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.
