| 340B Price Restoration | Data Submission Enrollment

Data Submission Enrollment FAQs

Overview

Due to recent manufacturer actions, many Covered Entities have lost 340B contract pricing on certain NDCs. In order to restore pricing, Covered Entities must designate a single Contract Pharmacy and then submit data to 340B ESP for each of their PIDs in order to scrub for any possible duplicate discounts.     

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The Problem

Currently, the primary means of having 340B pricing restored at Contract Pharmacies is to submit claims data via 340B ESP. This process is complicated and often CEs will not have the bandwidth or know-how to extract and submit data and to track the approval progression.


To support our customers, Macro Helix created the Data Submission Enrollment Page, located within the 340B Price Restoration menu, as a way to integrate with ESP. Macro Helix can now submit and track claims data for your designated manufacturers, avoiding the need to manually submit each claim through the 340 ESP website. 



Is there anything that I need to do before I enroll pharmacies for data submission?

Yes! You must first register with 340B ESP prior to enrolling for automated data submission at Macro Helix: https://340besp.com/register.


If I am interested in enrolling in 340B ESP Data Submission, how what do I need to do? 

  1. For automatic data submission to 340B ESP, you will need to first register with 340B ESP prior to opting in pharmacies at Macro Helix.
  2. If registration requires a HIN number, see the following 340B ESP resource for HIN registration: https://help.340besp.com/en/articles/4816982-hin-registration-overview
     
  3. Once registration at 340B ESP is completed, you may begin opting in PIDs (Pharmacy IDs) for which you have Admin Hospital User access. *You may have visibility into other pharmacies wherein they have some access but not the access level needed to change the opt-in status.
    • For a full explanation of how to enroll for Data Submission, click here and go to New Data Submission Setup. 


After submitting the data, will Macro Helix know the eligibility results?

No. You must log in to the 340BESP.com website to see what is "compliant" vs. "non-compliant" for your data, per pharmacy/site that you have submitted data for.


What are some potential reasons for failures?

There are several possibilities of failures. 

  • ESP Failures: A failure may occur on the 340B ESP side, which Macro Helix has no ability to interface with.  
  • Submission Failures: Another type of failure would be that Macro Helix could not submit the file to ESP.  For example, if the connection between MH and ESP is down for some reason, this will show up in the Submission History and Ops will be made aware files are failing.  
  • Missing Data: Records could be missing the NPI, have an improperly formatted RX number, or have a Prescribed Date after Service Date. You will need to manually make the correction and resend via the reporting method to ESP. 


What is the frequency of sending data to 340B ESP?

  • First Time Submissions for PIDs: For the first scheduled data submission by Macro Helix on May 1, 2023, of any PID + Manufacturer combination, we will analyze the past 45 days of claims from the date of opt-in and submit any qualifications the following day, that have happened during that time period for the selected PID and Manufacturers.
  • Subsequent Submissions for PIDs: After the initial scheduled transmission by Macro Helix on May 1, 2023, every subsequent 15 days, we will analyze 45 days of past claims and send qualifications and disqualifications that happened within the last 15 days.
  • Newly Added NDCs to a Previously Opted In Manufacturer: If a manufacturer adds an NDC to your list and a PID was opted in for data sharing prior to the addition of that NDC, then we will analyze the past 45 days of claims and submit any qualifications or disqualifications that have happened during that time period for the selected PID and Manufacturers.


Can I change the frequency of claim submission?

Currently there is no way to select the frequency of claim submission to 340B ESP. 


How do I see what and when was sent to 340B ESP?

In the Data Submission Enrollment screen, to the right of the hospital you will see Review Historical Submissions.  This will show the history of the actual data files sent to 340B ESP.  


Why can’t I see Macro Helix auto submissions in the Claims section of ESP?

Currently, you must use the ESP Reports page to view automatically-submitted claims to ESP as they are not visible in the ESP Claims page – this is due to how data is transmitted and handled by ESP from a TPA vs. manual/direct upload by a CE.  ESP is working to update documentation and is reviewing our request to allow automatically-submitted claims to be viewed on the ESP Claims page.


How can I see what records were not sent to ESP?

Report RID 745: ESP Submission Validation Errors will provide the records and the reason individual records were not sent to 340B ESP.  We are also developing a UI enhancement that will show records and will have the functionality to select just the scrubbed records. 


How do I know what manufactures have been opted in?

In the Data Submission Enrollment screen, click on the > to the left of the hospital. A drop down menu of all the PIDs will appear.  Click the > beside the PIDs and the manufacturers that PID has opted-in to will appear.


Macro Helix is automatically submitting my claims data to 340B ESP, can I still send one-time data submissions to 340B ESP on my own?

