Blockchain presents unprecedented challenges around national security. This is true not only for the federal government, but also for businesses in the private sector. From cross-border transactions involving cryptocurrency...more
9/26/2023
/ Bank Secrecy Act ,
Blockchain ,
CFIUS ,
Compliance Monitoring ,
Criminal Liability ,
Cross-Border Transactions ,
Cryptocurrency ,
Defense Production Act ,
Economic Sanctions ,
Export Administration Regulations (EAR) ,
Financial Institutions ,
FINSA ,
Foreign Corrupt Practices Act (FCPA) ,
National Security ,
Office of Foreign Assets Control (OFAC) ,
Popular
On May 11, 2023, the U.S. Department of Justice (DOJ) announced the launch of its Puerto Rico and U.S. Virgin Islands (USVI) Environmental Crimes Task Force. This new task force will focus specifically on combating...more
6/14/2023
/ Air Pollution ,
Chemical Spills ,
Criminal Liability ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Departments of Commerce ,
Enforcement Priorities ,
Environmental Crimes ,
Environmental Protection Agency (EPA) ,
Environmental Violations ,
FQPA ,
Fraud Abuse and Waste ,
Hazardous Substances ,
Marine Life Protections ,
Natural Resources ,
Navigable Waters ,
Oil Spills ,
Public Corruption ,
Puerto Rico ,
Virgin Islands ,
Water Pollution ,
Wetlands ,
Wildlife Protection
Similar to other types of healthcare entities, clinical laboratories have been facing enhanced scrutiny from federal authorities over the past couple of years. While this is due in part to fraud concerns related to COVID-19...more
3/8/2023
/ Anti-Kickback Statute ,
Civil Liability ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Criminal Liability ,
Defense Strategies ,
Department of Justice (DOJ) ,
Evidence ,
False Billing ,
FBI ,
Health Care Providers ,
Healthcare Fraud ,
Internal Audit Functions ,
Investigations ,
Risk Assessment
The U.S. Department of Justice (DOJ) has recently taken a renewed interest in management services organizations (MSOs), including physician-syndicated MSOs in which physician-owners provide medical services in exchange for...more
U.S. Immigration and Customs Enforcement (ICE) aggressively executes its mission “to protect America from the cross-border crime and illegal immigration that threaten national security and public safety.” With both political...more
1/31/2023
/ Criminal Liability ,
Defense Strategies ,
Department of Homeland Security (DHS) ,
Employer Liability Issues ,
Employment Eligibility Verification ,
Foreign Workers ,
Form I-9 ,
Immigration and Customs Enforcement (ICE) ,
Immigration Enforcement ,
Investigations ,
Search Warrant ,
Subpoenas
As a pharmacist, facing a board of pharmacy investigation can be extremely risky. While losing your professional license might seem like the greatest risk, this isn’t necessarily the case. Increasingly, boards of pharmacy are...more
The Federal False Claims Act (FCA) prohibits knowingly submitting a false or fraudulent claim for compensation to the federal government. Federal enforcement actions under the FCA can be civil or criminal in nature, depending...more
The Internal Revenue Service’s Criminal Investigation Division (IRS CI) is targeting tax preparers or the ones who prepare tax returns in 2022. IRS CI is focusing its efforts on tax preparers who underreport their clients’...more
6/1/2022
/ Criminal Investigations ,
Criminal Liability ,
Defense Strategies ,
Department of Justice (DOJ) ,
Income Taxes ,
Indictments ,
Internal Revenue Code (IRC) ,
Interviews ,
IRS ,
Tax Crimes ,
Tax Fraud ,
Tax Liability ,
Tax Preparers ,
Tax Returns
When registered brokers, their associates, or other financial advisors receive a FINRA 8210 letter, how they respond can make a big difference in the outcome of FINRA’s investigation. ...more
What is an FDA Warning Letter?
Did you receive an FDA warning letter? If so, then there are critical steps you can take today to prepare and to be able to respond promptly to the warning letter. The FDA will issue a...more
Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing.
