The Four Keys to 340B Contract Pharmacy Compliance

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The Four Keys to 340B Contract Pharmacy Compliance

340B pharmacistI feel like I am beating a dead horse here, but experience is the best teacher and a lot of recent experience at various covered entity sites tells me the horse can take it! (it is dead after all)

If you currently have or are considering 340B contract pharmacy or in-house pharmacy, then please read on. If you are not, then I recommend you read on anyway just in case you change your mind.

Key 1: The provider list. Make sure you think about which providers actually write prescriptions from your QUALIFIED covered entity areas. Also, make sure you know your providers that practice only in your covered entity areas versus the providers that see patients outside of the hospital in addition to patients in the hospital (or clinic).

Key 2: The encounter feed: Just because an area of your hospital or clinic qualifies for 340B doesn’t mean you should always send the encounter data. Like the provider list, review the encounter data for encounters that can actually generate a prescription. No lab or imaging only patients!

Key 3: Eligible window: What the heck is that you ask? It is the window of time after an encounter that you allow the third party vendor to qualify a prescription as 340B. I have seen lots of permutations and the key is to make the window as small as possible without missing out on too many eligible 340B prescriptions. Depending on your vendor, you may also be able to set different eligibility windows by provider.

Key 4: Audit, Audit, and … Audit: You should be auditing monthly for both compliance with 340B diversion regarding contract pharmacy scripts AND compliance with your policies and procedures. You should also have a detailed external audit at least annually to ensure the wheels haven’t come off the bus. From experience, this should be someone different than the person completing the monthly audits.

At the end of the day, you as the covered entity are fully responsible for compliance of your 340B program. So you need to own it. You can do this in contract pharmacy by directing your third party vendor to the process and criteria that you feel will provide a high degree of compliance for your hospital or clinic’s situation. Although third party vendors mean well and may provide some guidance, ultimately it is the covered entity that knows their situation the best.

Do you need help? We have tried to share our guidance in this article, but if you need more detailed support and consulting, let us know at Turnkey Pharmacy Solutions. Best of luck, -Rob

About Author

Rob Nahoopii, PharmD, MS, 340B ACE

Experience as a Director of Pharmacy for a 400 bed DSH hospital (also served as a regional director of pharmacy). Rob has presented at many 340B University sessions and on the topic of 340B at numerous other conferences around the country. He has provided many external 340B audits for various covered entity types, and onsite support for multiple 340B HRSA audits. Rob is part of our 340B independent auditing team and also supports our maintenance clients and 340B implementation. His perspective is from front line pharmacy leadership and program compliance.

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