Regulatory compliance

We provide end‑to‑end counsel from initiating participation in the 340B program to day‑to‑day compliance with program rules. Our work includes developing and refining policies and procedures, advising on programmatic definitions and duplicate discount risks, legal analysis of contract pharmacy and child site arrangements, and aligning 340B practices with Medicare, Medicaid, and commercial payer requirements.

Policy analysis and advocacy

We monitor and analyze legislative, regulatory, sub‑regulatory and judicial developments affecting 340B and advise clients on these developments. We support clients’ engagement with regulators and policymakers, and advocate for clients before these entities on proposed changes to the program.

Dispute resolution

Our practice includes representation in disputes between covered entities and manufacturers, as well as disputes with government oversight bodies, including matters arising from pricing disputes, data‑sharing requirements, contract performance, Medicare and Medicaid payment for drugs acquired under the 340B program, and audit outcomes. Our approach emphasizes early risk assessment, efficient resolution, and preservation of program integrity.

Contracting and operational agreements

We draft and negotiate 340B‑related agreements. Our focus is on contract terms that are operationally workable, legally sound, and aligned with HRSA requirements and expectations.

Audits, investigations, and remediation

We prepare clients for 340B program audits, conduct internal readiness reviews, and assist with responses to audit findings. Where issues are identified, we design and implement corrective action plans, including repayment methodologies, documentation remediation, and durable internal controls to reduce the risk of recurrence.

Education and training

We deliver tailored training for leadership, compliance teams, and finance personnel to promote consistent, accurate execution of 340B requirements. Our sessions translate regulatory and judicial developments into practical workflows.