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TIP: Prepare for additional HRSA scrutiny on 340B clean sites with these 3 best practices.
The CPS 340B solutions team routinely participates in HRSA 340B program audits as part of our ongoing partnership with covered entities across the nation. Recently, we’ve seen HRSA auditors focus additional scrutiny on 340B clean sites, which leads us to provide this expert tip. For those who may be unfamiliar, a 340B clean site refers to a 340B-eligible location which uses a physical 340B-only inventory.
For 340B clean sites, the following best practices are recommended to ensure 340B drug diversion does not occur:
- Perform periodic inventory counts of 340B drugs located and/or used in clean sites.
- Compare 340B clean site purchases with dispensations to ensure no variances exist.
- Maintain records to document when 340B drugs for the clean site are either destroyed or wasted.
In addition, we recommend your covered entity’s policies and procedures are updated accordingly based on any specific practices for clean sites.
Dennis Killian is director of 340B Solutions at CPS. He can be reached at Dennis.Killian@cps.com
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TIP: Keep the complicated operations of your 340B program compliant with the expertise of the Apexus Advanced 340B Operations Certificate Program.
The journey to maintaining a compliant 340B program requires a deep understanding of complicated and advanced 340B operations. The Apexus Advanced 340B Operations Certificate Program is designed to verify your expertise and provide you with the resources to keep your 340B program compliant through the ever-changing 340B landscape. However, it’s crucial to embark on this journey well prepared. Begin your path to excellence by reviewing your organization’s policies and procedures or completing the comprehensive 340B Prime Vendor Program education roadmap, which includes the essential 340B University OnDemand as well as virtual and in-person courses. This 340B operational experience will ensure that you have a solid grasp of the fundamentals to pass the Apexus Advanced 340B Operations Certificate Program entrance exam before diving into the advanced curriculum.
After enrolling in the program, measure your progress and maximize your learning experience by taking the baseline exam before delving into the 24 self-paced modules within the program. This step helps you identify areas where you excel and those where you can focus your efforts to enhance your knowledge further. In addition, as an Operations Certificate Program enrollee, you will gain access to exclusive tools and resources designed to bolster 340B compliance within your organization, giving you a unique advantage in the field.
Concerned about passing the final exam? The Apexus Advanced 340B Operations Certificate Program offers a practice exam that you can take first to prepare you for the types of questions on the exam and the exam format. Upon successfully passing the exam and earning the esteemed title of a 340B Apexus Certified Expert (ACE), you will become part of an elite community of 340B ACEs. Your status as a 340B ACE will be available for verification via the 340B Apexus Certified Expert search tool.
Once you become a 340B ACE, you will be able to enjoy the benefits of participation in exclusive 340B ACE events, 340B ACE Connect networking groups, and informative webinars that connect you with like-minded professionals in the industry. But remember, your journey doesn’t end here. To stay at the forefront of 340B knowledge and continue to elevate your career, commit to recertifying your 340B ACE credentials every two years. This ensures that you will remain a respected authority in the ever-evolving world of 340B pharmacy operations.
For questions, please email 340Bcertificate@apexus.com.
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TIP: Be prepared to answer 340B claims eligibility questions in an audit.
Covered entities need to be prepared for the possibility of a 340B audit. That includes being able to respond to any audit questions about how you work with your 340B TPA to determine 340B claims eligibility. Be ready to address these four key areas:
- First, know what data is being sent to your 340B TPA/s and how often it is being sent.
- Second, you should be able to explain how the data is being used by your 340B TPA/s, what other data the TPA is receiving, and how the different data sets are utilized.
- Third, understand the filters/configurations/rules you have chosen to determine 340B claims eligibility in your 340B TPA software. Be able to articulate how they work and how you ensure they work as expected.
- Lastly, ensure the rules you have chosen to align with your policies and procedures.
