Since 1996, the Health Resources and Services Administration (“HRSA”) has used one set of standards to describe the factors that determine when a 340B drug may be dispensed to an individual patient, otherwise known as the “Patient Definition Guidelines.” In the aftermath of the Genesis Health Care, Inc., v. Becerra ruling, will anything change?

The one-size-fits-all Guidelines currently apply to the diverse range of 340B covered entities, but each grant program is likely to have very different relationships with the persons they serve.  Federally Qualified Health Centers (FQHCs), Ryan White HIV/AIDS Program grantees, and others have very specific grant requirements that affect their 340B program. The Patient Definition Guidelines can be difficult to apply in the context of new treatment standards, including telemedicine, specialist referrals, and the development of medical homes and medical case management. Patient ineligibility and 340B drug diversion continue to account for a significant number of 340B audit findings, and potential repayments to affected manufacturers, especially in contract pharmacies. 

This focused four-hour training has been developed specifically to target the ins and outs of the Patient Definition Guidelines, including how to address the many “gray areas” that covered entities may encounter. Designed for both 340B “rookies” and “vets,” the training will cover these topics and more: 

• Critical elements of the Patient Definition Guidelines 
• Relationship between grant requirements and the Patient Definition Guidelines 
• The gray areas, such as telemedicine, clinic administered drugs, and patient referrals, and how to address each to maintain compliance 
• Documenting patient eligibility – before and after an audit 
• Patient eligibility issues in 340B contract pharmacy arrangements 
• Avoiding “too good to be true” deals and other pitfalls 
• Detecting and addressing instances of non-compliance