practical tips for preparing for a 340b hrsa audit

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340B HRSA Audit ToolkitPractical tips to prepare covered entities

Disclaimer

The information contained in this presentation is for informational purposes only. It shouldnot be construed or relied upon as legal advice.

HRSA plans to continue the current pace of340B audits of covered entities in 2016.

Now is the time toimplement proactivestrategies to increasecompliance and auditreadiness.

Proactively improve audit readiness

today

340B Audit Readiness

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Thoroughly prepare once notified of

an audit

Employ smart strategies during the

audit

Proactivesteps to starttoday

Proactive steps before an audit

Policies and Procedures

Ensure your policies and procedures are specific to your organization

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It is not enough to have policies and procedures. Covered entities should customizeprovided templates to reflect their unique circumstances. When a component of the 340Bprogram has room for interpretation, auditors may use the policy and procedures of thecovered entity to determine compliance. Because of this, it is critical the policies andprocedures are genuinely reflective of your organization's operating procedures.

Follow and know your policies and procedures

While it may seem obvious, an organization must actually follow its policies and procedures.Highly specific documentation that does not reflect actual operating procedures can leave acovered entity exposed.

Don't forget about your vendors. Know how your vendor is using your data to qualifyclaims and be certain it is in compliance with your policies and procedures.

PSG's solutions for split-billing and contract pharmacyadministration are highly customizable. We have theflexibility to comply with your existing technology aswell as your policies and procedures to driveconsistency and compliance.


Self-auditing

Implement a self-auditing program

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A regular, thorough self-auditing program is a critical element of a compliant 340B program.One significant benefit is it allows you to identify potential areas of risk and self-correct beforea HRSA audit occurs. It also prepares your team for a HRSA audit. Self-audits require thecovered entity to pull the necessary data elements and access the appropriate areas of theEHR. This ensures you can access that information during an audit. Self-auditors also becomehighly informed team members in the event of a HRSA audit.

Know your self-auditing program

Be sure your auditing program is well-documented within the policies and proceduresincluding frequency, what will be reviewed as well as what the organization will do in theevent of a self-finding. Also, be sure the 340B team is aware of this process as it is a prime areafor questions during an audit.

PSG offers our customers reports specifically designedwith the data elements often requested during a HRSAaudit. These reports are also very helpful for self-auditing.


Know your EHR

Designate at least one EHR expert

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You need a designated EHR expert, preferably from the 340B team. During an audit you mayneed to toggle through multiple screens and even multiple EHRs to provide neededdocumentation to demonstrate eligibility. Don't wait until an audit letter arrives to gain thisexpertise on your team. Self-auditing is a great way to gain this knowledge. Just be sure that atleast one individual is designated and appropriately trained.

Both PSG's split-billing and contract pharmacyadministration solutions consistently apply your entity'spatient definition across all applications. Additionally,our direct integration with the largest pharmacychains further enables patient definition consistency.

Patient Definition

Ensure consistency across the program

Inconsistency in the application of patient definition across owned and contract pharmacies isan unnecessary risk. It can confuse your team as well as an auditor and open the door for non-

compliance.


Hospital Departments

Ensure clinics/departments within the four walls of the 340B hospital are registeredappropriately

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It can be an opportunity for a HRSA finding when outpatient clinics/departments within thefour walls of a hospital are not registered correctly on the OPA website. For more detailedguidance on this, refer to the Apexus website. In summary, outpatient clinics/departmentswithin the four walls of the parent covered entity do not need to be registered separately.However, clinics/departments within the four walls of a child registered location do need to beregistered.

For more information with regard to the appropriate steps for registration, pleasevisit www.340bpvp.com.

You've beennotified: howto prepare

You've been notified: how to prepare

Assemble the dream team

Designate a core audit team with clear responsibilities and areas of expertise

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Start by identifying your core team and who will fill each of the following roles. While everyperson won't be meeting with the auditors the entire time be sure calendars are clear and teammembers are ready when called upon.

IT MemberSomeone from IT may need to pull the requested data in advance of the audit. He orshe should also be available during the audit in the event the auditor has questions onthe data. We highly recommend the same person who pulls the data is on hand toanswer questions during the audit.

Compliance MemberEmployees from the Compliance department are often highly experienced with auditprocures and can be an excellent resource to have in the room. A compliance teammember has a good sense of how best to answer the auditor's questions and speak thelanguage of policies and procedures.

EHR Expert MemberDesignate a person who knows the EHR and the nuances of 340B extremely well andcan quickly navigate to the right screens. Often the self-auditor is a great option for thisbecause he or she knows both the technology and the 340B program.


