Demetrios L. Kouzoukas

Demetrios L. Kouzoukas is of counsel in the firm's Washington, DC office and a member of the Health Care, Food & Drug, and Election & Political Law Practice groups.

Most recently, Mr. Kouzoukas served as Principal Associate Deputy Secretary of the U.S. Department of Health and Human Services (HHS). In that role, he was responsible for regulatory policy across HHS, with particular emphasis on Medicare & Medicaid reimbursement, food and drug regulation, and health information technology. Mr. Kouzoukas oversaw the programs and operations of the Centers for Medicare and Medicaid Services, Food and Drug Administration, Office of Inspector General, Departmental Appeals Board, Office of Medicare Hearings and Appeals, Office of the National Coordinator for Health Information Technology, Office for Civil Rights, Health Resources and Services Administration, and several other HHS agencies.

During Mr. Kouzoukas tenure at HHS, he also served as Deputy General Counsel. In that role, he helped lead a 400+ attorney nationwide law office and was responsible for legal advice across the Department with respect to public health law issues, including legal advice to the Agency for Healthcare Research and Quality, National Institutes of Health, Health Resources and Services Administration, Centers for Disease Control and Prevention, and Office of Public Health and Science.

While at HHS, Mr. Kouzoukas also advised senior officials throughout HHS regarding procurement and grants law, appropriations law, information law such as the Freedom of Information Act and Privacy Act, public-private partnerships, and human services law relating to programs of the Administration for Children and Families.

In addition, Mr. Kouzoukas was responsible for overseeing HHS's government ethics compliance function, and he has extensive experience with respect to government ethics rules governing procurement, financial and other conflicts of interest, and gifts. He was extensively involved in the process of vetting political appointees.

Prior to serving in government, Mr. Kouzoukas represented and counseled health care providers and manufacturers with respect to federal and state health care program compliance, reimbursement, fraud and abuse, and privacy issues.

Mr. Kouzoukas has donated time to several federal, state, and local political campaigns. He is a self-avowed political buff and amateur pundit. Mr. Kouzoukas and his wife reside in Virginia and are the proud parents of two children.

Publications

· "Comparative Effectiveness," AdvaMed's Medical Device Reimbursement Workshop (2/29/2012)

· "Parallel Review: Not for Everyone, Useful for Some, and Additional Considerations for Improvement," American Health Lawyers Association Life Sciences Practice Group Member Briefing (December 2011), Author

· "Coverage and Reimbursement for Life Sciences Products - Recommendations from the MEDCAC," Bloomberg Health Law Report (September 2011), Co-Author

· "Coverage and Reimbursement Considerations for In Vitro Diagnostics," Bloomberg Health Law Report (June 2011), Co-Author

· "Coverage and Reimbursement of Laboratory Tests," In Vitro Diagnostics: The Complete Regulatory Guide (Chapter (9) with permission from FDLI ) (2010), Author

· "Legal Preparedness for Obesity Prevention and Control: The Structural Framework and the Role of Government," The Journal of Law, Medicine, and Ethics (Summer 2009), Author

· "Public Health Emergency Legal Preparedness: Legal Practitioner Perspectives," Journal of Law, Medicine & Ethics (Spring 2008), Author

· "Rx Reimportation: A Legislative History," Health Care News (November 2002), Author

· "HIPAA's Impact on Sites: Questions & Answers," Clinical Trials Advisor (May 2002), Author

· "HIPAA's Privacy Rule on Research: Insight into the Tension between Privacy and the Value of Knowledge," Topics in Health Information Management (May 2002), Author

· "Politics, Law Delay Drug Discount Card," Health Care News (January 2002), Author

· "Lupron And You: How To Avoid Compliance Problems In Your Relationships With Pharmaceutical Companies," BNA's Health Law Reporter (6/7/2001), Co-Author

· "Congress Passes FUTA Provision: Planning and Implementation Issues for Tribal Employees," Native American Law Digest (March 2001), Co-Author

Presentations and Speeches

· "Comparative Effectiveness Research Developments and the Effect on Payers," CBI's 4th Annual Forum for Payers on Personalized Medicine (3/12/2012)

· "Comparative Effectiveness Research & The Future For Device Clinical Research," Q1 6th Annual Medical Device Clinical Research Conference (3/12/2012)

· "Developing and Implementing a Robust Compliance Program For Medicare Managed Care Plans," American Conference Institute Preventing Fraud, Abuse and Waste in Medicare Advantage & Medicare Prescription Drug Plans (1/30/2012)

· "Assumption or Denial of Liability in Clinical Trials: Regulatory, Liability and Reimbursement Issues," American Health Lawyers Association Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions (1/27/2012)

· "Reimbursement: A Critical Component of Valuation," Biotech Showcase 2012 (1/9/2012)

