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FDA Cracks Down on Unauthorized and Counterfeit COVID-19 Diagnostic Tests

May 9, 2022 | Blog | By Benjamin Zegarelli

As the COVID-19 public health emergency drags into its third year, we continue to keep track of efforts by the Food and Drug Administration (FDA) to combat fraud in the form of fake cures, counterfeit diagnostic tests, and other products claiming to prevent, treat, or detect infection by SARS-CoV-2 that are marketed without required FDA authorization. Our previous posts provided updates on joint and separate efforts by FDA and the U.S. Federal Trade Commission (FTC) throughout the pandemic to detect and eliminate these illegal products. In this post, we focus on FDA’s recent enforcement activities concerning COVID-19 diagnostic tests and the agency’s increasingly aggressive pursuit of entities offering counterfeit or unauthorized tests.
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DOJ Announces Another Wide-Ranging COVID-19 Fraud Enforcement Action

April 28, 2022 | Blog | By Samantha Kingsbury

Last week, the Department of Justice (DOJ) announced another significant takedown that it described as “build[ing] on the success of the May 2021 COVID-19 Enforcement Action.”  As part of this enforcement effort, criminal charges were announced against 21 defendants across the country for their alleged involvement in various COVID-19 related fraud schemes that resulted in over $149 million in “COVID-19 related false billings to federal programs and theft from federally-funded pandemic assistance programs.” 
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HRSA Demands Repayment from Providers that Failed to Comply with Provider Relief Fund Reporting Requirements

April 11, 2022 | Blog | By Jean D. Krebs, Nick Torres

Under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services (HHS) is authorized to distribute funds from its Provider Relief Fund (PRF) to certain providers. These providers can then use the funds to support COVID-19 prevention, preparedness, and response, or to alleviate loss of patient care revenue.  However, HRSA requires that providers receiving PRF funds comply with certain requirements, including post-payment reporting requirements.  HRSA is now notifying providers that failed to comply with the reporting requirements that they must return the PRF funds they received. 
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DOJ Keeps Focus on COVID-19 Related Fraud with Appointment of Director

March 14, 2022 | Blog | By Sarah Beth Kuyers

The U.S. Department of Justice (DOJ) has continued to investigate and prosecute alleged COVID-19 related fraud over the past two years since the pandemic began. On Thursday, DOJ announced the appointment of a Director for COVID-19 Fraud Enforcement, who will lead DOJ’s enforcement efforts in this area. Associate Deputy Attorney General Kevin Chambers will fill this position.
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FTC Engages in First Enforcement Action under COVID-19 Consumer Protection Act

April 27, 2021 | Blog | By Joanne Hawana, Samantha Kingsbury

In its first exercise of a newly granted authority, the Federal Trade Commission (FTC or the Commission) on April 15, 2021 charged a St. Louis-based chiropractor and his company (the Defendants) with violating the COVID-19 Consumer Protection Act (the COVID-19 Act) and the Federal Trade Commission Act (FTC Act).  The Commission’s allegations focus on the deceptive marketing of products containing Vitamin D and Zinc as being scientifically proven to treat or prevent COVID-19 and as being equally as effective as or more effective than currently available COVID-19 vaccines.
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Health Care Enforcement Update:  Covid-19 Fraud Cases Brought By DOJ And Private Plaintiffs

March 31, 2021 | Blog | By Grady Campion, Jane Haviland, Karen Lovitch

On Friday, March 26, 2021, the Department of Justice (DOJ) announced an update on its efforts to combat COVID-19 related fraud.  Since Congress first responded to the coronavirus pandemic by passing $2.2 trillion in relief through the Coronavirus Aid, Relief, and Economic Security (CARES) Act in March 2020, DOJ has pursued civil and criminal actions primarily targeting (1) fraudulent COVID-19 related tests or treatments, and (2) abuse of the CARES Act’s popular Paycheck Protection Program (PPP).  Friday’s announcement revealed that DOJ is also ramping up its efforts to prosecute fraud on the CARES Act’s Economic Injury Disaster Loan (EIDL) and Unemployment Insurance (UI) initiatives. 
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Health Care Enforcement Kept the DOJ Fraud Section Busy in 2020

