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Samantha P. Kingsbury

Of Counsel

[email protected]

+1.617.348.1829

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Samantha’s practice focuses on a wide array of federal, state, and administrative health care enforcement defense matters. She defends health care companies and providers in investigations conducted by the US Department of Justice and/or its US Attorneys’ Offices, which are often initiated by qui tam complaints filed under the federal False Claims Act.  Samantha also represents clients in investigations and audits conducted by federal and state enforcement and administrative agencies, including state Offices of the Attorney General.  She also structures and executes internal investigations stemming from government inquiries, as well as potential compliance issues identified by clients. 

In addition, Samantha advises clients regarding compliance with the federal Anti-Kickback Statute, the Eliminating Kickbacks in Recovery Act, the Stark Law, and the False Claims Act, among other state and federal statutes and regulations. Samantha also has experience preparing self-disclosures and other reports relating to such enforcement matters, as well as developing internal compliance programs.

In addition to enforcement defense matters, Samantha handles licensure, reimbursement, and regulatory matters for a variety of health care clients.

Samantha is actively involved in pro bono matters at Mintz and previously served on the firm’s Pro Bono Committee. She manages the firm’s participation in the Lawyers Clearinghouse Legal Clinic for the Homeless, through which Mintz attorneys provide legal representation to residents of Boston-area homeless shelters. She also represents a wide variety of clients seeking pro bono services.  

Before joining Mintz, Samantha completed a fellowship as a Special Assistant District Attorney for the Suffolk County District Attorney’s Office.

 

Experience

  • Represented a diagnostics company in a national criminal and civil investigation involving multiple US Attorneys’ Offices and state Attorneys' General Offices. The investigation involved alleged kickback issues and billing violations with respect to the Medicare, Medicaid, and TRICARE programs, among other federal health care programs.
  • Represented specialty laboratories in False Claims Act investigations in connection with the payment of processing and handling fees for specimen collection.
  • Represented a large physician practice in several investigations, including alleged violations of the Anti-Kickback Statute and False Claims Act violations stemming from medically unnecessary procedures.
  • Conducted internal investigations of several health care providers and prepared self-disclosures to the U.S. Department of Health and Human Services, Office of Inspector General (OIG) and Centers for Medicare & Medicaid Services (CMS).
  • Represented several clinical laboratories in administrative proceedings, opposing loss of CLIA certification and the imposition of the two-year owner/operator ban.
  • Successfully opposed the OIG’s proposed exclusion of a physician from participation in federal health care programs.
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viewpoints

Health care companies using algorithms and AI applications face increased compliance risks. Previous technology-related enforcement suggests how relators and enforcement agencies might use AI to detect potential fraud and develop allegations based on how the technology is being used.

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Government enforcement activities focused on tele-fraudsters remained active in 2023, with most enforcement actions focusing on fraud schemes involving medically unnecessary durable medical equipment or genetic testing, or both.

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In 2023, the DOJ amplified compliance-related incentives for companies under criminal investigation (including health care companies), while the OIG has substantially revised and modernized previously issued compliance guidance and resources applicable to health care companies and providers.

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This Q&A with John Koss, Managing Director of Mintz’s E-Data Consulting Group, delves into the work of the group along with the benefits, challenges, and emerging issues related to using AI in e-discovery.

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Since May 2023, federal legislators have introduced more than 50 bills focused on issues related to AI technologies, with patient privacy, the role of clinicians, and health equity emerging as areas of focus. In addition, the Biden administration released an Executive Order focused on promoting AI safety in October 2023.

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An uptick in DOJ cybersecurity enforcement in 2023, includes two FCA settlements, an unsealed qui tam complaint, and significant regulatory activity that could pose future enforcement risk.

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Last week the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO), which advised that a proposed arrangement between certain laboratories for the purchase of the technical component (TC) of anatomic pathology (AP) services (Proposed Arrangement) could generate prohibited remuneration under the federal Anti-Kickback Statute (AKS) and thus be grounds for the imposition of sanctions.  As we discuss below, this AO was notable because the OIG’s decision seems to be driven by its views on the (lack of) commercial reasonableness of the arrangement and its skepticism regarding arrangements that “carve out” federal health care program business.

