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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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TIP: The key to unlocking the full potential of your program starts with complete understanding of your data.
Having a firm understanding of your data is essential to effectively managing a 340B program, especially for covered entities with smaller teams or just one individual managing the program. The more comfortable and knowledgeable you are with your data, the easier it will be to access and interpret it, allowing you to move more seamlessly through your EMR and TPA, and enabling you to identify any discrepancies or potential issues in real-time. This also adds an extra layer of validation to your accumulators – ensuring your 340B savings are being optimized and utilized at an efficient and appropriate rate.
Other data elements that may be appropriate to monitor include business rules, NPI lists, price files, NDC blocks, and payor blocks. These critical components may seem complex, but they can be instrumental in maintaining a compliant and optimized program.
Familiarity with these data elements can help you better communicate the value of your 340B program to internal and external stakeholders. By having clear, accurate data that demonstrates the impact of the program, covered entities can build trust and support for the program, ultimately leading to its continued success.
Austin Shady is the Senior Director of Client Success at RxStrategies. He can be reached at ashady@rxstrategies.com
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TIP: If your entity engages a firm to independently audit your 340B Program, follow through on the auditor’s recommendations in a timely manner.
If you’re working with an outside auditor to examine your entity’s 340B activities annually, they should not be turning over the same findings year after year. Independent auditors are there to help your organization identify risks. It’s up to your team to leverage this expertise to resolve both compliance and administrative deficiencies. Diversion and duplicate discounts are top priorities for HRSA, but they also examine the 340B OPAIS, contract pharmacy service agreements, and wholesaler invoices.
This sounds like a no-brainer, but during my 20-plus years as a 340B compliance expert, I’ve seen HRSA auditors cite entities on findings that could have been resolved prior to the audit—using insights gleaned from the entity’s previously conducted external and internal reviews.
Cheryl Hetland, VP, 340B Program Management at Avita Care Solutions, can be reached at cheryl.hetland@avitacaresolutions.com.
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TIP: Don’t forget that in a replenishment model, 340B purchases are primarily made after determining eligibility through accumulated eligibility.
It’s important to understand that 340B purchases are primarily made after 340B eligibility has been determined in a replenishment model. Rather than having a separate inventory of “340B drugs” available to dispense to eligible patients, the 340B covered entity pharmacy pulls medications from an established neutral inventory and fills 340B physician orders. Then, if that drug dispensation passes the required eligibility checks, the pharmacy accumulates future purchases that may be made at 340B pricing. 340B orders are then placed to fulfill accumulated eligibility. Depending on the type of entity, any additional inventory is ordered on a wholesaler acquisition cost (WAC) or group purchasing organization (GPO) account.
Ivy Espendez is Director, 340B Compliance & Audit at The Craneware Group. She can be reached at iespendez@craneware.com
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TIP: Make sure you are taking time to review your 340B wholesaler invoices at least weekly to ensure you are getting the correct 340B price.
It is always important for covered entities to be reviewing their wholesaler invoices to ensure accurate 340B pricing is being applied. The entity should be looking to make sure that the 340B price is extended for all NDCs and that they are not being charged Wholesaler Acquisition Cost (WAC) for their 340B purchases. These pricing discrepancies can be caused by a delay in the manufacturer providing 340B contracts to the wholesaler, an administrative error by the wholesaler, or a misinterpretation of data resulting from ESP data submission complexities.
When reviewing wholesaler invoices, covered entities should note incorrect pricing and request a credit and rebill from the wholesaler. An inquiry should be sent to the wholesaler with all original invoice and item-specific information, the estimated 340B amount that should have been charged, and a calculation of the difference.
The volume of pricing discrepancies seen by Hudson Headwaters 340B’s wholesaler pricing verification team is at an all-time high. There are likely many covered entities losing 340B savings through inaccurate pricing being charged erroneously by the wholesalers.
Alex Homkey, Business Development Manager at Hudson Headwaters 340B, can be reached at ahomkey@Hudson340b.com
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TIP: When using outsourced telehealth services, be prepared to “Mind the Gap.”
Telehealth services are a great resource for covered entities who want to grow their program’s footprint with minimal investment, allowing them to quickly add patient volume without investing time and money into marketing and provider onboarding. Most tele-specialty services bill covered entities on a per patient basis, constituting a fee upon patient sign-up and a monthly service charge. However, how the tele-specialty vendor defines patient sign-up is key. Often, vendors charge the initial fee as soon as a patient enrolls and has an at-home lab test kit sent to them. However, if the patient does not return the kit or complete a telehealth visit, the covered entity ends up paying the sign-up fee while receiving no 340B benefit.
These “gaps”, either with patients not returning lab kits or completing telehealth visits, must be “minded” to avoid unnecessary costs. Savvy covered entities, or those with super savvy 340B consultants😉, can create patient outreach programs to complement their tele-specialty services. By performing outreach, covered entities assist patients with lab kit questions and remind them to return their kits and to schedule their telehealth visit. Thus, “Minding the Gap”, with a solid patient outreach program, ensures covered entities get the most bang for their buck when contracting with tele-specialty vendors.
Robert Ferraro is Chief Pharmacy Officer at Ravin Consultants. He can be reached at robert@ravinconsultants.com
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