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Frier Levitt’s White Collar Defense and Government Investigations Practice Group represents healthcare and life sciences professionals and companies who have, or may, become the subject of criminal investigations, prosecutions, and civil or administrative investigations. We recognize that effective representation begins before investigations are initiated or criminal charges are brought, and that not all matters which have caught the attention of the Government warrant criminal charges or resolution through the criminal justice system. We are capable of providing an independent review of potential problem areas and conduct internal corporate investigations. Civil or regulatory inquiries often become a criminal investigation or prosecution because the civil case was not handled with the requisite level of experience. Our attorneys have both extensive criminal defense experience and a deep understanding of federal and state healthcare laws and regulations. This experience is particularly important in light of the Government’s initiatives to prevent and crack down on COVID-19 related fraud, including prosecutions for scams involving the CARES Act, PPP loans, price gouging, and PPE acquisitions and sales.
Frier Levitt’s extensive regulatory and clinical knowledge, as well as experience in Government investigations and trials, enables us to understand and resolve the issues that underpin investigations and prosecutions in the healthcare and pharmacy-related arenas. Knowledge of these professions, and the regulatory climate that pervades them, are extremely important in deciding how best to defend an investigation or prosecution. These qualifications, along with diligent and aggressive preparation and a willingness and ability to try difficult cases, is the formula for effective negotiations with authorities, and favorable outcomes when trial is necessary.
Frier Levitt’s attorneys have decades of experience representing clients in trial settings as well as during pre-investigation and investigatory phases, including:
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), Office of Inspector General Department of Health and Human Services (OIG), Drug Enforcement Administration (DEA), Food and Drug Administration (FDA), 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.
These investigations are conducted pursuant to criminal and civil statutes, federal and state, pertinent to matters within the healthcare and life sciences arenas, such as:
Government investigations in the areas of healthcare and life sciences typically employ the methods utilized in white-collar criminal investigations. Request for interviews, taking statements, subpoenas for records, search warrants, data mining, surveillance, and undercover agents posing as patients or vendors or marketeers are illustrative of methods that can and will be employed by the government offices. You may first become aware of an ongoing investigation when receiving a call from patients or contacts who tell you that they were interviewed by agents. Other times it may be a visit to you, unscheduled and unexpected, from a federal agent wanting “to just ask a few questions and get some clarification.” It may be that your bank closes your account because it received a subpoena for your records. Or, you may receive a subpoena to testify in front of a grand jury or to produce records. The subpoena could be a Grand Jury subpoena, a HIPAA subpoena, an OIG subpoena, or a civil investigative demand, all meaning something different. More ominously, it could be the execution of a search warrant conducted at your place of business. Regardless, when you become aware of a pending criminal investigation in which you may be involved – regardless of how you became aware – it is paramount that you immediately contact legal counsel for advice and direction before deciding if and how to respond.
Whether it is in your best interest to respond to such investigative methods, and, if so, how to respond, are issues for counsel experienced in healthcare and life sciences investigations – criminal, civil and administrative. It is important that counsel have an in-depth knowledge of the healthcare and life sciences compliance and regulatory issues, and it is equally important that counsel have experience in protecting and guiding clients through the legal minefield of investigations, and have familiarity with the methods utilized in the investigations and the agencies that employ them. At Frier Levitt, we employ our extensive and diverse knowledge of the healthcare industry, layered with experience in the civil, criminal, and administrative realms, to guide a client on how best to proceed – whether to invoke a privilege or whether to furnish the requested information and, if so, how best to produce the requested information – in order to convince federal and state authorities that criminal charges are not warranted and, where necessary, to negotiate and seek a resolution of the matter that is a non-criminal resolution. During the course of our representation, and both following and in concurrent with the resolution, we seek to mitigate any further civil and administrative liability which may flow from the outcome.
