One of the first indicators that may tip off a healthcare provider or government contractor that their organization may be the subject of a False Claims Act (FCA) investigation is contact with a government investigator.  That contact may take many forms – service of a subpoena or Civil Investigative Demand (CID), an interview of an employee, or simply a phone call by a government regulator or investigator.  How an organization responds to those earliest contacts often sets the tone for how the government investigation unfolds.

Organizations with well-developed policies and procedures addressing how the organization will respond to contacts by government regulators often have a more orderly process to guide the organization in responding to government investigations (referred to herein as a Government Response Policy).  A Government Response Policy can set a clear tone of cooperation by the organization with any appropriately authorized government inquiry, while at the same time making clear that the organization will assert all protections afforded by law in any such investigation or inquiry.  And, a well-crafted Government Response Policy also can make clear to employees that concealment, alteration or destruction of information or the making of false or misleading statements to regulators will not be tolerated.

An effective Government Response Policy depends upon educating employees regarding the types of contacts that an organization or an employee may receive from government regulators and on establishing clear points of contact and lines of communication within the organization.  Typically, the organization will establish its legal department as a central point of contact for government inquiries or investigations (and organizations without a legal department would have to think through an alternative appropriate point of contact) as the entity within the organization best suited to coordinate the organization’s response either directly or through outside counsel.  Below we provide broad principles and guidelines that should be considered in preparing an organization’s Government Response Policy.

This post contains five parts and looks at the following:

  • Responding to a subpoena or CID.
  • Responding to visits by investigators at an office/facility.
  • Responding to a search warrant.
  • Responding to an interview request.
  • Responding to inbound calls from government officials.

Responding to a Subpoena or Civil Investigative Demand

Subpoenas are documents from a court or grand jury or issued by an administrative agency (such as the U.S. Department of Health and Human Services-Office of Inspector General) in either a criminal or civil matter requiring that a person testify that specified documents be produced at a particular time and place, or both.  A CID (authorized under the FCA or other federal statute) is a U.S. Department of Justice or state-level official document: (a) requesting production of documents; (b) demanding testimony; (c) containing interrogatories requiring a written response; or (d) some combination of the foregoing.

A subpoena or CID should be served on the organization’s registered agent, but often a government investigator may deliver such documents directly to a company’s office or facility.  Regardless of how the request is served, the organization’s Government Response Policy should require an employee receiving a subpoena or CID directed to the organization to notify their direct supervisor and provide the subpoena or the CID to the organization’s legal department (or otherwise designated individual within the organization).  The legal department then should be charged with reviewing the scope of the subpoena or CID and evaluating the distribution of a “hold notice” requiring affected personnel to suspend destruction of documents pursuant to the document retention policy.

The organization should make clear that no documents should be released in response to the subpoena or CID unless first reviewed by or in coordination with the organization’s legal department and the organization’s outside counsel (when applicable) to verify the appropriateness of  the response to the subpoena or CID.

If the subpoena or CID were to demand testimony from an organization representative, no one should testify as the representative without the specific approval of the organization’s legal department.

Responding to Visits by Investigators at an Office/Facility

Law enforcement officers or other government investigators may arrive at an organization’s offices or facilities for a variety of reasons.  One of their purposes could be to serve a subpoena or CID, but there could be others, including executing a search warrant or attempting to conduct interviews.

When investigators arrive, it is important to identify as soon as possible the purpose(s) of their visit and to have clear guidelines and procedures to be followed to enable the organization to determine why the investigators are there and how the organization should respond.  As with the receipt of a subpoena or CID, the critical first step is for an employee encountering a government investigator seeking an interview to notify their supervisor and the legal department.  Given the time-sensitivity of such requests, it is often helpful for the organization to have a “Government Response Team” in place to allow for a successive list of individuals within the organization to be contacted if there were difficulty in reaching a legal department designee.

An employee interacting with the government investigator who arrives at the organization’s offices or a facility should request identification and business card, identify agency affiliation, and obtain the reason for the investigator’s visit.  If the investigator were there to serve a subpoena or CID, the employee may accept the document and the Government Response Policy should reference how the organization should handle receipt of such documents, as set forth above.  If the investigator is on-site to execute a search warrant or conduct interviews, the procedures below can be followed.

Responding to a Search Warrant

A search warrant is a written document giving legal authorization to specific law enforcement officers to search a specified area and to seize specific material.  The search warrant typically must describe the material to be seized and the places that may be searched, and must be signed by or on behalf of a judge or magistrate with jurisdiction over the area to be searched.  It is critical that the organization’s employees not interfere in any way with the investigators during their search or prevent them from accessing anything listed in the search warrant.

If an investigator were to arrive to execute a search warrant and were identified as a government agent, the employee should contact the legal department and request that the investigator wait to begin the search until the legal department “Contact Person” were to arrive (but there would be no requirement that the investigator agree to such a request).  It is appropriate to request identification and a business card, agency affiliation, and the reason for the investigator’s visit.

