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Alston & Bird

Health Plan Impact of HHS’s Proposed HIPAA Security Rule Update

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Our Employee Benefits & Executive Compensation Group highlights the HIPAA Security Rule’s proposed new compliance requirements for health plans, plan sponsors, and their business associates....more

Troutman Pepper Locke

2025 SCOPE Conference Emphasizes AI and Better Technologies to Improve Patient Outcomes

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The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more

Troutman Pepper Locke

Cardiology Monopolization Case Confirms Antitrust Laws Protect Competition, Not Competitors

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Confirming the bedrock principle that the antitrust laws are designed to protect competition and not individual competitors, a federal court put an end to a legal turf war over the cardiology market in Laredo, TX on January...more

Seyfarth Shaw LLP

Executive Order on Health Care Access for Gender-Affirming Treatments for Minors

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Following through on a campaign theme focused on transgender issues and access to gender-affirming health care, on Friday, January 28, President Trump signed an Executive Order, titled “Protecting Children from Chemical and...more

Robins Kaplan LLP

Generic Launches - Winter 2024

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This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more

Parker Poe Adams & Bernstein LLP

How the Centers for Medicare and Medicaid Services 2025 Payment System Final Rule Impacts Ambulatory Surgical Centers

On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the 2025 hospital outpatient prospective payment system and ambulatory surgical centers (ASC) rule. The rule updates Medicare payment rates for...more

Holland & Knight LLP

Massachusetts District Court Temporarily Blocks NIH Research Funding Cut

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A Massachusetts federal judge has issued a temporary restraining order preventing the implementation and enforcement of the National Institutes of Health's (NIH) research funding cut (NOT-OD-25-086) (the Rate Change Notice)....more

Jenner & Block

California Sunsets Majority of Non-Emergency Workplace COVID-19 Requirements

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When the California Division of Occupational Safety and Health (“Cal/OSHA”) non-emergency COVID-19 prevention regulations took effect on February 3, 2023, they did so with a future sunset date of February 3, 2025, unless...more

Bass, Berry & Sims PLC

Can the NIH Cap Indirect Cost Rates at 15%?

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On February 7, the National Institutes of Health (NIH) issued Supplemental Guidance to its 2024 NIH Grants Policy Statement, Indirect Cost Rates, purporting to cap indirect cost (also called facilities and administration,...more

McDermott Will & Emery

New York Executive Budget Proposes Amendments to MCO Provider Tax

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The New York State Executive Budget for Fiscal Year (FY) 2026 proposes significant updates to the managed care organization (MCO) provider tax, aiming to enhance Medicaid funding through innovative financial strategies. The...more

Bradley Arant Boult Cummings LLP

Half-Baked: Proposal to Reform Alabama Medical Cannabis Licensing Seems Poised to Go Up in Smoke

Advocates and stakeholders in the medical cannabis world of Alabama are desperate. And as it is so often when we are faced with a desperate situation, we make well-intentioned but ultimately flawed decisions....more

Faegre Drinker Biddle & Reath LLP

10-for-1 Deregulation Executive Order: Key Health Policy Issues to Watch

On January 31, 2025, President Trump signed Executive Order 14192 which is formally titled, “Unleashing Prosperity Through Deregulation,” but could gain notoriety as the “10 for 1 Order.” The Order has several parallels to a...more

Cooley LLP

FDA Publishes Rule Updating ‘Healthy’ Nutrient Content Claim

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On December 27, 2024, the US Food and Drug Administration (FDA) published its final rule to update the definition for “healthy” claims on food labels. The new rule uses current nutrition science to both expand and restrict...more

Morgan Lewis

US Administration Signals Potential Changes to Inflation Reduction Act Drug Price Negotiations

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In what appears to be a response to manufacturer complaints regarding “black box” Inflation Reduction Act (IRA) drug price negotiations, the US administration issued a statement on January 29, 2025, stating it planned to...more

Morrison & Foerster LLP

China Issues First Compliance Guidelines to Combat Commercial Bribery Risks - UPDATED February 2025

On January 10, 2025, China’s State Administration for Market Regulation (“SAMR”) put into effect its Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Compliance Guidelines”)....more

Cozen O'Connor

Illinois Insights: An update from Cozen O'Connor (2/10)

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Judge declines to extend ‘swipe fee’ injunction to credit unions, applies it to out-of-state banks - “A federal judge on Thursday declined to issue an injunction to stop an Illinois law that bans certain credit card fees...more

Mintz - Health Care Viewpoints

PBM Policy and Legislative Update — Winter 2025

The PBM regulatory landscape is rapidly evolving at both federal and state levels, making it critical for our clients involved in the PBM space to stay apprised of developments in the industry as they happen. Our team...more

Morgan Lewis

Manufacturers Challenge CMS’s Definitions of ‘QSSD’ and ‘Bona Fide Marketing'

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Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price negotiation provisions. Recently filed suits contend that CMS has impermissibly expanded...more

Morgan Lewis - As Prescribed

FCA Enforcement Risk Remains for Rare Disease Stakeholders

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

Cozen O'Connor

Pennsylvania Perspective for Monday, February 10, 2025

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Gov. Shapiro’s Prison Closure Plan Sparks Debate Over Savings, Community Impact - Governor Josh Shapiro's proposal to close two Pennsylvania prisons and two community corrections centers aims to save $110 million annually,...more

Polsinelli

Monday Morning (Advertising) Quarterback – Unprecedented Hims & Hers Super Bowl Ad Has Legislators Concerned

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The Super Bowl is not just the biggest game of the year for football fans, but it is also one of advertising’s biggest nights. Therefore, the FDA lawyers at Polsinelli were not only tuned in to root for the Kansas City Chiefs...more

Epstein Becker & Green

The NIH IDC – Where Are We Now

Epstein Becker & Green on

On February 7, the National Institutes of Health (“NIH”) issued a Notice (NOT-OD-25-068) entitled “Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates” (the “Notice”), though which NIH announced...more

Troutman Pepper Locke

A Need for Balance – How SB25-076’s Requirements Could Hurt Licensed Cannabis Businesses in Colorado

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On January 22, lawmakers in Colorado introduced SB25-076, (the act) which aims to address concerns surrounding the availability of intoxicating products (including regulated cannabis products) within the state, especially to...more

Ropes & Gray LLP

[Podcast] Controlling Opinions: The Outlook for Controlled Substances in 2025

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On this episode of Ropes & Gray’s podcast series Controlling Opinions, life sciences regulatory and compliance partner Josh Oyster and counsel Beth Weinman are joined by health care partner Brett Friedman and litigation and...more

Quarles & Brady LLP

PE in Healthcare – Recent Governmental Commentary Could Indicate Policy Changes on the Horizon and Time for Increased Vigilance

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Recent reports published by the Senate Budget Committee (the “Committee”) and the U.S. Department of Health and Human Services (“HHS”) highlight what the authors characterize as concerns related to private equity (“PE”)...more

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