Assemble the dream team

Designate a core audit team with clear responsibilities and areas of expertise cont'd

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VendorAt PSG, we look at ourselves as a core audit team member for our covered entitycustomers. Your account executive, who is highly knowledgeable about yourprogram, is physically onsite with the customer during an audit and is in directcommunication with the rest of the PSG team for additional support. We also provideexpertise and have a proven protocol to coordinate with your contract pharmacies.

Pharmacy Member(s)

The pharmacy team member will be responsible for knowing the purchasing process forinternal pharmacies, day to day oversight, relationships with contract pharmacies and areare often the resident expert on patient definition. This key member of the team will likelyserve as the point of contact throughout the audit.

Authorizing OfficialThe executive designated as the Authorizing Official for the covered entity will be theone to receive the official notice of an audit and the audit report. This individual is notusually required to be present during the audit but it's important that he or she is madeaware of the audit process and knows what to be on the look out for from HRSA.


Policies and procedures refresh

Ensure core team and 340B employees are well versed in policies and procedures

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The core team as well as purchasers, pharmacists, pharmacy technicians, physicians,etc. may be asked about your 340B program by the auditor. Consider doing a refresheras appropriate with these individuals, especially around patient definition and mixed-

used pharmacy procedures.

Is PSG on your dream team? We are onsite with ourcustomers during an audit providing expertise andcoordinating communication with our team and yourcontract pharmacies.


Review claims and document

Review identified claims and document path of justification

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Don't wait until the auditor is watching the screen to confirm a claim's qualification.The auditor will usually provide a list 2-3 days in advance of the audit of what claimswill be reviewed. Designate a person or a small team to review each claim. Documentthe path to justification including what screens you would go to if questioned on theclaim. This may require a lot of work, possibly after hours, but will be well worth theeffort. It gives you time to clear up questions internally or with your vendors and canexpedite the audit.


Review OPA database

Perform a thorough review of the OPA database ensuring accuracy

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Prior to the auditor's arrival it is a great idea to conduct a thorough review of the OPAdatabase. A few common errors are not correctly registering outpatientclinics/departments within the four walls of a child site (see previous slide) as well asincorrect addresses. The OPA database is automatically updated basedon DEA licensing changes. This can cause an address mismatch between thedatabase and pharmacy contracts.

As previously mentioned, the auditor will provide you a list of claims that will bereviewed during the audit. Pull the pharmacy addresses from the claims and confirmeach of those addresses is registered on the OPA database.


Gather the right documentation

Review pharmacy contracts and ensure most recent version is readily available

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Prior to the auditor's arrival, do a review of your pharmacy contracts. Ensure you havethe latest version, including amendments, everything is accurate and you are preparedto provide when asked by the auditor.

Review contract with state or local government when required

To be eligible for the 340B Program, certain hospitals must be owned or operated by astate or local government; be a public or private non-profit corporation which is formallygranted governmental powers by a unit of state or local government; or be a privatenon-profit hospital which has a contract with a state or local government to providehealth care services to low income individuals who are not entitled to benefits underMedicare or Medicaid.

If the underlined statement applies to your covered entity, be sure that you havereviewed this contract with your state or local government for accuracy and have readyaccess to the document.


Gather the right documentation

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Patient definition historical overview

It is not uncommon for a covered entity to adjust its patient definition. If this hasoccurred at your organization, consider creating a historical timeline of the patientdefinition. Include the date and an overview of the change. You may even considerdocumenting if the change occurred because of a self-identified issue. As you reviewqualification criteria on a particular claim this quick reference will be helpful for bothyour team and the auditor.

Document the exchange of data between the covered entity and vendor

The burden of compliance is on the covered entity. Therefore someone on your dreamteam should be well versed on what data your vendor is gathering and how they arequalifying claims. Flow charts can be helpful tools. How the vendor uses the data andqualifies claims should be documented within your policies and procedures.

PSG utilizes multiple strategies to prepare your dreamteam to discuss how we use your data and qualifyclaims. We will provide flow charts and otherdocumentation and work closely with you to ensure ourprocesses and your policies and procedures are inalignment.

Stra teg iesdur i ng theaud i t

Strategies during the audit

Auditors are often willing to listen

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Every auditor is unique but we have found them to be professional, considerate andgenerally seek to understand your program. All of the preparatory work will prepareyour dream team to answer the auditor's questions and quickly provide requesteddocumentation with confidence.

Ending your program is unlikely

The occurrences of 340B entities being removed from the program due to non-

compliance are rare. If your organization is doing its due diligence to run a compliantprogram, negative outcomes will probably not occur. That being said, the audit mayresult in findings and opportunities for improvement. Prepare your team for thispossibility and understand the process of corrective action plans.

Be available and prepared

Review team roles, gather aforementioned documentation and clear your calendars.For the next few days you will need to be ready and available at the auditor's request.

340B Solutions

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Uninsured patientcard programs

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practical tips for preparing for a 340b hrsa audit

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