(NOTE: The purpose of this article is to explore 340B program requirements and the process of enrolling. If you’re not already familiar with the program’s benefits, and how it can work for your Health System, Click Here.)

340B-Eligible Entities

The first step in preparing your health system for enrollment in the 340B program is to ensure that you are indeed eligible to participate.

Here’s a comprehensive list of eligible entities.

Health Centers

Ryan White HIV/AIDS Program Grantees


 Specialized Clinics

Getting started with the 340B Program

The 340B Drug Pricing Program is administered by HRSA’s Office of Pharmacy Affairs (OPA).

MANUFACTURERS’ RESPONSIBILITY: Manufacturers participating in Medicaid are legally bound by an agreement with Health and Human Services ensuring that they will not charge covered entities prescription-replenishment prices that exceed the 340B program’s ceiling prices.

GOVERNMENT’S RESPONSIBILITY: The agreement requires the government to disclose — both to drug manufacturers and State Medicaid agencies — the identity of all covered entities. The 340B registration and pricing databases, which are known as the 340B Office of Pharmacy Affairs Information System (OPAIS), was created to meet these requirements.

The purpose of the 340B OPAIS public access system is to enable manufacturers and wholesalers to verify that all organizations requesting 340B pricing are active, eligible participants in the 340B program. New registrations from eligible organizations and their contracted pharmacy partners are accepted the first two weeks of every quarter.

OPA staff reviews and validates all registration records. Approved entities may begin accessing 340B program discounts at the start of quarter after they’ve been accepted. Once approved, participants must annually recertify their continued eligibility — as well as their compliance with the 340B program’s requirements.

340B Enrollment: Enrolling in the 340B drug program

To register, an eligible entity must have a 340B Office of Pharmacy Affairs (340B OPAIS) user account. To get started, visit the 340B OPAIS Registration page, and select the appropriate link toward the bottom of the page — either Grantee Registration or Hospital Registration.

The system should run you through the process from there. One critical consideration you should be aware of is that you must complete your registration in a single session. Which is why you’ll need to have your latest filed Medicare cost report handy while you’re completing the process.

What’s more, you’ll need to enroll your main location first, then add any Child Sites. We’ll discuss child sites later in this article.

What makes patients eligible for the 340B program?

First, patients must be outpatients, and they must receive care at a 340B eligible location or clinic.

Second, prescriptions must be written either by one of the entity’s providers, either employed or contracted.

Third, there must be a record of the care provided to demonstrate that the responsibility of care rests with the covered entity.

Finally, patients’ 340B-eligible prescriptions must be filled at one of the covered entity’s registered 340B pharmacies in order to realize the 340B savings available through a contract pharmacy arrangement..

What is a 340B Child Site?

A 340B Child Site is defined as an off-site outpatient clinic or location that uses, or purchases, 340B drugs for its patients. “Offsite” generally means a location has a separate physical address than the hospital parent site, and is not located within the main hospital. Outpatient facilities are eligible child sites of 340B hospitals under the following circumstances:

  • The outpatient facility is listed as a reimbursable facility on a 340B-covered entity’s most-recently filed Medicare cost report, and has associated outpatient costs and charges.

NOTE: If a facility is a free-standing clinic of the hospital that submits its own cost reports, using a different Medicare number from the covered entity, then it is NOT eligible.

  • All clinics located off-site of parent hospitals (regardless of whether those clinics are in the same offsite building) must register as child sites of the 340B-eligible parent hospitals if the covered entities purchase and/or provide 340B drugs to patients of those facilities.

Managing your 340B program

A 340B program requires careful, experienced oversight to ensure that your savings are optimized while — at the same time — maintaining compliance. Which is why you’ll need to dedicate a reliable professional to manage that ongoing task.

It’s a time-consuming responsibility, which is why so many hospitals rely on ProxsysRx’s professionals to manage their 340B programs for them.

ProxsysRx is here to help, if you have questions.

There are so many ways to optimize your 340B drug program savings & benefits, and overcome manufacturer restrictions while still minimizing the likelihood of noncompliance. For more information, contact Howard Hall. C: 214.808.2700 | howard.hall@proxsysrx.com