Grantee Site Visits

October 2014

HRSA has provided information to stakeholders on many aspects of 340B Program integrity efforts. This month, we’d like to focus on the expansion of our oversight of HRSA Grantees in the Bureau of Primary Health Care and the HIV/AIDS Bureau through the addition of a 340B Drug Pricing Program Assessment Supplement to program site visits. 

Starting in Fiscal Year 2015, grantees that participate in the 340B program and are scheduled for a HRSA site visit will be asked to demonstrate compliance with the 340B program. While the primary focus of the site visit remains on the HRSA grant, several basic questions will serve as an important reminder for grantees of the importance of 340B compliance, as well as a potential trigger for further investigation by the Office of Pharmacy Affairs (OPA). As a result of these site visits, the OPA will also be able to highlight best practices to assist covered entities with compliance. Our goal is to maximize the reach of our program integrity efforts, while ensuring transparency for all stakeholders to understand 340B compliance requirements and site visit expectations.

Site Visit Preparation

In general, covered entities should be able to efficiently and effectively prevent compliance issues and identify any material breach; propose a plan for periodic assessment and continuous monitoring; and outline a clear method to monitor contract pharmacies to maintain compliance with program requirements. Successful covered entities have also routinely identified annual policy review date, entity contact person, and clarified an internal 340B communication/education strategy.

Due to the diversity of covered entities and the need for flexibility in program implementation, HRSA recommends that each covered entity establish and document criterion that demonstrates compliance for the following requirements as outlined below.

1. Be prepared to share your organization’s 340B policies, procedures, and other related documents in order to document they address the following:
   1. Patient Definition
      1. Individuals provided access to 340B drugs purchased by the covered entity have an established relationship with the patient as documented by the covered entities maintaining records of that individuals healthcare.
      2. Individuals provided access to 340B drugs purchased by the covered entity have received healthcare services from a healthcare professional who is either employed by the covered entity or under contractual or other arrangements (e.g., referral for consultation) such that responsibility for care provided remains with the covered entity; i.e., 340B prescriptions are only made available that receive services that are either provided directly by the covered entity/or through formal written referral arrangements.
      3. 340B drugs purchased/dispensed by the covered entity to such individuals are consistent with the service or range of services for which grant funding was approved.
   2. Duplicate Discount
      1. The covered entity has the ability to prevent duplicate discounts for patients covered under Medicaid and who receive a 340B drug.
   3. Contract Pharmacy
      If the covered entity dispenses 340B drugs to patients through a contract pharmacy services model the covered entity should be prepared to provide the following:
      1. The written contract between the covered entity and the contract pharmacy.
      2. Policies, procedures, and/or other documents as to how the contract pharmacy will prevent diversion.
      3. Policies, procedures and/or other documents as to how the contract pharmacy will prevent duplicate discounts.
      4. How the covered entity provides oversight (e.g., annual audit or other mechanism) of the 340B drugs dispensed by the contract pharmacy.

Technical Assistance

There are many tools and resources available to 340B stakeholders to ensure compliance with 340B Program requirements. The 340B Prime Vendor Program, managed by Apexus, provides assistance with creating appropriate policies and procedures to address the criteria listed above.