As an Independent clinical laboratory or physician-owned laboratory (POL), you face unprecedented scrutiny in the current regulatory environment. While the federal government initially loosened restrictions during the early part of the COVID-19 pandemic, there has been a marked change in recent months. The Federal Bureau of Investigation (FBI) and the Health and Human Services Office of Inspector General (OIG) now take an aggressive approach to investigating and prosecuting labs.
If your lab is under investigation by the OIG or FBI, The Criminal Defense Firm can help. We have attorneys standing by to answer your questions and immediately get involved in your case. Many of our senior attorneys were formerly employed in high-ranking positions with the federal government and command an impressive knowledge of how these investigations proceed and what can be done to mitigate any potential civil or criminal liability.
At The Criminal Defense Firm, we handle all types of FBI and OIG investigations of clinical laboratories as well as physician-owned laboratories, including those involving the following matters:
- Clinical research contract and other contract disputes
- Clinical Laboratory Improvement Amendments (CLIA) violations
- False Claims Act (FCA) violations
- Health Insurance Portability and Accountability Act (HIPAA) violations
- Licensing violations
- Marketing and labeling violations
- Medicare, Medicaid, Tricare, and U.S. Department of Labor (DOL) billing violations
- MAC, RAC, UPIC, and ZPIC audits
- Stark Law and Anti-Kickback Statute violations
- U.S. Food and Drug Administration (FDA) defense
- U.S. Department of Health and Human Services’ Office of Inspector General (OIG) defense
An Effective Approach to an FBI or OIG Lab Investigation
Given the nature of the complex regulations facing clinical and physician-owned labs, there is no single response strategy that labs can rely upon when facing a federal investigation. Instead, labs must develop a custom-tailored defense plan, depending on their unique risk factors. However, there are some basic principles labs should follow when facing an FBI or OIG investigation.
Retain All Documentation
Once the FBI or OIG announces an investigation, it triggers an immediate duty on the lab’s part to preserve any evidence that may be related to the investigation. While it may be tempting to hide, destroy or alter evidence in hopes of keeping it from investigators, doing so is not advised. First, investigators may have other ways of obtaining the evidence they believe should exist but was not provided by a lab. If investigators discover that a lab hid or destroyed evidence, it can subject a lab to additional criminal charges. Even in situations where criminal charges can be avoided, destroying or hiding evidence can result in an inference that the missing evidence, if presented, would have been unfavorable to the lab.
At the same time, this doesn’t mean that labs should make everything available to investigators without a request or subpoena; it is essential to take an informed and strategic approach when it comes to providing documentation to investigators.
Develop a Comprehensive Defense Plan
Labs facing an upcoming federal investigation by the FBI or OIG must be proactive. Sitting back and allowing the investigators to dictate every aspect of the investigation only increases the likelihood of an unfavorable audit. Instead, labs should anticipate what documentation investigators will want to see and make sure these documents are available and easily accessible. It is also a good idea to keep all potentially relevant documents away from unrelated records that may draw the attention of investigators.
Additionally, by ensuring a coordinated response to an investigation, labs are able to put their best foot forward. Investigators with the FBI and OIG may make negative assumptions if they walk into a disorganized lab operated by an unprepared management team.
Be Strategic in all Communications with Investigators
When the OIG or FBI conducts an investigation of a clinical or physician-owned lab, investigators will be physically present. This means that lab workers, supervisors and managers may be questioned by investigators. Given the high stakes of an investigation, it is essential that lab management ensure everyone at the facility is on the same page and has been instructed on how to answer investigators’ questions. For example, one common strategy is to direct all lab workers to direct any questioning to a member of the management team. This ensures a single point of contact that will provide investigators with consistent positions throughout the investigation.
It is also imperative to consider whether answering an investigator’s question is beneficial—or even necessary. In most cases, management is under no obligation to speak with investigators. By talking with investigators, a management team may raise more questions than they answer. While labs must comply with certain aspects of a federal investigation, they do not need to cooperate to their own detriment.
Be Careful Who You Talk To
One aspect of FBI and OIG investigations that is often overlooked is that these investigations are not necessarily limited to the documentation obtained during the on-site portion of the investigation. By the time investigators arrive on-site, they may have already spoken to other parties, such as physicians with which the lab has an ongoing referral relationship. Thus, it is generally against a lab’s best interests to reach out to these parties in advance of the investigation, because there is no telling where their loyalties lie.
The last thing you want is to reach out to a colleague in an attempt to arrange a coordinated response when the investigators have already spoken to that person. In this situation, your colleague may turn right back to investigators, informing them of the conversation, which will only further raise investigators’ suspicions.
