Government Investigations, Litigation & White-Collar Defense
Government Investigations, Litigation & White-Collar Defense
HomeWhat we doGovernment Investigations, Litigation & White-Collar Defense

Who We Are

Frier Levitt’s Government Investigations, Litigation & White-Collar Defense Group is comprised of seasoned professionals, including a former Assistant United States Attorney, Deputy Attorneys General, and healthcare litigators who have decades of experience defending corporate entities, executives, and healthcare and life sciences professionals for alleged healthcare violations. Our attorneys bring a wealth of firsthand knowledge of how government agencies conduct investigations and prosecute cases. This litigation-centric experience and skillset, combined with the firm’s extensive regulatory, transactional, and clinical knowledge, work to resolve such cases successfully, often doing so before public charges are filed. Nonetheless, when even the most creative strategies fail to persuade the government, we leverage our extensive trial experience and courtroom tenacity to achieve success for our clients.

What We Do

Examples of our federal and state court representations include:

  • Medical Practices: defending against criminal and civil investigations, related to diagnostic testing, opioid and off-label prescribing, medical necessity, upcoding and phantom billing.
  • Management Service Organizations: Addressing civil investigations involving corporate practice of medicine and alleged violations of anti-kickback statutes.
  • Specialty Pharmacies: Handling criminal and civil investigations, as well as False Claims Act lawsuits, pertaining to the following:
    • Shared services arrangements
    • Dispensing of controlled substances, including opioids, and corresponding duty of pharmacists
    • Dispensing medications for off-label use
    • Inventory shortage/billing for medications not dispensed
    • Alleged violations of the anti-kickback statute, including waiver of copayments and sales/marketing arrangements
    • REMS programs
  • Mail-Order and Dispensing Pharmacies: Managing criminal and civil investigations involving prior authorization.
  • Telemedicine companies: Representing top executives, in criminal investigations involving healthcare fraud, wire fraud, anti-kickback statute, and money laundering.
  • Software Management Companies: Addressing criminal investigations regarding chronic care management.
  • Healthcare Data Analytics Companies: Addressing and resolving contract disputes on behalf of highly skilled healthcare data scientists as between payors and providers alike
  • Laboratories: Defending against investigations of marketing and referral practices.
  • Supplier Marketing: the-spread on ingredient costs.
  • Pharmaceutical Wholesalers: Addressing coronavirus-related investigations, including criminal investigations regarding hydroxychloroquine and Federal Trade Commission investigation involving advertisements and promotional material.
  • Health System, Management Organizations and CEOs: Managing criminal investigations involving bank fraud.
  • Healthcare Professionals and Entities: Representing pharmacies, pharmacists, physician practices and physicians in connection with ancillary and collateral consequences, such as OIG and CMS exclusion; administrative disciplinary proceedings and licensure; and payor and PBM contracting.
  • Health systems, pharmacies and providers: Assisting in self-disclosures to OIG, CMS and DOJ.

Experience & Knowledge 

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. Given our primary focus on healthcare and life sciences clients, our broad industry touchpoints permit us deep insights into regulatory and enforcement trends crucial for identifying significant risks. Thus, many clients turn to us for assistance in implementing effective compliance programs and successfully remediating internal compliance failures before external disclosure and scrutiny occurs.

The commencement of a government investigation typically represents the final opportunity for clients to limit the monetary and reputational consequences of a noncompliance event. Leveraging our past government experience and knowledge of internal processes, we work 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, and Government non-intervention. In all 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.

Understanding The Landscape 

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:

  • False Claims Act (FCA): relates to fraud perpetrated on federal and state governments; incentivizes whistleblowers to file qui tam lawsuits; the FCA is a particularly powerful tool within the government’s arsenal, given the potential for treble damages under the statute and a fine of up to $23,331 per claim.
  • Anti-Kickback Statute (AKS): provides that it is a crime to offer, solicit, pay or accept remuneration in exchange for referrals of certain items/services covered by government programs.
  • Food, Drug & Cosmetic Act (FDCA): governs the distribution of misbranded or adulterated drugs.
  • Criminal Statutes under Title 18 of the United States Code:
    • Healthcare Fraud (18 U.S.C. § 1347)
    • Wire & Mail Fraud (18 U.S.C. §§ 1341 & 1343)
    • Bank Fraud (18 U.S.C. § 1344)
    • Money Laundering (18 U.S.C. § 1956)
    • False Statements (18 U.S.C. § 1001)
  • Stark Law (or the physician self-referral law): prohibits referrals to entities in which the referring physician or immediate family member has ownership, financial interest, or compensation arrangement.
  • Controlled Substances Act: applies to all entities within the distribution chain of controlled substances, including manufacturers, wholesalers, pharmacies, prescribers and even recipients of medication.
  • Civil Monetary Penalties (CMP): broad-based civil penalties, including presenting a claim for item/service not provided as claimed or that is non-reimbursable.

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.

Civil Investigative Demand and Subpoena Defense

A Civil Investigative Demand (CID) is an investigative tool, created by statute, that allows the Government to request documents, answers, or oral testimony when it “has reason to believe that any person may be in possession, custody, or control of any documentary material or information relevant to a false claims law investigation.” Federal agencies also have administrative subpoena power to request that individuals or entities that may be under investigation produce documents for the Government’s review. A Grand Jury subpoena is used during a criminal investigation to obtain testimony or documents from a subject or a target of the investigation and question the target about his or her involvement in the crime under investigation.

Although the circumstances may differ regarding a CID, agency subpoena, or Grand Jury subpoena, an attorney should be engaged if you receive any of the three. An attorney can communicate with the Government to reduce the scope of the subpoena or lessen the burden associated with compliance, or even negotiate some other solution or resolution. An attorney also can determine any available defenses or even move to quash or limit the CID or subpoena.

Significantly, receipt of a CID or subpoena usually identifies that the Government is investigating you civilly, criminally, or sometimes both. Coordinating a response and strategy is critical from the outset. Our White Collar Defense team can help you navigate the defense of the Government’s investigation.

Getting Out in Front

We endeavor, together with our Regulatory and 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 retain counsel at the earliest stages of an investigation and/or adopt a proactive approach achieve the most favorable results in the event of regulatory action.

Self-Disclosure

Various agency protocols incentivize voluntary self-reporting of certain compliance failures or legal violations through sanction leniency or forgiveness. We collaborate with our clients to conduct a thorough analysis of various considerations. Drawing on extensive experience, we assess , whether a client may benefit from voluntarily self-reporting to these agencies. Given the general rule that these programs cannot be invoked once a government 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. In the majority of such cases, our experience shows that 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.

Collateral Consequences

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:

  • Professional licensure (revocation, suspension, conditions of licensure and limitations)
  • DEA registration and/or state CDS registration
  • Insurance, payor and/or medical staff credentialing
  • Medicare and Medicaid eligibility
  • Exclusion from participation in federal programs by OIG and/or Defense Health Agency
  • National Practitioner Data Bank reporting

Accordingly, a negotiated agreement on these terms should be included in any resolution. At Frier Levitt, we employ numerous attorneys with specialized expertise in various disciplinary and administrative proceedings to successfully navigate the collateral consequences that may arise with any government matter.

How Frier Levitt Can Help

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 to speak to an attorney about regulatory concerns, government inquiries, subpoena and CID defense, as well as litigation defense.

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