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The U.S. Food and Drug Administration (FDA) recently announced what appears to be the first public warning made by the agency to a company promoting an approved prescription drug product for the unapproved use of treating COVID-19 symptoms. Although the regulatory action was announced in the FDA’s daily pandemic update on October 2, 2020, the warning letter issued by the Office of Prescription Drug Promotion (OPDP) is dated September 22, 2020. From our perspective, this public FDA action is notable for two distinct policy reasons.
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As predicted, the Department of Justice (DOJ) and other enforcement agencies have acted quickly to bring substantial criminal enforcement actions for fraud against the Paycheck Protection Program (PPP). Acting Assistant Attorney General (AAG) Brian Rabbitt announced recently that the DOJ’s Criminal Division reached the important milestone that day of criminally charging more than 50 individuals for alleged fraud committed to obtain PPP funds.
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On September 9, 2020, the Department of Justice (DOJ) announced a $50 million settlement with Wheeling Hospital, Inc. of West Virginia to resolve False Claims Act allegations that Wheeling Hospital violated the Anti-Kickback Statute (AKS) and Stark Law. The settlement resolved False Claims Act allegations that were triggered by a qui tam lawsuit brought by a former vice president of Wheeling Hospital who oversaw hospital operations and physician engagements. According to the relator's complaint, Wheeling Hospital, under its former management, paid several physicians annual compensation in excess of a million dollars based on the volume or value of their referrals.
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The U.S. Department of Justice and U.S. Health and Human Services Office of Inspector General recently announced the indictment of a pharmacy marketer who allegedly received and paid kickbacks in violation of the federal Anti-Kickback Statute (AKS). While the alleged fraudulent scheme isn’t anything new, the actions that the marketer allegedly took to try to cover up the scheme serve as a good lesson.
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Seventh Circuit Adds to Circuit Split Over Standard for DOJ Dismissals in FCA Cases

August 25, 2020 | Blog | By Laurence Freedman, Geoffrey Friedman, Caitie Hill

The Seventh Circuit Court of Appeals recently decided a case that created a new standard to assess requests by the Department of Justice (DOJ) to dismiss declined qui tam (whistleblower) suits under the False Claims Act (FCA). See U.S. ex rel. CIMZNHCA LLC V. UCB Inc. et al., No. 19-2273 (7th Cir. 2020). Prior to this decision, federal Courts of Appeals applied either the Sequoia Orange standard or the Swift standard, discussed below. In this decision, the Seventh Circuit opined that the standard should be informed by Federal Rule of Civil Procedure (FRCP) 41, and this standard “lies much nearer to Swift.” The Seventh Circuit also decided a key jurisdictional issue: whether the United States can appeal a denial of its motion to dismiss a declined qui tam action. Again, taking a new tack, the panel resolved this issue by construing the motion to dismiss also as a motion to intervene and construing the district court’s decision as a denial of that motion, thus obviating the need to invoke the collateral order doctrine.
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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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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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Last Friday, the Department of Justice (DOJ) announced another increase to civil monetary penalties assessed under the False Claims Act (FCA), among other statutes. DOJ made these adjustments to account for inflation, in accordance with the Bipartisan Budget Act of 2015, and they apply to penalties assessed after June 19, 2020, for violations occurring after November 2, 2015.
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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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A few weeks ago, we posted about a publication by the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) of responses to certain frequently asked questions (FAQs) received from the health care community regarding regulatory flexibility for providers that needed it to adequately respond to COVID-19 concerns.  This flexibility specifically relates to the OIG’s administrative enforcement authorities, including the federal Anti-Kickback Statute (AKS) and Civil Monetary Penalties Law prohibiting beneficiary inducement (Beneficiary Inducement CMPL).
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On Friday, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued responses to a series of frequently asked questions (FAQs), in an effort to provide some level of regulatory flexibility for health care providers responding to COVID-19 concerns.  These FAQs relate to enforcement of the OIG’s administrative enforcement authorities under the federal Anti-Kickback Statute (AKS) and Civil Monetary Penalties Law prohibiting beneficiary inducement (Beneficiary Inducement CMPL) only.
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In Case You Missed It: COVID-19 Webinars to Keep You Informed

