According to a recent article from law practice Baker Ober Health Law, “Over the past several months, the Health Resources and Services Administration (HRSA) has issued a number of guidance updates related to the agency’s expectations for health care providers participating in the 340B drug pricing program, referred to as covered entities.” The recent changes highlighted in the article include:
- HRSA updated its program integrity page in May 2018 to reflect its latest expectations regarding audits of 340B covered entities
- That same month, HRSA issued an update regarding audit findings and corrective action plans (CAPs). HRSA now expects 340B covered entities to address “areas for improvement” when submitting a CAP in response to a HRSA audit report
- HRSA also makes clear that covered entities with a re-audit that identifies the same exact finding of noncompliance may be subject to additional audits
- In August 2018, HRSA updated its guidance to 340B covered entities regarding their obligation to self-disclose to HRSA when a material breach of a program requirement occurs
It’s clear that the HRSA audit process for covered entities participating in the 340B Drug Pricing Program is constantly evolving. White House administrations change, Congress changes, policies change. As that occurs, HRSA becomes ever more sophisticated and educated in learning what questions to ask of covered entities, and so the audit questions change as well. In an ocean where you never see the same wave twice, covered entities must maintain a rigorous audit readiness process to keep the ship afloat and heading in the right direction. The most recent HRSA audit forms reflect a significant update in terms of shifts in focus. Key takeaways include:
- Hospitals should ensure their paperwork for covered entity eligibility determination is documented; in particular, they should be sure to note any exclusions to the patient definition
- Hospitals should contact the government official listed for their internal audit and surveillance monitoring to verify the phone number and email contact
- Hospitals should be able to demonstrate if the hospital is government-owned or granted government powers
- Hospitals’ change logs should be able to demonstrate what was done and provide an audit trail
- Auditor focus has shifted to review how hospitals are operationalizing their policy related to date administered versus date written
It’s true that looking back, the initial 2012 HRSA audit forms hardly even resemble the ones we see today. The good news is that, with the right strategy, covered entities can actually use surprises like these latest changes to their advantage, incorporating the new information into their mock audit process.
Often, hospitals will bring in an external auditor, typically on an annual basis, to conduct mock audits. This is a helpful practice, but if the auditor doesn’t have an understanding of the 340B management and compliance technology the covered entity is using, this can result in frustration and wasted resources on all sides.
For example, an auditor who doesn’t know the inner workings of the covered entity’s technology might make assumptions that—too late—turn out not to be true. Or they might miss potential concerns or pitfalls that they would have otherwise flagged, had they been using the technology to pull and read the right reports and information. At the very least, an external auditor with no connection to the technology comes with the added burden of requiring hospital staff to take the time to go into the system and pull certain reports, because they’re missing the tech savvy needed to do so independently.
Riding the wave
Fortunately, Sentry offers the only full-time, Apexus-certified audit team in the industry. When HRSA first announced they were starting 340B audits in 2012, we knew we had to be there for our customers. We created the 340B Compliance & Audit team to ensure our customers knew they’d have our support. Our team is prepared to answer covered entities’ questions any time, on-site or off-site as requested by the customer, during both mock and real HRSA or manufacturer audits.
Our audit team takes the learnings from previous HRSA audit forms and from the more than 177 HRSA audits we’ve completed for our customers to ensure that every question is answered. We work closely with hospital staff, analyzing reports to find and address potential flags long before a HRSA auditor walks through the doors. With expert knowledge of both the 340B program and Sentry’s software, we can support a covered entity self-audit for prescription eligibility, location eligibility, individual physician events and more. And because our audit specialists know the software inside and out, our team can pull the reports, leaving hospital staff resources free to continue with critical day-to-day operations.
If opportunities for improvement are uncovered, Sentry’s audit team will help the covered entity to make changes to their chosen configurations so those obstacles can be mitigated in the future. If challenges or potential audit concerns are uncovered on the customer side, not related to software settings, our team’s depth and breadth of experience allows them to advise the hospital staff based on what we’ve seen work in hundreds of other instances over the years.
For covered entities using external consultants for audit prep, Sentry will also come on-site to collaborate with these consultants. Additionally, we have a list of 14 external organizations who have consultants that have been certified on Sentry’s software, so it’s easy to find a resource that can help ensure you’re prepared. Whether for regular mock audits or for real-time HRSA or manufacturer audits, Sentry’s audit team has the experience and expertise needed to help covered entities understand the audit process and make better decisions.
No matter how the seas are changing, Sentry is proud to offer our dedicated audit and compliance team as an example of yet another way our customers can expect MORE.