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Section 340B(a)(1) of the Public Health Service Act requires that the Secretary of Health and Human Services enter into a Pharmaceutical Pricing Agreement (PPA) with each manufacturer of covered outpatient drugs.
The manufacturer must:
- Offer each covered entity covered outpatient drugs for purchase at or below the ceiling price if the drug is made available to other purchasers at any price.
- Provide the Secretary with quarterly reports on the price of each covered outpatient drug that shows the maximum price covered entities may pay for the drug.
A manufacturer must sign the PPA and PPA Addendum (PDF - 103 KB) as a condition for participating in the Medicaid program. Signing the PPA doesn't stop 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 340B Office of Pharmacy Affairs Information System (OPAIS) has an updated registration system for covered entity and manufacturer registrations. 340B OPAIS allows manufacturers to securely and easily upload and submit their quarterly pricing data. The pricing component of 340B OPAIS allows us (the Office of Pharmacy Affairs or OPA) to validate manufacturer-submitted data. After validation, authorized covered entity users will have access to the pricing component of the system to view 340B ceiling prices.
Under the 340B OPAIS pricing component, access is restricted to authenticated and authorized users based on account roles and permissions to limit the unauthorized re-disclosure of privileged pricing data. To access the system, a manufacturer’s Authoring Official (AO) and Primary Contact (PC) must obtain a user account. Each time the user logs into the 340B OPAIS, they must acknowledge and agree to the 340B OPAIS Rules of Behavior. This process allows us 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 these requirements:
- Sign a PPA and PPA Addendum
- Register with 340B OPAIS – routinely verify that manufacturer information is accurate and up-to-date
- Submit quarterly pricing data in 340B OPAIS
- Comply with all 340B Program requirements
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