The Office of Pharmacy Affairs Information System (OPAIS) database contains the official 340B Program participation record for every covered entity. Within its digital corridors lie the intricate details defining a participant's program involvement, which is used by all stakeholders in the 340B Program as the single source of truth. This system is crucial for ensuring the Program's integrity, efficacy, and compliance.
The OPAIS database encapsulates a covered entity's identity within the Program: their registered 340B sites, contract pharmacies, and Medicaid billing status. For HRSA, OPAIS is the lens through which they perceive and comprehend how each entity navigates its 340B Program.
The OPAIS database isn't solely an internal tool. Manufacturers rely on it to understand which covered entities are participating in the Program, while wholesalers use it to discern to whom they can distribute 340B medications.
Accuracy here is paramount; it assures all program participants that an entity is eligible to receive and pass on 340B discounts to patients.
Confusion often arises within the realms of Medicaid billing. Especially in health centers choosing to carve-in or carve-out, operating under a prospective payment system, also known as PPS. This means that when they're billing Medicaid, their claims are often bundled, so medications are not billed out separately. Answering the question about billing Medicaid for drugs purchased at 340B prices might seem straightforward, yet the intricacies of bundled claims in these centers often create ambiguity. The solution? Simplify the process: did you purchase medications at 340B prices? If yes, and if you're billing Medicaid Fee-For-Service (FFS), the answer on OPAIS should reflect that. In addition, OPAIS will prompt you to enter the Medicaid billing numbers based on the states where you are billing Medicaid FFS. If you need assistance locating this information, contact your billing department to learn more about your internal processes.
One of the most common pitfalls is the disparity between updates in the Electronic Handbook and the OPAIS database. Regular reviews, preferably quarterly, serve as the net to catch discrepancies and rectify them before they morph into compliance issues during a HRSA audit. As sites are being added to the Electronic Handbook, you must add those sites to OPAIS during the registration period, which runs from the first through the fifteenth of the first month of each quarter.
Annual recertification within OPAIS is a critical ritual. Overlooking this can jeopardize an entity's 340B eligibility. Ensuring all details are accurate, from the authorizing official, the primary contact, clinic locations, pharmacy shipping addresses, contract pharmacy locations, and Medicaid billing requirements is essential to maintaining compliance and eligibility.
Often overlooked, the 340B ceiling price tool is a hidden gem within OPAIS. It's a resource for covered entities to verify the 340B ceiling price at the beginning of each quarter, aiding in smoother negotiations with wholesalers for corrected pricing, which often can be completed in one to two days.
Designating the primary contact and authorizing officials within OPAIS is a strategic decision. The authorizing official, typically the CEO or CFO, holds legal responsibility and can bind the covered entity. By contrast, the primary contact is typically an individual who is more hands-on with the organization’s 340B Program and helps manage the database on a quarterly basis. This is often a Director of Pharmacy or Compliance.
While OPAIS is a frequent hotspot for HRSA audit findings, it's also a realm where entities can exert control. Regular engagement, review, and accuracy in the database ensure security in anticipation of an audit. External support in navigating OPAIS complexities can be immensely beneficial. Targeted reviews and ongoing checks ensure accuracy and alignment with the entity's activities, especially for those opting for monthly service or undergoing annual audits.
For those seeking guidance through this process, our team at FQHC 340B Compliance offers consulting services, where we conduct a thorough review of your OPAIS Database by comparing it to many different sources, such as the Electronic Handbook and your contract pharmacy agreements. In addition, we ensure that our clients are billing Medicaid in a manner consistent with how they have indicated on OPAIS.
Our team has decades of experience providing invaluable assistance in navigating the nuances of the OPAIS database. The OPAIS database isn't merely a repository of information; it is vital for a covered entity's success and compliance within the 340B Program. Reach out to our team today.
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FQHC 340B Compliance is the dedicated partner for Federally Qualified Health Centers seeking assistance with the 340B Program. Their mission is to provide the necessary resources to secure and optimize the 340B Program, enabling health centers to offer more comprehensive services to those in need. With a focus on improved compliance and oversight, they act as more than just consultants or automated systems, tailoring their services to meet your health center's unique needs. Visit their website, call (760) 780-7469, or email admin@fqhc340b.com to learn more about FQHC 340B Compliance and how they can help your health center thrive.
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