The Trump administration recently announced the renewal of a new cross-agency collaboration between the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) in the form of the DOJ-HHS False Claims...more
7/22/2025
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Electronic Protected Health Information (ePHI) ,
Enforcement Actions ,
Enforcement Priorities ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Kickbacks ,
Medicare ,
Medicare Advantage ,
Trump Administration ,
Whistleblowers ,
Working Groups
As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
7/9/2025
/ Abbreviated New Drug Application (ANDA) ,
Artificial Intelligence ,
Budget Reconciliation ,
Deregulation ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Life Sciences ,
Medicaid ,
Medical Devices ,
Medical Technology Companies ,
Medicare ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Reform ,
Regulatory Requirements ,
Tariffs ,
Trump Administration ,
UK
On May 12, 2025, President Trump signed the most recent Executive Order on drug pricing, Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. ...more
5/13/2025
/ Department of Health and Human Services (HHS) ,
Drug Pricing ,
Enforcement Actions ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicare ,
Most-Favored Nations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Trump Administration
As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more
6/30/2023
/ Biologics ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Marketing ,
Marketing Authorization Application ,
Med Tech ,
Medicaid ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs
On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) released initial program guidance addressing the inflation rebate provisions of the Inflation Reduction Act of 2022 (IRA). These provisions apply to how...more
2/24/2023
/ Biologics ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Inflation Adjustments ,
Inflation Reduction Act (IRA) ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
OIG ,
Prescription Drugs ,
Proposed Guidance ,
Rebates ,
Section 340B
On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) released initial program guidance on the inflation rebate provisions of the Inflation Reduction Act of 2022 (IRA). These provisions apply to how Medicare...more
On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more
8/10/2022
/ Civil Monetary Penalty ,
Drug Pricing ,
Enforcement ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medicaid Drug Rebate Program ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pending Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rebates ,
Secretary of HHS
On January 11, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed National Coverage Determination (NCD) decision memo limiting Medicare coverage for Biogen’s new Alzheimer’s drug, Aduhelm. Under...more