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340B Impact Hub
340B Reinstatement Support

Regain Your 340B Eligibility

Expert guidance and support for covered entities seeking to reinstate their 340B program participation after termination.

2.5-3

Months to Reinstate

Minimum timeline

100%

Preventable

With proper systems

Expert

Guidance Available

Personalized support

Quick Links
Reinstatement ProcessRequirementsTimelineFAQsRequest Consultation
Resources
Reinstatement ChecklistPrevention StrategiesCertification Guide

Reinstatement Process

1
Address Root Cause
Identify and resolve the issue that led to termination. For Code 13, implement reminder systems. For Code 30, improve DSH percentage.
2
Wait for Registration Window
Reinstatement can only occur during quarterly 15-day windows: January 1-15, April 1-15, July 1-15, October 1-15.
3
Submit Application
Complete the full registration process via 340B OPAIS with updated documentation and Authorizing Official attestation.
4
HRSA Review & Approval
HRSA reviews application and may request additional documentation. Response time varies but typically takes 4-8 weeks.
5
Eligibility Begins
Upon approval, eligibility begins the first day of the quarter following registration (minimum 2.5-3 months from application).

Reinstatement Requirements

Documentation
  • Current Medicare Cost Report (hospitals)
  • Grant award documentation (grantees)
  • Proof of corrective actions taken
  • Updated compliance policies
Organizational
  • Active OPAIS accounts for AO and PC
  • Designated Authorizing Official
  • Compliance infrastructure in place
  • Auditable record-keeping systems

Expected Timeline

1

Preparation Phase

2-4 weeks

Gather documentation, implement corrective measures, prepare application materials.

2

Registration Window

15 days (quarterly)

Submit application during Jan 1-15, Apr 1-15, Jul 1-15, or Oct 1-15 window.

3

HRSA Review

4-8 weeks

HRSA reviews application, may request additional information. Monitor email daily.

4

Eligibility Restored

First day of next quarter

340B purchasing eligibility begins. Total timeline: 2.5-3 months minimum.

Frequently Asked Questions

Can I expedite the reinstatement process?

No. HRSA does not offer expedited processing. The quarterly registration windows and review timelines are fixed. However, thorough preparation can help avoid delays from incomplete applications.

What if I miss a registration window?

You must wait until the next quarterly window. There are no exceptions. This adds 3 months to your reinstatement timeline, so careful planning is essential.

Do I need to repay any 340B savings from before termination?

Generally no, unless the termination was due to program violations. However, you cannot make 340B purchases during the termination period and must ensure all billing reflects non-340B pricing during that time.

Will my contract pharmacies need to re-register?

Yes. After reinstatement, you must re-establish all contract pharmacy relationships through 340B OPAIS. Previous arrangements are terminated and must be renewed.

Request a Consultation

Get Expert Guidance
Our 340B compliance experts will review your situation and provide personalized guidance for reinstatement.

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Call us directly at (555) 340-2787 to speak with a 340B compliance expert.

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