The Health Resources and Services Administration (HRSA) 340B program plays a vital role in expanding access to affordable medications for eligible patients. To ensure compliance with program requirements, Covered Entities (CEs) must maintain accurate records and documentation. This white paper outlines tips and tricks for CEs preparing for a HRSA audit, focusing on three primary areas of HRSA's data requests – The Crosswalk, the Provider List and the Account List. These insights from industry expert, Curtis Frazier of Alinea, will help ensure preparedness and success in the event of a HRSA audit.

DRL - Crosswalk

The crosswalk is item 2C on HRSA's DRL.

2C. For each off-site facility that utilizes 340B drugs at the facility or through contract pharmacy(ies), provide the trial balance that was submitted to CMS with the MCR(s). For each MCR and corresponding trial balance, include a trial balance crosswalk.

• 340B ID
• Name, as identified on OPAIS
• Address
• MCR line number and cost center description, as listed on MCR Worksheets A & C
• Trial balance name and department code/account
• Location code or shorthand used to identify the site in the electronic health record (EHR)
• Indicate if 340B drugs are utilized during encounters at each site

Alinea has developed a methodology – adding on to this HRSA crosswalk –that has led to quick and successful HRSA audits. We feel that by providing the auditors this information upfront, you are less likely to receive questions about site eligibility during the actual audit.

Crosswalk Tips

Tips for a successful HRSA audit:

• Consider also including “Four Walls” EMR locations in your crosswalk.
  • Demonstrates complete program oversight of your program.
  • Allows audit to be completed faster
  • Allows CE to VERIFY all locations in their dispense data
  • Link to Cost Center and MCR line - you DO NOT need to include revenue and expense figures.
• Location VERIFICATION
  • ALL EMR locations within your dispense data should be on your crosswalk
• Address VERIFICATION
  • The same 340B ID should not be linked to more than one address.

DRL - Provider List

The Provider List is one area of focus that has evolved over the last couple years. HRSA is requesting that CEs:

4. Provide a provider list:

A. Provide a list of the CE’s eligible providers, including:

1. First name

2. Last name

3. National provider identifier (NPI)

4. Indicate employed or contracted, include start and termination dates of employment or contract (preferably in Excel format)

Also note that the CE should be prepared to show the auditor proof of employment, contract, or credentialing for providers during the onsite/remote audit.

Provider List Tips

All providers should be reflected on your list, including Advanced Practice Providers such as CRNAs, NPs, PA's, residents and fellows, and temporary and contracted providers. These are often left off The Provider List and need to be included. It’s also important to consider the date range of which employees need to be included on this list. For example, providers practicing 12 months prior to the audit date should be included on the list, even if they are not practicing during the time of the audit. For example, a provider who left in August 2021 should be included on the list if that same provider wrote a prescription with 12 refills July 25, 2021 could be filled within the audit window.

As it pertains to provider verification, all providers within audit data should be on your list – it’s essential to check before submitting.

HRSA sends your audit sample three days prior to your audit, which provides you time to prepare ahead of the audit itself. This is especially important when gathering provider screenshots as HRSA wants all screenshots uploaded prior to the audit. Reach out to your credentialing department and notify them of an upcoming audit. Request them to do a small write up on their process that you can include with a sample image to HRSA, highlighting the elements the auditor will want to see. Putting in a little bit of homework on the front-end of your audit can significantly reduce the amount of time that your HRSA audit takes.

DRL - Account List

The Account List has been recently revamped by HRSA – now requiring a list of all accounts. Along with purchasing documentation: (wholesaler, direct, and consignment) used to purchase drugs for the parent, off-site facility(ies), and all pharmacy(ies), including contract pharmacy(ies). Contract pharmacies are commonly left out by mistake, but they do in fact, need to be included.

For each account, provide the following (preferably in Excel format):

• DRL – Account List
• Wholesaler name
• Account number
• Account name
• Location that receives the drugs (e.g. unique identifier for CE site or pharmacy)
• Location(s) that dispenses the drugs (e.g. unique identifier for CE site or pharmacy)
• Pricing associated with each account (e.g. 340B, GPO, WAC, etc.)
• Indicate if the account is used in a controlled substance ordering system (CSOS)
• 340B ID associated with each 340B account (i.e. the 340B ID used to open or establish the account)

Account List Tips

Check your account setup TODAY! This way, if you identify any issues, it takes time to open additional accounts if needed. In the event of a HRSA audit, you may only have a few weeks to submit these items to HRSA.

Questions to ask when conducting a self-evaluation include:

• What account type are your direct accounts? VERIFY!
• Do you have any “single” GPO or 340B accounts?
• Do you know how/where to get purchase history and invoice copies

Ex. Account Setup:

Account List Tips

Taking a bit of time for pre-audit groundwork can lead to significant impacts on both the duration and success of your HRSA audit. Focusing on the three audit requests – The Crosswalk, Provider List, and Account List – you can empower your 340B program and cement your state of audit readiness.

When’s a good time to start implementing these tips and tricks? TODAY!

Curtis Frazier, Subject Matter Expert, 340B ACE

The Alinea Group

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