Dr. John Pepe and Dr. Richard Sherman (“Relators”), acting as whistleblowers, brought a qui tam action against Fresenius Medical Care Holdings, Fresenius Vascular Care, Inc., and Dr. Gregg Miller (“Defendants”).  Relators’ complaint alleged that the Defendants engaged in fraudulent billing practices under the False Claims Act (“FCA”) and analogous state laws.  Last week, the United States District Court for the Eastern District of New York dismissed Relators’ case because they failed to plead their allegations with particularity as required by Federal Rule of Civil Procedure 9(b).

Relators accused Defendants of systematically defrauding Medicare and Medicaid by performing unnecessary medical procedures and billing the government for these services.  The alleged fraudulent activities included: (1) scheduling follow-up visits for patients without proper referrals from treating physicians; (2) billing for medically unnecessary x-rays and other procedure; (3) falsifying patient records to include non-existent or insufficient reasons for the follow-up visits; and (4) creating prohibited financial incentive policies to encourage unnecessary procedures.

The court’s analysis revolved around the application of Rule 9(b), which requires that allegations of fraud be pleaded with particularity.  A complaint must provide detailed information about the who, what, when, where, and how of the alleged fraudulent activities.  Here, the court found that the Relators failed to meet this standard for several reasons:

  • A Lack of Specific Examples:  While Relators provided examples of fraudulent activities involving six patients, these examples were limited to a small geographic area. The court determined that these examples were insufficient to support allegations of nationwide fraud.
  • Generalized Allegations:  Relators’ claims were often based on generalized assertions and speculation rather than specific, detailed facts.  For instance, Relators alleged that Fresenius’s financial incentive policies encouraged fraud but did not provide concrete examples linking these policies to specific claims.
  • Insufficient Connection to Billing:  The court noted that Relators failed to connect the alleged fraudulent activities to specific claims submitted to the government.  Without this connection, the court could not reasonably infer that the fraud was widespread.

This holding underscores the importance of pleading fraud with particularity and the difficulties of proving nationwide fraud without detailed, specific allegations.  Going forward, individuals and entities targeted with qui tam actions can point to this case as setting a high bar for pleading FCA violations with particularity.

Note: Our lawyers leveraged AI in creating this blog post, including using a transcript summary created by generative AI. 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 innovation@crowell.com.

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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.