These federal investigations can be surprising and confusing for lab...more
4/5/2022
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Liability ,
CLIA ,
Clinical Laboratories ,
Criminal Liability ,
Defense Strategies ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
FBI ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Fraud ,
Investigations ,
OIG ,
Penalties ,
Physicians ,
Stark Law
21 U.S.C. § 331: Selling Counterfeit Drugs -
Under Section 331, it is illegal to sell counterfeit drugs in interstate commerce. Because this includes online sales, the “interstate commerce” element is very easy to...more
2/22/2022
/ Controlled Substances ,
Counterfeiting ,
Criminal Defense ,
Criminal Investigations ,
Criminal Liability ,
Criminal Penalties ,
Criminal Prosecution ,
DEA ,
Defense Strategies ,
Department of Justice (DOJ) ,
Drug Trafficking ,
False Statements ,
Food and Drug Administration (FDA) ,
Fraud ,
Interstate Commerce ,
Misleading Statements ,
Prescription Drugs
The federal government has recently made clear its intention to go after healthcare providers who provide amniotic injections to certain Medicare and Medicaid recipients. Over recent years, the federal government has...more
10/26/2021
/ Anti-Kickback Statute ,
Billing ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Investigation Demand ,
Civil Liability ,
Criminal Liability ,
Defense Strategies ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
False Claims Act (FCA) ,
Government Investigations ,
Health Care Providers ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Physicians ,
Stark Law
Durable medical equipment (DME) is particularly important for many Medicare beneficiaries. However, companies that manufacture and sell DME need to be careful because there are strict federal regulations outlining almost...more
7/28/2021
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Chief Compliance Officers ,
Civil Liability ,
Compliance ,
Compliance Commitees ,
Corrective Action Plans (CAPs) ,
Criminal Liability ,
Department of Health and Human Services (HHS) ,
Disciplinary Proceedings ,
Durable Medical Equipment ,
Employee Training ,
Health Care Providers ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
OIG ,
Physicians ,
Policies and Procedures ,
Standard of Conduct ,
TRICARE
The U.S. Securities and Exchange Commission (SEC) protects investors by enforcing the nation’s securities laws. It can investigate all forms of securities fraud, including fraud committed by securities issuers,...more
6/1/2021
/ Business Entities ,
Corporate Executives ,
Criminal Liability ,
Defense Strategies ,
Document Productions ,
Electronically Stored Information ,
Internal Investigations ,
Investors ,
Privileged Communication ,
Securities and Exchange Commission (SEC) ,
Securities Fraud ,
Securities Violations ,
Subpoenas ,
Testimony
As federal agencies and law enforcement investigate pharmacies around the country for health care fraud and kickback schemes, pharmacies should be proactive in understanding their regulatory environment and the importance of...more
5/11/2021
/ Civil Liability ,
Compliance ,
Criminal Liability ,
Government Investigations ,
Healthcare Fraud ,
Kickbacks ,
Pharmaceutical Industry ,
Pharmacies ,
Policies and Procedures ,
Prescription Drugs ,
Regulatory Requirements
The U.S. Securities and Exchange Commission (SEC) investigates companies (and individuals) for a broad range of federal offenses. This includes offenses that are both civil and criminal in nature, and that can carry penalties...more
5/4/2021
/ Civil Liability ,
Corrective Actions ,
Criminal Liability ,
Defense Strategies ,
Enforcement Actions ,
Investigations ,
Securities and Exchange Commission (SEC) ,
Securities Fraud ,
Securities Litigation ,
Securities Violations ,
Subpoenas
Corporate investigations can serve a variety of different purposes. From uncovering accounting fraud to responding to cybersecurity breaches and preparing for litigation, there are various circumstances in which corporate...more
3/23/2021
/ Accounting Fraud ,
Board Members ,
Board of Directors ,
Breach of Duty ,
Bribery ,
Civil Investigation Demand ,
Civil Liability ,
Commercial Litigation ,
Corporate Executives ,
Corporate Investigations ,
Corruption ,
Criminal Liability ,
Cybersecurity ,
Data Breach ,
Employment Discrimination ,
Fiduciary Duty ,
Financial Fraud ,
Harassment ,
Internal Investigations ,
National Security ,
Private Investigators ,
Shareholder Litigation ,
Subpoenas ,
Target Letters ,
Whistleblowers
Today’s modern world enables complex business transactions to occur both within the United States as well as abroad in cross-border activities. Many of these transactions pose significant risks to business operations and the...more
1/20/2021
/ Business Operations ,
Civil Liability ,
Compliance ,
Corporate Counsel ,
Corporate Investigations ,
Corporate Liability ,
Corporate Misconduct ,
Criminal Liability ,
Cross-Border Transactions ,
Due Diligence ,
Fraud Prevention ,
Internal Controls ,
Internal Investigations ,
Reputation Management ,
Risk Management ,
Third-Party Risk
Most health care providers have at least a basic understanding of the Anti-Kickback Statute. This federal law prohibits providers from offering, paying, soliciting, or accepting any form of “remuneration” for patient...more
12/11/2020
/ Anti-Kickback Statute ,
Civil Liability ,
Clinical Laboratories ,
Criminal Liability ,
Criminal Penalties ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Facilities ,
Medicaid ,
Medicare ,
Medicare Part D ,
Noncompliance ,
Patient Referrals ,
Physicians ,
Policies and Procedures ,
Stark Law