News & Analysis as of

Regulatory Reform Drug Pricing Centers for Medicare & Medicaid Services (CMS)

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+

Filling in More Puzzle Pieces with HHS’s Newly Released Budget Documents

McDermott+ on

McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts. June 5, 2025 – On May 30, 2025, the US Department of Health and Human Services...more

Holland & Knight LLP

Holland & Knight Health Dose: June 3, 2025

Holland & Knight LLP on

Looking Ahead: Fiscal Year 2026 Appropriations - This week, the U.S. House of Representatives and U.S. Senate return to Capitol Hill following the Memorial Day recess. The Senate is expected to begin work behind the scenes on...more

McDermott+

First Steps in Implementing the Trump Administration’s Price Transparency Agenda

McDermott+ on

Recently, the Trump administration took steps toward implementing one of its major priorities: improving price transparency. As discussed in a previous Regs & Eggs blog post, President Trump signed an executive order (EO) on...more

Mintz - Health Care Viewpoints

PBM Legislation in the Reconciliation Bill is Far From Sweeping PBM Reform

Over the past few years, Congress has attempted to pass “federal PBM reform.” Members of Congress have held numerous hearings related to PBMs and introduced numerous bills seeking to regulate PBMs (we regularly track these...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

McDermott+

Trump Administration Executive Order Tracker

McDermott+ on

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

Epstein Becker & Green

CMS Issues CY 2026 MA & Part D Rate Announcement, Final Rule on CY 2026 Policy and Technical Changes to Programs, While Seeking...

Epstein Becker & Green on

Several April releases seem to signal some basis for optimism for stakeholders in Medicare Advantage and Part D, though with sufficient undertones to recommend caution....more

McDermott+

McDermott+ Check-Up: April 25, 2025

McDermott+ on

HELP Committee Releases 340B Report. Health, Education, Labor, and Pensions (HELP) Chair Cassidy (R-LA) released findings from his investigation and laid out potential reforms to the 340B Drug Pricing Program....more

McDermott+

Trump Administration Executive Order Tracker (UPDATED)

McDermott+ on

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

Faegre Drinker Biddle & Reath LLP

The Effects of HHS Workforce Reductions, Tariffs on Pharma, the ‘Pill Penalty’ and More

With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - April 2025 #2

Latham & Watkins LLP on

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

Alston & Bird

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

Alston & Bird on

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

McDermott+

McDermott+ Check-Up: April 11, 2025

McDermott+ on

THIS WEEK’S DOSE - House Passes Concurrent Budget Resolution for Reconciliation Process. Passage of the resolution didn’t resolve the policy differences between the House and the Senate. Those still need to be addressed as...more

Foley Hoag LLP

HHS Under the Second Trump Administration

Foley Hoag LLP on

On February 11, 2025, President Trump signed Executive Order (E.O.) 14210, Implementing The President’s “Department of Government Efficiency” Workforce Optimization Initiative, which instructed the newly formed Department of...more

Alston & Bird

Health Care Week in Review | The House of Representatives Approved a Budget Resolution and President Trump Signed an EO on...

Alston & Bird on

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

Mintz - Health Care Viewpoints

Mintz IRA Update — From the Desk of ML Strategies: The Medicare Drug Price Negotiation Program Under the Second Trump...

The start of Donald Trump’s second presidency and Republican control in the 119th Congress raises questions about the future of the IRA’s Medicare Drug Price Negotiation Program (the Negotiation Program), which could be...more

Morgan Lewis

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

Morgan Lewis on

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

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing and Health Care Fraud Remain Key Issues

Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

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

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - December 2022

Latham & Watkins LLP on

Inflation Reduction Act Implementation: On Dec. 1, 2022, the Centers for Medicare & Medicaid Services (CMS) distributed an invitation addressed to “All Drug Manufacturers” announcing that CMS “will host monthly one-hour calls...more

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