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Karen S. Lovitch

Member / Chair, Health Law Practice

KSLovitch@mintz.com

+1.202.434.7324

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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

  • 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 favorable to the laboratories. 
  • Designed and drafted a diagnostics company’s compliance program policies and conducted general and specialized compliance training programs for employees and board members.
  • Advised a national independent laboratory on state, federal, and accrediting agency notice and approval requirements in connection with the division of the company and oversaw the preparation of hundreds of filings to be submitted to all licensure and accreditation agencies, the Medicare program, and state Medicaid programs nationwide.
  • 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.
  • Counseled a national independent laboratory on state, federal, and accrediting agency notice and approval requirements in connection with its acquisition by an international diagnostics and laboratory services company, and prepared over one hundred filings to be submitted to a variety of agencies.

Recognition & Awards

  • Chambers USA: District of Columbia – Healthcare (2014 – 2020)
  • Recognized by The Legal 500 United States for Healthcare: Service Providers (2014 – 2019)
  • Included on the Washington DC Super Lawyers: Health Care list (2017, 2019-2020)
  • 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)

Recent Insights

News & Press

Viewpoints

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CMS Allows Pharmacies and Other Suppliers to Bill Medicare for COVID-19 Testing

May 15, 2020 | Blog | By Karen Lovitch, Jane Haviland

In an effort to address the need to increase the availability of COVID-19 testing, the Centers for Medicare & Medicaid Services (CMS) has issued guidance notifying pharmacies and other Medicare-enrolled suppliers that they may temporarily enroll as independent clinical diagnostic laboratories during the COVID-19 public health emergency (PHE) so that they may bill Medicare for COVID-19 testing. 
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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

Today the Small Business Administration (SBA) issued additional guidance with respect to the “necessity” certification required under the CARES Act in connection with the Paycheck Protection Program (PPP). The relevant guidance appears in FAQ 46, and it is very good news for borrowers who received PPP loans under $2 million (together with PPP loans to affiliates, if any). The SBA, in consultation with the U.S. Department of Treasury, has determined that a safe harbor will apply with respect to SBA’s review of the certification of necessity in connection with respect to such loans. Specifically, “[a]ny borrower that, together with its affiliates, received PPP loans with an original principal amount of less than $2 million will be deemed to have made the required certification concerning the necessity of the loan request in good faith.”
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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

In Part 5 of our Roadmap Series, we take a closer look at COVID-19 screening and testing, including best practices and legal implications, as potential tools to maintain a safe workplace.
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In an effort to increase access to COVID-19 testing for Medicare and Medicaid beneficiaries, the Centers for Medicare & Medicaid Services (CMS) has issued a second round of regulatory waivers that includes relaxed Medicare requirements for ordering COVID-19 diagnostic laboratory tests, flexibility for Medicaid coverage requirements of COVID-19 tests, and Medicare coverage of COVID-19 serology tests to identify antibodies.
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On Friday, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued responses to a series of frequently asked questions (FAQs), in an effort to provide some level of regulatory flexibility for health care providers responding to COVID-19 concerns.  These FAQs relate to enforcement of the OIG’s administrative enforcement authorities under the federal Anti-Kickback Statute (AKS) and Civil Monetary Penalties Law prohibiting beneficiary inducement (Beneficiary Inducement CMPL) only.
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As authorized by Section 1135 of the Social Security Act, the Centers for Medicare & Medicaid Services (CMS) has announced that it will extend temporary Medicare billing privileges to physicians and non-physician practitioners via telephone and that it will expedite pending enrollment applications submitted by all other providers and suppliers, including DMEPOS.  CMS made the announcement on March 13th and followed up with the publication of FAQs related to enrollment relief earlier this week.

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Tackling False Claims Being Made for COVID-19 Treatments and Products

March 24, 2020 | Blog | By Christian Tamotsu Fjeld, Joanne Hawana, Karen Lovitch, Joseph MIller, Aaron Josephson

