In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more
President Trump issued an Executive Order on April 15, 2025, titled "Lowering Drug Prices by Once Again Putting Americans First," with the express goal of providing Americans and taxpayers access to prescription drugs. One...more
Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...more
4/2/2025
/ Administrative Procedure Act ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B ,
Statutory Interpretation
The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services and Office of the Secretary (collectively, HHS) released on May 6, 2024, the agencies' Final Rule governing the implementation of...more
5/13/2024
/ Affordable Care Act ,
Anti-Discrimination Policies ,
Compliance ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance ,
Non-Discrimination Rules ,
Notice Requirements ,
Policies and Procedures ,
Section 1557
The U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services and the Office of the Secretary (collectively, HHS) released the agencies' Final Rule governing the implementation of Section 1557 of...more
5/13/2024
/ Affordable Care Act ,
Anti-Discrimination Policies ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Disabilities ,
Health Care Providers ,
Health Insurance ,
Limited English Proficiency (LEP) ,
Medicaid ,
Medicare ,
Non-Discrimination Rules ,
Section 1557
President Biden recently announced that his administration plans to end the COVID-19 PHE on May 11, 2023. This provides more clarity about the long-anticipated end date for certain telehealth waivers and enforcement...more
On September 14, 2022, the U.S. Department of Health and Human Services (HHS) published its Roadmap for Behavioral Health Integration outlining how HHS plans to advance President Biden’s national strategy to address mental...more