Current News

Statement of HDMA President and CEO John M. Gray on the Centers for Medicare & Medicaid Services' Proposed AMP Implementation Rule

HDMA Recognized As One of the Best Places to Work in Virginia for Second Year in a Row

HDMA's John M. Gray Highlights 2012 Industry Priorities in Jan. 2 Issue of Chain Drug Review

HDMA Presents Rx Safety and Healthcare Leadership Award to Senator Pat Roberts (R-Kan.)

Pharmaceutical Distributors Continue to Deliver Operational Efficiencies and Value to U.S. Healthcare System Amidst Economic and Regulatory Challenges

Visit HDMA Press Room >


print page

 


 

 

 

EDI Usage Guidelines

Electronic Data Interchange (EDI) is commonly defined as the transfer of structured data (by agreed message standards) from one computer system to another without human intervention. Even with such technology advances as XML, Web services and use of the Internet, EDI is still the data format used for the vast majority of electronic commerce transactions in the world. Once the EDI information is sent, back-end systems convert the data through a translator into a single format for use by the receiver.

print page

With the advent and evolution of fee-for-service or inventory agreements between distributors and manufacturers in the healthcare supply chain, the accurate and efficient exchange of information surrounding sales, inventory levels, forecasts and more is critical. The development and use of voluntary guidelines for specific EDI standards provide industry trading partners with a means to effectively convey the necessary information.

HDMA supports the development of guidelines for EDI transactions that enable the use of standards in support of distributor service agreements in our industry. HDMA’s eCommerce Task Force (eCTF) periodically reviews and updates voluntary technical standards and guidelines for healthcare distribution.  For the past several years, the eCTF has evaluated and updated the following HDMA EDI Guidelines:

This resource is a synopsis of the recent updates made to these specific HDMA Guidelines for EDI transaction sets to support inventory management or distribution service agreements between trading partners. It follows the following outline:

  1. The Value of EDI
  2. Process Flow (Work flow of transaction sets)
  3. Transaction Set Descriptions and Update Summary (Covers the purpose and highlights recent changes)
  4. EDI Use Data
  5. FAQ
  Click to expand or collapse each section below; “Print Page” to print the entire Usage Guidelines.
I. The Value of EDI

Why use Electronic Data Interchange? It:

  • Establishes a baseline for efficient information exchange between trading partners;
  • Enables electronic commerce;
  • Provides visibility into channel data;
  • Supports distributor service agreements.
II. Process Flow (Work flow of transaction sets)

The diagram below illustrates the flow of EDI information typically exchanged between various parties in the healthcare supply chain. As indicated by the directional arrows, certain transactions are one-way and others are bidirectional. The transactions listed in bold face are covered in this document. HDMA’s EDI Guidelines focus on the exchange of information between manufacturers and distributors (and third-party agents or data service providers acting on their behalf).

Click here to see a larger version of this image.

III. Transaction Set Descriptions and Update Summary (Covers the purpose and highlights recent changes)

Below are descriptions of recently updated HDMA EDI Guidelines, followed by a table summarizing the updates to the various guidelines.

852 (Product Activity Data)

The implementation guideline for the 852 Product Activity Data EDI transaction set can be used by a distributor to efficiently provide inventory, sales and other product activity information to manufacturers as part of the distributor service or inventory management agreements. The transaction set also can support a more consistent and common understanding of the data provided, and will more accurately reflect business requirements used to identify a product’s status. By using these guidelines, trading partners will gain:

  • Greater supply chain visibility;
  • Increased information on product movement;
  • Greater levels of efficiency; and
  • Improved service levels to retail and institutional end customers.

It is recommended that this transaction set be sent on a daily or weekly basis.

867 (Product Transfer and Resale)

The implementation guideline for the 867 Product Transfer and Resale Report EDI transaction set supports the customary and established business and trading partner practices relative to the reporting of sales. Normally, the Product Transfer and Resale Report transaction set may be used to report the following information:

  • Intracompany product transfer;
  • Sales of product from one or more locations to an end customer;
  • Returns from end customers to distributors; and
  • Market intelligence data.

