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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

Health Care Viewpoints Thumbnail

The Pandemic Response Accountability Committee (PRAC) Health Care Subgroup recently published an expansive report that highlighted the sheer volume of expanded access to and use of telehealth services in certain federal health care programs during the first year of the COVID-19 pandemic. The report also focused on program integrity risks related to this expanded use and included recommended safeguards for future oversight of telehealth services.

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New York Office of Medicaid Inspector General Proposes Regulations on Self-Disclosure Program

September 26, 2022 | Blog | By Karen Lovitch , Jean D. Mancheno, Cody Keetch

This post is the third and final installment of our blog series on the proposed regulations published by the New York State Office of Medicaid Inspector General (OMIG). The proposed regulations would repeal the current Part 521 - Provider Compliance Programs of Title 18 of the New York Codes, Rules and Regulations in its entirety and establish new requirements for providers to detect and prevent fraud, waste, and abuse in the Medicaid Program under a new Part 521: Fraud, Waste, and Abuse Prevention (Part 521). If enacted, the proposed rules would implement changes related to Medicaid provider compliance programs, Medicaid managed care organization (MMCO) fraud, waste, and abuse prevention, and Medicaid providers’ “obligation to report, return, and explain Medicaid overpayments through OMIG’s Self-Disclosure Program.”

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Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA)  have recently occurred.  As a result, the clinical laboratory industry is hopeful that Medicare cuts scheduled to resume in 2023 and other aspects of PAMA’s price reporting requirements will be reformed. This blogpost provides an analysis of the ACLA lawsuit and newly introduced legislation that amends PAMA.  

 

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Disclosing known or suspected fraud to regulators can have its benefits.  As reported in a previous post, the Department of Justice (DOJ) issued policy guidance in 2019 on providing credit in False Claims Act (FCA) settlements to corporations for “disclosure, cooperation, and remediation” (the Policy Guidance).  Since then, the industry has been watching to see how  DOJ implements this Policy Guidance. 

Two settlements announced earlier this month seem to demonstrate that DOJ is applying the Policy Guidance in resolving FCA cases.  Although the facts of these two settlements differ significantly, they highlight the benefits of self-disclosure, cooperation with the government in its investigation, and proactive efforts to remediate non-compliance.

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Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a network of laboratories (the Requestor) would compensate hospitals for certain specimen collection services related to testing performed by Requestor (the Proposed Arrangement).  The OIG ultimately concluded that the Proposed Arrangement poses a risk of fraud of abuse under the federal Anti-Kickback Statute (AKS). In this post, we will cover the OIG’s rationale for this decision, as well as some of the history of the OIG’s scrutiny of specimen collection arrangements.

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OIG Approves Manufacturer’s Offer of Free Genetic Testing

April 14, 2022 | Blog | By Karen Lovitch , Theresa Carnegie, Pat Ouellette

The Office of Inspector General for the Department of Health and Human Services (OIG) recently published an Advisory Opinion in which it concluded that the provision of free genetic testing and counseling services by a pharmaceutical manufacturer would not result in the imposition of sanctions under the federal Anti-Kickback Statute (AKS) and the beneficiary inducements civil monetary penalty provision (Beneficiary Inducements CMP).  This Advisory Opinion is the first to address this type of arrangement and thus provides useful insight for the health care and life sciences industries.

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Webinar Recording: Health Care Enforcement Year in Review & 2022 Outlook

February 16, 2022 | Webinar | By Grady Campion, Randy Jones, Samantha Kingsbury, Karen Lovitch , Kevin McGinty

In our annual webinar, Mintz’s Health Care Enforcement Defense team reviewed the key health care fraud enforcement developments and trends from 2021, assessed their likely impact in 2022, and provided recommendations to avoid government scrutiny.
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Removing Barriers to Second Chances

January 24, 2022 | Article

Mintz initiated many pro bono projects to combat systemic racism after the murder of George Floyd, including organizing Massachusetts Criminal Offender Record Information sealing clinics with the Lawyers Clearinghouse and conducting research for a Boston-based nonprofit into how housing authorities around the country evaluate applicants with open criminal charges.
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Webinar Recording: Telehealth Regulation & Enforcement: 2021 Year in Review & 2022 Outlook

December 7, 2021 | Webinar | By Alexander Hecht, Ellen Janos, Karen Lovitch , Kate Stewart

Over the past year, the demand for health care via telehealth has continued to skyrocket as a result of the COVID-19 pandemic and the public’s increased comfort with obtaining health care goods and services virtually. Join Ellen Janos, Karen Lovitch, Kate Stewart and Alex Hecht as they demystify the current status of laws and regulations, untangle the web of legislation before Congress related to the expansion of telehealth services, discuss recent enforcement activity, and look ahead to trends we see on the horizon.  
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OIG Revises and Renames the Provider Self-Disclosure Protocol

November 10, 2021 | Blog | By Karen Lovitch , Rachel Yount

For the first time since April 2013, the Department of Health and Human Services’ Office of Inspector General (OIG) revised the Provider Self-Disclosure Protocol (SDP) on November 8, 2021. The SDP allows providers and other entities to voluntarily disclose and resolve instances of potential fraud involving federal health care programs, including potential overpayments and Anti-Kickback Statute (AKS) violations. The OIG originally published the SDP in 1998, and has since modified the SDP several times generally to make the SDP a more appealing option for providers and other health care entities.
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News & Press

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Lab Institute 2016 Recap

November 8, 2016|

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podcasts

Health Law Diagnosed – New Year's Gratitude

February 3, 2025 | Podcast | By Bridgette Keller, Alison H. Peters, Samantha Kingsbury, Theresa Carnegie, Joanne Hawana , Abdie Santiago, Stephnie John, Pamela Polevoy, Karen Lovitch , Jean D. Mancheno, Deborah Daccord, Rachel A. Alexander, Jane Haviland, David Gilboa, Kathryn Edgerton, Hassan Shaikh, Madison Castle, Laurence Freedman, Priyanka Amirneni, Samantha Hawkins, Tara E. Dwyer, Rachel Yount, Sophia Temis, Xavier Hardy

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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Health Law Diagnosed – EnforceMintz – Part 2: DOJ Regulatory and Policy Update

April 25, 2023 | Podcast | By Bridgette Keller, Eoin Beirne, Karen Lovitch , Brian Dunphy

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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Podcast Viewpoint Image

Health Law Diagnosed – EnforceMintz: Analyzing Health Care False Claims Act Cases

April 18, 2023 | Podcast | By Bridgette Keller, Karen Lovitch , Brian Dunphy, Eoin Beirne

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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Podcast Viewpoint Image

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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Podcast Viewpoint Image
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
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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