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Karen S. Lovitch

Member / Chair, Health Law Practice

[email protected]

+1.202.434.7324

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Karen focuses her practice on representing health care companies in regulatory, transactional, and operational matters. She has a substantial health care regulatory background and advises clients on matters pertaining to the federal anti-kickback statute, the Stark law, state statutes prohibiting kickbacks and self-referrals, the Clinical Laboratory Improvement Amendments of 1988, and the federal Physician Payments Sunshine Act. Karen often applies her strategic insight on these matters to counsel companies on regulatory issues arising in connection with mergers and acquisitions and other transactions. She also defends companies in high-stakes state and federal investigations. Karen regularly speaks and writes on challenges facing laboratories, diagnostic companies, and other health care companies.

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 and has represented numerous laboratories and diagnostics companies in state and federal government investigations.

Karen has written and lectured on a variety of issues confronting laboratories and others in the health care industry. She is the co-author of What Is…the Anti-Kickback Statute?, a book recently published by the American Bar Association.

Education

  • American University (JD, magna cum laude)
  • West Virginia University (BA, summa cum laude)

Experience

  • Served as lead counsel to two national independent laboratories 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, and the parties reached a settlement favorable to the laboratories. 
  • Designed and drafted a diagnostics company’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 licensure and accreditation agencies, the Medicare program, and state Medicaid programs nationwide.
  • Counseled a specialty laboratory regarding whether and how to make a self-disclosure related to a Medicare overpayment and met with the U.S. Attorney’s Office regarding the self-disclosure, which did not lead to further investigation or enforcement action.
  • Counseled a national independent laboratory on state, federal, and accrediting agency notice and approval requirements in connection with its acquisition by an international diagnostics and laboratory services company, and prepared over one hundred filings to be submitted to a variety of agencies.

Recognition & Awards

  • Chambers USA: District of Columbia – Healthcare (2014 – 2019)
  • Recognized by The Legal 500 United States for Healthcare: Service Providers (2014 – 2019)
  • Included on the Washington DC Super Lawyers: Health Care list (2017, 2019)
  • Nightingale’s Healthcare News: Outstanding Young Healthcare Lawyer (2007)
  • Phi Beta Kappa

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, DC SCORES
  • Board member, Suited for Change (2007 – 2010)

Recent Insights

News & Press

Viewpoints

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HHS Proposed Changes to Anti-Kickback Statute and Stark Law

February 10, 2020 | Video | By Karen Lovitch, Theresa Carnegie

Karen Lovitch, Chair of Mintz's Health Law Practice, and Theresa Carnegie, a Member in the Health Law Practice, discuss the proposed changes to the Anti-Kickback Statute (AKS) and Stark Law issued by Department of Health & Human Services (HHS) and dive into some of the key issues.
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HHS Proposed Changes to AKS and Stark Law: Cybersecurity and EHR

February 10, 2020 | Video | By Karen Lovitch

Karen Lovitch, Chair of Mintz’s Health Law Practice, discusses the proposed new safe harbor and Stark Law exception for donations of cybersecurity technology and related services as well as the significant proposed modifications to the existing safe harbor and exception for electronic health records (EHR) technology and services.
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The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Requestor) to provide financial assistance for travel, lodging, and other expenses to certain patients receiving a cell therapy that it offers (the Arrangement). The OIG concluded that the Arrangement could potentially violate the Anti-Kickback Statute as well as the prohibition on beneficiary inducement in the Civil Monetary Penalties Law (the Beneficiary Inducement CMP) but ultimately declined to impose administrative sanctions.
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Health Care Enforcement Year-in-Review and 2020 Outlook: Civil Fraud Enforcement Developments and Trends

January 21, 2020 | Blog | By Brian Dunphy, Laurence Freedman, Karen Lovitch, Julianna Hanlon, Nicole Henry, Clare Prober

