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
STOs and NFTs -
STOs stands for “security token offerings.” They involve an offering of digitalized securities such as stocks, bonds, or other token and coin projects. The difference between an IPO and an STO is that STOs...more
3/31/2022
/ Blockchain ,
Digital Assets ,
Investment Contract ,
Non-Fungible Tokens (NFTs) ,
Popular ,
Registration Requirement ,
Securities and Exchange Commission (SEC) ,
Securities Regulation ,
Securities Violations ,
Security Token Offering (STOs) ,
Utility Tokens
Congress is the law-making body of the federal government. It constantly makes new laws or modifies or repeals old ones in every area of federal law – from finance to foreign affairs. Congress is one of three equal branches...more
U.S. taxpayers have an obligation to both report their cryptocurrency transactions to the IRS and pay taxes on it. Individuals who hold on to their cryptocurrencies as an investment are subject to short- and long-term capital...more
Responding to a congressional subpoena requires thorough preparation and a clear understanding of the process and the risks involved. Congressional committees established by Supreme Court rulings issue subpoenas to targets...more
FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an experienced FDA defense attorney....more
3/2/2022
/ Attorney-Client Privilege ,
Corrective Actions ,
Criminal Investigations ,
Deadlines ,
Defense Strategies ,
Enforcement Actions ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Internal Investigations ,
Manufacturer Liability ,
Manufacturers ,
Risk Assessment
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 Controlled Substances Act (“CSA”) -
The CSA (21 U.S.C. 801 et seq.) imposes a framework that regulates different categories of certain drugs that pose dependency and abuse risks to the public. The CSA applies only to...more
What Is A DAO?
A decentralized autonomous organization (“DAO”) is a collectively owned and managed entity with a set of rules written in computer code. They are organized around a set of rules on the blockchain and...more
The IRS, Taxpayers, and Cryptocurrencies or virtual currencies -
The Internal Revenue Service (“IRS”) issued its first guidance on cryptocurrencies— “virtual currencies''—in 2014, taking the position that crypto...more
The COVID-19 pandemic increased the business opportunities available to clinical labs, including molecular and respiratory labs. As the nation—and the world—struggled to develop adequate testing infrastructure, the federal...more
1/19/2022
/ Audits ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Defense Strategies ,
Department of Health and Human Services (HHS) ,
FBI ,
Health Care Providers ,
Healthcare Fraud ,
Investigations ,
Medical Billing Codes ,
Medical Necessity ,
OIG ,
Patient Referrals ,
Physicians
The United States Department of Justice (DOJ) is the federal agency tasked with enforcing a wide range of federal laws and regulations. When the DOJ suspects that an individual or business has violated a federal law or...more
For diabetic patients and the doctors who treat them, blood sugar levels are crucially important. However, the traditional method of testing one’s blood sugar with a pin-prick is undesirable for many patients, which leads to...more
Cybercrime has been on the rise in recent years. In response, the federal government has shown an increased interest in prosecuting cybercrime offenses. The Computer Fraud and Abuse Act, codified at 18 U.S.C. Section 1030, is...more
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
Section 206 of the Investment Advisers Act of 1940 is one of the many laws the U.S. Securities and Exchange Commission (SEC) uses to combat investment fraud. Under Section 206, investment advisers can face enforcement action...more
Several federal agencies rely on search warrants to gather evidence in support of their law enforcement efforts. If you have received a search warrant from the Federal Bureau of Investigation (FBI), Drug Enforcement...more
9/28/2021
/ Admissible Evidence ,
Asset Seizure ,
Criminal Investigations ,
Criminal Prosecution ,
DEA ,
Defense Strategies ,
Electronically Stored Information ,
