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McDermott Will & Emery

FDA Gives Companies a New Way to Fight Misinformation

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Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2024 #4

News Briefs - Biden Places New Tariffs on Chinese Medtech Product Imports - The Biden administration announced its plan to increase tariffs on Chinese-made medical supplies as part of a broader push to tax imports from the...more

Ankura

Four Lessons for Health Systems From the Private Equity Playbook

Ankura on

The value of private equity (PE) deals in the healthcare sector has grown from <$2B in 2001 to $151 billion in deals in 2021. Barring government intervention, PE in healthcare is here to stay....more

Foley & Lardner LLP

FDA: New Draft Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

Foley & Lardner LLP on

On October 23, the U.S. Food and Drug Administration (FDA) issued draft guidance, Communication from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products on...more

Bass, Berry & Sims PLC

OIG Approves DME Manufacturer Loan Program in Latest Advisory Opinion

Bass, Berry & Sims PLC on

On June 23, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-13, approving an arrangement under which a durable medical equipment (DME) manufacturer...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Alston & Bird

Alston & Bird Health Care Week in Review - January 2022 #2

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

Goodwin

Alere Pays $198.75 Million to Settle False Claims for Allegedly Billing Medicare for Defective POC Devices, Not Charging Copays,...

Goodwin on

Alere Inc. and Alere San Diego Inc. (collectively “Alere”) have come under fire recently by the U.S. Department of Justice (“DOJ”) and other government agencies, agreeing to settle several rounds of accusations of False...more

Alston & Bird

COVID-19 Medical Products Supply Chain Week in Review – May 2021 #4

Alston & Bird on

In the past week, President Biden revealed a new plan to share COVID-19 vaccines with other countries, and the CDC allowed vaccination sites to prioritize vaccinations over minimizing waste; both actions reflect the...more

Oberheiden P.C.

With Latest COVID-19 Surge, Federal Officials Will Be Prepared to Combat PPE Fraud

Oberheiden P.C. on

When the COVID-19 crisis struck in early 2020, the immediate need for mass quantities of personal protective equipment (PPE) resulted in major supply shortages that made headlines across the country. As suppliers scrambled to...more

Seyfarth Shaw LLP

More Than a Game Changer: Fourth Amendment to PREP Act Declaration Establishes Federal Jurisdiction, Bolsters Immunities, and...

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On December 3, 2020, the U.S. Department of Health and Human Services (HHS) issued another groundbreaking amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). ...more

McDermott Will & Emery

Supporting Health Through Supply Chain Management

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On this episode of Leaders Moving 2020 Forward, Chaun Powell, Group Vice President, Strategic Supplier Engagement with Premier, Inc. is interviewed by Jennifer Geetter, a partner in McDermott Will & Emery’s Health practice....more

Womble Bond Dickinson

Emergency Use Authorization Issued for COVID-19 Antibody

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On November, 10, 2020, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the investigational neutralizing antibody bamlanivimab (Eli Lilly and Company, Indianapolis, IN) for the...more

Womble Bond Dickinson

Medical Rationing: Putting the Greatest Good to the Test?

Womble Bond Dickinson on

Medical rationing is not something Americans are accustomed to, but COVID-19 may soon change that. As local hospitals become overwhelmed with COVID-19 patients, they may reach the point where they have to make grim decisions...more

Epstein Becker & Green

Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast

Epstein Becker & Green on

This Diagnosing Health Care episode looks at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing...more

Robinson+Cole Data Privacy + Security Insider

Reinventing Supply Chains to Reach Patients in Remote Areas

Greater access to medicines and other health commodities (as well as timely delivery of test results) in remote areas could improve health outcomes and potentially save lives....more

Hogan Lovells

EU Commission adopts Communication on Brexit including anticipated changes in the health sector

Hogan Lovells on

On 9 July 2020 the European Commission adopted a Communication regarding readiness at the end of the transition period between the European Union and the United Kingdom. ...more

Hinshaw & Culbertson - The LHD/ERISA Advisor

The LHD/ERISA Advisor: Eighth Circuit Upholds Payment for Out-of-Network Air Ambulance Flight at 150 Percent of Medicare Rates

In Mitchell v. Blue Cross Blue Shield of N.D., 2020 U.S. App. LEXIS 8818 (8th Cir. Mar. 20, 2020), the Eighth Circuit upheld the payment of 150% of Medicare rates for an out-of-network air ambulance flight, although the...more

Holland & Hart LLP

Use of CARES Act Provider Relief Funds

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Healthcare providers who received or receive payments from the CARES Act Provider Relief Fund (“PRF”) may only use the payment for permissible purposes, must document and report the proper use, and return any excess funds to...more

Sheppard Mullin Richter & Hampton LLP

3D-Printed Masks, Disinfecting Devices, and Simplified Ventilators – a Sampling of Tech Advances in the Age of COVID-19 from...

The current COVID-19 environment has disrupted standard operations in nearly every industry and created fertile grounds for innovation. This is the first of a series of blog posts that will look at how industries have enabled...more

Society of Corporate Compliance and Ethics...

Who gets treated? The ethics of a health crisis

ethikos 34, no. 5 (May 2020) - Doctors around the world are facing choices that no one wants to make. As healthcare facilities run out of beds, supplies, ventilators, and drugs, doctors must “triage”—a term coined during...more

McGuireWoods LLP

OIG Responds to Physician Group COVID-19 Personal Protective Equipment Arrangement Inquiry

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As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement...more

Baker Donelson

Alabama Malpractice Liability and Immunities During COVID-19 Pandemic

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With the rapid and expansive spread of the COVID-19 pandemic, Alabama health care providers may face a shortage of critical supplies, including ventilators and dialysis machines, which would require difficult decisions...more

Akerman LLP

Summary of Healthcare Provisions in CARES Act

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The United States is experiencing an unprecedented shutdown affecting almost all aspects of life due to the current pandemic. To speed relief to the economy, on March 27, 2020, Congress enacted the Coronavirus Aid, Relief,...more

Mintz - Health Care Viewpoints

FDA Continues Its Diverse Agency Actions in Response to COVID-19 Pandemic

Since our last roundup-style blog post on the response of the Food and Drug Administration (FDA) to the COVID-19 public health emergency, the agency has taken a wide variety of additional actions with the goal of getting...more

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