Frequently Asked Questions (FAQs)

What is 340B ESP™?
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340B ESP™ supports manufacturers’ contract pharmacy and in-house policies by enabling covered entities to make contract pharmacy designations, apply for wholly owned contract pharmacy exemptions and submit 340B claims data.
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How is 340B ESP™ different from Beacon?
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​340B ESP™ supports manufacturers’ contract pharmacy and in-house policies by enabling covered entities to make contract pharmacy designations, apply for wholly owned contract pharmacy exemptions and submit 340B claims data.
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Beacon Rebate Model enables 340B covered entity access to 340B pricing through a direct discount payment made upon receipt of eligible claims data. Beacon MFP provides near real time visibility into MFP rebate status as well as access to good faith inquiry tools.
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Has HRSA required 340B covered entities to submit 340B contract pharmacy claims data to 340B ESP™?
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HRSA encourages 340B covered entities to work with pharmaceutical manufacturers in good faith to resolve issues of non-compliance in the 340B program. Although HRSA has not commented publicly on 340B ESP™, this platform enables 340B covered entities and pharmaceutical manufacturers to engage collaboratively and in good faith to address duplicate discounts.
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Does submitting data to 340B ESP™ impact the 340B price at which covered entities purchase drugs dispensed through contract pharmacies or the reimbursement amount received from the payer?
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The 340B price is provided to covered entities at the point of sale in a chargeback model, and the submission of claims data to 340B ESP™ occurs after 340B pricing has been provided. The reimbursement amount received by a 340B contract pharmacy is established by the commercial terms between the pharmacy and the payer and is distinct from the use of 340B. Use of 340B ESP™ does not change those commercial terms. Some manufacturers may require the submission of claims data for access to 340B pricing at certain pharmacies

My covered entity exclusively serves patients with no form of insurance such as Medicaid, Medicare Part D or commercial insurance. Does my covered entity need to register with 340B ESP™ and submit claims data?
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Covered entities that exclusively serve uninsured patients should still register at www.340besp.com. During the registration process, you will have an opportunity to complete an attestation form indicating that your covered entity does not serve patients with any form of insurance such as Medicaid, Medicare Part D or commercial insurance. Upon completing the attestation, you will be notified as to whether you will be required to submit 340B claims data for any of the pharmaceutical manufacturers utilizing 340B ESP™.
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My covered entity already ensures that duplicate Medicaid rebates do not occur. Does my covered entity still have to submit 340B claims data?

Covered entities that exclusively serve uninsured patients should still register at www.340besp.com.

How does my covered entity register a 340B ESP™ account?

Covered entities can register a 340B ESP™ account by navigating to https://340besp.com/register. The registration process requires you provide your contact information, select your covered entity, and authorize your registration. Visit 340B ESP™ Support’s registration resources in the Help Desk to learn more.
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Does 340B ESP™ enable access to multiple 340B covered entities from a single ESP account?

Each 340B covered entity must be registered in ESP. Once a covered entity is registered, the entity can be added to an account. Users on the account will then have access to the covered entity. An account can accommodate multiple covered entities. For security purposes, a covered entity can only be registered to a single account and registering users must undergo account verification before being approved to join the account.
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Can multiple users be registered for a single account?

Once your covered entity is registered with 340B ESP, you can invite other individuals from the same covered entity to register under the account. The initial registered user is set up as the account administrator and subsequent users can be granted different levels of access. Visit ESP Support’s navigation resources in the Help Desk to learn more about inviting additional users.
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Does 340B ESP™ enable deactivation of user accounts?

The account administrator can deactivate individual user accounts in the User module by selecting a user record and clicking “Deactivate Account”. You can also submit a request to [email protected] with a request to “Deactivate Account.”
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What information is required to register my covered entity with ESP?

To register an ESP account, you will need to provide basic contact information including an email address associated with the covered entity being registered. Once authorized, you will be asked to agree to 340B ESP’s Terms of Use and Privacy Policy. After the account is verified, 340B ESP™ Support will send an email inviting you to create credentials to access the 340B ESP™ account.
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How does my covered entity know if it is subject to a pharmaceutical manufacturer’s policy?

Covered entities and their affiliates are encouraged to review all available manufacturer policies from the Resources page. Any active contract pharmacies in HRSA may be subject to a manufacturer’s policy.

How does my covered entity designate a contract pharmacy on ESP?
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​Covered entities can designate a contract pharmacy by visiting the designations page at https://340besp.com/designations or through their Entity profile when logged in to 340B ESP.

Why is my covered entity unable to see the contract pharmacy from the designations page or the Entity profile?
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​340B ESP’s contract pharmacy database is driven by HRSA. HRSA designations update on a quarterly basis. If your covered entity has just submitted a contract pharmacy to HRSA, it may not yet be active. ESP only displays active retail contract pharmacies for a covered entity to designate. Once the retail contract pharmacy is active in HRSA (this means the ‘Begin Date’ in HRSA is either today or in the past for the contract pharmacy), your covered entity will be able to designate this retail contract pharmacy in ESP.

