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Section 340B(a)(1) of the Public Health Service Act (PHSA) requires that the Secretary of Health and Human Services (the Secretary) enter into a pharmaceutical pricing agreement (PPA) with each manufacturer of covered outpatient drugs in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed an amount determined under the statute (340B ceiling price).
The 340B statute further states the following:
- The Agreement “shall require that the manufacturer furnish the Secretary with reports, on a quarterly basis, of the price for each covered outpatient drug subject to the agreement that, according to the manufacturer, represents the maximum price that covered entities may permissibly be required to pay for the drug”; and
- The Agreement “shall require that the manufacturer offer each covered entity covered outpatient drugs for purchase at or below the applicable ceiling price if such drug is made available to any other purchaser at any price.”
The PPA, and the subsequent PPA Addendum, must be signed by a manufacturer as a condition for participating in the Medicaid program. Signing the PPA does not prohibit a manufacturer from charging a price for a covered outpatient drug that is lower than the 340B ceiling price. A manufacturer may not condition the offer of 340B discounts upon a covered entity's assurance of compliance with section 340B Program requirements.
The integrated 340B Office of Pharmacy Affairs Information System (340B OPAIS), includes an updated and enhanced 340B registration system for covered entity and manufacturer registrations and a secure, web-based application that allows manufacturers participating in the 340B Program the ability to easily upload and submit their quarterly pricing data. The pricing component of 340B OPAIS also allows HRSA to validate manufacturer-submitted data, and once validated, authorized covered entity users will have access to the pricing component of the system to view 340B ceiling prices.
Access to the 340B OPAIS pricing component is restricted to authenticated and authorized users based on account roles and permissions to limit the unauthorized re-disclosure of privileged pricing data. In order to access the system, a manufacturer’s Authoring Official (AO) and Primary Contact (PC) 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.
Manufacturers Must Meet the Following Requirements:
- Sign a Pharmaceutical Pricing Agreement and Addendum. (340B OPAIS Account Creation and Manufacturer PPA/PPA Addendum registration tutorial can be found on the 340B Office of Pharmacy Affairs Information System page.)
- Register with 340B OPAIS and routinely verify that manufacturer information is accurate and up-to-date.
- Submit quarterly pricing data through the pricing component of the 340B OPAIS.
- Comply with all 340B Program requirements.