Once a hospital has tightened its 340B program’s operations and has the right processes and controls in place to ensure it is running compliantly, some facilities continue on their 340B journey by expanding their program. There are three primary pathways to expansion:
- Compliant network of child sites: Some entities work with qualifying outpatient facilities, typically clinics or services outside the four walls of the main hospital, to expand their quality care mission.
- Contract pharmacy network: Other entities form relationships with community retail or specialty pharmacies to expand their programs, and some also expand participation through their own outpatient pharmacies.
- Acquisitions: As hospitals acquire other facilities, it’s also important to think about whether these facilities operate sites that would be a good fit for 340B participation, and whether they would be eligible for enrollment.
When considering 340B expansion, it’s critical to verify that the expansion will receive the necessary level of oversight to deliver sustainable compliance. Covered entities also need to have a clear picture of both costs and savings associated with any expansion, and a plan for how those savings will be reinvested in the covered entity’s care mission, especially as it relates to vulnerable patient populations. Finally, covered entities should remember that, as the size and complexity of their 340B program grows, the Health Resources and Services Administration (HRSA) may also consider the risk profile for non-compliance to have grown. This can result in a greater likelihood of selection for a HRSA audit.
Compliance: The tie that binds
Compliance is not a single phase of the 340B journey. It’s a critical component of each and every phase. Why? Because the ability to navigate complex guidelines is the key to protecting critically important program savings. Each covered entity has its own unique operational requirements, and as a facility advances from one phase in the 340B journey to another, the aggregate amount of complexity increases. It’s critical to put in place the right resources to test and fine-tune compliance processes. In our next article in this 340B series, we’ll focus exclusively on best practices to ensure ongoing compliance.
As with any worthwhile initiative – especially in today’s evolving healthcare landscape – creating a strong 340B program is best viewed not as a destination, but as a journey. When managed correctly, including appropriate oversight, planning and preparation, this program can continue to be a cornerstone of an eligible hospital’s ability to improve access to care and sustain their community mission.