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COVID Test Kit Fraud Defense Attorneys

Former Top Prosecutors, Federal Investigators & Government Regulators Working for You

25+ Years of Experience

COVID Test Kit Fraud Defense Attorneys for Labs & Pharmacies

Allegations of COVID test kit fraud can lead to severe legal and financial consequences. If your business is facing a government investigation, it’s critical to act fast. At Health Law Alliance, we defend healthcare providers and businesses accused of COVID test kit fraud. Our experienced legal team helps you navigate the investigation, protect your rights, and minimize penalties.

  • Rapid Legal Action: We quickly respond to fraud allegations to protect your business and reputation. Our attorneys are available when you need them, including nights and weekends.
  • Experienced Defense Team: Extensive experience in defending clients against government investigations and regulatory actions. We have defended against alleged multi-million dollar test kit fraud in federal cases around the country.
  • Customized Defense Strategy: Tailored legal strategies based on your specific situation to reduce risk and exposure. We use our knowledge of the government's playbook to protect you.
  • Regulatory Compliance Support: Before questions arise, ensure compliance with government guidelines to avoid future legal challenges.
  • Post-Investigation Protection: Ongoing support to safeguard your business and maintain compliance after the investigation, including corrective action.
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    Past Experience

    Why Health Law Alliance?

    Our team is your best defense.

    Healthcare Specialty Attorneys and Consultants - Health Law Alliance specializes in healthcare law and is dedicated to defending healthcare providers and their licenses from overreach.

    Tenacious Defense - Health Law Alliance has gone after – and beaten – much bigger opponents. When faced with a seemingly daunting legal issue, our attorneys are the ones to call.

    ‍Proven Track Record - The attorneys at Health Law Alliance have a demonstrated track record of success against the most aggressive government regulators and industry behemoths.

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    FAQs

    What is COVID test kit fraud?

    COVID test kit fraud involves actions like unauthorized billing, distributing test kits outside approved channels, or falsifying documentation to receive higher reimbursements. The federal government has teams of investigators that are focused on auto-refills and beneficiary complaints relating to unnecessary COVID test kits.

    Why am I being investigated for COVID test kit fraud?

    Investigations may result from discrepancies in billing, failure to meet regulatory requirements, or complaints. The government is closely monitoring test kit distribution and billing to prevent fraud, including by using Task Forces in offices across the country to prioritize COVID fraud cases.

    What should I do if I receive a notice of COVID test kit fraud investigation?

    Contact an experienced attorney immediately. They can help you understand the allegations, gather evidence, and build a robust defense strategy.

    What are the potential consequences of COVID test kit fraud?

    Consequences can include significant fines, exclusion from federal programs, and even criminal charges. Legal representation is crucial to minimize these risks.

    Can I appeal the findings of a COVID test kit audit?

    Yes, the government often uses private firms, like Safeguard Services or Qlarant to conduct test kit audits. Following any adverse findings, there is a formal process for challenging those findings, which an experienced attorney can lead you through.

    How can your firm help defend against COVID test kit fraud allegations?

    Our team of former federal prosecutors and healthcare compliance experts provides comprehensive legal support, from initial consultations to courtroom representation.

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    01

    Understanding COVID-19 Test Kit Fraud Law

    The outbreak of the COVID-19 pandemic brought unprecedented challenges and changes to the healthcare industry. Amid the urgent need for testing, some healthcare providers found themselves navigating a complex web of regulations they hadn't encountered before. COVID-19 Test Kit Fraud refers to illegal activities related to the production, distribution, or billing of COVID-19 testing kits. This can include actions like billing for tests that were never administered, using unauthorized test kits, or misrepresenting the necessity of tests to receive higher reimbursements.

    It's essential to understand that federal agencies are intensely scrutinizing these activities. The Department of Justice (DOJ) and the Office of Inspector General (OIG) have made COVID-19 healthcare fraud a top priority. According to the DOJ's official statements, they've charged numerous individuals and entities with COVID-19 related fraud offenses source.

    For healthcare providers and businesses, staying informed about these laws isn't just about compliance—it's about protecting your livelihood and reputation in a time when the stakes are incredibly high.

