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DOJ Releases COVID-19 Fraud Enforcement Task Force Report Touting Its Successes and Urging Lawmakers to Enact New Legislation
April 18, 2024 | Blog | By Jane Haviland, Abdie Santiago
The government’s continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 Fraud Enforcement Task Force’s (CFETF) report released on April 9, 2024. The CFETF, which represents a concerted effort across numerous federal agencies to investigate pandemic-related fraud, has, according to its 2024 report, succeeded in prosecuting over 3,500 defendants in criminal enforcement matters, in bringing civil enforcement actions resulting in more than 400 civil settlements and judgments, and in securing more than $1.4 billion in seizures and forfeitures. The report itself is a showcase of the CFETF’s COVID-19 fraud enforcement efforts to date.
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Telehealth Update: DEA Extends Flexibility in Prescribing Controlled Substances via Telehealth Through 2024
October 24, 2023 | Blog | By Cassandra Paolillo, Stephnie John
On October 10, 2023, the Drug Enforcement Administration (DEA) published another temporary rule extending the COVID-era telemedicine flexibilities that allow physicians and other prescribers to prescribe controlled substances without an in-person evaluation. With just over a month to go before the expiration of the first set of flexibilities, the DEA announced that the telemedicine flexibilities, which have been in place since March 2020, will be extended through the end of 2024 in order to give the agency more time to consider feedback received in response to the proposed rule, which was announced in March of this year. As a reminder, under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, providers may not prescribe controlled substances without an in-person visit, unless an exception applies. The COVID public health emergency triggered one such exception, which lead to the telehealth flexibilities.
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Telehealth Update: DEA Issues Temporary Rule on Prescribing Controlled Substances via Telehealth as the Public Health Emergency Comes to an End
May 10, 2023 | Blog | By Ellen Janos, Cassandra Paolillo
As we previously covered, in March 2023, the Drug Enforcement Agency (DEA) announced a proposed rule on prescribing controlled substances via telehealth, aimed at addressing the “telehealth cliff” that was expected to occur once the COVID-19 Public Health Emergency (PHE) ends on May 11, 2023. The proposed rule provided some flexibility, but required a much more restrictive framework for prescribing controlled substances via telehealth compared to the flexibilities available during the PHE. During the 30-day comment period following the announcement of the proposed rule, the DEA received over 38,000 comments, which the agency says it is closely reviewing. Many commentators across the health care industry criticized the proposed rule because the in-person examination requirement would limit access to care. The DEA, working with the Department of Health and Human Services, is also considering revisions to the proposed rule.
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The End of the Federal COVID-19 Public Health Emergency is Near: What to Expect as HHS Transitions beyond the Emergency Phase
April 27, 2023 | Blog | By Jean D. Mancheno, Sophia Temis
With less than two weeks left until the end of the federal COVID-19 Public Health Emergency (PHE), which is set to expire on May 11, 2023, the Department of Health and Human Services (HHS) is preparing to transition certain COVID-19 flexibilities. On February 9, 2023, HHS released a COVID-19 PHE Transition Roadmap, which provides guidance on what to expect beyond the emergency phase of the COVID-19 pandemic. While many of the relaxed rules and regulations that helped facilitate an efficient and timely response during the PHE have been permanently signed into law, others, some of which are discussed below, will soon expire.
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Massachusetts to End Public Health Emergency
March 23, 2023 | Blog | By Ryan Rasdall
On March 15, 2023, Massachusetts Governor Maura Healey and Lieutenant Governor Kim Driscoll announced that the state’s COVID-19 public health emergency would end on May 11, 2023, in conjunction with the federal government’s end date for the public health emergency. This announcement by the Healey-Driscoll administration puts state organizations on notice, as required by law, at least 45 days ahead of the changes. As part of this announcement, Governor Healey also announced that she will be (i) rescinding Executive Order 595 which required state employees to be vaccinated against COVID-19, and (ii) proposing new legislation that allows for further flexibility in health care settings.
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Telehealth Update: DEA Issues Long-Awaited Proposed Rule on Prescribing Controlled Substances via Telehealth
March 3, 2023 | Blog | By Ellen Janos, Cassandra Paolillo
With just over two months before the COVID-19 Public Health Emergency (PHE) expected expiration on May 11, 2023, the Drug Enforcement Agency (DEA) has finally announced its proposed rule on prescribing controlled substances via telehealth. This post provides continued coverage of telehealth updates and dissects what this DEA's proposed rule could entail.
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OIGs Report on Expanded Telehealth Service Access and Use, Program Integrity Risks During Year One of COVID-19 Pandemic
December 21, 2022 | Blog | By Karen Lovitch, Pat Ouellette, Sophia Temis
The Pandemic Response Accountability Committee (PRAC) Health Care Subgroup recently published an expansive report that highlighted the sheer volume of expanded access to and use of telehealth services in certain federal health care programs during the first year of the COVID-19 pandemic. The report also focused on program integrity risks related to this expanded use and included recommended safeguards for future oversight of telehealth services.
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Regulatory Roundup: Important FDA Developments at the End of September 2022
October 10, 2022 | Blog | By Joanne Hawana, Benjamin Zegarelli
There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022 that we decided to create a summary roundup for our readers!
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The Government's Long Game for Investigating COVID-era Relief Fraud
September 16, 2022 | Blog | By Eoin Beirne
Various COVID relief programs pumped $5 trillion into the economy, incredibly quickly, and with relatively minimal vetting. Within that enormous and necessary set of economic stimulus packages was likely the greatest amount of fraud committed on the government in the shortest amount of time in history. This article takes a look at the various issues facing government agencies as they attempt to investigate allegations of PPP fraud related to pandemic-era applications and the role of the Pandemic Response Accountability Committee in coordinating and overseeing these investigations.
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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. Mancheno
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
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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Viewpoint Editors
Karen S. Lovitch
Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice
Joanne S. Hawana
Member
Rachel E. Yount
Of Counsel
Pat G. Ouellette
Associate
Stephnie A. John
Associate
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