Karen Lovitch
(she/her/hers)
Member / Chair, Health Law Practice & Chair, Health Care Enforcement Defense Practice
+1.202.434.7324
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.
viewpoints
OIGs Report on Expanded Telehealth Service Access and Use, Program Integrity Risks During Year One of COVID-19 Pandemic
December 21, 2022 | Blog | By Karen Lovitch , Pat Ouellette, Sophia Temis
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.
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.”
PAMA Laboratory Reporting In Flux: ACLA Wins HHS Lawsuit and Congress Introduces PAMA Amendment Legislation
July 29, 2022 | Blog | By Karen Lovitch , Pat Ouellette
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.
Two Recent False Claims Act Settlements Highlight the Benefits of Self-Disclosure, Remediation, and Cooperation
July 19, 2022 | Blog | By Karen Lovitch , Lauren Moldawer, Jane Haviland
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.
OIG Expresses Concern about Laboratory Specimen Collection Payments to Hospitals in AO 22-09
May 5, 2022 | Blog | By Karen Lovitch
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.
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.
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
Removing Barriers to Second Chances
January 24, 2022 | Article
Webinar Recording: Telehealth Regulation & Enforcement: 2021 Year in Review & 2022 Outlook
December 7, 2021 | Webinar | By Alexander Hecht, Ellen Janos, Karen Lovitch , Kate Stewart
OIG Revises and Renames the Provider Self-Disclosure Protocol
November 10, 2021 | Blog | By Karen Lovitch , Rachel Yount
News & Press
Federal Contractor Fraud Defenses Broadened by DOJ Policy Shift
September 23, 2026|
Mintz Advises TPG on Sale of Equity Interest in OneOncology to Cencora
December 17, 2025|
Court: Percentage-Based Comp Is Not Illegal in Itself
September 15, 2025|
9th Circ. Clarifies Kickback Boundaries for Referral Bonuses
July 29, 2025|
DOJ Sends Warning in Gender Care Provider Subpoenas
July 11, 2025|
The Pros and Cons of Self-Disclosure: Q&A With Karen Lovitch
March 14, 2025|
Healthcare’s AI Deal Advantage
October 21, 2024|
Mintz Advises TPG in Strategic Partnership with Surescripts
October 4, 2024|
Special Report: The 2024 Lab Enforcement Landscape
August 29, 2024|
Mintz Adds Fire Power to Leading Health Law Practice with New Member
December 4, 2023|
Settlement Highlights Benefits of Self-Disclosure
July 5, 2023|
Feds Bring 18 Charges in Covid Crackdown, Lab Implicated
May 10, 2023|
Mintz Forms Pioneering Women’s Health & Technology Practice
March 9, 2023|
Mintz Debuts 'Femtech' Practice For Life Science Clients
March 9, 2023|
What’s Old Is New Again: Key Compliance Issues for Clinical Laboratories
January 24, 2023|
Mintz Appoints New Health Care And Enforcement Defense Leadership
January 18, 2023|
DOJ Crackdown on Genetic Testing Telefraud
August 15, 2022|
Healthcare Enforcement & Litigation 2022
August 27, 2021|
How New Kickback Rules Benefit Health Care Industry: Part 1
December 18, 2020|
How New Kickback Rules Benefit Health Care Industry: Part 2
December 18, 2020|
CMS Publishes Proposed 2021 Medicare Physician Fee Schedule
August 24, 2020|
Mintz Attorneys and Practices Recognized by Chambers USA 2020
April 24, 2020|
TPG Invests in Behavioral Health Firm LifeStance
April 20, 2020|
2019 Trends In DOJ Civil Health Care Fraud Cases
January 15, 2020|
Hospitals’ Risk May Rise as Anti-Fraud Proposal Narrows Loophole
October 25, 2019|
Mintz Recognized by Chambers USA 2019
April 26, 2019|
AHLA Health Care Compliance Legal Issues Manual
March 5, 2019|
Chambers USA 2018 Ranks Mintz Attorneys & Practices
May 3, 2018|
Private Equity FCA Suit More Likely Outlier Than Omen
March 16, 2018|
Laboratory Economics' PAMA Teleconference Highlights
February 19, 2018|
2017 Health Care Enforcement Review: Final Thoughts
January 19, 2018|
Mintz Advising Consortium in $4+ Billion Acquisition of Kindred Healthcare
December 21, 2017|
Labs Wage Legal Fights Over Fees, Medical Necessity Checks
November 14, 2017|
New Safe Harbor Allows Labs to Provide Patient Transport
February 28, 2017|
Health Care Enforcement Review And 2017 Outlook: Part 4
January 19, 2017|
Health Care Enforcement Review And 2017 Outlook: Part 3
January 18, 2017|
Health Care Enforcement Review And 2017 Outlook: Part 2
January 17, 2017|
Lab Institute 2016 Recap
November 8, 2016|
Mintz Represents Myriad Genetics in Acquisition of Assurex Health
September 8, 2016|
CMS finalizes lab fee schedule changes: 5 key takeaways
June 21, 2016|
49 Mintz Attorneys Featured in Chambers USA 2016 Guide
May 31, 2016|
What Is The Anti-Kickback Statute?
