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.

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.

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CMS Relaxes Medicare and Medicaid Ordering Requirements for COVID-19 Testing and Finalizes Coverage of Antibody Testing

May 1, 2020 | Blog | By Karen Lovitch , Rachel Yount

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.

April 28, 2020 | Blog | By Samantha Kingsbury, Karen Lovitch

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.

March 25, 2020 | Blog | By Karen Lovitch , Jane Haviland

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.

March 24, 2020 | Blog | By Christian Tamotsu Fjeld, Joanne Hawana , Karen Lovitch , Joseph Miller

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.

March 12, 2020 | Blog

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.

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.

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.

January 30, 2020 | Blog | By Karen Lovitch , Jane Haviland

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Requestor) to provide financial assistance for travel, lodging, and other expenses to certain patients receiving a cell therapy that it offers (the Arrangement). The OIG concluded that the Arrangement could potentially violate the Anti-Kickback Statute as well as the prohibition on beneficiary inducement in the Civil Monetary Penalties Law (the Beneficiary Inducement CMP) but ultimately declined to impose administrative sanctions.

January 21, 2020 | Blog | By Brian Dunphy, Laurence Freedman, Karen Lovitch , Nicole Henry, Clare Prober

As discussed in our article recently published by Law360, 2019 brought yet another year of robust health care enforcement activity, and the False Claims Act (FCA) remains the government’s most powerful civil health care enforcement tool. This post will give an overview of our article, which covers these issues and more in great detail.

December 18, 2019 | Blog | By Karen Lovitch , Rachel Yount, Jane Haviland

As reported previously, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published two proposed rules that seek to implement wholesale changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law). This final post in our blog series focuses on a proposed new safe harbor that would protect patient engagement and support arrangements designed to improve quality, efficiency of care, and health outcomes. The OIG is also proposing modifications to the existing safe harbor for local transportation and a new safe harbor for remuneration provided in connection with certain payment and care delivery models developed by the Centers for Medicare & Medicaid Innovation Center or by the Medicare Shared Savings Program. Lastly, the OIG is codifying an existing statutory safe harbor for Accountable Care Organization (ACO) beneficiary incentives and an existing statutory exception to the Civil Monetary Penalty (CMP) rules on beneficiary inducement for telehealth technology related to in-home dialysis services.

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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 Receives High Rankings in the 2024 Edition of Legal 500 United States

July 10, 2024

Chambers USA Ranks 83 Individual Attorneys and 42 Mintz Practices

June 06, 2024

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.

Mintz Attorneys Recognized as 2024 Washington DC Super Lawyers and Rising Stars

April 22, 2024

Former Lab Owners, Compliance Officer Face Prison Time Over False Claims

March 12, 2024

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.

Mintz Receives High Rankings In The 2023 Edition Of Legal 500 United States

June 09, 2023

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.

Chambers USA Ranks 39 Mintz Practices and 81 Individual Attorneys

June 01, 2023

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.

Feds Bring 18 Charges in Covid Crackdown, Lab Implicated

May 10, 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 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.

Five Mintz Attorneys Recognized as 2023 Washington, DC Super Lawyers

April 24, 2023

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.

What’s Old Is New Again: Key Compliance Issues for Clinical Laboratories

January 24, 2023

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.

One Hundred Eight Mintz Attorneys Ranked as Leaders by Best Lawyers 2023

August 18, 2022

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

Fifty-Eight Attorneys And 15 Practices Recognized As Leading by The Legal 500 US in 2022

June 08, 2022

Eighty-three Mintz Attorneys And 34 Practices Recognized in Chambers USA 2022

June 01, 2022

Six Mintz Attorneys Named 2022 Washington, DC Super Lawyers and Rising Stars

April 28, 2022

Mintz Advises Kindred Healthcare in Sale to LifePoint Health, Launching ScionHealth

December 23, 2021

Mintz served as health regulatory legal advisor to Kindred Healthcare in the recently completed sale of Kindred Healthcare to LifePoint Health, a national network of hospitals, post-acute service providers, and outpatient centers. As a result of the successful transaction, ScionHealth, a new healthcare system focused on high-quality acute and post-acute hospital solutions, was launched on December 23rd.

Healthcare Enforcement & Litigation 2022

August 27, 2021

Mintz Member and Chair of the firm’s Health Law and Health Care Enforcement Defense Practices Karen Lovitch, Member Laurence Freedman, Of Counsel Samantha Kingsbury, and Associates Grady Campion and Caitlin Hill co-authored the Global Overview and corresponding United States chapter of the seventh edition of Lexology’s Healthcare Enforcement & Litigation 2022. Together these pieces outlined federal enforcement priorities in 2020, including matters involving opioids, COVID-19-related fraud, Medicare, and more, and look ahead to how health care enforcement is expected to evolve in the coming year.

