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Regulatory Reform Regulatory Requirements Healthcare Reform

Skadden, Arps, Slate, Meagher & Flom LLP

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more

Arnall Golden Gregory LLP

Wind of Change: FDA Commissioner Makary Outlines His Vision for FDA

In his first major public remarks as commissioner of the U.S. Food and Drug Administration, Dr. Marty Makary laid out a comprehensive, reform-oriented vision for the agency during a fireside chat at the 2025 Food & Drug Law...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

Groom Law Group, Chartered

The Trump Administration Explores Deregulation of Medicare

On April 11, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published a Request for Information (“RFI”) requesting the public provide feedback on how to streamline regulations and reduce administrative burdens on...more

Sheppard Mullin Richter & Hampton LLP

CMS Proposes Medicare Payment Policies for Hospital Inpatient Services for Federal Fiscal Year 2026

The Centers for Medicare & Medicaid Services (CMS) recently published the fiscal year (“FY”) 2026 proposed rule for Hospital Inpatient Prospective Payment Systems (IPPS) (the “Proposed Rule”). Comments to the Proposed Rule...more

McDermott+

The First 100 Days: By the Numbers

McDermott+ on

To state the obvious, a lot has happened in healthcare over the first 100 days of President Trump’s second term. But how much? ...more

Quarles & Brady LLP

Arkansas Law Prohibits Pharmacy Benefit Managers from Obtaining or Holding Pharmacy Permits

Quarles & Brady LLP on

On April 16, 2025, Arkansas House Bill 1150 (the “Bill”) was signed by Governor Huckabee Sanders. The Bill will have substantial implications for pharmacy benefit managers (“PBMs”) and pharmacies across the country....more

McDermott+

FY 2026 Proposed Rules Are Out! Overview of the IPPS Proposed Rule

McDermott+ on

Last Friday, the Centers for Medicare & Medicaid Services (CMS) officially launched the health policy community into reg season, releasing in one fell swoop all the fiscal year (FY) 2026 Medicare proposed regulations for...more

McDermott+

Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off

McDermott+ on

Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off - It’s March, which means one thing for sports fans: the madness of the NCAA men’s and women’s basketball tournaments. However, to folks in the...more

Mintz - Health Care Viewpoints

CMS’s ACA Marketplace Integrity and Affordability Proposed Rule – What it may mean for Health Plans

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2025 Marketplace Integrity and Affordability Proposed Rule (Proposed Rule), proposing a number of enrollment and eligibility policies...more

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

Maynard Nexsen

HHS Abandons Public Comment Practices Under the Richardson Waiver

Maynard Nexsen on

On March 3, 2025, the Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., officially announced the rescission of the Richardson Waiver, a policy in place since 1971 that required public...more

Quarles & Brady LLP

Alabama Bill Proposes Rewrite of Pharmacy Practice Act

Quarles & Brady LLP on

The future direction of the Alabama Board of Pharmacy (“the Board”) hangs in the balance following recent legislation that, if passed, would revise many portions of the state Pharmacy Practice Act. House Bill 123, sponsored...more

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

A&O Shearman on

The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

Husch Blackwell LLP

New Legislation Revises Massachusetts' Determination of Need Statute

Husch Blackwell LLP on

On January 8, 2025, Massachusetts Governor Maura Healey signed into law “An Act Enhancing the Health Care Market Review Process.” Part of this sweeping healthcare oversight law includes changes to the Determination of Need...more

ArentFox Schiff

Top Legal Considerations for the GCs and CFOs in the Life Sciences Industry in 2024

ArentFox Schiff on

The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more

Burr & Forman

Proposed Stark Law Changes May Impact Physician Compensation Models

Burr & Forman on

On October 9, 2019, the Centers for Medicare and Medicaid Services (“CMS”) proposed sweeping changes to the federal Physician Self-Referral Law, commonly referred to as the Stark Law. While many of the changes reflect CMS’...more

Ballard Spahr LLP

Final Regulations Expand Availability of Individual Insurance Not Meeting ACA Requirements

Ballard Spahr LLP on

The U.S. Departments of the Treasury, Labor, and Health and Human Services have jointly issued final rules modifying the definition of short-term, limited-duration insurance (STLDI). STLDI provides health coverage that is...more

Bricker Graydon LLP

Association Health Plans: Another tool for small employers to manage health care costs and increase employee access to affordable...

Bricker Graydon LLP on

Following last fall’s Executive Order 13813, which directs regulatory agencies to improve access to affordable employer coverage, the Department of Labor (DOL) recently released the final regulations on small business...more

Ballard Spahr LLP

DOL Releases Final Regulation Expanding Association Health Plans

Ballard Spahr LLP on

The U.S. Department of Labor (DOL) on Tuesday released final regulations modifying the Association Health Plan (AHP) rules to expand their availability for small and large employers and to address their affordability by...more

Stinson LLP

DOL Issues Final Association Health Plan Rule

Stinson LLP on

On June 19, 2018, the Department of Labor (DOL) released a final rule that offers new options for associations to sponsor health plans for their members. These new options allow more small businesses to come together to...more

Littler

Association Health Plans: How Do You Solve a Problem Like a MEWA?

Littler on

On June 19, 2018, the Department of Labor issued its highly anticipated final rule expanding the availability of association health plans (“AHPs”). ...more

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