Karen is the Practice Leader of the firm’s Health Law Practice. She counsels health care clients on regulatory, transactional, and operational issues, including Medicare coverage and reimbursement, the development and implementation of health care compliance programs, and licensure and certification matters. In addition, Karen advises clients on the legal, practical, and fraud and abuse implications of business arrangements and sales and marketing practices. Her experience includes matters related to the anti-kickback statute, the Stark law, state statutes prohibiting kickbacks and self-referrals, and the federal Physician Payments Sunshine Act.
Karen applies her compliance and regulatory experience in transactional as well as litigation contexts. In addition to counseling health care entities on regulatory matters arising in connection with mergers and acquisitions, she has successfully defended clients subject to state and federal surveys, Medicare and Medicaid overpayment and reimbursement appeals, and state licensure proceedings. Karen also represents clients subject to state and federal investigations alleging violation of the anti-kickback statute, the federal False Claims Act, and other state and federal laws.
Karen also specializes in the representation of laboratories and diagnostics companies. She regularly counsels on compliance with CLIA and state laboratory licensure laws, federal and state limitations on billing for diagnostic services, and legal restrictions on sales and marketing activities. Karen has served as regulatory counsel in a number of mergers and acquisitions involving laboratories and diagnostics companies.
Karen has written and lectured on a variety of issues confronting laboratories and others in the health care industry. In November 2008, Karen completed the Harvard Business School's seven-day program on Leading Professional Service Firms.
Representative Matters
- Represented an academic medical center in a Medicare reimbursement appeal that resulted in a $21 million settlement in favor of the provider.
- Served as lead counsel in a federal investigation of violations of the federal False Claims Act based on billing and sales/marketing practices as well as quality of care allegations. The government filed a notice of non-intervention in the now-unsealed qui tam case.
- Designed and drafted an independent laboratory's compliance program policies and conducted general and specialized compliance training programs for employees and board members.
- Advised a national independent laboratory on state, federal, and accrediting agency notice and approval requirements in connection with the division of the company and oversaw the preparation of hundreds of filings to be submitted to all agencies.
Recognitions & Awards
- Nightingale’s Healthcare News: Outstanding Young Healthcare Lawyer (2007)
- Phi Beta Kappa
Professional & Community Involvement
- Member, BNA Bloomberg Medicare Report Editorial Board
- Member, Law360 Healthcare Editorial Advisory Board
- Associate, The Women Business Leaders of the U.S. Health Care Industry Foundation
- Board member, Suited for Change (2007 – 2010)
Karen is the Practice Leader of the firm’s Health Law Practice. She counsels health care clients on regulatory, transactional, and operational issues, including Medicare coverage and reimbursement, the development and implementation of health care compliance programs, and licensure and certification matters. In addition, Karen advises clients on the legal, practical, and fraud and abuse implications of business arrangements and sales and marketing practices. Her experience includes matters related to the anti-kickback statute, the Stark law, state statutes prohibiting kickbacks and self-referrals, and the federal Physician Payments Sunshine Act.
Karen applies her compliance and regulatory experience in transactional as well as litigation contexts. In addition to counseling health care entities on regulatory matters arising in connection with mergers and acquisitions, she has successfully defended clients subject to state and federal surveys, Medicare and Medicaid overpayment and reimbursement appeals, and state licensure proceedings. Karen also represents clients subject to state and federal investigations alleging violation of the anti-kickback statute, the federal False Claims Act, and other state and federal laws.
Karen also specializes in the representation of laboratories and diagnostics companies. She regularly counsels on compliance with CLIA and state laboratory licensure laws, federal and state limitations on billing for diagnostic services, and legal restrictions on sales and marketing activities. Karen has served as regulatory counsel in a number of mergers and acquisitions involving laboratories and diagnostics companies.
Karen has written and lectured on a variety of issues confronting laboratories and others in the health care industry. In November 2008, Karen completed the Harvard Business School's seven-day program on Leading Professional Service Firms.
Representative Matters
- Represented an academic medical center in a Medicare reimbursement appeal that resulted in a $21 million settlement in favor of the provider.
- Served as lead counsel in a federal investigation of violations of the federal False Claims Act based on billing and sales/marketing practices as well as quality of care allegations. The government filed a notice of non-intervention in the now-unsealed qui tam case.
- Designed and drafted an independent laboratory's compliance program policies and conducted general and specialized compliance training programs for employees and board members.
- Advised a national independent laboratory on state, federal, and accrediting agency notice and approval requirements in connection with the division of the company and oversaw the preparation of hundreds of filings to be submitted to all agencies.