As discussed in our article recently published by Law360, 2019 brought yet another year of robust health care enforcement activity, and the False Claims Act (FCA) remains the government’s most powerful civil health care enforcement tool.  This post will give an overview of our article, which covers these issues and more in great detail.
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As reported previously, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published two proposed rules that seek to implement wholesale changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). This final post in our blog series focuses on a proposed new safe harbor that would protect patient engagement and support arrangements designed to improve quality, efficiency of care, and health outcomes. The OIG is also proposing modifications to the existing safe harbor for local transportation and a new safe harbor for remuneration provided in connection with certain payment and care delivery models developed by the Centers for Medicare & Medicaid Innovation Center or by the Medicare Shared Savings Program. Lastly, the OIG is codifying an existing statutory safe harbor for Accountable Care Organization (ACO) beneficiary incentives and an existing statutory exception to the Civil Monetary Penalty (CMP) rules on beneficiary inducement for telehealth technology related to in-home dialysis services.
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As we previously reported, the Department of Health & Human Services (HHS) recently issued two proposed rules intended to reduce the regulatory burden associated with the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). Although the rules’ main focus is on value-based arrangements, the proposed rule issued by the Centers for Medicare & Medicaid Services (CMS) also includes a number of provider-friendly changes and clarifications to the Stark Law. As discussed below, CMS is proposing several changes to key Stark Law requirements as well as modifications to existing Stark Law exceptions.
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This post is the fourth installment of our blog series on significant, proposed changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) recently announced by the Department of Health & Human Services (HHS).  The proposed rule issued by the Centers for Medicare & Medicaid Services (CMS) offers new and revised definitions on key Stark Law terms, some of which CMS has previously neglected to define or provide significant guidance.  In addition, CMS proposes a new Stark Law exception for limited remuneration to a physician, which offers health care entities more flexibility for unwritten, short-term compensation arrangements with physicians.
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This post is the third installment of our blog series on recent proposed rules from the Department of Health & Human Services (HHS) that, if finalized, would implement major changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). Below is an in-depth summary of the Office of Inspector General’s (OIG) proposed modifications to the safe harbors for personal services and management contracts, which includes a proposed new provision protecting outcomes-based payments. We also cover the OIG’s proposed modifications to the warranties safe harbor.
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HHS Proposes Sweeping Changes to AKS and Stark Law, Part 2: Cybersecurity Technology and Electronic Health Records

October 21, 2019 | Blog | By Karen Lovitch, Dianne Bourque, Theresa Carnegie, Rachel Yount

On October 17, 2019, the Department of Health & Human Services published two proposed rules that, if finalized, would implement significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). This post is the latest installment in our blog series covering these proposed rules.
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HHS Proposes Sweeping Changes to Anti-Kickback Statute and Stark Law

October 10, 2019 | Blog | By Karen Lovitch, Theresa Carnegie, Rachel Yount

On October 9, 2019, the Department of Health & Human Services (HHS) announced significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (known as the Stark Law) through proposed rules issued by the Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS). The proposed rules are part of HHS’s Regulatory Sprint to Coordinated Care, which aims to promote value-based care and ease regulatory burden on health care providers, particularly with respect to the AKS and the Stark Law.
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News & Press

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Mintz Members Brian Dunphy and Laurence Freedman, and Member and Co-Chair of the firm’s Health Law Practice Karen Lovitch co-authored this Law360 expert analysis article examining trends in U.S. Department of Justice health care enforcement in 2019, noting that the False Claims Act remains the government’s most powerful civil health care enforcement tool.
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Bloomberg Law reported that the Centers for Medicare & Medicaid Services plans to narrow an existing exception for isolated financial transactions that attorneys say has been a safety net to catch mistakes that would otherwise result in costly violations under the Stark Law. The article included a quote from Mintz Member and Chair of the Health Law Practice Karen Lovitch.
Karen Lovitch, Mintz’s Health Law Practice leader, provided commentary on a federal law passed to combat the opioid crisis that could have unintended consequences by criminalizing sales commissions paid by clinical laboratories to their salaried sales representatives for patient referrals.

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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.
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Mintz is advising a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their acquisition of Curo Health Services, one of the nation’s leading hospice providers. The definitive agreement was announced on April 23, 2018. The deal is valued at approximately $1.4 billion.
Mintz is pleased to announce that eight attorneys have been named Washington, D.C. Super Lawyers for 2018 and three others have been named Washington, D.C. Rising Stars. The annual publication identifies lawyers who have attained a high degree of peer recognition and professional achievement.
Member and Leader of the firm’s Health Law Practice Karen Lovitch is quoted in this article. The feature story discusses implications of the DOJ's recent False Claims Act complaint targeting a private equity firm.

Laboratory Economics' PAMA Teleconference Highlights

February 19, 2018 | Laboratory Economics

Karen Lovitch, the leader of Mintz’s Health Law practice, was recently quoted in an article from the Laboratory Economics journal on its PAMA teleconference. During the February 1st teleconference, Karen spoke about the ongoing lawsuit filed against the HHS by the ACLA.
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.
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Mintz is advising a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their acquisition of Kindred Healthcare, Inc. The definitive agreement totals approximately $4.1 billion in cash including the assumption or repayment of net debt.