Two weeks ago, on March 9, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to seven companies that allegedly made false or deceptive claims about their products’ ability to treat Coronavirus Disease 2019 (COVID-19).  The agencies warned the companies that their health claims lacked credible supporting evidence and emphasized the FDA does not recognize a vaccine, drug, or treatment for the disease.  
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Following years of discussion, on March 5, 2020, U.S. Representatives Larry Buchson (R-IN) and Diana DeGette (D-CO) and U.S. Senators Richard Burr (R-NC) and Michael Bennet (D-CO) introduced identical versions of the Verifying Accurate and Leading-edge IVCT Development (VALID) Act in both chambers of Congress. The bipartisan legislation closely tracks existing medical device laws, with some notable exceptions, discussed below and in a prior post. If enacted, many regulatory elements familiar to in vitro diagnostic (IVD) and other medical device manufacturers would be applied to clinical laboratories that develop their own tests, commonly known as laboratory developed tests (LDTs). The bill also includes elements that are priorities for the Food and Drug Administration (FDA), including a program conceptually similar to pre-certification, third-party review, and Collaborative Communities. Unlike previously-circulated discussion drafts, the introduced bills include specific language designed to address public health emergencies, including COVID-19.
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HHS Proposed Changes to AKS and Stark Law: Cybersecurity and EHR

February 10, 2020 | Video | By Karen Lovitch

Karen Lovitch, Chair of Mintz’s Health Law Practice, discusses the proposed new safe harbor and Stark Law exception for donations of cybersecurity technology and related services as well as the significant proposed modifications to the existing safe harbor and exception for electronic health records (EHR) technology and services.
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HHS Proposed Changes to Anti-Kickback Statute and Stark Law

February 10, 2020 | Video | By Karen Lovitch, Theresa Carnegie

Karen Lovitch, Chair of Mintz's Health Law Practice, and Theresa Carnegie, a Member in the Health Law Practice, discuss the proposed changes to the Anti-Kickback Statute (AKS) and Stark Law issued by Department of Health & Human Services (HHS) and dive into some of the key issues.
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News & Press

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The Deal reported that Mintz, led by Member and Health Law Division Head Susan Berson and Member and Chair of the Health Law Practice Karen Lovitch, served as legal 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.
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Mintz Members Brian Dunphy and Laurence Freedman, and Member and Co-Chair of the firm’s Health Law Practice Karen Lovitch co-authored this Law360 expert analysis article examining trends in U.S. Department of Justice health care enforcement in 2019, noting that the False Claims Act remains the government’s most powerful civil health care enforcement tool.
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Bloomberg Law reported that the Centers for Medicare & Medicaid Services plans to narrow an existing exception for isolated financial transactions that attorneys say has been a safety net to catch mistakes that would otherwise result in costly violations under the Stark Law. The article included a quote from Mintz Member and Chair of the Health Law Practice Karen Lovitch.
Karen Lovitch, Mintz’s Health Law Practice leader, provided commentary on a federal law passed to combat the opioid crisis that could have unintended consequences by criminalizing sales commissions paid by clinical laboratories to their salaried sales representatives for patient referrals.

