340B Certification Roadmap
A step-by-step guide to navigating the registration process, meeting critical deadlines, and securing your 340B status.
Expert Insight: The "Day 3" Rule
Don't wait until Day 15. Submit your application by Day 3 of the window. If you make a mistake, submitting early gives you time to retract and resubmit before the window closes.
Get more expert strategies →*Registration must be completed online during these exact dates. No extensions.
Critical Approval Process
Follow this ordered workflow to ensure your application is complete and approved. Click the links to access official HRSA resources directly.
Pro Tip: The "AO Buddy System"
The #1 cause of rejection is a missed attestation email. Have your Primary Contact physically (or virtually) sit with the Authorizing Official when the email is expected to ensure it's signed immediately.
Phase 1: Preparation & Account Setup
Create OPAIS Accounts
Both the Authorizing Official (AO) and Primary Contact (PC) must create individual accounts.
Gather Required Documents
Prepare your latest filed Medicare Cost Report (Worksheet S-2) and supporting contracts.
Phase 2: Submission (Days 1-15)
Submit Online Registration
Log in to OPAIS during the open window and complete the registration form.
Monitor & Respond
Check email daily. You have exactly 5 days to respond to any OPA reviewer requests.
Phase 3: Certification & Implementation
Authorizing Official Attestation
The AO will receive an email to attest to the application's accuracy. This must be electronically signed immediately.
Approval & Start Date
Once approved, your 340B start date will be the first day of the following quarter. Verify your status online.
Don't risk a rejection. Get a "Pre-Flight" audit of your application before you submit.
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