Eleanor (Miki) A. Kolton has wide-ranging legal, administrative and management experience in medical practice law; HIPAA, Stark, Medicare and CMS regulations; with the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC); and other civil and administrative law areas. She possesses executive corporate experience and broad clinical background in a variety of health care settings, including the ability to understand scientific and medical community cultures, business challenges and concerns.
Prior to joining the firm, Miki acted as a consultant to XCEL Healthcare and served as Executive Director of Pharmaceutical Programs and Director of Quality Improvement and Risk Management at OPTIONS Health Care, Inc. She holds a master's degree in nursing and is licensed to practice nursing in Virginia.
Areas of Concentration
•Medicare and Medicaid law
•Medical practice law
•Food and drug law
Articles, Publications, & Lectures
•Mentioned, Greenberg Traurig Guides Opko in $1.47B Buy for Lab Co., Law360, June 4, 2015
•Co-Author, Life Sciences & Medical Technology Newsletter, Fall 2013 - Winter 2014, GT Alert, January 10, 2014
•Co-Author, The HIPAA Omnibus Rule: Covered Entity Liability for Business Associate Actions, GT Alert, September 9, 2013
•Author, The Deadline for Compliance with the HIPAA Omnibus Rule is September 23, 2013. Are You Ready? GT Alert, August 12, 2013
•Author, FDA Defines 'Gluten-Free', GT Alert, August 5, 2013
•Co-Author, Sunscreen Label and Performance Compliance, SupplySide Cosmetics Insights, January 2013
•Co-Author, Health Insurance Portability and Accountability Act - Expanded Privacy and Security Enforcement Authority, Increased Potential for Significant Financial Penalties, GT Alert, March 4, 2011
•Author, Health Care Reform's Impact on MA and PDP Plans, GT Alert, May 3, 2010
•Author, Changes to Health Care Privacy Rules as Contained in the American Recovery and Reinvestment Act of 2009, Privacy & Data Security Law Journal, May, 2009
•Co-Author, Changes to Health Care Privacy Rules, GT Alert, February 13, 2009
•Chapter Co-Author, Designing and Implementing a Hospital Compliance Program (including HIPAA Privacy Rule Compliance), Health Care Administration: Planning, Implementing, and Managing Organized Delivery Systems, L. F. Wolper, ed. 2004
•Author, OBRA and the Natural Pharmacist, Natural Pharmacy, August 1998
•Author, chapters and essays in The Comprehensive Legal Guide for Doctors, Emord & Associates, P.C., American Preventive Medical Association
•Author, Monthly Regulation Report, Emord & Associates, 1998-2000
•Author, articles in The Legal Edge, a series of briefing papers published by American Preventive Medical Association that address complex regulatory issues confronting health care providers and practitioners
• Physicians, Private Contracting and Medicare Part B, January 1998
• Medicare Fraud Under HIPAA: Common Risks and Ways to Reduce Them, May 1998
• The Stark and Anti-Kickback Amendments, June 1998
• HCFA Proposes Changes in the Private Contracting Option Requirements, October 1998
• Sale of Dietary Supplements by Physicians and Other Health Care Practitioners, November 1998
• Importing Drugs from Foreign Sources Under the FDCA, July 1998
•Speaker, Legal Issues for the Compounding Pharmacist, Annual International Conference of the International Academy of Compounding Pharmacists and Professional Compounding Centers of America, Houston, TX
•Speaker, Expansion of the Pharmacist Role Creates Business Opportunities, Natural Pharmacy West Conference, Palm Springs, CA
•Speaker, A Legal and Legislative Seminar for Physicians Who Use Complementary and Alternative Therapies, American College for Advancement in Medicine (ACAM) Annual Conference, Ft. Lauderdale, FL
•Speaker, Practicing Smart: A Legal preparation Seminar for Alternative Practitioners, International College for Advanced Longevity Medicine (ICALM) Annual Conference, Las Vegas, NV
•Speaker, Protecting Your Medical Practice: A Legal Seminar for Physicians, Natural Pharmacy East Conference, Washington, D.C.
Associated News & Events
06.09.15 Greenberg Traurig Represents Longtime Client OPKO Health In $1.47 Billion Merger Agreement with Bio-Reference Laboratories
03.03.15 Greenberg Traurig Sponsors the International Association of Privacy Professionals' Global Privacy Summit 2015
01.20.15 Greenberg Traurig Team Focuses on Federal Regulatory and Administrative Law
05.22.13 Greenberg Traurig Represents Danone in its Acquisition of Happy Family
07.05.12 Greenberg Traurig Represents Linde AG as Health Regulatory Counsel in its Agreement to Acquire Lincare Holdings Inc.
08.23.01 Greenberg Traurig LLP's Washington, D.C., Office Expands Health Law Practice
01.01.13 Sunscreen Label and Performance Compliance
05.01.09 Changes to Health Care Privacy Rules as Contained in the American Recovery and Reinvestment Act of 2009
05.01.02 Compliance with Privacy Requirements Protecting Personal Medical Records Under the Health Insurance Portability and Accountability Act of 1996 ( HIPAA )
01.10.14 Life Sciences & Medical Technology Newsletter, Fall 2013 - Winter 2014
09.09.13 The HIPAA Omnibus Rule: Covered Entity Liability for Business Associate Actions
08.12.13 The Deadline for Compliance with the HIPAA Omnibus Rule is September 23, 2013. Are You Ready?
08.05.13 FDA Defines 'Gluten-Free'
03.04.11 Health Insurance Portability and Accountability Act - Expanded Privacy and Security Enforcement Authority, Increased Potential for Significant Financial Penalties
05.03.10 Health Care Reform's Impact on MA and PDP Plans
02.13.09 Changes to Health Care Privacy Rules
•Consultant, XCEL Healthcare, Woodland Hills, CA
•Provided strategic advice to a limited liability company that formulates and compounds pharmaceutical products and dietary supplements.
•Executive Director, Pharmaceutical Programs, OPTIONS Health Care, Inc., Norfolk, VA
•Instrumental in the development and implementation of multi-tiered pharmacy management program for OPTIONS.
•Procured and negotiated state contracts for pharmacy benefit management.
•Lead in design and implementation of an integrated disease management program that facilitated coordinated care amongst physicians and specialty providers.
•Coordinated clinical experts' efforts in developing and implementing pharmacy oriented clinical protocols.
•Served as corporate contact with pharmaceutical manufacturers for outcomes research.
•Director of Quality Improvement and Risk Management, OPTIONS Health Care, Inc. and Northside Mental Health Center, Tampa, FL
•Directed day-to-day operations of regional QI and Risk Management Departments for the southern regional office of a national health care corporation and contract compliance with several multimillion dollar contracts with state agencies and commercial HMOs.
•Ensured compliance with federal and state regulations.
•Ensured care delivered was appropriate: according to contract specifications consistent with professionally acceptable standards of sound health care practices, and in compliance with NCQA, JCAHO, and URAC standards.
•Implemented performance improvement initiatives in accordance with CQI to enhance all operational, clinical and member services with an emphasis on improved clinical outcomes in a cost effective health care system.
•Adjunct Professor (Business Law), Fayetteville Technical Community College
•Associate Professor of Nursing, Orange County Community College, Middletown, NY
•Emergency Room Nurse, Breckenridge Medical Center, Austin, TX
•Legal Intern, Douglas County Legal Aid Society, Lawrence, KS
•Legal Intern, U.S. Attorney for the Eastern District of North Carolina, Raleigh, NC, 1991