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Karen S. Lovitch

(she/her/hers)

Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense 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 Chair of the firm’s Health Law Practice and Co-Chair of the Health Care Enforcement Defense Practice. She is a member of the firm’s Executive 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.

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.
  • Served as health care regulatory counsel to Kindred Healthcare, a specialty hospital company focused on acute care, and private equity firm TPG Capital in the sale of Kindred Healthcare to national health services provider LifePoint Health, launching the combined company ScionHealth.
  • 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.
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viewpoints

States are increasingly exercising regulatory oversight of health care transactions by enacting laws requiring prior notice or approval of certain health care transactions. Currently, 15 states have enacted health care transaction review laws applicable to for-profit transactions. On Wednesday, March 20, 2024, Mintz members Daniel A. Cody, Deborah A. Daccord, and Karen S. Lovitch engaged in an insightful discussion with Lois Johnson, General Counsel of Massachusetts Health Policy Commission, to discuss the latest developments surrounding these laws and gain valuable insight from Ms. Johnson’s expertise, as Massachusetts was one of the first states to implement a health care transaction review process. The highlights of this informative conversation are summarized below, and the webinar can be viewed here.

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In early March 2024 at the American Bar Association’s 39th National Institute on White Collar Crime, Deputy Attorney General (DAG) Lisa Monaco’s keynote remarks previewed the development of new and significant Department of Justice (DOJ or the Department) policy initiatives. Her speech reemphasized many of DOJ’s key themes throughout the current administration, including individual accountability, the importance of strong corporate compliance programs, incentivizing voluntary self-disclosure of misconduct, and adapting to keep up with disruptive technologies such as artificial intelligence.

 

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Read about the FTC’s March 5, 2024 workshop on private equity (PE) investments in the health care industry and a joint request for information on the effects of PE transactions in the health care industry issued by the FTC, DOJ, and HHS.

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California Attorney General Rob Bonta (AG) and Assembly Speaker pro Tempore Jim Wood recently introduced legislation (AB-3129) that would authorize the AG to review private equity group and hedge fund health care transactions. The proposed legislation’s stated intention is to address price increases and lower quality of and decreased accessibility to services associated with private equity acquisitions of certain health care entities, including physician practices. This article provides an overview of the proposed bill, an analysis of the key issues raised by the proposed legislation, and suggestions for next steps for those potentially affected by the proposal. 

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California’s health omnibus trailer bill SB-184 and the final cost and market impact review (CMIR) regulations (CMIR Regulations), which went into effect on December 18, 2023, have ushered in a significant change in California’s health care regulatory landscape with the creation of the Office of Health Care Affordability (OHCA). On January 2, 2024, OHCA began accepting notices of covered transactions through its notice of material change transaction submission portal.

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Safeguarding Reproductive Rights

February 23, 2024 | Article

Lawyers for Good Government, in partnership with the American College of Obstetricians and Gynecologists, initiated a vital project known as The Policy Resource Hub in 2022.

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In 2023, DOJ announced significant updates to the Criminal Division’s Corporate Enforcement Policy, the agency’s Voluntary Self-Disclosure Policy for corporate criminal enforcement, and a new safe harbor for voluntary self-disclosures made in connection with M&A deals, all aimed at incentivizing companies to self-disclose their misconduct.

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After growing significantly over the last decade, private equity health care deal activity nevertheless remained robust last year, with an estimated deal volume of about $29 billion in North America.

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As the Mintz Health Law team welcomes the beginning of 2024, many of its members take a moment to reflect on the exciting growth of the Health Law Practice, opportunities to partner with clients on complex legal issues, and the celebration of numerous milestones.

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News & Press

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Health Law Chair and Health Care Enforcement Defense Co-chair Karen Lovitch spoke with Laboratory Economics offering insight on two recent cases where the former owner of a Missouri healthcare company, Genotec DX, and clinical laboratory, Advanced Geriatric Management LLC (AGM), and a compliance officer face prison time over fraudulent claims. The former owner admitted to submitting more than $3.8 million in false claims to Medicare, Medicaid, and private healthcare benefit programs.

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WASHINGTON, DC – Mintz has deepened its health care bench with the addition of new Member, Rachel Alexander.

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Mintz Member Karen Lovitch, Chair of the firm’s Health Law Practice and Co-Chair of the Health Care Enforcement Defense Practice, was interviewed for an article included in the July 2023 issue of Laboratory Economics. Commenting on a recent settlement by a company providing billing services for clinical laboratories, Karen highlights the benefits of self-disclosure when noncompliance is discovered.