January 1, 2015|
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.
Health Law Diagnosed — Mintz Health Law Team: Reflecting on What We Are Grateful For
February 5, 2024 | Podcast | By Bridgette Keller
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.
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.
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.
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.
Health Law Diagnosed — Mintz’s 2022 Health Law New Year’s Resolutions
January 12, 2022 | Podcast | By Bridgette Keller
Health Law Diagnosed — Final Rules Amending the Anti-Kickback Statute and Stark Law Regulations: Part 2
March 17, 2021 | Podcast | By Karen Lovitch , Rachel Yount
Health Law Diagnosed — Final Rules Amending the Anti-Kickback Statute and Stark Law Regulations: Part 1
February 16, 2021 | Podcast | By Karen Lovitch , Rachel Yount
Events & Speaking
DOJ Fraud and Health Care Enforcement: Latest Priorities, Trends, and Compliance Considerations
Virtual Event
Important Developments in Laboratory Legal, Regulatory, and Compliance Requirements
29th Annual Executive War College on Laboratory and Pathology Management
New Orleans, Louisiana
CMS Final Rule Targeting Private Equity and REIT Ownership of Nursing Facilities
Strafford Webinars
Virtual
Health Care Fraud Enforcement Developments and Whistleblower Avoidance
G2 Lab Institute: Advancing the Profession of Diagnostic Medicine
Virtual Event
Can We Do This? Avoiding Marketing and Business Development Compliance Pitfalls
REDC Member Meeting
InterContinental Minneapolis
Telehealth Regulation & Enforcement: 2021 Year in Review & 2022 Outlook
Mintz & ML Strategies
Online Event
Reducing Patient Leakage by Directing Physician Referrals, AKS Safe Harbors, and Stark Law Exceptions
Strafford
Online Event
HHS’s Holiday Gift to the Health Care Industry: Historic Changes to the Anti-Kickback Statute and Stark Law Regulations
View the Webinar Recording
Received COVID-19 Funding? How to Mitigate and Respond to Enforcement Risks and Government Actions
View the Webinar Recording
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
Laboratory & Pathology Management
Executive War College
Sheraton New Orleans 500 Canal St. New Orleans, LA 70130
American Clinical Laboratory Association 2018 Annual Meeting
American Clinical Laboratory Association
Washington, DC
Medicare's Market-Based Payment Startup: Strategic Options & Compliance Red Flags for Labs
Laboratory Economics
Webinar
Trends in Enforcement and Regulatory Guidance - What Should be on Your AKS Radar?
The American Bar Association
Webinar
Hot Topics in Laboratory Compliance
American Health Lawyers Association
Hilton Baltimore Hotel, Baltimore, MD
Publications
- Co-author, What Is...The Anti-Kickback Statute?, Second Edition, Published by the American Bar Association (2022)
- Co-author, Crackdown on COVID-19 Testing Fraud Continues, Published by G2 Intelligence (2024)
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)
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
Karen Lovitch
(she/her/hers)