    02

    Key Laws and Regulations in COVID-19 Test Kit Fraud

    Navigating the legal landscape surrounding COVID-19 test kits can feel overwhelming, but being aware of the key laws and regulations is crucial:

    • False Claims Act (FCA): This federal law makes it illegal to submit false or fraudulent claims for payment to government programs like Medicare and Medicaid. Violations can result in severe penalties, including treble damages and hefty fines. Learn more about the FCA.
    • Anti-Kickback Statute (AKS): Under the AKS, it's illegal to offer, pay, solicit, or receive any remuneration in exchange for referrals of services covered by federal healthcare programs. This includes any form of compensation intended to induce or reward patient referrals. AKS details.
    • Stark Law: Also known as the physician self-referral law, Stark Law prohibits physicians from referring patients to receive "designated health services" payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. More on Stark Law.
    • COVID-19 Relief Fund Regulations: Funds provided under pandemic relief programs come with strict guidelines on their use. Misuse or misrepresentation can lead to allegations of fraud.

    Understanding these regulations isn't just about avoiding penalties—it's about maintaining the trust of your patients and the integrity of the healthcare system as a whole.

    03

    Common Issues and Challenges in COVID-19 Test Kit Fraud

    Even well-intentioned healthcare providers can find themselves facing allegations due to the complexities of billing and compliance during the pandemic. Here are some common issues:

    • Improper Billing Practices: With rapid changes in billing codes and procedures, it's easy to make mistakes. For example, billing for tests that weren't medically necessary or upcoding services to receive higher reimbursements.
    • Use of Unauthorized Test Kits: In the rush to meet testing demands, some providers may have inadvertently used test kits that weren't authorized by the FDA, leading to compliance issues.
    • Kickback Allegations: Offering incentives to patients or other providers for referrals or for choosing certain test kits can violate the Anti-Kickback Statute.
    • Documentation Errors: Inadequate or improper documentation can raise red flags during audits, leading to investigations by agencies like the OIG.

    Facing these challenges can be daunting, but awareness is the first step toward protecting your practice. It's important to implement robust compliance programs and seek legal advice when uncertainties arise.

    04

    The Legal Process for COVID-19 Test Kit Fraud Cases

    If you find yourself under investigation for COVID-19 test kit fraud, understanding the legal process can help alleviate some of the stress:

    1. Initiation of Investigation: Investigations can begin in various ways—through data analysis revealing irregularities, whistleblower reports, or routine audits. Agencies like the DOJ or OIG may get involved.
    2. Receiving a Notice or Subpoena: You might receive a subpoena requesting documents or a civil investigative demand (CID). It's crucial to respond appropriately and promptly.
    3. Evidence Collection: Investigators will gather evidence, which may include reviewing billing records, emails, and other communications.
    4. Interviews and Depositions: You and your staff may be interviewed. It's advisable to have legal representation during these interactions.
    5. Legal Action: Depending on the findings, the government may decide to pursue civil or criminal charges.
    6. Defense Strategy: Working with a seasoned COVID-19 test kit fraud attorney is essential. They can help you understand the allegations, develop a defense strategy, and represent you in negotiations or court proceedings.
    7. Resolution: This could involve dismissal of charges, settlement agreements, or, in some cases, trial verdicts.

    Remember, the earlier you engage legal counsel, the better your chances of a favorable outcome. Acting quickly can make a significant difference in how your case unfolds.

    05

    Potential Consequences and Outcomes

    The repercussions of a COVID-19 test kit fraud investigation can be severe and far-reaching:

    • Financial Penalties: Under the False Claims Act, penalties can include fines of up to $23,607 per false claim (adjusted annually for inflation), plus three times the amount of damages sustained by the government.
    • Criminal Charges: Intentional fraud can lead to criminal charges, which may result in imprisonment.
    • Exclusion from Federal Programs: Being excluded from Medicare and Medicaid can be devastating for healthcare providers, effectively ending your ability to practice in many settings.
    • Professional License Actions: State medical boards may take disciplinary action, including suspension or revocation of your medical license.
    • Reputational Damage: Allegations alone can harm your reputation, leading to loss of patients and professional relationships.
    • Operational Disruptions: Investigations can consume significant time and resources, distracting from patient care and daily operations.

