News & Analysis as of

Regulatory Reform Healthcare

Sheppard Mullin Richter & Hampton LLP

Trump Revokes Biden Administration’s Executive Order on Antitrust & Competition but other Biden Administration Antitrust Policy...

On August 13, 2025, President Trump revoked the Biden Administration’s 2021 Executive Order (Promoting Competition in the American Economy). ...more

Sheppard Mullin Richter & Hampton LLP

New York Adopts Major Certificate of Need Amendments Effective August 6, 2025

On August 6, 2025, the New York State Department of Health (DOH) finalized amendments to its Certificate of Need (CON) regulations in 10 N.Y.C.R.R. Part 710, raising the financial thresholds for full review, expanding...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

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

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 6, Issue 7, July 2025

Welcome to our seventh issue of 2025 of Decoded - our technology law insights e-newsletter. What does the US GENIUS Act Mean for Stablecoins? “The White House categorically states it is a historic piece of legislation that...more

Polsinelli

Virtual Oversight, Real Impacts: “Incident-To” and Beyond in CMS’s CY 2026 PFS Proposed Rule

Polsinelli on

Key Takeaways - CMS proposes to significantly expand the use of virtual direct supervision for incident-to services, removing prior limitations based on Professional Component (PC)/Technical Component (TC) indicators and...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

Jones Day

Congress Expands Orphan Drug Exemptions From Medicare Price Negotiations

Jones Day on

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

McDermott+

McDermott+ Check-Up – July 25, 2025

McDermott+ on

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 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

Smith Anderson

OBBB Act Brings Major Medicaid Changes: What North Carolina Providers Need to Know

Smith Anderson on

The One Big Beautiful Bill Act (P.L.119-21) (the “OBBB”) passed by slim margins in the U.S. Senate (51-50) and U.S. House (218-214) and was signed into law by President Trump on July 4, 2025....more

K&L Gates LLP

Microplastics Under the Microscope: Federal and California Proposals Target Microplastics

K&L Gates LLP on

On 17 July 2025, a bipartisan bill aimed at uncovering the potential human health implications of exposures to microplastics in the food and water supply was introduced into Congress. Introduced by Rep. Janelle Bynum (D-OR),...more

Troutman Pepper Locke

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

Troutman Pepper Locke on

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

Sheppard Mullin Richter & Hampton LLP

Policy Brief: Aligning Nursing Home Bed Planning with New York’s Certificate of Need Reform Goals

Last month, New York State began a formal review of its Certificate of Need (CON) process for nursing homes, launching a timely conversation about how best to align regulatory oversight with evolving system needs. A new...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Biosimilars Boom: 2025’s Fast Track Approvals Look to Reshape Healthcare

With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close...more

Foley & Lardner LLP

Colorado Medicaid: RAC Program Overhauled with Enhanced Transparency, Greater Provider Protections, and Increased Oversight

Foley & Lardner LLP on

In June 2025, Colorado passed a new law that makes significant changes to the state’s Medicaid Recovery Audit Contractor (RAC) program. Colorado has one of the most aggressive RAC programs in the country that has been rife...more

Quarles & Brady LLP

DOJ and HHS Announce New False Claims Act Working Group

Quarles & Brady LLP on

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

Foley & Lardner LLP

FDA: Commissioner’s National Priority Voucher Program Aims to Streamline Some Drug Reviews

Foley & Lardner LLP on

Share on Twitter Share by Email Share Back to top The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, via a press release accompanied by a list of...more

Foley & Lardner LLP

The Patent Eligibility Restoration Act and Life Sciences Innovation

Foley & Lardner LLP on

The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more

Jones Day

CMS Updates Kidney Care Choices Model

Jones Day on

The Center for Medicare and Medicaid Innovation ("CMMI") announced sweeping changes to the Kidney Care Choices Model ("KCC Model"), a key set of value-based programs....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

Tucker Arensberg, P.C.

New CMS Model Targets Inefficient Medicare Spending Through AI and Clinical Oversight

The Centers for Medicare & Medicaid Services (CMS) has launched the WISeR Model (Wasteful and Inappropriate Service Reduction) to modernize and streamline Medicare’s prior authorization process. ...more

BakerHostetler

HHS Issues a Request for Information on Deregulation and Innovation: Considerations for Legal and Compliance Teams

BakerHostetler on

On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued its Request for Information (RFI) “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again,” which HHS describes as...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

262 Results
 / 
View per page
Page: of 11

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide