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Regulatory Agenda Healthcare

Troutman Pepper Locke

Health Care Industry Under Attack for Independent Contractor Misclassification: July 2025 IC Legal News Update

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Unless you were in the health care industry, July 2025 was a relatively slow month for judicial developments in the law of independent contractor (IC) misclassification and compliance. Only two significant IC cases came to...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

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

Haynes Boone

False Claims Act - 2025 Mid-Year Review

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The False Claims Act continues to be one of the most commonly used weapons in the government’s enforcement arsenal to address various forms of fraud. In addition to our “Year in Review” publication providing an overview of...more

McDermott+

McDermott+ Check-Up – July 25, 2025

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CBO releases final scores for OBBBA. The Congressional Budget Office (CBO) estimates that the One Big Beautiful Bill Act (OBBBA) will increase the uninsurance rate by 10 million individuals over 10 years. House Energy and...more

McDermott+

Site neutrality is on the menu in the CY 2026 Medicare Outpatient Prospective Payment System proposed rule

McDermott+ on

Last week, the Centers for Medicare & Medicaid Services (CMS) issued two major regs: the calendar year (CY) 2026 Medicare Physician Fee Schedule (PFS) proposed rule and the CY 2026 Outpatient Prospective Payment System (OPPS)...more

White & Case LLP

New EU Responsibility and Liability Landscape for Smart Medical Devices in a Global Context

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Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more

Troutman Pepper Locke

Congressional Briefing Highlights Growing Bipartisan Consensus on the Need for Federal Clarity in Hemp-Derived Cannabinoid...

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On July 17, the U.S. House Committee on Agriculture hosted a closed-door roundtable briefing focused on the regulatory gray areas surrounding hemp-derived cannabinoid products. The session, convened in response to ongoing...more

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

McDermott+

CMS releases CY 2026 Physician Fee Schedule Proposed Rule

McDermott+ on

On July 14, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B [CMS-13271]...more

McDermott+

Healthcare Preview for the Week of: July 14, 2025

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Rescissions rescissions - Congressional focus this week is on the rescissions package and appropriations. The rescissions bill has a July 18 deadline to reach the president’s desk for signature. The bill is pending in the...more

Quarles & Brady LLP

DOJ and HHS Announce New False Claims Act Working Group

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On July 2, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) announced that they are forming the DOJ-HHS False Claims Act Working Group to further combat healthcare fraud—an...more

McDermott+

Healthcare Preview for the Week of: July 7, 2025

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Reconciliation aftermath - Last week, President Trump signed H.R. 1, the One Big Beautiful Bill Act, into law after months of work on the reconciliation package. This week, things will slightly cool down in Washington, DC....more

Sheppard Mullin Richter & Hampton LLP

Oregon Prohibits Medical Debt in Credit Reports

On June 23, Oregon enacted SB 605, barring medical-debt information from appearing in consumer credit reports. The measure, which amends the Oregon Unlawful Trade Practices Act, takes effect January 1, 2026....more

Benesch

AI Reporter - June 2025

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The FDA began integration of generative AI across all its centers, a project that should be completed by the end of June. Newly appointed chief AI officer, Jeremy Walsh, and Office of Strategic Programs at CDER, Sridhar...more

Skadden, Arps, Slate, Meagher & Flom LLP

The European Health Data Space – What EU Health Care Providers and Data Holders Need To Know

- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more

McDermott+

Healthcare Preview for the Week of: June 16, 2025

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The House is out this week for the Juneteenth holiday, but the Senate will be in town through Wednesday. We expect these three days to be significant because the Senate Finance Committee has announced that it intends to...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

Pullman & Comley - Connecticut Health Law

Three Bills Affecting Health Care Transactions That Will Not Be Signed into Law This Year

Members of the health care community may recall that the 2025 legislative session of the Connecticut General Assembly started out with Governor Lamont signing into law an emergency certificate of need (CON) process for...more

Seyfarth Shaw LLP

States Seeking Remedies for the Rising Costs of Prescription Drugs

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As expected, the lawsuits have commenced following the enactment of the Arkansas legislation prohibiting pharmacy benefit managers (PBM’s) from owning or operating actual pharmacies within the state. Michigan has filed its...more

McDermott+

Healthcare Preview for the Week of: May 27, 2025

McDermott+ on

Short Congressional Recess, Short Preview - While Congress is in recess this week, we are still on reconciliation watch as consideration of the One Big Beautiful Bill Act moves to the Senate. We are on the lookout for a...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | April 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2025, including Centers for Medicare & Medicaid Services (CMS) updates to Medicare Advantage (MA) and other Medicare programs....more

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

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The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

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Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

DarrowEverett LLP

The DOJ’s New White-Collar Agenda: Implications for Businesses

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On May 12, 2025, the Department of Justice (the “DOJ”) released its criminal—and, more specifically, white collar crime enforcement—initiatives under the current administration. This is typical each time new leadership...more

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