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