April 24, 2020 | Blog | By Michelle Caton

The ongoing COVID-19 pandemic has introduced uncertainty and unique challenges in nearly every aspect of life. During this unprecedented time, Mintz is working to keep our clients and community informed and empowered to navigate this new world. To that end, we’ve created a number of webinars on a variety of COVID-19-related topics of interest to health care industry stakeholders. In case you missed them, here’s a highlights reel of what we’ve covered so far – just click on the links below to access the webinar recordings.
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As many of our readers know, as a result of the public health emergency caused by COVID-19, effective March 1, 2020, the U.S. Department of Health and Human Services (“HHS”) issued blanket waivers of its authority under Section 1877(g) of the Social Security Act (which authorizes the imposition of certain sanctions for violations of the Stark Law) with respect to 18 categories of remuneration and/or referrals (the “Blanket Waivers”).
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In response to the spread of COVID-19, on March 23, 2020, President Trump signed Executive Order 13910 (Order) to prevent the hoarding of health and medical resources necessary to respond to the spread of COVID-19 within the United States. Through the Order, the President delegated his authority under the Defense Production Act of 1950, 50 U.S.C. § 4512 (Act) to the Secretary of Health and Human Services (HHS). The Order authorizes HHS to protect scarce and threatened health care and medical items by designating particular items as protected under the Act (Designated Items). Once an item is designated, the Act makes it a crime for any person to accumulate Designated Items: (i) in excess of the reasonable demands of business, personal, or home consumption; or (ii) for the purpose of resale at prices in excess of prevailing market prices. In this post, we discuss four things to know in connection with the Order.
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Law Enforcement Stays Active During the COVID-19 Pandemic

April 13, 2020 | Blog | By Hope Foster

Last Tuesday, we blogged about the arrest of the owner of a Georgia-based marketing company who was charged with health care fraud and conspiracy to violate the Anti-Kickback Statute. The government has alleged that laboratories paid the company kickbacks for Coronavirus (COVID-19) testing leads.

The very next day, the United States Attorney’s Office in San Antonio, Texas charged 39 year-old Christopher Perez with allegedly perpetuating a COVID-19-related hoax by posting a false threat on Facebook in which he claimed to have paid someone to spread COVID-19 at grocery stores in Texas. These prompt actions to implement Attorney General William Barr’s March 16 call to prioritize the detection, investigation, and detection of all criminal conduct related to the COVID-19 pandemic caused us to wonder what the federal government is doing about enforcement. The answer is: a lot.
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On March 16th, Attorney General William Barr issued a memorandum to all United States Attorneys directing each U.S. Attorney’s Office (USAO) to “prioritize the detection, investigation, and prosecution of all criminal conduct related to the current pandemic,” noting that “the pandemic is dangerous enough without wrongdoers seeking to profit from public panic.”  It appears that USAOs have wasted no time in prioritizing such cases, as the owner of a Georgia-based marketing company that generated leads for medical-testing companies was arrested earlier this week and charged with conspiracy to commit health care fraud and conspiracy to violate the Anti-Kickback Statute.
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The Department of Justice recently filed suit against Anthem, Inc. (Anthem) alleging that the Medicare Advantage Organization (MAO) violated the False Claims Act when it knowingly failed to delete inaccurate diagnosis codes submitted to the Centers for Medicare and Medicaid Services (CMS) for risk adjustment purposes. As predicated in our 2020 outlook post, we continue to see enforcement activity and ongoing litigation against Medicare Advantage plans. Notably, this trend is referenced in SDNY’s complaint, alleging that the government has “sought to enforce” data accuracy in the risk adjustment system by “actively pursuing legal remedies against [] MAOs that have knowingly submitted inaccurate and untruthful diagnosis data to CMS[.]” The complaint provides four examples of settlements obtained from 2012-2019 against MAOs and healthcare providers who, purportedly like Anthem, submitted inaccurate diagnosis codes to CMS or allegedly failed to delete unsupported diagnosis codes.
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The Ninth Circuit Court of Appeals recently allowed a False Claims Act (FCA) case based on an alleged lack of medical necessity to proceed, rejecting the lower court's decision that subjective medical opinions about the necessity of hospitalization cannot be "objectively false." The Ninth Circuit joins several other circuits (including the Third Circuit, which recently issued the Druding decision that we posted about a few weeks ago) in reaching this decision, which has been a rapidly evolving area of FCA law.
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India Orders Shutdown Impacting Millions of Outsourced Technology and Financial Sector Workers

March 26, 2020 | Alert | By Julie Korostoff, Meredith M. Leary, Laura A. Stacey

This alert discusses what companies outsourcing critical business process functions to India should do in light of the Indian government’s order that telecom, IT, and other technology companies should, as far as possible, work from home.
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