The FisherBroyles Pharmacy Law team has observed an increase in the Department of Justice and Department of Defense’s coordinated efforts to conduct investigations into alleged violations of the False Claims Act for claims submitted to TRICARE. Lately, the Department of Labor has joined the enforcement actions for what they perceive as alleged overbilling for compounded medications. The aggressiveness of the federal agencies enforcement was in full view when pharmacies in Mississippi, Alabama, Florida and Utah were part of coordinated take-down raid this past February. We believe similar national take-down raids are likely to occur in the future.
Pharmacies who submitted claims to TRICARE and the Department of Labor should take notice of this alarming trend. These investigations appear to be largely targeted on past business and billing practices. Proactively being prepared should your pharmacy be contacted by government agents will certainly help mitigate potential liability. In the event your pharmacy receives an investigative demand letter, subpoena or search warrant from a government agency, you should be prepared to respond appropriately and effectively in an honest and open manner.
- Appoint someone on site to be in charge of communication with the government representative;
- Should management or the compliance officer not be on site, an associate may request that the government representative allow them to contact management and/or the compliance officer and they should do so immediately;
- Outside counsel should be contacted immediately to coordinate the response to the government;
- Remain calm, polite and observant – you can ask questions and it is appropriate to ask to see identification/business card of the government representative in charge and demand a copy of the warrant;
- Check the date and time on the legal documentation to make sure the document is valid – government representatives may not search a business other than the time specified on the warrant;
- Take detailed notes and a keep a thorough list of all documents the government representative is taking or copying as well as document what they reviewed but did not take or copy;
- Take notes of all conversations amongst the government representatives and conversations they have with any pharmacy associate;
- Do not remove, alter, create or destroy documents or records including, but not limited to, paper, tape and computer records;
- Get a detailed receipt from the government representative of all documents/items including the number of pages copied for reimbursement purposes;
- If computers are seized, you can ask to copy all files onto a disk or other media;
- Associates are required to answer questions concerning the location of documents if they know where they are located, but are NOT required answer other questions;
- Associates can tell the government investigator that they prefer to wait until management or legal counsel is present before responding to any inquiries;
- Government representatives cannot demand an associate or management speak with them immediately – you are entitled to have someone present during an interview;
- Lastly, you can assert your Fifth Amendment rights.
Pharmacies and healthcare providers should take a proactive approach now to ensure their compliance programs are effectively implemented and ready to withstand a government investigation. Given the complexity and aggressiveness of the enforcement activity, it would be prudent to discuss your legal rights with counsel.