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
New DOJ-HHS Pilot Offers Health Care Companies a Limited-Time Path to Resolve FCA Liability Through Self-Disclosure
October 27, 2026 | Blog | By Karen Lovitch
DOJ and HHS launch a temporary pilot offering health care companies a path to resolve False Claims Act liability through self-disclosure.
DOJ Rejects Petition to Allow Labs to Compensate Employed Sales Reps Using Variable Compensation Under EKRA
October 13, 2026 | Blog | By Samantha Kingsbury, Karen Lovitch
DOJ denied ACLA’s EKRA rulemaking petition, signaling scrutiny of referral-based sales commissions and prompting labs to reassess compensation plans.
DOJ Formalizes Key FCA Enforcement Reforms: Limits on Agency Guidance and Expanded Dismissal Authority
September 24, 2026 | Blog | By Grady Campion, Karen Lovitch , Raymond Vanderhyden
On September 18, 2026, the Department of Justice (DOJ) announced revisions to the Justice Manual formalizing two significant changes to False Claims Act (FCA) enforcement policy. First, DOJ reestablished and enhanced a prior policy providing that alleged noncompliance with nonbinding agency guidance documents cannot establish civil FCA liability. Second, when making a declination decision, DOJ attorneys “will in each case” assess whether to seek dismissal.
Zafirov Update: Eleventh Circuit Sides With Relators on Appointments Clause, But Article II Challenges Remain
September 3, 2026 | Blog | By Grady Campion, Karen Lovitch , Kevin McGinty, Raymond Vanderhyden
On September 1, 2026, the Eleventh Circuit issued its long-awaited decision in United States ex rel. Zafirov v. Florida Medical Associates, vacating the district court’s ruling that the False Claims Act’s (FCA) qui tam provisions violate the Appointments Clause of Article II. The court found that FCA relators are not “Officers of the United States” because they do not occupy a “continuing position established by law,” and therefore are not subject to the Appointments Clause’s requirements. The Eleventh Circuit’s decision is in line with decisions from other circuits rejecting similar Appointments Clause challenges, but it is the first to do so since Justice Thomas’s dissent in United States ex rel. Polansky v. Executive Health Resources.
Cooperation, Compliance, and Consequences: Inside DOJ's $46 Million Veloxis Settlement
August 26, 2026 | Blog | By Karen Lovitch , Raymond Vanderhyden
The Department of Justice’s recent resolution with Veloxis Pharmaceuticals sends a clear signal: pharmaceutical companies’ relationships with health care professionals remain under close scrutiny. Veloxis Pharmaceuticals Inc., a North Carolina-based drug manufacturer, agreed to pay more than $46 million to resolve criminal and civil allegations arising from a purported years-long kickback scheme involving its kidney transplant drug, Envarsus. The resolution included a deferred prosecution agreement (DPA), a civil False Claims Act (FCA) settlement, and the largest recovery on record under the federal Open Payments Program (Sunshine Act), which underscores the government’s continuing focus on pharmaceutical manufacturers’ relationships with health care professionals (HCPs) and its willingness to pursue both criminal and civil remedies when it considers those relationships to have crossed the line.
Women's Health at a Turning Point: What Federal Policy Changes Mean for the FemTech Industry
August 4, 2026 | Blog | By Traci L. Vitek, Theresa Carnegie, Karen Lovitch , Daniel Cody
For decades women's health has too often been treated as a narrow policy category, despite affecting roughly half the population. That is changing. There is now an emerging category of medicine built around regulated software, biomarker-based decision-making, and new regulatory and reimbursement pathways. FemTech now spans menstrual health, fertility, pregnancy and postpartum care, pelvic and sexual health, menopause, contraception, and conditions that affect women differently or disproportionately.
DOJ Fraud and Health Care Enforcement: Latest Priorities, Trends, and Compliance Considerations
July 31, 2026 | Webinar | By Karen Lovitch , Eoin Beirne, Samantha Kingsbury, Nick A. LaPalme
Watch Mintz's on-demand webinar on DOJ health care fraud and False Claims Act enforcement priorities, emerging risk areas, whistleblower trends, and compliance strategies for 2026.
Crushing and Flexing: CMS Proposes to Expand Its Discretion to Deny and Revoke Medicare Enrollment
July 14, 2026 | Blog | By Karen Lovitch , Jane Haviland
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (Proposed Rule) on July 6 that would expand its authority over Medicare enrollment denials and revocations applicable to all providers and suppliers (Providers). CMS’s proposed expansion of Medicare enrollment denial and revocation authorities is consistent with the Trump administration's broader strategy of preventing improper payments before they occur.
DOJ’s 2026 Health Care Fraud Takedown Signals Heightened Medicaid Scrutiny and Data-Driven Enforcement
June 26, 2026 | Blog | By Karen Lovitch , Lauren Moldawer, Raymond Vanderhyden
The annual National Health Care Fraud Takedown, announced by the Department of Justice (DOJ) on June 23, 2026 (the “2026 Takedown”), reinforces several enforcement priorities—opioid diversion, wound care fraud, and kickback schemes—while signaling a sharper focus on Medicaid fraud and the government’s expanding use of advanced data analytics.
Hawaii MFCU Defunding Signals Increased Scrutiny for Providers and MCOs
June 8, 2026 | Blog | By Karen Lovitch , Lauren Moldawer
The Trump administration has decertified and defunded Hawaii’s Medicaid Fraud Control Unit (MFCU), withholding $3 million in federal funds. As detailed in a previous post, in May, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) informed every state of its intent to review the activities of its MFCU. On June 4, 2026, HHS-OIG escalated further and followed through with its threats by formally denying recertification of Hawaii’s MFCU based on its failure to pursue Medicaid fraud effectively.
News & Press
Federal Contractor Fraud Defenses Broadened by DOJ Policy Shift
September 23, 2026|
Mintz has again earned top rankings in the 2026 edition of Legal 500 United States. The firm is ranked across 20 practice categories and boasts 82 recognized individual attorneys, including seven ranked as “Leading Partner,” one “Leading Associate,” and five “Next Generation Partner” designations.
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)