Yes. Enrollment into Macro Helix data submission to 340B ESP does not inhibit the ability to submit to 340B ESP via other methods.


What types of pharmacies are available to opt-in for data submission?

Currently, the following criteria must be met for an PID to be available for inclusion:
  • Contract Pharmacy Retail or CE Owned Retail site
  • Active Pharmacies only 
All billable statuses are currently available. Future development will display the Billable Status next to the PID and PID Name.


Gateway Contract Pharmacies have not yet been excluded from Data Submission Enrollment. These PIDs should not be opted in. Future development will hide these PIDs from the page by filtering out Billable = Gateway PIDs.


What are the possible statuses for file submission on the Data Submission Enrollment screen?

Files are sent to 340B ESP at the 340BID / Hospital ID (HID) level. On the Data Submission Enrollment screen, opted in PIDs and Manufacturers can be found beneath the HID in the tree hierarchy. The Status column shows the status of the most recent file submission at the HID level. 

HID Level Submission Statuses

Status Description
File Creation Error

There was a validation error with summary or claims level data which prevented the creation of a file. For details, see RID 745: ESP Submission Validation Errors. 
Created

Claims have been gathered for the required time period (45 days of qualifications and disqualifications dates from the past 45 days of scripts for first time submissions and newly restricted NDCs, or 15 days of qualifications and disqualifications from the past 45 days of scripts for preexisting enrollments. This file has not yet been processed through ESP’s submission API.
Processed, Sent

Claims previously having the "Created" status have been inserted into a file and that file has been sent to 340B ESP
File Submission Error

The completed file previously having the  "Created" status was submitted to 340B ESP, but was rejected. 340B ESP does not currently provide explanations for file submission rejections – but likely the error derives from a validation error in a required ESP field

Because different Manufacturers can be opted in at different times for a single PID, it's possible to have submission statuses for Manufacturers beneath a PID that differ from one another.

PID + Manufacturer Level Submission Statuses

Sent

All data from the selected manufacturer for this PID were included in the most recent submission.
Pending

No data was included for any of the manufacturers this PID was opted into in the most recent submission.
 Sent + Pending The manufacturers beneath this PID have a mix of Sent and Pending statuses.


Manufacturer Level Submission Statuses (below PIDs) 

(blank)

Expected sub-status. Data for this manufacturer was included in the most recent submission. 
Not Included Outlier. Data for this manufacturer was not included in the most recent submission (Manufacturer was opted in for the PID after the previous submission for other Manufactures)


Why is my manufacturer level status blank?

Only Manufacturers that have an outlier submission status have their statuses displayed at the Manufacturer level. Otherwise, the submission status is the same as the PID level. See last table in previous question. 

This will change in a coming release where, for clarity, we'll assign a submission value to each PID beneath an HID, even if it is the same as the HID. 


What data does Macro Helix send to 340B ESP during automatic submissions and what is the source of that data?

ESP 340B Field Description Source Tech Data Source
Covered Entity ID 340B ID Pharmacy Settings Pharm340BID
Date of Service Service Date Retail Dispense ServiceDate
Date Prescribed The Date in which the NDC was prescribed. Retail Dispense MiscDate
NDC National Drug Code Retail Dispense NDC
Quantity The number of units dispensed to the patient Retail Dispense quantity
RX Number An identifier applied to a prescription by a pharmacy Retail Dispense RXNumber
Service Provider ID The unique identifier of the pharmacy that filled the prescription Retail Dispense, Pharmacy Settings 1. Claim NPI, if none, 
2. Pharmacy NPI (PharmNPI)] if none, 
3. Pharmacy NABP (PharmNABP). 
Service Provider ID Qualifier A code that indicates the type of identifier included in the Service Provider ID fie Retail Dispense, Pharmacy Settings If Retail Dispense NPI used: 01
If Pharmacy NPI used: 01
If Pharmacy NABP used: 07


What happens if a 340B claim previously submitted to 340B ESP loses its 340B qualification?

We will transmit the disqualification to 340B ESP as a negative quantity.


Does 340B ESP provide a "Received" flag so that I can know if my latest claims submission has been successfully received?

Currently, no. 340B ESP does not provide TPAs with flags or status updates for individual submitted claims or submitted claims files.


I'm already submitting for a Manufacturer, but what happens if they add a new NDC to their restricted list?

If a manufacturer adds an NDC to their list and a PID was opted in for data sharing prior to the addition of that NDC, then we will analyze the past 45 days of claims and submit any qualifications or disqualifications that have happened during that time period for the selected PID and Manufacturers.


How does Macro Helix know which NDCs to submit to 340B ESP on my behalf?

Macro Helix keeps its Manufacturer and Affected NDC List synced with 340B ESP's published NDC list. We receive NDC listing updates from 340B ESP every 4 hours.

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The Problem