March 8, 2021 | Blog | By Eoin Beirne, Grady Campion

On February 24, 2021, DOJ’s Criminal Division Fraud Section published its annual year-end summary. The Fraud Section focuses on prosecuting white-collar crime. The report summarizes enforcement activity in the past year and discusses notable cases from the Fraud Section’s three litigation units: (1) the Health Care Fraud (HCF) Unit; (2) the Foreign Corrupt Practices Act (FCPA) Unit; and (3) the Market Integrity and Major Frauds (MIMF) Unit. In summarizing the Fraud Section’s main achievements from 2020, the report also provides valuable insights on what lies ahead for the Fraud Section in 2021. This post focuses on the health care enforcement portion of the Fraud Section’s report.
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Recent DOJ Comments Shed Light on Expected Civil Enforcement of COVID-19 Cases

August 18, 2020 | Blog | By Nicole Henry, Karen Lovitch

Comments made by Department of Justice attorneys during a recent webinar provided insight into the government’s civil enforcement priorities related to the coronavirus pandemic. In particular, government attorneys expect that civil enforcement related to COVID-19 relief funds will focus on certifications made by applicants seeking loan forgiveness and anticipate increased investigations into telemedicine services.
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Massachusetts U.S. Attorney’s Office Enters into MOU with Office of the Special Inspector General for Pandemic Recovery

July 30, 2020 | Blog | By Karen Lovitch, Caitie Hill

United States Attorney Andrew E. Lelling recently announced that the U.S. Attorney’s Office for the District of Massachusetts entered into a Memorandum of Understanding with Special Inspector General Brian D. Miller of the Office of the Special Inspector General for Pandemic Recovery to investigate and prosecute fraud in the distribution of the funds authorized by the Coronavirus Aid, Relief, and Economic Security.
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COVID-19 Relief Programs: Recent Criminal Enforcement and Anticipated Trends

July 9, 2020 | Blog | By Eoin Beirne, Nicole Henry

Leading up to a webinar on July 15, 2020, we are publishing a blog series covering the risks of enforcement against companies that received COVID-19 relief funds under the CARES Act and strategies for mitigating those risks.  This third, and final, installment of our series discusses emerging and anticipated criminal enforcement involving COVID-19 relief programs.
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COVID-19 Relief Programs: The Anticipated Wave of False Claims Act Cases and Oversight Agency Enforcement Activities

July 2, 2020 | Blog | By Brian Dunphy, Geoffrey Friedman, Caitie Hill, Jane Haviland, Karen Lovitch

Leading up to a webinar on July 15, 2020, we are publishing a blog series covering the risks of enforcement against companies that received COVID-19 relief funds under the CARES Act and strategies for mitigating these risks.  This second installment of our series discusses our predictions related to litigation and enforcement activities. We expect a substantial number of False Claims Act (“FCA”) investigations and lawsuits initiated mainly by whistleblowers (also known as “relators”). The FCA remains the government’s primary enforcement tool for pursuing alleged fraud by recipients of government funds, and FCA claims present substantial risk because the statute permits treble damages and significant per-claim penalties. For example, an erroneous $100,000 loan under the Paycheck Protection Program (“PPP”) can result in $300,000 in FCA damages, or more.
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COVID-19 Relief Programs: Mitigating and Responding To Enforcement Risk

June 22, 2020 | Blog | By Brian Dunphy, Jane Haviland, Nicole Henry, Karen Lovitch

Since the early days of the pandemic, Mintz’s COVID-19 Compliance & Enforcement Defense Task Force has closely monitored and advised clients on the evolving COVID-19 relief programs, including those created by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The CARES Act provided for over $2 trillion in relief funds, which is the largest emergency assistance package in American history. The numerous CARES Act programs have continued to develop through, among other things, the passage of the Paycheck Protection Program and Health Care Enhancement Act, the Paycheck Protection Program Flexibility Act of 2020, and rapidly changing regulatory guidance and FAQs. As one example, the government recently wrestled with whether to make public the list of about 4.6 million entities that received more than $500 billion from the Paycheck Protection Program (PPP) under the CARES Act. After initially refusing to disclose PPP loan recipients, the Small Business Administration and Treasury Department decided to make public the names of entities that received loans larger than $150,000, as well as the dollar range of each loan.
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