Skip to Main Content
Our Commitment to Diversity
Leah D'Aurora Richardson

Leah D’Aurora Richardson is a partner in the firm’s global Health Care and FDA practice group and her practice is exclusively focused on health law, representing academic medical centers, health systems, hospitals, hospices, and ancillary service providers, such as pharmacies, durable medical equipment suppliers, wound care providers, infusion providers, clinical laboratories, IDTFs, specialized management services organizations, and other healthcare clients on transactional and regulatory health law.

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

Leah has experience in advising hospital and health system-owned and independent retail and specialty pharmacy and infusion providers on all facets of regulatory, reimbursement, operational, compliance and risk management issues including Robinson-Patman requirements, federal DEA and state controlled substances laws, state licensure requirements, limited distribution drug access, manufacturer purchasing arrangements (including fraud and abuse compliance), data sharing arrangements (including HIPAA compliance), payor/PBM negotiations, wholesaler contracts and disputes, and acquisitions/changes of ownership. She is a nationally recognized professional in the 340B Program and serves as primary counsel for dozens of 340B covered entities on all facets of 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 almost ten years at GlaxoSmithKline and Albany Molecular Research.

Additional Thought Leadership Pages
  • 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).
Additional News & Event Pages
Return to top of page

Email Disclaimer

We welcome your email, but please understand that if you are not already a client of K&L Gates LLP, we cannot represent you until we confirm that doing so would not create a conflict of interest and is otherwise consistent with the policies of our firm. Accordingly, please do not include any confidential information until we verify that the firm is in a position to represent you and our engagement is confirmed in a letter. Prior to that time, there is no assurance that information you send us will be maintained as confidential. Thank you for your consideration.

Accept Cancel