Recognitions & Awards
- Nightingale’s Healthcare News: Outstanding Young Healthcare Lawyer (2007)
- Phi Beta Kappa
Professional & Community Involvement
- Member, BNA Bloomberg Medicare Report Editorial Board
- Member, Law360 Healthcare Editorial Advisory Board
- Associate, The Women Business Leaders of the U.S. Health Care Industry Foundation
- Board member, Suited for Change (2007 – 2010)
Publications
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Author,
Will Federal Protection for Electronic Health Records (EHR) Donations Be Extended Beyond December 31, 2013?, Med Monthly Magazine ()
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Co-author,
Updated Self-Disclosure Protocol Clarifies Disclosure Process and Obligations, Health Law Advisory ()
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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,
Labs Beware: Business and Legal Challenge Presented By Out-of-Network Billing, G2 Compliance Report ()
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Co-author,
How CMS Plans to Recoup Medicare, Medicaid Overpayments, Law 360 ()
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Co-author,
CMS Publishes Proposed Rule on Return of Medicare and Medicaid Overpayments, Health Law Advisory ()
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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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Author,
Health Law Article: When Is It Time to Pull the Plug in a Health Care Transaction?, The Deal Pipeline ()
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Author,
Pulling the Plug?, The Deal Pipeline ()
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Co-author,
Electronic Health Record Donations: Best Practices to Minimize Liability, G-2 Compliance Report ()
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Co-author,
CMS Issues Proposed Rule Addressing Enhanced Program Integrity Requirements, Health Care Reform Advisory ()
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Co-author,
The Game Has Changed: Medicare and Medicaid Overpayments, Health Care Enforcement Defense Advisory ()
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Co-author,
CMS Kicks Off Program Integrity Rulemaking Process, Health Care Reform Advisory ()
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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,
The HITECH Act: Is Your Organization Ready for Implementation?, G-2 Compliance Perspectives ()
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Co-author,
Massachusetts Department of Public Health Issues Guidance Document IV To Clarify the Pharmaceutical and Medical Device Manufacturers Code of Conduct, Health Law Alert ()
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Co-author,
Reforming the Health Care Delivery System through Medicare Payment Reforms, Health Care Reform Advisory ()
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Co-author,
Comparative Effectiveness Research Proposals: Potential Implications for Stakeholders, 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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Author,
Legal Issues in Structuring Lab Outreach Programs, Washington G-2 Reports ()
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Author,
Issues and Trends in the Regulation of Genetic Testing, Health Care Law Monthly ()
Speaking Engagements
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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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Moderator,
Planning for 2013: Health Care Industry Trends in the New Year,
Health Beat Webinar Series hosted by Mintz Levin and ML Strategies, Webinar
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Co-chair,
Health Care and Life Sciences Law 2012,
Practising Law Institute (PLI), New York, NY
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Understand How the ACA Will Affect Compliance Programs,
Medicaid Managed Care Congress,
Baltimore, MD
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Panelist,
Analyzing Implications of State Aggregate Spend Laws and the Potential Physician Payments Sunshine Act on Clinical Compliance,
Clinical R&D Compliance Forum,
CBI
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Panelist,
Re-Evaluate Compliance Controls Applicable to Clinical Research Activities,
Medical Device and Diagnostic Compliance Congress,
CBI
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Speaker,
BioBoardroom Executive Event: Impact of Healthcare Legislation on the Bioscience Industry,
MdBio Division of the Tech Council of Maryland
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Speaker,
U.S. Health Care Reform — A Special Presentation for Israeli Pharma, Biotech and Medical Device Companies and Their Investors,
U.S. Health Care Reform — A Special Presentation for Israeli Pharma, Biotech and Medical Device Comp,
Mintz Levin, Israel-America Chamber of Commerce, and Israel Life Science Industry, Webinar
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Speaker,
Health Care Reform Seminar: An Update for Employers,
Mintz Levin and ML Strategies, Boston, MA
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Speaker,
Changes to Program Integrity Provisions/Overview of New Transparency Requirements,
Health Care Reform: What’s Happened and What’s Next for the Health Care Industry,
Mintz Levin and ML Strategies, Boston, MA
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Speaker,
Promotion, Advertising & Marketing,
Health Care 2010: Managing Risks in the New Compliance and Enforcement Environment Conference,
Practising Law Institute
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Speaker,
Health Care Reform: What’s Happened and What's Next for California Companies,
Mintz Levin and ML Strategies, San Diego, CA
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Speaker,
Making History with Health Care Reform: What’s Happened and What’s Next?,
Mintz Levin and ML Strategies, Webinar
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Moderator,
The Commercial Implications of Personalized Medicine,
Tech Council of Maryland BioBreakfast Series
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Speaker,
Medicare Reporting and Recovery: New Requirements,
Current Developments in Insurance Law,
Practising Law Institute
Newsroom
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Quoted in
Groups React to New Rules for Electronic Health , Reuters ()
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Mintz Levin Supports Senior Executive Women in Health Care as Sponsor of Women Business Leaders’ 12th Annual Summit, ()
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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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Mintz Levin Attorney Karen S. Lovitch to Co-Chair PLI’s Health Care and Life Sciences Law 2012, ()
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Quoted in
Whistleblower Charges New Mexico Hospital Laboratory Ignored Quality Control Measures, BNA’s Health Care Daily Report ()
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Quoted in
Q&A with Mintz Levin’s Karen Lovitch, Law360 ()
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Mintz Levin Attorney Karen S. Lovitch to Present at Medicaid Managed Care Congress, ()
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Quoted in
Bloomberg Law Reports: Health Law, Bloomberg Law Reports: Health Law ()
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Mintz Levin Ranked in the Top Ten Largest Healthcare Law Firms in the Nation by Modern Healthcare, ()
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Mintz Levin Attorney Karen Lovitch to Co-Chair PLI's "Health Care 2011", ()
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Mintz Levin Supports Senior Executive Women in Health Care as Sponsor of Women Business Leaders' 10th Annual Summit, ()
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Mintz Levin Launches Center for Health Law & Policy, ()
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Mintz Levin Represents Alphatec Holdings, Inc. in $92 Million Public Offering, ()
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Mintz Levin Represents Oppenheimer & Co., Inc. in Back-to-Back Closings of Two Offerings, ()
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Quoted in
Technology Allowing Patients to Participate in Own Health Care, The San Diego Daily Transcript ()
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Karen S. Lovitch to Manage Mintz Levin's Health Law Practice, ()
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Mintz Levin Expands Health Care Enforcement Defense Practice Group, ()
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Karen Lovitch speaking at the 7th Annual Laboratory Outreach Conference, ()
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Karen Lovitch Named Outstanding Young Healthcare Lawyer by Nightingale's Healthcare News, ()