One Hundred Six Mintz Attorneys Ranked as Leaders by Best Lawyers 2022

August 19, 2021

Legal 500 United States 2021 Recognizes 14 Practices and 50 Attorneys at Mintz

June 15, 2021

Mintz Advises Myriad Genetics in Sale of Pharmaceutical Research Services Business, Myriad RBM, to Q2 Solutions

May 25, 2021

Sixty-Nine Mintz Attorneys and 19 Practices Recognized by Chambers USA 2021

May 20, 2021

Nine Mintz Attorneys Selected to the 2021 Washington, D.C. Super Lawyers and Rising Stars Lists

April 27, 2021

How New Kickback Rules Benefit Health Care Industry: Part 1

December 18, 2020

Mintz Member and Chair of the firm’s Health Law Practice Karen S. Lovitch and Associate Rachel E. Yount co-authored a two-part Law360 expert analysis series that examined key provisions of the U.S. Department of Health and Human Services’ final rules amending the regulations implementing the Anti-Kickback Statute (AKS), the Physician Self-Referral Law — commonly known as the Stark Law — and the civil monetary penalty rules regarding beneficiary inducements, and provided practical examples of how the industry can take advantage of these significant changes.

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 Member and Co-chair of the firm’s Health Law Practice Karen Lovitch was quoted in an article published by The Dark Intelligence Group on developments related to the Centers for Medicare & Medicaid Services (CMS)’s proposed 2021 Physician Fee Schedule (PFS) rule.

One Hundred Ten Mintz Attorneys Ranked as Leaders by Best Lawyers 2021

August 20, 2020|

Mintz Practice Groups and Attorneys Garner Top Rankings in 2020 Edition of The Legal 500 United States

June 12, 2020

In the latest guide, Mintz garnered rankings as a top national firm in eight practice areas, and 32 firm attorneys were individually recognized.

Mintz Attorneys and Practices Recognized by Chambers USA 2020

April 24, 2020

TPG Invests in Behavioral Health Firm LifeStance

April 20, 2020

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.

Mintz Advises TPG Capital to Support LifeStance Health Company Growth

April 17, 2020

Ten Mintz Attorneys Honored as 2020 Washington, D.C. Super Lawyers and Rising Stars

April 16, 2020

2019 Trends In DOJ Civil Health Care Fraud Cases

January 15, 2020

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.

Hospitals’ Risk May Rise as Anti-Fraud Proposal Narrows Loophole

October 25, 2019

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.

Mintz Practice Groups and Attorneys Earn Strong Rankings in The Legal 500 U.S. 2019

June 11, 2019

Mintz Recognized by Chambers USA 2019

April 26, 2019

Thirteen Mintz Attorneys Named Washington, D.C. Super Lawyers and Rising Stars

April 23, 2019

Antiopioid Law Could Criminalize Sales Commissions for Clinical Lab Patient Referrals

April 18, 2019

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.

AHLA Health Care Compliance Legal Issues Manual

March 5, 2019

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.

Mintz Attorneys and Practices Recognized By 2018 Legal 500 Guide

July 03, 2018

Chambers USA 2018 Ranks Mintz Attorneys & Practices

May 03, 2018

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.

Eleven Mintz Attorneys Named Washington, D.C. Super Lawyers and Rising Stars

April 24, 2018

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.

Mintz Advising Consortium in $1.4 Billion Acquisition of Curo Health Services

April 24, 2018

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.

Private Equity FCA Suit More Likely Outlier Than Omen

March 16, 2018

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.

Laboratory Economics' PAMA Teleconference Highlights

February 19, 2018

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.

2017 Health Care Enforcement Review: Final Thoughts

January 19, 2018

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.

Mintz Advising Consortium in $4+ Billion Acquisition of Kindred Healthcare

December 21, 2017

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.

Labs Wage Legal Fights Over Fees, Medical Necessity Checks

November 14, 2017

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.

Leader of Mintz Health Law Practice Karen Lovitch to Speak at 2017 G2 Intelligence Lab Institute Conference

October 11, 2017

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’s Health Law Practice Recognized Among Industry Leaders in Annual BTI Power Rankings

August 17, 2017

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.

Mintz Attorneys and Practice Areas Recognized By 2017 Legal 500 Guide

August 17, 2017

Twelve Mintz Attorneys Named 2017 Washington, D.C. Super Lawyers and Rising Stars

April 24, 2017

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.

New Safe Harbor Allows Labs to Provide Patient Transport

February 28, 2017

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.

Health Care Enforcement Review And 2017 Outlook: Part 4

January 19, 2017

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.

Health Care Enforcement Review And 2017 Outlook: Part 3

January 18, 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.

Health Care Enforcement Review And 2017 Outlook: Part 2

January 17, 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.

Mintz Attorney Karen S. Lovitch to Speak at 2016 G2 Intelligence Lab Institute

October 19, 2016

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.

Lesson from RML's $1.1 Million Settlement: Beware of Carve-Outs and Pull-Through Arrangements

October 18, 2016

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.

Mintz Represents Myriad Genetics in Acquisition of Assurex Health

September 08, 2016

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.

CMS Regulations Overhaul Medicare Clinical Laboratory Fee Schedule

July 21, 2016

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.

CMS finalizes lab fee schedule changes: 5 key takeaways

June 21, 2016

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.