If you aren’t prepared to respond to these claims eligibility questions today, prepare now for a potential audit by reviewing your policies and talking to your TPA.
Maxor340B is a TPA that values transparent partnerships with covered entities and helps them be fully prepared for audits.
Holly Russo is Senior 340B Director for Maxor. She can be reached at herusso@maxor.com
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TIP: Make sure you keep an eye on your prescriber lists.
As one of the key pillars of 340B contract pharmacy compliance, you want to be sure there aren’t discrepancies associated with your prescribers and the 340B scripts coming through your program.
Some easy ways to stay on top of this include:
- Make sure you have a documented and outlined approach to how you are updating your eligible prescriber lists. Whether you are updating/configuring the list in your TPA’s portal or sending a routine update email to your TPA, the information within your policies and procedures should be followed by the staff person overseeing your program.
- When conducting internal audits, you should always keep an eye on the prescriber column to ensure scripts associated with terminated prescribers aren’t still being included in your program.
- Your TPA should be able to provide you with a file/list of omitted 340B claims and the reasons they were not accepted. Entities should review these routinely and look for scripts that were denied based on prescribers and determine whether said prescribers should have been listed on their active prescriber lists.
Alex Homkey is Business Development Manager at Hudson Headwaters 340B. He can be reached at ahomkey@hudson340b.com
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TIP: Ensure 340B program compliance by frequently changing how you audit claims.
Audits help stakeholders confirm that their 340B program stays compliant. This tip refers to self-auditing claims, not integrity audits. For the latter, HRSA recommends 340B program teams carry out integrity audits through a third party once per year.
When self-auditing claims, we recommend frequently changing the process to help spot issues before they affect compliance. Here are three ways to change your routine for the better.
1. Examine claims based on variances in past audits. Look at things that fall out as you zero in on, for instance, a site of care, a particular provider, a drug or class of drugs, or anything that lands within a variance.
2. Take note of high-risk transactions. Review claims that have a threshold-value greater than the typical pattern. This could be, for instance, claims over $5,000. A manager could examine the value of claims for a new contract pharmacy, a new site of care, or deregistered pharmacies.
3. Assess high-risk business conditions related to claims. Perhaps, the covered entity added a new physician practice. Maybe the covered entity implemented new software for EHRs or changed its split-billing vendor. Situations like these can be a prompt for managers to change the way they’re self-auditing claims.
With auditing, variety can be a manager’s ally. When a team regularly looks at data from new angles, people can spot telltale signs and mitigate issues before they affect compliance.
Danielle Boehm is customer support manager at Sectyr, LLC. She can be reached at danielle.boehm@sectyr.com
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TIP: To ensure you’re not leaving any 340B dollars behind, assess your ineligible claims to understand if claims are being missed.
Small technical errors can cause eligible claims to be misclassified as ineligible. On average,our clients typically find an additional 2% or more in misclassified claims from prescriptions written by employed providers. There could be several reasons why claims can be falsely identified as ineligible:
- Incorrect provider list or patient characteristics
- Missing wholesale / manufacturer pricing
- Incorrect Medicaid status
- Flawed TPA settings that disqualify eligible claims
- Missing data from EMR
Additionally, assess your referral opportunities if your covered entity refers patients to ineligible 340B locations for care. Understanding what ineligible claims you really have access to is the first step of building a 340B referral program. TPA dependent covered entities may: A) not have access to any ineligible claims, B) only have access to ineligible claims if a patient has had an encounter at the CE recently, or C) have access to all ineligible claims if the patient has ever had an encounter with the CE.
Once you determine there is referral opportunity, make sure you choose the right partner for your needs. Referral claim audits can require manual verification for each claim, and additional internal support may not be available.
Minh Hoang is Director of 340B Hospital Operations at Cloudmed. She can be reached minh.hoang@cloudmed.com
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TIP: Have your own tracking system for manufacturer contract pharmacy requirements.
As the manufacturers continue to impose new restrictions, it’s imperative to stay on top of all these changes to remain in compliance with their requirements to ensure you maintain 340B pricing. There are several resources available to find the data you need such as 340B ESP and 340B Health. We find it valuable to create a spreadsheet for your own tracking as many covered entities have multiple contract pharmacies, PA’s, and utilize different pharmacies for different manufacturers. If you are interested in viewing a sample tracker, please reach out to us by emailing 340BTeam@SignfiyHealth.com.
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TIP: Nurture the relationship with your contract pharmacy affiliates to ensure regular orders are placed for 340B savings.
Savings for the covered entity in a contract pharmacy relationship are realized as a result of the pharmacies placing regular orders. While many pharmacies are eager to participate in the 340B program and experience some savings of their own, daily realities can be hectic and make ordering on the 340B account a lower priority. With ever-evolving manufacturer restrictions, the orderable accumulations the pharmacy was planning to catch up on can disappear on short notice.
CEs should nurture the relationship with their contract pharmacy affiliates and explore a few different options: 1) Educate the pharmacy team about the 340B landscape and how savings potential can be reduced due to manufacturer actions; 2) Enable the auto-order feature (if your TPA offers such functionality) so that orders can be generated without the need for staff involvement; 3) Enlist the help of your TPA to provide the pharmacy team an educational refresher on how to manage manual orders; 4) Renegotiate the PSA terms so savings are shared with the pharmacy in an alternate way.
A few gestures of outreach can result in a better informed pharmacy partner and greater savings for both parties.
Bilyana Yakova is Senior Supervisor, Account Management Team, at Verity. She can be reached at byakova@verity340b.com
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TIP: Double check your TPA’s 340B capture settings to ensure they match your manufacturer restriction designations.
If you have designated a pharmacy or are uploading data to the 340B ESP platform, make sure to communicate the status for each manufacturer to your TPA. Your TPA’s settings and each manufacturer’s status must be aligned in order to keep your 340B program running smoothly.
Lee Harris, Managing Principal, Sales & Strategic Relations at SUNRx can be reached at lharris@sunrx.com
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TIP: When it comes to duplicate discount prevention, don’t assume that all 340B drugs are billed to Medicaid using the same NPI. Routine internal auditing of Medicaid claims and proactive communication with finance/billing can help identify additional NPI numbers that may need to be listed on HRSA’s Medicaid exclusion file.
Many covered entities are not aware of additional NPI numbers that may be used to bill 340B drugs in unique areas of their hospital or clinic. Separately certified dialysis centers, psychiatric units, and rural health clinics often have separate NPI numbers used for billing. Some hospitals may even have a separate NPI number for inpatient billing, which could include 340B drugs administered in an emergency room or observation status prior to the inpatient transition. If 340B drugs are billed to Medicaid in these areas, the NPI number(s) must be listed on the Medicaid exclusion file (MEF) for the applicable clinic sites/registrations to comply with HRSA’s requirements for carve-in entities.
Covered entities should also remember that entity-owned retail pharmacies may have a separate NPI number from the covered entities. If the entity-owned retail pharmacy is billing 340B drugs to Medicaid, the retail NPI must also be listed on the MEF at the parent entity. HRSA publishes the MEF quarterly. Entities may add or remove billing numbers at any time, but the changes will not be effective or appear on the MEF until the following quarter. All changes must be made by the 15th of the month that precedes the new quarter. For example, to appear on the July 1st Medicaid exclusion file, changes must be made by June 15th.
Routine internal auditing of Medicaid bill images from all registered child sites and areas of the covered entities utilizing 340B drugs can help to identify additional NPI numbers in use. Additionally, asking proactive questions and engaging with the Finance and Billing teams is a great way to identify alternate NPIs that should be listed on the Medicaid exclusion file.
Jamila Seibel, Director at Alinea Group, can be reached at jamila.seibel@alinea-group.com
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