It is expected that 2008 will bring further aggressive enforcement and investigation efforts touching on a wide span of healthcare organizations and business practices. These matters will range from criminal investigations (including the use of search warrants) to civil inquiries and accompanying whistleblower and qui tam litigation under state and federal False Claims Acts. Subjects of investigation will include quality of care, Medicare Part D, health plans, billing and coding, Stark self-referrals, kickbacks, and pharmaceutical and device pricing and marketing activities.

Concerned organizations should have practical procedures in place to assist in properly responding to government investigators. These guidelines will assist healthcare organizations in the event an investigation is launched by government investigators, e.g., FBI, FDA, and OIG agents, who arrive at an institution seeking documents or interviews. The manner in which healthcare organizations handle these initial contacts largely sets the tone and stage for the entire course of an investigation.

When contacted by government representatives in connection with an investigation or enforcement proceeding, be polite and cooperative and consider the following procedures:

Initial Contact With Government Agents

  • Request formal identification, e.g., a badge and/or picture identification card. Record the agent’s name and contact information. 
  • Immediately notify the Corporate Compliance Officer (CCO) or other corporate designee, of the agent’s presence.
  • Ask the agent to wait for the CCO or other corporate designee to arrive.
  • The CCO or designee should show the agent into a room and introduce himself/herself and an alternate person, e.g., manager or department supervisor, if appropriate, to contact regarding investigation issues.
  • The agents should be accompanied at all times while on premises.

Coordinated Handling Of Government Requests

  • Inform the CCO, CEO and Counsel of the investigation.
  • The CCO or designee should receive and handle all requests made by the agents.
  • The CCO or designated official should coordinate with Counsel before providing any response or records to government agents.
  • The CCO and Counsel should establish a team to assemble responsive materials and perform an internal assessment of the issues under investigation.
  • Based on the subpoena or any other information provided by the agents, the organizational areas at issue in the investigation should be identified and contacted.

Questioning By Government Agents

  • Agents may request to interview employees while the employees are at work. These requests may come with no prior notice.
  • Employees are not obligated to talk to agents and the organization has the right to restrict interviews to mutually convenient times and places.
  • If employees are requested to submit to questioning by an agent, they have the right to speak with an attorney before agreeing to an interview and to have the attorney present at the interview.
  • The organization may provide an attorney for the employees prior to talking to the agent, or at other times during the investigation.
  • If employees agree to be interviewed, they should always be truthful even though they are not under oath. 

Government Requests For Documents And Warrants

Subpoena

  • Agents often serve subpoenas that require the production of documents relating to the issues under review.
  • There is no requirement that documents be produced immediately.
  • No records should be provided to the agent without CCO approval and review by Counsel.
  • Separate copies and an index should be made to accurately record what was provided in response to the subpoena.
  • Do not copy or produce documents subject to the attorney-client or other privileges. Look for documents labeled “attorney-client privilege,” “attorney work product” or “confidential.”
  • Counsel should review documents to determine whether privileges apply.
  • Once on notice of a governmental investigation, no documents or electronic data should be destroyed or deleted without clearance from the CCO or Counsel.

Search Warrant

  • When executing a search warrant, agents are entitled to immediately seize all responsive documents.
  • Agents will provide a copy of the search warrant as well as an inventory of all seized items.
  • The agents are entitled to take original documents and other items as specified in the warrant.
  • Request time to have the CCO, General Counsel or other designated official present.
  • If the agents will not wait, or if the appropriate officials cannot be located:
    • Review the warrant to understand the scope.
    • Direct the agents to where the requested records are kept.
    • Monitor and note if agents take documents that exceed the scope of the warrant.
    • Inform the agents of any privileged documents and request them from the agents.
    • Cooperate and do not try to prevent or obstruct the removal of records.
    • Do not interfere in any way with the agents’ execution of the search warrant.
  • Request copies of any original records being taken by the agents.
  • As to computer data, the CCO should request that the agents mirror the server or hard drive to allow for business to continue.

Patient Records

  • Agents conducting an investigation are entitled to documents with no signed release of a Medicare patient.