The 340B program faces increasing scrutiny from both government and non-government entities. Compliance with evolving regulations and a continued focus on program transparency, program intent and utilization of 340B savings create multiple risk points for your organization. Visante’s independent, external audit support provides transparency to your 340B processes, allowing you to recognize any compliance gaps.
We work with all types of covered entities and tailor our approach accordingly:
- Internal and external audit support, on-site and virtual HRSA audit support and Corrective Action Plan guidance in the event of HRSA audit findings
- Management of manufacturer inquiries and audits
- Gap analysis and targeted recommendations, focusing on long-term strategy in the mixed-use, clinic-administered and contract pharmacy space to ensure program optimization
- Program implementation and development of internal oversight structure and maintenance, as well as interim staffing to operate the program
- 340B Software RFP guidance, implementation and program re-designs
- Program management and oversight for CEs such as Grantees and Vulnerable Hospitals
Visante’s experienced team members include Apexus 340B University graduates, many of whom have completed the Advanced Ops Certificate. Visante continues to support dozens of HRSA audits and manufacturer audits on behalf of our clients annually, which provides Visante the latest with auditing practices in the industry.