The Health Resources and Services Administration (HRSA)’s Office of Pharmacy Affairs (OPA) has announced it will replace its current database with a new system, the Office of Pharmacy Affairs Information System (OPAIS). When launched, OPAIS will serve as the 340B registration and pricing system for covered entities and manufacturers. Estimated launch date is October 2017. Here are key takeaways of OPAIS from the 2017 340B Coalition Summer Conference session with Josh Volpe, Public Health Analyst at HRSA.
New features:
two-step authentication process for each instance of login
user defined access
pricing upload and viewing
user accessibility to change records
email communication for registration/change requests
User defined access:
Public users can search covered entity and contract pharmacy reports and files, and can export data on Medicaid exclusion files, contract pharmacy carve-ins and daily reports but cannot view ceiling prices.
Authorizing Official (AO) and Primary Contacts (PC) level access can register, terminate, and reinstate covered entities. AO and PC can register and terminate contract pharmacies, submit change requests in the registration system, and view ceiling prices. The AO must review and attest to any change the PC requests.
The AO and PC must be different individuals for the covered entity 340B ID. There will be only one AO and one PC account per 340B ID.
Hospital Child Sites: OPAIS requires the same AO for both parent and child sites, but the PC must be a different individual than the AO. Each child site may have a different PC than the parent site.
Requirements to be an Authorizing Official (AO):
Individual is fully authorized to legally bind the Covered Entity (CE)
Hospital’s AO would be CEO, CFO, COO, President, Vice-President or equivalent
Non-hospital’s AO is any one individual who can legally bind the CE and be responsible for compliance
Not a consultant
Requirements to be a Primary Contact (PC):
Employee of the CE designated by the AO to request and receive communication regarding compliance and audits
Not a consultant
Covered Entity eligibility requirements have not changed.
The OPA Home Page will have announcements including start date, webinars and tutorials on OPAIS. It is advised for users to verify current contact information in the 340B Database to expedite communication from OPA regarding updates on OPAIS. Annual August recertification is delayed until October, pending implementation of OPAIS. Further notification will be posted on OPA’s website:
