On July 2, 2025, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) announced the reinvigoration of their False Claims Act (FCA) enforcement efforts through the formation of a joint FCA...more
7/9/2025
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Medicaid ,
Medical Devices ,
Medicare
On May 12, 2025, President Donald Trump signed the executive order (EO) “Delivering Most-Favored-Nation Prescription Drug Pricing To American Patients.” The EO sets forth policy positions that attempt to further rein in drug...more
5/14/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Healthcare ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Legislative Agendas ,
Medicare ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agenda ,
Trump Administration
On April 15, 2025, President Trump issued the executive order “Lowering Drug Prices by Once Again Putting Americans First,” aimed at lowering the prices of prescription drugs and biologics, encouraging competition in the drug...more
Key Points -
- It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively.
- The Trump administration will likely focus on drug...more
1/21/2025
/ Affordable Care Act ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Fraud ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform ,
Secretary of HHS ,
Trump Administration
On August 7, 2022, the Senate passed the Inflation Reduction Act (the Act), which is expected to have a significant impact on climate, tax and health care policy in the United States. The result of intense negotiations among...more
The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and Medicare Part D plans and...more
2/5/2019
/ Amended Rules ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Health Plan Sponsors ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Rebates ,
Safe Harbors
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
12/13/2018
/ Anti-Bribery ,
Anti-Corruption ,
Anti-Kickback Statute ,
Bribery ,
Compliance ,
Corporate Misconduct ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Drug Pricing ,
Enforcement Actions ,
Ethical Standards ,
False Claims Act (FCA) ,
FDA Approval ,
First Amendment ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Internal Investigations ,
Kickbacks ,
Life Sciences ,
Materiality ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
PHRMA ,
Popular ,
Product Labels ,
Rebates ,
Safe Harbors ,
Securities and Exchange Commission (SEC) ,
Sunshine Act ,
Transparency ,
Universal Health Services Inc v United States ex rel Escobar ,
Whistleblowers