Kathleen McDermott

Email: kmcdermott@morganlewis.com

Washington, D.C.
1111 Pennsylvania Ave., NW
Washington, DC 20004-2541
Phone: 202.739.5458
Fax: 202.739.3001

education

Suffolk University Law School, 1986, J.D., Cum Laude

Wright State University, 1982, B.A., With Honors

Publications

Date	Title	Publication
01/26/1201/26/12	Transparency Compliance Webinar View Presentation	Webinar
01/25/1201/25/12	2011 American Health Lawyer’s Association Annual Meeting View Presentation	Speech
12/21/1112/21/11	CMS Issues Transparency Reporting Proposed Rule View LawFlash	Life Sciences and Healthcare LawFlash
11/21/112011	Seminal Fraud, Program Integrity and Transparency Provisions Complement the PPACA Reform Provisions (Chapter 5, co-author), Health Care Rulemaking Guide, Administrative Rules Implementing New Healthcare Laws (2011-2012 edition, West Publication)	Chapter
06/29/1106/29/11	The Compliance Revolution Will Be Televised: OIG Videos Offer Practical Compliance Pointers, BNA's Health Law Reporter View Article	Article
06/21/1106/21/11	False Claims Act and Qui Tam Update: The Times They Are a-Changin' View Presentation	Webinar
06/08/1106/08/11	Transparency Update: Vermont Revises Disclosure Form and Seeks Comment on 2011 Draft Consolidated Disclosure Guide View LawFlash	FDA and Healthcare LawFlash
06/07/1106/07/11	The Compliance Revolution Will Be Televised: As Government Turns Up Heat on Healthcare Fraud, OIG Videos Offer Practical Compliance Pointers View LawFlash	FDA and Healthcare LawFlash
05/24/1105/24/11	Medicare ACOs: Details From the Fraud and Abuse Perspective (an American Health Lawyers Association webinar) View Presentation	Webinar
05/17/1105/17/11	U.S. Supreme Court Resolves Circuit Split: FCA Relators Cannot Base Claims on Information Received Through FOIA Requests View LawFlash	Litigation LawFlash
06/10/1006/10/10	Government, Industry, and Health Profession Compliance Guidance: Welcome to the Era of Ethics and Transparency, presented at Seton Hall Law School's Healthcare Compliance Certification Program, Newark, NJ View Presentation	Speech
05/01/10May 2010	New Healthcare Fraud and Abuse and Program Integrity Provisions: Let’s Fasten Our Seat Belts for the Bumpy Ride, AHLA Connections View Article	Article
03/31/1003/31/10	Healthcare Reform Law: Healthcare Fraud and Abuse and Program Integrity Provisions View LawFlash	Washington Government Relations and Public Policy LawFlash
03/30/1003/30/10	False Claims Act Qui Tam Defense: Employment Releases Not Presumptively Void for Public Policy under the False Claims Act View LawFlash	FDA and Healthcare LawFlash
03/29/1003/29/10	Healthcare Reform Law Delivers New Transparency Requirements for the Health Industry View LawFlash	Washington Government Relations and Public Policy LawFlash
03/12/1003/12/10	Developments in the Evolving Orthopaedic Surgeon - Industry Relationship, presented at the American Academy of Orthopaedic Surgeons 2010 Annual Meeting, New Orleans, LA View Presentation	Speech
03/10/1003/10/10	Off-Label Device Use: When Clinical Need Outpaces Regulatory Approval The Legal Parameters of Off-Label Use, presented at the American Academy of Orthopaedic Surgeons 2010 Annual Meeting, New Orleans, LA View Presentation	Speech
01/13/1001/13/10	Medical Record Confidentiality and Litigation: The Process for Lawfully Obtaining Information, presented at a Maryland State Bar Association Litigation And Criminal Section Councils Program, Columbia, MD View Presentation	Speech
01/08/1001/08/10	What is in Store for Orthopaedic Surgeons? Healthcare Policy and DOJ Update View Presentation	Speech
11/17/0911/17/09	Industry Representatives in the Operating Room: New Scrutiny and Expectations, presented at an AdvaMed Teleconference	Speech
11/10/0911/10/09	False Claims Act Amendments Under FERA and DOJ Enforcement Initiatives: How New Provisions Will Impact Device Industry Compliance, presented at an AdvaMed Teleconference	Speech
11/05/0911/05/09	How Current DOJ, OIG, and Whistleblower Suits Impact Promotional Activities - An Update and Forecast, presented at an AdvaMed Conference, Washington, D.C.	Speech
10/29/0910/29/09	False Claims Act Enforcement for the Health Industry—The FERA Game Changer for Compliance and Enforcement, presented at AHLA's False Claims Act Enforcement for the Health Industry Teleconference	Speech
10/26/0910/26/09	Understanding Industry Guidance(s), presented at Seton Hall's Healthcare Compliance Certification Program, New Brunswick, NJ	Speech
10/13/0910/13/09	Beyond FDA Enforcement Against FDA Regulated companies: Other Enforcement Concerns, presented at FDLI's Enforcement and Litigation Conference: Enforcement in a Post-Wyeth, New Administration World, Washington, D.C.	Speech
