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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

Husch Blackwell LLP

Texas Attorney General Reaches Generative AI Settlement

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Keypoint: The Texas Attorney General reaches a first-of-its-kind settlement with a healthcare company that provides generative AI products. On September 18, 2024, the Texas Attorney General announced that it had reached a...more

Vicente LLP

Ongoing Delta-8 THC Legal Battle Moves to the Texas Supreme Court

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The Delta-8 THC ("D8") battle in Texas continues, with the arena now moving to the Texas Supreme Court. On August 21, 2024, the Texas Department of State Health Services (DSHS) filed an opening brief with the Texas Supreme...more

Harris Beach PLLC

Paging All Nurses – Wherever in the World You Are: Immigration Options for Foreign Nurses

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As hospitals and medical centers continue to face enormous challenges in staffing, employers are looking for alternatives to meet these seemingly unfillable positions. The high demand for foreign nurses has contributed to a...more

Foley & Lardner LLP

Medicare Advantage: A Circuit Court Addresses What is (or is not) Material in False Claims Act Cases

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Friday the 13th is not all bad luck. On September 13, 2024, the United States Court of Appeals for the Eighth Circuit’s published its much-anticipated decision in United States ex rel. Holt v. Medicare Medicaid Advisors,...more

Snell & Wilmer

Arizona Supreme Court Decides Cipro’s Black Box Warning Cannot Replace an Expert Opinion

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In Arizona, civil claims against health care professionals must be accompanied by a certified statement regarding whether “expert opinion testimony is necessary to prove the health care professional’s standard of care or...more

Brownstein Hyatt Farber Schreck

As Election Looms, Headwinds Brewing for Private Equity Health Care Dealmaking

As this fall’s election approaches, headwinds have been brewing in DC and state legislatures for private equity health care dealmaking, many of them with bipartisan support. While a key Senate committee scrutinized patient...more

Bennett Jones LLP

Proposed Changes to the Guidance on Recognized Standards for Medical Devices in Canada

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Changes affecting the approval of medical devices in Canada are coming. Health Canada has released a notice on Proposed Changes to the Guidance on Recognized Standards for Medical Devices along with a Draft List of Recognized...more

Foley & Lardner LLP

Final Mental Health Parity Rules – Top Five Changes to the Status Quo

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The Mental Health Parity and Addiction Equity Act and its implementing regulations and guidance (MHPAEA) prohibit health insurance policies and group health plans that cover mental health and substance use disorder (MH/SUD)...more

Troutman Pepper

Antitrust Considerations in Long-Term Care — Assisted Living and the Law Podcast

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Assisted Living and the Law, hosted by Troutman Pepper attorneys Cal Stein and Emma Trivax, offers timely insights and practical advice on navigating the complex and evolving legal landscape of the long-term care industry. ...more

Manatt, Phelps & Phillips, LLP

Biden Administration Finalizes Mental Health Parity Rules and Priorities

On September 9, the U.S. Departments of Labor, Health and Human Services, and the Treasury (collectively, the Departments) released a final rule to strengthen implementation of the Mental Health Parity and Addiction Equity...more

Sheppard Mullin Richter & Hampton LLP

Ubrelvy Untitled Letter – A Double Fault for AbbVie? Or Makeup Misread for FDA?

On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more

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