Andrew I. Namkung
Associate
Overview
Andrew Namkung is an attorney in Holland & Knight's Boston office and a member of the firm's Healthcare Regulatory & Enforcement Practice Group. His practice comprises of three broad categories, all within the healthcare and life sciences industry: regulatory advising, investigations and enforcement actions, and healthcare transactions.
Mr. Namkung's regulatory practice involves advising clients on a wide range of healthcare issues, including fraud, abuse, compliance, pricing, reimbursement and licensing matters. He has experience counseling a wide range of clients in the healthcare industry, including manufacturers, pharmacy benefit managers, pharmacy chains, managed care organizations and healthcare information technology companies. Mr. Namkung frequently advises clients on complex business relationships and joint ventures within the healthcare industry, in particular, to comply with healthcare fraud and abuse laws. He also has experience assisting life sciences companies navigate the Controlled Substances Act and state law analogues. Moreover, he has experience navigating the Food, Drug, and Cosmetics Act (FD&C Act) and the Health Insurance Portability and Accountability Act (HIPAA).
In the enforcement context, Mr. Namkung has experience representing clients in healthcare white-collar criminal proceedings and in civil healthcare cases, with an emphasis on healthcare fraud and abuse matters such as those involving the Anti-Kickback Statute (AKS), False Claims Act (FCA), Stark Law and the healthcare fraud statute. Mr. Namkung has also conducted numerous internal investigations and assisted clients with responding to inquiries by the Office of Inspector General (OIG) and subpoenas issued by the U.S. Department of Justice (DOJ) and U.S. Attorney's Offices.
On the transactions side, Mr. Namkung has performed targeted healthcare regulatory diligence and licensure analysis in connection with healthcare mergers, acquisitions, sales and investments, including for non-healthcare clients such as private equity firms, lenders and underwriters.
At the firm, Mr. Namkung is a member of the Hiring Committee for the Boston office and serves as one of two Summer Associate Assignment Coordinators.
Representative Experience
- Counsel to pharmacies and pharmacy benefit managers on complex business relationships and business initiatives to minimize risks under fraud, waste and abuse laws
- Assisted with the establishment of a large pharmaceutical product group purchasing organization
- Advise providers, physician groups and management service organizations on structuring ownership and compensation to comply with the Physician Self-Referral Statute (Stark Law)
- Assist large, integrated healthcare companies draft and implement corporate compliance programs
- Advise various types of pharmacies navigate state boards of pharmacy laws and regulations
- Advised life sciences manufacturers and researchers navigate the Controlled Substances Act (CSA)
- Represented a nationwide specialty pharmacy against a federal U.S. Department of Justice (DOJ) investigation involving the Anti-Kickback Statute, criminal Health Insurance Portability and Accountability Act (HIPAA) and other issues pertaining to relationships with prescribers
- Represented a large ophthalmology practice against a federal DOJ investigation of its relationship with manufacturers and distributors of ophthalmology drugs
- Represented two individuals against government investigation under the federal Health Care Fraud Statute and the Anti-Kickback Statute
- Conducted several internal investigations at large healthcare companies pertaining to potential criminal or civil violations involving the Anti-Kickback Statute, Stark Law, HIPAA and the False Claims Act (FCA)
- Represent a national pharmacy benefit manager in its sale to a large insurance company and assisted with integration matters
- Represent a long-term care pharmacy in its acquisition of another long-term care pharmacy
- Represent a nationwide nephrology organization in connection with a strategic investment by a private equity firm
- Represent and evaluate regulatory risk for non-healthcare companies such as insurers, banks and private equity firms in potential transactions involving various healthcare companies
Credentials
- Boston University School of Law, J.D., magna cum laude
- University of Washington, B.A., Political Science, cum laude
- Massachusetts
- Dean's Award, Healthcare Fraud and Abuse, 2015
- G. Joseph Tauro Distinguished Scholar, Boston University School of Law, 2014
- Editor, Boston University Law Review, 2014-2016
- Dean's List, University of Washington, 2009-2012