In the world of False Claims Act (“FCA”) litigation, the recent case United States ex rel. Robert C. O’Laughlin, M.D. v. Radiation Therapy Services, P.S.C., et al. serves as an important reminder of the need for concrete evidence when asserting qui tam FCA claims.

In this case, Dr. O’Laughlin filed a qui tam action under the FCA, alleging that Radiation Therapy Services and its affiliates submitted fraudulent claims to Medicare and Medicaid for radiation oncology and chemotherapy services.  Despite multiple amendments to his complaint and extensive discovery, however, O’Laughlin could not meet his burden of showing that Radiation Therapy Services knowingly submitted or caused to be submitted false or fraudulent claims to the government, and the court ultimately dismissed the case on summary judgment.

Throughout this case, O’Laughlin relied on generalized allegations and speculative theories rather than any concrete proof.  For example, O’Laughlin broadly alleged a scheme in which chemotherapy services were billed as if provided by a physician (and thus eligible for a higher reimbursement rate by Medicare) when, in fact, they were purportedly neither provided by nor directly or personally supervised by a physician.  Yet when pressed during his deposition, O’Laughlin could not identify a single specific claim meeting this criterion.  

O’Laughlin similarly tried and failed on multiple occasions to demonstrate that Defendants billed for chemotherapy services when no physician was present at the clinics.  O’Laughlin relied on a so-called “Master Schedule” maintained by the Defendants to argue that the schedule proved the absence of physicians during chemotherapy sessions.  However, the Defendants offered reliable testimony from several individuals explaining that the Master Schedule was merely a summary of patient appointments and was not intended to document physician presence or absence, shattering O’Laughlin’s already shaky evidentiary foundation. 

To this, the court emphasized that actual evidence of a submitted claim is required in order to establish FCA liability.  And to survive a defendant’s motion for summary judgment in particular, the plaintiff is challenged to “put up or shut up” on critical issues.  This case highlights the high burden of proof required in FCA cases and provides a helpful guideline to both plaintiffs and defendants in how to effectively navigate discovery and litigate strategically. Both sides need to keep in mind that reliance on generalized allegations of fraud, without identifying specific instances, is insufficient to meet the evidentiary burden required to survive summary judgment in an FCA matter. 

Note: Our lawyers leveraged AI in creating this blog post.  As we explore the potential of generative AI in the legal space, it is our intention and our practice to be transparent with our readers and to showcase the results we are achieving using generative AI with publicly available resources. Crowell’s AI group is comprised of lawyers and professionals across our global offices, including from Crowell & Moring International (CMI), our international public policy entity, with decades of sector-specific experience. We intend to lead by example in our own responsible use of AI, as it pertains to both the risks and benefits. Should you have questions about the use of generative AI in the legal sector or Crowell’s use of AI, please contact inovation@crowell.com.

Print:
Email this postTweet this postLike this postShare this post on LinkedIn
Photo of Michael Shaheen Michael Shaheen

Michael Shaheen is a partner in the White Collar & Regulatory Enforcement and Health Care groups in the Washington, D.C. office of Crowell & Moring. His practice focuses on federal litigation, investigations, and enforcement actions. Michael has significant experience with the False Claims…

Michael Shaheen is a partner in the White Collar & Regulatory Enforcement and Health Care groups in the Washington, D.C. office of Crowell & Moring. His practice focuses on federal litigation, investigations, and enforcement actions. Michael has significant experience with the False Claims Act (FCA), with particular emphasis on health care fraud.

Before joining Crowell & Moring, Michael served as a Trial Attorney with the Fraud Section of the Department of Justice (DOJ), where his work primarily involved investigating and prosecuting FCA matters. At DOJ, he obtained judgments totaling hundreds of millions of dollars and was involved in the settlement of numerous false claims cases of similar magnitude. Michael served in a variety of roles in these cases, ranging from first-chair trial attorney to lead investigator.

Photo of Spencer Bruck Spencer Bruck

Spencer Bruck is counsel in Crowell & Moring’s Health Care group where he represents clients in litigation, fraud and abuse, and compliance matters. He recently joined the firm from the Office of the New York State Attorney General where he led civil health

Spencer Bruck is counsel in Crowell & Moring’s Health Care group where he represents clients in litigation, fraud and abuse, and compliance matters. He recently joined the firm from the Office of the New York State Attorney General where he led civil health care fraud and qui tam investigations involving managed care organizations, pharmaceutical companies, national pharmacies chains, hospital groups, nursing homes, independent medical groups, and other providers.

These investigations arose under the False Claims Act, Anti-Kickback Statute, Stark Law, the New York State Executive and Social Services laws, and managed care contracts. As part of his investigations, Spencer regularly liaised with CMS, HHS-OIG, DOJ, NYS DOH, NYS OMIG, and the New York State Comptroller. Spencer also negotiated self-disclosures with providers involving the HHS-OIG, the NYS OMIG, and the NYS MFCU protocols.

Spencer’s government experience helps him counsel health care entities on regulatory policy and guidance; represent health care entities responding to government surveys, audits, and investigations; conduct internal investigations or compliance reviews; advise on managed care contracts and reimbursement issues; and assist on administrative applications and matters before regulatory agencies; and represent entities in matters in state and federal courts, and in administrative proceedings.

Spencer also litigates complex commercial disputes federal, state, and arbitral forums with a focus on representing managed care companies.

Photo of Michelle Chipetine Michelle Chipetine

Michelle Chipetine is a counsel in Crowell & Moring’s New York office and a member of the firm’s Intellectual Property and Health Care groups. Michelle’s practice focuses on patent litigation and representing health care entities and not-for-profit corporations on a wide range of…

Michelle Chipetine is a counsel in Crowell & Moring’s New York office and a member of the firm’s Intellectual Property and Health Care groups. Michelle’s practice focuses on patent litigation and representing health care entities and not-for-profit corporations on a wide range of transactional, corporate, and regulatory matters. Michelle also maintains an active pro bono practice.

Michelle graduated cum laude from Fordham University School of Law, where she was a legal writing and torts teaching assistant and actively involved with Fordham’s Neuroscience and Law Center. During law school, Michelle worked for Mount Sinai Innovation Partners, where she facilitated the transfer and commercialization of technologies developed by Mount Sinai researchers. Michelle also studied neuroscience at Vassar College, where she graduated cum laude.