Karen S. Lovitch
(she/her/hers)
Chair, Health Law Practice & Chair, Health Care Enforcement Defense Practice
+1.202.434.7324
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 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.
viewpoints
CMS Proposes New Disclosure of Ownership Regulations for Nursing Facilities - Top Five Takeaways for Private Equity Firms and REITs
February 21, 2023 | Blog | By Lauren Moldawer, Karen Lovitch
Private equity ownership of health care providers is unquestionably under scrutiny by federal and state regulators. States are passing laws that either directly or indirectly target PE health care transactions. This post highlights the top five takeaways related to the proposed regulations for private equity companies or real estate investment trust ownership.
EnforceMintz — With Telemedicine Here to Stay, Enforcement Agencies Continued their Scrutiny
February 9, 2023 | Blog | By Karen Lovitch
While the Biden Administration has indicated it will let the PHE expire on May 11, 2023 and not all telehealth flexibilities will remain in place, the expansion of telehealth is undoubtedly here to stay, given its continued popularity. Telehealth providers should continue to monitor state and federal developments closely to ensure ongoing compliance with applicable billing requirements, conduct auditing and monitoring activities, and evaluate compliance program effectiveness.
EnforceMintz Newsletter — Health Care Enforcement Year In Review & 2023 Outlook
February 9, 2023 | Article | By Karen Lovitch , Brian Dunphy, Grady Campion, Kathryn Edgerton, Cory S. Flashner, Samantha Kingsbury, Kevin McGinty
Mintz’s Health Care Enforcement Defense Practice regularly provides a comprehensive examination of health care fraud enforcement trends in its new EnforceMintz newsletter. The inaugural issue delved into False Claims Act cases and enforcement activity related to telemedicine, Medicare Advantage, opioids, kickbacks, and more.
EnforceMintz Newsletter — Quick Hits
February 9, 2023 | Blog | By Karen Lovitch
Record Settlement in a Declined Case Continued; Pursuit of EHR Technology Vendors; Slowdown in Qui Tam Cases Involving Private Equity Firms; First Settlement of a Civil Cyber-Fraud Case
Mintz Health Law: What We Are Grateful For
January 11, 2023| Podcast|
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.
News & Press
Healthcare’s AI Deal Advantage
October 21, 2024
Health Law Practice Chair Karen Lovitch recently spoke with Mergers & Acquisitions about some of the different ways AI is transforming the healthcare industry and how PE firms and strategic buyers are viewing the space advantageously.
Mintz Advises TPG in Strategic Partnership with Surescripts
October 04, 2024
Mintz advised global alternative asset management firm TPG in a strategic partnership with Surescripts®, the nation’s leading health information network. The partnership includes an investment in Surescripts through TPG Capital, the firm’s U.S. and European private equity platform.
Special Report: The 2024 Lab Enforcement Landscape
August 29, 2024
Health Law Practice Chair Karen Lovitch and Of Counsel Samantha Kingsbury were quoted in a G2 Intelligence special report about the 2024 lab enforcement landscape.
The Best Lawyers in America 2025 Recognizes 184 Mintz Attorneys across 56 Practice Areas
August 15, 2024
187 Mintz attorneys have been recognized by Best Lawyers® in the 2025 edition of The Best Lawyers in America©. Notably, three Mintz attorneys received 2025 “Lawyer of the Year” awards, and 64 firm attorneys were included in the 2025 edition of Best Lawyers: Ones to Watch.
Mintz announced today that 42 of its practices and 83 of its attorneys earned recognition in the 2024 edition of Chambers USA, a guide to the country’s leading law firms. Of those included in the guide, 18 attorneys and seven practice areas were awarded Chambers’ highest ranking, Band 1. The firm obtained new listings in three practice areas and 10 of its lawyers were recognized for the first time.
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.
Mintz Adds Fire Power to Leading Health Law Practice with New Member
December 04, 2023
WASHINGTON, DC – Mintz has deepened its health care bench with the addition of new Member, Rachel Alexander.
Settlement Highlights Benefits of Self-Disclosure
July 5, 2023
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.
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.
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.
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.
WASHINGTON, DC – Mintz is pleased to announce the inclusion of five Members to the 2023 Washington, D.C. Super Lawyers list.
Mintz Forms Pioneering Women’s Health & Technology Practice
March 09, 2023
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.
Mintz Debuts 'Femtech' Practice For Life Science Clients
March 9, 2023
Law360 featured the launch of the firm's Women's Health and Technology practice and highlighted founding Members Ellen Janos, Joanne Hawana, Karen Lovitch, and Melanie Levy.
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.
Mintz Appoints New Health Care And Enforcement Defense Leadership
January 18, 2023
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.
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.
DOJ Crackdown on Genetic Testing Telefraud
August 15, 2022
Mintz Advises Kindred Healthcare in Sale to LifePoint Health, Launching ScionHealth
December 23, 2021
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 Practice Groups and Attorneys Garner Top Rankings in 2020 Edition of The Legal 500 United States
June 12, 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
Antiopioid Law Could Criminalize Sales Commissions for Clinical Lab Patient Referrals
April 18, 2019
AHLA Health Care Compliance Legal Issues Manual
March 5, 2019
Chambers USA 2018 Ranks Mintz Attorneys & Practices
May 03, 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
Labs Wage Legal Fights Over Fees, Medical Necessity Checks
November 14, 2017
Leader of Mintz Health Law Practice Karen Lovitch to Speak at 2017 G2 Intelligence Lab Institute Conference
October 11, 2017
Mintz’s Health Law Practice Recognized Among Industry Leaders in Annual BTI Power Rankings
August 17, 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
Lesson from RML's $1.1 Million Settlement: Beware of Carve-Outs and Pull-Through Arrangements
October 18, 2016
Mintz Represents Myriad Genetics in Acquisition of Assurex Health
September 08, 2016
CMS finalizes lab fee schedule changes: 5 key takeaways
June 21, 2016
What Is The Anti-Kickback Statute?
January 1, 2015
Events & Speaking
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
Included on the Washington DC Super Lawyers: Health Care list (2017 – 2024)
Best Lawyers in America: Health Care Law (2021 – 2025)
Chambers USA: District of Columbia – Healthcare (2014 – 2024)
Recognized by The Legal 500 United States for Healthcare: Service Providers (2014 – 2024)
Phi Beta Kappa
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
Recent Insights
Health Law Practice Chair Karen Lovitch recently spoke with Mergers & Acquisitions about some of the different ways AI is transforming the healthcare industry and how PE firms and strategic buyers are viewing the space advantageously.
Karen S. Lovitch
(she/her/hers)