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Karen S. Lovitch

Member / Chair, Health Law Practice

[email protected]

+1.202.434.7324

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Karen draws from her deep health care regulatory knowledge to provide legal and practical business counsel to clients across the health care and life sciences industries. Recognized by a client in Chambers USA as an “absolute star attorney in the area of health care compliance,” Karen applies this foundation when representing clients in state and federal government investigations, transactions, and day to day regulatory and operational matters. She is known and highly regarded for her commitment to providing exceptional client service and her unique ability to guide clients through the complex maze of regulatory and business issues, providing holistic guidance on both to in-house counsel. Karen is the Chair of the firm’s Health Law Practice and serves as a member of the Policy Committee. 

Karen’s substantial health care regulatory and compliance background includes advising clients on matters pertaining to the federal anti-kickback statute, the Stark law, state statutes prohibiting kickbacks and self-referrals, Medicare and Medicaid program requirements, the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the federal Physician Payments Sunshine Act, and state licensure laws. She routinely works with clients to develop and implement health care compliance programs in order to avoid the government spotlight, oversees internal investigations, and advises clients on the legal, practical, and fraud and abuse implications of business arrangements and sales and marketing practices.

In the transactional context, Karen serves as health care regulatory counsel to clients across the industry, including private equity firms and other investors, in mergers, acquisitions, and other transactional matters. Karen has led many complex due diligence projects involving health care companies in a vast array of industry areas, including behavioral health, laboratories, diagnostic companies, hospice and home health providers, and benefit management companies, to name a few. 

In addition to counseling health care and life sciences entities on regulatory matters arising in connection with transactions, Karen represents clients subject to federal False Claims Act investigations and qui tam litigation, state investigations involving false claims/insurance fraud, state and federal surveys and inspections, and state licensure proceedings. Her extensive experience representing clients in high-stakes government investigations has involved the negotiation and structuring of settlement agreements with the US Department of Justice and its US Attorneys’ Offices and state Attorneys’ General Offices, as well as corporate integrity agreements with the Department of Health and Human Services Office of Inspector General. In the negotiation of a recent significant settlement on behalf of a client with several US Attorneys’ offices and the Department of Justice, Karen successfully negotiated no admission of liability or implementation of a corporate integrity agreement. 

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.

She is a frequent author and speaker on regulatory and compliance issues confronting the industry, and editor of the firm’s Health Care Viewpoints.

Education

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

Experience

Transactions

  • Served as health care regulatory counsel to TPG Capital in its new partnership with existing investors, Summit Partners and Silversmith Capital Partners, to back outpatient behavioral health services provider, LifeStance Health.
  • Advised a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their $4.1 billion acquisition of Kindred Healthcare, Inc. (NYSE:KND) and their $1.4 billion acquisition of Curo Health Services. The Kindred Healthcare transaction was recognized by The Deal as the 2018 Private Equity Deal of the Year.
  • Provided health care regulatory advice to Myriad Genetics, a Nasdaq-listed molecular diagnostics company, in its acquisition of Assurex Health, an informatics-based precision medicine company.
  • Served as health care regulatory counsel to Miraca Life Sciences, Inc., in the sale of the company to Avista Capital Partners.

Investigations

  • Negotiated the settlement of a five-year False Claims Act investigation conducted by multiple U.S. Attorney’s Offices and DOJ’s Civil Division on behalf of a national health care provider. We successfully convinced the Office of Inspector General for the Department of Health and Human Services not to pursue a Corporate Integrity Agreement.
  • Represented a national health care provider in a False Claims Act investigation conducted by the U.S. Attorney’s Office for the Southern District of New York. The government ultimately declined to intervene, and the relator chose to voluntarily dismiss the case.
  • 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.
  • 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 through mediation favorable to the laboratories. 
  • Represented a national health care provider in a False Claims Act investigation conducted by the U.S. Attorney’s Office for the Northern District of Ohio. Following the government’s declination, the court dismissed the case upon the provider’s motion and refused to allow the relator to amend his complaint a second time.

