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:
HRSA has updated their 340B audit protocol to streamline the 340B audit process.
HRSA piloted desk audits in fiscal year 2015 and said they were very successful. In an effort to save money and complete more audits, they plan to continue with some desk audits.
Covered entities (CE) with findings from a HRSA audit that may require repayment to manufacturers no longer have to submit a public letter. HRSA does require that the CE post contact information on the public website so manufacturers can reach out to the CE’s contact if they have questions.
In order to monitor compliance of the 340B Program in more CEs, OPA worked with the HRSA Bureau of Primary Healthcare and HIV/AIDS Bureau to develop a one-page questionnaire for contractors to ask during their site visits. The questionnaire serves as an initial screening tool for compliance for the HRSA Grantees that participate in the 340B Program.
In 2016, HRSA began including a Corrective Action Plan (CAP) template when they issue audit findings in order to help CEs develop their CAP and ensure they are covering all elements of the CAP.
OPA audit tips and reminders:
The CE is solely responsible for 340B Program compliance.
The CE should have a plan for both internal and 340B external audits to test the CE’s compliance with the 340B program requirements. It should include testing all offsite outpatient facilities and contract pharmacies.
CEs need to ensure that their contract pharmacies and any other third party vendor involved in the CE’s 340B Program understand that the CE and HRSA must have access to the records for purposes of audit. Zadecky stated, “You would be surprised how often HRSA auditors come across contract pharmacies unwilling to give records”. It is the CE’s responsibility to supply HRSA with auditable records. Access to records should be included in contract pharmacy agreements and agreements with any software vendor utilized.
CEs must have 340B policy & procedures oversight and ensure compliance with all 340B requirements.
A written contract that meets all the requirements in contract pharmacy guidance needs to be in place before the pharmacy is registered in the OPA database.
When a new contract pharmacy location is added to an existing contract pharmacy arrangement, the new location should be specified on the written contract before registering the pharmacy in the OPA database.
When utilizing a 340B software system, it is the CE’s responsibility to ensure software systems are compliant with the 340B Program requirements. Findings of diversion have been based on software systems not being set up correctly.
When using a replenishment model, the accumulation of the 340B account must be tied to an exact 11-digit NDC match that was originally dispensed to an eligible patient and ensure the 340B inventory is appropriately controlled and the integrity of the 340B purchase is maintained. In cases where the 11-digit replenishment is not possible because the CE is not able to match the package size, the entity may replenish with a 9-digit NDC but is responsible for maintaining auditable records and having policies and procedures explaining the process.
If a CE disagrees with an audit finding, all appropriate and applicable supporting documentation should be submitted with the summary of disagreement. The summary should reference the applicable documents that support the CE’s case.
If a CE receives their final audit report with findings, they must submit a CAP for HRSA’s approval within 60 days. If a CE fails to submit a CAP, they may be removed from the program.
Zadecky further explained that the OPA divides audits into the three main areas:
Diversion
Duplicate Discounts
Reviewing HRSA audit findings in these three areas posted on the OPA database can help entities understand the areas of their own 340B Programs that need to be tested for 340B compliance.
Zadecky stated that, “covered entity healthcare records should include but are not necessarily limited to drug name, patient name, location of healthcare service, date and time of healthcare service, services rendered and prescriber name. The pharmacy healthcare records should include but are not limited to the drug name, patient name, location drug was dispensed, date and time medication was ordered, dispensed and/or administered, prescriber's name and payor information”.
She went on to say, “The best practice is to utilize independent, annual audits that audit all aspects of compliance of contract pharmacies”. It is crucial that participating entities maintain auditable records and assess their level of compliance with ALL 340B drug pricing program rules. Covered entities should be performing regular 340B self-audits and it is expected by HRSA that an annual, independent 340B audit is conducted.
Southwest Consulting Associates has experience in assisting clients through HRSA audits as well as performing annual 340B compliance reviews and 340B quarterly compliance audits to minimize or prevent adverse findings in a HRSA audit. To find out more about SCA’s 340B Program external audit services, please visit our website or request a proposal at 340B@southwestconsulting.net.
