Samantha’s practice focuses on defending clients in government investigations and advising on a wide array of fraud and abuse and compliance matters. She represents health care companies and providers in investigations and enforcement actions conducted by various federal and state enforcement agencies, including the US Department of Justice and/or its US Attorneys’ Offices, as well as state Offices of the Attorney General, among many others. Many such actions are initiated by qui tam complaints filed under the federal False Claims Act and allege violations of the federal Anti-Kickback Statute and Stark Law, among other authorities. Samantha has also represented clients in investigations involving consumer protection issues and COVID-related programs. She also negotiates and coordinates settlements with state and federal agencies, as well as corporate integrity agreements with the Office of Inspector General for the Department of Health and Human Services.
In addition, Samantha advises clients on a wide variety of health care regulatory issues, including coverage, billing, and reimbursement, and arrangements with referral sources. She develops and implements compliance programs, structures and conducts internal investigations, advises on voluntary self-disclosure to government agencies, and defends administrative proceedings involving licensure and reimbursement issues, among other matters.
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.
Experience
- Defended 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 a clinical laboratory in a False Claims Act investigation involving alleged violations of the Stark Law stemming from arrangements with referring physicians.
- Defended a provider in an investigation conducted by the Federal Trade Commission involving alleged consumer protection violations.
- Represented a health care company in a False Claims Act investigations involving alleged performance of, and billing of federal health care programs for, medically unnecessary services.
- Advised several hospitals on submissions of self-disclosures under the CMS Self-Referral Disclosure Protocol and settling those matters with the agency.
- Representing a provider in investigations by numerous Attorneys’ Generals involving alleged violations of state consumer protection laws.
- 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 and arrangements with referring physicians.
- 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 and laboratory directors 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.
- Settled numerous False Claims Act investigations without imposition of Corporate Integrity Agreements.
viewpoints
Eleventh Circuit Rules in AseraCare Case that Disagreements in Clinical Judgment, Without Objective Falsity, Do Not Prove Fraud Under the FCA
September 11, 2019 | Blog | By Samantha Kingsbury, Laurence Freedman, Brian Dunphy
On Monday, the U.S. Court of Appeals for the Eleventh Circuit issued its long-awaited and closely watched decision in United States v. AseraCare Inc.. The court ruled that a claim cannot be deemed false under the False Claims Act (FCA) based on a difference in clinical judgment. Instead, there must be proof of an objective falsehood. More than three years have passed since the U.S. District Court for the Northern District of Alabama issued the series of rulings that gave rise to the Eleventh Circuit case.
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Insys Bankruptcy Filing Immediately After Global Settlement Triggers Powerful Remedies
June 25, 2019 | Blog | By Samantha Kingsbury, Laurence Freedman
Over the last two years, much of the healthcare world has been watching the government’s prosecution of Insys Therapeutics for its sales and marketing practices related to its Subsys spray. Subsys is powerful and highly addictive fentanyl spray (administered under the tongue) that was approved by the FDA in 2012 for the treatment of persistent breakthrough pain in adult cancer patients who were already receiving, and tolerant to, regular opioid therapy. On June 5, 2019, DOJ announced a global resolution with Insys, including criminal pleas, a Deferred Prosecution Agreement (DPA), a civil settlement agreement, and a Corporate Integrity Agreement (CIA). Then, on June 10, 2019, Insys filed for bankruptcy protection, which triggered DOJ and HHS’s ability to upend these agreements and impose powerful criminal, civil, and exclusion remedies against Insys. While much of the coverage of this case over the last few years has focused on the high-profile prosecution and conviction of company executives (including Insys’s founder) and other employees who were accused of paying kickbacks to prescribers in exchange for increased prescriptions and increased doses of Subsys, the resolution of this case on the corporate side has proven to be equally fascinating.
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FCA Relator and U.S. Weigh in on Defendants' Argument that the FCA is Unconstitutional
May 9, 2019 | Blog | By Samantha Kingsbury, Brian Dunphy
As part of our ongoing discussion of the Polukoff False Claims Act (FCA) qui tam case (involving allegations that certain heart procedures performed by a cardiologist, and billed for by two hospital defendants, were not medically necessary), we reported in February that some defendants filed a petition for a writ of certiorari with the United States Supreme Court.
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Health Care Fraud Investigations and Litigation Offer Unexpected Lessons for Bankruptcy Counsel
April 25, 2019 | Blog | By Samantha Kingsbury
As many of our readers know, we have been closely following the Polukoff False Claims Act (FCA) qui tam case in the Tenth Circuit for the lessons it might offer in defending FCA cases premised on allegations related to lack of medical necessity (among other topics). Recently, we had the opportunity to consider this case from a different angle: the lessons it might offer to bankruptcy counsel advising clients who are or have been the subject of a health care fraud investigation and/or FCA qui tam case.
