HRSA Publishes More Information About 340B Audits

by admin | June 21, 2012 8:34 am

June 21, 2012—The Health Resources and Services Administration (HRSA) has issued a document[1] to give 340B stakeholders a clearer picture of what it is looking for when it audits a 340B covered entity and its overall process for conducting such reviews.

The document, however, does not include the actual protocol that HRSA is using to conduct the audits. [ms-protect-content id=”2799″]HRSA previously said it would release it to help covered entities prepare for an audit.  But an agency spokesperson said yesterday that “the audit protocol will not be made public.”

“The document posted [yesterday] does outline the overall process so entities and manufacturers have transparency into the process,” the spokesperson said.

In the new document, HRSA said the audits’ purpose is to determine:

• if covered entities and their satellite facilities are eligible for the program;
• if they comply with applicable prohibitions on using a group purchasing organization (GPO) for outpatient purchases;
• if they comply with rules against drug diversion; and
• if they have safeguards to protect manufacturers from paying both 340B discounts to covered entities and rebates to state Medicaid agencies.

According to the document, HRSA officials who conduct the audits will disclose their preliminary findings to covered entities during an exit interview. HRSA’s Office of Pharmacy Affairs (OPA) will then review those findings and work with the covered entity “to obtain any necessary additional information, address any concerns, and discuss the appropriate remedy and required corrective action(s), including potential removal from the 340B program and/or repayment to manufacturers.” When the audit report becomes final, OPA is to post a summary of the findings and the entity’s response on its Web site.

The document does not mention a right to appeal an adverse finding or say to whom an appeal could be made.

The one-page document, entitled “HRSA 340B Program Audits,” was posted on the OPA Web site on June 21. Late last week, the Senate Appropriations Committee urged HRSA[2] “to make public information on the general audit process, including areas of review, as soon as possible and consider suspending audits until this information is publicly available.” The committee made the request in the report that accompanied its fiscal 2013 spending bill for health care and other domestic programs.

During the audit initiative’s test phase late last year, OPA said it intended to make both its audit protocol and its selection criteria publicly available[3] prior to the audits’ commencement. The office described the selection criteria, but not the protocol, in a March 5 clarification of its audit policy[4]. Nearly 40 of the 50 government audits planned for this year have already been conducted. It is not clear whether OPA issued yesterday’s document in direct response to the Appropriation Committee’s request and whether it will satisfy its concerns.

HRSA said its audit process has three stages: pre-audit, onsite audit, and post-audit. It described them as follows:

Pre-Audit 

• Covered entities selected for audit receive an engagement letter explaining what to expect and how to appropriately prepare.
• HRSA regional auditors conduct an introductory teleconference with the entity to request and obtain specified documents, including policies, procedures, and internal controls.
• HRSA regional auditors work with the entity to schedule an entrance conference with key entity management to discuss expectations for the onsite audit.

Onsite Audit

• HRSA regional auditors obtain and review select program data and internal controls.
• Audit procedures include, at a minimum:
  • review of relevant policies and procedures and how they are operationalized;
  • verification of eligibility, including GPO and outpatient clinic eligibility;
  • verification of internal controls to prevent diversion and duplicate discounts, including appropriateness of inpatient/outpatient designations and Medicaid exclusion file designations;
  • review of contract pharmacy compliance; and
  • test 340B drug transaction records on a sample basis.
  • HRSA regional auditors conduct an exit interview, sharing areas of concern and preliminary findings.

Post-Audit

• HRSA regional auditors forward preliminary findings to OPA for review.
• OPA reviews the preliminary findings and works directly with the covered entity to obtain any necessary additional information, address any concerns and discuss the appropriate remedy and required corrective action(s), including potential removal from the 340B program and/or repayment to manufacturers.
• Once an audit report is finalized by OPA, the findings and the entity’s response will be summarized on the OPA public Web site at www.hrsa.gov/opa[5].
• OPA will pursue further follow up with the entity as needed.[/ms-protect-content]

Source URL: https://340bemployed.org/hrsa-publishes-more-information-about-340b-audits/

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