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, voluntary 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) around the country. 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, 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. 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.
Representative Matters
Litigation & Defense
- Counsel for cardiologists in qui tam False Claims Act case alleging medical device company kickbacks
- Counsel for a physician facing mandatory exclusion which led to the OIG withdrawing its action
- Lead counsel in Colorado Heart Institute, LLC v. Leavitt (D.D.C. No. 1:08-cv-01626-RMC), a suit challenging the CMS Stark Law regulations
- Counsel to a hospital executive and his management company in United States v. Jones (5th Cir. January 16, 2007), a criminal-related party cost report fraud case reversing the district court’s sentencing and restitution order based on a failure of the government’s proof
- Part of the criminal defense team in the trial of TAP managers in Boston, resulting in a Rule 29 judgment of acquittal for the firm’s client
- Lead amici counsel to the American Hospital Association, Federation of American Hospitals, Association of American Medical Colleges, American Osteopathic Association, and Missouri Hospital Association in United States v. McClatchey, (217 F.3d 823, 10th Circ. 2000) and United States v. Lahue, (261 F.3d 993, 10th Circ. 2001), cases that challenged the application of the so-called one purpose rule which holds that a provider can be found guilty under the anti-kickback statute if one purpose in paying remuneration is to induce referrals
Compliance & Regulatory
- Representing academic medical center in its affiliation agreements with community physicians and hospitals
- Represented academic physician groups in considering restructuring options to better face health care reform challenges.
- Led audit team of an academic medical center’s compliance program
- Represented numerous cardiology practices in developing strategic relationships with hospitals
- Represented national trade association in seeking Stark law regulatory changes
Recognitions & Awards
- Best Lawyers in America: Health Care Law (2011 – 2013)
- Chambers USA: Massachusetts – Healthcare (2009 – 2012)
- Massachusetts Super Lawyers: Criminal Defense: White Collar (2004 – 2012)
- Martindale-Hubbell AV Preeminent
- Nightingale’s Healthcare News: Outstanding Fraud and Compliance Lawyers (2004)
Professional & Community Involvement
- Advisory Board, Health Care Fraud Report, published by the Bureau of National Affairs, Inc.
- 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
- 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 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, voluntary 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) around the country. 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, 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. 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.
Representative Matters
Litigation & Defense
- Counsel for cardiologists in qui tam False Claims Act case alleging medical device company kickbacks
- Counsel for a physician facing mandatory exclusion which led to the OIG withdrawing its action
- Lead counsel in Colorado Heart Institute, LLC v. Leavitt (D.D.C. No. 1:08-cv-01626-RMC), a suit challenging the CMS Stark Law regulations
- Counsel to a hospital executive and his management company in United States v. Jones (5th Cir. January 16, 2007), a criminal-related party cost report fraud case reversing the district court’s sentencing and restitution order based on a failure of the government’s proof
- Part of the criminal defense team in the trial of TAP managers in Boston, resulting in a Rule 29 judgment of acquittal for the firm’s client
- Lead amici counsel to the American Hospital Association, Federation of American Hospitals, Association of American Medical Colleges, American Osteopathic Association, and Missouri Hospital Association in United States v. McClatchey, (217 F.3d 823, 10th Circ. 2000) and United States v. Lahue, (261 F.3d 993, 10th Circ. 2001), cases that challenged the application of the so-called one purpose rule which holds that a provider can be found guilty under the anti-kickback statute if one purpose in paying remuneration is to induce referrals
Compliance & Regulatory
- Representing academic medical center in its affiliation agreements with community physicians and hospitals
- Represented academic physician groups in considering restructuring options to better face health care reform challenges.
