Data Integrity (340B)
Definition
Data integrity is foundational to 340B compliance. The entire compliance framework—patient eligibility determination, diversion prevention, duplicate discount prevention, and auditable record-keeping—depends on the accuracy and reliability of underlying data. When data is inaccurate, incomplete, or inconsistent, compliance controls fail even when they are properly designed.
Common data integrity issues in 340B programs include: patient eligibility data that is not synchronized between the EHR and split-billing software; dispensing records that do not match purchasing records; incorrect NDC mappings in split-billing configurations; Medicaid billing designations in OPAIS that do not reflect actual billing practices; and contract pharmacy transaction data that cannot be reconciled to covered entity records.
Data integrity problems are particularly insidious because they often go undetected until an HRSA audit. Regular data reconciliation, vendor data audits, and system configuration reviews are essential to maintaining data integrity across the program.
Frequently Asked Questions
Why Data Integrity (340B) Matters
Data integrity failures are the root cause of many 340B compliance violations. Inaccurate patient eligibility data leads to diversion. Incorrect billing data leads to duplicate discounts. Data that cannot be reconciled creates audit findings. Investing in data integrity is one of the highest-return compliance activities a covered entity can undertake.
How Virtue 340B Uses It
Virtue 340B treats data integrity as a priority in every audit and consulting engagement. We evaluate data quality across all program elements, identify specific integrity failures, and help entities implement the data controls and reconciliation processes needed to maintain accurate records.