Miki 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
· Health law
· Administrative law
· Medicare and Medicaid law
· Medical practice law
· Food and drug law
· Advised providers, individual and group physician practices, pharmacies, complementary medicine practitioners, and dietary supplement manufacturers and distributors.
· Conducted risk reduction audits for physician and other independent practitioner practices.
· Evaluated complex scientific data and incorporated analysis and findings into legal opinions and pleadings in accordance with applicable federal law.
· Advised advocacy groups and congressional staff member 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
· Legal Intern, Douglas County Legal Aid Society, Lawrence, KS
· Legal Intern, U.S. Attorney for the Eastern District of North Carolina, Raleigh, NC, 1991
· Nurse, U.S. Army, Ft. Bragg, NC; Ft. McCoy, WI, and Wuerzburg, Germany, 1978-1982
Publications & Presentations
Articles, Lectures & Publications
· Co-Author, "Sunscreen Label and Performance Compliance," SupplySide Cosmetics Insights, January 2013
· 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
· 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 healthcare 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.