SPONSORED CONTENT
The phrase “we’re scheduling an audit” generally triggers angst, tension and even fear. Audits of your 340B operations look deeply into your prescription records and billing procedures. They are complex and require a great deal of preparation and data. But it doesn’t have to be that way. Utilizing a competent and experienced contract pharmacy can help a program sail through an audit and be an extremely valuable asset to their 340B clients.
Red Chip of Nevada’s specialty pharmacy (RCN) recently completed a self-imposed audit to ensure our procedures represent best practices within HRSA’s 340B guidelines and regulations. If you’ve never endured an audit, you may be surprised by the breadth and depth of the data reviewed. There are several areas of focus that you will want to be prepared for.
- Policies & Procedures: It’s so important to update and distribute your P&Ps (and in particular your audit P&Ps) to managers and pharmacy personnel so they can field questions without fumbling for an answer.
- 340B Drug Dispenses: This is the crux of the audit! Dispense records will be requested for all drugs your contract pharmacies dispensed in a given 6-month period and then a sample size will need to be submitted. This is especially important if your contract pharmacy, like RCN, dispenses for a variety of 340B entities.
- Drug Purchase History: You’ll need to have an invoice-level purchase history of the medications being audited easily accessible. The contract pharmacy will need to clearly demonstrate their procedures to differentiate which purchases were made by each entity.
- Eligible 340B Provider File: It is extremely important to have a list that documents the clinicians at each 340B site who are eligible to submit scripts and the locations from which prescriptions may be initiated. It is optimal to have the Authorizing Official review and sign the list annually.
- Correct Billing Procedures: Nothing sets off more red flags during an audit than incorrectly billed claims! You will be asked to provide a list of all states where Medicaid is billed and the corresponding state claims procedures to avoid duplicate discounts.
Our self-imposed audit was a unique opportunity to confirm the areas that are working well and to uncover any areas that may need attention. For example, auditors identified several of our clients had inaccuracies on their OPAIS webpage. The audit report opened the door for us to assist clients in correcting the inaccuracies, which subsequently benefits them in the event they are audited.
If you are a 340B covered entity looking for a contract pharmacy partner, look for one who can demonstrate their compliance and help guide you as well. If you’re a specialty pharmacy like RCN, you may want to invite a self-imposed audit to check your own processes and to provide assurance to your clients of your compliance to 340B guidelines and regulations. At Red Chip of Nevada we submit to a self-imposed audit every couple of years utilizing The Alinea Group, a nationally recognized leader in performing audits on all types of 340B programs and their contracted pharmacies.
Mary Ann Barth is co-founder and partner at Red Chip Enterprises. She can be reached at mbarth@redchip.org.