- Led audit team of an academic medical center’s compliance program
- Represented numerous cardiology practices in developing strategic relationships with hospitals
- Represented national trade association in seeking Stark law regulatory changes
Recognitions & Awards
- Best Lawyers in America: Health Care Law (2011 – 2013)
- Chambers USA: Massachusetts – Healthcare (2009 – 2012)
- Massachusetts Super Lawyers: Criminal Defense: White Collar (2004 – 2012)
- Martindale-Hubbell AV Preeminent
- Nightingale’s Healthcare News: Outstanding Fraud and Compliance Lawyers (2004)
Professional & Community Involvement
- Advisory Board, Health Care Fraud Report, published by the Bureau of National Affairs, Inc.
- 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
- 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)
Publications
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Co-author,
CMS Publishes Final Sunshine Act Rule Creating New Regulatory Landscape for Physician-Manufacturer Interactions, BNA’s Health Care Fraud Report ()
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CMS Publishes Final Sunshine Act Rule; Data Collection to Begin on August 1, 2013, Health Law Alert ()
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Sunshine Act Rule Reference Chart, Health Law Alert ()
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Co-author,
HHS Issues Report to Congress on the Self-Referential Disclosure Protocol, BNA's Health Care Fraud Report ()
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Co-author,
Proposed Physician Payment Sunshine Act Regulations Leave Many in the Dark, BNA's Health Care Fraud Report ()
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Co-author,
Delicate Balance: Waiver of Fraud and Abuse Laws and Implementation of Program Integrity Requirements for the Medicare Shared Savings Program, BNA's Health Care Fraud Report ()
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Co-author,
Will the Supreme Court Weigh In? Implied Certification Theory Under The False Claims Act, Health Care Enforcement Defense Advisory ()
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Co-author,
The Bundled Payments Initiative — A Non-ACO Approach to Promoting Coordinated Care, Health Law Advisory ()
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Co-author,
Seventh Circuit Upholds Conviction of a Physician for a Violation of the Anti-Kickback Statute, Health Care Enforcement Defense Advisory ()
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Co-author,
CMS and OIG Issue Joint Notice, Solicit Comments Related to Waivers of Fraud and Abuse Provisions for Accountable Care Organizations, Health Care Reform Alert ()
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Co-author,
Stark Law Update: CMS Finalizes Rule Regarding Disclosure Requirements for Certain In-Office Ancillary Services, Health Care Reform Alert ()
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Co-author,
CMS Implements Self-Referral Disclosure Protocol Process to Self-Disclose Stark Law Violations, Health Care Reform Alert ()
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Co-author,
Medicare in the 21st Century: Achieving Quality and Efficiency Through Payment and Service Delivery Reforms, BNA's Medicare Report ()
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Co-author,
Risky Business: Health Care Reform's Fraud-Fighting Provisions Increase the Potential for Liability for All in the Health Care Industry, BNA Health Care Fraud Report ()
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Co-author,
Payment Reform—A Catalyst for Increased M&A Activity, Health Care Reform Advisory ()
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Co-author,
Solidarity in a Sea of Dissent: Consistencies Between the House and Senate Bills' Provisions Targeting Fraud and Abuse, Health Care Reform Advisory ()
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Co-author,
The Health Care Fraud Enforcement Juggernaut Continues, BNA Health Care Fraud Report ()
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Author,
Self-Disclosure of Overpayments and Violations of Healthcare Laws, Journal of Health & Life Sciences Law ()
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Co-author,
Health Care Article: Tennessee Settlement Shows Failure to Refund Overpayments Can Be a Crime, BNA's Health Care Fraud Report ()
Speaking Engagements
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Speaker,
Stark Self-Disclosure,
Institute on Medicare and Medicaid Payment Issues,
American Health Lawyers Association, Baltimore, MD
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Speaker,
The Nuts and Bolts of the Sunshine Act and Enforcement Implications,
Bloomberg BNA, Webinar
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Speaker,
Review of Sunshine Act Reporting Regulations,
