Start Date (OPAIS)
Definition
OPAIS records a start date for each covered entity and registered site, indicating the effective date of 340B program participation. This date is updated quarterly and determines when the entity became eligible to purchase 340B drugs.
The start date is significant for compliance purposes because it defines the period during which 340B purchasing is authorized. Purchases made before the start date are not compliant 340B transactions. For newly registered sites or contract pharmacies, the start date similarly defines when compliant purchasing can begin.
During audits, HRSA may review whether purchases were made consistent with the registered start date. Covered entities should ensure their purchasing systems are configured to reflect accurate start dates for all registered sites.
Frequently Asked Questions
Why Start Date (OPAIS) Matters
Purchasing 340B drugs before a site's start date is a compliance violation. Covered entities with multiple sites must ensure their purchasing and inventory systems accurately reflect the start dates of each registered location.
How Virtue 340B Uses It
Virtue 340B verifies start dates as part of OPAIS data reviews during audit preparation and continuous monitoring engagements to ensure purchasing activity aligns with registered program dates.