This Fiscal Year, Congress provided HHS an additional six million dollars – an investment HRSA had been formally requesting to improve the program integrity and oversight of the 340B Program. We’ve been keeping Congress apprised of our progress and want to make sure everyone in the 340B Program stakeholder community is aware as well. This month, we would like to outline the staffing investments we are making to support the 340B Program.
Prior to this Fiscal Year, the Office of Pharmacy Affairs (OPA), which administers the 340B Program, had operated with two branches – one that governed information systems and one that ran the operations function. With the $6 million, OPA stood up a new branch, Program Performance and Quality, which oversees the program integrity initiatives for covered entities and manufacturers. HRSA has always considered every single staff member of OPA to be responsible for program integrity, and that remains the case today, but staff in the new Branch will devote all their expertise in this area.
The Program Performance and Quality staff are responsible for developing covered entity audit reports. Audits are conducted by a team of auditors in the HRSA regional offices, who send preliminary findings to our office, and we work to develop the final report that goes to the covered entity. As each health care provider’s pharmacy operations are incredibly complex, staff works closely with the auditors to ensure that our assessments are consistent and accurate. For those audits with findings, our staff work with the covered entities to develop Corrective Action Plans. These staff are also responsible for posting summaries of audit information on our website.
This new Branch will also be responsible for the recertification function, which is at its core a program integrity tool. During annual recertification, every 340B covered entity must attest that they are in compliance with all 340B program requirements, and that they have reported any and all material breaches to our office. The staff are also responsible for reviewing “self-disclosures” by covered entities, which are the reports of those material breaches. OPA is working on a more standardized process for these disclosures, which are currently handled on a case by case basis, but frequently require restitution and repayment with manufacturers and ongoing corrective action.
Staff in this new Branch will also be responsible for working with our HRSA partners in the Ryan White and Community Health Center Programs on covered entity compliance. These two programs are adding 340B related questions to their site visits, which number in the hundreds every year. These questions are designed to trigger further review by our staff who will triage and assess next steps after referral.
OPA is also reinvigorating the two existing Branches. The Operations Branch will be augmenting its proactive technical assistance and education. Just this past Monday, we held a webinar with hospitals on registration requirements, designed to address the high error rates in registration documentation we’ve seen in recent quarters. The Operations Branch will be working even more closely with our contracted 340B Prime Vendor, who operates a high volume call center for covered entities and provides individualized technical assistance. In response to stakeholder feedback, we will be revamping the FAQs on the 340B Prime Vendor website. Many entities rely on these FAQs for program implementation guidance.
In our Information Systems Branch, OPA will be hiring more specialized assistance in the data areas, as we have an increasing need to understand the data around covered entities and manufacturers, their purchasing and their pricing.
OPA is excited about the potential that these new staff positions bring to enhancing and strengthening the 340B Program. In the coming months, we will continue to update you on the additional investments being made with this new appropriation.
340B University with slides, notes and other tools