OPAIS Registration happens quarterly, and with the summer registration period approaching this July, it is important for organizations to have all of their ducks in a row and feel confident, prepared, and organized. That is where 340Basics comes in to help! We are equipped with answers and advice for a smooth OPAIS registration period.

History and Enrollment Periods


In order to qualify your organization for the 340B Program, HRSA requires you to go through a registration and approval process. This process happens four times a year:

  • January 1-January 15 for an effective start date of April 1;
  • April 1-April 15 for an effective start date of July 1;
  • July 1-July 15 for an effective start date of October 1; and
  • October 1-October 15 for an effective start date of January 1.

Please note that if the 15th falls on a Saturday, Sunday, or Federal Holiday, the deadline will be the next business day.

It is important to have all terms established well before the program ever gets started. A contract must be established a PSA with the pharmacy to be signed and executed prior to your registration date. In certain cases, exceptions are made by the Secretary of the Department of Health and Human Services for Public Health Emergencies. This last quarter, many exceptions were pushed through because people were dealing with the pandemic and needed to have these one-off windows created. When you are stating your issue to HRSA for assistance, it is best to describe what the need is, or the benefit is, to the community so that they understand why you’re asking for it. They are very good at responding and will usually give you a one-time open registration window in which you can reach out to 340Basics to help you register at that time.


Preparing for Registration


Section 340B(L)(i) of the Public Health Services Act defines the Covered Entity (CE) classifications eligible for the 340B program. An entity must know what classification they plan on registering as and have the associated documentation ready.


Setup User (if new) – Each user assigned a role with OPAIS must create a unique account using the email address of the organization (no private email).

– Authorizing Official

– Primary Contact


Medicare Cost Report – Hospitals Only

– Signed and digitally stamped Worksheet S;

– Worksheet S-2

– Worksheet E Part A (Line 33)

– Worksheet S3

– Children’s Hospital


Proof of Ownership Status

– State or Local Government

– Private Non-Profit with a contract with State or Local Government

– Public corporation/Private non-profit formally granted governmental powers


Function Availability


Certain functions can be completed whenever the AO or PC are logged in, while other functions are restricted to specify yearly intervals.



Two-Step User Authentication


First, enter the email and password used to create your account. Password expiration is 6 months. Retrieve a 6-digit code from registered email account and fill in request on OPAIS. This code is for a one-time use and is valid for a limited time. After 5 failed log ins, your account will be locked out for 15 minutes. OPAIS related notifications will come from: noreply@hrsa.gov The Secure Two-Step User Authentication process is now complete.

Helpful Tip: If you are using or planning to use a screen sharing application for assistance or training purposes, wait until after login to begin sharing.




It is important to know that there are no “Save Progress” options within OPAIS. When you begin the process, what you set out to do must be completed in one session and the login session will be terminated if there is no activity for thirty minutes.


For a step by step guide for registering Non-Hospitals, Hospitals, Off-Site Locations, and Contract Pharmacies, please view our manual here.


Submission and Acceptance


You will be given one final review before submitting the registration. User role will determine the next step. The site will show as “Pending” on the Landing Page and an email will be sent. On Approval by OPA, both PC and AO will receive additional email.  Check the OPAIS “My Entities” site to confirm approved status, check with Apexus/HRSA if status not updated.

Eligibility will begin the 1st day of the following Quarter.



340Basics Compliance Recommendations


  • Establish 340B Program Requirements
    • New/Updates to Policies and Procedures
    • Setup 340B purchasing accounts
    • Establish eligibility tracking processes
    • Sign up with Prime Vendor Program
  • Test compatibility with OPAIS and ensure all contact emails are active and up to date prior to registering sites/pharmacies
  • Each registration should be completed in one continuous session to ensure accurate and timely submission
  • Keep a paper/digital trail – document everything
  • If you are unsure, submit an inquiry
  • Do not wait until the last minute


Important Terminology