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Department of Health and Human Services (HHS) Drug Pricing Healthcare

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

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The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

McDermott+

McDermott+ Check-Up – August 1, 2025

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Senate HELP Committee advances legislation, examines healthcare affordability. The legislation would reauthorize expiring programs, including the Over-the-Counter Monograph Drug User Fee Program. Senate Appropriations...more

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

Sheppard Mullin Richter & Hampton LLP

DOJ False Claims “Working Group” Update

ICYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human Services (HHS) to enforce the False Claims Act...more

Alston & Bird

Getting the Band Back Together: DOJ and HHS Launch New False Claims Act Enforcement Working Group

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The Department of Health and Human Services and the Department of Justice have formed a False Claims Act (FCA) enforcement working group to target health care fraud. Our Health Care Litigation Group highlights what industry...more

Stevens & Lee

HHS and DOJ Announce False Claims Act Joint Working Group and Identify Enforcement Priorities

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The U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced on July 2 their formation of a False Claims Act Working Group. The announcement and the formation of the Working Group...more

Troutman Pepper Locke

DOJ-HHS Establishes New Working Group to Enhance FCA Enforcement

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On July 2, 2025, the U.S. Department of Justice (DOJ) announced the formation of a new working group in collaboration with the U.S. Department of Health and Human Services (HHS) focused on the enforcement of the False Claims...more

Skadden, Arps, Slate, Meagher & Flom LLP

HHS and DOJ Launch FCA Working Group With New Joint Enforcement Priorities

On July 2, 2025, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) announced the reinvigoration of their False Claims Act (FCA) enforcement efforts through the formation of a joint FCA...more

ArentFox Schiff

Investigation Newsletter: DOJ and HHS Emphasize Continued, Robust, and Coordinated Health Care Enforcement with Revival of False...

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The government has announced a renewed and expanded focus on False Claims Act (FCA) enforcement, doubling down on traditional health care priorities like kickbacks and drug pricing while signaling increased scrutiny of...more

DLA Piper

Relaunch of DOJ-HHS Working Group Reinforces False Claims Act Enforcement Focus in Healthcare and Life Sciences Industries

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The Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the relaunch of a Working Group to enhance enforcement of the False Claims Act (FCA) across the healthcare and life...more

WilmerHale

DOJ and HHS Announce New False Claims Act Working Group

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On July 2, 2025, the Department of Justice (“DOJ”) and the Department of Health and Human Services (“HHS”) announced a joint DOJ-HHS False Claims Act Working Group (the “Working Group”) that will focus on enhanced enforcement...more

Epstein Becker & Green

DOJ, HHS Announce Revamped False Claims Act Working Group

Now in its sixth month, the second Trump administration has made clear that the False Claims Act (FCA) will remain a central tool in its efforts to combat fraud, waste, and abuse across federal programs....more

Husch Blackwell LLP

DOJ and HHS Launch New False Claims Act Working Group: What The Healthcare Industry Needs to Know

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On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at...more

Goodwin

Health Headlines: June 2025

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Welcome to the seventh issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice. Iowa Governor Kim Reynolds signed Senate File 383 into law, placing new restrictions on pharmacy benefit...more

Alston & Bird

Health Care Week in Review | CMS Rescinds Biden-Era EMTALA Abortion Guidance; CBO Projects 16 Million Could Lose Coverage Under...

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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

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Akin Gump Strauss Hauer & Feld LLP

Five FDA Takeaways from the FY26 Budget

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...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

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

Carlton Fields

Executive Order Seeks to Eliminate Discrepancies in Drug Pricing Between United States and Other Countries

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President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...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

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

McDermott+

McDermott+ Check-Up: May 9, 2025

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THIS WEEK’S DOSE - - Republicans Advance Reconciliation Debate. Work continued behind the scenes among Republicans to reach consensus on Medicaid policies, with a House Energy and Commerce Committee markup announced for May...more

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

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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

Mintz - Health Care Viewpoints

White House Budget Documents Provide Additional Insights into the Trump Administration’s Priorities for HHS

Over the past few weeks, we have been closely following the Trump administration’s restructuring of the Department of Health and Human Services (HHS), the major reduction in the department’s workforce (RIF), and its broader...more

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