The Health Resources and Services Administration (HRSA) is on pace again this year to conduct about 200 audits of covered entities in the 340B Drug Pricing Program. And once again this year, it appears that more than 60 percent of audits will return with findings. 340B audits with findings can result in serious financial sanctions including repayment to manufacturers, termination of ineligible contract pharmacies and outpatient facilities from the program, or complete program exclusion.
HRSA 340B Audit Results
2022*: 141 audits conducted, 86 with OPA findings, 22 with sanctions
2021: 199 audits conducted, 128 with OPA findings, 46 with sanctions
2020: 200 audits conducted, 93 with OPA findings, 48 with sanctions
*through 11/15
While the total number of HRSA audits and sanctions has been consistent for the past few years, the OPA (Office of Pharmacy Affairs) audit findings have noticeably increased. There’s good reason that preparing for a HRSA audit is a program requirement, since eventually every covered entity will undergo one. With millions of dollars in prescription drug discounts at stake that can fund more healthcare services, failing to comply is simply not an option.
Proven to produce more savings without more risk
To date, all R1 340B Recovery clients that have undergone HRSA audits have completed them with no findings. This record of accomplishment is only possible because of our compliance-first approach to 340B ineligible claim and referral capture. Documenting ownership of patient care and prescriptions from outside referrals is essential. Having a clear definition of patient ownership in written policies can prevent considerable back-end justification when the time comes to defend your rationale for 340B drug discount claims. And of course, a bad audit can mean reimbursing drug companies for inappropriate discount claims or exclusion from the program. The R1 340B team knows what it takes to optimize program savings while minimizing compliance and audit risk, and we are committed to helping covered entities do just that.
“The benefit that we’ve realized through R1 has been fantastic because we would not have been able to realize it in any other way through our retail pharmacy stores,” stated Corrine Hill, Chief Administrative and Compliance Officer at Thundermist Health Center. “There are so many prescriptions that we could not realize written by referral providers. On top of that, some of the value of the drugs has been surprisingly high.”
One-stop shop for 340B audit readiness
Recently audited clients have indicated that HRSA audits are becoming broader and deeper, and the preparation for and participation in audits is taking more time and effort, often with far less advance notice compared to previous years. To help with audit preparation, we have launched the HRSA Audit Ready Resource Center for covered entities.
Our 340B experts have developed resources that providers can freely leverage to maintain a compliance-first program. We have compiled these tips, tools, and guides in a centralized location for easy access and welcome you to use them for your HRSA audit preparations. We hope you find them useful.
While we created the HRSA Audit-Ready Resource Center primarily for R1 340B Recovery customers, all covered entities can benefit from the tools and guides available there. You can learn more about our 340B solution that captures ineligible claims and referral prescriptions to optimize program savings.
