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Ned Milenkovich is an associate in the law firm of McDermott Will & Emery LLP, based in the Firm's Chicago office. He is a registered pharmacist in two states and is currently a practicing attorney with McDermott's Health Law Department. Ned has been involved with multiple legal issues relating to pharmacy matters. With respect to pharmacy practice, he has been involved with drug therapeutic interchange/drug substitution issues for long-term care facilities and health systems, professional practice act issues on behalf of pharmacies and pharmacy management companies, pharmacy credentialing matters, including advanced-level credentials and specialty certification, collaborative drug therapy management issues, e-prescribing, telepharmacy, supportive personnel in pharmacy practice, specialty pharmacy issues including supply chain and third-party contracting, medication error reporting and NABP credentialing of VIPPS and VAWD. Additionally, Ned has licensed pharmacies in over 40 states in various board of pharmacy licensure proceedings, including obtaining state-authorized controlled substance licensure. He is also versed in DEA pharmacy licensure requirements and DEA compliance activities, including destruction of controlled substances through reverse distributors and government agencies.
Ned has also been involved with several 340B drug discount pricing analyses and has recently assisted a client in providing comments to HRSA respecting the latest clarification of the definition of "patient" for 340B purposes. He also has extensive HIPAA privacy, security, transaction code sets and national provider number compliance experience and has counseled countless clients respecting HIPAA matters and has both spoken and written on the subject numerous times. Furthermore, he has experience relating to state-mandated prescription drug monitoring programs and preventing diversion as well as the federal NASPER program. Ned has also addressed, on an issue-specific basis, federal Food, Drug and Cosmetic Act matters, including direct to consumer advertising issues, among others.
Ned has also participated in due diligence acquisitions in the pharmaceutical sector and has analyzed aspects relating to hazardous materials transportation, prescription drug marketing act, authorized distributor of record and drug pedigree issues. He has also addressed compounding vs. manufacturing issues relating to the tension between FDA enforcement and a pharmacist right to compound within the scope of professional practice. He has also been involved with numerous health and welfare benefits issues including the most recently enacted Medicare Part D prescription drug benefit on various issue specific assignments.
Education:
John Marshall Law School, J.D. (cum laude), 2000
University of Illinois at Chicago, Doctor of Pharmacy (with honors), 1997
Ohio State University, B.S., 1992 | 