HRSA audits continue to focus on covered entities providing appropriate oversight of their contract pharmacy arrangements. The Office of Pharmacy Affairs issued Program Updates in 2014 and 2015 stating that, “vigilant oversight [of the contract pharmacy] is critical”. One measure of vigilant oversight expected by HRSA are annual audits performed by an independent entity. In addition to annual audits, the proposed Mega-Guidance introduced (as a separate compliance mechanism) that covered entities should be conducting quarterly audits of their contract pharmacy. Before the proposed Mega-Guidance, HRSA’s expectation was that covered entities perform oversight through periodic review of transactions at its contract pharmacies. The proposed Mega-Guidance defined periodic review as at least quarterly.
Contract pharmacy risk continues to stand out in HRSA audit results. On February 5, 2016, HRSA posted 20 additional covered entities’ audit results for FY 2015, increasing the total number of audits posted to 172. This also increased the number of contract pharmacy findings in FY 2015. Of the 172 audits posted, 89 (52%) had findings in their contract pharmacy. Click HERE for additional statistics on HRSA’s audit findings for covered entities with regards to contract pharmacy from FY 2015.
At a minimum, the covered entity should be comparing 340B prescribing records to the contract pharmacy 340B dispensing records and ensure there are no violations of the 340B Program requirements. It is the covered entity’s responsibility to provide oversight and ensure that their contract pharmacies are preventing diversion, duplicate discounts and maintaining auditable records. It is safe to conclude that there will be expanding pressure on the covered entity to do everything reasonable to ensure comprehensive compliance with the 340B program.
SCA continues to develop its service offerings in anticipation of changes in the regulatory environment and last year added quarterly monitoring to our 340B services to meet the changing needs of our clients. SCA reviews 100% of contract pharmacy prescriptions for provider eligibility, encounter eligibility and duplicate discounts. This also includes monitoring prescription reversals, targeting prescriptions that are a high risk for diversion and provide self-audit guidance. This helps narrow the focus of internal self-audits to high risk areas and saves staff time. What steps has your covered entity taken to comply with the changing expectations of HRSA in this area? Will you be in compliance when the associated Mega Guidance contract pharmacy proposed changes become final?