The Nuts and Bolts Of The Sunshine Act Regulation,
Massachusetts Medical Device Industry Council (MassMEDIC), Waltham, MA
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Speaker,
Dealing with Whistleblowers: Lessons Learned & Best Practices,
MDMA Compliance Conference ,
Medical Device Manufacturers Association, Waltham, MA
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Speaker,
Antikickback and Stark Update,
Fraud and Compliance Forum,
American Health Lawyers Association and Health Care Compliance Association, Baltimore, MD
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Speaker,
The Federal Anti-Kickback Law: An Overview, Recent Enforcement Trends and Impact of Healthcare Reform,
The Federal Anti-Kickback Law: An Overview, Recent Enforcement Trends and Impact of Healthcare Refor,
American Health Lawyers Association, Webinar
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Speaker,
Anti-Kickback Statute Current Developments,
Fraud & Compliance Forum,
American Health Lawyers Association and Health Care Compliance Association, Baltimore, MD
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Speaker,
Medicare and Medicaid Repayments and Self-Disclosures,
AHLA Institute on Medicare and Medicaid Payment Issues,
AHLA, Baltimore, MD
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Speaker,
Fraud and Abuse Issues in Off-Labeling Marketing,
The A to Z of Off-Label Issues,
AdvaMed Medical Technology Learning Institute, Orlando, FL
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Panelist,
Healthcare Reform’s Fraud-Fighting Provision,
Fraud and Compliance Forum,
AHLA, Baltimore, MD
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Moderator,
FCA Enforcement Against Pharmaceutical and Device Manufacturers and Health Care Providers,
National Institute on the Civil False Claims Act and Qui Tam Enforcement,
American Bar Association, Washington, DC
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Speaker,
Fraud and Abuse Issues in Off-Label Marketing,
The A to Z of Off-Label Issues,
AdvaMed Medical Technology Learning Institute, Washington, DC
-
Speaker,
Repayments and Disclosures: Legal Requirements and Hard Choices,
Institute on Medicare and Medicaid Payment Issues,
American Health Lawyers Association, Baltimore, MD
-
Speaker,
Why Your Organization Should Consider an External Review of Its Compliance Program,
Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions,
American Health Lawyers Association, Washington, DC
-
Moderator,
Prepare for New Federal and State Enforcement as Manufacturer Spending Becomes More Transparent,
Physician Payments Disclosure & Aggregate Spend,
American Conference Institute
-
Speaker,
Self-Disclosure of Overpayments and Violations of Health Care Laws,
Institute on Medicare and Medicaid Payment Issues,
American Health Lawyers Association, Baltimore, MD
-
Speaker,
Stark Law Development: What You Need to Know to Keep Your Arrangements Compliant,
Compliance Update,
Healthcare Financial Management Association
-
Panelist,
Stark Law Realities Continued: Attorney-Client Discussions on the New Stark Law Provisions,
American Health Lawyers Association, Teleconference
-
Speaker,
Anti-Kickback Discounts Arrangements,
AHLA/HCCA Fraud & Compliance Forum
-
Chair,
The A to Z Of Off-Label Issues,
AdvaMed Seminar
Newsroom
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Quoted in
Hospitals Queasy over Medicare’s Impatient Billing Fix, Law360 ()
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Quoted in
CMS Just Getting Started on Hospital Readmission Penalties, Law360 ()
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Quoted
Feds Clear Path for Cos. to Come Clean on Medicare Fraud, Law360 ()
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Quoted in
Health Information OIG, CMS Proposed Rules Indicate EHR Penetration Still Lagging, Attorneys Say, BNA’s Daily Healthcare Report ()
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Quoted in
Enforcement CMS Expects to Receive About 100 Stark Law Disclosures in 2013, Official Says, BNA’s Health Care Daily Report ()
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Mintz Levin Attorneys Karen S. Lovitch and Thomas S. Crane to Present at Massachusetts Medical Device Industry Council Program, ()
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Quoted in
Reps. Jump at Chance to Kill Reviled Medicare Pay Method, Law360 ()
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Quoted in
CMS Releases Sunshine Act Final Rule, Healthcare Finance News ()
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Quoted in
Final Sunshine Rule Gives Doctors More Room to Experiment, Law360 ()
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Quoted in
Fraud and Abuse Outlook 2013: More Provider Exclusions, Greater Contractor Activity, FCA Actions, BNA’s Daily Health Care Report ()