· "Success in the Marketplace for your Product: Current and Emerging Coverage and Reimbursement Considerations," Health Plans and PBM's Efficient Program Planning Session (12/12/2011)

· "Delivery System Reform: Legal And Strategic Considerations in Developing ACOS," AdvaMed 2011 (9/28/2011)

· "Molecular Diagnostic Reimbursement: What Does The Future Hold," AdvaMed 2011 (9/27/2011)

· "Opening Remarks" and "State Medicaid Programs and Their Relationship to the Federal Rebate System," American Conference Institute's Rx Drug Pricing Boot Camp (6/22/2011-6/23/2011)

· "How Coverage and Reimbursement Considerations Can Shape R&D and Marketing Strategies," New York Biotechnology Association 2011 Annual Meeting (4/7/2011)

· "What to Do When (and Before) Congress Comes Knocking: The Law and Politics of Congressional Oversight," American Health Lawyers Association Webinar (3/15/2011)

· "Notions of Health Privacy as a Function of Technology, Law and Policy," International Association of Privacy Professionals Global Privacy Summit (3/11/2011)

· "Looking at the Consequences of Comparative Effectiveness Research and the Device Industry," Q1 Medical Device Clinical Research & Reimbursement Conference (3/8/2011)

· "Managed Care: The Boy Scout's Guide to Reimbursement - Be Prepared," 13th Annual Biotechnology Industry Organization CEO & Investor Conference (2/14/2011)

· "Comparative Effectiveness and the Relationship between Cost and Coverage: What It Is and Why it Matters to the Healthcare and Life Sciences Lawyer," American Health Lawyers Association Legal and Compliance Issues in Biomedical Innovation (1/26/2011)

· "Getting Paid: Strategic Insights on Coverage and Reimbursement," Biotech Showcase 2011 (1/12/2011)

· "Comparative Effectiveness Research Developments," American Bar Association Washington Healthcare Summit (12/7/2010)

· "Comparative Effectiveness," AdvaMed Medical Technology Reimbursement Professionals Workshop (11/10/2010)

· "Congressional Oversight of the U.S. Department of Health & Human Services," Food and Drug Law Institute Update Magazine Luncheon (10/22/2010)

· "Reimbursement and Medical Technology" and "Fraud and Abuse," FDA and AdvaMed Essentials of Medical Device Regulations: A Primer for Manufacturers and Suppliers Conference (9/15/2010)

· "Positioning Your Product for Market Success," Silicon Valley Bank Session on Positioning Your Product for Market Success (7/27/2010)

· "Reimbursement and Medical Technology" and "Fraud and Abuse," FDA and AdvaMed Essentials of Medical Device Regulations: A Primer for Manufacturers and Suppliers Conference (7/14/2010)

· "Reimbursement and Medical Technology," FDA and AdvaMed Essentials of Medical Device Regulations: A Primer for Manufacturers and Suppliers Conference (6/30/2010)

· "Health Care Reform: What Life Sciences Companies Need to Know," Practising Law Institute Audio Webcast (6/25/2010)

· "Payment and Reimbursement From the Perspectives of Both Private and Public Payors," American Conference Institute In-House Counsel Forum on Medical Device Pricing & Reimbursement (6/16/2010)

· "Device Pricing and Reimbursement Boot Camp: A Primer on the Present and Evolving Landscape of Reimbursement, Coverage, Pricing, and Payment," American Conference Institute In-House Counsel Forum on Medical Device Pricing & Reimbursement (6/14/2010)

· "Medicare Part D Donut Hole Discount Program Agreement and Administration," Center for Business Intelligence 12th Annual Medicaid Rebates Seminar (5/12/2010)

· "The FDA of the Future," 2010 Food & Drug Law Institute Annual Conference (4/23/2010)

· "Negotiating Contract Provisions with Research Sites to Protect Research Participants: The Sponsor's Perspective," Association for the Accreditation of Human Research Protection Programs Annual Meeting (4/14/2010)

· "Bracing for Health Care Reform - Analyzing the Legislation That Will Impact Manufacturers, Plans, PBMs and Pharmacies," American Conference Institute 8th Annual Advanced Forum on Government Regulation of Prescription Drug Pricing (3/18/2010)

· "Cost-Effectiveness," Advamed Medical Technology Reimbursement Professionals Workshop (2/16/2010)

· "Current and Emerging Health Care Regulatory Policy Issues for Life Sciences Companies," Centers for Business Intelligence 9th Annual Strategic Medicare Policy Summit Conference (2/12/2010)

· "Perspectives on FDA and HHS - Including Practical Take Away Tips on Dealing With These Agencies," Association of Corporate Counsel, San Diego Chapter (2/4/2010)