10/03/0910/03/09	Breach of Notification and Reporting, presented at the 81st AHIMA Annual Convention and Exhibit, Grapevine, TX	Speech
07/14/0907/14/09	Important Amendments Under the Fraud Enforcement & Recovery Act of 2009, presented as an ALI-ABA Webcast	Speech
07/09/0907/09/09	Department of Justice and Sports Medicine: Are We Immune?, presented at the AOSSM: 2009 Annual Meeting, Keystone, CO	Speech
06/25/0906/25/09	The Fraud Enforcement and Recovery Act of 2009: A New Day has Dawned for the False Claims Act Webinar View Presentation	Webinar
06/23/0906/23/09	Supreme Court to Resolve the Scope of the FCA’s Jurisdictional “Public Disclosure Bar” View LawFlash	Litigation LawFlash
06/17/0906/17/09	False Claims Act Amendments and New Anti-Fraud Provisions: Important Changes to Know About, presented an American Health Lawyers Association Webcast	Speech
06/10/0906/10/09	Understanding Industry Guidance(s), presented at the Seton Hall Health Care Compliance Certification Program, Newark, NJ	Speech
05/27/0905/27/09	Medical Device Counterfeiting: IP, Regulatory and Compliance Implications, presented at the AdvaMed 2009 International Medical Device Industry Compliance, Regulatory and IP Conference, Rome, Italy	Speech
05/09/0905/09/09	Compliance: Focus on Drug Enforcement Agency (DEA) Issues in Long-Term Care, presented at the American Society of Consultant Pharmacists Midyear Educational Session, Orlando, FL	Speech
05/07/0905/07/09	Remediation, Special Monitors, and Settling with the Government, presented at the National Institute on Internal Corporate Investigations and In-House Counsel 2009, Washington, D.C.	Speech
04/29/0904/29/09	Compliance and Enforcement Update, presented at the 2009 AAOS National Orthopaedic Leadership Conference, Washington, D.C.	Speech
03/24/0903/24/09	Lessons of Eli Lilly’s $1.4 Billion Off Label Zyprexa Settlement, presented at the National Pharma Audioconference	Speech
03/05/0903/05/09	AKS and Industry Guidance, presented at the Seton Hall Health Care Compliance Certification Program, Newark, NJ	Speech
03/05/0903/05/09	Multi-Jurisdictional Qui Tam Practice, presented at the ABA 23rd Annual National Institute on White Collar Crime, San Francisco	Speech
02/27/0902/27/09	Developments in the Evolving Orthopaedic Surgeon: Industry Relationship, presented at the AAOS 2009 Annual Meeting Instructional Course and Symposium, Las Vegas, NV	Speech
01/22/0901/22/09	Industry, Hospital and Physician Codes of Ethic and Financial Conflict of Interest Policies—How to Navigate Collaborations in a New and Evolving Compliance Era, presented at the AHLA Teleconference	Speech
01/01/082008	Stark Marches On: The 2009 IPPS Final Rule (co-author), a Member Briefing published by the American Health Lawyers Association's Fraud and Abuse Practice Group	Article
01/01/072007	Pharmaceutical Law: Regulation of Research, Development, and Marketing (co-author), Chapter 8: Federal Sentencing Guidelines and Compliance Measures, BNA and ABA Health Law Section	Article
06/01/04June 2004	Compliance Perspectives: Laboratory Compliance Hot Button Issues, Washington G2 Compliance Reports	Article
01/01/04January 2004	Physicians, Institutions and Pharma Relationships, APA Matrix	Article
08/01/03August 2003	OIG and Industry Pharma Guidance: How it Changes Compliance Advice, American Health Lawyers	Article
04/01/02April 2002	TAP Pharmaceuticals: “Mercy, Mercy, Me – Things Ain’t What They Used To Be…” American Health Lawyers	Article
07/01/01July 2001	Voluntary Disclosures: Telling All to the Government Brings Legal and Practical Challenges, Journal of Health Care Compliance	Article
02/01/01February 2001	Fraud and Abuse Due Diligence in Health Care Transactions, Group Practice Journal	Article
10/01/00October 2000	Compliance and Enforcement for Physician Practices, Washington G2 Compliance Report	Article
10/01/99Fall 1999	Government Enforcement Initiatives Caution Compliance Awareness in Pharmacy Industry, Update, Pharmaceutical Distribution and Marketing Audits, Inc., Vol. 6B	Article
10/01/97October 1997	Qui Tam: An AUSA's Perspective, 11 False Claims Act and Qui Tam Quarterly 9	Article

Date	Title	Description
Apr 28, 2009	Morgan Lewis Adds Attorneys to Its Healthcare Group	Following the addition earlier this month of six healthcare partners on the East and West Coasts, Morgan Lewis today announced another seven attorneys have joined the firm, doubling the size of its FDA & Healthcare Practice.
Apr 03, 2009	Morgan Lewis Broadens Life Sciences Capabilities with Healthcare Group	Solidifying its position as a full-service legal resource for the life sciences industry, Morgan Lewis today announced the addition of six healthcare partners to its FDA/Healthcare Regulation Practice.

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Kathleen McDermott

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