Kim Le is an associate in the Corporate Practice Group in the firm's New York office.
Areas of Practice
Kim works closely with clients to solve healthcare compliance issues and navigate challenges presented by an ever-changing regulatory landscape. She structures complex, cutting-edge alignment strategies, including population health management models, integrated health delivery systems, and risk-sharing arrangements.
Kim regularly advises investors and companies on multijurisdictional business strategy and implementation matters specific to healthcare entities, including formation/licensing, corporate governance, and operational issues. She assists clients with sophisticated corporate and transactional matters, providing analyses of the health regulatory requirements and risks related to mergers, acquisitions, sales, and joint ventures, using her extensive corporate experience to trouble-shoot obstacles and bring challenging projects to bear.
Kim represents a diverse range of healthcare industry stakeholders, including hospitals, medical groups, managed care organizations (MCOs), accountable care organizations (ACOs), academic medical centers, biotechnology and device companies, skilled nursing facilities, home health providers, clinical laboratories, and pharmaceutical manufacturers/distributors. She provides clients with comprehensive health regulatory and compliance counseling, including: health information privacy and security compliance (HIPAA and HITECH); fraud and abuse laws (the Anti-Kickback Statute, Stark Law, and the False Claims Act); corporate practice of medicine; FDA pharmaceutical and medical device regulation; Medicare/Medicaid enrollment and reimbursement issues; licensing, certification, and accreditation; telemedicine, mobile medicine, and e-health. Kim routinely designs and implements HIPAA compliance programs for covered entities, hybrid entities, and business associates alike, working alongside clients’ privacy and security officers to improve governance practices and operational effectiveness.
Additionally, Kim has extensive experience in the managed care sector, assisting Medicare Advantage Organizations (MAOs), Medicaid MCOs, and Knox-Keene HMO plans with regulatory compliance, licensure issues, and contract negotiations. She has advised Fortune 500 companies and other large, multi-lateral organizations on managed care market entry, scale-up, and strategic growth initiatives. Further, she has assisted Medicare Part D plans in the negotiation of pharmacy benefit management (PBM) contracts, governing pharmacy network contracting, pharmacy claims processing, mail and specialty drug pharmacy, cost containment and clinical safety programs, and formulary administration.
“U.S. Supreme Court Finds Tolling Doctrine Inapplicable to Medicare PRRB Appeals,” Jan. 23, 2013, American Health Lawyers Association: Regulation, Accreditation, and Payment Practice Group
“Joint Commission Announces Behavioral Health Home Certification Option,” May 16, 2013, American Health Lawyers Association: Accreditation, Certification, and Enrollment Affinity Group
OIG Issues 2014 Work Plan: Significant New Hospital Focus Areas; Prescription Drug Audits," February 2014, Health Care Alert
"The RACs Are Back," February 2014, Health Care Alert
"CMS Reforms RAC; Providers Remain Skeptical," February 2014, Health Care Alert
Healthcare Law Blog Posts
- "Highlights From The Wall Street Journal’s Health Forum," March 31,2020
- "Blog Series Part 7: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Medicaid Fee-For-Service, and Medicaid Managed Care Programs for 2020 and 2021," November 20, 2018
- "Are You a “Hybrid Entity” under the Health Insurance Portability and Accountability Act of 1996? The $4,348,000 Question," September 24, 2018
- "A $31,000 Mistake: Failing To Manage Business Associate Agreements Proves Costly For Providers," April 27, 2017
- "What Physicians Need to Know About the New California End of Life Option Act," May 19, 2016
- “Negotiating Physician Employment Contracts: Key Strategies,” Ronald Reagan UCLA Medical Center, Division of General Surgery
- “U.S. Healthcare Regulations: What Foreign Healthcare IT Companies Need to Know,” Consulate General of Canada, Canadian Technology Accelerator, May 12, 2014
- “Gold Rush: Data Mining in False Claims,” Navigant Webinar, August 24, 2012
- “District Health Benefits Exchange (HBX): A Capitol Debate,” Healthcare Technology Network of Greater Washington, June 21, 2012
J.D., Georgetown University, 2008
MSc, Biomedical Ethics and Health Law, University of Birmingham, Edgbaston, U.K., Wolfson Centre for Medical Education, with honors
B.A., University of Maryland, 2003, summa cum laude
- Admitted in New York
- Admitted in District of Columbia
- Admitted in California