Referral claims represent one of the most nuanced aspects of 340B patient eligibility. HRSA’s patient definition allows individuals to qualify as 340B-eligible patients when they receive care from a provider under contractual or other arrangements with the covered entity—such that the covered entity maintains responsibility for the care provided. Referrals can qualify under this provision.
For a referral to qualify a patient for 340B drugs, the covered entity must maintain responsibility for the patient’s care under the referral arrangement. This typically requires a documented contractual or formal arrangement with the referring or receiving provider, and the covered entity must maintain records of the patient’s care.
Referral claims are a high-risk area in 340B compliance because they require clear documentation of the care relationship and the covered entity’s ongoing responsibility. Entities that include referral patients in their 340B population without adequate documentation of the care relationship face diversion risk.
Frequently Asked Questions
Are referral patients eligible for 340B drugs?
Referral patients can be eligible if the covered entity maintains documented responsibility for the patient's care under a contractual or other formal arrangement. The key requirement is that the covered entity must maintain records of the patient's health care and responsibility for the care provided.
What documentation is needed to support referral eligibility?
Documentation should include the contractual or formal arrangement with the referring or receiving provider, evidence that the covered entity maintains the patient's health records, and a clear written policy defining how referral eligibility is determined and documented.
What is the biggest risk with referral claims?
The biggest risk is including referral patients in the 340B population without adequate documentation of the care relationship. If the covered entity cannot demonstrate that it maintains responsibility for the patient's care, the referral prescription may be classified as diversion.
Why Referral Claims (340B) Matters
Referral claims are a significant source of audit findings. Without clear documentation of the care relationship and the covered entity's responsibility, referral prescriptions can constitute diversion. A well-defined referral policy with supporting documentation is essential.
How Virtue 340B Uses It
Virtue 340B evaluates referral claim policies and documentation as part of our audit services, assessing whether the entity has adequate evidence of care relationships and appropriate controls to prevent ineligible referral claims from being processed as 340B transactions.