Engage Experienced Lab Investigation Defense Counsel
If your lab faces an upcoming investigation by the FBI or OIG, this very well could be your first time facing a federal investigation. Understandably, you may not know what to expect or how to protect your interests. By retaining the experienced clinical lab defense lawyers at The Criminal Defense Firm, you will benefit from our decades of experience. Whether it’s helping you identify potential risk areas, ensuring investigators follow the rules, negotiating with the government after an unfavorable investigation, or defending you against civil or criminal charges at trial, our lawyers are an invaluable asset to labs throughout all stages of a federal investigation.
How The Criminal Defense Firm Can Assist Labs Through an OIG or FBI Investigation
At The Criminal Defense Firm, we have extensive laboratory defense and compliance experience. Our attorneys handle all aspects of OIG and FBI investigations into clinical and physician-owned labs. While every lab needs varying types of assistance, depending on the situation, some of the services we provide include the following:
Lab Compliance Consulting
Developing and maintaining a comprehensive and robust compliance program is the best way to avoid an FBI or OIG investigation in the first place. The Criminal Defense Firm represents independent and physician-owned laboratories across the nation as compliance counsel. We regularly draft custom-tailored compliance policies and procedures, assist with compliance training and implementation, and conduct internal compliance audits for our clients.
Laboratory Audit Defense
MAC, RAC, UPIC, and ZPIC audits all pose unique challenges to labs, not the least of which is ensuring that auditors follow all rules and regulations when reviewing a lab for compliance. At The Criminal Defense Firm, we have successfully represented many independent and physician-owned laboratories in all types of audits, including MAC audits, RAC audits, UPIC audits and ZPIC audits. We have an in-depth understanding of the correct manner in which these audits are conducted and will ensure auditors do not overstep their bounds. We also defend labs undergoing private insurance audits.
Civil and Criminal Federal Investigations
What may seem like an insignificant violation can open the door to a full-blown audit, potentially leading to civil or even criminal liability. The consequences of an unfavorable investigation can not only disrupt the daily operations of a lab but may also subject owners and operators to a federal prison sentence. At The Criminal Defense Firm, we have successfully defended countless clinical and physician-owned laboratories in pending federal investigations.
Frequently Asked Questions:
Q: Why don't we call ourselves the 'best laboratory investigation defense attorneys'?
Attorneys are subject to strict ethical rules relating to their communications with the general public and potential clients. One of these rules precludes lawyers from making any potentially misleading statements. At The Criminal Defense Firm, we believe that using the word “best” to describe an attorney’s services is subjective. For this reason, we refrain from labeling ourselves the best lab defense lawyers. However, we believe that our track record speaks for itself. Those who are looking for the best lawyer to assist a lab through an OIG or FBI audit are encouraged to review our past results. To learn more about The Criminal Defense Firm, and to discuss what we can do to help you through an FBI or OIG audit, give us a call to schedule a free case evaluation today.
Q: What documentation will FBI or OIG investigators want to review during a lab investigation?
Every federal investigation is different; however, often, these investigations focus on two areas: laboratory billing practices and lab referral relationships. Thus, during an investigation, labs should be prepared to provide the following to investigators:
- Billing records;
- Documentation of medical necessity;
- Documentation of any referral relationships with doctors, pharmacies, hospitals, marketers or consultants; and
- The lab’s OIG compliance program.
When preparing for an upcoming FBI or OIG investigation, it is essential not only to ensure these documents exist but also that they are readily accessible and kept in a separate location from other, unrelated documentation. Organization is a critical component during a federal investigation, as it is one way that labs can control the flow of information. At The Criminal Defense Firm, we work closely with physician-owned and clinical labs to develop comprehensive defense strategies that take all contingencies into account.
Q: Does a lab facing an OIG or FBI investigation need a lawyer?
Strictly speaking, labs facing an upcoming FBI or OIG audit are not required to have counsel. However, given the stakes involved, most labs who are either concerned about the results of the investigation or have not been through an investigation in the past secure the assistance of an experienced lab investigation defense attorney. One reason for this is the information disparity between investigators and labs. As a lab operator, you specialize in what you do. However, you may not have the knowledge and experience necessary to successfully handle a federal investigation. Thus, to protect your interests, it is imperative to bring an experienced federal healthcare fraud defense attorney onto your legal team as soon as possible. At The Criminal Defense Firm, we can help identify all areas of possible compliance risk in advance of the audit, giving you an idea of what to expect and how to prepare.
Schedule a Free and Confidential Case Evaluation with an Experienced Laboratory Investigation Defense Attorney at The Criminal Defense Firm
If you recently learned that your lab will face an FBI or OIG investigation, reach out to The Criminal Defense Firm, as soon as possible. At The Criminal Defense Firm, we have centuries of experience helping labs survive federal investigations. We have senior attorneys standing by to discuss your upcoming investigation and what we can do to help. To learn more, and to schedule a case evaluation with a clinical lab defense lawyer, give The Criminal Defense Firm a call at 888-680-1745 or reach out online.