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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

This post is the third installment of our blog series on recent proposed rules from the Department of Health & Human Services (HHS) that, if finalized, would implement major changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). Below is an in-depth summary of the Office of Inspector General’s (OIG) proposed modifications to the safe harbors for personal services and management contracts, which includes a proposed new provision protecting outcomes-based payments. We also cover the OIG’s proposed modifications to the warranties safe harbor.
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On October 17, 2019, the Department of Health & Human Services published two proposed rules that, if finalized, would implement significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). This post is the latest installment in our blog series covering these proposed rules.
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On October 9, 2019, the Department of Health & Human Services (HHS) announced significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (known as the Stark Law) through proposed rules issued by the Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS). The proposed rules are part of HHS’s Regulatory Sprint to Coordinated Care, which aims to promote value-based care and ease regulatory burden on health care providers, particularly with respect to the AKS and the Stark Law.
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The Department of Justice (DOJ) recently announced that it has agreed to a $21.36 million settlement with compounding pharmacy Diabetic Care Rx LLC d/b/a Patient Care America (PCA), private equity firm Riordan, Lewis & Haden Inc. (RLH), and two PCA executives to resolve a pending False Claims Act (FCA) case. As discussed in a previous post regarding DOJ's decision to intervene, this case is notable because a private equity firm does not typically find itself subject to FCA action, and it is reported to be the first case against a private equity firm in which DOJ has chosen to intervene.
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The Centers for Medicare & Medicare Services (CMS) recently published a final rule with comment period (the “Final Rule”) that is designed to increase CMS’s ability to identify and prevent bad actors from participating in Medicare, Medicaid, and CHIP. Providers and suppliers should take note because implementation will be costly and burdensome. Among other things, the Final Rule requires the disclosure of certain provider and supplier affiliations and permits CMS to revoke or deny enrollment where those affiliations pose an undue risk of fraud and abuse. The Final Rule also grants CMS several additional authorities to revoke or deny a provider’s Medicare enrollment and increases the duration of such revocations and denials. The Final Rule takes effect on November 4, 2019. Comments on the Final Rule are due by 5:00 p.m. on that same day.
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On August 20, 2019, the United States exercised its authority under the False Claims Act (FCA) to seek dismissal of a relator’s qui tam suit because of the defendant’s burdensome discovery demands, in Polansky v. Executive Health Resources, Inc.  Since the lawsuit’s inception in 2012, the U.S. Department of Justice (DOJ), the U.S. Department of Health and Human Services' (HHS) Centers for Medicare and Medicaid Services (CMS), and other government agencies have attempted to fend off a series of burdensome Touhy requests but failed to do so.  Meanwhile, the scope of discovery has ballooned.  Collectively, DOJ and HHS have deployed six attorneys to work this case.  And, to top it off, DOJ is concerned about relator’s credibility and his ability to prove a FCA violation.  DOJ’s dismissal request thus comes as no surprise.
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Earlier this week the OIG took the somewhat unusual step of issuing a fraud alert directed to Medicare beneficiaries (rather than to Medicare providers) regarding “fraud schemes” that involve genetic testing. According to the OIG, beneficiaries are being offered genetic tests in order to obtain their Medicare information, which is then used to commit identity theft or to submit fraudulent claims to Medicare. Beneficiaries are being targeted through telemarketing calls, booths at public events, health fairs, and door-to-door visits.
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The Maryland General Assembly recently passed a bill that permits any person to directly or indirectly advertise diagnostic laboratory tests in the state, with certain limitations.  The bill currently awaits the Governor’s signature and will go into effect on October 1, 2019. Maryland law currently prohibits any marketing of laboratory tests to consumers, as well as any direct-to-consumer (“DTC”) testing without a physician’s order. 
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Last week, a U.S. district court judge in the Southern District of Florida upheld a magistrate judge’s decision to dismiss False Claims Act (FCA) allegations against a compounding pharmacy, its private equity firm owner, and two individuals. DOJ filed its complaint in intervention last February against the pharmacy, Patient Care America (PCA); its private equity backer, Riordan Lewis & Haden, Inc.; and two individual executives. The government alleged that the parties engaged in an illegal kickback scheme that resulted in the submission of false claims to TRICARE for expensive compounded drugs. This case is reportedly the first in which the federal government intervened against a private equity firm owner.
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The Department of Justice (DOJ) recently announced a $1.99 million False Claims Act (FCA) settlement with GenomeDx Biosciences Corp. (“GenomeDx”), a laboratory headquartered in Vancouver, British Columbia with operations in San Diego. The matter arose as the result of a qui tam case brought by two former employees in September 2017.
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News & Press

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Lab Institute 2016 Recap

November 8, 2016|

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podcasts

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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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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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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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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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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.
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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