Recognition & Awards

  • Included on the Washington DC Super Lawyers: Health Care list (2017, 2019-2021)
  • Chambers USA: District of Columbia – Healthcare (2014 – 2020)
  • Recognized by The Legal 500 United States for Healthcare: Service Providers (2014 – 2020)
  • Phi Beta Kappa
  • Best Lawyers in America: Health Care Law (2021) 

Involvement

  • Membership Committee, The Women Business Leaders of the U.S. Health Care Industry Foundation
  • Board Member, DC KinCare Alliance
  • Board Member, DC SCORES (2013 – 2016)
  • Board Member, Suited for Change (2007 – 2010)

Recent Insights

News & Press

Events

Viewpoints

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Health Care Enforcement Update:  Covid-19 Fraud Cases Brought By DOJ And Private Plaintiffs

March 31, 2021 | Blog | By Grady Campion, Jane Haviland, Karen Lovitch

On Friday, March 26, 2021, the Department of Justice (DOJ) announced an update on its efforts to combat COVID-19 related fraud.  Since Congress first responded to the coronavirus pandemic by passing $2.2 trillion in relief through the Coronavirus Aid, Relief, and Economic Security (CARES) Act in March 2020, DOJ has pursued civil and criminal actions primarily targeting (1) fraudulent COVID-19 related tests or treatments, and (2) abuse of the CARES Act’s popular Paycheck Protection Program (PPP).  Friday’s announcement revealed that DOJ is also ramping up its efforts to prosecute fraud on the CARES Act’s Economic Injury Disaster Loan (EIDL) and Unemployment Insurance (UI) initiatives. 
Read more
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Health Law Diagnosed — Final Rules Amending the Anti-Kickback Statute and Stark Law Regulations: Part 2

March 17, 2021 | Podcast | By Nili Yolin, Karen Lovitch, Rachel Yount

At the end of 2020, the US Department of Health and Human Services Office of Inspector General and Centers for Medicare and Medicaid Services issued final rules modifying and expanding upon the regulatory safe harbors and exceptions to the federal Anti-Kickback Statute and the Stark Law, respectively.
Read more
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Webinar Recording: Health Care Enforcement Year in Review & 2021 Outlook

February 24, 2021 | | By Eoin Beirne, Brian Dunphy, Hope Foster, Karen Lovitch

In our annual webinar, Mintz’s Health Care Enforcement Defense team reviewed the key policy developments, settlements, and court decisions from 2020 and assessed their likely impact in 2021 and beyond.
Read more
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Health Care Enforcement Year in Review & 2021 Outlook

February 18, 2021 | | By Eoin Beirne, Brian Dunphy, Karen Lovitch, Kevin McGinty, Samantha Kingsbury, Keshav Ahuja, Grady Campion, Jane Haviland, Caitie Hill, Rebecca Zeidel

Despite the threat of COVID-19 paralyzing much of the country in 2020, government health care fraud enforcement continued even though the Department of Justice (DOJ) had the added burden of pursuing COVID-19 related fraud. Mintz’s Health Care Enforcement Defense team has reviewed the key policy issues, statistics, settlements, and court decisions from 2020, and in this report we reflect on those developments and also predict the trends in health care enforcement in 2021 and beyond.
Read more
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Final Rules Amending the Anti-Kickback Statute and Stark Law Regulations: Part 1

February 16, 2021 | Podcast | By Nili Yolin, Karen Lovitch, Rachel Yount

At the end of 2020, the U.S. Department of Health and Human Services Office of Inspector General and Centers for Medicare and Medicaid Services issued final rules modifying and expanding upon the regulatory safe harbors and exceptions to the federal Anti-Kickback Statute and the Stark Law, respectively.
Read more
Health Care Viewpoints Thumbnail
In this final post of our blog series on the substantial changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law), we cover change to (i) key Stark Law terminology, and (ii) the scope and application of the Stark Law exceptions. The Centers for Medicare & Medicaid Services (CMS) finalized new definitions for various key terms used in the Stark Law regulations as well as revisions to existing terms that are generally intended to provide more certainty and flexibility. This post discusses a few of the highlights, but the final regulations contain many others.
Read more
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On January 19, 2021, significant changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) went into effect. The sweeping changes come through two final rules – one issued by the Office of Inspector General (OIG) addressing changes to the AKS and the Beneficiary Inducements CMP, and one issued by the Centers for Medicare & Medicaid Services (CMS) addressing changes to the Stark Law.

