340B Drug Discount Program
EBG Advisors’ 340B team includes 340B independent audit and compliance consultants and highly skilled lawyers. This team is adept at providing strategic, regulatory, and compliance counseling and consulting services to covered entities, pharmacies, technology vendors, and other 340B stakeholders; guiding clients through the 340B Drug Pricing Program’s complicated requirements; and helping clients establish compliant and well-supported programs, and effectively respond to governmental inquiries.
Members of our 340B team are frequent speakers on the 340B circuit and present at the major 340B stakeholder and pharmaceutical conferences addressing the 340B program. They also keep clients abreast of new developments in 340B compliance and enforcement and stay responsive to client needs.
Our 340B team provides comprehensive services, which include, but are not limited to:
- Performing 340B eligibility and feasibility assessments
- Working with covered entities, contract pharmacies, and 340B management service providers on 340B compliance, outlook, and strategy
- Conducting independent audits of a client’s 340B program, including a financial and compliance review and test of internal controls
- Preparing for, and assisting, with HRSA audits, manufacturer audits, and self-disclosures, including drafting follow-up audit responses and corrective action plans
- Developing 340B programs, including preparing all necessary government contracts; drafting and implementing 340B compliance policies and procedures; and providing staff training
- Structuring, drafting, and negotiating 340B contract pharmacy and technology vendor arrangements
- Assisting with 340B Drug Pricing Program database registrations and re-certifications, and advising clients on registration deadlines affecting program eligibility
- Negotiating and resolving disputes between 340B participants
- Updating covered entities and other 340B participants on new regulatory, industry, and enforcement guidance and developments