Twenty-Two Mintz Attorneys and Seven Practice Areas Featured in 2016 Legal 500 United States Guide

June 15, 2016

49 Mintz Attorneys Featured in Chambers USA 2016 Guide

May 31, 2016

Firm’s National Healthcare Practice, NY Corporate/M&A and Litigation: General Commercial Among Newest Rankings

Uptick in Lab Enforcement; Custom Panels Under Increased Scrutiny

April 1, 2016

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.

Mintz Attorney Karen S. Lovitch to Speak at American Clinical Laboratory Association Annual Meeting

March 02, 2016

Mintz Attorneys Karen S. Lovitch and Dionne Lomax to Speak at G2 Intelligence’s 33rd Annual Lab Institute 2015

October 12, 2015

Mintz Attorney Karen S. Lovitch to Present at American Health Lawyers Association’s Fraud and Compliance Forum

September 18, 2015

Fifty-Two Mintz Attorneys Featured in Chambers USA 2015 Guide

May 19, 2015

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.”

Twelve Mintz Attorneys Named Washington, D.C. Super Lawyers and Rising Stars

April 17, 2015

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.

Mintz Attorney Karen Lovitch to Present Health Care Compliance Association Webinar on Laboratory Compliance

April 07, 2015

Mintz Supports Senior Executive Women in Health Care as Sponsor of Women Business Leaders’ 14th Annual Summit

March 16, 2015

What Is The Anti-Kickback Statute?

January 1, 2015

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.

Mintz Ranked Among Top Ten Largest Health Care Law Firms by Modern Healthcare

July 02, 2014

Fifty-One Mintz Attorneys Featured in Chambers USA 2014 Guide

May 23, 2014

Mintz Supports Senior Executive Women in Health Care as Sponsor of Women Business Leaders’ 13th Annual Summit

March 12, 2014

Mintz Bolsters Health Care Enforcement Defense Capabilities With Addition of Former Senior DOJ Official

January 06, 2014

Mintz Attorney Karen S. Lovitch to Speak on Inclusive Leadership Panel Presented by West Virginia University’s Eberly College of Arts and Sciences

October 24, 2013

Mintz Ranked in the Top Ten Largest Healthcare Law Firms by Modern Healthcare

Current Trends in State Health Care Transaction Review and What to Expect in 2024

Virtual Webinar

Speaker

Nov

2022

Health Care Fraud Enforcement Developments and Whistleblower Avoidance

G2 Lab Institute: Advancing the Profession of Diagnostic Medicine

Virtual Event

Speaker

Oct

2022

Can We Do This? Avoiding Marketing and Business Development Compliance Pitfalls

REDC Member Meeting

InterContinental Minneapolis

Panelist

Apr

2022

2022 Executive War College

The Dark Intelligence Group

Speaker

Feb

2022

Health Care Enforcement Year in Review & 2022 Outlook

Mintz

Online Event

Speaker

Dec

2021

Telehealth Regulation & Enforcement: 2021 Year in Review & 2022 Outlook

2021

Health Care Enforcement Year in Review & 2021 Outlook

Mintz

Webinar

Speaker

2019

Unpacking HHS’s Proposed Changes to Anti-Kickback Statute and Stark Law

Panelist

Apr

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

Jan

Jan

2017

Health Care Enforcement Review & 2017 Outlook

Webinar

Oct

2016

G2 Intelligence Lab Institute

Washington, DC

Panelist

Mar

2016

ACLA 2016 Annual Meeting

American Clinical Laboratory Association

Washington, DC

Panelist

Oct

2015

33rd Annual Lab Institute

G2 Intelligence

Hyatt Regency Washington on Capitol Hill, Washington, DC

Speaker

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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)

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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

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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

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Healthcare’s AI Deal Advantage

October 21, 2024

Off-Cycle Nursing Facility Revalidations Are Starting: Is Your SNF Ready for the Required Disclosures?

October 15, 2024| Blog|

DOJ Reinforces Emphasis on Voluntary Self-Disclosure With Latest Updates to the Evaluation of Corporate Compliance Programs Guidance

October 7, 2024|

Karen S. Lovitch
(she/her/hers)

Chair, Health Law Practice & Chair, Health Care Enforcement Defense Practice

Washington, DC

Experience

Transactions

Investigations

viewpoints

May 1, 2020 | Blog | By Karen Lovitch , Rachel Yount

April 28, 2020 | Blog | By Samantha Kingsbury, Karen Lovitch

March 25, 2020 | Blog | By Karen Lovitch , Jane Haviland

March 24, 2020 | Blog | By Christian Tamotsu Fjeld, Joanne Hawana , Karen Lovitch , Joseph Miller

March 12, 2020 | Blog

February 10, 2020 | Video | By Karen Lovitch

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

January 30, 2020 | Blog | By Karen Lovitch , Jane Haviland

January 21, 2020 | Blog | By Brian Dunphy, Laurence Freedman, Karen Lovitch , Nicole Henry, Clare Prober

December 18, 2019 | Blog | By Karen Lovitch , Rachel Yount, Jane Haviland

News & Press

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