When disputes arise, Reed Smith has the firepower to provide a strong defense. We have built a leading regulatory litigation practice, and our lawyers can defend you, as we’ve done for other clients, when you’re subject to civil and criminal investigations; actions brought by the Department of Health & Human Services’ Office of Inspector General (HHS-OIG) and Department of Justice (DOJ); and whistle blower matters, at both the state and federal level. We are one of a handful of law firms that have litigated against the DOJ in intervened federal False Claims Act (FCA) cases.
Many health care entities, like yours, – including academic medical centers (AMCs), ambulatory surgical centers (ASCs), comprehensive outpatient rehabilitation facilities (CORFs)/outpatient rehabilitation facilities (ORFs), hospices, hospitals, independent diagnostic testing facilities (IDTFs), inpatient rehabilitation facilities (IRFs), skilled nursing facilities (SNFs), and managed care entities – trust our team to guide them through complex government inquiries, audits, and investigations, including negotiating innovative settlements. Indeed, our lawyers have helped favorably resolve many high-profile government investigations within the past decade. Our edge lies not only in our strong relationships with government agencies, but also in our reputation of integrity and efficiency.
Our lawyers have helped guide health care companies like yours through inquiries and investigations by all of the principal federal enforcement and oversight entities, including the DOJ, HHS-OIG, the Federal Bureau of Investigation and Congress, as well as state investigations instituted by Lawyer General offices.
These matters frequently involve alleged violations of federal and state fraud and abuse authorities such as the federal Anti-Kickback Statute, the Stark and Beneficiary Inducement Laws, the federal FCA, and the Foreign Corrupt Practices Act.
To be successful in today’s health care climate, companies need more than top-level legal advice—you need counsel who have strong relationships with the regulators who interpret the law, and the authorities and agencies that enforce it. Our lawyers have built reputations as leaders in the field, and have the relationships and credibility to propose creative solutions to the most difficult dilemmas.
Many members of our team have years of experience in federal health care enforcement, including a number who served as former Assistant United States Attorneys (AUSAs), and those who have worked at nearly every other health care regulatory and/or enforcement agency, including the HHS-OIG, the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Department of Veterans Affairs (VA). In addition, former Reed Smith lawyers have gone on to work for CMS, HHS-OIG and the DOJ.
We handle every aspect of government investigations, from requests for documents or subpoenas, to witness interviews, negotiation with agency personnel, the structuring of settlements and, as appropriate, corporate integrity agreements (CIAs) or certification of compliance agreements (CCAs). In addition to negotiating CIAs and CCAs, we assist clients with on-going CIA/CCA compliance and reporting activities. Our team regularly coordinates with the firm’s e-discovery group to manage the document review and retention aspects of these investigations.
Our team also has particular experience in negotiating global settlements, which differ from typical fraud settlements because they encompass all liabilities that an entity may have with the United States. We have employed this settlement method to help health care entities like yours, successfully and simultaneously resolve all outstanding claims, including claims in bankruptcy.