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BOSTON – Mintz has earned top rankings in the 2023 edition of Legal 500 United States guide. The firm is recognized in 14 practice categories, and 59 individual attorneys are also recognized in the guide, some in more than one category.

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BOSTON –Mintz announced today that 39 of its practices and 81 of its attorneys earned recognition in the 2023 edition of Chambers USA, a guide to the country’s leading law firms.

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Mintz Member Karen Lovitch, Chair of the firm’s Health Law Practice and Co-Chair of the Health Care Enforcement Defense Practice, was interviewed for an article included in the May 2023 issue of Laboratory Economics, concerning the federal government's continued focus on Covid-19 fraud and recent criminal charges brought by the Department of Justice.

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WASHINGTON, DC – Mintz is pleased to announce the inclusion of five Members to the 2023 Washington, D.C. Super Lawyers list.

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Mintz’s new Women’s Health and Technology Practice brings together attorneys from our transactional, intellectual property, health care, FDA regulatory, and litigation teams to serve FemTech and other life sciences clients. The practice advises companies, entrepreneurs, and investors focused on addressing unmet needs in women’s health.

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Law360 featured the launch of the firm's Women's Health and Technology practice and highlighted founding Members Ellen JanosJoanne HawanaKaren Lovitch, and Melanie Levy.

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Mintz Member and Chair of the firm’s Health Law and Health Care Enforcement Defense Practices Karen Lovitch was interviewed for an article included in the January 2023 issue of Laboratory Economics covering the top compliance challenges faced by clinical laboratories, Covid-19 testing fraud, and more.

BOSTON – Mintz has appointed Brian Dunphy as Co-Chair of the firm’s Health Care Enforcement Defense Group with immediate effect. Brian joins Karen Lovitch, who also serves as Chair of the Health Law Practice, in joint leadership.

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Best Lawyers® recognized 108 firm attorneys in the 2023 edition of The Best Lawyers in America©. Notably, two Mintz attorneys – Poonam Patidar and Scott M. Stanton – received 2023 “Lawyer of the Year” awards, and 28 firm attorneys were included in the inaugural edition of Best Lawyers: Ones to Watch.

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Mintz served as health regulatory legal advisor to Kindred Healthcare in the recently completed sale of Kindred Healthcare to LifePoint Health, a national network of hospitals, post-acute service providers, and outpatient centers. As a result of the successful transaction, ScionHealth, a new healthcare system focused on high-quality acute and post-acute hospital solutions, was launched on December 23rd.
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Mintz Member and Chair of the firm’s Health Law and Health Care Enforcement Defense Practices Karen Lovitch, Member Laurence Freedman, Of Counsel Samantha Kingsbury, and Associates Grady Campion and Caitlin Hill co-authored the Global Overview and corresponding United States chapter of the seventh edition of Lexology’s Healthcare Enforcement & Litigation 2022. Together these pieces outlined federal enforcement priorities in 2020, including matters involving opioids, COVID-19-related fraud, Medicare, and more, and look ahead to how health care enforcement is expected to evolve in the coming year. 
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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.
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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.
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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.
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.
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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.
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.
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.
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Events & Speaking

Panelist
Apr
30
2024

Important Developments in Laboratory Legal, Regulatory, and Compliance Requirements

29th Annual Executive War College on Laboratory and Pathology Management

New Orleans, Louisiana

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Speaker
Nov
9
2022

Health Care Fraud Enforcement Developments and Whistleblower Avoidance

G2 Lab Institute: Advancing the Profession of Diagnostic Medicine

Virtual Event

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Speaker
Oct
27
2022
Seminar Reference Image
Panelist
Apr
27
2022

2022 Executive War College

The Dark Intelligence Group

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Speaker
Speaker
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

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Publications

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Recognition & Awards

  • Included on the Washington DC Super Lawyers: Health Care list (2017 – 2024)

  • Chambers USA: District of Columbia – Healthcare (2014 – 2024)

  • Recognized by The Legal 500 United States for Healthcare: Service Providers (2014 – 2024)

  • Phi Beta Kappa

  • Best Lawyers in America: Health Care Law (2021 – 2023) 

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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)
  • Foster Parent, Mid-Atlantic German Shepherd Rescue
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Karen S. Lovitch

(she/her/hers)

Chair, Health Law Practice & Co-Chair, Health Care Enforcement Defense Practice

Washington, DC