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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

McDermott Will & Emery on

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

Mayer Brown on

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.

DLA Piper on

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

Venable LLP on

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

Conn Maciel Carey LLP on

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

Burr & Forman on

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

Morrison & Foerster LLP on

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

Epstein Becker & Green

CMS Rule for CY 2026 Highlights AI, Behavioral Health, Anti-Obesity Drug Coverage, and More

Epstein Becker & Green on

Closing out 2024, the Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule entitled “Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more

Dinsmore & Shohl LLP

New Ohio Law Tightens Mandatory Reporting Following Dr. Strauss Report

Dinsmore & Shohl LLP on

Legislation signed by Ohio Governor Mike DeWine on December 20, 2024 will significantly expand mandatory reporting duties for professionals and facilities. These changes, and others from Ohio Substitute Senate Bill 109, not...more

Morgan Lewis - As Prescribed

Congress Temporarily Extends Hospice Telehealth Face-to-Face Flexibility

US Congress on December 20, 2024 passed a last-minute temporary government funding bill that keeps the government open for three months. As part of this package, a number of existing telehealth flexibilities were also...more

Ankura

Beyond the Prescription: Ozempic's Influence on Health, Retail, and Consumer Behavior

Ankura on

Ozempic's meteoric rise has reshaped the landscape of healthcare, retail, and consumer behavior. Its initial popularity as a weight loss medication has sparked a broader conversation around health, wellness, and body image....more

ArentFox Schiff

Important Recent Developments in Massachusetts Affecting Assisted Living Residence Operators

ArentFox Schiff on

In November, we wrote about Massachusetts legislative and regulatory updates that impact both nursing homes and assisted living residences....more

Flaster Greenberg PC

Pennsylvanians Struggle To Strike Balance On Fracking Regulations

Flaster Greenberg PC on

By a 3-2 vote on November 11, the Board of Supervisors of Cecil Township in Western Pennsylvania increased the setback distance for fracking operations to 2,500 feet from protected structures like residences and businesses,...more

King & Spalding

Texas Sues Federal Government to Protect Medicaid Financing

King & Spalding on

On December 11, 2024, the Texas Health and Human Services Commission filed a complaint in the United States District Court for the Western District of Texas. The complaint seeks to block the enforcement of a May 9, 2014,...more

Proskauer - Health Care Law Brief

This New Year, California Imposes Guardrails on the Use of AI by Payors for Utilization Management Determinations

SB 1120 (the “Bill”), which takes effect on January 1, 2025, amends existing California law to adopt guardrails around the use of artificial intelligence tools for the purpose of utilization management. As discussed in a...more

Foley & Lardner LLP

Medicare Telehealth Flexibilities Get a Three-Month Lifeline

Foley & Lardner LLP on

After much uncertainty, Congress has extended many Medicare telehealth flexibilities through March 31, 2025, in its end-of-year appropriations bill. However, several important flexibilities, such as first-dollar coverage of...more

Array

This Week in eDiscovery: Survey on eDiscovery Growth | ‘Tis the Season for CLEs & More

Array on

This week’s post covers the period of December 15-20. Here’s what’s happening....more

Bodman

HIPAA and Reproductive Health: Certain Updates Take Effect December 23, 2024

Bodman on

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule regulations have been updated to impose additional requirements on covered entities to safeguard the privacy of reproductive health related...more

Akerman LLP - Health Law Rx

Don’t Be Suspicious, Don’t Be Suspicious: New OIG Special Fraud Alert Warns About Suspect Payments in Medicare Advantage Marketing...

The latest Special Fraud Alert from the U.S. Department of Health and Human Services Office of Inspector General (OIG) warns about marketing schemes involving questionable payments and referrals among Medicare Advantage...more

Holland & Knight LLP

HHS Finalizes Key Information Blocking Exceptions

Holland & Knight LLP on

The finalization of information blocking exceptions were announced just in the "St. Nick" of time by the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy (ASTP), formerly known as...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit: Patent Must Claim Active Ingredient for Orange Book Listing

On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more

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