    Understanding these potential consequences underscores the importance of taking any investigation seriously and seeking experienced legal representation to protect your rights and career.

    06

    How Does Health Law Alliance Assist with COVID-19 Test Kit Fraud Matters

    At Health Law Alliance, we understand the immense pressure and uncertainty that comes with facing allegations of COVID-19 test kit fraud. Our team is dedicated to providing personalized, strategic legal defense to help you navigate this challenging time.

    • Expertise in Healthcare Law: With years of experience in healthcare fraud defense, we are well-versed in the nuances of laws like the FCA, AKS, and Stark Law.
    • Proactive Defense Strategies: We don't just react—we anticipate the government's moves and build a robust defense accordingly.
    • Navigating Investigations: From responding to subpoenas to representing you in interviews, we guide you through every step of the process.
    • Negotiation Skills: Our attorneys are skilled negotiators, often able to resolve issues without the need for prolonged litigation.
    • Trial Experience: If your case goes to court, you can trust our seasoned litigators to advocate fiercely on your behalf.
    • Client-Centered Approach: We prioritize clear communication, keeping you informed and involved in your defense strategy.

    Don't face this situation alone. Reach out to us for a confidential consultation, and let us put our expertise to work for you.

    Take the first step toward protecting your future. Contact us today at (800) 345 - 4125 or info@healthlawalliance.com, or fill out our online contact form for a confidential consultation.

    government & commercial claims Auditors

    Payor & PBM Audit Companies

    PBM Audit Information

    The Role of Pharmacy Benefit Managers in Pharmacy Audits

    To design an effective PBM audit response strategy, providers must understand the chain of events both prior to the initiation of a PBM audit and afterwards. For example, Special Investigative Units (SIUs) are often the genesis of a pharmacy audit, and the presence or absence of "audit risk factors" is informative on potentially broader exposure beyond the claims under audit. Any decision to resolve an audit should be informed and result in a full and final settlement of all liability, but PBM audit settlements need to be structured carefully to achieve this goal.

    PBMs that Conduct the Most Pharmacy Audits


    CVS Caremark, OptumRx, and Express Scripts, control at least 80% of the market, making them the three biggest PBMs. Humana also ranks among the largest. In addition, these PBMs regulate access to networks for smaller competitors, such as ESI's partnership with Prime. Plan sponsors, such as United Health, Cigna and Aetna, are vertically integrated with these PBMs, increasing audit risk for pharmacies because network sanctions are more likely to affect a significant aspect of a pharmacy's business across both government and commercial claims.

    Common Pharmacy Audit Areas


    PBMs and payors use artificial intelligence and data mining across medical and pharmacy claims to identify areas of potential inquiry. Among other areas, these inquiries typically involve high-reimbursing medicines, brand/generic substitution, inventory discrepancies, co-payment collection, prior authorization, and telehealth relations. Separately, DEA conducts audits and inspections for compliance to controlled substance regulations.  

    Types of Pharmacy Audits


    Common types of PBM audits include desk audits; on-site audits; invoice audits; and prescription audits. Irrespective of the type of PBM audit, all interactions with PBMs should be taken extremely seriously and can lead to severe consequences if not handled appropriately. For example, there has been a sharp increase in the federal prosecution of pharmacists for audit-related conduct, including answering PBM questions incorrectly. Accordingly, pharmacies should consider using outside audit counsel to avoid these pitfalls.

    Preparing for Pharmacy Audits


    Pharmacies can take various steps to prepare to meet PBM audits, including routine self-audits. In fact, the government publishes comprehensive guidance and a checklist to assist pharmacies in their audit planning, including self-audits around prescribing practices, controlled substance management, invoice management, and billing practices. If you need assistance designing or implementing an audit protection plan, please do not hesitate to contact us.

    Defending Pharmacy Audits


    Defending against a PBM audit requires comprehensive knowledge of the rights, responsibilities, and intricacies of pharmacies and their laws and regulations.  If your pharmacy has been identified for a PBM audit, there are a number of potential defenses available to you. The first defense against a PBM audit is to be proactive, and audit planning can lessen the chance of unfavorable findings. That said, it is often necessary to involve an attorney to hold PBMs to their obligations under law and provider agreements. For this reason, national audit services and pharmacy audit consultants are often ineffective.

