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Thomas S. Crane

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[email protected]

+1.617.348.1676

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Tom is nationally recognized for his work defending health care clients against anti-kickback, Stark Law, false claims, and whistleblower allegations. His work includes litigation, internal investigations, corporate integrity agreements, and self-disclosures. Tom also counsels clients on the legal, practical, and fraud and abuse implications of business arrangements and sales and marketing practices. Additionally, Tom has worked with several academic medical center clients in restructuring arrangements among medical school, teaching hospital, and faculty physicians. Tom gained national recognition for his work on the anti-kickback statute during his tenure at the HHS Office of Inspector General, where he prosecuted the Hanlester Network case and was the principal author of the 1991 safe harbor regulations. He is an elected Fellow of the American Health Lawyers Association.

Tom is nationally recognized for his experience with fraud and abuse. Practicing in Boston and Washington, DC, he advises national and local clients on structuring complex strategic affiliation arrangements and transactions to comply with the applicable fraud and abuse laws as well as the variety of other regulatory requirements to meet today’s health reform challenges. His work in defending clients against anti-kickback, Stark Law, false claims, and whistleblower allegations includes litigation, internal investigations, self-disclosures, and negotiating settlements and Corporate Integrity Agreements (CIAs).

He has appeared before numerous US attorneys’ offices, the FBI, and the Office of Inspector General (OIG) and Centers for Medicare & Medicaid Services (CMS) around the country and in Washington. In addition, he has served as an expert witness and consulting expert in health care fraud cases.

In addition to his fraud and abuse defense work, Tom advises clients on the legal, practical, and fraud and abuse implications of business arrangements and sales and marketing practices. This part of his practice focuses on Medicare and Medicaid fraud and abuse compliance and reimbursement issues and related laws, including the federal Physician Payments Sunshine Act, ‘meaningful use’ of EHR technology, under arrangement and provider-based rules, and OIG issues.

Tom has implemented and audited comprehensive corporate compliance programs for clients in various health care sectors.

His clients have included hospital systems and executives, medical device and pharmaceutical manufacturers, pharmacies and pharmacy benefit management companies, physicians and groups, renal dialysis providers, supply companies, home care providers as well as national and state trade groups.

Tom has served in leadership positions with the American Health Lawyers Association (AHLA), the largest organization of health care attorneys in the country, including election as a Fellow (as only the third private-practice fraud and abuse attorney elected), which is one of AHLA’s highest recognition for lifelong leadership. He has written numerous articles, lectures frequently to health care providers and attorneys critiquing government fraud and abuse enforcement policies, and has extensive knowledge regarding the ethics of financial relationships among health care providers.

He became nationally known for his work on the anti-kickback statute during his tenure at the Office of Inspector General at the Department of Health and Human Services in Washington, DC. In particular, Tom gained recognition as a prosecutor in the Hanlester Network joint venture case and as the principal author of the 1991 safe harbor regulations.

Education

  • Antioch College (JD)
  • University of Michigan (MHA)
  • Harvard University (BA)

Experience

  • Representing academic physician groups in considering merger options and restructuring academic affiliation with medical school
  • Represented numerous cardiology practices in developing strategic relationships with hospitals
  • Represented hospitals and other providers in self-disclosures to the OIG, CMS and US Attorneys’ Offices for potential Stark Law, Anti-Kickback and FCA violations
  • Secured a dismissal of a False Claims Act suit brought by an ex-employee whistleblower who accused the company of knowingly overcharging Medicaid for the cost of pharmaceuticals.
  • Representing non-profit academic medical practice plans in restructuring their relationship with the medical school with which they are affiliated.
  • Advised University Physicians, Inc., a physician group organized by six Rhode Island-based, tax-exempt faculty practice plans at the Warren Alpert School of Medicine of Brown University (SOM) and Rhode Island Hospital, with respect to an affiliation agreement with a new unifying entity, Brown Physicians, Inc. (BPI).

