The Health Resources and Services Administration (HRSA), Healthcare Systems Bureau (HSB), Office of Pharmacy Affairs (OPA) is providing an update to manufacturers participating in the 340B Drug Pricing Program (340B Program). The 340B Office of Pharmacy Affairs Information SystemThe secure pricing component of the 340B Office of Pharmacy Affairs Information System (340B OPAIS) will be open for the submission of manufacturer pricing data in the first quarter of 2019. The system includes security safeguards to protect privileged pricing data from unauthorized re-disclosure, including the strict segregation of each manufacturer’s data. The manufacturer Authorizing Official (AO) and Primary Contact (PC) listed in the 340B OPAIS will have access to the pricing component of the 340B OPAIS only for the labeler codes associated with their 340B OPAIS user account. The following details the workflow from data submission to price publication:
Important Dates and Next Steps
Uploading DataManufacturers have two ways of uploading data into the 340B OPAIS. Data can be uploaded as a fixed length.txt instrument file or the data can be entered manually. If a manufacturer decides to upload their data as a fixed length .txt instrument file, it must be in the .txt file format identified below. To assist manufacturers in preparing to collect the required data for submission, we have included a list of the required fields for the .txt file submission in the chart below.
Additional Information and EducationIn the coming weeks, additional information on the pricing component of the 340B OPAIS, including tutorials and FAQs, will be posted on the OPA website. HRSA encourages all stakeholders to regularly check the OPA website (http://www.hrsa.gov/opa) for announcements and further information. HRSA will host a manufacturer-specific webinar on Tuesday, January 22, 2019 to provide an overview of the pricing component of the 340B OPAIS and provide additional details for how to upload data in the system. Please stay tuned for further information on how to register for the webinar. |
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