Profilo
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.
Concentrations
- Health law
- Administrative law
- Medicare and Medicaid law
- Medical practice law
- Food and drug law
Competenze
Esperienze Professionali - Attività Accademiche
- Represented H.I.G. Growth Partners in connection with its acquisition of a regional provider of comprehensive hospice related services.
- Provides HIPAA Privacy & Security GAP analyses, training, review and drafting of business associate agreements.
- Conducts HIPAA compliance reviews and assists in development and implementation of policies and procedures for:
- covered entities including hospitals, hospital systems, health plans, practitioners, laboratories, clinic groups, pharmacies
- business associates including data analysts, administrators and systems managers; billing services; software vendors, and services providers and law firms.
- Advises providers, individual and group physician practices, pharmacies, complementary medicine practitioners, and dietary supplement manufacturers and distributors.
- Conducts risk reduction audits for physician and other independent practitioner practices.
- Evaluates complex scientific data and incorporated analysis and findings into legal opinions and pleadings in accordance with applicable federal law.
- Advises advocacy groups and congressional staff members on health care policy issues.
- 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
- Nurse, U.S. Army, Ft. Bragg, NC; Ft. McCoy, WI, and Wuerzburg, Germany, 1978-1982
- Legal Intern, Douglas County Legal Aid Society, Lawrence, KS
- Legal Intern, U.S. Attorney for the Eastern District of North Carolina, Raleigh, NC, 1991
Riconoscimenti e Premi
- Member, Personal Care Products Council (PCPC)
Formazione
Formazione
- Laurea magistrale in Giurisprudenza, University of Kansas School of Law
- M.S., Nursing, The University of Texas
-
B.S., Nursing, University of Maryland
- Walter Reed Army Institute of Nursing
Abilitazioni
- District of Columbia
- North Carolina
- Virginia