Health Care and Life Sciences Investigations and Enforcement

Overview

For companies in the health care and life sciences sectors, the prospect of running afoul of the complex laws and regulations surrounding the payment of government reimbursement claims is not a welcome one.

Any and all organizations within those sectors are rightfully wary of the ever-increasing attention and resources that state and federal governments are expending on investigations related to potential violations of these complex regulations and requirements. These government investigations can result not only in substantial monetary penalties and potential exclusion from future participation in the federal and state health care programs but also in significant reputational harm even when no wrongdoing is ultimately proven.

Our Health Care and Life Sciences Investigations and Enforcement group works with clients, conducting both internal investigations and responding to enforcement actions. Known for our comprehensive knowledge of all phases of health care financing, delivery, and reimbursement, we have the resources—as well as the credibility with regulators—to resolve disputes at their earliest stages. In both civil and criminal cases, our deep roots in the health care and life sciences industries underscore both our thorough understanding of the regulatory issues and our formidable investigative and litigation skills.

Self-Initiated Investigations

Health care laws, whether federal or state, generally require active self-policing on the part of every company in the chain of commerce. To that end, clients count on us to ensure they are fully compliant and to help them identify risk areas—including from vendors and customers—that could trigger an enforcement action. If a noncompliance issue is discovered, we conduct a thorough internal investigation. We assess the scope of the issue and recommend remedial steps, if any—which might or might not include disclosure and return of overpayments to the appropriate agencies.

Government Audits & Investigations

Government regulators have the resources to conduct audits and investigations into every aspect of a health care entity’s operations. Those audits and investigations can result in significant overpayment demands or substantial fines and penalties. Our team has a deep knowledge of the enforcement tools at the government’s disposal and how audits and investigations are conducted. We regularly counsel clients that must respond to audits and investigations and work with them through every phase of the process, from the initial response to resolution. Clients rely on us to represent them in administrative hearings and litigation arising from audits and investigations. Our experience covers a wide range of activities, including:

Medicare Administrative Contractor (MAC) audits
Unified Program Integrity Contractor (UPIC) audits
Recovery Audit Contractor (RAC) audits
Investigations by the U.S. Department of Health and Human Services (HHS) Office of Inspector General or U.S. Department of Justice into potential false claims
Investigations by the HHS Office of Inspector General or Department of Justice into potential violations of the Anti-Kickback Statute, Stark Law, health care fraud statute, and other criminal laws
Investigations by HHS involving potential civil monetary penalties
Medicare and Medicaid cost report audits and program appeals
Revocations of Medicare billing privileges and payment suspensions
Investigations and audits involving federal research grants
Medicaid Fraud and Control Unit (MFCU) investigations

Government Enforcement Actions

While qui tam cases are on the rise—with whistleblowers highly incented to bring claims alleging fraud—the government is now increasing the number of cases it brings on its own, using its own data analytics as evidence. In either event, an effective response requires extensive familiarity both with the regulations in question and with the agencies bringing the claim. We have a long history with the entire panoply of federal and state agencies empowered to launch investigations, and we are inevitably our client’s first call when they become a subject or target. Whether the claim is civil or criminal, we act quickly to direct preservation, assess the scope of the investigation, and, where possible, negotiate an early settlement. At every stage in the process, we work to resolve our clients’ issues while protecting their good name.

Selected Representative Experience

Defended a global pharmaceutical manufacturer in a multifaceted federal and state government investigation with civil and criminal implications. The U.S. Department of Justice, the U.S. Food and Drug Administration, and other governmental agencies examined allegations of inappropriate sales, marketing, and promotional activities to prescribers and purchasers of numerous drugs in the client’s product portfolio; potential violations of the Anti-Kickback Statute; and the promotion of products using inaccurate and untruthful statements. We negotiated a settlement on terms favorable to our client.
Represented multiple Medicare Advantage (MA) health plans in connection with internal investigations and voluntary disclosures to the Centers for Medicare & Medicaid Services related to overpayments. The disclosures did not result in an assessment of additional penalties. In one instance, we assisted the MA organization with litigation to recoup amounts from a vendor whose services were central to the overpayment.
Convinced the U.S. Department of Justice to close, without prosecution, complex criminal investigations against health care systems for alleged improper billing.
Led an investigation for a home health and hospice provider in response to a whistleblower retaliation complaint lodged by a hospice nurse. We concluded the matter by negotiating a favorable settlement.
Represented a regional health care system in a multiyear investigation by the U.S. Department of Health and Human Services Office for Civil Rights (OCR) involving allegations of failure to comply with HIPAA, leading to the disclosure of protected patient information. After significant documentary and testimonial evidence, the case was closed by OCR without a finding of liability, the imposition of any sanction, or a requirement of remedial conduct.
Achieved a successful resolution for multiple provider clients in a criminal health care fraud investigation stemming from the filing of a qui tam complaint alleging improper billing and performance of medically unnecessary testing. Our advocacy resulted in the U.S. Department of Justice concluding that investigation without prosecution.
Conducted an investigation brought forward by a senior compliance official who alleged that senior executives at a publicly traded Fortune 100 health care company engaged in retaliation after the compliance official raised concerns over perceived fraudulent billing practices. We presented the findings of our investigation to the company’s audit committee.
Defended a corporate executive in a three-week criminal fraud trial involving charges of government contract fraud and taking kickbacks and in related False Claims Act litigation.
Represented a witness in the investigation and trial of a former member of the U.S. House of Representatives involving bribery and violations of the Foreign Corrupt Practices Act.