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HRSA Audits Are Inevitable. Preparation Ensures Success.

To navigate the complexities of the 340B Drug Pricing Program, covered entities must regularly scrutinize the systems that support program implementation and management.  In their quest to serve patient populations as effectively and consistently as possible, covered entities are tasked with maintaining a state of continuous readiness for inevitable HRSA audits. 

In preparing for a HRSA audit, the CPS 340B Solutions team recommends conducting regular internal audits to identify issues before they lead to larger problems.  Not only does this approach support program health, it provides assurance to the covered entity that it is prepared for any scrutiny that comes its way.

Let’s explore best practices for maintaining audit readiness, as recommended by the CPS 340B team.

Policy and Procedure Review

The CPS 340B Solutions team recommends a review of policies and procedures:

1) At least annually, or
2) Any time there is a change in process or 340B rules

The pace at which regulations can change can make covered entities vulnerable, especially if they are not accustomed to maintaining constant visibility to updates. By being vigilant in their review processes, covered entities know they are aligned with HRSA guidance and operating a compliant program.

Regular evaluation of policy and procedure processes helps ensure that auditable records are accessible. It also ensures that the right data is collected and managed appropriately, allowing the covered entity to produce the reports needed to demonstrate compliance.
If the above is not happening, then procedures should likely be changed.

The CPS 340B Solutions team recommends that reviews take place within the multidisciplinary structure of a 340B Oversight Committee:

1) Any time there is a change in clinic/child site status, or
2) Any time there is a potential change in 340B eligibility for the entity or any portion of the entity

Staff from different areas of the hospital will provide diverse perspectives of areas for inclusion within policies and procedures, including:

1) What is working
2) What is not working
3) How to correct issues

The 340B Solutions team suggests recruiting representatives from areas across the organization, including pharmacy, hospital leadership, finance, billing, information technology, risk management, and quality control. Regular, year-round policy reviews will allow the organization to make updates that ensure that the entity is consistently up to date with HRSA guidance.

Quarterly Review of OPAIS

HRSA is required to collect information from manufacturers to verify the accuracy of 340B ceiling prices and then make those ceiling prices available to covered entities. HRSA stores this information in its integrated system, known as the 340B Office of Pharmacy Affairs Information System (OPAIS).

To keep your internal pricing information current, covered entities should confirm that they are reviewing the information in OPAIS each quarter to keep their internal pricing information current. In addition, OPAIS posts regular updates to 340B-related questions and answers to inform covered entities of 340B details.

Monthly Transaction Review

To be prepared for an audit, organizations should have all records required by HRSA up to date and readily available. HRSA provides a data request list to communicate exactly what they will be looking for in the audit ahead of time. It is prudent to perform a “dry run” to generate this information. If you wait until the data is requested, it may take too long to generate the reports.

It is important to confirm that the medical staff office or the applicable department of the health system is keeping the provider list current and communicating it to the individual responsible for maintaining the updates. This should be done no less often than monthly, as well as anytime there is an addition or deletion of a provider from the formal list.

It is additionally important to organize data in such a manner that someone other than the pharmacy director can identify how to access reports. This practice ensures that if the pharmacy director is not available when the HRSA auditor is on-site, then the reports still can be located and provided to the HRSA auditor.


Information uncovered during the internal audit process will shine a light on areas of opportunity where a system can be improved, thereby supporting audit readiness. For assistance with internal audits, contact the CPS 340B Solutions team: 

Posted: Monday, April 19, 2021

Tags: 340B,340B Contract Pharmacies,CPS, Blog