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Manatt, Phelps & Phillips, LLP

CMS Guidance on Expectations for State Compliance with Medicaid and CHIP Renewal Requirements

On September 20, the Centers for Medicare & Medicaid Services (CMS) issued guidance detailing the timeline and expectations for states to fully comply with federal Medicaid and Children’s Health Insurance Program (CHIP)...more

Polsinelli

FDA Issues Exemptions from November 27, 2024 Compliance Deadline for Updated DSCSA Requirements

Polsinelli on

On Wednesday, the Food and Drug Administration (FDA) issued a statement granting additional exemptions from its November 27, 2024 deadline for compliance with certain product transaction requirements.  The exemptions followed...more

Marshall Dennehey

The Delaware Supreme Court Affirms Decision That a COVID-19 Workplace Exposure at a Poultry Processing Plant Did Not Qualify as a...

Marshall Dennehey on

Fowler v. Perdue, 2024 WL 3196775, --- A.3d --- (Del. June 24, 2024) - Mr. Fowler alleged that he suffered a compensable COVID-19 exposure while working as a “boxer” at a poultry processing plant. The Industrial Accident...more

Holland & Knight LLP

5 Key Antitrust Takeaways from Holland & Knight's Panel at Nashville Healthcare Sessions 2024

Holland & Knight LLP on

2024 has been an eventful year for federal and state antitrust enforcement in healthcare with many in the industry wondering where do we go from here in 2025. Holland & Knight sponsored a breakout panel discussion at the...more

McDermott+

McDermott+ Check-Up (Special Regulatory Edition): October 11, 2024

McDermott+ on

Congress Continues Election Recess. Members are on the campaign trail and are scheduled to return for the lame duck session on November 12, 2024. CMS Releases Proposed NBPP for 2026. The proposed Notice of Benefit and...more

McDermott+

Pending DEA Extension on Prescription of Controlled Substances via Telemedicine

McDermott+ on

A new rule posted on the Office of Management and Budget (OMB) registry suggests that the Drug Enforcement Administration (DEA) is planning an additional extension of COVID-19 flexibilities for telemedicine prescribing of...more

McDermott Will & Emery

MHRA Updates its Timeline for Medical Device Regulatory Changes in the UK

McDermott Will & Emery on

The MHRA recently published an update on its plans for MedTech regulatory change. The update confirmed that the new framework will be introduced through four statutory instruments to update and replace the UK Medical Devices...more

Holland & Knight LLP

Podcast - What’s Next After Gov. Gavin Newsom’s Veto in California?

Holland & Knight LLP on

In this episode of "Counsel That Cares," healthcare attorney John Saran and PitchBook Lead Healthcare Analyst Rebecca Springer, Ph.D., discuss the state of healthcare transaction laws and their future in 2025. Mr. Saran and...more

Akin Gump Strauss Hauer & Feld LLP

In Effort to Avoid Supply Chain Disruptions, FDA Extends DSCSA Exemptions

On October 9, the FDA announced that the agency is providing exemptions from the enhanced drug distribution security requirements of section 582 of the Federal Food, Drug and Cosmetic Act (FD&C Act) for eligible trading...more

Akin Gump Strauss Hauer & Feld LLP

FDA Publishes Digital Health and Artificial Intelligence Glossary

On September 26, 2024, FDA published a compilation of commonly used terms in the digital health, artificial intelligence (AI), and machine learning space and their definitions, available here. FDA intends the glossary to be...more

Bergeson & Campbell, P.C.

