Frier Levitt has identified an alarming trend in government investigations of pharmacies whereby Office of Inspector General (“OIG”) and Drug Enforcement Administration (“DEA”) issue subpoenas simultaneously or almost at the same time. While dual subpoenas had been common in investigations into Controlled Substance Act violations – with the DEA issuing an administrative subpoena and the local U.S. Attorney’s Office issuing a criminal subpoena (ostensibly leveraging all jurisdictional tools to get the same information) – this new trend suggests that investigators are equally concerned with potential drug diversion, as they are with potential fraudulent billing. By issuing two separate subpoenas at the same time, the government is seeking broad and extensive information on a much larger scope of conduct, not failing exclusively into Controlled Substance Act compliance or potential false claims.
The recent subpoenas seek information pertaining to Medicare Part D and Medicaid prescription claims, which also include prescriptions for Schedule II controlled substances. As noted above, the information and/or documents requested in the subpoenas are quite broad and extensive. For example, one subpoena issued by OIG requested certain information and documents on a number of Medicare Part D claims submitted by a pharmacy in the past five years. Meanwhile, DEA’s subpoena requested certain information and documents on Schedule II controlled substance prescription claims, which may partially overlap with claims at issue in the OIG’s subpoena.
Upon receipt of the subpoenas, the pharmacy is tasked with responding to the subpoenas in a proper and prompt manner. In the event that the pharmacy decides to ignore the subpoenas, the Federal/State Attorney General can file an enforcement action against the pharmacy to compel production of the information and documents requested in the subpoenas. Another pitfall when responding to the subpoenas often arises when the pharmacy responds to the subpoenas in a wrong way. Exactly what needs to be produced, whether the subpoena can be challenged as onerous or that the requested records are outside the scope of the investigation, whether explanations should be given along with production of records, whether documents are responsive or non-responsive to the subpoena, whether the production of records actually equals a testimonial response, whether any documents are privileged, and how to comply with HIPAA requirements, are just some of the legal issues that confront a production of records pursuant to a subpoena in the health care and life sciences arenas. Finally, and perhaps most concerning with this new trend, there a limitations as to when and how the government can seek and obtain certain information, and what it can do with it once it’s received, including sharing information gleaned through criminal subpoenas with civil agencies. These are not questions to be answered without the benefit of legal counsel.
Government investigations of the healthcare and life sciences professions are typically conducted by a variety of agencies, including the Department of Justice (DOJ), the United States Attorneys of the various federal districts, Federal Bureau of Investigation (FBI), Food and Drug Administration (FDA), OIG, DEA, State Attorneys General and their insurance fraud and Medicaid fraud units, and other federal, state, and even local law enforcement agencies; these investigations are oftentimes coordinated by the above-referenced offices. Many times, the investigations are civil or administrative investigations that are run parallel to a criminal investigation or are the subject of an audit or other seemingly regular oversight activity that morphs into a criminal investigation.
How Frier Levitt Can Help
If and when served with a subpoena, cordially take it and engage in no conversation other than informing the agents or officials serving the subpoena that they will hear from your legal counsel, and then call counsel immediately. For more information on subpoena compliance, contact us to speak to an attorney.
