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 and Health Care Enforcement Defense Practices and is a former 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.
- American University (JD, magna cum laude)
- West Virginia University (BA, summa cum laude)
- 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.
- 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.
- 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 – 2021)
- Recognized by The Legal 500 United States for Healthcare: Service Providers (2014 – 2021)
- Phi Beta Kappa
- Best Lawyers in America: Health Care Law (2021-2022)
- 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
News & Press
Five Takeaways from DOJ’s Latest National Enforcement Action, Including Continued Focus on Opioids and Telemedicine
September 27, 2021 | Blog | By Sarah Beth Kuyers, Brian Dunphy, Karen Lovitch
July 29, 2021 | Blog | By Karen Lovitch, Rachel Yount
To the contrary, the Stark Law actually permits directed referral requirements, provided that certain conditions are met. CMS recently enacted changes to the Stark Law regulations, effective January 19, 2021, that provide additional clarity on how health care providers can permissibly use directed referral requirements. These recent changes have seemingly triggered new awareness and interest in how health care systems can utilize directed referral requirements to combat patient leakage.
June 1, 2021 | Blog | By Jane Haviland, Samantha Kingsbury, Karen Lovitch
March 31, 2021 | Blog | By Grady Campion, Jane Haviland, Karen Lovitch
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
February 24, 2021 | | By Eoin Beirne, Brian Dunphy, Hope Foster, Karen Lovitch
February 18, 2021 | | By Eoin Beirne, Brian Dunphy, Karen Lovitch, Kevin McGinty, Samantha Kingsbury, Keshav Ahuja, Grady Campion, Jane Haviland, Caitie Hill, Rebecca Zeidel
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
HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part VI: Changes to Fundamental Stark Law Terminology
February 8, 2021 | Blog | By Karen Lovitch, Rachel Yount
HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part V: Cybersecurity Technology and Electronic Health Records
February 4, 2021 | Blog | By Karen Lovitch, Rachel Yount
In this fifth installment of our blog series covering the changes, we dive into (i) the new AKS safe harbor and Stark Law exception for cybersecurity technology and related services, and (ii) the significant changes to the existing safe harbor and exception for electronic health records (EHR) technology.