Facing a Qlarant audit is a serious matter for healthcare providers and other entities that bill Medicare or Medicaid. While the Qlarant Foundation is a non-profit entity, Qlarant Integrity Solutions is a profit-driven entity...more
Government agency audits focused on Medicare, Medicaid, and pharmacy benefit manager (PBM) compliance can result in substantial losses for pharmacies. Each pharmacy is audited the same way it is done with other similarly...more
U.S. companies with international clients or customers have to comply with far more laws and regulations than companies that only operate domestically. These include laws and regulations enforced by the U.S. Office of Foreign...more
Medical professionals, patients, and others can commit healthcare fraud by deceiving the healthcare system, such as providing medically unnecessary services, in order to get unauthorized benefits or payments. Facing...more
A civil investigative demand (CID) is a powerful law enforcement tool that federal agencies including the U.S. Department of Justice (DOJ) use during the early stages of civil investigations into potential violations of the...more
Federal criminal cases can broadly be divided into four phases: (i) the government’s investigation, (ii) grand jury proceedings, (iii) pretrial practice, and (iv) trial. The empanelment of a grand jury is a critical juncture,...more
8/2/2022
/ Attorney-Client Privilege ,
Criminal Convictions ,
Criminal Investigations ,
Criminal Prosecution ,
Defense Strategies ,
Department of Justice (DOJ) ,
Grand Juries ,
Guilty Pleas ,
Indictments ,
Motion to Dismiss ,
Motions to Quash ,
Self-Incrimination ,
Subpoenas
Nearly all healthcare providers will face an audit (if not multiple audits) during their careers. Federal agencies such as the U.S. Department of Health and Human Services (HHS) routinely audit healthcare providers for...more
Civil investigative demands (CIDs) are powerful investigative tools that federal agencies use to gather information in support of a broad range of charges. Identifying the federal agencies that issued a civil investigative...more
7/12/2022
/ Attorney-Client Privilege ,
Civil Investigation Demand ,
Consumer Financial Protection Bureau (CFPB) ,
Cooperation ,
Defense Strategies ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Litigation Hold ,
Meet and Confer ,
Motions to Quash ,
Privileged Documents
When current or former employees or clients blow the whistle on alleged corporate wrongdoing, it can create the potential for significant legal liability. It can even create the possibility of criminal charges being...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
U.S. Food and Drug Administration (FDA) audits can uncover violations of the Food, Drug, and Cosmetic Act (FD&C Act) and other federal food and drug laws and regulations. Those violations can lead to administrative, civil, or...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
Over recent years, the federal government has shown an increased interest in bringing healthcare fraud prosecutions. In fact, in 2020 alone, the federal government opened 1,148 new criminal healthcare fraud investigations,...more
Pharmacy benefit managers (PBM) audits are becoming increasingly dangerous for independent pharmacies. While the role of the PBM was initially to reduce costs for all parties involved, abusive PBM practices have led to the...more
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
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
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 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
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