340B Manufacturer Update

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 System

The 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:

• HRSA obtains relevant data points for each covered outpatient drug from the Centers for Medicare & Medicaid Services (CMS) including the average manufacturer price (AMP) and the unit rebate amount (URA).  Package size and case package size will be obtained from First Databank (FDB), a third party commercial data broker.  The 340B ceiling price (AMP minus URA) and a package adjusted price (340B ceiling price multiplied by package size and case package size) is then computed in the 340B OPAIS.
• The manufacturer AO or PC will then submit corresponding data points to HRSA via the 340B OPAIS.  The manufacturer’s data will be compared to the same data obtained from CMS and FDB and any discrepancies between HRSA and manufacturer-calculated 340B ceiling prices will be automatically identified and brought to the attention of the manufacturer AO and PC.  The manufacturer AO or PC will have the ability to reconcile data discrepancies and upload replacement data if appropriate to assist HRSA in its adjudication of the 340B ceiling price and the package adjusted price.
• Once HRSA adjudicates any data discrepancies, the 340B ceiling price and a package adjusted price will be published in the 340B OPAIS and be available for viewing by authorized covered entity AO and PC users.

Important Dates and Next Steps

1. Manufacturers must verify the accuracy and completeness of the information on file for each labeler code in the 340B OPAIS, including the contact information for AOs and PCs.  If the manufacturer’s record is not accurate, please submit an online change request as soon as possible.  To learn more about how a manufacturer can manage its 340B OPAIS record(s) please view the recorded tutorials available in the 340B OPAIS educational resources section at https://www.hrsa.gov/opa/340b-opais/index.html.
2. To access the pricing component and load data in a secure manner, AOs and PCs must first create a user-name and password.  Only the individuals with an email address that have been listed as a manufacturer AO or PC for a particular labeler code will be able to access the pricing component and upload data for that specific labeler code. To learn more about how to create a 340B OPAIS user account, please view the recorded tutorials available in the 340B OPAIS educational resource section at (https://www.hrsa.gov/opa/340b-opais/index.html).
3. Manufacturers should begin now to prepare data submissions to HRSA.  The pricing component of the 340B OPAIS will be available for approximately two-weeks each quarter for manufacturers to upload their data.  The first two-week manufacturer submission period is February 15, 2019 through March 4, 2019.  Registered manufacturer AOs and PCs will receive an email to alert them that the pricing upload period is open.  During this two-week period, manufacturer AOs and PCs will have unlimited system access to upload their data.

Uploading Data

Manufacturers 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 Education

In 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.