Turnkey has had the opportunity to support over 45 HRSA audits for our amazing clients. One thing we have noted from each audit is the close evaluation of the new 340B Office of Pharmacy Affairs Information System (OPAIS) database and entity’s information. Apexus tells us the purpose of the OPAIS database “increases the integrity and effectiveness of 340B stakeholder information and focuses on three key priorities: security, user accessibility, and accuracy.
The new database replaced the legacy 340B Database in its entirety which includes security updates and enhancements used for covered entity/manufacture registrations, change requests, recertification and other updates. Some key features of the 340B OPAIS include:
- Manufactures and covered entities ability to manage their own 340B record.
- Improved efficiency through a task-oriented landing page for the covered entity/manufactures Authorizing Officials (AOs). Additionally, covered entities and manufactures receive e-mail notifications of pending tasks.
- Enhanced security features such as two-part authentication for covered entities and manufactures.”
With this spiffy new database comes an obligation for the covered entities to make sure that all information regarding the site is accurate. HRSA findings abound from minute details that can be easily identified and updated without waiting for a registration period. Our auditors call this “low hanging fruit” in regards to a HRSA audit, as it takes little effort to identify, and a finding is sure to follow.
Authorizing Official and Primary Contact Information should include a correct address as well as a direct telephone number. Turnkey’s audit experience includes a HRSA auditor picking up a cell phone and dialing the numbers listed. Make sure they are correct and in working order.
Incorrect billing addresses. This is often a confusing topic. An easy way to determine if you have the correct billing address is to ask yourself this question. ‘If a patient is sending payment for a bill, what is the address on a postage paid envelope?’ Do you have an offsite billing address or PO Box? If patient payments are not going directly to your parent site, you should list a separate address. Billing offices will help clear this up and get you a accurate address.
Contract Pharmacy information should match both the OPAIS database and the contract pharmacy contract. HRSA auditors will be checking both the database as well as the contracts provided to ensure pharmacy names and addresses match including suite numbers. They will also be looking to ensure that the contracts include all pharmacies, child sites, or
the contract should contain an inclusive statement that it includes all parent and all child/associated sites listed in OPAIS;
Hospital ownership type should be accurate and listed appropriately on the database. Hospital ownership type is listed on the OPAIS database and should be consistent with what is listed on the cost report.
Regular review of your OPAIS database should be done at least quarterly. This small step will not take long yet will ensure an accurate database as well as peace of mind.
Apexus 340B Prime Vendor Program (2019, March 22). FAQ ID: 2437. Retrieved from www.340bpvp.com/resourceCenter/faqSearch.html?category=content&Ntt=OPAIS+database