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Mintz Member and Chair of the Health Law Practice Karen S. Lovitch served as an editor of the Fifth Edition of the American Health Lawyers Association’s “Health Care Compliance Legal Issues Manual,” which provides strategies for addressing the full scope of legal issues critical to health care compliance. Mintz Member Thomas S. Crane also contributed to the publication as an author.
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Mintz partner and Massachusetts lawyer Julie Korostoff is one of 49 attorneys recognized as “Leaders in Their Fields” by the 2018 Chambers USA: America's Leading Lawyers for Business guide. Chambers named Korostoff a “Recognized Practitioner” in Technology.
Mintz is pleased to announce that eight attorneys have been named Washington, D.C. Super Lawyers for 2018 and three others have been named Washington, D.C. Rising Stars. The annual publication identifies lawyers who have attained a high degree of peer recognition and professional achievement.
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Mintz is advising a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their acquisition of Curo Health Services, one of the nation’s leading hospice providers. The definitive agreement was announced on April 23, 2018. The deal is valued at approximately $1.4 billion.
Member and Leader of the firm’s Health Law Practice Karen Lovitch is quoted in this article. The feature story discusses implications of the DOJ's recent False Claims Act complaint targeting a private equity firm.
Karen Lovitch, the leader of Mintz’s Health Law practice, was recently quoted in an article from the Laboratory Economics journal on its PAMA teleconference. During the February 1st teleconference, Karen spoke about the ongoing lawsuit filed against the HHS by the ACLA.
Karen Lovitch, practice leader of the Mintz Health Law Practice, Eoin Beirne, a Member in the firm’s Litigation practice, along with Associates Samantha Kingsbury and Mackenzie Queenin authored the last in a four-part series of articles on health care enforcement trends in 2017.
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Mintz is advising a consortium of investors led by TPG Capital and Welsh, Carson, Anderson & Stowe in their acquisition of Kindred Healthcare, Inc. The definitive agreement totals approximately $4.1 billion in cash including the assumption or repayment of net debt.
Karen Lovitch, Mintz’s Health Law Practice leader, provided commentary on the repercussions of lower Medicare rates and exclusion of smaller private lab fee data from pricing methodology for the Bloomberg Law Health Care blog.
Karen Lovitch, a Member and Leader of the Health Law Practice at Mintz, will be a featured speaker at the 2017 G2 Intelligence Lab Institute conference. Her panel, “Compliance Traps to Avoid,” will provide attendees guidance to recognize and avoid costly compliance issues.
Mintz is proud to announce that the firm’s Health Law Practice has been recognized by the BTI Industry Power Rankings 2017. The report names the firm as “A Leading Core Firm” in the health care industry.
Eight Mintz attorneys have been named Washington, D.C. Super Lawyers for 2017 and four have been named Washington, D.C. Rising Stars. The list will be published in a special advertising supplement in The Washington Post Magazine and in a stand-alone magazine, Washington D.C. Super Lawyers Magazine.
Karen Lovitch is featured in this Laboratory Economics article addressing the potential impact of a new safe harbor that would afford laboratories a new ability to provide transport to patients under certain circumstances.
This is the fourth and final installment of a series from Mintz’s Health Law team recapping key government policies, regulations and enforcement actions from 2016 and discussing their potential impacts on 2017.
This is the third installment of a four-part series recapping key government policies, regulations and enforcement actions from 2016 and discussing their potential impacts on 2017.
Three attorneys from Mintz author the second installment of a four-part series recapping key government policies, regulations and enforcement actions from 2016 and discussing their potential impacts on 2017.

Lab Institute 2016 Recap

November 8, 2016

Karen Lovitch, the leader of Mintz’s Health Law practice, is quoted in a G2 Compliance Advisor article recapping hot topics and trends covered during G2 Intelligence’s 34th annual Lab Institute.
Karen S. Lovitch, Leader of the Health Law Practice at Mintz, is speaking at the 2016 G2 Intelligence Lab Institute. Ms. Lovitch will discuss the current legal and compliance “hotspots” for labs and pathologists.
Karen Lovitch, Member and leader of Mintz’s Health Law practice, is quoted in this Laboratory Economics article on a settlement regarding self-reported violations of anti-kickback and self-referral laws.
Attorneys from Mintz represented Myriad Genetics, Inc. in its acquisition of Assurex Health, an informatics-based precision medicine company providing treatment decision support to health care providers for mental health patients.
Karen Lovitch, the leader of Mintz’s Health Law practice, and Kate Stewart, Mintz Health Law Associate, authored this Bloomberg Medicare Report article on the Centers for Medicare & Medicaid Services’ issuing of the Final Rule.
Karen Lovitch, Member and leader of Mintz’s Health Law practice, is quoted in this Becker’s Hospital CFO article discussing the Centers for Medicare and Medicaid Services’ final rule on the Clinical Laboratory Fee Schedule changes.  
Firm’s National Healthcare Practice, NY Corporate/M&A and Litigation: General Commercial Among Newest Rankings
Karen Lovitch, Member and Leader of Mintz’s Health Law practice, is quoted in this Laboratory Economics article on whether the rise in enforcement actions against clinical labs, coupled with increased focus on custom panels, could indicate more settlements later in the year.
The 2015 Chambers USA: America's Leading Lawyers for Business guide names 52 Mintz, Cohn, Ferris, Glovsky and Popeo, P.C.  attorneys as “Leaders in Their Fields.”
Seven Mintz attorneys have been named Washington, D.C. Super Lawyers for 2015 and five have been named Washington, D.C. Rising Stars. The list will be published in a special advertising supplement in Washington Post Magazine and in a stand-alone Washington D.C. Super Lawyers Magazine.
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Mintz Member and Chair of the Health Law Practice Karen S. Lovitch, Member Thomas S. Crane, and Associate Samantha P. Kingsbury co-authored a book published by the American Bar Association examining the federal Anti-Kickback Statute, one of the best-known federal fraud and abuse statutes, which prohibits transactions intended to induce or reward referrals for items or services reimbursed by the federal health care programs. The criminal statute has wide-ranging effects on business relationships in the health care, pharmaceutical, and medical device sectors.

Events

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