Leah Richardson

Practice Areas

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.

Publications

340B Program Omnibus Guidance: Mega-Changes on the Horizon?, American Health Lawyers Association Rap Sheet, November 2015

Information Exchange in the Formation of an ACO, American Health Lawyers Association, May 2013

Recent Development, The "Substantial Uncertainty" of the Viability of Woodson Claims After Valenzuela v. Pallet Express, Inc., 90 N.C. L. Rev. 884 (2012).

Education