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Over the last year, a few important questions related to False Claims Act (FCA) cases have garnered significant attention. Two of those questions ultimately made their way to the Supreme Court. In one case, which has already been argued, the Court addresses whether the government has authority to dismiss an FCA case brought by a private citizen on the government’s behalf (a qui tam action) after originally declining to intervene and, if so, the applicable standard of judicial review. More recently, the Court has agreed to hear two cases that address whether a defendant’s “objectively reasonable” interpretation of ambiguous statutory language presents a cognizable defense to “knowledge” under the FCA. We cover both of these issues in more detail.

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Mintz’s Health Care Enforcement Defense Practice regularly provides a comprehensive examination of health care fraud enforcement trends in its new EnforceMintz newsletter. The inaugural issue delved into False Claims Act cases and enforcement activity related to telemedicine, Medicare Advantage, opioids, kickbacks, and more.

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From an agency guidance and regulatory developments perspective, 2022 was fairly quiet until the latter part of the year. Consistent with past practice, the Office of Inspector General for the Department of Health and Human Services (HHS OIG) issued a number of Advisory Opinions throughout the course of 2022. But DOJ issued four guidance documents between September 2022 and January 2023, all of which related to criminal prosecution of both individuals and corporations and reiterated a theme we have seen from DOJ over the last several years when discussing the resolution of cases: individual accountability, cooperation, and self-disclosure (among others). At tail end the end of December, Centers for Medicare & Medicaid Services (CMS) also issued a new proposed rule setting forth potential amendments to regulations for Medicare Part A - D regarding overpayments. We highlight some key takeaways from these publications below.

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News & Press

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Health Law Practice Chair Karen Lovitch and Of Counsel Samantha Kingsbury were quoted in a G2 Intelligence special report about the 2024 lab enforcement landscape.

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Mintz Member and Chair of the firm’s Health Law and Health Care Enforcement Defense Practices Karen Lovitch, Member Laurence Freedman, Of Counsel Samantha Kingsbury, and Associates Grady Campion and Caitlin Hill co-authored the Global Overview and corresponding United States chapter of the seventh edition of Lexology’s Healthcare Enforcement & Litigation 2022. Together these pieces outlined federal enforcement priorities in 2020, including matters involving opioids, COVID-19-related fraud, Medicare, and more, and look ahead to how health care enforcement is expected to evolve in the coming year. 
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Given the many substantive and strategic lessons to be learned from FCA investigations and litigations, bankruptcy counsel advising the various constituents impacted by an FCA case should be mindful of these potential lessons, as they may raise issues relevant to the bankruptcy estate, says Health Law attorney Samantha Kingsbury in this article.
Karen Lovitch, practice leader of the Mintz Health Law Practice, Eoin Beirne, a Member in the firm’s Litigation practice, along with Associates Samantha Kingsbury and Mackenzie Queenin authored the last in a four-part series of articles on health care enforcement trends in 2017.
Three attorneys from Mintz author the second installment of a four-part series recapping key government policies, regulations and enforcement actions from 2016 and discussing their potential impacts on 2017.
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Mintz Member and Chair of the Health Law Practice Karen S. Lovitch, Member Thomas S. Crane, and Associate Samantha P. Kingsbury co-authored a book published by the American Bar Association examining the federal Anti-Kickback Statute, one of the best-known federal fraud and abuse statutes, which prohibits transactions intended to induce or reward referrals for items or services reimbursed by the federal health care programs. The criminal statute has wide-ranging effects on business relationships in the health care, pharmaceutical, and medical device sectors.
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Events & Speaking

Speaker
Faculty
May
12
2016

Anti-Kickback Fundamentals

ABA | Health Law

Webinar

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Publications

Co-author, What Is...The Anti-Kickback Statute?, Second Edition, Published by the American Bar Association (2022)

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Recognition & Awards

  • Included on the Massachusetts Super Lawyers Rising Star: Health Care list (2017-2019)

  • Phi Beta Kappa

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Involvement

  • Member, American Health Lawyers Association
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