EFSA Publishes Reports under NAMs4NANO Project

The European Union (EU) Observatory for Nanomaterials (EUON) announced on September 26, 2024, that the European Food Safety Authority (EFSA) has published the following reports under its NAMs4NANO Project...more

Morgan Lewis

Shanghai’s 2024 Enforcement Framework on Healthcare Practices – Key Takeaways and How to Prepare

Morgan Lewis on

The Shanghai Health Commission, together with 13 other governmental authorities in Shanghai, jointly published on October 10, 2024 the Shanghai version of the 2024 Notice on Issuing the Key Points of Correcting Improper...more

DLA Piper

Food and Beverage News and Trends - October 2024

DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. California: Newsom signs three significant food bills. California Governor Gavin...more

Alston & Bird

Health Care Week in Review: CMS Publishes 2025 MA and Part D Star Ratings and Releases RFI on Medicare $2 Drug List Model

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Dentons

Yes, No, Maybe? Informed Consent in the Medical Environment

Dentons on

Informed consent remains critical in healthcare, and over the last several years, there have been multiple updates from agencies and commissions providing clarifications. Most recently in April 2024, Centers for Medicare &...more

JUSTICENTER

Are You Suffering from PTSD After a Car Accident?

JUSTICENTER on

A car accident can shake you to the core. While your body may heal, the mental impact can linger long after the crash. If you’re still feeling anxious or can’t get rid of those flashbacks, you might be dealing with...more

Buchalter

New Broad-Reaching Wage Law for Health Care Workers

Buchalter on

On October 16, 2024, Senate Bill 525 will go into effect and requires every applicable “covered health care facility” to meet certain minimum wage requirements for most of their workforces. The new law applies to a broad...more

ArentFox Schiff

Investigations Newsletter: US Supreme Court Declines to Consider AKS ‘Willfulness’ Question

ArentFox Schiff on

US Supreme Court Declines to Consider AKS ‘Willfulness’ Question - On October 7, the US Supreme Court denied a petition in which a whistleblower asked the Court to decide whether a “willful” act under the federal...more

Mintz - Health Care Viewpoints

Health Law Diagnosed – Women Leaders in Health Care: Investing in Women’s Health

In the latest episode of Health Law Diagnosed – Women Leaders in Health Care, a series that brings together women leaders for discussions on timely key issues and reflections on developing a career in the industry, host...more

K&L Gates LLP

The Wait Is Over: Revised CMS Enrollment Form Puts SNF Ownership and Management Under a Microscope

K&L Gates LLP on

With the release of an updated CMS-855A enrollment form (855A), skilled nursing facilities (SNFs) will be required to identify substantially more detailed ownership and control information to Centers for Medicare and Medicaid...more

Polsinelli

California's New Health Care Workers Minimum Wage is Finally Set to Increase

Polsinelli on

While California SB 525 was originally passed over a year ago, after several delays, it is scheduled to finally go into effect on October 16, 2024. The bill will raise the minimum wage for many health care employees in the...more

Faegre Drinker Biddle & Reath LLP

In re Taxotere (Docetaxel) MDL Court Rejects Plaintiffs’ Argument that Lone Pine Order is Unfair

We think Lone Pine orders are pretty fair. Lone Pine orders are case management orders that require plaintiffs in multidistrict litigation (MDL) to produce specific evidence without which the plaintiffs cannot make a prima...more

DLA Piper

FDA Outlines Its Proposed Process for Post-market Assessment of Chemicals in Food

DLA Piper on

At a public meeting on September 25, 2024, FDA discussed its proposed process for post-market assessment of chemicals in food. Deputy Commissioner Jim Jones opened the meeting to emphasize that food chemical safety is a top...more

Hissey, Mulderig & Friend, PLLC

Ozempic Weight Loss Users at Risk of Gastroparesis and Other Stomach Problems, New Study Reveals

A recent study published by the Journal of the American Medical Association (JAMA) found that patients taking the drugs Ozempic (semaglutide) and Wegovy (liraglutide) for weight loss were more than three-times more likely to...more

Holland & Knight LLP

The Future for AI Usage in California Healthcare Hinges on Governor's Indication of State Limits

Holland & Knight LLP on

With the surge of artificial intelligence (AI) development in recent years, state legislatures, including California's, have contemplated how to balance patient safety and quality of care with the need for and expectation of...more

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