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Laughlin, Falbo, Levy & Moresi LLP

A NEW MEDIC-ERA; Changes to CMS Review Guidelines in 2025

Vast changes are swiftly approaching regarding the efforts Workers’ Compensation practitioners must make in protecting Medicare’s interests in future medical settlements. The Centers for Medicare/Medicaid Services (CMS) has...more

Hissey, Mulderig & Friend, PLLC

Women With Meningioma Brain Tumors From Depo-Provera May Qualify to File a Lawsuit

Women who were diagnosed with meningioma brain tumors after using Depo-Provera birth control shots may be eligible to file a lawsuit and receive compensation for their illness....more

Hogan Lovells

The European Commission tackles shortages of critical medicines through the Critical Medicines Act

Hogan Lovells on

On Tuesday 11 March 2025, the European Commission published a legislative proposal for a Critical Medicines Act. The objective of this Act is to ensure stable supply and continuous availability of critical medicinal products,...more

McDermott+

Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off

McDermott+ on

Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off - It’s March, which means one thing for sports fans: the madness of the NCAA men’s and women’s basketball tournaments. However, to folks in the...more

McDermott Will & Emery

Even Jepson Preambles Require Written Description Support

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit found a Jepson claim unpatentable where the specification did not provide adequate written description for the portion of the claim purporting to recite what was already well...more

Skadden, Arps, Slate, Meagher & Flom LLP

Makary Is Confirmed as Commissioner of an FDA in Transition

Dr. Martin Makary has been confirmed by the Senate as the next commissioner of the Food and Drug Administration (FDA). Dr. Makary is taking the helm at FDA during an unprecedented time for the agency, which has been subject...more

McDermott Will & Emery

What’s the (Re)issue? Patent Term Extensions for Reissue Patents

McDermott Will & Emery on

Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...more

Zuckerman Spaeder LLP

What to Expect in Consumer Protection in the New Administration

Zuckerman Spaeder LLP on

At the 2025 American Bar Association (“ABA”) White Collar Crime Institute in Miami, industry veterans forecasted the new Trump Administration’s white collar objectives by examining trends during the first Trump presidency. In...more

Butler Snow LLP

Turnabout is Fair Play – “Junk Science” Litigation Aftermath: Requisite Retractions and Dubious Do-Overs

Butler Snow LLP on

Do plaintiffs’ experts get to put junk science before juries more often than their opinions are excluded? The answer is a resounding “probably.” Even in light of the December 2023 amendment to Federal Rule of Evidence and its...more

Butler Snow LLP

Junk Science: What Courts are Seeing and How It Affects Us: A Judge’s Eye View

Butler Snow LLP on

Trial lawyers, especially defense lawyers in the pharmaceutical and medical device arena, strive to ensure that “junk science” stays out of the courtroom. Unfortunately, that is often wishful thinking. When I spoke with an...more

McDermott Will & Emery

European Health Data Space Regulation enters into force

McDermott Will & Emery on

March 26, 2025, marked a pivotal moment in the EU with the European Health Data Space Regulation, (EU) 2025/327 (“EHDS Regulation”), coming into force. The EHDS represents a transformative initiative by the European Union...more

McDermott Will & Emery

This Week in 340B: March 18 – 24, 2025

McDermott Will & Emery on

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

Holland & Knight LLP

New York Court Strikes Down CDPAP Reimbursement Changes

Holland & Knight LLP on

In a significant development for fiscal intermediaries (FIs) and the Consumer Directed Personal Assistance Program (CDPAP), a New York Supreme Court Justice ruled on March 20, 2025, that the New York State Department of...more

Health Care Compliance Association (HCCA)

Compliance Program Effectiveness: Keep it Streamlined and Strategic

KISS takes on a new meaning in this podcast: Keep it Streamlined & Strategic. Keeping it streamlined and strategic is also the topic of a session at the 2025 HCCA Compliance Institute...more

Knobbe Martens

FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers

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Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to...more

Knobbe Martens

Two Bills Introduced to Target “Patent Thickets” and “Product Hopping”

Knobbe Martens on

On March 17, 2025, a bipartisan group of senators introduced two bills intended to decrease the cost of prescription drugs. The sponsors include Chuck Grassley (R-Iowa), John Cornyn (R-Texas), Richard Blumenthal (D-Conn.),...more

Knobbe Martens

National Institutes of Health (NIH) Announces Plan to Centralize Peer Review Process

Knobbe Martens on

On March 6, 2025, the National Institutes of Health (NIH) announced plans to centralize peer review of all applications for grants, cooperative agreements and research and development contracts within its Center for...more

Ballard Spahr LLP

Republican Senators seek to use CRA to void medical debt rule

Ballard Spahr LLP on

Republican senators have introduced a Congressional Review Act resolution to nullify the rule that bans banks and credit unions from including medical debt on credit reports and generally prohibits the use of medical...more

Husch Blackwell LLP

Litigation Looms: ERIC Seeks Stay on 2024 Mental Health Parity Rule Enforcement

Husch Blackwell LLP on

On February 20, 2025, the ERISA Industry Committee (ERIC) announced that its legal counsel submitted a letter to the U.S. Departments of Labor (DOL), Health and Human Services (HHS) and Treasury, requesting a stay of...more

Warner Norcross + Judd

OCR Enforcement Intensifies: Key Takeaways on Risk Analysis and Right of Access

Warner Norcross + Judd on

The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services has renewed its focus on two critical areas of HIPAA compliance: risk analysis and individual right of access. These enforcement...more

Axinn, Veltrop & Harkrider LLP

Compounding Problems: Recent Decisions on Tirzepatide Highlight Interplay Between FDA Anti-Compounding Enforcement and Private...

Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more

Ropes & Gray LLP

Hospital & Health System Reimbursement Check Newsletter - MARCH 2025

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In the short time since taking office on January 20, President Donald Trump has taken executive actions calling for sweeping changes affecting the health care sector. While new administrations always bring changes, the speed...more

Husch Blackwell LLP

Eliminating the GRAS “Loophole”: Implications for Functional Foods and Beverages

Husch Blackwell LLP on

On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that U.S. Secretary of HHS Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore closing the GRAS...more

King & Spalding

NY Department of Health Issues Clarifying FAQs on Healthcare Transaction Notice Law

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Earlier this month, the New York State Department of Health (DOH) released its first formal guidance under Public Health Law (PHL) Article 45-A, the state’s recently enacted healthcare transaction notice law. Issued in the...more

Davis Wright Tremaine LLP

Stay ADvised: 2025, Issue 6

Reckitt Benckiser Tastes Sweet Success as Mucinex Honey False Ad Dismissed - Plaintiffs alleging that Reckitt Benckiser falsely advertised certain Mucinex products as containing honey failed to sufficiently allege that the...more

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