The Contact Person should serve as the primary point of contact with all government investigators during the execution of the search warrant.  While the Contact Person may not interfere with the search in any way, specific policies otherwise should govern the Contact Person’s interaction with government investigators executing a search warrant, including recording the details of the materials seized, any understanding reached with investigators regarding the execution of the search warrant, and requesting an inventory of all documents and items taken.

Special consideration should be given to the fact that employees are not authorized to consent to the search of the organization, consent to any expansion of the search warrant or the collection of documents not encompassed by the search warrant.  It is typically appropriate for the Contact Person to object to the seizure of privileged or otherwise protected documents pending a resolution of those objections and to request that such documents be kept separate from other seized documents.

Seizure of electronic devices presents separate challenges and often will result in significant disruption of the organization’s business.  If electronic devices were seized versus merely copying of such devices, attempts should be made by the Contact Person to negotiate an acceptable methodology to minimize disruption from unavailability of electronic devices and associated data.

Finally, it is often prudent to send all non-essential personnel home or temporarily assign them to other areas outside the scope of the area to be searched.  It is typically appropriate to inform employees that there is no obligation to consent to questioning and that employees have the right to consult with counsel before the search or questioning.  And, as stated, it is critically important that employees be instructed not to interfere with the search.

Responding to an Interview Request

Investigators could request interviews of employees in a variety of contexts.  They may do so at the organization’s offices or facilities in conjunction with serving a subpoena or executing a search warrant as described above.  Alternatively, they may contact employees away from the workplace, either at the employee’s home or some public place.  Several considerations apply to requests to interview, question, or otherwise speak with employees.

Employees can be apprised that under the law no one is required to consent to an interview, and typically, the organization should take no position on whether employees should participate in an outside interview.  Employees who consent to interviews, however, must be truthful and accurate in responding to any questions.

Employees can be instructed that they should refuse to give any response to the extent the response would require them to divulge information about communications between the organization and legal counsel representing the organization.   And, employees may condition consent to be interviewed on reasonable conditions they choose, such as interviewing in a particular place, with particular persons present, or under particular circumstances.  In addition, an employee can end a voluntary interview at any time.

Employees have the right to condition consent to an interview on a legal department representative or their counsel attending the interview.  However, it should be made clear that the organization’s legal department represents the organization and its interests, and not any individual employee’s interests.  The organization’s legal counsel should be present for interviews whenever possible and should request, but not require, that its legal counsel be invited to such interviews.

Employees should be instructed that they may not allow the government investigator to take company property or information – including documents or medical records – during or after an interview unless authorized by the organization’s legal department.

As discussed above, an investigator may approach an employee for an interview either at the organization’s offices or facilities or at home.  If an individual representing themselves as a government investigator were to arrive at the organization’s office or facility to request an interview, the procedures regarding Responding to Visits by Investigators at an Office/Facility should apply as to the identification and treatment of the individual and the notification of members of the Government Response Team.

If an employee were approached for an interview at home or otherwise away from the organization’s offices or facilities and outside of work hours, the employee should request identification, agency affiliation, a copy of the investigator’s business card, and the reason for the visit.  The organization may request, but should not require, that the employee immediately notify their supervisor(s) and provide as much information and documentation known at that time regarding the interview and interviewer.  Upon such notification, the employee’s supervisor should immediately notify the legal department of the contact.

To the extent the investigator also serves a subpoena, CID or search warrant, the applicable procedures regarding Responding to a Subpoena or Civil Investigative Demand or Responding to a Search Warrant discussed above would apply.

Responding to Inbound Calls from Government Officials

Employees of an organization could receive an inbound call from a government official while at work, including anyone who represents themselves as a federal agent; federal investigator; FBI agent; an investigator from Medicare, Medicaid or any other governmental agency; a police officer; or any other official requesting information about the internal processes of the organization.

If such a phone call were received, an organization’s employees should not attempt to answer any questions posed by the government official.   Instead, employees should be directed to politely inform the caller that he or she cannot answer their questions and shall transfer the caller to the legal department.  In turn, the legal department should be responsible for contacting the government official or coordinating for outside counsel to do so.

Other Considerations

In most instances, it will be helpful to equip employees who may interact with government investigators or officials with a “Ready Reference” setting forth the key points of the organization’s Government Response Policy.  This may include maintaining the “Ready Reference” in a convenient location on the organization’s computer system or even on a laminated front-and-back summary sheet to be kept at key locations within the organization, such as the administrative suite, business office, reception area, etc.  Training also may be helpful to walk employees through the Government Response Policy and the purpose behind the policy.  It also may be necessary to integrate a Government Response Policy with other key policies within the organization, such a media response policy.

Finally, while the Government Response Policy discussed above may not allow for a one-size-fits-all approach, the principles discussed above likely should be considered as part of creating a comprehensive policy.  There also may be other unique aspects of an organization that require additional provisions to be included within such a policy.  In any event, these principles can provide a key starting point for organizations that have not yet implemented a Government Response Policy and a checklist against which to measure existing policies.  Given the high likelihood that healthcare providers and government contractors will face investigations stemming from whistleblower complaints and/or FCA lawsuits at some point, such a policy is not a luxury, but a necessity.

If you would like a sample Government Response Policy and Ready Reference or have any questions about establishing effective policies, please contact the author.