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Quoted
Health Information Outlook 2013: Interoperability Tops Health IT Issues for New Year, BNA’s Daily Health Care Report ()
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Seventy-One Mintz Levin Attorneys Named 2012 Massachusetts Super Lawyers and Rising Stars , ()
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Mintz Levin Represents New England Sinai Hospital in Acquisition by Steward Health Care System, LLC, ()
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Sixty Mintz Levin Attorneys Included in The Best Lawyers in America, 2013 Edition, ()
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Featured in
Supreme Court Upholds PPACA’s Individual Mandate, Alters Medicaid Provision, The Lexblog Network ()
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Forty-One Mintz Levin Attorneys Featured in Chambers USA 2012 Guide, ()
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Quoted in
Health Care Ruling Brings Contract, Grant Opportunities, Law360 ()
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Quoted in
CMS Has Received $805,000 in Self-Referral Disclosure Settlements, G2 Compliance Report ()
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Quoted in
Fraud and Abuse: CMS Has Received $805,000 in Self-Referral Disclosure Settlements, Official Says, BNA’s Health Care Daily Report ()
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Quoted in
Increased Individual Fraud Prosecutions, RAC Expansion on Tap for 2012, Experts Say, BNA's Health Care Daily Report ()
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Quoted in
No Sanctions for Proposed Online Referral Service for Health Professionals, BNA's Health Care Daily Report ()
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Quoted in
U.S. Supreme Court Declines Review of Case on Liability for Causing False Claims, BNA's Health Care Daily Report ()
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Quoted in
Online Coupons May Violate Anti-Kickback Rules, Medical Practice Compliance Alert ()
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Fifty-Two Mintz Levin Attorneys Recognized as Massachusetts Super Lawyers, ()
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Forty-Three Mintz Levin Attorneys Included in The Best Lawyers in America, 2012 Edition, ()
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Thirty Four Mintz Levin Attorneys Featured in Chambers USA 2011 Guide, ()
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Mintz Levin Attorney Thomas Crane to Testify Before U.S. Sentencing Commission on Guidelines for Health Care Fraud Convictions, ()
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Thomas S. Crane Gives Presentation at AdvaMed's Medical Technology Learning Institute, ()
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Quoted in
OUTLOOK 2011: Permissive Exclusions, Increase in Oversight Expected for 2011, BNA's Health Care Fraud Report ()
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Forty-Nine Mintz Levin Attorneys Recognized as Massachusetts Super Lawyers, ()
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Thomas S. Crane Gives Speech at AHLA/HCCA Fraud and Compliance Forum, ()
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Thirty-Nine Mintz Levin Attorneys Included in The Best Lawyers in America, 2011 Edition, ()
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Mintz Levin Adds Six Attorneys to Chambers USA 2010 Guide, ()
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Forty-Eight Mintz Levin Attorneys Recognized as Massachusetts Super Lawyers, ()
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Mintz Levin Expands Health Care Enforcement Defense Practice Group, ()
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Chambers USA Names 22 Mintz Levin Attorneys Leaders in Their Fields for 2009, ()
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Forty-Six Mintz Levin Attorneys Recognized as Massachusetts Super Lawyers, ()
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Thomas S. Crane speaks at an American Bar Association Teleconference, ()
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Thomas S. Crane is Conference Program Chair of AdvaMed's Medical Technology Learning Institute's Seminar, ()
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Thomas S. Crane speaks at the Medical Device Manufacturers Meeting (MDMA), ()
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Thomas S. Crane speaks at The 7th Annual ABA National Institute on Civil False Claims Act and Qui Tam Enforcement, ()
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Forty-Five Mintz Levin Attorneys Recognized as Massachusetts Super Lawyers, ()
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Mintz Levin's Health Law Section prepares Health Care Fraud Report, ()