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Defense Strategies for Labs Facing an FBI or OIG Investigation

fbi investigations

The United States Health and Human Services Office of Inspector General (HHS OIG) and the Federal Bureau of Investigation has recently illustrated a renewed interest in investigating and prosecuting clinical laboratories. While it seemed as though many labs were given a “free pass” during the COVID-19 pandemic, that time appears to be up. Recently, the federal government has announced dozens of prosecutions involving molecular and respiratory labs; many of these cases relate to how these labs handle COVID-related issues.

Once the OIG or FBI gets their foot in the door, their investigation is not limited to COVID-related procedures; they will often conduct a lab-wide investigation looking for any sign of misconduct. And given the complexity of the regulatory environment labs face, even well-intentioned labs may find themselves in violation of the federal healthcare fraud laws. Thus, after the announcement of an upcoming federal investigation, everything must be done to ensure a favorable outcome.

How Labs Can Defend Themselves in the Face of an FBI/OIG Investigation

If you recently learned that your lab is under investigation by the FBI or OIG, there are steps you can take to protect yourself from civil and criminal liability. While the best life of defense against a federal investigation into your lab is to develop a robust compliance program, at the moment an investigation is opened, your efforts should shift away from compliance and onto damage control. This isn’t to say that a late-in-the-game compliance strategy is worthless; that’s not the case at all. However, while developing a compliance strategy to address any deficits will help mitigate liability, it may not be enough, and other efforts must be made.

That said, below are a few things to keep in mind if you recently learned that your lab is under investigation by the FBI or OIG.

Put our highly experienced team on your side

Dr. Nick Oberheiden
Dr. Nick Oberheiden

Founder

Attorney-at-Law

John W. Sellers
John W. Sellers

Former Senior Trial Attorney
U.S. Department of Justice

Local Counsel

Joanne Fine DeLena
Joanne Fine DeLena

Former Assistant U.S. Attorney

Local Counsel

Joe Brown
Joe Brown

Former U.S. Attorney & Former District Attorney

Local Trial & Defense Counsel

Amanda Marshall
Amanda Marshall

Former U.S. Attorney

Local Counsel

Aaron L. Wiley
Aaron L. Wiley

Former Federal Prosecutor

Local Counsel

Roger Bach
Roger Bach

Former Special Agent (OIG)

Michael Koslow
Michael Koslow

Former Supervisory Special Agent (FBI)

Chris Quick
Chris Quick

Former Special Agent (FBI & IRS-CI)

Kevin M. Sheridan
Kevin M. Sheridan

Former Special Agent (FBI)

Ray Yuen
Ray Yuen

Former Supervisory Special Agent (FBI)

Dennis A. Wichern
Dennis A. Wichern

Former Special Agent-in-Charge (DEA)

Retain All Records (Especially Those You Don’t Want To)

The moment that the Department of Justice of OIG announces an investigation, you assume an immediate duty to preserve any evidence that relates to the government’s investigation. Thus, anything you do to hide, alter or destroy evidence will very likely come back to bite you. For example, if the federal government learns that you destroyed or altered evidence, it could lead to an adverse inference allowing the judge or jury to assume that the evidence, if presented, would have been harmful to your case. It can also result in new criminal charges for the destruction of evidence or interfering with a federal investigation. Thus, despite any temptations, refrain from doing anything to hinder the investigation.

Evidence that investigators may want to review includes:

  • 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.

Of course, this is a partial list, and federal agents may seek a broad range of evidence during the course of their investigation.

Be Prepared

When FBI or OIG agents arrive to conduct an investigation, a clinical or molecular lab should be expecting their arrival and have taken the necessary steps to prepare for the investigation. This includes making all records that the investigators will likely want to examine easily accessible. The last thing you want is for agents to be rifling around your lab any more than absolutely necessary. You also do not want to appear unorganized, as agents may take your lack of organization as an indication that you play fast and loose with the rules.

Don’t Talk to Federal Agents Any More Than Necessary

If the FBI or OIG comes to your lab to conduct an investigation, they are naturally going to ask you questions. However, you are under absolutely no duty to answer them. Not only that, but answering federal agents’ questions can only hurt you. For example, if you say something you think is helping you, will the agents believe you? Probably not without documentation that supports what you told them. On the other hand, if you say something against your interest, they will certainly believe you. The result is that there is no reason to talk to FBI or OIG investigators if they ask questions during an investigation. The better option is to retain an experienced federal defense lawyer who can interact with law enforcement on your behalf.

Be Careful Who Else You Talk To

An FBI or OIG investigation is not necessarily limited to what is within the walls of your lab. Investigators may ask affiliated third parties for evidence or testimony. Thus, once you are made aware of an investigation, it is important not to talk with these parties about the investigation. Innocent words can be taken out of context, and you can’t be sure who is going to end up working with federal agents. Often, agents will try to “flip” certain participants, providing them with immunity or a favorable plea agreement in exchange for their testimony against other participants. You don’t want to be on the wrong end of that deal.

Reach Out to an Experienced Clinical Lab Defense Attorney with Experience Defending Molecular and Respiratory Labs

If you are under investigation by the FBI or OIG, chances are this is the first time. That being the case, you may not know what to expect or how to best protect your interests. By retaining an experienced clinical lab defense law firm, you will benefit from their decades of experience. Whether it’s helping you identify the potential areas of compliance concern, negotiating with the DOJ after an unfavorable investigation, or litigating civil or criminal charges at trial, an attorney’s assistance is an invaluable asset to molecular and respiratory labs subject to a federal investigation.

Oberheiden, P.C. Represents Molecular and Respiratory Labs Under Federal Investigation

If your respiratory or molecular lab is under investigation by the OIG or FBI, reach out to Oberheiden, P.C. as soon as possible. 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 in-depth knowledge of how these investigations are handled. We are prepared to put this knowledge to use, protecting you and your lab. To learn more, and to schedule case evaluation with a clinical lab defense lawyer, give Oberheiden, P.C. a call at 888-680-1745 or fill out our online form.

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