News & Analysis as of August 29, 2025

Healthcare

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Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms helping to make sense of insurance, employment, tax, securities, M&A, risk management, and every other consideration touched by this crisis. Follow the channel for a daily email brief of the latest and best updates. less -

RFK Jr., HHS Pull the Plug on Federal Funding for mRNA Vaccine Research and Development

ArentFox Schiff on 8/26/2025

On August 5, the US Department of Health and Human Services (HHS) announced a significant change in its vaccine development strategy, ending its support for mRNA vaccine projects under the Biomedical Advanced Research and...more

False Claims Act Settlements to Know from the First Half of 2025

Bass, Berry & Sims PLC on 8/12/2025

With the first half of 2025 in the rearview mirror, the government’s continued focus on False Claims Act (FCA) enforcement shows no signs of slowing. In fact, the Department of Justice recently announced the results of a...more

Regulatory Escalation in Pharma Sector: China Imposes First Executive Sanctions in a Cartel Case

Dacheng on 5/27/2025

On May 9, 2025, the Tianjin Municipal Administration for Market Regulation (“Tianjin AMR”) announced administrative penalties against four manufacturers of dexamethasone sodium phosphate (“DSP”) active pharmaceutical...more

Five Years Ago Today . . .

McDonnell Boehnen Hulbert & Berghoff LLP on 3/12/2025

On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," and cautioned that the WHO has "rung the alarm bell loud and clear." At...more

In Trump’s Second Term, Healthcare Enforcement May Remain Business as Usual

Lowenstein Sandler LLP on 1/6/2025

Compared with other issues, healthcare enforcement during President-elect Donald Trump’s upcoming second term has received little attention. When he takes office again on January 20, should industry actors like pharmaceutical...more

Hospital and Health Systems Reimbursement Check - NOVEMBER 2024

Ropes & Gray LLP on 11/5/2024

Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more

Pending DEA Extension on Prescription of Controlled Substances via Telemedicine

McDermott+ on 10/14/2024

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

Health Care Week in Review: House Committee on Oversight and Accountability Held a Hearing on PBMs; HHS Reorganizes Technology,...

Alston & Bird on 7/29/2024

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

Healthcare Preview for the Week of: June 3, 2024

McDermott+ on 6/4/2024

Congress is in session for three weeks in June and also will be session for three weeks in July before the August recess. This week we continue to see committee activity examining various aspects of the healthcare space....more

Rethinking Interchangeability, Top Cases, and Battling Misinformation at FDLI’s Annual Conference

Axinn, Veltrop & Harkrider LLP on 5/22/2024

1 Last week, the Food and Drug Law Institute held its Annual Conference while also celebrating its 75th anniversary. There, members of FDA and industry players gathered to discuss the latest legal, policy, and regulatory...more

Exploring the Virtual Care Policy Landscape One Year Post-PHE

McDermott+ on 5/15/2024

May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more

New Informed Consent Guidance and Pharmacy Immunity

McCarter & English, LLP on 4/11/2024

New guidance released by the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) on April 1, 2024, clarified that hospitals will not be eligible for Medicare or Medicaid...more

Healthcare Issues to Watch Following the FY2024 Spending Deal

Foley Hoag LLP on 4/9/2024

Six months into the fiscal year, Congress has finally passed FY2024 appropriations. It was a painstaking process, which many expected to include policy victories that both sides could celebrate. Instead, the spring work...more

12th Annual Healthcare Fraud & Abuse Review - A Critical Resource for Healthcare Providers

Bass, Berry & Sims PLC on 2/27/2024

We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

Key Takeaways From the 2024 J.P. Morgan Healthcare Conference

Ballard Spahr LLP on 1/22/2024

Ballard Spahr attorneys from the firm’s Life Sciences and Health Care Industry Teams were on the ground for the 42nd Annual J.P. Morgan Healthcare Conference (JPM24) from January 7-10. While still less crowded than...more

Navigating the Future of Pharmacy Law: Key Takeaways From the 2023 American Society of Pharmacy Law Conference

Troutman Pepper Locke on 12/1/2023

Earlier this month, the American Society of Pharmacy Law hosted its annual conference in San Antonio, TX. This gathering of industry leaders provided a unique opportunity to delve into the ever-evolving landscape of pharmacy...more

HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics

Robinson+Cole Health Law Diagnosis on 10/30/2023

On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA...more

HRSA Issues Notice Confirming 340B Registration Requirement

McDermott Will & Schulte on 10/30/2023

On October 26, the Health Resources and Services Administration (HRSA) published a Federal Register notice addressing the use of 340B drugs at off-campus hospital outpatient locations that have not yet appeared on a filed...more

McDermottPlus Check-Up: September 15, 2023

McDermott+ on 9/20/2023

CONGRESS - Senators Sanders and Marshall Release Bipartisan Primary Care and Health Workforce Act. Released on September 14, the legislation would reauthorize funding for a number of healthcare workforce programs that are...more

FDA Issues Final Guidance on Informed Consent in Clinical Investigations

McDermott Will & Schulte on 9/6/2023

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more

FDA to EPA: Pump the Brakes on New EtO Rules During Supply Chain Shortage

Goldberg Segalla on 8/11/2023

With COVID diagnoses spiking across the United States this summer, we cannot yet claim that the pandemic is behind us. In fact, we are still experiencing residual medical device and equipment shortages, which has caused...more

FDA Updates Medical Device Shortages List

Knobbe Martens on 7/28/2023

The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more

Healthcare Regulatory Check-Up Newsletter | May 2023 Recap

McDermott Will & Schulte on 6/23/2023

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for May 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA)...more

McDermottPlus Check-Up: May 19, 2023

McDermott+ on 5/19/2023

The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more

McDermottPlus Check-Up: May 12, 2023

McDermott+ on 5/12/2023

The House and Senate were both in session this week. The House Ways & Means Health Subcommittee met to discuss policies inhibiting innovation and patient access, and the House Energy & Commerce Health Subcommittee held a...more

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