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Healthcare Reform Healthcare Prescription Drugs

McDermott+

Trump Administration Executive Order Tracker

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Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

Sheppard Mullin Richter & Hampton LLP

DOJ and FTC Host Second Session on Structural and Regulatory Impediments to Drug Competition

On July 24, 2025, the Federal Trade Commission (“FTC”) and the U.S. Department of Justice (“DOJ”) convened the second of three public listening sessions aimed at identifying barriers to drug price competition in the U.S....more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025 #2

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The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...more

McDermott Will & Schulte

Reducing hospital payments: CMS proposes expanded site-neutral payment policy for drug administration services

Consistent with recent attention from Congress and rhetoric from the Trump administration, the Calendar Year 2026 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule (the Proposed Rule) includes...more

McDermott Will & Schulte

This Week in 340B: July 8 – 14, 2025

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

McDermott Will & Schulte

This Week in 340B: July 1 – 7, 2025

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

Sheppard Mullin Richter & Hampton LLP

What to Watch: Potential Increase in Enforcement of “RUO” Diagnostics

Last spring, we wrote about a warning letter the United States Food & Drug Administration (“FDA” or the “Agency”) issued to Agena Bioscience Inc. (the “Agena Warning Letter”) for allegedly promoting its diagnostic product...more

McDermott Will & Schulte

This Week in 340B: June 10 – 16, 2025

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

McDermott Will & Schulte

GLP-1 Update: Court Backs FDA in Tirzepatide Compounding Case

On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more

White & Case LLP

Arkansas Bans PBMs from Owning Pharmacies, Escalating Scrutiny of Vertical Integration in Pharmacy Distribution

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In a first-of-its-kind move, Arkansas Governor Sarah Huckabee Sanders has enacted legislation prohibiting pharmacy benefit managers ("PBMs") from owning or operating pharmacies within the state. The law—Act 624—takes effect...more

McDermott+

McDermott+ Check-Up: May 23, 2025

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THIS WEEK’S DOSE - - House Passes Reconciliation Package. The package now moves to the Senate, where substantive changes, including in healthcare, will likely be made. - HHS Secretary Kennedy, FDA Commissioner Makary...more

Skadden, Arps, Slate, Meagher & Flom LLP

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more

Alston & Bird

Health Care Week in Review | President Trump Announces Actions to Lower Prescription Drug Costs; House Committees Mark Up Their...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Skadden, Arps, Slate, Meagher & Flom LLP

Trump Attempts To Rein In Drug Prices With Most-Favored-Nation Approach

On May 12, 2025, President Donald Trump signed the executive order (EO) “Delivering Most-Favored-Nation Prescription Drug Pricing To American Patients.” The EO sets forth policy positions that attempt to further rein in drug...more

McGuireWoods Consulting

Senate Health Education Labor and Pensions Committee Releases Report on 340B Program and Recommendations for Change

When Sen. Bill Cassidy became Chairman of the U.S. Senate Health, Education, Labor and Pensions Committee this year, he stated one of his priorities was reforming the 340B Program. On April 24, 2025, he released a majority...more

Seyfarth Shaw LLP

Cutting Out the Middle Man

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Arkansas has become the first state in the nation to enact legislation, effective starting in 2026, prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. We take a look at...more

Sheppard Mullin Richter & Hampton LLP

Navigating the Evolving Pharmacy Landscape in 2025: Challenges, Opportunities and Innovations

As we stride further into 2025, the pharmacy industry faces a landscape teeming with challenges and opportunities. From tackling drug price transparency to juggling implementation of artificial intelligence, the industry is...more

Quarles & Brady LLP

Arkansas Law Prohibits Pharmacy Benefit Managers from Obtaining or Holding Pharmacy Permits

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On April 16, 2025, Arkansas House Bill 1150 (the “Bill”) was signed by Governor Huckabee Sanders. The Bill will have substantial implications for pharmacy benefit managers (“PBMs”) and pharmacies across the country....more

Sheppard Mullin Richter & Hampton LLP

CMS Issues CY 2026 Medicare Advantage and Part D Final Rule

On April 4, 2025, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year (“CY”) 2026 final rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”),...more

McDermott+

An MA Extravaganza: Overview of the Final Rule and Rate Announcement

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This past week, the Trump administration put its first major stamp on the Medicare Advantage (MA) program. The Centers for Medicare & Medicaid Services (CMS) released two final regulatory documents related to MA: - The...more

Jones Day

Constitutional Challenges to Inflation Reduction Act Head to Courts of Appeals

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No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more

McDermott+

Healthcare Preview for the Week of: March 31, 2025

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Reconciliation Watch - Reports indicate that the Senate will move as soon as Wednesday to begin advancing a unified budget plan. The Senate hopes to be able to advance the budget resolution by having the two chambers...more

Skadden, Arps, Slate, Meagher & Flom LLP

Makary Is Confirmed as Commissioner of an FDA in Transition

Dr. Martin Makary has been confirmed by the Senate as the next commissioner of the Food and Drug Administration (FDA). Dr. Makary is taking the helm at FDA during an unprecedented time for the agency, which has been subject...more

Smart & Biggar

PMPRB announces Anie Perrault as acting Chairperson and releases latest expenditure report on private drug plan costs and...

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On March 6, 2025, the Patented Medicine Prices Review Board (PMPRB) announced that Thomas Digby stepped down from his role as Chairperson of the PMPRB. Vice-Chairperson Anie Perrault is now serving as acting Chairperson until...more

Smart & Biggar

Government of Canada announces first pharmacare agreements

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Update: The Government of Canada announced an agreement with the Yukon ($9.5 million over four years). The agreement text is available in the updated National pharmacare bilateral agreements resource....more

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