Southwest Consulting Associates Blog

There is a considerable number of moving parts associated with 340B compliance and ongoing monitoring by the covered entity is essential for a successful program. As we perform independent 340B compliance audits across the country, we find that contract pharmacy is by far the highest compliance risk area of the 340B Drug Pricing Program. Over half of all HRSA audit findings are in the 340B contract pharmacy component, as well as paybacks to the drug manufacturers.

Southwest Consulting Associates will be participating in the 33rd Annual Conference of the Texas Association of Community Health Centers (TACHC) this month and we have been looking back over 340B compliance audits that we have performed for CHCs this year to be able to provide some insight on common findings. In 2015, HRSA added some basic 340B compliance questions to the regular grant operational site visit to potentially identify covered entities that need further investigation of their 340B compliance. These questions revolve around 340B policies and procedures, self-auditing and 340B monitoring. Basically, if you don’t have 340B policies and procedures and you have not set up a self-auditing program for 340B compliance monitoring, it is very likely that your entity will move up the list for a HRSA 340B Compliance Audit.

At the July 340B Coalition, participants had several opportunities to hear directly from OPA on various 340B Program topics. Julie Zadecky, a pharmacist within the Program Performance and Quality Branch at the Office of Pharmacy Affairs, spoke about their latest audit enhancements and the Office of Pharmacy Affairs (OPA) strategy for program integrity. She also offered a few 340B audit tips based on HRSA audit findings.

A few of the program integrity improvements discussed:

Reviewing HRSA audit results can offer 340B covered entities excellent insight to areas that HRSA is focusing on during their audits.  Additionally, entities can get ideas for areas where their self-audits should be concentrated by monitoring HRSA’s audit results.

Fiscal year 2016 marks HRSA’s fifth year auditing the 340B program. They are on track to conduct 200 audits of 340B covered entities this year as well as five manufacturer audits. The selection process for entities to be audited continues to be the same:

The 340B Coalition had another record breaking attendance. The Coalition was held on Monday, July 11th through Wednesday, July 13th in Washington, DC. The 340B Coalition agenda was loaded with informative speakers and there was a lot to talk about!

The 340B Summer Coalition was held earlier this month in Washington D.C.  Julie Zadecky, a Pharmacist in the Program Performance and Quality Branch for the Office of Pharmacy Affairs was asked two questions regarding the OPA’s requirement for a 340B independent audit during her presentation on July 12, 2016:

HRSA has made it clear that it is an expectation for 340B covered entities to have an annual independent audit of their contract pharmacies. Covered entities should not take the wording “expectation” lightly because in the audit process, HRSA will ask when the last independent audit of contract pharmacies was performed. HRSA set the expectation of an independent audit as a tool to ensure covered entities have adequate oversight of their contract pharmacy.