Recognition & Awards

  • Included on the Massachusetts Super Lawyers: Criminal Defense: White Collar list (2004 – 2012, 2014 – 2017, 2019)
  • Elected a Fellow of the American Health Lawyers Association (as only the third private-practice fraud and abuse attorney elected), which is one of AHLA’s highest recognition for lifelong leadership (2015).
  • Recognized by the The Legal 500 United States for Healthcare: Service Providers (2014 – 2015)
  • Best Lawyers in America: Health Care Law (2011 – 2020)
  • Chambers USA: Massachusetts – Healthcare (2009 – 2012, 2015 – 2019)
  • Martindale-Hubbell AV Preeminent
  • Nightingale’s Healthcare News: Outstanding Fraud and Compliance Lawyers (2004)

Involvement

  • Board of Directors, Massachusetts Medical Device Industry Council (MassMEDIC)
  • Member, Bloomberg Law’s Health Law and Business Editorial Advisory Board
  • Founding chairman, Fraud and Abuse, Self-Referrals, and False Claims Committee; Past member, Program Committee, AHLA/HCCA Annual Fraud and Abuse and Compliance Forum; Member, Technology Task Force: AHLA
  • Neutral arbitrator, AHLA
  • Member, Massachusetts Bar Association (Health Section)
  • Member, District of Columbia Bar Association (Health Law Section, Steering Committee 1987 – 1990)
  • Board of Directors, (Executive Committee, Audit Committee Chairman) Marine Biological Laboratory, Woods Hole, Massachusetts
  • Town Moderator, Weston, Massachusetts (previously Assistant Town Moderator, 2011-2012, and Chairman, Town Meeting Advisory Committee, 2012)
  • Tom is a life-long sailor, including racing and white water passages

Viewpoints

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A Review of the Affordable Care Act at 10 Years, Part 2: Medicaid Expansion

April 8, 2020 | Blog | By Xavier Hardy, Thomas Crane

This post is the second installment in our blog series looking back on the 10-year anniversary of the Affordable Care Act (ACA) and will cover Medicaid expansion under the ACA. Medicaid is joint federal-state program that provides health insurance coverage to people with low incomes.  State participation in the program is voluntary, although all states currently participate.  The program has historically provided states with a significant amount of flexibility and autonomy in how it is administered.  However, in exchange for federal matching funds, states are required to comply with federal Medicaid laws and guidance. 
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A Review of the Affordable Care Act at 10 Years, Part 1: The Individual Mandate

April 7, 2020 | Blog | By Xavier Hardy, Thomas Crane

This post is the first installment in our blog series looking back on the 10-year anniversary of the Affordable Care Act (ACA).  The most controversial of the ACA's reforms has been the individual mandate, which requires that individuals maintain health care coverage that meets certain standards (known as “minimum essential coverage”) or pay a penalty in the form of a tax.  Even as the law was winding itself through the legislative process, the individual mandate received a fair amount of attention outside the typical industry specific publications that cover the minutia of health care reform.  While  there were some critics of the individual mandate who, even prior to enactment, specifically argued the individual mandate was unconstitutional, most of the coverage dealt with a more basic underlying question: was it appropriate for the government to mandate that everyone pay for health insurance? 
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A Review of the Affordable Care Act at 10 Years

April 6, 2020 | Blog | By Xavier Hardy, Thomas Crane

Two weeks ago marked the tenth anniversary of the enactment of the Affordable Care Act (ACA).  Given the ongoing COVID-19 pandemic, which Mintz has been closely monitoring, it is understandable why the anniversary has largely flown under the radar.  However, now is as good a time as any to reflect on all the controversy that has surrounded the law over the last decade, as well as how much the law has accomplished. While far from comprehensive, our upcoming blog series will review some of the impacts the law has had on the U.S. healthcare system, in particular focusing on the legal issues and debates that have surrounded the law.  Mintz has previously covered many of these items, and links to our prior coverage is included throughout.
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On June 26, 2019, a divided Supreme Court in Kisor v. Wilkie issued one of its most important administrative law decisions in decades. The Supreme Court decided to uphold, but dramatically narrow, the doctrine of judicial deference to agency regulations, known as Auer deference, but at the same time unanimously found for petitioner James Kisor in overturning the Federal Circuit’s affirmance of the Board of Veteran’s Appeals decision to deny part of his claim for Vietnam War disability benefits.  We discuss below the majority and minority opinions on Auer deference, the narrow unanimous holding of reversal, and the importance of this decision.
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On June 3, 2019, the U.S. Supreme Court issued a decision in Azar v. Allina Health Services. The case involved a challenge by hospitals over whether the Department of Health and Human Services (“HHS”) was required to proceed through notice-and-comment rulemaking before promulgating a retroactive Medicare rate calculation methodology for Disproportionate Share (DSH) payments to hospitals. In a 7-1 decision by Justice Gorsuch, the Court ruled in favor of the hospitals, holding that the new rate calculation established a substantive legal standard, and therefore notice-and-comment was required under the Medicare Act.
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Next Tuesday, January 12th, Mintz and ML Strategies will host the first installment of our three-part series focusing on the 21st Century Cures Act (“Cures Act”).  The Cures Act represents significant legislation that will have overarching implications on medical research, product development, and drug and biologic manufacturing.
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21st Century Cures Act – Med Tech Impact Webinar January 18