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FCA Defendant Petitions Supreme Court, Argues Statute is Unconstitutional
February 7, 2019 | Blog | By Samantha Kingsbury
As many of our readers know, we have been closely following the Polukoff False Claims Act (FCA) qui tam case, which is based on allegations that certain heart procedures performed by a cardiologist were not medically necessary. The latest development in this case came a few weeks ago, when defendants Intermountain Health Care, Inc. and IHC Health Services, Inc. d/b/a Intermountain Medical Center (Intermountain) filed a Petition for a Writ of Certiorari with the United States Supreme Court. The Petition raised two issues: (1) whether a court may create an exception to Federal Rule of Civil Procedure 9(b)’s particularity requirement when the plaintiff claims that only the defendant possesses the information needed to satisfy that requirement; and (2) whether the False Claims Act’s qui tam provisions violate the Appointments Clause of Article II of the Constitution.
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DOJ Updates its Justice Manual to Include Section Limiting Use of Guidance Documents in Litigation
January 7, 2019 | Blog | By Samantha Kingsbury
Nearly one year ago, on January 25, 2018, the Department of Justice’s (DOJ) Regulatory Reform Task Force issued a memorandum entitled “Limiting Use of Agency Guidance Documents In Affirmative Civil Enforcement Cases.” Many refer to this memorandum as the “Brand Memo” because it was authored by Associate Attorney General Rachel Brand. The Brand Memo implemented the prohibition previously issued by U.S. Attorney General Jeff Sessions in November 2017 against, in part, DOJ using guidance documents issued by other agencies “to create binding standards by which [DOJ] will determine compliance with existing statutory or regulatory requirements” (the “Sessions Memo”).
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Tenth Circuit Rejects Request for Rehearing in Closely Watched FCA Medical Necessity Case
November 13, 2018 | Blog | By Samantha Kingsbury, Laurence Freedman
In a three-sentence order issued on October 29th, the Tenth Circuit Court of Appeals declined to grant a Request for Rehearing in the closely watched Polukoff case. One of the questions raised in the Request was whether, by submitting a claim for reimbursement and certifying the medical necessity of the charged service, providers also certify that the claim meets all of the standards set forth in the Medicare Program Integrity Manual (MPIM).
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Mintz’s Antitrust Group Covers Third Circuit Reinstatement of $67 Million Antitrust “Refusal to Deal” Suit Against Blues
September 5, 2018 | Blog | By Samantha Kingsbury
Last week, Bruce Sokler and Farrah Short from Mintz’s Antitrust practice group published a detailed alert regarding the Third Circuit’s reinstatement of an antitrust suit brought by medical device manufacturer LifeWatch Services, Inc. (“LifeWatch”) against the Blue Cross Blue Shield Association and five of its member insurance plan administrators: LifeWatch
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Mintz’s Health Care Enforcement Defense Group Publishes New Qui Tam Update
August 13, 2018 | Blog | By Samantha Kingsbury
Last week, Mintz’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 46 health care-related False Claims Act qui tam cases unsealed in February and March 2018 and the trends they reflect:
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Mintz’s Health Care Enforcement Defense Group Publishes Latest Qui Tam Update
June 12, 2018 | Blog | By Samantha Kingsbury
Last week, Mintz’s Health Care Enforcement Defense Group published a new Qui Tam Update, which analyzes 60 health care-related False Claims Act qui tam cases unsealed in December 2017 and January 2018 and the trends they reflect.
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News & Press
Special Report: The 2024 Lab Enforcement Landscape
August 29, 2024
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.
Healthcare Enforcement & Litigation 2022
August 27, 2021
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.
Health Care Fraud Investigations and Litigation Offer Unexpected Lessons from Bankruptcy Counsel
May 1, 2019
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.
2017 Health Care Enforcement Review: Final Thoughts
January 19, 2018
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.
Health Care Enforcement Review And 2017 Outlook: Part 2
January 17, 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.
What Is The Anti-Kickback Statute?
January 1, 2015
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.
podcasts
Health Law Diagnosed – New Year's Gratitude
February 3, 2025 | Podcast | By Bridgette Keller, Alison H. Peters, Samantha Kingsbury, Theresa Carnegie, Joanne Hawana , Abdie Santiago, Stephnie John, Pamela Polevoy, Karen Lovitch , Jean D. Mancheno, Deborah Daccord, Rachel A. Alexander, Jane Haviland, David Gilboa, Kathryn Edgerton, Hassan Shaikh, Madison Castle, Laurence Freedman, Priyanka Amirneni, Samantha Hawkins, Tara E. Dwyer, Rachel Yount, Sophia Temis, Xavier Hardy
Host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead. Hear from a dynamic group of Members, Of Counsel, and Associates as they share their perspectives on what’s coming up over the horizon.
Mintz Health Law: What We Are Grateful For
January 11, 2023 | Podcast | By Bridgette Keller
Bridgette Keller speaks with the Mintz Health Law team about what they are grateful for as they look back on a year of client service, mentorship, and working together as a team.
Events & Speaking
Publications
Co-author, What Is...The Anti-Kickback Statute?, Second Edition, Published by the American Bar Association (2022)
Read lessRecognition & Awards
Included on the Massachusetts Super Lawyers Rising Star: Health Care list (2017-2019)
Phi Beta Kappa
Involvement
- Member, American Health Lawyers Association
Recent Insights
Health Law Diagnosed – New Year's Gratitude
February 3, 2025| Podcast|
