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ArentFox Schiff

RFK Jr., HHS Pull the Plug on Federal Funding for mRNA Vaccine Research and Development

ArentFox Schiff on

On August 5, the US Department of Health and Human Services (HHS) announced a significant change in its vaccine development strategy, ending its support for mRNA vaccine projects under the Biomedical Advanced Research and...more

Hogan Lovells

2025 Horizons Life Sciences and Health Care

Hogan Lovells on

In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more

McDermott+

Trump Administration Executive Order Tracker - updated 8.18.25

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

Carlton Fields

Executive Order Seeks to Build Resilience in Pharmaceutical Supply Chains

Carlton Fields on

On August 13, 2025, President Trump signed an executive order aimed at strengthening America’s pharmaceutical supply chains. Officially titled “Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic...more

A&O Shearman

Italian Medical Device Payback: Italy approves 75% reduction on medical device payback to end disputes

A&O Shearman on

Background: The Payback Mechanism and Its Impact - Italy’s payback system for medical devices has been a source of significant upheaval in the sector, with both domestic and international companies closely monitoring...more

McNees Wallace & Nurick LLC

Navigating Pa.’s unique IBHS licensing requirement for ABA therapy providers

Per Autism Speaks’ “Autism by the Numbers: 2025 Annual Report” (see autismspeaks.org/ABN, last visited July 20, 2025), currently one in 35 children in the United States has autism....more

Stevens & Lee

Budget Negotiations May Delay Payments from the PA Department of Aging, DDAP, DOH or DHS

Stevens & Lee on

On July 29, 2025, Uri Monson, Secretary for the Pennsylvania Governor’s Office of the Budget issued a letter to its “partners in health and human services,” notifying them that since they work for a human services...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

McDermott+

Healthcare Preview for the Week of: July 28, 2025

McDermott+ on

Senate Steers Toward Summer Break - With the House already on August recess, the Senate will consider several of President Trump’s nominees, including Gustav Chiarello III to be an assistant secretary of the US Department of...more

McDermott Will & Schulte

A need for speed: FDA piloting voucher program to expedite drug review

On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot. This one-year initiative – announced on June 17 – aims to...more

Epstein Becker & Green

AI Infrastructure, Ideology, and Exports: Inside the White House’s New AI Orders

Epstein Becker & Green on

On July 23, 2025, the president signed three AI-related Executive Orders (“E.O.s”) to accompany the recently released White House’s Artificial Intelligence (AI) Action Plan (“AI Action Plan”). These E.O.s seek to add clarity...more

Health Care Compliance Association (HCCA)

Amid Seeming Error, HHS Finalizes Klote’s Termination As Director of Crippled OHRP; She Issues a Warning

In the end, the final termination letter arrived in the mail on July 18. For nearly three months—about half of the length of time she was director of the HHS Office for Human Research Protections (OHRP)—Molly Klote, M.D.,...more

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check July 2025

Ropes & Gray LLP on

In the early days of the second Trump Administration, several federal funding agencies announced caps to indirect cost (“IDC”) rates for federally funded research awards. In many cases, these caps would substantially reduce...more

McDermott Will & Schulte

This Week in 340B: July 15 – 21, 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

ArentFox Schiff

Associations Can Continue Winning Nationwide Injunctions After Supreme Court Ruling

ArentFox Schiff on

The US Supreme Court’s recent decision in CASA v. Trump, 606 US ___ (June 27, 2025), sharply limited the ability of individual plaintiffs to obtain nationwide injunctions....more

Rivkin Radler LLP

NY Medical Transport Owner Sentenced for Medicaid Fraud

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The owner of Sublime Medical Transportation in Schenectady County, New York was recently sentenced to three to nine years in state prison for orchestrating a large Medicaid fraud scheme. Muhammed Adnan Saeed netted over...more

Groom Law Group, Chartered

This Week From the Hill (July 13 – July 19, 2025)

Each week while Congress is in session, our Policy team delivers a key update to highlight a topical benefits, health, or retirement news item from the Hill, such as a newly introduced bill, a summary of a committee hearing,...more

Polsinelli

HCBS Update: Indiana Implements Home-Grown 70/30 Direct Caregiver Compensation Requirement

Polsinelli on

Executive Summary: On July 10, 2025, Indiana Medicaid issued guidance to providers of attendant care and structured family caregiver services requiring providers to pass through a specific percentage of their Medicaid...more

King & Spalding

CMS Escalates Aggressive Rates Cut in Home Health Prospective Payment System Proposed Rule for CY 2026

King & Spalding on

On June 30, 2025, CMS issued its annual Home Health Prospective Payment System Proposed Rule for Calendar Year (CY) 2026 (the Proposed Rule). The Proposed Rule continues the agency’s policy of using provisions of the...more

Stikeman Elliott LLP

Canada’s Drug Agency Launches Public Consultation on Proposed List of Essential Prescription Drugs and Related Products

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On June 19, 2025, Canada’s Drug Agency (“CDA”) opened a public consultation to gather input on a proposed list of essential prescription drugs and related products. This initiative is part of the agency’s responsibilities...more

McDermott+

Healthcare Preview for the Week of: July 14, 2025

McDermott+ on

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

Alston & Bird

Health Care Week in Review | HHS Blocks Access to Select Federal Health Programs for Undocumented Individuals; Senate HELP...

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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

McDermott+

Healthcare Extenders Tracker (July 2025 Update)

McDermott+ on

Many healthcare programs are extended for specific time periods, as short as one or two years or as long as 10, and are usually attached to a larger piece of must-pass legislation. Additionally, while traditional...more

Cozen O'Connor

Pennsylvania Perspective for Thursday, July 10, 2025

Cozen O'Connor on

Gov. Shapiro Warns About Medicaid Cuts, Rural Hospital Closures - During a press conference in York on Monday, Governor Josh Shapiro (D) sharply criticized Pennsylvania Republicans for supporting a federal reconciliation...more

McDermott+

Three key takeaways from the CMS Innovation Center’s new WISeR Model

McDermott+ on

The last week of June was a busy one when it comes to news about prior authorization – a major tool used by health plans and the federal government to manage healthcare utilization. The week started with a commitment from...more

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