340B Compliance

Compliance should be the cornerstone of any 340B program. Our compliance services take a deep dive into all aspects of your program and provide actionable recommendations for any remediation necessary in order to keep you compliant.

Both HRSA and manufacturer audits are on the rise, and it’s important to be prepared for a 340B program audit at any time. Our eligibility [hyperlink to eligibility and feasibility] and program management [hyperlink to program management] services will help you design a program that is compliant and audit-ready. The final step is to review your program for important compliance elements and conduct a comprehensive mock audit. We will walk you through the audit process from start to finish, and provide a detailed findings report including any recommendations necessary for remediation.

Comprehensive Data Review

Understanding what data is being used by your 340B vendor in order to make eligibility determinations is the foundation of a compliant 340B program. 340B vendors use varying data elements to determine patient, provider, pill and location eligibility.

As part of our mock audit, we will help you evaluate and answer the following questions related to data:

• Who is responsible for sending and maintaining certain data?
• What data are you sending to your 340B vendor?
• How often do you send this data?
• How long does it take your vendor to update data in the system once it has been sent?
• How is the data you’re providing being used to determine eligibility?
• What configurations and filters are being applied to the data?
• What’s the process for making a change to a filter or configuration?

Checklists for Key Compliance Elements

We’ve developed a set of proprietary checklists to help ensure you have all the correct program elements in place necessary to remain compliant. These lists will guide you through key program elements and considerations that will be important in an audit, including everything from the handling of claims data to policies and procedures to staff education.

Mock Audit

Our mock audit is designed to mimic a HRSA audit so there won’t be any surprises if you are faced with a real audit. We conduct an in-depth review of key 340B program compliance and management elements, and provide strategies for remediation as necessary.

During our audit, we will review a number of key areas including:

  • Claim compliance
    • Duplicate discount
    • Diversion
    • GPO exclusion
    • Orphan drug exclusion (if applicable)
  • Claim eligibility
    • Provider eligibility
    • Patient eligibility, including definition and compliance to that definition
    • Referrals
  • Purchasing practices
    • 340B account
    • Group purchasing organization (GPO) account
    • Wholesaler acquisition cost (WAC) account
  • OPA database information
    • Confirm covered entity details plus any child sites
    • Annual recertification process
    • Contract pharmacy details including ship to, discharge descriptions and mail-order pharmacy
  • Policies and procedures
  • Patient assistance program
  • Inventory replenishment model
  • Medicaid “carve in” or “carve out”