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Health Securities

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

The NIH Funding Cuts: Implications and Status of Lawsuits

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The proposed cuts would place a 15% indirect cost rate on all new and existing grant awards received by research institutions and universities....more

Mintz - Health Care Viewpoints

Mintz IRA Update — The IRA in 2025: The Future of Medicare Part D

Last year was a pivotal year for the pharmaceutical industry. Under the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program), the US government negotiated the prices of 10 selected high-expenditure,...more

Mintz - Health Care Viewpoints

Mintz IRA Update — Fourth Edition: Q1 2025

Mintz’s Pharmacy Benefits and PBM Contracting Practice is pleased to present the ‘Fourth Edition: Q1 2025’ of our Mintz IRA Update, a regular publication that delves into developments of the Inflation Reduction Act of 2022...more

Mintz - Health Care Viewpoints

Mintz IRA Update — The Future of the Medicare Drug Price Negotiation Program

The Centers for Medicare and Medicaid Services (CMS) and pharmaceutical drug manufacturers are gearing up for the second round of negotiations as part of the Medicare Drug Price Negotiation Program (the Negotiation Program),...more

Benesch

Dialysis & Nephrology Digest - February 2025

Benesch on

A New Hope in Kidney Transplants: The Promise of Xenotransplantation - Joe’s struggle for a kidney transplant highlights a dire reality: donor shortages are leaving countless patients in limbo. Enter Dr. PK, a pioneering...more

BCLP

California Turns to the Use of AI in Healthcare

BCLP on

In another example of the patchwork of AI laws quietly coming into force across the US, California passed at the beginning of this year a new law regulating the use of certain AI technologies by some types of healthcare...more

Seyfarth Shaw LLP

Federal Lawsuit and Tri-Agency Report Shake Up Mental Health Parity

Seyfarth Shaw LLP on

On January 17, 2025, the U.S. Departments of Treasury, Labor and Health and Human Services (the “Agencies”) released its annual report to Congress assessing compliance with statutory mental health parity requirements under...more

Troutman Pepper Locke

RICO's Person/Enterprise Distinction - RICO Report Podcast

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Join Troutman Pepper Locke White Collar and Litigation Partner Cal Stein for a special podcast series, discussing the legal landscape surrounding the Racketeer Influenced and Corrupt Organizations Act (RICO). In this...more

Cozen O'Connor

Democratic AGs Secure Order Blocking Cuts to NIH-Funded Research Grants

Cozen O'Connor on

A group of 22 Democratic AGs obtained a temporary restraining order blocking Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates (Rate Change Notice), which would reduce to 15 percent all...more

Mintz

Mintz IRA Update — Duplicate Discounts Between the 340B Program & Medicare Drug Price Negotiation Program

Mintz on

The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more

Mintz

Mintz IRA Update — Operationalizing the Medicare Prescription Payment Plan and Medicare Inflation Rebate Program

Mintz on

In addition to the Part D Benefit Redesign, the IRA’s Medicare Prescription Payment Plan (MPPP) went into effect beginning January 1, 2025. The MPPP requires Part D Sponsors (PDPs) to allow Part D beneficiaries to pay for...more

Morris James LLP

Urgent Tuna Recall: Understanding the Botulism Risk

Morris James LLP on

A recent recall of certain canned tuna products sold at major retailers such as Costco, Trader Joe's, and Walmart has raised concerns about botulism, a rare but potentially fatal illness. The recall was issued due to a...more

McGuireWoods LLP

Proposal Would Introduce Approval Requirement on Healthcare Transactions in Indiana

McGuireWoods LLP on

On Jan. 21, 2025, Indiana legislators introduced a new bill in the Indiana House of Representatives targeting healthcare transaction reporting and healthcare provider ownership disclosures (the IN Bill). The IN Bill proposes...more

Cozen O'Connor

Pennsylvania Perspective for Thursday, February 13, 2025

Cozen O'Connor on

Gov. Shapiro Sues Trump Admin. Over $2B Federal Funding Freeze -Governor Josh Shapiro has filed a lawsuit against the Trump administration for allegedly withholding over $2 billion in federal funds from Pennsylvania, despite...more

Greenbaum, Rowe, Smith & Davis LLP

Criminalizing Reproductive Care and Abortion Services through Telehealth

The January 30, 2025 issue of the New England Journal of Medicine contains an article entitled “Providing Interstate Telehealth Abortion Services to Patients in Restrictive States.” In the second sentence, the authors write:...more

Foley & Lardner LLP

Understanding the Legal Pitfalls of Virtual Second Opinions: What You Need to Know

Foley & Lardner LLP on

Virtual medical second opinion (VSO) programs continue to roll out across the country, delivering expert recommendations to better help patients’ diagnoses or treatment options. These VSO programs can offer immense value to...more

Cozen O'Connor

Republican AGs Have Beef with Nutritional Standards Report

Cozen O'Connor on

Twenty-three Republican AGs submitted a comment letter to HHS and Department of Agriculture officials opposing aspects of the Scientific Report of the 2025 Dietary Guidelines Advisory Committee; the Dietary Guidelines are...more

Alston & Bird

False Claims Act FY 2024 Update: Increase in Overall Recoveries, Decrease in Whistleblower Awards – Constitutional Questions...

Alston & Bird on

Our False Claims Act Team highlights key FCA enforcement trends in 2024, including the continued focus on health care fraud by the Department of Justice (DOJ)....more

Polsinelli

CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices

Polsinelli on

Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...more

Arnall Golden Gregory LLP

Insights From the 2025 American Health Law Association’s Long Term and Post-Acute Care Law and Compliance Conference

This year, health lawyers, providers, consultants, and government experts from across the country convened in Orlando, Florida, for the American Health Law Association’s Long Term and Post-Acute Care Law and Compliance...more

Robins Kaplan LLP

New ANDA Cases - Winter 2024

Robins Kaplan LLP on

This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings...more

Troutman Pepper Locke

DOJ and 18 States Reach False Claims Act Settlement with QOL

Troutman Pepper Locke on

The U.S. Department of Justice (DOJ) and 18 state attorneys general (AG) announced a settlement with Boston-based QOL Medical, LLC (QOL) and its CEO, Frederick Cooper, to resolve allegations that the company provided unlawful...more

Wyrick Robbins Yates & Ponton LLP

First Lawsuit Filed under Washington’s My Health My Data Act

After Washington adopted the My Health My Data Act (MHMDA) almost two years ago, we and others predicted that the law would lead to a wave of private lawsuits against companies operating in or adjacent to the health space....more

Holland & Knight LLP

Holland & Knight Health Dose: February 11, 2025

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Knobbe Martens

Zimmer Biomet to Acquire Paragon 28

Knobbe Martens on

Zimmer Biomet recently announced entering a definitive agreement to acquire all outstanding common shares of Paragon 28. Under the agreement, Zimmer Biomet will pay $13.00 per share, valuing Paragon 28 at approximately $1.1...more

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