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Karen Lovitch

(she/her/hers)

Member / Chair, Health Law Practice & Chair, Health Care Enforcement Defense Practice

[email protected]

+1.202.434.7324

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Karen draws on her deep health care regulatory and enforcement experience to advise clients navigating complex and high-stakes matters across the health care and life sciences industries. She counsels clients on transactions and strategic growth initiatives, as well as government investigations, bringing a practical understanding of how business decisions may be examined by regulators over time. Clients value her ability to connect regulatory considerations with business objectives and to guide them through issues requiring both strategic judgment and technical precision.

A significant part of Karen’s practice focuses on advising health care companies, investors, and platform businesses as they scale and evolve. She regularly assesses regulatory and enforcement risk in connection with acquisitions, new service lines, and operational changes, helping clients address issues before they become more significant challenges.

She advises on health care transactions, including mergers and acquisitions involving private equity sponsors, strategic investors, and health care companies. She regularly leads diligence, assesses regulatory and enforcement risk, and advises on transaction structure, representations and warranties, and related insurance considerations. Her approach helps clients identify issues that may affect both the transaction and post-closing operations.

Karen works with clients to develop and implement compliance programs and assess risk in evolving business models, new services, and operational changes. She oversees internal investigations and advises on the legal and practical risks associated with business arrangements and sales and marketing practices.

Her experience includes advising on the federal anti-kickback statute, the Stark law, the Eliminating Kickbacks in Recovery Act (EKRA), state self-referral and anti-kickback laws, Medicare and Medicaid reimbursement requirements, CLIA, the Physician Payments Sunshine Act, and state licensure requirements. She also advises clients operating in the value-based care arena.

Karen represents clients in federal and state government investigations, including False Claims Act matters and qui tam litigation. She is particularly experienced in advising on complex situations where business, operational, and regulatory issues intersect, often from early-stage strategy through resolution. She has negotiated high-stakes settlements with the Department of Justice, US Attorneys’ Offices, and state attorneys general, as well as corporate integrity agreements with the Office of Inspector General for the Department of Health and Human Services. In a number of matters, she has secured favorable outcomes that avoided admissions of liability and corporate integrity agreements.

Karen has substantial experience representing laboratories and diagnostics companies. She advises on the regulatory, reimbursement, and enforcement issues that arise as these businesses scale, including CLIA compliance, state licensure, billing requirements, and sales and marketing restrictions. She has served as regulatory counsel on numerous transactions involving these companies and has represented them in state and federal investigations.

Karen is a frequent author and speaker on regulatory and compliance issues and serves as editor of the firm’s Health Care Viewpoints. She serves as Chair of the firm’s Health Law Practice and Health Care Enforcement Defense Practice.

 

"Karen is hands-down my favorite lawyer. She has a fantastic attitude, is incredibly responsive and treats the problem as if it's her own. She is pragmatic in her approach and gives practical advice."

— Health Care Client, Chambers USA 2026

"She is hyper responsive and her knowledge and abilities in health law are just unmatched. She is just top-notch."

— Health Care Client, Chambers USA 2026

"Karen is great at taking something incredibly complex and simplifying it. She is always calm and collected."

— Health Care Client, Chambers USA 2025

Experience

Transactions

  • Advised TPG Capital as health care regulatory counsel on the sale of its equity interest in OneOncology, a physician-led national platform empowering independent medical specialty practices rooted in oncology, to Cencora, a leading global pharmaceutical solutions organization. The transaction was valued at approximately $5 billion.
  • Served as health care regulatory to TPG Capital in its majority investment in Surescripts, the nation’s leading health information network.
  • Served as health care regulatory counsel to TPG Capital in its acquisition of One Oncology, along with its co-investor, Cencora.
  • Advised TPG Growth on health care regulatory issues associated with its acquisition of a majority stake in Crowe LLP’s health care consulting unit, which was rebranded as Kodiak Solutions.
  • 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 Fulgent Genetics, in its acquisition of CSI Laboratories.