· "Distinction without a Difference? Quality Improvement vs. Research," American Health Lawyers Association Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions (1/21/2010)

· "Conference Chair Opening Remarks," American Conference Institute Rx Drug Pricing Boot Camp (11/12/2009)

· "Comparative Effectiveness Research as a Tool of Healthcare Reform," American Bar Association Health Law Section Washington Healthcare Summit (10/26/2009)

· "Perspectives From Within FDA and HHS," Covington and Burling LLP (10/21/2009)

· "The Value and Challenges of Device Registries," AdvaMed 2009 (10/13/2009)

· "Taste vs. Recipe: Potential Discrepancies Between Legal Requirements, Operational Mechanics, and Implementation Practicalities," Drug Information Association 3rd Annual Clinical Trial Disclosure Workshop - Recipes for Success (10/8/2009)

· "Complying With Clinical Trial Payment Related Disclosure Regulations," American Conference Institute Physician Payments Disclosure & Aggregate Spend (9/30/2009)

· "Cost-Effectiveness," AdvaMed Medical Technology Reimbursement Professionals Workshop (9/23/2009)

· "Mock Quarantine Hearing and Motion for Writ of Mandamus to Quash Designation as Quarantine Hospital," American Health Lawyers Association 2009 Annual Meeting Teaching Hospitals and Academic Medical Centers Practice Group Luncheon (6/29/2009)

· "Legal Issues Related to Validation of Electronic Data," Drug Information Association 45th Annual Meeting (6/25/2009)

· "Clinical Trials Disclosure: Critical Legal and Policy Issues," Drug Information Association 45th Annual Meeting (6/24/2009)

· "Implementing Health Information Technology Legislation: Challenges and Predictions," Marwood Group Healthcare Elements of Stimulus Package D.C. Day (January 2009)

· "Government Perspective on Scientific Exchange and Drug Promotion," Center for Business Intelligence Pharma Compliance Congress (January 2009)

· "The Future of Medicare Part D," American Bar Association Health Law Section Washington Healthcare Summit (November 2008)

· "Health Care Initiatives for Quality Treatment," National Academies of Sciences Opportunities & Challenges in the U.S. & Polish Innovation Systems (October 2008)

· "The Structure and Role of Governments," Centers for Disease Control & Prevention National Summit on Legal Preparedness for Obesity Prevention and Control (June 2008)

· "Agency Practices in Developing/Drafting Guidance and Complying with the Executive Order and Bulletin," American Bar Association Agency Guidance under Amended Executive Order 12866 and the "Good Guidance Practices" Bulletin (May 2008)

· "Public Health Legal Preparedness: The Legal Framework," Centers for Disease Control & Prevention and American Society of Law, Medicine, and Ethics National Summit on Public Health Legal Preparedness (June 2007)

· "Ethics: Views from Inside and Outside the Government," American Bar Association Health Law Section Washington Healthcare Summit (December 2004)

· "Emerging Issues in Human Subject Protection," Association of Clinical Research Professionals Annual Meeting (April 2003)

· "Understanding the Impact of HIPAA on Clinical Research; Clinical Trials in the Post-HIPAA World," Barnett International (March 2003)

· "HIPAA Issues for Pharmaceutical Sales Organizations," Barnett International Sample Accountability (December 2002)

· "HIPAA for Clinical and Records-Based Research; Understand the Relationship Between HIPAA and Other Laws Relevant to Research," Center for Business Intelligence (November 2002)

· "HIPAA and Clinical Research Professionals," Baltimore/Chesapeake Bay Chapter of the Association of Clinical Research Professionals (November 2002)

· "What Healthcare Providers Want From Pharmaceuticals for HIPAA Compliance," Institute for International Research HIPAA and Pharmaceuticals (August 2002)

· "Implications of HIPAA on Pharmaceutical Commercial Activities and Compliance Identification and Mitigation Strategies: What Needs to be Done, When and By Whom?," Institute for International Research HIPAA and Pharmaceuticals (August 2002)

· "HIPAA Research Issues," Health Care Compliance Association/American Hospital Association HIPAA Forum Boston (June 2002)

· "HIPAA and Clinical Research Professionals," Baltimore/Chesapeake Bay Chapter of the Association of Clinical Research Professionals (April 2002)

· "Understanding the Impact of HIPAA on Clinical Research; Clinical Trials in the Post-HIPAA World," Barnett International (March 2002)

· "Phase IV Clinical Trials in the Post-HIPAA World," Barnett International Phase IV Clinical Research (February 2002)

· "EU Privacy Directive and National Privacy Regulations," Regulatory Affairs Professionals Society Global Awareness: EU Drugs and Biologics (January 2002)

· "Understanding the Impact of HIPAA on Clinical Research; Clinical Trials in the Post-HIPAA World," Barnett International (November 2001)