Frier Levitt’s White Collar Defense & Government Investigations Practice Group has decades of experience defending corporate entities, executives, and healthcare and life sciences professionals under scrutiny for alleged healthcare violations. Our attorneys use their firsthand knowledge of how government agencies conduct investigations, and our broader firm’s specialized regulatory, transactional and clinical knowledge, to resolve these challenges successfully, often prior to the filing of public charges. Nonetheless, when even the most creative strategies fail to persuade the government, we leverage our extensive trial experience and courtroom tenacity to achieve complete victories for our clients.
Illustrative federal and state representations include:
Government investigations involving healthcare laws are among the most complex and sophisticated cases brought by regulators and agencies with criminal investigative authority. These probes often involve parallel criminal, civil and administrative proceedings, and may have profound collateral consequences, including suspension, debarment, and even exclusion from participation in certain types of programs. Because we service primarily healthcare and life sciences clients, our broad industry touchpoints permit us deep insight into regulatory and enforcement trends critical to analyzing where the most significant risks are likely to arise. Thus, many clients turn to us for assistance in deploying effective compliance programs and successfully remediating internal compliance failures before these events result in outside disclosure and scrutiny.
The commencement of a government investigation typically represents the final opportunity for clients to limit the monetary and reputational consequences of a noncompliance event. Here, too, we utilize our prior government experience and knowledge of internal processes to limit our client’s exposure and negotiate favorable resolutions. Because we understand the inner considerations that guide regulators, we have been able to make compelling presentations on behalf of clients that have resulted in non-prosecution or deferred-prosecution agreements. In all of these negotiations, we are backstopped by decades of courtroom experience, an aggressive litigating posture, and willingness to try cases to jury verdict should the need arise.
Healthcare regulators involve the so-called “alphabet soup” of government agencies, including the Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Department of Health & Human Services (HHS)-Office of Inspector General (OIG), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Medicare Fraud Strike Force/Health Care Fraud Unit (HCF); Medicaid Fraud Control Units (MFCUs); and state Attorneys General (AGs).
Medicare and Medicaid fraud implicates extensive laws and regulations; the more common scenarios, however, implicate the following criminal and civil statutes:
Investigations may arise from a variety of sources, including “whistleblower” tips, qui tam relator complaints, referrals from private payors, PBMs, and the government’s analysis of claims data for deviations and outliers. In the initial stages, the government’s investigation typically proceeds covertly, and will not be known to its targets. At some point, however, the government will move to an overt phase, and either continue to collect evidence through search warrants, subpoenas and interviews, or file criminal, civil or administrative actions.
We endeavor, together with our Compliance Department, to effectively manage legal risk through the appropriate scaling and implementation of compliance program strategy. This allows our clients to learn about and successfully remediate noncompliance events before outside disclosure—when costs and reputational consequences are lowest. Such early intervention also permits the implementation of prophylactic measures in the event external scrutiny arises, whether from public disclosure or regulatory action. In short, it has been our experience that clients who adopt such a proactive approach achieve the most favorable results in the event of regulatory action.
Given the complex interplay among healthcare laws and regulations, we recommend that our clients take immediate action at the first sign a government investigation may be underfoot. Critical opportunities and certain defense strategies may be lost once the government’s investigation has become overt. Thus, for example, if a Payor or Pharmacy Benefit Manager audit has raised concerns, it may be prudent to retain counsel to review the matter and provide advice based on the regulatory and enforcement environment. Similarly, any contact with regulators whatsoever, whether that be in the form of a search warrant, subpoena, or simply an investigator with “just a few” questions, should prompt serious consideration whether to retain counsel before responding. We have found that clients who retain counsel at the earliest stages of an investigation have the most flexibility in crafting defense strategy and managing the investigation toward favorable outcomes.
For example, from the outset, clients need to obtain a fulsome understanding of the conduct under investigation because criminal, civil and administrative liability may arise from the same operative facts. Counsel should be involved in any such fact gathering to protect the process and interpret the evidentiary significance of information learned. This provides opportunities to influence the investigation towards a more lenient resolution, i.e., civil vs. criminal disposition. If Fraud, Waste & Abuse is discovered, clients may be able to avail themselves of various Self-Disclosure Protocol (SDP) to limit exposure. In addition, clients may seek to limit potential liability through cooperation or other remedial action, including the implementation or amplification of compliance measures. In short, any government inquiry must be met promptly with affirmative action to influence the scope and potential outcome of any investigation.
At Frier Levitt, we have represented publicly traded corporations, middle-market and closely held entities, and executives and employees. Different strategic considerations apply to representation of entities compared to individuals. For example, the size and structure of the organization may influence the response to an investigation, including considerations of whether, and how, to appropriately handle employees, some of whom may be implicated in the conduct. In addition, federal prosecutors consider different factors when weighing whether to charge an entity versus an individual.
Various agency protocols incentivize, through sanction leniency or forgiveness, the voluntary self-reporting of certain compliance failures or legal violations. Accordingly, we work closely with our clients to critically analyze and weigh a number of considerations which permit us to determine, based on our experience, whether a client may benefit from voluntarily self-reporting the matter to these agencies. Because, as a general rule, these programs cannot be invoked once the government’s investigation has become known, it is imperative that clients act expeditiously to fully investigate potential noncompliance and make self-reporting decisions before such opportunities are lost. Finally, it has been our experience that, in the significant majority of such cases, voluntary self-disclosures to agencies, including OIG and CMS, are effective to mitigate penalties and avoid the most draconian remedies, including exclusion from participation in federal programs.
Will I Still Be Able to Practice My Profession? We understand the lifelong dedication and commitment that healthcare and life sciences professionals have made to their careers. The ability to continue in the profession is often the most pressing concern for many of our clients. And for good reason, as government matters often implicate myriad collateral consequences, including:
Accordingly, a negotiated agreement on these terms should be included in any resolution. Here, at Frier Levitt, we employ numerous attorneys with specialized expertise in various disciplinary and administrative proceedings to successful navigate the collateral consequences that may arise with any government matter.
Knowledge of your rights and quality representation is imperative with respect to any governmental contact, whether that be an indictment, complaint, civil investigative demand, subpoena or other regulatory action. Our decades of government experience, combined with Frier Levitt’s focused representation of entities and individuals across the healthcare and life sciences supply chain, enables clients to navigate these daunting challenges with confidence.
Contact Frier Levitt today to speak to an attorney about regulatory concerns or government inquiries.