Often, a client becomes aware of information that prompts it to conduct an internal investigation; this may take the form of negative results following a PBM audit, a patient complaint, information from another provider, or an investigation into a related entity, such as a referral source. If the client feels that something may be awry, it is generally best to conduct an internal investigation, either before the onset of a Government investigation or during or as a response to a Government investigation. An internal investigation into an organization to determine whether fraud, waste or abuse, or some other form of misconduct or malfeasance occurred, or whether corporate practices are compliant with the standards of the profession, is helpful in many ways. Most relevant, conducting an internal investigation shows a willingness to adhere to ethics and best practices; it can also go a long way in demonstrating a lack of criminal intent. Internal investigations are very useful tools in preparing organizations for expected scrutiny from an oversight body or in anticipation of a Government investigation. Where misconduct, wrongdoing, or malfeasance is identified, internal investigations can lead to remedial measures which many times are the lifeline for corporate survival in the face of the onslaught of investigative or other oversight scrutiny. Knowing if it is in the client’s best interest, when to launch the investigation, and how to conduct an investigation objectively, thoroughly, and effectively, with findings based on evidence and recommendations consistent with the findings, are matters for legal counsel experienced in internal investigations and with a compendious knowledge of the regulatory and compliance issues underlying the healthcare and life sciences professions.
In many circumstance where a client finds that they may have engaged in some proscribed behavior, it may be prudent for the client to avail themselves of one of a variety of “Self-Disclosure” protocols offered by government agencies. Our team possesses extensive experience in the utilization of government “Self-Disclosure” programs. Self-Disclosure is offered by a number of federal and state agencies, including CMS, allowing providers that may have run afoul of regulations to affirmatively investigate, report, and remediate certain transgressions. Self-Disclosure protocols offer those that self-report an opportunity to mitigate penalties and avoid the most draconian enforcement remedies. Frier Levitt has the experience to determine whether and when a Self-Disclosure is in the best interests of our clients; we have successfully utilized the Self-Disclosure protocol and negotiated countless settlements with federal and state agencies, saving clients money and preserving their ability to continue their practices or businesses.
Although our overarching goal is to convince the Government that criminal charges or other adverse resolution are not warranted, in the event our clients are charged criminally, we are prepared to aggressively protect and defend clients’ rights, whether by demonstrating their innocence or establishing that the Government cannot prove its case. Thorough investigation of the Government’s accusations, a keen knowledge of the regulatory underpinnings of the client’s profession, and extensive review of discovery and legal research and legal motions enable us to demonstrate a preparedness and willingness to try even the most difficult of cases. This stance can facilitate continued negotiations that leads to an improved resolution offered by the Government. When the only option is trial, we possess the experience and tenacity to develop and carry out a winning defense strategy, including the location and engagement of appropriate expert witnesses that support our theory of the case.
It is of utmost importance in life sciences and healthcare cases that the collateral consequences of a criminal matter are understood, and that a comprehensive, “global approach” is taken in the defense of the licensed individual or entity. A criminal charge, or a mere investigation, can trigger collateral consequences and have a cascading effect on a provider’s career. Professional licensure (including revocation, suspension, and limitations placed thereon), DEA registration, insurance credentialing, medical staff credentialing, Medicare and Medicaid eligibility and exclusion, and National Practitioner Data Bank reporting, are just a few of the collateral issues that can be effected by a Government investigation or prosecution. Our team of attorneys have the multidisciplinary knowledge and experience to protect you from every angle. We utilize a team approach to provide the most comprehensive advice to our clients in order to develop the best possible strategy for dealing with each client’s specific needs, never losing sight of the global picture.
Knowledge of your rights and best quality of representation is imperative at every stage of a governmental adverse action, from initial contact by the authorities through final disposition of the matter. The attorneys at Frier Levitt and their combined experience and expertise, and team approach, fit those criteria. Our attorneys will inform you of your rights and provide you with the best possible defense in every case.
Contact Frier Levitt today to speak to an attorney about defending against or avoiding criminal prosecution and government enforcement actions.