Don’t Forget Referral Capture Strategies

Written By: Rich Bucher

While implementing a referral capture strategy can potentially lead to significant 340B savings for your 340B covered entity (CE), it is important to remember that you, the CE, remain responsible for ensuring full compliance. Managing a fully compliant and cost-effective referral process will require diligence and resources, despite what some third-party vendors or others may tell you. The old proverb “You don’t get something for nothing” applies here. For this reason, it is important for you to first take steps to estimate the potential benefit that implementing such a strategy will provide and then compare the estimated benefit to the cost/resources that it will take to maintain full compliance (cost/risk vs. benefit analysis). For the potential benefit, the reality is every CE is unique with respect to its particular mix of prescribers, types of clinics and healthcare services, drugs prescribed to its patients, and retail pharmacies where prescriptions are filled. All these factors will influence the cost to you that will offset the 340B savings benefit you receive.

Don’t rely on data that is not specific to your CE or that is not comprehensive. When reviewing filled prescription data, work with your third-party administrator (TPA) vendor(s) to determine which prescriptions are accessible for review since those that were not qualified (but potentially could be) is key. In addition to prescription data and operational costs, it is important to also account for the specific expenses associated with internal oversight and auditing.

While third-party referral capture vendors can play an important part as partners to CEs in their referral capture processes, there is simply no substitute for the CE itself proactively maintaining responsibility for compliance and financial oversight. Each CE must maintain a clear understanding of each step in the process and the specific role that its vendor(s) play. Miscommunication with vendors about responsibilities or complacency with respect to internally confirming ongoing compliance and operational efficiency can lead to disastrous results.

Have you already implemented a referral capture process or are you considering it? Do you want a 340B partner with extensive 340B experience and expertise that you can trust? SpendMend Pharmacy’s Referral Capture program focuses first and foremost on full compliance, while also optimizing the 340B savings available to you. Learn more at:

Recent HRSA Audit Trends: Supporting Documentation for Eligible Providers

Historically, HRSA auditors have requested a list of eligible providers from covered entities during HRSA audits. Recently, however, HRSA auditors have been requesting that covered entities upload documents demonstrating that, for each audited utilization record, the prescriber was (at the time the medication was administered or prescription written) employed by, under contract with, or had some other type of arrangement/relationship with the hospital such that responsibility for the clinical care provided to the patient remained with the covered entity. HRSA FAQ 1442 further explains that non-covered entity providers solely with admitting privileges at a covered entity hospital are insufficient to demonstrate that any person treated by that provider is a patient of the covered entity, for 340B Program purposes.

We often hear; the provider is credentialed or has privileges, but what does that really mean? Credentialing is the process of obtaining, verifying, and assessing the qualification of a provider to provide care or services for a health care organization. Credentialing documents include evidence of licensure, education, training, and experience. A privilege is defined as an advantage, right, or benefit that is not available to everyone. For providers, the act of being privileged is the process whereby a specific scope and clinical service of patient care is authorized for a healthcare practitioner by a health care organization, based on evaluation of the individual’s credentials and performance.

Back to the question at hand, what have HRSA auditors been requesting to demonstrate provider eligibility? The answer may depend on the type of provider.

Employed or Contracted Providers – Hospital or Clinic Administered and Retail Prescriptions

If the provider is employed by the covered entity, an auditor would expect to see confirmation of employment of the provider by the covered entity. This could be the cover or signed page of a provider contract, a checklist of privileges granted to the provider, a screenshot of the internal Medical Staffing Office platform, or other such document.

For residents (often an area of challenge for entities and focus for auditors), requested documentation may include a signed contract between the covered entity and the resident, or with a college/educational institution that allows residents to practice at the covered entity and is accompanied by a list of past and current residents.

For health care providers who may not be directly employed with the hospital to provide services, an auditor may expect to see a signed collaborative practice agreement to provide services to patients whereby the care of the patient remains with the hospital. For contracted services, such as for the emergency department, a HRSA auditor may request a signed document with the contracted entity to provide services and a list of providers that fall under the contracted services agreement.

For providers with “privileges,” HRSA will expect to see a signed agreement that shows the scope of privileges and preferably documentation or confirmation from the covered entity that the responsibility for care of the patient remains with the covered entity and the providers privileges are not merely admitting privileges.

For each of these supporting documents, auditors have requested that they indicate start dates and, when possible or appropriate, duration of the agreement or granted privileges. Eligible provider lists are also requested to indicate start and term dates for providers.

Healthcare Professionals – Hospital and Clinic Administered Drugs

While supporting documentation to demonstrate responsibility of care may seem more straight forward for providers employed by or contracted with the covered entity, it can leave a bit of gray area for orders written by outside providers. For hospital or clinic administered drugs that are administered as a result of an order from an outside provider, most often observed in the infusion setting, many entities qualify drugs as 340B eligible under their healthcare professional definition. In doing so, they assert their responsibility of care through patient assessment and care related to the administration delivered by members of the entity healthcare team, such as nurses. As HRSA auditors have become more familiar with this practice, they have begun requesting documentation in the medical record to substantiate care beyond the simple administration of the drug, such as vital signs or clinic notes stating the patient was evaluated for appropriateness of receiving the drug and that it was well tolerated (or that the patient had a reaction and was treated accordingly). In these instances, HRSA auditors have further validated the inclusion of this definition in the entity’s policy and requested documentation that the healthcare professional providing patient care is employed by the entity and was working that day. This may include a contract, privileging documentation, and/or a timecard.

Referrals – Retail Prescriptions

In scenarios in which covered entities have captured retail prescriptions as a result of a referral arrangement, HRSA auditors have requested copies or screen shots of the referrals in the course of the audit and for them to be uploaded to the NIH portal subsequent to the audit. While obtaining documentation back from the referral provider remains a best practice to demonstrate continued responsibility of care, this has not been requested in recent audits, and documentation of the medication in the patient’s medication list with the covered entity has been sufficient.

Preparing for HRSA Audit Success

The key to supporting documents is that they demonstrate that care for the patient by the provider remains with the covered entity at the time the medication was administered, or the prescription was written. Covered entities should consider all aspects of patient definition to use 340B drugs. It is also important to include entity management of provider privileges in policies and procedures.

Unfortunately, these documents are not always found in one location, with one person, or even within the same department. Start checking for these documents during your monthly self-audits, understand each provider type and the documents needed, and lastly, know who would be your point person for each type of provider to obtain the necessary documents and establish a working relationship with them so that you’re both prepared when your number is up for a HRSA audit.

Article written in collaboration with Chelsea Violette, Turnkey Pharmacy Lead Auditor.