By Ryan Doskocil

Verity Solutions Account Manager

It’s no secret that 340B data accuracy is the sole responsibility of the Covered Entity, but sometimes the “source of truth” for data can be hazy. This is especially true when it comes to child sites and contract pharmacies. You may be attuned to the recent address change of your nearest clinic, and you may have heard your contracted big box pharmacy moved down the street, but when HRSA comes knocking with an audit request, you’ll need more concrete records at your disposal.

HRSA uses the OPAIS database (https://340bopais.hrsa.gov/) as a source of truth for your 340B program. If a contract pharmacy has a change of address, OPAIS will update their database to reflect it. This can cause problems, however, if the OPAIS record doesn’t match your Pharmacy Services Agreement contracts (such as different addresses, zip codes, etc.). Occasionally pharmacy information changes, and you won’t necessarily receive notice about it. In addition, OPAIS won’t automatically update changes to your CE, such as clinic status, address, contact information, or child sites. It can all be a bit of a moving target, so what’s the best way to navigate it?

As a best practice, your 340B Program Manager (or whoever is primarily responsible for your 340B program) should review the OPAIS record at least quarterly. During this review, check the following:

• All contract pharmacy locations listed in OPAIS match your PSAs for that relationship, including:
  • Pharmacy name
  • Store number
  • Address (including suite numbers)
  • City, State, and Zip (including trailing 4 digits if applicable)
  • All active sites are listed, and all inactive sites show the correct Term Date.
• Shipping addresses are accurate under the Shipping Addresses tab.
• Primary Contact and Authorizing Official contact information is complete and current.

Remember, the Contract Pharmacy information on the PSA contract must match OPAIS exactly. A HRSA auditor may fault a CE for even minor mismatches, such as a PSA reading “123 Main Street,” when the OPAIS record shows “123 Main Avenue,” or even “123 Southwest 1^st Street” instead of “123 SW First St.” It’s important to be diligent with your contracts to ensure these records are meticulously matched. If you find a mismatch during your regular checks, talk to your TPA or pharmacy contact to request an amendment to your PSA as soon as possible.

A CE cannot modify contract pharmacy information on the OPAIS record, but can modify and update information about the CE itself. However, only the Authorizing Official (AO) or Primary Contact (PC) can make changes to the OPAIS record.

Because these records often slip under the radar, they’re a common source of findings from a HRSA audit. Consider implementing these best practices today. They’re a quick and simple way to strengthen your 340B program compliance.