Leah D'Aurora Richardson
Parceiro
Leah D'Aurora Richardson centra a sua prática no direito da saúde, representando centros médicos académicos, sistemas de saúde, hospitais, hospícios e uma série de prestadores de serviços auxiliares, incluindo farmácias, fornecedores de equipamento médico duradouro, prestadores de cuidados a feridas, prestadores de infusões, laboratórios clínicos, IDTF, organizações especializadas em serviços de gestão e outras entidades de cuidados de saúde em questões transaccionais e regulamentares.
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.
Prémios e reconhecimentos
- Recognized, Chambers USA, Healthcare in Texas (2025)
- The Best Lawyers in America®, Health Care Law (2025)
- Recognized, Chambers USA, “Up and Coming Lawyer” in the practice area of Healthcare (2024)
Publicações e apresentações
- Speaker, “Getting Aligned: Structuring Strategic Affiliations for Community Providers,” AHLA Annual Meeting (June 30, 2025)
- Speaker, “Getting Aligned: Structuring Strategic Affiliations for Community Providers,” AHLA Health Care Transactions Conference 2025 (May 5, 2025)
- 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)