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
Based on recent policy signals and statements from incoming administration officials, a picture of potential regulatory and policy changes that could affect biotech, pharmaceutical, and medical device companies in coming...more
1/22/2025
/ Antitrust Provisions ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Public Policy ,
Regulatory Agenda ,
Trump Administration
Proposed federal legislation known as the BIOSECURE Act is being considered in both the U.S. House of Representatives and the U.S. Senate....more
3/6/2024
/ Advanced Notice of Proposed Rulemaking (ANPRM) ,
Biotechnology ,
Bureau of Industry and Security (BIS) ,
China ,
Cuba ,
Data Collection ,
Department of Justice (DOJ) ,
Entity List ,
Export Controls ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Federal Funding ,
Iran ,
National Security ,
NDAA ,
North Korea ,
Pharmaceutical Industry ,
Popular ,
Proposed Legislation ,
Russia ,
Technology Sector
For a healthcare or life sciences company settling a government enforcement action, the prospect of being subject to an independent monitor, independent review organization (IRO), or other government-mandated compliance...more
As part of a recent series of announcements regarding updates to its corporate compliance policies, the Department of Justice (DOJ) announced significant revisions to its evaluation criteria for corporate compliance programs,...more
3/8/2023
/ Chief Compliance Officers ,
Clawbacks ,
Compliance ,
Corporate Crimes ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
Electronic Communications ,
Enforcement Priorities ,
Executive Compensation ,
Monaco Memo ,
White Collar Crimes
The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more
3/8/2022
/ Anti-Kickback Statute ,
Clinical Laboratories ,
Department of Justice (DOJ) ,
Digital Health ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Technology ,
Healthcare Fraud ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Private Equity ,
Telehealth
After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more
11/5/2021
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Failure to Report ,
False Claims Act (FCA) ,
Health Care Providers ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Physician-Owned Distributors ,
Physicians ,
Settlement Agreements ,
Sunshine Act
Alere Inc. and Alere San Diego Inc. (collectively “Alere”) have come under fire recently by the U.S. Department of Justice (“DOJ”) and other government agencies, agreeing to settle several rounds of accusations of False...more
8/13/2021
/ Co-payments ,
Department of Justice (DOJ) ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medical Devices ,
Medical Supplies ,
Medicare ,
Settlement Agreements