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Arnall Golden Gregory LLP

Healthcare Authority Newsletter - December 2024 #3

News Briefs - Lawmakers Strike Deal to Extend Expiring Healthcare Programs - Lawmakers reached a deal to extend expiring healthcare programs, lobbyists close to the issue said. The package is more robust than lobbyists...more

Akerman LLP - HR Defense

Year-End Watch List: Possible Simplification to Employer Group Health Plan Reporting

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2024 might almost be over, but the Senate recently passed two bills that are intended to ease at least some employer burdens under the Patient Protection and Affordable Care Act (ACA) moving forward. The bills, both of which...more

Holland & Knight LLP

Holland & Knight Health Dose: December 17, 2024

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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

Sheppard Mullin Richter & Hampton LLP

Navigating Gainsharing Pitfalls in Value-Based Models

As the shift toward value-based care continues to transform the healthcare industry, hospitals and health systems are increasingly utilizing incentive-based physician compensation structures. Incentive-based compensation...more

Troutman Pepper

Takeaways From Texas AG’s Novel AI Health Settlement

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On Sept. 18, Texas Attorney General Ken Paxton announced a settlement with healthcare technology company Pieces Technology pursuant to the Texas Deceptive Trade Practices-Consumer Protection Act. Originally published in...more

Quarles & Brady LLP

Missouri’s New Year Resolution: New Prescription Delivery Requirements for Mail Order Pharmacies

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Effective December 30, 2024, significant revisions to the Missouri Board of Pharmacy’s Rule 20 CSR 2220-2.013 (Prescription Delivery Requirements) will kick in, introducing new patient safety measures for pharmacies that mail...more

Seyfarth Shaw LLP

The Year in Weed: 2024 Edition

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Welcome back to The Year In Weed, The Blunt Truth’s annual roundup of cannabis-related stories. As usual, I’ll adopt Dave Barry’s Year in Review (sadly, no longer available for free) format and look at stories month by...more

Greenbaum, Rowe, Smith & Davis LLP

The CMS Managed Care Final Rule: Access Standards, Consumer Surveys, Payment Standards and More for Managed Medicaid and CHIP

Greenbaum healthcare attorneys Neil M. Sullivan and Jennifer A. Belardo analyze the CMS’s Medicaid and Children’s Health Insurance Program (CHIP) Managed Care final rule – and its impact on states, healthcare providers, and...more

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

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As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

Quarles & Brady LLP

Compliance Eve Ends with HIPAA Reproductive Health Privacy Rule Order out of Texas: But is it a Gift or Lump of Coal for Regulated...

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December 23, 2024, was the compliance deadline for HIPAA covered entities and business associates to apply the protections of the HIPAA Privacy Rule to support Reproductive Health Care Privacy Final Rule—that is all covered...more

Goodwin

EMA’s CHMP Recommends Approval of Six New Biosimilars

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The European Medicines Agency’s (EMA) Committee for Medicinal Use Products (CHMP) recently recommended approval of six new biosimilars....more

Mintz - Health Care Viewpoints

California Health Care Legislative Update: Winter 2024

Governor Newsom signed over 1300 bills and vetoed almost 190 bills in 2024. Consistent with prior years, in 2024, California enacted multiple laws significantly impacting the health care industry. From artificial intelligence...more

Kohrman Jackson & Krantz LLP

Title IX Protections for LGBTQ+ Students: Legal and Mental Health Benefits

Title IX is a powerful federal law that protects students from sex-based discrimination and sexual harassment. If a school does not promptly investigate reports of sex discrimination or harassment, it can lose federal...more

Davis Wright Tremaine LLP

Effective Care: California Left Behind as Other States Expand Hospital at Home Programs

Hospital at Home (“HaH”) programs received renewed interest during the COVID-19 pandemic as a way to relieve hospital capacity issues and allow patients to receive effective care outside of the traditional hospital setting....more

Pietragallo Gordon Alfano Bosick & Raspanti,...

The Medicare Advantage Program: Public Money & Private Insurance Companies

When I investigated and litigated False Claims Act (FCA) cases at the U.S. Department of Justice (DOJ) over the last 10 years, I was often surprised by just how little I knew about the broad array of government agencies and...more

Wolf, Greenfield & Sacks, P.C.

CAFC Decision on Orange Book Listings for Drug/Device Combination Patents

On December 20th, 2024, the Court of Appeals for the Federal Circuit issued an important decision in Teva Branded Pharmaceutical Products R&D v. Amneal Pharmaceuticals that impacts Orange Book (OB) listings for patents...more

Brownstein Hyatt Farber Schreck

Bipartisan AI Task Force Report Sets the Stage for Health Care AI Action in 2025

The House Task Force on Artificial Intelligence (AI) released a comprehensive 253-page report providing a roadmap for Congress as it develops policies to regulate and optimize the use of this rapidly advancing technology. The...more

McDermott Will & Emery

FDA Seeks Comments on Updates to MoCRA Guidance on Registration, Listing of Cosmetic Product Facilities

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On December 11, 2024, the US Food and Drug Administration (FDA) updated its Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. As discussed in our previous On the Subject, FDA...more

Mayer Brown

IRS Annual Limits for Benefit Plans: 2025 Cost of Living Adjustments

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The US Internal Revenue Service (IRS) has released its 2025 cost-of-living adjustments applicable to employee benefit plans. A year-to-year comparison of limitations is below....more

DLA Piper

Case-Narrowing Decisions are a One-Way Street: Reviewing Exeltis USA v. Lupin Ltd.

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Exeltis USA, Inc. and other parties (Exeltis) recently prevailed against Lupin Ltd. and Lupin Pharmaceuticals, Inc. (Lupin) in a patent infringement suit brought in the District of Delaware. After a three-day bench trial, the...more

Venable LLP

Event in Review: Healthcare Services Licensure and Change of Ownership Issues

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Investment in the healthcare industry requires careful consideration, as it involves numerous distinct areas of the law. Venable's Private Equity Investment in Healthcare webinar series explores the unique issues and timely...more

Conn Maciel Carey LLP

Cal/OSHA Year End Roundup: Revised Silica Regulation Passes and More

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With 2024 coming to a close, here is a roundup of Cal/OSHA updates from the recent Standard Board meetings and Cal/OSHA’s triannual advisory committee meeting:...more

Burr & Forman

HHS OIG Launches Segment-Specific Compliance Guidance for Nursing Facilities

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On November 20, 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued the Nursing Facility Industry Segment-Specific Compliance Program Guidance (Nursing Facility ICPG). This...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: FCPA Enforcement

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Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the seventh episode of When Your Life Sciences Are on...more

Wilson Sonsini Goodrich & Rosati

Medicare Telehealth Flexibilities Extended Through March 2025

Certain telehealth flexibilities, including geographic requirements, have officially been extended. Just before midnight on Friday, December 20, 2024, by a vote of 366-34, the U.S. House of Representatives passed the American...more

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