May 9, 2024 in Rev. Proc....more

Sheppard Mullin Richter & Hampton LLP

Over 940,000 Medicare Beneficiaries Impacted by Data Breach

The Centers for Medicare & Medicaid Services (“CMS”) and its contractor, Wisconsin Physicians Service Insurance Corporation (“WPS”), recently notified over 940,000 Medicare beneficiaries of a data breach that has potentially...more

Foley & Lardner LLP

Private Equity Investments in Oncology: Top Five Things to Know

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Although private equity (PE) sponsors have been active investors in the health care services industry for the last decade, PE-backed health care providers today constitute only 4% of the United States health market by...more

Faegre Drinker Biddle & Reath LLP

Biopharma & Medical Device Briefing: PFAS Reporting Requirements; ECHA Substances of Very High Concern List; and MicroRNA...

With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more

Morgan Lewis - Health Law Scan

CMS Announces Updated List of Drugs Under the Inflation Rebate Program

Bipartisan efforts to lower prescription drug costs remains a core focus for the US Congress. Effective October 1, 2024, the Centers for Medicare and Medicaid Services (CMS) has announced the follow-on cohort for its...more

Vicente LLP

Hemp-Derived THC Products in California: Overview of U.S. Hemp Roundtable et al. v. California Department of Public Health et al.

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On September 23, 2024, California Governor Gavin Newsom announced emergency regulations that, among other things, prohibited hemp products containing any “detectable” amount of THC. The next day, September 24, several small...more

Proskauer - Employee Benefits & Executive...

Deadlines Approaching for New ACA Section 1557 Nondiscrimination Requirements: Action Items for Covered Group Health Plans

Earlier this year, the Department of Health and Human Services (“HHS”) released a final rule under Section 1557 of the Affordable Care Act (“ACA”), which prohibits discrimination in health programs and activities. The 2024...more

Woodruff Sawyer

​​​​​IRS Adjusts Health Flexible Spending Account and Other Benefit Limits for 2025

Woodruff Sawyer on

On October 22, 2024, the Internal Revenue Service (IRS) released Revenue Procedure 2024-40, which increases the health flexible spending account (FSA) salary reduction contribution limit to $3,300 for plan years beginning in...more

Troutman Pepper

Navigating Hot Topics in Consumer Finance: Litigation Trends, Regulatory Changes, and Medical Debt Collection – The Consumer...

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In this episode of The Consumer Finance Podcast, Chris Willis is joined by Troutman Pepper Partner David Anthony and Rami Haddad, deputy general counsel for Compliance, Litigation, and Privacy at PRA Group. The discussion...more

Manatt, Phelps & Phillips, LLP

Strategies for Meeting Patient Expectations and Improving Patient Experience During Cancer Treatment

Scientific advances have led to a significant reduction in cancer mortality and increased survival rates,  yet the number of annual cancer diagnoses continues to grow, with over two million new diagnoses expected in 2024....more

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