Labs Wage Legal Fights Over Fees, Medical Necessity Checks

November 14, 2017 | Bloomberg BNA Health Care Blog

Karen Lovitch, Mintz’s Health Law Practice leader, provided commentary on the repercussions of lower Medicare rates and exclusion of smaller private lab fee data from pricing methodology for the Bloomberg Law Health Care blog.
Karen Lovitch, a Member and Leader of the Health Law Practice at Mintz, will be a featured speaker at the 2017 G2 Intelligence Lab Institute conference. Her panel, “Compliance Traps to Avoid,” will provide attendees guidance to recognize and avoid costly compliance issues.
Mintz is proud to announce that the firm’s Health Law Practice has been recognized by the BTI Industry Power Rankings 2017. The report names the firm as “A Leading Core Firm” in the health care industry.
Eight Mintz attorneys have been named Washington, D.C. Super Lawyers for 2017 and four have been named Washington, D.C. Rising Stars. The list will be published in a special advertising supplement in The Washington Post Magazine and in a stand-alone magazine, Washington D.C. Super Lawyers Magazine.
Karen Lovitch is featured in this Laboratory Economics article addressing the potential impact of a new safe harbor that would afford laboratories a new ability to provide transport to patients under certain circumstances.
This is the fourth and final installment of a series from Mintz’s Health Law team recapping key government policies, regulations and enforcement actions from 2016 and discussing their potential impacts on 2017.
This is the third installment of a four-part series recapping key government policies, regulations and enforcement actions from 2016 and discussing their potential impacts on 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.

Lab Institute 2016 Recap

November 8, 2016

Karen Lovitch, the leader of Mintz’s Health Law practice, is quoted in a G2 Compliance Advisor article recapping hot topics and trends covered during G2 Intelligence’s 34th annual Lab Institute.
Karen S. Lovitch, Leader of the Health Law Practice at Mintz, is speaking at the 2016 G2 Intelligence Lab Institute. Ms. Lovitch will discuss the current legal and compliance “hotspots” for labs and pathologists.
Karen Lovitch, Member and leader of Mintz’s Health Law practice, is quoted in this Laboratory Economics article on a settlement regarding self-reported violations of anti-kickback and self-referral laws.
Attorneys from Mintz represented Myriad Genetics, Inc. in its acquisition of Assurex Health, an informatics-based precision medicine company providing treatment decision support to health care providers for mental health patients.
Karen Lovitch, the leader of Mintz’s Health Law practice, and Kate Stewart, Mintz Health Law Associate, authored this Bloomberg Medicare Report article on the Centers for Medicare & Medicaid Services’ issuing of the Final Rule.
Karen Lovitch, Member and leader of Mintz’s Health Law practice, is quoted in this Becker’s Hospital CFO article discussing the Centers for Medicare and Medicaid Services’ final rule on the Clinical Laboratory Fee Schedule changes.  
Firm’s National Healthcare Practice, NY Corporate/M&A and Litigation: General Commercial Among Newest Rankings
Karen Lovitch, Member and Leader of Mintz’s Health Law practice, is quoted in this Laboratory Economics article on whether the rise in enforcement actions against clinical labs, coupled with increased focus on custom panels, could indicate more settlements later in the year.
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.”
Seven Mintz attorneys have been named Washington, D.C. Super Lawyers for 2015 and five have been named Washington, D.C. Rising Stars. The list will be published in a special advertising supplement in Washington Post Magazine and in a stand-alone Washington D.C. Super Lawyers Magazine.

Events

Panelist
Apr
30
2019

Executive War College on Lab and Pathology Management

Current Issues in Clinical Lab and Pathology Law, Compliance, Managed Care Contracting, and More

Sheraton New Orleans

Speaker
May
1
2018

Laboratory & Pathology Management

Executive War College

Sheraton New Orleans 500 Canal St. New Orleans, LA 70130

Speaker
Mar
6
2018

American Clinical Laboratory Association 2018 Annual Meeting

American Clinical Laboratory Association

Washington, DC

Panelist
Speaker
Dec
6
2017

How to Prepare Your Lab for 2018

Pathology Webinars

Webinar

Speaker
Oct
25
2017

Compliance Traps to Avoid

G2 Intelligence Lab Institute

Washington, D.C.

Panelist
Jul
12
2017
Oct
27
2016
Panelist
Mar
3
2016

ACLA 2016 Annual Meeting

American Clinical Laboratory Association

Washington, DC

Panelist
Oct
15
2015

33rd Annual Lab Institute

G2 Intelligence

Hyatt Regency Washington on Capitol Hill, Washington, DC

Speaker
Sep
27
2015

Hot Topics in Laboratory Compliance

American Health Lawyers Association

Hilton Baltimore Hotel, Baltimore, MD

Panelist
Speaker
Apr
8
2015

Hot Topics in Laboratory Compliance Webinar

Health Care Compliance Association