As of October 1, 2015, HRSA had posted the results of 103 covered entity audits to its website. According to the 2015 workplan and presentations at both the Winter and Summer 340B Coalitions, HRSA announced that they planned on performing at least 200 340B audits by the end of 2015. According to Apexus, HRSA did in fact complete 200 audits in 2015. HRSA’s fiscal year has come to a close and although not all of the audit results have been published, Southwest Consulting Associates (SCA) has analyzed what is available to establish trends in the findings.
Published Audit Results for 2015
Based on 2015 audits published through October 1, 20151, the percentage of audits breakdown as follows:
|
• DSH Hospitals |
55% |
|
• Community Health Centers |
13% |
|
• Children’s Hospitals |
1% |
|
• Critical Access Hospitals |
15% |
|
• Sole Community Hospitals |
3% |
|
• Other Centers |
13% |
In terms of results:
Adverse findings in 71% of the Covered Entities audited
27% were found with Diversion
30 entities had 340B drugs dispensed at contract pharmacies for prescriptions written at ineligible sites not supported by responsibility of care
12% were found with Duplicate Discounts
20 entities had an incorrect NPI or Medicaid Number listed in the Medicaid Exclusion File
42% were found with Incorrect Database
19 entities had 340B drugs administered at offsite outpatient facilities that were not listed in HRSA’s database
16 entities registered a Contract Pharmacy without a contract in place
Of the adverse finding group, 41% had multiple identified deficiencies
Repayments were required in 50% of the cases
Contract Pharmacy was terminated in 10% of the covered entities audited
We think the glaring takeaway from this analysis is that during a HRSA audit, most covered entities are found noncompliant in at least one area and many in multiple areas. Violations could put the facility at risk of being prohibited from future participation in the program and/or repayments to drug manufacturers. It is essential that participating facilities maintain auditable records and assess their level of compliance with ALL 340B drug pricing program rules. Covered entities should be performing regular self-audits and it is expected by HRSA that an annual independent audit is conducted.
Southwest Consulting Associates has experience in assisting clients through HRSA audits as well as performing third-party external audits to minimize or prevent adverse findings in a HRSA audit. To find out more about SCA’s 340B external audit program, please visit our website or request a proposal at 340B@southwestconsulting.net.
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1 Per HRSA website.