Investigations

  • Represented a national pathology laboratory in its False Claims Act self-disclosure made to the Boston US Attorney’s Office, which resulted in a monetary settlement far below the potential damages amount.
  • Conducted an internal investigation for a statewide hospital system related to a Medicare Part A issue, advised on repayment and disclosure options, and prepared the overpayment return submission to the Medicare Administrative Contractor.
  • Convinced the Seattle US Attorney’s Office to decline to intervene in a qui tam case involving risk-adjustment related allegations made against an accountable care organization support company. We are defending the company in a follow-on False Claims Act retaliation case brought by the former employee relator, who has dismissed all other False Claims Act claims.
  • Represented a national health care company in a government investigation conducted by the Delaware US Attorney’s Office that initially involved a damages claim for tens of millions of dollars, but which ultimately resulted in a settlement of just over $700,000.
  • Convinced the US Attorney’s Office for the Middle District of Florida to decline a qui tam case brought against a national health care provider. After winning on a motion to dismiss three times, the litigation team won the case on appeal to the Third Circuit Court of Appeals.
  • Represented a national health care insurer in its response to an Office of Inspector General subpoena focused on its relationship with a particular pharmaceutical manufacturer.
  • Negotiated the settlement of a five-year False Claims Act investigation conducted by multiple US Attorneys' 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 US 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 US Attorney’s Office regarding the self-disclosure, which did not lead to further investigation or enforcement action.
  • Represented a national health care provider in a False Claims Act investigation conducted by the US 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

Comments made by Department of Justice attorneys during a recent webinar provided insight into the government’s civil enforcement priorities related to the coronavirus pandemic. In particular, government attorneys expect that civil enforcement related to COVID-19 relief funds will focus on certifications made by applicants seeking loan forgiveness and anticipate increased investigations into telemedicine services.
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United States Attorney Andrew E. Lelling recently announced that the U.S. Attorney’s Office for the District of Massachusetts entered into a Memorandum of Understanding with Special Inspector General Brian D. Miller of the Office of the Special Inspector General for Pandemic Recovery to investigate and prosecute fraud in the distribution of the funds authorized by the Coronavirus Aid, Relief, and Economic Security.
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Leading up to a webinar on July 15, 2020, we are publishing a blog series covering the risks of enforcement against companies that received COVID-19 relief funds under the CARES Act and strategies for mitigating these risks.  This second installment of our series discusses our predictions related to litigation and enforcement activities. We expect a substantial number of False Claims Act (“FCA”) investigations and lawsuits initiated mainly by whistleblowers (also known as “relators”). The FCA remains the government’s primary enforcement tool for pursuing alleged fraud by recipients of government funds, and FCA claims present substantial risk because the statute permits treble damages and significant per-claim penalties. For example, an erroneous $100,000 loan under the Paycheck Protection Program (“PPP”) can result in $300,000 in FCA damages, or more.
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Since the early days of the pandemic, Mintz’s COVID-19 Compliance & Enforcement Defense Task Force has closely monitored and advised clients on the evolving COVID-19 relief programs, including those created by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The CARES Act provided for over $2 trillion in relief funds, which is the largest emergency assistance package in American history. The numerous CARES Act programs have continued to develop through, among other things, the passage of the Paycheck Protection Program and Health Care Enhancement Act, the Paycheck Protection Program Flexibility Act of 2020, and rapidly changing regulatory guidance and FAQs. As one example, the government recently wrestled with whether to make public the list of about 4.6 million entities that received more than $500 billion from the Paycheck Protection Program (PPP) under the CARES Act. After initially refusing to disclose PPP loan recipients, the Small Business Administration and Treasury Department decided to make public the names of entities that received loans larger than $150,000, as well as the dollar range of each loan.
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The Department of Justice (DOJ) has announced its first criminal securities fraud prosecution related to COVID-19, and it involves health care fraud as well. Mark Schena, president of Arrayit Corporation, a publicly traded medical technology company, faces criminal charges in connection with false and fraudulent claims submitted for allergy and COVID-19 testing. The complaint charges Schena with one count of securities fraud and one count of conspiracy to commit health care fraud. From 2018 to present, Arrayit, under Schena’s direction, allegedly submitted or caused the submission of over $5.9 million in Medicare claims and over $63 million in private insurance claims for allergy and COVID-19 tests that were not medically necessary, were not provided as claimed, or were tainted by the payment of kickbacks and bribes.
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In an effort to address the need to increase the availability of COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) has issued guidance notifying pharmacies and other Medicare-enrolled suppliers that they may temporarily enroll as independent clinical diagnostic laboratories during the COVID-19 public health emergency (PHE) so that they may bill Medicare for COVID-19 testing. 
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Today the Small Business Administration (SBA) issued additional guidance with respect to the “necessity” certification required under the CARES Act in connection with the Paycheck Protection Program (PPP). The relevant guidance appears in FAQ 46, and it is very good news for borrowers who received PPP loans under $2 million (together with PPP loans to affiliates, if any). The SBA, in consultation with the U.S. Department of Treasury, has determined that a safe harbor will apply with respect to SBA’s review of the certification of necessity in connection with respect to such loans. Specifically, “[a]ny borrower that, together with its affiliates, received PPP loans with an original principal amount of less than $2 million will be deemed to have made the required certification concerning the necessity of the loan request in good faith.”
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In Part 5 of our Roadmap Series, we take a closer look at COVID-19 screening and testing, including best practices and legal implications, as potential tools to maintain a safe workplace.
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In an effort to increase access to COVID-19 testing for Medicare and Medicaid beneficiaries, the Centers for Medicare & Medicaid Services (CMS) has issued a second round of regulatory waivers that includes relaxed Medicare requirements for ordering COVID-19 diagnostic laboratory tests, flexibility for Medicaid coverage requirements of COVID-19 tests, and Medicare coverage of COVID-19 serology tests to identify antibodies.
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On Friday, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued responses to a series of frequently asked questions (FAQs), in an effort to provide some level of regulatory flexibility for health care providers responding to COVID-19 concerns.  These FAQs relate to enforcement of the OIG’s administrative enforcement authorities under the federal Anti-Kickback Statute (AKS) and Civil Monetary Penalties Law prohibiting beneficiary inducement (Beneficiary Inducement CMPL) only.
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News & Press

