Important HRSA Audit Updates for Covered Entities in FY26

As published in 340B Report

By: Dennis Killian, Pharm.D., Ph.D., 340B ACE 
Vice President, 340B Solutions 

HRSA has made several changes to the data request list (DRL) for fiscal year 2026 that covered entities (CEs) need to be aware of in the event of a HRSA audit. The DRL, which HRSA provides to CEs in the initial stages of the audit process, delineates all the information an auditor has requested a CE to provide before the on-site or remote HRSA audit.

The changes and explanations described below also appear within the sample copy of the updated DRL, which is available from the 340B Prime Vendor Program (PVP) website.  

Changes & Explanations 

Section 2: Provide CE Eligibility Documentation  

Section 2B has a new statement directing CEs to include any amended Medicare cost reports (MCRs).  

• Explanation: This change emphasizes that CEs need to submit all MCRs filed during the sample period through the date of the HRSA audit. 

Section 2C phrasing was modified from “For each off-site facility that uses 340B drugs at the facility…” to the following statement: “For each service area/clinic that administers 340B drugs as part of medical encounters or generates prescriptions deemed 340B-eligible at entity-owned or contract pharmacies…” 

• Explanation: The new statement indicates the service area/clinic may administer 340B drugs or generate prescriptions that may be 340B eligible. While the previous version’s language implied this sentiment, the revision clearly outlines both scenarios.  

Section 3: Provide a 340B Universe for the Sample Period 

Section 3C now includes additional clarifying information for 340B drug transactions in two areas: (1) the word “furnished” was added to this section’s initial phrasing, and (2) both data elements pertaining to dates were amended to clarify those for hospital-administered drugs. 

• Explanation: (1) The use of “furnished” indicates a broader scope than dispensed, which may include additional methods in which CEs supply drugs to patients. (2) Additional clarification for hospital-administered drugs indicates that the data set should include both “time the drug was ordered” and “the time the drug was administered.”

Section 5: Provide Purchasing Documentation 

Section 5A has several modifications and additions related to pharmaceutical purchasing accounts. Additional questions for each purchasing account were also included.

• Explanation: These changes expand this section’s scope to ensure inclusion of all locations receiving 340B-priced drugs.  

Completing Section 5A is usually resource-intensive for CEs, and the additional questions therein may make it even more time consuming than before.  

Section 7: Provide Documentation for Any Location 

Section 7 now uses “location” instead of “pharmacy” in several instances; additionally, “state-issued pharmacy license for any entity-owned pharmacy” now appears as a separate bullet from the ownership one listed above it. 

• Explanation: This change indicates CEs should include all locations (other than contract pharmacies) that receive 340B-priced drugs. With the “state-issued pharmacy license” separately listed for any entity-owned pharmacy, CEs will need additional documentation to demonstrate pharmacy ownership (i.e., business license, certificate of liability insurance, or listing on the CE’s grant or MCR and corresponding trial balance).   

Section 9: Provide Medicaid Billing Documentation 

Section 9A and 9D now both include the word “furnished” in addition to “administered or dispensed” as they relate to 340B-priced drugs billed to Medicaid fee-for-service.  

• Explanation: Similar to the update in Section 3C, the use of “furnished” indicates a broader scope than dispensed, which may include additional methods in which CEs supply drugs to patients. 

Why This Information Matters 

Keeping abreast of DRL changes is critical for CEs to maintain a state of continual readiness for a HRSA audit. As a best practice, DRLs utilized during annual external audits should align with HRSA’s updated data request. While some DRL changes are minor in nature, they appear to indicate increased scrutiny related to locations receiving 340B-priced drugs and the demonstration of CE ownership for applicable locations (e.g., CE-owned pharmacies). Some of the more significant DRL changes may also make the process more time-consuming for your team to complete.  

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