To develop and maintain the integrity of your 340B program and to demonstrate to HRSA that your organization is making a serious effort to provide oversight of the program, it’s important to implement a self-audit program.
Monthly: conduct self-audits of sample patient dispensations from outpatient areas, mixed-use settings, offsite clinics and contract pharmacies. The sample size can vary, dependent on facility size and program complexity. At a minimum, a total of 30 dispensations should be reviewed and self-audited per month. The review should test patient eligibility, provider eligibility and Medicaid billing, if applicable. If monthly frequency cannot be achieved, then quarterly is an option. In fact, the proposed Omnibus Guidance indicates a minimum expectation of quarterly reviews.
Annually: conduct a thorough review of your HRSA database records, prior to your annual recertification as a 340B participant. During the database review, verify all eligibility documents, registered child sites and contract pharmacies, contact personnel, and ship-to / bill-to addresses. Remember – the authorizing official is attesting to the validity of all data during recertification, so it’s critical to do a thorough review for accuracy.
Also make sure that your self-audit program is included in your 340B policies and procedures, and that it defines how to establish a threshold for materiality for self-reporting any findings, and how to respond to findings.