Navigating 340B Audits

Navigating Audits and Major Transitions for 340B Compliance and Optimization

Our 340B experts held their quarterly 340B Insider interactive webinar on March 22, 2023, and we compiled a list of questions from the session. Included here are the attendee questions and responses provided by our experts related to HRSA audits, the patient definition, and major conversions affecting 340B programs.

What type of documentation does HRSA request to see from Internal Audit?

HRSA would like to see proof that ongoing audits are performed at the cadence outlined in your policies and procedures (P&P), along with the elements that are audited during internal audits. HRSA has not required patient information to be shown as proof of internal audit.

Once you have an audit and it turns out to be favorable how long would it be before the next audit?

It is difficult to predict how long a covered entity (CE) can expect to be audited again if the CE has already had a HRSA audit. It is always recommended to stay audit ready to be a good steward of the 340B program. However, a CE is likely to have a higher chance of getting audited if they have never been audited before.

Can my facility establish 340B eligibility or does it need the TPA to establish 340B eligibility?

The CE is fully responsible for program compliance so the CE should be establishing 340B eligibility criteria and ensure that the chosen TPA can meet the compliance measures.

Is a visit to the physician’s office once a year an acceptable timeframe to match an encounter and should that be in your P&P?

The CE has flexibility on determining patient ownership timeframe. It is recommended that such a timeframe is clearly outlined in your policies and procedures.

Have there been any Diversion findings for incorrect written location? Does HRSA still perform the written location test?

Based on audit results released for FY22, there have been no written location-related findings. We do not have insights into whether such testing was performed in any of the audits.

Has anyone included clinic-administered medications that are used during an emergency at your CE that may include a person that is not a patient? For example, a guest of a patient experiences an overdose and needs to have Narcan administered.

The drug administration is considered 340B eligible if all aspects of your patient definition are met, such as the drug being administered in an outpatient setting at a 340B eligible location, and with clear documentation in the person’s record in your EMR.

What methods are there to minimize the impact of the contract pharmacy actions?

Ensure your mixed-use environment is optimized. Audit non-340B claims for missed qualifications and convert them when compliant. Opening entity-owned pharmacies can mitigate contract pharmacy restrictions. Consider adding referral capture to your program to realize additional savings.

If the 340B staff are off-site hundreds of miles away, have you seen HRSA demand an on-site audit?

We have seen that HRSA could allow a hybrid option, where the audit is held on-site with staff who are available to attend in-person, and with remote staff participating virtually during the audit.

How concerned are auditors with National Drug Code (NDC) replenishment in areas where barcode scanning is not used, like the OR?

In such instances, staff should be able to speak clearly to how a split biller selects which NDC to replenish. Some examples for acceptable replenishment methods include limiting NDCs used in such areas, leveraging the autosub function of the split biller, and making such facility areas clean sites.

What referral P&P guidance is needed to capture dispenses from pediatric medical specialties prescribed from non-CE locations or by non-CE providers?

Ensure that you have unambiguous language on what would constitute referral evidence to such specialty locations from 340B-eligible sites, which consult note documentation the CE must have access to, and how patient ownership is defined.

How should you handle it when you cannot see the prescription that was written for the patient? For example, if there is a specialist referral that you can document but the prescription is in your queue to manually authorize with the TPA as your patient. How would this stand up in an audit?

The CE must have a consult note from the referral specialist in a pre-defined timeframe from the prescription written date to show ownership of care when it comes to that prescription. It is further recommended that the consult note should be from the prescriber or the office where the prescriber practices, and the consult note references the medication in some place beyond the medication list. The CE must also ensure that the patient is being managed at a 340B-eligible location by showing care encounters within a reasonable timeframe of the prescription and encounter from the referral specialist.

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