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McDermott Will & Emery

Trending in Telehealth: August 26 – September 17, 2024

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Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more

McDermott+

McDermott+ Check-Up: September 20, 2024

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Senate Judiciary Human Rights and the Law Subcommittee Holds Hearing on Georgia Abortion Ban. The field hearing examined how Georgia’s abortion ban impacts women’s health, and featured patient and physician witnesses. ...more

Hogan Lovells

New FDA clinical trials guidances promote efficient drug development, innovative designs, diversity

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The U.S. Food and Drug Administration (FDA) issued this week three guidance documents related to clinical trials: a draft guidance on multiregional trials in oncology, a draft guidance on integrating randomized controlled...more

Benesch

CMS Announces a Second Preview Period for the October 2024 SNF Preview Reports

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On September 19, 2024, CMS announced a second preview period for the October 2024 SNF Preview Reports (“Preview Reports”) following the identification of a technical glitch that prevented the posting of these reports for...more

Orrick, Herrington & Sutcliffe LLP

Generative AI and Health Care: Key Takeaways

Generative AI is converging with every sector – and health care is no exception. With it, companies should keep up with the array of laws and regulations – existing and envisioned – that govern its use. Read on for highlights...more

Jackson Lewis P.C.

From Fentanyl to Freon: Customs and Border Protection Seizures

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Customs and Border Protection (CBP) is an enforcement agency that does much more than deal with immigration. This summer, CBP made the largest fentanyl seizure in its history – approximately 4 million blue fentanyl pills...more

Alston & Bird

Health Care Week in Review: House Energy & Commerce Committee Held a Markup of 16 Bills; HRSA Demands Johnson & Johnson Cease 340B...

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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

Hendershot Cowart P.C.

FTC Advertising Compliance for Med Spas, IV Hydration

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The Federal Trade Commission (FTC) has broad authority over marketing and advertising, including for medical spas and other healthcare businesses. While there aren't specific regulations tailored solely to med spas or...more

DLA Piper

Amarin v. Hikma: Defining the Limits of Protection That Skinny Labels Afford

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On August 22, 2024, Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals, PLC (collectively Hikma), filed a petition for rehearing en banc, asking the US Court of Appeals for the Federal Circuit to reconsider its recent...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - September 2024 #2

News Briefs - Licensure Compact Aims to Allow PAs to Practice in Other States - By 2028, the nation as a whole will be short some 100,000 critical health care workers, according to a new report....more

Manatt, Phelps & Phillips, LLP

House Passes BIOSECURE Act

As part of the House’s “China Week”—focusing on legislation to curb threats from Beijing—the House passed the BIOSECURE Act (H.R. 8333) on September 9 with strong bipartisan support (in a 306–81 vote). If signed into law,...more

Akerman LLP - Health Law Rx

MHPAEA Final Rule: Clarity on Mental Health Parity?

The three federal agencies tasked with enforcement of the Mental Health Parity and Addiction Equity Act (MHPAEA) — the Departments of Labor, Health & Human Services (through CMS), and Treasury (the Departments) — issued their...more

Nelson Mullins Riley & Scarborough LLP

Avoid NC Medical Board Scrutiny of Your Medical Spa

The North Carolina Medical Board ("Board") recently issued a guidance document describing a situation involving a physician serving as the medical director of a medical spa, where the medical spa is owned by a non-licensee....more

Holland & Knight LLP

Holland Knight Health Dose: September 17, 2024

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Holland & Knight Health Dose Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

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

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