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Health Tax

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
Arnall Golden Gregory LLP

Rock You Like a Migraine: OPDP Issues Notice of Violation for Misleading Representations in TV Ad That Promoted Popular Migraine...

In 1984, the international rock band, The Scorpions, released the song, “Rock You Like a Hurricane.” Forty years later, the Food and Drug Administration’s Office of Prescription Drug Promotion rocked a pharmaceutical company...more

Goodwin

Antitrust & Competition Healthcare Quarterly Update Q2 2024

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In the second quarter, federal and state antitrust enforcers continued their intense scrutiny of consolidation in the healthcare market by implementing new initiatives and laws designed to gather additional information...more

Foley Hoag LLP - Security, Privacy and the...

The Health Sector Cybersecurity Coordination Center’s September 19 Threat Briefing on Healthcare Technology Security

As healthcare technology continues to evolve, so does the need for robust compliance strategies to safeguard patient information and ensure the integrity of medical devices. In a joint September 19, 2024 presentation, the...more

Bradley Arant Boult Cummings LLP

Alabama CON Report - September 2024

AL2024-006, The Health Care Authority of the City of Hoover d/b/a Riverwalk Health and Wellness Center, Shelby County, AL: Proposes to develop a freestanding, non-hospital-based multi-specialty ambulatory surgery center (ASC)...more

Blank Rome LLP

Tech-enabled Services in Healthcare – Challenges and Opportunities with Artificial Intelligence and Machine Learning

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In this episode of BRight Minds in Healthcare Delivery, Blank Rome partner Alex C. Nisenbaum talks with Rajni Natesan, MD, MBA, Chief Executive Officer of Clarified Precision Medicine, about how technology is rapidly changing...more

Fox Rothschild LLP

New Jersey Regulates Intoxicating Hemp Products

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Businesses selling intoxicating hemp products in New Jersey without a cannabis license could soon face significant fines. Governor Phil Murphy signed Senate Bill No. 3235 on Sept. 12, 2024, regulating intoxicating hemp...more

Constangy, Brooks, Smith & Prophete, LLP

FMLA abuse: 5 things this employer did right

How'd that happen? An employer who terminated an employee after he took intermittent FMLA leave for diabetes won its case, and recently won again on appeal. According to both courts, the employee appeared to be trying to...more

Health Care Compliance Association (HCCA)

Privacy Briefs: September 202

The HHS Centers for Medicare & Medicaid Services (CMS) and Wisconsin Physicians Service Insurance Corporation (WPS) are notifying 946,801 people whose protected health information or other personally identifiable information...more

Whiteford

California Department of Public Health's (CDPH) Limits On CRNA Scope of Practice Reminds Hospitals Nationwide to Revisit...

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The California Department of Public Health (CDPH) issued a letter on September 6, 2024, to all general acute care hospitals clarifying the scope of practice for Certified Registered Nurse Anesthetists (CRNAs) following...more

Burr & Forman

Federal Agency Deference Eliminated, Now What?

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On June 28, 2024, the U.S. Supreme Court issued a decision that overrules the “Chevron doctrine.”  This means that federal agencies are limited in their ability to rely on their own interpretation of the laws they...more

The Volkov Law Group

Oak Street Health Pays $60 Million to Resolve False Claims Act Violations

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Federal whistleblowers have been exposing health care fraud for years.  The False Claims Act (“FCA”) contains robust whistleblower provisions and protections that reward whistleblowers with financial payouts. The process for...more

McDermott+

Responses to the PFS Proposed Reg Are In: 10 Major Comments

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McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts. September 19, 2024 – Comments on the calendar year (CY) 2025 physician fee...more

Bass, Berry & Sims PLC

More Losses than Gains? OIG Declines to Approve Certain Medicare Advantage Gainsharing Arrangements in Advisory Opinion 24-08

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On September 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 24-08, in which it declined to approve a proposal by a Medicare Advantage organization (MAO)...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 5, September 2024

Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the Biden administration's proposed insurance rule regarding mental health and substance use...more

A&O Shearman

Complaint Against Health Company Sufficiently Pleads Non-Interchangeability Of Emergency Room And Urgent Care Services

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On September 5, 2024, the United States District Court for the Middle District of Florida denied Health First, Inc.’s motion to dismiss plaintiffs’ amended complaint in a class action lawsuit alleging monopolization and...more

McDermott Will & Emery

This Week in 340B: September 10 – 16, 2024

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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

Bradley Arant Boult Cummings LLP

DEA Announces Marijuana Rescheduling Hearing Following Elections and the Stakes Are Hugely Consequential

There’s a great scene towards the end of The Shawshank Redemption – which Budding Trend readers know is one of the greatest films ever made – where the character played by Tim Robbins encourages the Morgan Freeman character:...more

Knobbe Martens

Test Anxiety: FDA Issues Warning Letters to Test Laboratories

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The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories for “oversight failures and animal care violations that raise concerns...more

McDonnell Boehnen Hulbert & Berghoff LLP

Astellas Pharma, Inc. v. Sandoz Inc. (Fed. Cir. 2024)

One of the anticipated consequences of the Supreme Court's Loper decision is that it will unleash judges to impose their statutory interpretations of administrative agencies' applications of the law within their areas of...more

Health Care Compliance Association (HCCA)

The CMS Interoperability and Prior Authorization Rules

Healthcare lives on data. Getting it to the patient and providers is essential for delivering quality care, but that can be a challenge. As Eden Avraham-Katz, Vice President, Legal and Compliance at 1upHealth explains in...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

What the Final Mental Health Parity Rules Mean for Employers

The wait is over, and now the work begins for health plan sponsors. Much-anticipated final rules implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) were...more

Baker Botts L.L.P.

23andMe’s $30M Settlement: What It Means for Companies Handling Genetic and Genomic Data

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The recent $30 million settlement between 23andMe and 6.4 million users following a major data breach offers important lessons for businesses dealing with sensitive genetic and genomic information....more

Keating Muething & Klekamp PLL

Benefits Monthly Minute - September 2024

The September Monthly Minute highlights the DOL’s extension of existing cybersecurity guidance to health and welfare plans and also addresses the new HIPAA reproductive health privacy rule....more

Goodwin

Celltrion Wins Brazilian Federal Tender for Trastuzumab for Fifth Consecutive Year

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On September 13, 2024, Celltrion announced that its Brazilian subsidiary won the Federal Government of Brazil’s bid to supply HERZUMA (trastuzumab-pkrb) for the fifth consecutive year, with around 660,000 vials to be...more

MG+M The Law Firm

The Chevron Ruling Shake Up: US Air Force Avoids PFAS Water Clean Up

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The overturning of the “Chevron Doctrine” is already making waves. The US Air Force is refusing to comply with an EPA clean-up order, claiming federal regulators lack authority. In brief, here is the timeline of events: •...more

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