
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 the Chair of the firm’s Health Law Practice and serves as a member of the Policy 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.
Education
- American University (JD, magna cum laude)
- West Virginia University (BA, summa cum laude)
Experience
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.
Recognition & Awards
- Included on the Washington DC Super Lawyers: Health Care list (2017, 2019-2021)
- Chambers USA: District of Columbia – Healthcare (2014 – 2020)
- Recognized by The Legal 500 United States for Healthcare: Service Providers (2014 – 2020)
- Phi Beta Kappa
- Best Lawyers in America: Health Care Law (2021)
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)
Viewpoints
HHS Finalizes Highly Anticipated Final Rules Amending Anti-Kickback Statute and Stark Law Regulations
November 23, 2020 | Blog | By Karen Lovitch, Rachel Yount
CMS Announces One-Year Delay in Finalizing Highly Anticipated Stark Law Reform
August 27, 2020 | Blog | By Karen Lovitch, Rachel Yount
Recent DOJ Comments Shed Light on Expected Civil Enforcement of COVID-19 Cases
August 18, 2020 | Blog | By Nicole Henry, Karen Lovitch
Massachusetts U.S. Attorney’s Office Enters into MOU with Office of the Special Inspector General for Pandemic Recovery
July 30, 2020 | Blog | By Karen Lovitch, Caitie Hill
COVID-19 Relief Programs: The Anticipated Wave of False Claims Act Cases and Oversight Agency Enforcement Activities
July 2, 2020 | Blog | By Brian Dunphy, Geoffrey Friedman, Caitie Hill, Jane Haviland, Karen Lovitch
COVID-19 Relief Programs: Mitigating and Responding To Enforcement Risk
June 22, 2020 | Blog | By Brian Dunphy, Jane Haviland, Nicole Henry, Karen Lovitch
DOJ Announces Criminal Charges against Lab Executive Accused of Fraudulently Promoting COVID-19 Tests
June 11, 2020 | Blog | By Karen Lovitch, Rachel Yount
CMS Allows Pharmacies and Other Suppliers to Bill Medicare for COVID-19 Testing
May 15, 2020 | Blog | By Karen Lovitch, Jane Haviland
SBA Issues Additional Guidance Regarding “Necessity” Certification Required under the CARES Act
May 13, 2020 | Blog | By Hope Foster, Karen Lovitch, Joseph Price, Sahir Surmeli
Part Five of the COVID-19 Roadmap Series: Ensuring a Safe Workplace - COVID-19 Screening and Testing
May 6, 2020 | Blog | By Nicole Rivers, Michael Arnold, Karen Lovitch, Hope Foster, Cynthia Larose
News & Press
How New Kickback Rules Benefit Health Care Industry: Part 2
December 18, 2020
How New Kickback Rules Benefit Health Care Industry: Part 1
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
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
