Leah D'Aurora Richardson

Partner

Leah D'Aurora Richardson

Partner

Leah D’Aurora Richardson focuses her practice on health law, representing academic medical centers, health systems, hospitals, hospices, and a range of ancillary service providers, including pharmacies, durable medical equipment suppliers, wound care providers, infusion providers, clinical laboratories, IDTFs, specialized management services organizations, and other health care entities in transactional and regulatory matters.

Leah advises health care clients on complex regulatory, compliance, and transactional matters related to new business initiatives and existing service lines. Her experience includes compliance with fraud and abuse laws, anti-kickback statutes and physician self-referral laws, HIPAA and state privacy, security, breach notification rules, state licensure rules, government and commercial reimbursement issues, enterprise-wide health care and supply chain contract negotiations, and regulatory diligence.

Leah has extensive experience advising hospital and health system-owned, independent retail, specialty pharmacies, and infusion providers on regulatory, reimbursement, operational, compliance, and risk management issues. She counsels on Robinson-Patman requirements, federal DEA and state-controlled substances laws, state licensure requirements, limited distribution drug access, manufacturer purchasing arrangements, fraud and abuse compliance, HIPAA compliance for data sharing arrangements, payor/PBM negotiations, wholesaler contracts and disputes, and acquisitions/changes of ownership.

Leah is a nationally recognized professional in the 340B Program, serving as primary counsel for dozens of 340B covered entities. She provides comprehensive guidance on 340B Program compliance, including contract pharmacy arrangements, HRSA audits, manufacturer inquiries, Medicaid billing audits, federal grant compliance, government and private billing compliance related to 340B drug claims, and program strategy and public policy.

Prior to attending law school, Leah was a medicinal chemist for nearly 10 years at GlaxoSmithKline and Albany Molecular Research.

Accolades and Recognition

  • Recognized, Chambers USA, “Up and Coming Lawyer” in the practice area of Healthcare (2024)

Publications

  • Author, “The 340B Drug Pricing Program: An Evolving Legal and Policy Landscape,” Journal of Health Care Compliance (September-October 2023)
  • Author, “Unpacking CMS’s Proposed Rule for Correcting Underpayments for 340B Drug Reimbursement” (August 22, 2023)
  • Author, “DEA Temporarily Extends COVID-19 Flexibilities for Controlled Substance Prescriptions via Telemedicine While Evaluating Permanent Rule Changes” (May 11, 2023)
  • Author, “Consolidated Appropriations Act of 2023 Extends Telehealth Waivers” (February 6, 2023)
  • Author, “Recent Developments to the 340B Drug Pricing Program” (December 15, 2022)
  • Author, “Transforming Health: Digital Health Legal Insight Series 2022, Parts I, II, and III: D2C Telehealth Services” (March-October 2022)
  • Author, “Rutledge and the Future of State Laws Prohibiting 340B Two-Tier Pricing,” AHLA Practice Group Briefing (June 18, 2021)
  • Author, “Uncertain Relief: Navigations CARES Act Provider Relief Fund Guidance and False Claims Act Risk,” Journal of Health Care Compliance (January-February 2021)
  • Author, “Interactions between Medical Technology Companies and Health Care Professionals: Updates to the AdvaMed Code of Ethics and Federal Anti-kickback Statute Implications,” Journal of Health Care Compliance (July-August 2019)