Use our unique POWERS methodology to stay in an audit-ready status:

P – Policy & Procedure

• Keep most up-to-date policy & procedure manual for 340B program
• When changes are made, make sure they are tracked with date stamp at the end of a particular policy 
• Have a material breach threshold and a process to self-report. Apexus has a great tool to help with these.
  • Establishing Material Breach Thresholds
  • Self Reporting Non-Compliance

O – OPAIS Database

• Review OPAIS Database every Quarter during the registration window. 
• Make sure address on OPAIS matches address on your Contract Pharmacy Agreements
• Accurately answer the Medicaid Carve-in/out question accurately for each site
• If you process Medicaid claims for more than one state, make sure the Medicaid number from each state is listed on OPAIS
• Make sure you terminate a Contract Pharmacy on OPAIS once the relationship is discontinued. Note: You don’t have to wait until registration period to report a termination of Contract Pharmacy
• Make sure your Authorizing Official and Primary Contact information is most accurate 

W – Workflow Optimization

• Use technology to your advantage. There are numerous ways to automate processes inside your In-house or Contract Pharmacies that can help prevent and detect non-compliance quickly
• Allocate sufficient resources to ensuring compliance of 340B Program. But, do not over-allocate. Again, automation of processes can help reduce resource allocation

E – External Independent Audit (Annually)

• Schedule an Annual Independent External Audit. HRSA expects that an external audit is conducted on an annual basis. 
• Use the following template when evaluating external auditing companies

R – Random Sample Audits (Monthly)

• Audit sufficient sample on claims from In-house and Contract Pharmacies on Monthly basis
  • Make sure to have high risk claims (e.g. Medicaid, high cost medications, prescriptions from outside prescribers, etc.)
• Match the prescription against a record on your EMR. There must be a face-to-face/telehealth visit on or prior to the date prescription was sent.

S – Staff Education

• Provide basic level of staff education to your entire staff on an “annual” basis
• Keep a log of all employees that completed the training, similar to the ones you keep for HIPAA or OSHA Comliance

At GapRx 340B Consultants, we understand that there are many layers of complexities in trying to manage 340B Program. We can customize our solutions for all your 340B needs. Reach out to us to find out more. We hope this guide will be useful to your 340B program.

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By Purnank Gandhi, Pharm. D.