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K&L Gates LLP

The Wait Is Over: Revised CMS Enrollment Form Puts SNF Ownership and Management Under a Microscope

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With the release of an updated CMS-855A enrollment form (855A), skilled nursing facilities (SNFs) will be required to identify substantially more detailed ownership and control information to Centers for Medicare and Medicaid...more

Polsinelli

California's New Health Care Workers Minimum Wage is Finally Set to Increase

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While California SB 525 was originally passed over a year ago, after several delays, it is scheduled to finally go into effect on October 16, 2024. The bill will raise the minimum wage for many health care employees in the...more

Faegre Drinker Biddle & Reath LLP

In re Taxotere (Docetaxel) MDL Court Rejects Plaintiffs’ Argument that Lone Pine Order is Unfair

We think Lone Pine orders are pretty fair. Lone Pine orders are case management orders that require plaintiffs in multidistrict litigation (MDL) to produce specific evidence without which the plaintiffs cannot make a prima...more

DLA Piper

FDA Outlines Its Proposed Process for Post-market Assessment of Chemicals in Food

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At a public meeting on September 25, 2024, FDA discussed its proposed process for post-market assessment of chemicals in food. Deputy Commissioner Jim Jones opened the meeting to emphasize that food chemical safety is a top...more

Hissey, Mulderig & Friend, PLLC

Ozempic Weight Loss Users at Risk of Gastroparesis and Other Stomach Problems, New Study Reveals

A recent study published by the Journal of the American Medical Association (JAMA) found that patients taking the drugs Ozempic (semaglutide) and Wegovy (liraglutide) for weight loss were more than three-times more likely to...more

Holland & Knight LLP

The Future for AI Usage in California Healthcare Hinges on Governor's Indication of State Limits

Holland & Knight LLP on

With the surge of artificial intelligence (AI) development in recent years, state legislatures, including California's, have contemplated how to balance patient safety and quality of care with the need for and expectation of...more

Baker Donelson

The Office for Civil Rights Recently Settled Two Ransomware Related Investigations

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The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently settled two ransomware cases with covered entities. These cases signal the government's growing concern with health care...more

Arnall Golden Gregory LLP

A Potential Poison Pill for Dosage Claims

On August 14, 2024, the US District Court for the District of Delaware entered final judgment in Wyeth—a patent infringement case relating to pharmaceuticals for treating non-small cell lung cancer (“NSCLC”)—vacating a jury...more

Fox Rothschild LLP

CMS to Require All Skilled Nursing Facilities to Complete Off-Cycle Revalidation

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The Centers for Medicare & Medicaid Services (CMS) recently announced it will require off-cycle revalidation of skilled nursing facilities (SNFs) through the end of 2024. During this process, CMS will collect ownership,...more

Cozen O'Connor

Broad Street Brief: City Wellness Facility to Open This Fall

Cozen O'Connor on

During Thursday’s meeting, City Council voted to create a new Special Committee on Enhancing Efficiency & Transparency in Municipal Services and call on the state to ban the use of rental software that utilizes...more

Quarles & Brady LLP

Happy Halloween: RIP to the HIPAA Privacy Rule?

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As we settle into spooky season, let’s take a minute to consider a recent development in health care privacy as we ask ourselves, is this a trick or a treat?...more

Quarles & Brady LLP

FDA Issues Broad Exemptions from DSCSA Enhanced Drug Distribution Security Requirements

Quarles & Brady LLP on

On October 9, 2024, the Food and Drug Administration (“FDA”) issued a document that provides exemptions to the enhanced drug distribution security requirements (enhanced requirements) required by section 582(g) of the Food,...more

McDermott+

CMMI’s Accountable Care Strategy: A Perspective

McDermott+ on

McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts. October 10, 2024 – For several years, the Center for Medicare & Medicaid...more

McDermott Will & Emery

This Week in 340B: October 1 – 7, 2024

McDermott Will & Emery on

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

McAfee & Taft

Gavel to Gavel: What will legislature do about private equity in healthcare?

McAfee & Taft on

State legislatures across the country are beginning to consider and debate the pros and cons of passing laws aimed at regulating private equity’s role in the healthcare industry. According to an article in the Wall Street...more

Stevens & Lee

Intent Required Under the Anti-Kickback Statute: Supreme Court Lets Stand Second Circuit’s Decision in the McKesson Case

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On Oct. 7, the U.S. Supreme Court denied a petition for review and let stand a widely watched Second Circuit Court of Appeals decision in which the court ruled that the term “willfully” as used in the Anti-Kickback Statute...more

Fenwick & West LLP

Heart of Healthcare Podcast: FTC Chair Lina Khan on Healthcare, Antitrust, and the Future of Competition

Fenwick & West LLP on

In a recent episode of the Heart of Healthcare podcast, co-hosts Michael T. Esquivel and Halle Tecco, sat down with Federal Trade Commission (FTC) Chair Lina Khan, who offered her perspective on the intersection of antitrust...more

King & Spalding

OIG Report Concludes That CMS Needs to Strengthen its Oversight of Remote Patient Monitoring

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On September 24, 2024, OIG released a report recommending that CMS exercise additional oversight of remote patient monitoring (RPM) services provided to Medicare beneficiaries. Medicare reimburses RPM for any chronic or acute...more

Foley & Lardner LLP

USC Announces Stem Cell Collaboration

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Treatment and prevention of heart failure are unmet medical needs in the United States. One in every eight deaths in the United States can be linked to this disease. The Keck School of Medicine at USC and the biotechnology...more

Fisher Phillips

Open Enrollment Season in the Workplace: 5 Legal Considerations + Employer Takeaways

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Open enrollment season can put a spotlight on the many complex rules applicable to employer-sponsored health and welfare plans. As you announce your benefit offerings for the upcoming plan year and tirelessly work to inform...more

Baker Botts L.L.P.

California Extends Privacy Law to Cover Neural Data

Baker Botts L.L.P. on

On September 29, 2024, California took a significant step forward in data privacy protection by passing a law that extends the California Consumer Privacy Act (CCPA) to cover neural data—brain activity and related information...more

Morgan Lewis

February 2, 2026 Is Quickly Approaching—Are You QMSR Ready?

Morgan Lewis on

With the February 2, 2026 compliance deadline approaching, medical device manufacturers must prepare for FDA’s updated regulations. The new Quality Management System Regulation (QMSR) will replace the existing Quality System...more

Vinson & Elkins LLP

Supreme Court Declines to Revisit Limitations on Anti-Kickback Statute: What This Means for Enforcement of Corruption, Kickbacks...

Vinson & Elkins LLP on

On October 7, 2024, the U.S. Supreme Court declined to hear a case concerning the “willfulness” element of the Anti-Kickback Statute (the “AKS”). This decision leaves intact a recent Second Circuit holding, which established...more

Cozen O'Connor

Multistate Coalition Settles False Claims Allegations with Precision Diagnostics

Cozen O'Connor on

A multistate coalition of 44 AGs and the U.S. Department of Justice settled with Precision Toxicology, LLC d/b/a Precision Diagnostics, Inc. (Precision) to resolve allegations that it made false claims to multiple federal...more

BakerHostetler

Make no mistake, pharmacies can still deliver controlled substances to patients

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Under the federal Controlled Substances Act (CSA) and the Drug Enforcement Administration’s (DEA) implementing regulations, pharmacies must deliver controlled substances to the ultimate user. Common sense, as well as DEA’s...more

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