When attempting a designation and a manufacturer’s policy is applying a 40-mile geo-restriction, contract pharmacies that fall outside of the 40-mile radius will not be available to select.

If my covered entity changed the entity type, does my covered entity have to make any changes to the contract pharmacy designations or HINs?

If the covered entity type has changed, you will need to re-designate all contract pharmacy relationships. This can be done through the designations form or through the Entity profile. Similarly, your HINs will also need to reflect the change. HIN updates can be made through HIBCC. Utilize the 340B ESP™ Support resource on updating a HIN to learn more.

If my covered entity is exempted from a policy, does my covered entity still have to designate?
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Covered entities should review manufacturer policies to determine if designations are required. If your covered entity has lost access to pricing, but is exempted from the policy, you should consult with your wholesaler on pricing access.

My covered entity just registered a contract pharmacy in HRSA, can my covered entity designate a contract pharmacy, submit a wholly owned application, and/or submit data?
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​340B ESP™ utilizes HRSA to determine if a contract pharmacy is active. Your covered entity is not able to designate, apply for a wholly owned exemption or submit data for a contract pharmacy prior to it becoming active. Once the contract pharmacy is active in HRSA, your covered entity will be able to perform a designation, submit an application, or upload claims data depending on the manufacturer policy.

Can my covered entity upload data for some of my contract pharmacy arrangements but not others?

340B ESP™ supports the submission of data for individual contract pharmacy arrangements. This allows a 340B covered entity to submit data for certain contract pharmacies but not others. Manufacturers may adopt differing policies as to how they will manage 340B purchases for Bill To / Ship To arrangements for which a 340B covered entity is not providing data. These policies are communicated by the pharmaceutical manufacturer to 340B covered entities.
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How are new contract pharmacy registrations managed through 340B ESP™?
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New contract pharmacy registrations are identified on OPAIS and automatically associated with a 340B covered entity’s account in 340B ESP™. Once a registered contract pharmacy is listed as Active in HRSA OPAIS, it will populate for the covered entity in the Entity profile or the designations form. Existing contract pharmacy designations may undergo verification by the covered entity. through the 340B ESP platform depending on a manufacturer's policy.
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What data does my covered entity need to submit to 340B ESP™?
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340B ESP™ supports the collection of 340B claims as dictated by the pharmaceutical manufacturer policy. Covered entities should review manufacturer policies on the Resources page to learn more about what data may be required.
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How does a pharmaceutical manufacturer use the 340B claims data submitted to 340B ESP?

The 340B ESP™ platform supports manufacturers’ contract pharmacy policies and will continue to do so by enabling covered entities to make contract pharmacy designations, apply for wholly owned contract pharmacy exemptions and submit 340B claims data.

Data uploaded to 340B ESP™ may be used to identify duplicate Medicaid, Medicare, TriCare and commercial payer rebates that are not eligible for reimbursement. Additional information on use of 340B claims data can be found in the Terms of Use agreement available here.

How frequently can my covered entity upload claims data to 340B ESP™?

Covered entities can submit 340B claims data to ESP as soon as claims are qualified as 340B eligible by the covered entity or its TPA. Covered entities should ensure that 340B qualified claims submitted to ESP are fully audited by their administrator and have been replenished against.

Covered entities should review manufacturer policies on the Resources page to ensure they submit claims data in a timely manner.

Can a third-party contract pharmacy claims administrator submit data on my covered entity’s behalf?

340B ESP™ encourages 340B covered entities to discuss claims submissions with their 340B contract pharmacy claims administrators. 340B ESP™ enables direct submissions by a third-party on behalf of the covered entity through a software development kit (SDK). A third-party may first require 340B covered entities to complete an authorization that permits their covered entity to provide 340B claims to 340B ESP™. For more information on setting up an SDK, reach out to [email protected]

Should my covered entity upload 340B claims data for all products?

340B ESP™ will only collect claims for the products that are subject to a pharmaceutical manufacturer’s policy. Claims provided for NDCs that are not subject to a manufacturer’s contract pharmacy policy are omitted automatically. Prior to uploading the 340B claims data, you can preview the specific records that will be included in the data submission. Please ensure each 340B ID and its affiliated dispensing contract pharmacy ID is present for each claim row.
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Prior to attaching your data file, covered entities may also elect to limit their data file to only those NDCs in scope of a pharmaceutical manufacturer’s contract pharmacy policy. You can access a list of NDCs in the 340B ESP™ Help Desk here.
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What file types does 340B ESP™ support?
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340B ESP™ supports uploads of Microsoft Excel and CSV files.
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How are claim reversals submitted and processed in 340B ESP™?
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340B ESP™ supports the collection of claims that are initially designated as 340B but subsequently reversed. In the event that a previously submitted and validated claim must be reversed, covered entities should submit the same claim detail with a negative unit amount. Reversed claims should be included in your data submissions.

