340B Drug Pricing Program & Regulatory Counsel

Lanton, Lanton & Sosa Law provides legal, regulatory and government affairs counsel on the federal 340B Drug Pricing Program. We advise hospitals, health systems, federally qualified health centers (FQHCs), contract pharmacies and other healthcare and life sciences organizations on matters affecting 340B participation, compliance and commercial relationships.

Our work includes contract pharmacy agreements, manufacturer requirements, reimbursement policies, regulatory compliance and state and federal legislation affecting the program. We work with executive leadership, pharmacy directors, compliance officers and legal departments on existing 340B operations and expansion plans.

340B Legal Services

Contract Pharmacy Agreements: Preparation, negotiation and review of agreements between covered entities, independent pharmacies, specialty pharmacies and other contract pharmacy providers.

340B Regulatory Compliance: Legal counsel on program eligibility, patient eligibility, diversion, duplicate discounts, documentation and regulatory requirements.

Manufacturer Restrictions and Data Requirements: Legal analysis of pharmaceutical manufacturer policies, contract pharmacy restrictions, data submission requirements and drug distribution arrangements.

340B Program Development and Expansion: Legal and commercial counsel on establishing, expanding and restructuring 340B pharmacy arrangements.

Third-Party Administrator Agreements: Review and negotiation of agreements with third-party administrators (TPAs), technology providers and other vendors supporting 340B operations.

Audit Preparedness and Regulatory Inquiries: Legal guidance concerning HRSA audits, manufacturer inquiries, compliance reviews and corrective action requirements.

Medicare and Medicaid Reimbursement: Legal and regulatory analysis of reimbursement policies, Medicaid billing requirements and government payment changes affecting 340B participants.

PBM Contracting: Review of pharmacy benefit manager agreements, reimbursement policies, network participation requirements and contractual restrictions affecting 340B pharmacies.

340B Government Affairs: State and federal legislative representation, regulatory advocacy and policy analysis concerning 340B protections, reimbursement, contract pharmacy arrangements and patient access.

Ongoing Legal and Regulatory Representation

We provide continuing legal counsel to organizations participating in the 340B program, including outside general counsel services and government affairs representation. Clients may engage the firm for individual commercial or regulatory matters or through ongoing monthly arrangements.

With offices in Boston and Washington, D.C., Lanton, Lanton & Sosa Law advises healthcare and life sciences organizations on the legal, commercial and public policy matters affecting 340B operations.

Speak With Our Attorneys

Contact Lanton, Lanton & Sosa Law to discuss your organization's 340B legal and regulatory needs.