Are you interested in participating in the 340B program? Is your organization already registered and has an opportunity to add new outpatient facilities or new contract pharmacy relationships? Are your plan members that meet the patient definition filling at a pharmacy not currently contracted with your covered entity for 340B?
If any of these questions apply to your or your client’s organization but you don’t know where to begin, here are some of the first steps to know and answers to frequently asked questions about the 340B registration process to help you get started.
What should you do before you register for the 340B Program?
1) Check if your site is already registered.
To confirm that you are in the system, search 340B OPAIS for registered sites. This will prevent you from registering duplicates or identify terminated registrations you may want back in the 340B Program. If you aren’t sure if your sites are already registered, you can contact the 340B Prime Vendor Program (PVP) for assistance.
2) Identify who your Authorizing Official and Primary Contact will be.
The Authorizing Official (AO) must be an individual who can bind the organization to a contract, such as a CEO, COO, CFO, clinic administrator, or program manager. The Primary Contact should be an employee of the organization. They may not be the same as the AO and cannot be a consultant or contractor.
3) Set up your account.
To participate in the 340B Program, covered entities are required to register through the Office of Pharmacy Affairs Information System (OPAIS). To register, you must first set up or have an existing 340B OPAIS user account.
4) Contact your grant Program Director or Program Manager.
Contact your state grantee to let them know you are applying to the 340B Drug Pricing Program. They will receive an email from the Health Resources & Services Administration (HRSA) asking them to verify the receipt of grant funds.
To confirm eligibility, OPAIS will send an email to the Project Director or Program Manager to confirm that the entity receives eligible grant funding for all grantee types, which they will have five business days to confirm. If they don’t respond to the email by the deadline, the registration(s) will be rejected.
5) Gather needed information.
You’ll need to have certain information on hand to complete your registration. This includes a federal grant number, and if you plan to use 340B drugs for Medicaid patients, you must provide your Medicaid billing number or National Provider Identifier.
You can also find the federal grant number at the agency that receives the grant from the Federal Grant Program.
6) Prepare your contract pharmacy agreements.
Be prepared to register all contract pharmacies at the time of registration. However, you may register contract pharmacies only after having a written contract with a contract pharmacy before the registration period.
Additional questions:
What is the registration period for 340B enrollment?
It’s important to be aware of the program’s quarterly registration periods, as covered entities cannot register outside of these designated time periods. 340B Program registration of new covered entities and the addition of outpatient facilities occur:
- October 1 – October 15 for an effective start date of January 1.
- 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.
How long does the registration process take?
The entire process typically takes around 10 minutes per pharmacy if Contract Pharmacy Service Agreements, Pharmacy’s Drug Enforcement Agency (DEA) number and pharmacy address are ready in hand when registering. But be sure you have enough time to complete it in one sitting, as the online registration must be completed in one session. Otherwise, the registration will time out and restart.
It is also important to note that after completing the online registration, entities are required to submit supporting documentation on the same day of registration submission. Supporting documentation to have ready when registering includes:
- Medicare cost report (Hospitals only) – Worksheet S, Worksheet S-2, Worksheet E Part A, and Worksheet S-3.
- Proof of Ownership Status.
- Contract Pharmacy Service Agreements.
- Pharmacy’s Drug Enforcement Agency (DEA) number.
- Pharmacy address.
What happens after I complete registration?
After submitting your 340B registration, you might be thinking, What next? Following the submission, OPAIS will contact you if they need any additional information.
When can I begin utilizing 340B drug pricing?
Once approved, OPAIS will send an email to the AO confirming successful enrollment in the 340B Program, as well as the date that you may begin purchasing 340B drugs and your covered entity’s 340B identification number.
