Every aspect of medicine and healthcare business has compliance implications. An irregularity or compliance deficiency in this segment can trigger scrutiny from the U.S. Department of Justice (DOJ), the Drug Enforcement Administration (DEA), the Federal Bureau of Investigation (FBI), and other federal authorities. In such cases, initiating a corporate internal investigating and determining remedial actions is critical to protect your business or medical practice from being exposed to legal liability or federal prosecution.
Corporate internal investigations are complex. Hence, healthcare professionals and business leaders should be aware of the legal and practical aspects of conducting such investigations. Further, it's critical to involve an external legal counsel for strategic advice in this matter. A poorly-managed corporate internal investigation can put your medical practice, healthcare setup, or pharmacy business at risk of steep penalties, negative publicity, and criminal and civil litigation.
Internal investigations have become an important aspect of fair corporate governance in every industry. Read on to know how you can go about managing a corporate internal investigation in the healthcare domain.
Internal investigations are resource-intensive and expensive. Consider the below-mentioned questions before initiating one.
The answers to these questions will help you determine when to initiate a prompt and thorough investigation, allowing you to prevent a separate federal investigation.
Most of the information fueling your internal investigation will come from witness interviews. Witness interviews are conducted with these goals in mind -
First, the investigators are required to prepare an outline, a set of documents (like witness outlines), and well-crafted questions to touch upon the relevant issues during the interview. Secondly, never approach an interview like an interrogation. This may instill fear and cause business disruption, discouraging employees from sharing candid and reliable information.
The federal law requires attorneys to share the Upjohn warning or the corporate Miranda warning with the witness before starting the interview. This makes it clear to the employee that -
The attorney represents its client (the company), not the employee
Though the interview is covered by the attorney-client privilege, the privilege over communications belongs solely to the company
The company may choose to waive the privilege and share any or all of the information provided with third parties including government agencies.
Finally, think about the interview logistics. Give careful consideration to these pointers to determine how, when, and who will interview the witnesses.
Determine the sequence of the interview. Initially, you may need to interview everyone who may have knowledge of the conduct in question. But as the investigation proceeds you will have to modify your approach.
What will be the location and format of the interview? Choose a site that will put the witness at ease and cause minimum business disruption. Further, a face-to-face interview is any day better than a telephonic one or a video conference as it allows the investigator to observe the witness and size up their statements.
Document the interview and the significant events to keep track of the witness statements and point out inconsistent ones.
Pay attention to the witness's background like their financial status, professional experience, performance at work, criminal or legal history, and relationship with other employees.
At the end of the interview, it's important to remind the witness to maintain the confidentiality of the investigation and preserve the relevant documents and data.
Owing to their complex nature, internal corporate investigations often demand the involvement of an expert who can offer advice on matters beyond the purview of healthcare professionals and business leaders. For instance, only a federal healthcare fraud defense lawyer can help investigate an allegation pertaining to flaws in the billing software of your healthcare setup.
The expert you choose should be proficient in the subject, reliable, and impartial (no vested interest with the outcome of the investigation). In addition to an external counsel, you may need professionals with knowledge of the laws at issue and experience in dealing with the federal regulators.
Deciding to go for self-disclosure can put your medical practice or healthcare business in an awkward position. That's because it requires businesses to share confidential information (protected by attorney-client privilege) with the government, making the authorities doubt its accuracy.
Hence, it's important to carefully consider a few factors like timing and scope before going for self-disclosure. For instance, you may need to consider at what stage of the internal investigation you should contact the federal authorities. Similarly, you need to determine what information you need to self-disclose to fulfill your obligations without triggering a federal investigation.
Further, you should also have a solid post-self-disclosure strategy in place to protect your practice or business from the direct and indirect consequences of a federal investigation and prosecution.
Internal corporate investigations are a necessary task that all healthcare settings and medical practitioners should be prepared to undertake. A well-organized investigation will not only help you minimize the collateral damage of corporate wrongdoing but also protect your practice or business from federal prosecution in the future.
Use the information shared in this post to get ahead of federal investigators and law enforcement authorities and maintain the reputation of your healthcare setup or business.(Image Courtesy: Unsplash)