Kaitlyn L. Dunn

Profile

Kaitlyn Dunn is a Manatt Health counsel in the firm’s Boston office. She focuses her practice on health care fraud and abuse, regulatory compliance, government investigations, and strategic transactional matters. Katie works with a diverse array of clients, ranging from hospitals and health systems, physician practices, post-acute care providers, clinical laboratories, and pharmacies to pharmaceutical, medical device, and other life sciences companies.

Katie assists clients in navigating the complex health care regulatory environment, including with respect to Medicare and Medicaid billing and reimbursement-related issues; licensure and payor enrollment requirements; and development and implementation of arrangements to comply with the Anti-Kickback Statute (AKS), Stark Law, and other fraud and abuse authorities. Katie also provides regulatory support in connection with health care mergers, acquisitions, private equity transactions, and joint venture arrangements. Finally, Katie aids health care providers and life sciences companies in efficiently and effectively responding to civil, criminal, and administrative enforcement actions, including False Claims Act (FCA) matters and third-party payor audits.

Prior to entering private practice, Katie served as an associate counsel with the Office of Inspector General for the U.S. Department of Health & Human Services (OIG). In that capacity, Katie functioned as Team Leader for the New York, Chicago, and Kansas City regions, and worked closely with the Department of Justice to litigate and resolve dozens of FCA cases involving alleged violations of the AKS, Stark Law, and Medicare and Medicaid payment rules. While with OIG, Katie was instrumental in the negotiation of multiple novel Corporate Integrity Agreements and assisted in the formulation of new guidance on the OIG’s exercise of its permissive exclusion authorities. Katie received an Inspector General’s Award for Excellence in Fighting Fraud, Waste, and Abuse during her tenure with OIG.

Experience

Served as legal and regulatory counsel to InTandem Capital Partners, a health care services-focused private equity firm, in its formation of Vivo Infusion, a leading ambulatory infusion services provider, through the recapitalization and combination of two infusion centers.

Represented large non-profit health system in complex internal investigation of contractual arrangements with certain cardiology groups that implicated the Stark and Anti-Kickback laws. Representation resulted in a voluntary disclosure to, and favorable settlement with, the Office of Counsel to the Inspector General.

Represented large non-profit health system in dissolution of professional services agreement with independent specialty physician practice and then subsequent conversion of this physician practice to employment model with health system.

Represented prestigious pediatric hospital in complex investigation involving Stark law compliance with several independent physician practices. Representation included disclosure to the Centers for Medicare and Medicaid under its Self-Referral Disclosure Protocol.

Speaking Engagements

Speaker, “Effective Compliance and Due Diligence,” Healthcare Enforcement Compliance Conference, Health Care Compliance Association, November 8, 2022.

Presenter, “Implications of OIG’s Proposed Rule on Prescription Drug Safe Harbors,” American Health Lawyers Association Fraud and Abuse Education Call, April 2019.

Co-presenter, “The Art of Self Disclosure: When, Where, How,” 28th Annual Tennessee Bar Association Health Law Forum, October 2016.

Co-presenter, “Self-Disclosure: Why, When, Where, and How,” Annual American Bar Association Health Law Summit, December 2015.

Co-presenter, “Physician Compliance Program Fundamentals,” American Bar Association CLE Webinar, December 2014.

Publications

Co-author, “Off-Label Marketing of Pharmaceutical Products in the Wake of United States v. Caronia and United States v. Harkonen,” 9 J. Health & Biomed. L. 385, April 2019.

Co-author, “Prescription Data Mining, Medical Privacy and the First Amendment: The U.S. Supreme Court in Sorrell v. IMS Health Inc.,” 21 Annals Health L. 447, 2012.

09.20.22

Manatt Serves as Regulatory Counsel to Vivo Infusion in Acquisition ...

A team led by Manatt Health Partner Brian Bewley and including Counsel Katie Dunn and Associates Michael Herrmann, Krusheeta Patel and Marisa ...
08.18.22

14 Manatt Attorneys Named to Best Lawyers’ “Ones to Watch” List

Fourteen Manatt professionals were named to Best Lawyers in America ’s 2023 “Ones to Watch” list, which recognizes ...
04.07.22

Manatt Advises InTandem Capital Partners on Formation of Infusion ...

Manatt Health provided legal and regulatory counsel to InTandem Capital Partners in its formation of Vivo Infusion through the recapitalization and...
01.03.22

Manatt Announces the Advancement of 14 Professionals Across Various ...

Manatt, Phelps & Phillips, LLP, a multidisciplinary, integrated professional services firm, announced today the advancement of 14 professionals, ...

05.21.21

HHS Advisory Highlights Need For Anti-Kickback Law Update

Manatt Health Partner Brian Bewley and Associate Kaitlyn Dunn co-authored an article for Law360 analyzing the U.S. Department of Health and ...

01.09.23

OIG Advisory Opinion Offers a Cautionary Tale on Utilization of ...

On December 19, 2022, the Office of Inspector General of the U.S. Department of Health & Human Services issued an advisory opinion blessing the ...
08.11.22

New DOJ and OIG Actions Warn the Telemedicine Industry About Suspect ...

On July 20, the U.S. Department of Health and Human Services Office of the Inspector General issued a new Special Fraud Alert on practitioner ...
07.21.22

EMTALA v. State Abortion Laws: Navigating the Legal Uncertainties of ...

In the wake of the Supreme Court’s decision overturning Roe v. Wade, the Centers for Medicare & Medicaid Services issued guidance to health ...
04.28.22

OIG Advisory Opinion Recognizes Legitimacy of Certain Physician-Owned ...

After years of government skepticism and enforcement activity targeting physician-owned medical device companies, a recent favorable advisory opinion ...

11.09.22

Bewley and Dunn to Speak at HCCA’s Healthcare Enforcement Compliance ...

Manatt Health Partner Brian Bewley and Counsel Katie Dunn will speak at the annual Healthcare Enforcement Compliance Conference hosted by the ...

02.23.22

Prepare for More Health Care Investigations: A Primer on Navigating ...

In FY 2020, the Department of Justice opened 1,079 new civil health care fraud investigations and had 1,498 civil health care fraud matters ...

03.23.21

What’s Past Is Present: Key Regulatory Trends Impacting Health ...

From Pricing to Compliance to Coordinated Care, a Wide Range of Critical Areas Saw Regulatory Changes in 2020 That Will Impact the Health Care and ...

Kaitlyn L. Dunn

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