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Lab Institute 2016 Recap

November 8, 2016|

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podcasts

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Host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead. Hear from a dynamic group of Members, Of Counsel, and Associates as they share their perspectives on what’s coming up over the horizon.

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Podcast Viewpoint Image

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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In this episode, Health Care Enforcement Defense specialists Eoin Beirne, Karen Lovitch, and Brian Dunphy discuss key regulatory and policy updates issued by the DOJ and their potential impact on False Claims Act cases, from self-disclosure to privacy regulations.

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Bridgette Keller speaks with Karen Lovitch, Brian Dunphy, and Eoin Beirne about the Mintz Health Care Enforcement Defense Practice’s recent edition of the EnforceMintz newsletter, Analyzing Health Care False Claims Act Cases, and key health care enforcement trends.

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Mintz Health Law: What We Are Grateful For

January 11, 2023 | Podcast | By Bridgette Keller

Bridgette Keller speaks with the Mintz Health Law team about what they are grateful for as they look back on a year of client service, mentorship, and working together as a team.

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Podcast Viewpoint Image
In this episode of the Health Law Diagnosed podcast, members of the Mintz Health Law team discuss their health law–focused 2022 New Year’s resolutions and how they’re helping clients and colleagues navigate the continued challenges and opportunities of the current era.
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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.
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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.
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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

Conference Reference Image
Speaker
Oct
27
2022
Seminar Reference Image
Panelist
Apr
27
2022

2022 Executive War College

The Dark Intelligence Group

Conference Reference Image
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

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

  • The Best Lawyers in America: Health Care Law (2021 – 2027) 

  • Chambers USA: District of Columbia – Healthcare (2014 – 2026)

  • The Legal 500 United States: Healthcare – Service Providers (2014 – 2026)

  • Mondaq: Thought Leadership Award Winner (Autumn 2025)

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Involvement

  • The Women Business Leaders of the U.S. Health Care Industry Foundation
  • Board Member (2019 - 2022), Advisory Board Member (2022 - present), DC KinCare Alliance
  • Council Member, American University Washington College of Law - Health Law and Policy Program Alumni Advisory Council
  • 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 Lovitch

(she/her/hers)

Member / Chair, Health Law Practice & Chair, Health Care Enforcement Defense Practice

Washington, DC