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K&L Gates LLP

Directors and Officers of Retirement Villages in Western Australia–The Retirement Villages Amendment Bill 2024 Materially...

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The changes in Western Australia to the Retirement Villages Act 1992 (WA) (RV Act) that have been passed by the State Parliament and known as the Retirement Villages Amendment Bill 2024 (RV Bill) have been more than a decade...more

Holland & Knight LLP

HHS OHRP Amends Protections of Human Research Subjects Rule for Specified Populations

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The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services on Oct. 25, 2024, issued nonsubstantive amendments to subparts B, C and D of 45 CFR Part 46, which provide additional...more

Holland & Knight LLP

CMS Releases CY 2025 Medicare Physician Fee Schedule Final Rule

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The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2024, released the calendar year (CY) 2025 Revisions to Payment Policies under the Physician Fee Schedule (MPFS) and Other Revisions to Medicare Part B...more

Robins Kaplan LLP

Allergan Holdings Unlimited Co. v. MSN Labs. Private Ltd. - Viberzi® (eluxadoline)

Robins Kaplan LLP on

Case Name: Allergan Holdings Unlimited Co. v. MSN Labs. Private Ltd., Civ. No. 23-794-RGA, 2024 WL 3444368 (D. Del. July 17, 2024) (Andrews, J.)....more

McDermott Will & Emery

This Week in 340B: November 5 – 11, 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

Foley Hoag LLP - Cannabis and the Law

Trump Tabs Controversial Florida Congressman as Attorney General Nominee

In perhaps his most controversial cabinet appointment yet, earlier today, President-elect Trump said he would nominate Florida Rep. Matt Gaetz as U.S. Attorney General. Although Gaetz’s nomination was met with skepticism by...more

McDermott Will & Emery

Five Questions With a Life Sciences Lawyer: Michael Ryan

McDermott Will & Emery on

What is your favorite part about practicing life sciences law at McDermott? Clients come to us with difficult questions that require not just a command of the law, but an in-depth understanding of their business – and in some...more

Hogan Lovells

FDA now recommends only one study to show bioequivalence for certain oral drug products - FDA also revises several hundred product...

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The U.S. Food and Drug Administration (FDA) issued final guidance on “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which provides advice on conducting bioequivalence (BE) studies – during both...more

McDermott+

Another Trip to the Buffet: Highlights from the CY 2025 OPPS Final Reg

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As mentioned last week, the Centers for Medicare & Medicaid Services (CMS) recently put out a large buffet of regs – too many to digest in one blog post. While we focused on the Calendar Year (CY) 2025 Physician Fee Schedule...more

Hogan Lovells

FDA Advisory Committee outlines informed consent best practices

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The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed consent practices. Below, we summarize key takeaways from the meeting, including a...more

DLA Piper

FDA Responds to Objections Over Phthalates in Food Packaging

DLA Piper on

On October 29, 2024, the US Food and Drug Administration (FDA) provided an Update on Phthalates in Food Packaging and Food Contact Applications (the Update), affirming its 2022 Final Rule to remove 25 plasticizers in various...more

Epstein Becker & Green

Telemental Health Laws: 2024 Overview

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Since 2016, Epstein Becker Green (EBG) attorneys have researched, compiled, and analyzed state-specific content relating to the regulatory requirements for professional mental/behavioral health practitioners and stakeholders...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - December 6th, Lafayette, CA

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Sheppard Mullin Richter & Hampton LLP

California Votes to Impose 340B Spending Restrictions on Targeted 340B Providers

California is poised to pass a ballot measure aimed at imposing 340B spending restrictions for certain healthcare entities participating in the 340B Program who have historically engaged in spending that is not directly...more

Mintz - Employment Viewpoints

Fertility Related Loss To Be Covered Under the Massachusetts Earned Sick Time Act

Effective November 21, 2024, Massachusetts employees may take earned sick time to “address the employee’s own physical and mental health needs, and those of their spouse, if the employee or the employee’s spouse experiences...more

Shook, Hardy & Bacon L.L.P.

Bill Banning Weight Loss Supplement Sales to Minors Passes NJ Assembly - Dietary Supplement & Cosmetics Legal Bulletin

The New Jersey General Assembly has passed a bill that would prohibit the sale of certain diet pills and dietary supplements for weight loss or muscle building to those under 18. AB 1848...more

Proskauer Rose LLP

How Expanded Birth Control Coverage May Affect Employers

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The U.S. Departments of Labor, Treasury, and Health and Human Services proposed regulations last month that would expand group health plans' required coverage of preventive services and contraceptives. Originally published...more

Health Care Compliance Association (HCCA)

Recognized Security Practices ‘Saved’ Covered Entity $60K of $300K Fine, But Which Ones Remain a Mystery

Covered entities (CEs) and business associates (BAs) may receive a “discount” for having recognized security practices (RSPs) in place when the HHS Office for Civil Rights (OCR) calculates financial penalties for Security...more

Health Care Compliance Association (HCCA)

Privacy Briefs: November 2024

Change Healthcare Inc. has amended its initial breach report to the HHS Office for Civil Rights (OCR) to state that 100 million individuals were impacted by its mammoth ransomware attack and breach. However, as of Oct. 24,...more

Stinson - Benefits Notes Blog

Annual Limits on Qualified Plans for 2025

On November 1, 2024, the Internal Revenue Service (IRS) released Notice 2024-80, which sets forth the 2025 cost-of-living adjustments affecting dollar limits on benefits and contributions for qualified retirement plans. The...more

McDermott+

Healthcare Preview for the Week of: November 12, 2024

McDermott+ on

Election Day 2024 has come and gone. Republicans have all but officially achieved a trifecta – control of the White House, Senate, and House of Representatives. Both the House and Senate return today for the lame duck...more

Dickinson Wright

Final Rules Released: What They Mean for Mental Health and Substance Use Disorder Benefits

Dickinson Wright on

Previously published in Healthcare News and Healthcare Michigan - On Sept. 9, 2024, the Departments of Health and Human Services, Labor, and the Treasury (collectively “the Departments”) released final rules strengthening and...more

Holland & Knight LLP

Illinois Dental Practices Face New Third-Party Financing Guardrails in 2025

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In August, Illinois Gov. J.B. Pritzker signed into law HB 4891 that amends the Illinois Dental Practice Act to include significant guardrails for dental practices looking to offer third-party financing in dental offices in...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - December 6th, Houston, TX

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Holland & Knight LLP

Final Medicare Overpayment Rules a Mixed Bag for Providers

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The Centers for Medicare & Medicaid Services (CMS) released highly anticipated updates this month to the Medicare regulations interpreting the federal 60-day overpayment refund requirement (the Overpayment Statute). The...more

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