Evidence ,
FBI ,
Federal Prosecutors ,
Government Investigations ,
Immigration and Customs Enforcement (ICE) ,
Indictments ,
Law Enforcement ,
Obstruction of Justice ,
Risk Mitigation ,
Search & Seizure ,
Search Warrant ,
Subpoenas
Receiving a federal grand jury subpoena is a serious matter. Whether you are the target of a federal investigation or prosecutors believe you have information they can use to pursue charges against another person or company,...more
9/21/2021
/ Criminal Investigations ,
Criminal Prosecution ,
Defense Strategies ,
Document Review ,
Evidence ,
Government Investigations ,
Grand Juries ,
Litigation Hold ,
Motions to Quash ,
Noncompliance ,
Subpoenas ,
Testimony ,
U.S. Attorney ,
Witness
The Food and Drug Administration (FDA) is the federal agency charged with ensuring the safety of foods, medications and other consumer products sold in the United States....more
The U.S. Securities and Exchange Commission (SEC) investigates companies, brokerage firms, and individuals for a broad range of statutory and regulatory violations. These investigations can lead to civil or administrative...more
9/7/2021
/ Broker-Dealer ,
Churning ,
Defense Strategies ,
Enforcement Actions ,
Evidence ,
Initial Coin Offering (ICOs) ,
Initial Public Offering (IPO) ,
Insider Trading ,
Investigations ,
Investment Adviser ,
Investment Advisers Act of 1940 ,
Investment Companies ,
Investment Company Act of 1940 ,
Investment Firms ,
Market Manipulation ,
Misappropriation ,
Misrepresentation ,
Omissions ,
Publicly-Traded Companies ,
Regulatory Violations ,
Securities Act of 1933 ,
Securities and Exchange Commission (SEC) ,
Securities Exchange Act of 1934 ,
Securities Fraud ,
Securities Violations ,
Statutory Violations ,
Subpoenas ,
Unregistered Securities ,
Wells Notice ,
Witness Statements
The Computer Fraud and Abuse Act (CFAA), codified at 18 U.S.C. Section 1030, is one of the U.S. Department of Justice’s most potent weapons in its fight against cybercrimes. It outlines numerous offenses, and it imposes...more
9/1/2021
/ Computer Fraud and Abuse Act (CFAA) ,
Criminal Conspiracy ,
Criminal Prosecution ,
Cyber Crimes ,
Cyber Threats ,
Cybersecurity ,
Defense Strategies ,
Department of Justice (DOJ) ,
Felonies ,
Misdemeanors ,
Popular ,
Risk Mitigation ,
Unauthorized Access
Cardiovascular stress testing to diagnose patients with coronary artery disease (CAD) and other related types of conditions can be a highly-effective tool in many cases. In fact, many cardiologists routinely recommend stress...more
8/24/2021
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Documentation ,
False Billing ,
Health Care Providers ,
Investigations ,
Local Coverage Determinations (LCDs) ,
Medical Necessity ,
Medicare ,
Medicare Fraud ,
OIG ,
Policies and Procedures ,
Stress Tests
The Centers for Medicare and Medicaid Services (CMS) and U.S. Department of Justice (DOJ) are scrutinizing health care providers’ Medicare billings for amniotic injections. These injections are only eligible for Medicare...more
8/17/2021
/ Anti-Kickback Statute ,
Billing ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Investigation Demand ,
Department of Justice (DOJ) ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Medicare Fraud
The tragedy of the COVID-19 pandemic is something we all agree we wish we could have avoided. However, the fact of the matter is that many respiratory and clinical labs have seen a boon to their bottom line due to the...more
8/10/2021
/ Chief Compliance Officers ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Compliance ,
Compliance Monitoring ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Infectious Diseases ,
OIG ,
Policies and Procedures ,
Regulatory Requirements ,
Virus Testing
In October 2020, the U.S. Department of Justice (DOJ) filed charges against eight individuals accused of operating “repatriation squads” in the United States on behalf of the People’s Republic of China (PRC). It announced...more
7/29/2021
/ China ,
Criminal Convictions ,
Criminal Investigations ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
FBI ,
Foreign Agents ,
Foreign Governments ,
Foreign Nationals ,
National Security ,
Popular ,
United Arab Emirates (UAE)