December 21, 2016 | Blog | By Rachel Irving Pitts

As you have seen in our recent coverage, the 21st Century Cures Act is a major legislative undertaking, and it will have a great impact the medical device industry. Join my Mintz Levin and ML Strategies colleagues Tom Crane, Bethany Hills, and Rodney Whitlock on January 18th for a MassMEDIC webinar, “Impact of the Cures Act on the Medical Device Industry.”
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Promise to Repeal the ACA Poses Threat to MACRA Implementation

November 21, 2016 | Blog | By Thomas Crane

Most of the post-election discussion of the ACA has focused on how promises to repeal the law could impact the newly insured. But one priority area of the ACA that has received very little discussion is the federal government's strategy to try to reign in health care costs by reducing volume and promoting quality.
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On October 14, 2016, the Centers for Medicare and Medicaid Services (CMS) released the final rule for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).
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On June 16, 2016, a unanimous Supreme Court issued its long-awaited decision in Universal Health Services v. United States ex rel. Escobar (“Escobar”). The Court ruled that under certain circumstances the theory of “implied false certification” can give rise to liability under the False Claims Act (“FCA”).
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News & Press

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Mintz Member and Chair of the Health Law Practice Karen S. Lovitch served as an editor of the Fifth Edition of the American Health Lawyers Association’s “Health Care Compliance Legal Issues Manual,” which provides strategies for addressing the full scope of legal issues critical to health care compliance. Mintz Member Thomas S. Crane also contributed to the publication as an author.
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Mintz partner and Massachusetts lawyer Julie Korostoff is one of 49 attorneys recognized as “Leaders in Their Fields” by the 2018 Chambers USA: America's Leading Lawyers for Business guide. Chambers named Korostoff a “Recognized Practitioner” in Technology.
In looking ahead to 2018 health care trends, Mintz Member Tom Crane, a fraud and abuse and health care enforcement defense attorney, is referenced in the Bloomberg Law article on possible changes to the Stark Law in 2018.
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Best Lawyers named 85 Mintz attorneys to its 2018 list of The Best Lawyers in America. In addition, Mintz attorneys Matthew J. Gardella and Samuel M. Tony Starr were named “Lawyer of the Year” in their respective practice areas.
Member Tom Crane authors this article discussing the decision by the Fourth Circuit court of Appeals in United States ex rel. Drakeford v. Tuomey. The judgment premised on Stark Law violations, and was, according to some, not grounded in Stark Law regulations.
This article notes that due to the Trump administration’s delay of a program integrity final rule fraud enforcement could become more of a challenge. Mintz health care attorneys Ellyn Sternfield and Tom Crane weigh in on the issue.
Thomas S. Crane, a Member of the Health Law Practice at Mintz, is speaking on a panel at the Advanced Forum on False Claims and Qui Tam Enforcement. The event is sponsored by the American Conference Institute.
In this Bloomberg BNA Health Law Resource Center article, Tom Crane discusses the potential consequences of reforming Stark law. Tom is known for his fraud and abuse defense work and is involved in Mintz’s Health Care Enforcement Defense Practice.
Mintz Member Tom Crane is quoted in this Modern Healthcare article discussing the American Hospital Association’s request to President-elect Trump to cancel Stage 3 of the meaningful use program.
Fifty-three Mintz attorneys have been named Massachusetts Super Lawyers for 2016 and thirty-one have been named Massachusetts Rising Stars. The findings will be published in the November 2016 issue of Boston Magazine and in a stand-alone magazine, New England Super Lawyers. 
Best Lawyers named 73 Mintz attorneys to its 2017 list of The Best Lawyers in America. Mintz attorneys selected for inclusion in this year’s list span 44 practice areas. 
Firm’s National Healthcare Practice, NY Corporate/M&A and Litigation: General Commercial Among Newest Rankings
Mintz Member Tom Crane is quoted in this BNA’s Health Care Daily Report article discussing the expectation that the health care industry will face increased False Claims Act cases and enforcement actions in 2016.
The 2015 Chambers USA: America's Leading Lawyers for Business guide names 52 Mintz, Cohn, Ferris, Glovsky and Popeo, P.C.  attorneys as “Leaders in Their Fields.”
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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.

Events

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