In this fifth installment of our blog series covering the changes, we dive into (i) the new AKS safe harbor and Stark Law exception for cybersecurity technology and related services, and (ii) the significant changes to the existing safe harbor and exception for electronic health records (EHR) technology.
Read more
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Webinar Recording: Historic Changes to HHS's Anti-Kickback Statute and Stark Law Regulations

December 17, 2020 | Webinar | By Karen Lovitch, Rachel Yount

In this webinar, Karen Lovitch and Rachel Yount reviewed the sweeping changes and provided practical examples as to how the industry can take advantage of the sweeping changes to the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (known as the Stark Law), and the civil monetary penalty rules regarding beneficiary inducements. 
Read more
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As you know, we have been parsing through the HHS rules that finalize important changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations, which go into effect January 19, 2021. Today, we are taking a look at changes to existing AKS safe harbors and Stark Law exceptions, and, an extra add-on: a new Stark Exception for Limited Remuneration to a Physician. Mintz is also hosting a webinar during which we will review the key provisions from the final rules and provide practical examples of how the industry can take advantage of these significant changes. We hope you can join us.
Read more
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HHS Finalizes Highly Anticipated Final Rules Amending Anti-Kickback Statute and Stark Law Regulations, Part II: Beneficiary Inducement

December 1, 2020 | Blog | By Karen Lovitch, Ellyn Sternfield, Rachel Yount, Jane Haviland

While health care entities often want to provide free or discounted items or services to patients (e.g., free transportation, co-payment waivers, free supplies), these free or discounted items or services pose risk under both the federal Anti-Kickback Statute (AKS) and the civil monetary penalty rules regarding beneficiary inducements (Beneficiary Inducements CMP), so minimizing risk when providing such items or services is important.  Fortunately, as announced last week, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a final rule making sweeping changes to the regulations implementing the AKS and the Beneficiary Inducements CMP, many of which will result in greater flexibility and reduced administrative burdens for the health care industry. 
Read more

News & Press

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Mintz Member and Chair of the firm’s Health Law Practice Karen S. Lovitch and Associate Rachel E. Yount co-authored a two-part Law360 expert analysis series that examined key provisions of the U.S. Department of Health and Human Services’ final rules amending the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law — commonly known as the Stark Law — and the civil monetary penalty rules regarding beneficiary inducements, and provided practical examples of how the industry can take advantage of these significant changes.
News Thumbnail
Mintz Member and Chair of the firm’s Health Law Practice Karen S. Lovitch and Associate Rachel E. Yount co-authored a two-part Law360 expert analysis series that examined key provisions of the U.S. Department of Health and Human Services’ final rules amending the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law — commonly known as the Stark Law — and the civil monetary penalty rules regarding beneficiary inducements, and provided practical examples of how the industry can take advantage of these significant changes.
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Mintz Member and Co-chair of the firm’s Health Law Practice Karen Lovitch was quoted in an article published by The Dark Intelligence Group on developments related to the Centers for Medicare & Medicaid Services (CMS)’s proposed 2021 Physician Fee Schedule (PFS) rule.
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In the latest guide, Mintz garnered rankings as a top national firm in eight practice areas, and 32 firm attorneys were individually recognized.
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The Deal reported that Mintz, led by Member and Health Law Division Head Susan Berson and Member and Chair of the Health Law Practice Karen Lovitch, served as legal counsel to TPG Capital in its new partnership with existing investors, Summit Partners and Silversmith Capital Partners, to back outpatient behavioral health services provider LifeStance Health.
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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 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.
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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.
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.
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.
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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

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