340B Registration

Participation in the 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. allows nonprofit healthcare organizations to receive outpatient drugs at significantly reduced prices. In order to participate in the 340B drug pricing program, organizations must register using 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).. Registration occurs four times a year between the first and 15th days of January, April, July, and October. Registration periods last for 15 days, excluding federal holidays. Registrations must be submitted to OPA by the Authorizing Official prior to the end of the registration period. 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.

The registration links are not active until OPA staff open the registration period.

Once registered and approved, an entity will be recognized as being active the first day of the following quarter. For example, if an entity registers in October, it will be recognized as active on January 1 of the following year.

In addition to registering the main entity, off-site outpatient facilities who wish to purchase 340B drugs or provide 340B drugs to their patients must also be registered.

340B OPAIS is updated daily with information for those entities that are eligible for the program. The hospital or non-hospital being registered must already exist in the application. That information comes from files provided by 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. Health Cost Report Information System (HCRIS Healthcare Cost Report Information System – HCRIS contains annual reports submitted by healthcare providers to Medicare. It provides information to CMS that assists with the annual settlement summary between CMS and healthcare providers.) and PECOS (Provider Enrollment, Chain & Ownership System). The Medical Provider Number (MPN) is used as the unique identifier for each entity.