The 340B Program enables covered entities to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services. Manufacturers participating in Medicaid agree to provide outpatient drugs to covered entities at significantly reduced prices.

Covered entities must immediately notify the Office of Pharmacy Affairs (OPA) in 340B OPAIS when there is a change in their eligibility, and stop purchasing drugs through the 340B Drug Pricing Program.

Our website provides resources to help 340B Program stakeholders with navigating the 340B Program, including registration and implementation, requirements compliance, program integrity, and more: Educational webinars; FAQs; Monthly program updates; Audit results; Manufacturer notices; Listen to our 340B Welcome Webinar for an introduction to ...

Covered entities must meet these requirements to purchase drugs at 340B prices: Keep 340B Office of Pharmacy Affairs Information System (OPAIS) records accurate and up to date . Register all outpatient facilities and contract pharmacies.

We have developed a new, integrated information system that focuses on three key priorities: security, user accessibility, and data accuracy.The 340B registration and pricing databases are known as the 340B Office of Pharmacy Affairs Information System (340B OPAIS).

Under section 340B(a) of the Public Health Service Act (PHSA), the 340B ceiling price is calculated by subtracting the unit rebate amount (URA) from the average manufacturer price (AMP) for the smallest unit of measure of each covered outpatient drug (as identified by the product's 11-digit National Drug Code (NDC).

To participate in the 340B Program, eligible hospitals must first register in the 340B Office of Pharmacy Affairs Information System (OPAIS). Do this during one of the quarterly registration periods. Have these documents with you when you register your hospital: Hospital’s latest filed Medicare cost report; Worksheet E Part A (line 33)

What should you do before you register for the 340B Program? Review detailed 340B Program hospital registration instructions, including how to convert from one hospital type to another. Set up your account. To register, you must have a 340B Office of Pharmacy Affairs Information System (340B OPAIS) user account.

Click here for more information on 340B Program Eligibility and Registration (https://www.hrsa.gov/opa/eligibility-and-registration/index.html). Registration is initiated through the Register Covered Entity and/or Outpatient Facility link on the 340B home page or by clicking the large Register icon and selecting the Covered Entities option.

HRSA’s 340B Program audits review covered entity compliance with several statutory provisions, including eligibility status, duplicate discounts, and diversion in accordance with sections 340B(a)(4), (5)(A) and (B) of the PHSA.