    Pharmacy Audit Appeals


    Audit discrepancies and findings can be appealed based on the specific procedures outlined in the provider manuals. It is important to follow these requirements exactly, within the timeframes established, or your appeal rights could be lost and further review denied. In an appeal, it is critically important to make a complete record of why the audit findings or sanctions should be reversed, including through documentation, legal arguments, and corrective actions, if any. Depending on the outcome of the appeal, you may have further legal recourse against the PBM.

    Potential Consequences of Pharmacy Audits

    PBM audits can have severe repercussions depending on the results of the pharmacy audit, including recoupments, network sanctions, and criminal, civil and administrative investigations involving jail time, significant fines, and license revocation or exclusion. We publish a 10-part PBM Audit Guide that discusses the overlap between PBM audits and government investigations and how to successfully manage audit risk. This resource is complimentary to subscribers HERE.

    Healthcare Fraud Defense Information

    Healthcare Fraud Defense

    Government investigations may come in many forms, but criminal matters involving potential jail time, mandatory exclusion, loss of licensure, and reputational harm are the most severe and scary scenarios that anyone can face. Unfortunately, it often is not clear, particularly at the outset, whether an investigation involves criminal violations or what your status might be in the investigation. For example, our clients might be informed that the FBI is interviewing patients, or that their partners have received subpoenas. The uncertainty that results from these types of events is particularly difficult for our clients to manage, and typically involves sleepless nights, loss of appetite, anxiety and potential depression.

    Our experienced healthcare defense attorneys understand what clients are going through, and focus on providing them with insight into the government’s investigation and how best to defend it. There are a variety of potential outcomes, many of them involving far less severe ramifications than might be contemplated. Indeed, in healthcare, parallel criminal, civil, and administrative laws provide an opportunity for potential resolution of government investigations under terms that do not involve loss of liberty or livelihood. The range of outcomes that might be available depends on the evidence available to the government, but cases involving patient harm typically receive more focus from a criminal perspective than run-of-the-mill billing irregularities, particularly when the federal government is involved.

    That said, there are several notable exceptions. At Health Law Alliance, our healthcare defense attorneys have decades of federal and state prosecutorial experience, and we rely on that background to highlight areas of increased risk. In particular, the below agencies focus on the prosecution of criminal healthcare fraud.

    Medicare Fraud Strike Force and Prescription Opioid Strike Force

    The Medicare Fraud Strike Force, operated by the U.S. Department of Justice (DOJ) in regions across the country, is particularly adept at prosecuting healthcare fraud criminal matters. Medicare Fraud Strike Force Teams harness data analytics and the combined resources of federal, state, and local law enforcement entities to prevent and combat healthcare fraud, waste, and abuse. More specifically, the Strike Force uses advanced data analysis techniques to identify aberrant billing levels in healthcare fraud “hot spots” – cities with high levels of billing fraud – combined with traditional investigative techniques to target suspicious billing patterns in addition to emerging schemes and fraudulent practices that move from one location to another.First established in March 2007, prosecutors operate in 16 Strike Forces, including the National Rapid Response Strike Force based in Washington, DC. The Strike Force Model centers on a cross-agency collaborative approach, bringing together the investigative and analytical resources of DOJ’s Fraud Section, the Federal Bureau of Investigation (FBI), the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG), the Centers for Medicare & Medicaid Services (CMS), Drug Enforcement Administration (DEA), Defense Criminal Investigative Service (DCIS), Federal Deposit Insurance Corporation Office of the Inspector General (FDIC-OIG), Internal Revenue Service (IRS), Department of Labor-OIG, United States Postal Service – Office of the Inspector General (USPS-OIG), Veterans Administration – Office of the Inspector General (VA-OIG), and other agencies. Strike Force Health Care Fraud and Prescription Opioid teams are located across the country, as depicted by the chart below:

    The Medicare Strike Force has filed thousands of criminal actions and indictments and recovered billions of dollars in assets resulting from healthcare fraud. The Strike Force teams bring together the Office of Inspector General (OIG), the Department of Justice (DOJ), Offices of the United States Attorneys (USAOs), the Federal Bureau of Investigation (FBI), local law enforcement, and others. These attorneys and investigators have a proven record of success in analyzing data and investigative intelligence to quickly identify fraud and bring prosecutions. The interagency collaboration also enhances the effectiveness of the Strike Force model. For example, OIG refers credible allegations of fraud to the Centers for Medicare & Medicaid Services (CMS) so that it can suspend payments to the alleged healthcare fraud perpetrators, thereby preventing losses to federal programs. Finally, the Medicare Strike Force does not focus exclusively on healthcare fraud but also prosecutes wire fraud, mail fraud, bank fraud, money laundering offenses, violations of the Anti-Kickback Statute (AKS), false statements offenses, Title 42 offenses, Title 26 offenses, and Title 21 offenses, in the highest intensity regions.

    Department of Justice’s Health Care Fraud Unit

    The Medicare Strike Force is a specialized department within the DOJ’s Health Care Fraud Unit, based in Washington, D.C., with operations across the country. DOJ’s Health Care Fraud Unit is led by over 80 experienced white-collar prosecutors who focus solely on prosecuting the nation’s most complicated healthcare fraud matters and the illegal prescription, distribution, and diversion of opioids and other controlled substances. The Health Care Fraud Unit’s mission is to protect the public treasury from wide-scale healthcare fraud, protect patients from significant fraudulent schemes that result in patient harm, and to detect, limit, and deter fraud and illegal prescription, distribution, and diversion of controlled substance offenses. The Health Care Fraud Unit endeavors to prosecute defendants who orchestrate schemes that result in the loss of hundreds of millions or billions of dollars, the distribution of tens of millions of opioids or controlled substances, and complex money laundering, tax, and other financial crime offenses.

    The Health Care Fraud Unit prides itself on conducting the most trials of any DOJ component, including the U.S. Attorney's Offices. DOJ prosecutors, referred to as “Trial Attorneys,” have participated in the largest and most complex healthcare fraud and opioid distribution trials in the country. Notably, the Health Care Fraud Unit is a leader in using advanced data analytics and algorithmic methods to identify newly emerging healthcare fraud schemes and to target the most egregious fraudsters. The Health Care Fraud Unit’s team of dedicated data analysts works with prosecutors to identify, investigate, and prosecute cases using data analytics. At the Health Law Alliance, our healthcare defense attorneys have extensive experience in the use of data analytics to identify potential fraud, waste, and abuse, having served as the Chief Compliance Officer and Executive Leadership Team member for UnitedHealth Group, with oversight of Optum and UnitedHealthcare, including Special Investigative Units (SIUs) within those platforms.

    The Health Care Fraud Unit’s cases are complex and wide-reaching. In particular, the National Rapid Response Strike Force was created in 2020 to investigate and prosecute fraud cases involving major healthcare providers that operate in multiple jurisdictions. The National Rapid Response Strike Force coordinates with the Civil Division’s Fraud Section and Consumer Protection Branch, U.S. Attorneys’ Offices across the country, state Medicaid Fraud Control Units (MFCUs), the FBI, HHS-OIG, and other agency partners to investigate and prosecute multi-jurisdictional and corporate healthcare fraud. The National Rapid Response Strike Force’s recent successes include the conviction of owners of a multi-state network of rural hospitals in a $1 billion billing fraud matter; the $500 million global resolution with Tenet Healthcare Corporation and related individual prosecutions for a hospital kickback scheme; the prosecution of billions of dollars in telemedicine fraud; prosecution of over $1 billion in fraudulent addiction rehabilitation facility fraud as part of the Sober Homes Initiative; and leadership of the Unit’s efforts to prosecute those seeking to criminally exploit the COVID-19 pandemic, including the conviction at trial of the President of a Silicon Valley technology company for healthcare fraud, illegal kickback, and securities fraud related to the announcement of purportedly revolutionary testing for COVID-19 using only a few drops of blood, i.e., Elizabeth Holmes and associates.

