HRSA 340B Registration and Recertification Support
Registration and recertification look administrative until something is wrong. An inaccurate site list, a child site registered against the wrong cost report line, or a lapsed authorizing official turns a routine attestation into an eligibility finding.
At a glance
- Registration windows
- 4 per year
- Recertification
- Annual, by entity type
- Cost report linkage
- Required for child sites
- Record accuracy
- Audited first
What we handle
HRSA maintains the 340B Office of Pharmacy Affairs Information System — OPAIS — as the public record of every covered entity, every registered site, every contract pharmacy arrangement and every Medicaid billing election. It is public, searchable, and the first place an auditor looks.
Keeping it accurate is not difficult. Keeping it accurate while opening clinics, acquiring practices, changing authorizing officials, adding contract pharmacies and filing cost reports is where entities fall behind.
Included in scope
- Initial entity registration and eligibility evidence assembly
- Child site registration with documented cost report linkage
- Contract pharmacy arrangement registration and termination
- Authorizing official and primary contact changes
- Medicaid billing election review and Medicaid Exclusion File status
- Annual recertification preparation, evidence and submission support
- Record accuracy audit against your actual operating footprint
Registration errors are one of the most common findings.
A mismatch between your OPAIS record and your actual cost report is a straightforward, avoidable finding — and one of the first things a mock audit or HRSA review checks.
- We recommend beginning recertification evidence review at least 60 days before your window opens
- We prepare and support registration end to end, working with your designated authorizing official, who retains sign-off
- We identify OPAIS-versus-cost-report mismatches and the correction path before they become a finding
Registration and recertification — common questions
When can we register a new site?
HRSA opens registration four times a year, each window covering the following quarter. A site cannot purchase at 340B pricing before its effective date, and the pre-registration period is not recoverable, so the calendar should drive your clinic opening and acquisition planning rather than the reverse.
What is recertification?
An annual attestation that your entity remains eligible and that your OPAIS record is accurate. Periods differ by entity type. It is short to complete and consequential to get wrong, because you are attesting to accuracy you may not have tested.
What happens if we miss recertification?
The entity is removed from the 340B database and loses the ability to purchase at 340B pricing until it re-registers in a subsequent window. For most entities that is a materially expensive administrative failure.
Can you do this alongside our existing team?
Yes. Many clients keep registration in-house and engage us only for record accuracy auditing and recertification readiness, which is a much smaller scope than full registration management.
Does your OPAIS record match your actual footprint?
It is a two-hour check that prevents one of the most common audit findings in the program.