What claims data should my covered entity submit if my covered entity currently does not have access to 340B pricing at its contract pharmacies for a particular pharmaceutical manufacturer?
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Covered entities may submit claims that have been qualified as 340B eligible even if a replenishment order has not yet been placed for those claims. Once 340B pricing is restored for a specific contract pharmacy, the covered entity may then place a replenishment order for those qualified claims that adhere to a pharmaceutical manufacturer's lookback policy.
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If a covered entity is unable to submit 340B qualified claims due to limitations in a contract pharmacy administrator's software, the entity should submit the most recent 340B claims data available. 340B ESP™ will evaluate historical 340B claims data submissions according to the specifics of each pharmaceutical manufacturer's policy in determining whether the claims submission is sufficient for purposes of restoring access to 340B pricing.
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What fields are collected as part of pharmacy claim submissions?
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​The below outlines the pharmacy fields collected in ESP. Any additional data elements included in a data file selected for upload will automatically be removed prior to data submission.

What are Data + Encounter submissions?

Data + Encounter submissions include the 340B qualified dispense or administration plus the associated healthcare encounter visit information.

What does Pharmacy Data + Encounter include?

A Pharmacy Data + Encounter claim is a prescription claim originating from a retail, mail-order or a specialty pharmacy dispense of a medication for subsequent self-administration by the patient, as well as data elements from the encounter between the patient and the physician.

What does Medical Data + Encounter include?

A Medical Data + Encounter claim is a healthcare claim originating from a physician’s administration of a medication directly to a patient in an outpatient setting, as well as data elements from the encounter between the patient and the physician.

Where does my covered entity submit this data?

340B ESP will be releasing an updated submission experience that allows covered entities and their Partners to submit claims data that includes encounter elements. When this functionality is live, covered entities will be submitting the dispense or administration data plus the associated encounter within a single claim submission. Stay tuned for trainings and webinars throughout the month of September to learn more about the updated submission experience.

What fields are collected as part of Pharmacy Data + Encounter?

What happens when a pharmaceutical manufacturer identifies a duplicate Medicaid rebate using the 340B claims data we submitted?
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Pharmaceutical manufacturers will work to resolve identified duplicate discounts with payers and/or the 340B covered entity. Typically, pharmaceutical manufacturers have attempted to withhold or recover duplicate rebates from the payer first.

Can a 340B covered entity dispute the findings with a pharmaceutical manufacturer?
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340B ESP™ identifies instances of duplicate rebates but does not determine the root cause of the duplicate rebate. In some instances, a third party such as a rebate claim administrator, PBM, or plan may have failed to pass along certain information to prevent a duplicate rebate request from being submitted to a pharmaceutical manufacturer. 340B covered entities and pharmaceutical manufacturers may work together in good faith to address these types of issues. Some manufacturers may have additional mechanisms to engage in good faith with covered entities.

How does 340B ESP™ ensure the security of 340B claims data?

To keep claims data safe, 340B ESP™ is designed with multiple layers of protection, distributed across a scalable, secure infrastructure.
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How does 340B ESP™ ensure that only employees of the 340B covered entity can register an account with the entity?
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340B ESP™ utilizes a multi-step process to verify and authorize all covered entity employee registrations. This includes verifying a unique phone number used for 2FA (two-factor authentication) and verifying an associated organization's email address.

To confirm and identify valid registrations, you must have access to the email address provided upon registration, this address must be owned and operated by the 340B covered entity. If we are unable to match your email with our internal records or automatically verify your registration you may be required to complete our manual verification steps.
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What technology specifications are required to successfully upload data to 340B ESP™?

Users will need an internet connection and access to a supported browser to successfully upload data. 340B ESP™ is compatible with most internet browsers including Microsoft Edge, Google Chrome, Safari, and Firefox. However, we strongly recommend using Google Chrome for the best user experience.
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How does 340B ESP™ protect the privacy of my patients?
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Data uploaded to 340B ESP™ meets the definition of a De-identified Data Set under HIPAA. This means no actual protected health information (PHI) is collected and the data cannot be combined with other data sets to reveal the identity of a patient.For more information, visit 340B ESP’s Terms of Use.

What data elements are deidentified in 340B ESP?

The Rx Number and Product Serialization number are de-identified through a HIPAA compliant hashing process known as SHA-3 hashing. An additional layer of security called a “salt” is applied prior to any data being uploaded to 340B ESP™. This process was granted an Expert Determination indicating that it meets the definition of a De-Identified Data Set under HIPAA and does not contain PHI. Additional information on this expert determination may be requested by contacting us.

What if PHI is inadvertently mapped to a non-PHI data element?

Prior to data being uploaded to 340B ESP™, a machine learning algorithm is applied to the data to assess the integrity of the data mapping. Inaccurate mappings are identified, and the user is alerted to remap the impacted data element(s) prior to data submission. Uploaded data is further reviewed by the 340B ESP™ team and any identified PHI will be immediately destroyed and the covered entity will be notified.

My covered entity requires that we enter into a Business Associate Agreement (BAA) with Second Sight Solutions prior to submitting data. How does my covered entity initiate that process?

Second Sight Solutions does make a standard BAA available to 340B covered entities that require a BAA be in place prior to submitting data. To request a BAA you can email [email protected].
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