Nikki Leon counsels a broad range of clients in healthcare and life sciences on regulatory, compliance, enforcement, and legislative matters. Her clients include pharmaceutical and medical device manufacturers, healthcare research organizations, physician practice groups and professional societies, medical technology companies, clinical laboratories, and makers of conventional food products, cosmetics, over-the-counter drugs, and dietary supplements.

Ms. Leon's regulatory practice focuses on state and federal legislative initiatives affecting the healthcare and pharmaceutical industries; healthcare fraud and abuse regulation (including "Stark" physician self-referral laws and the healthcare Anti-Kickback Statute) and enforcement; and coverage, coding, and reimbursement issues. As part of her practice, she represents clients in criminal and civil investigations, internal investigations, and compliance audits. Her transactional practice focuses on the regulatory, structuring, and business aspects of healthcare business transactions, including compliance considerations for promotional activities, clinical research, educational grants, and charitable giving.

Experience

  • Major pharmaceutical and medical device manufacturers—advise on regulatory and compliance considerations in structuring charitable donation agreements and educational grants
  • Enterprise software company—counsel on contracting considerations in agreements to provide cloud-based services for Medicare Advantage Plans 
  • Leading prosthetics manufacturer—advise on state and federal policy developments, including advocacy for parity in coverage and reimbursement
  • Biopharmaceutical company—assist in compliance audit of managed markets activities and patient support programs
  • Physician practice group—represent group practice in government investigation relating to coding and reimbursement

Perspectives

Appendix – Legal and Compliance Considerations
Contributor, The Ultimate Ophthalmic Marketing Guide: Work Less. Make More. The Science of Implementing Data-Driven Marketing in Your Practice in 90 Days, Emedikon LLC
HHS OIG's Proposed Rule: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
Advisory
Discussing the Effects of State Transparency Laws on Drug Pricing
ACI's Rx Drug Pricing Master Class, Philadelphia, PA
Trump Administration Issues Blueprint to Lower Drug Prices and Reduce Out-Of-Pocket Costs
Advisory
Updated FDA Guidance Helps Device Study Sponsors Better Anticipate Coverage for Investigational Devices
Advisory
More

Credentials

Education
  • JD, Stanford Law School, 2016
  • AB, Princeton University, 2011, summa cum laude
Admissions
  • District of Columbia
Overview

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