Getting Started
Introduction
The 
Health Resources and Services Administration (HRSA) An agency of the U.S. Department of Health and Human Services, HRSA is the primary federal agency for improving access to health care services for people who are uninsured, isolated, or medically vulnerable., Healthcare Systems Bureau, Office of PharmacyAffairs (OPA), administers the 340B Drug Pricing Program (340B Program The federal drug discount program authorized under section 340B of the Public Health Service Act and established by Congress under the Veterans Health Care Act of 1992 (Public Law 102-585, codified at 42 USC § 256b). The 340B program requires drug manufacturers to enter into pharmaceutical pricing agreements with the HHS Secretary, under which manufacturers agree not to sell covered outpatient drugs to covered entities above 340B ceiling prices.) established by section 340B of the Public Health Service Act (PHSA). Manufacturers participating in Medicaid enter into an agreement with the Department of Health and Human Services (HHS) and agree tocharge 340B covered entities a price that does not exceed the statutorily defined ceiling price.
Section 340B(d)(1)(B) of the PHSA requires HRSA to collect information from manufacturers to verify the accuracy of 340B ceiling prices and then make the ceiling prices available to covered entities. To this end, HRSA developed an integrated information system of which the pricing component is one piece.
The system focuses on three key priorities: security, user accessibility, and data accuracy. The integrated system also includes an updated and enhanced 340B registration system for covered entity and manufacturer registrations to strengthen the integrity and effectiveness of all 340B stakeholder information. The 340B Office of Pharmacy Affairs Information System (340B OPAIS The 340B Office of Pharmacy Affairs Information System (OPAIS) is a collection of information submitted by covered entities, contract pharmacies, and manufacturers maintained and verified by HRSA's Office of Pharmacy Affairs (OPA).) functions as one system, though it has two separate components which include a covered entity and manufacturer registration component and a secure pricing component.
The 340B OPAIS pricing component is the official federal source for 340B ceiling prices, and it calculates those prices based on information supplied by manufacturers, the Centers for Medicare & Medicaid Services (CMS Centers for Medicare and Medicaid Services, the federal agency within Health and Human Services (HHS) that administers the Medicare and Medicaid programs, including the Medicaid drug rebate program and the Medicare Part D prescription drug benefit.), and First Data Bank (FDB First Databank, Inc., is the publisher of pharmaceutical information that is used within healthcare information systems serving hospitals, physician practices, other providers, payers, retail pharmacies, state health programs, and others for the purpose of medication decision support and negotiating reimbursement rates paid to pharmacies and other providers.). Ceiling prices are considered confidential information due to the proprietary nature of the underlying data.
The 340B OPAIS pricing component is a secure web-based application that allows manufacturers participating in the 340B Program the ability to easily upload and submit their quarterly pricing data for their portfolio of covered outpatient drugs to HRSA and validate their prices with the HRSA calculated 340B ceiling price. The 340B OPAIS pricing component increases the efficiency of data submissions, improves data integrity, and is user friendly. The system allows for secure manufacturer submissions through data encryption and storage in a secure manner with defined access controls and data security classifications. Manufacturers are notified of any potential discrepancies in pricing data and are given an opportunity to reconcile the pricing data before HRSA verifies and posts the final 340B ceiling price for authorized covered entity users.
Access to the 340B OPAIS Pricing component is restricted to authenticated and authorized users based on account roles and permissions that limit the unauthorized re disclosure of privileged pricing data. In order to access the system, a manufacturer Authoring Official (AO) and Primary Contact (PC External user who is designated as a Primary Contact for an entity. This user can enter registrations and update entity information. This user can enter registrations, and update entity information. Any changes to an entity performed by the PC user must be attested to by the AO for that entity.) must obtain a user account and each time the user logs into the 340B OPAIS they must acknowledge and agree to the 340B OPAIS Rules of Behavior. This process allows HRSA to validate the user’s status as a participating drug manufacturer in the 340B Program. Manufacturers will only have access to pricing data for their designated labeler codes. Authorized users from covered entities will have view only access to verified 340B ceiling prices for covered outpatient drugs
Information on the 340B statute, regulations, and program guidance required for manufacturer participation in the 340B Drug Pricing Program can be found on the HRSA Office of Pharmacy Affairs website at HRSA OPA Homepage.
| Component | Description |
|---|---|
| Security | The 340B pricing component security requires a user account. Users log in using their email address as their ID and enter a two-step authentication code that is sent to their email address. Each time the user logs into the system, the user must accept the 340B Rules of Behavior to access the system. |
| Appearance | The 340B Pricing component has been integrated and combined with the 340B Database that was previously used for covered entity registrations to form the 340B OPAIS. |
| Manufacturer Dashboard | The manufacturer dashboard contains widgets that display the manufacturer’s quarterly progress and assigned reconciliation tasks. |
| Uploading Quarterly Pricing Data | The system allows for manual entry and /or .txt file upload of the specific data fields requested by OPA on a quarterly basis. |
| Reconciliation Features | A reconciliation task is assigned when there is a discrepancy between the manufacturer’s data point and a HRSA’s data point. The task requires that the manufacturer reconcile the pricing data point(s) in question. |
