Information Guide: How to Navigate Audits with a Referral Program

April 4, 2023

Referral prescriptions are becoming a common topic during audits these days, meaning Covered Entities should have already-written policies to match their referral operations and clear definitions of what they consider to be sufficient documentation for capturing a referral prescription. But what does “sufficient documentation” include? And why is it important to have these items prepared in advance?

What makes referrals compliant?

The 340B statute and patient definition are clear about the compliance of referrals. The points below summarize patient eligibility per Health Resources and Services Administration’s (HRSA) standards:

  • An eligible patient is an active outpatient, where the responsibility of care for the patient remains with the Covered Entity.
  • The outpatient received healthcare services from an outpatient department, clinic, or facility within the Covered Entity’s 340B eligible locations.
  • Eligible providers are healthcare professionals employed by the Covered Entity, under contract or through other arrangements (such as referrals or a contractual basis).
  • Covered Entity maintains auditable records in the event of an audit.

In terms of outgoing and consult notes, it is considered “best practice” to obtain both sets of documentation. Yet, we are hearing in the field from Covered Entities, dependent on their staffing bandwidth, operational workflow, or technology capacity, they are limited in obtaining both the outgoing referral and consult notes. Therefore, it depends on how you’ve defined what is required in your policies and procedures as acceptable documentation. Just another reason why having written referral policies is crucial.

You must follow the procedures you’ve outlined in your 340B referral policies & procedures to ensure captured referral claims are eligible. Be consistent.

What should my policy include?

When it comes to matching policies to referral prescriptions, one must know what necessary documentation is needed for their Covered Entity:

Outgoing referral to the specialist

As the patient is leaving the Covered Entity to receive care outside their health network, the outgoing referral documents begin the transition of care from the Covered Entity’s Provider(s) to the referral specialist. These outgoing referral documents can be logged manually or in the patient chart of the CE’s Electronic Medical Record (EMR). In the unlikely event the CE cannot record the outgoing referral, a copy of the consult notes (see section below) or a written link in the patient’s chart to the referral specialty should be clearly noted.

Consult notes from the specialist

Once the patient has seen the referral specialist, a copy of the specialist’s patient assessment and treatment plan will need to be obtained. This documented assessment from the visit is referred to as ‘consult notes’ and notates any drug(s) prescribed by the specialist. Acquiring a copy of this document is significant as it shows evidence of the drug(s) prescribed (which was outside the CE’s health network) and is referred to as “closing the loop”.

Other factors include how often a patient needs to be seen at a Covered Entity to be considered active as a 340B patient. This patient eligibility window is dependent on the Covered Entity’s operations and how they define it in their policies (most common is 12-24 months). Furthermore, it should be discussed if the Covered Entity requires a renewal for referral to occur. There are organizations that deem it necessary to have the patient come in, as an example, every 12 months to get a new referral to continue seeing the specialist.

If a patient has not been seen by their Covered Entity provider within the ‘defined’ eligibility window, it could mean they are seeking their primary care elsewhere and should be considered a new patient. People often forget this on the referral side!

Consistency is key. If you’re not consistently following certain procedures when it comes to referrals, don’t put them in your policies.

Inconsistency could harm your Covered Entity’s compliance and result in financial paybacks to the manufacturers, potential diversion findings in the event of a HRSA audit and even loss of 340B eligibility.

Why is it important to have these items prepared?

Ensuring you have documentation to create an audit trail for the Covered Entity to claim 340B savings and maintain integrity in their program compliance is crucial. Moreover, this documentation will provide measurable standards for defining what makes a patient 340B eligible, which will in turn offer higher volumes of referral prescription capture and increased savings.

How can we help?

As you can see from the steps and procedures above, this can be complicated and consume staff hours, we suggest working with a professional, trained and dedicated to this is imperative. Our referral and 340B consulting team of professionals is here to guide your Covered Entity through this process, coordinating and communicating directly with you to act as an extension of your existing staff. We assist in both the referral and audit process, aiding in the creation of your 340B referral policies and procedures and equipping you with the solutions and services you need to be ready for whatever is thrown your way.

To get started with our Advanced Referral program or 340B Audit services, contact us today.

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