Expertise: USP 795, 797, 800. 503A

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Expertise: Regularly advise hospital and health system-owned and independent retail and specialty pharmacy and infusion clinic clients on all facets of regulatory, reimbursement, operational, compliance and risk management issues including Robinson-Patman requirements, federal 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, and acquisitions/changes of ownership; serve 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.

Area of Practice: Health care regulatory and compliance advice; health care transactions; 340B Program compliance, audits, and strategy; pharmacy supply chain and reimbursement contract negotiations.

Expertise: Pharmaceutical Care Standards (nursing homes/long-term care, acute care, hospice, home health); Geriatric Drug Therapy Management; Clinical Pharmacy Services (drug information services, patient assessment, counseling requirements); Drug Safety/Misadventure (drug interactions, adverse reactions, medication errors, death/overdose); Pharmacology (causal relationship between drug exposure and subsequent effects, pharmacokinetics); Pharmacy Operations, controlled substances/narcotics, drug distribution systems)

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