News & Analysis as of

Regulatory Reform Medicare Prescription Drugs

Jones Day

Congress Expands Orphan Drug Exemptions From Medicare Price Negotiations

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The One Big Beautiful Bill Act ("OBBB") expands exemptions for orphan drugs from mandatory Medicare price negotiations and modifies their eligibility timeline....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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more

Ropes & Gray LLP

Executive Order Calls for Most-Favored-Nation Pharmaceutical Pricing for American Patients

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On May 12, 2025, President Trump issued an executive order (the “Executive Order”) directing executive agencies and, imminently, pharmaceutical manufacturers to take steps to deliver most-favored-nation (“MFN”) prescription...more

Epstein Becker & Green

Medicare Drug Price Negotiation Program: The Inflation Reduction Act “Pill Penalty” and Other IRA Reforms on the Horizon for 2026

Epstein Becker & Green on

When Congress adopted the Inflation Reduction Act (IRA) in 2022, creating the Medicare Drug Price Negotiation Program (MDPNP), the bill did not receive support from any Republican senators....more

King & Spalding

Executive Order to Deliver Lower Prescription Drug Prices

King & Spalding on

On April 15, 2025, President Trump issued an Executive Order (the EO) titled, “Lowering Drug Prices By Once Again Putting Americans First,” directing HHS to take action on a list of specific proposals with the goal of lower...more

DLA Piper

President Trump Signs Executive Order to Lower Prescription Drug Costs

DLA Piper on

President Donald Trump recently signed an Executive Order (EO) aimed at lowering the cost of prescription drugs, titled, “Lowering Drug Prices by Once Again Putting Americans First.” On April 15, 2025, through this EO, the...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - April 2025 #2

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On April 15, 2025, President Trump signed an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order includes various provisions that are relevant to the pharmaceutical industry,...more

Brownstein Hyatt Farber Schreck

Trump Administration Issues Wide-Ranging EO to Lower Drug Prices

On April 15, President Donald Trump signed an Executive Order (EO) titled “Lowering Drug Prices by Once Again Putting Americans First,” outlining a renewed policy agenda to reduce prescription drug costs. The EO is framed as...more

Alston & Bird

Health Care Week in Review | President Trump Announces Actions to Lower Drug Prices; Trump Administration Initiates Section 232...

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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

President Trump Issues Executive Order Intended To Lower Drug Prices

On April 15, 2025, President Trump issued the executive order “Lowering Drug Prices by Once Again Putting Americans First,” aimed at lowering the prices of prescription drugs and biologics, encouraging competition in the drug...more

Maynard Nexsen

Prescription Revolution: Trump’s Bold Move to Slash Drug Prices

Maynard Nexsen on

An Overview of the Executive Order on Lowering Drug Prices - On April 15, 2025, President Donald J. Trump signed an Executive Order aimed at reducing prescription drug prices in the United States. This order builds upon...more

Akin Gump Strauss Hauer & Feld LLP

Lowering Drug Prices by Once Again Putting Americans First (Trump EO Tracker)

This order makes it the policy of the United States that Federal health care programs, intellectual property protections, and safety regulations are optimized to provide access to prescription drugs at a lower cost to...more

Lathrop GPM

Flying Through the Whirlwind: Health Care Industry Continues To Be Buffeted as Administration Rolls Out New Initiatives

Lathrop GPM on

Health care providers and payers have been subject to a flurry of developments at the federal level in recent weeks. Considering that health care represents almost 18% of the U.S. gross domestic product, this was perhaps...more

Woods Rogers

Employee Benefits Likely Impacted by Executive Orders

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During the first weeks of the second Trump Administration, a number of executive orders and other actions have been implemented, with some having potential implications for employee benefits. Executive Orders can, and do,...more

Ropes & Gray LLP

Adapting to the IRA: Early Lessons Learned on the IRA’s Impact on Deal-Making, Drug Economics, and Business Strategy

Ropes & Gray LLP on

More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more

Holland & Knight LLP

Florida Enacts Comprehensive Pharmacy Benefit Plan Regulation

Holland & Knight LLP on

This legislative session, Florida has joined Arkansas and Oklahoma among the most regulatory-minded states with respect to pharmacy benefit plans and programs as well as pharmacy benefit managers (PBMs). Florida's...more

Bricker Graydon LLP

Federal appeals court rules against the American Hospital Association’s challenge to the $1.6 billion in Medicare 340B cuts

Bricker Graydon LLP on

On July 17, 2017, the U.S. Court of Appeals for the District of Columbia Circuit ruled in favor of the Department of Health and Human Services (HHS), finding that the American Hospital Association’s (AHA) legal challenge of...more

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