    In addition, in 2022, the DOJ Criminal Division announced the formation of the New England Prescription Opioid (NEPO) Strike Force, a joint law enforcement effort to investigate and prosecute healthcare fraud schemes in the New England region, and to prosecute individuals involved in the illegal distribution of prescription opioids and other controlled substances. NEPO leverages the success of the October 2018 formation of the Appalachian Regional Prescription Opioid (ARPO) Strike Force, a joint effort between DOJ, FBI, HHS-OIG, DEA, and state and local law enforcement to combat healthcare fraud and the opioid epidemic in locations that have been harmed significantly by addiction. ARPO has partnered with federal and state law enforcement and U.S. Attorneys’ Offices throughout Alabama, Kentucky, Ohio, Virginia, Tennessee, and West Virginia to prosecute medical professionals involved in the illegal prescription and distribution of opioids.

    U.S. Attorneys’ Offices Health Care Fraud Units

    In addition to DOJ’s Strike Forces and Health Care Fraud Units, all of the U.S. Attorneys’ Offices are staffed by federal prosecutors, referred to as Assistant United States Attorneys (AUSAs), who investigate and prosecute healthcare fraud crimes in their respective jurisdictions. There are 93 U.S. Attorneys’ Offices in the country, and the U.S. Attorney in each district is the chief federal law enforcement officer, reporting to the Attorney General of the United States. The U.S. Attorneys’ Offices are coordinated by the Executive Office for U.S. Attorneys, which oversees the DOJ’s Health Care Fraud and Abuse Act Program, established as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). To most, HIPAA is better known for privacy and nondiscrimination rules, but the statute also created a number of healthcare offenses and enforcement tools, including the “HIPAA subpoena,” and mandated that the DOJ and HHS-OIG coordinate to support efforts to investigate and prosecute healthcare fraud.

    To this end, HIPAA provided a funding source, specifically requiring that amounts equaling recoveries from healthcare fraud investigations be deposited in or transferred to the Federal Hospital Insurance Trust Fund. Recoveries are then appropriated from the Trust Fund to the Health Care Fraud and Abuse Control Account in an amount the Attorney General and HHS Secretary certify annually are necessary to finance healthcare fraud enforcement activities. Appropriations from the Control Account fund attorneys, investigators, and litigation support to combat healthcare fraud. Since 1997, over $57 billion has been collected by the DOJ and HHS. Of that, nearly $40 billion has been returned to the Medicare Trust Funds, an average of approximately $1.5 billion per year, and Medicaid, Tricare, the Veteran’s Administration, among others. In the same period, 13,628 defendants have been convicted of healthcare fraud offenses, an average of 545 every year. These numbers are startling, to be sure.

    State Medicaid Fraud Control Units

    All states also operate Medicaid Fraud Control Units (MFCUs), typically within the State Attorney General’s Office, to investigate and prosecute Medicaid-related fraud. The Social Security Act (SSA) requires each state to effectively operate an MFCU unless the Secretary of Health and Human Services (HHS) determines that (1) the operation of a Unit would not be cost-effective because minimal Medicaid fraud exists in a particular state; and (2) the state has other adequate safeguards to protect enrollees from abuse or neglect. MFCUs are funded jointly by the federal and state governments. Each Unit receives a federal grant award equivalent to 90 percent of total expenditures for new Units and 75 percent for all other Units.

    MFCU cases often begin as referrals from external sources or are generated from data mining. MFCU staff review referrals of possible fraud to determine the potential for criminal prosecution or civil action. If the Unit accepts a referral, the case may result in various outcomes. Criminal prosecutions may result in convictions; civil actions may result in civil settlements. Both criminal prosecutions and civil actions routinely include the assessment of monetary recoveries. The approach of the MFCUs varies state-by-state, with some offices, such as Pennsylvania’s MFCU, that pursue criminal cases exclusively. In other words, the Pennsylvania MFCU will either bring a criminal case or decline the matter completely; that office does not interpret its enabling statutes to permit the resolution of investigations on civil terms. Other state MFCUs, however, investigate and prosecute both criminal and civil cases. The OIG has the authority to exclude convicted individuals and entities from any federally funded healthcare program, such as Medicaid, on the basis of convictions referred from MFCUs. In addition to achieving these outcomes, MFCUs may also make recommendations to their state governments to strengthen program integrity.