This 867 transaction set may be used by a healthcare distributor to report sales transactions to a manufacturer. It is recommended that the 867 should only be used to reflect actual product movement, and not financial transactions (e.g., credit and rebill or inventory adjustments).

Note that this transaction is not to be used for the reporting of returns from the distributor to the manufacturer. A return from the distributor to the manufacturer is reported through the 180 Return Merchandise Authorization transaction.

845 (Price Authorization Acknowledgment/Status)

The implementation guideline for the 845 Price Authorization Acknowledgment/Status EDI transaction set, sometimes referred to as the Bid Award/Change Notification, can be used by a vendor or manufacturer to transmit specific data relative to the status of or changes to outstanding price authorizations. The 845 is sent by the manufacturer (or agent) to the distributor to indicate a bid award on a contract or a change notification on a contract. 

This notification should include all awarded products, prices and eligible customers for the awarded contract. Notification to the appropriate distributor(s) should occur 45 to 60 days prior to the effective date of the awarded contract. 

The 845 also should be used by the manufacturer to notify the appropriate distributor(s) of any changes to an existing contract — previously sent to the distributor(s) — as these changes occur during the time the contract is in effect. Notification of changes to an existing contract should occur not less than 15 days prior to the effective date of the change to allow the distributor time to update the computer files necessary to manage the transactions.

844 (Product Transfer Account Adjustment)

The 844 Product Transfer Account Adjustment is the chargeback claim relating to pre-authorized product transfer actions, providing the distributor with an electronic mechanism to request reimbursement from the manufacturer. The 844 chargeback transaction also can be used by the distributor to send an electronic credit memo (reverse chargeback) to the manufacturer in cases where a previously “charged-back” product has been returned by the eligible customer to the distributor or manufacturer.  

As a guideline, distributors should transmit chargeback claims to the manufacturer no later than 60 days after the sale of the product to the eligible customer. The chargeback claim should be processed by the manufacturer within 30 days of chargeback transmission. 

849 (Response to Product Transfer Account Adjustment)

The implementation guideline for the 849 Response to Product Transfer Account Adjustment EDI transaction set, sometimes referred to as the Chargeback Reconciliation with Resubmittal, can be used to transmit a detailed or summary response to a party requesting an accounting adjustment relating to a preauthorized product transfer. The 849 is the response to the 844 chargeback claim.

In response to the chargeback claim received through the 844 from the distributor, the manufacturer processes the chargeback claim and sends an electronic credit document to the distributor through the transmission of an 849 Response to Product Transfer Account Adjustment (Chargeback Reconciliation) transaction set. This is used by the manufacturer to reduce paperwork and expedite the chargeback payment process.

If the chargeback claim submitted by the distributor is found to be without error, the manufacturer will transmit a chargeback payment process. If the chargeback claim submitted by the distributor is found to include errors, the manufacturer will transmit a chargeback reconciliation with line item detail of the item(s) found to be in error in the original chargeback claim. This chargeback reconciliation should include credit for the undisputed and adjusted credit amounts along with any line item denied for credit. Only items found in error (adjusted or denied) should be transmitted back to the distributor with an HDMA reject reason code.

180 (Return Merchandise Authorization)

The implementation guideline for the 180 Return Merchandise Authorization and Notification EDI transaction set may be used to report the following information:

  • A return authorization request by a distributor, third party or customer to the manufacturer;
  • The response to a return authorization request by the manufacturer or third party;
  • A notification of a return not requiring authorization;
    • By a manufacturer for a recall
    • By a distributor or third party to the manufacturer
  • The response to the notification of a return.


The 180 transaction set is not intended cover returns from end customers to distributors, which are covered in the 867 Product Transfer and Resale Report Guidelines.

Due to other regulatory requirements, it also is not appropriate to use the 180 as the sole means of product recall notification.

812 (Credit/Debit Adjustment)

The 812 Credit/Debit Adjustment EDI transaction set can be used bidirectionally for any debit or credit memo between a distributor and a manufacturer or their reverse distributor or agent.

The guidelines are not intended for chargeback-related debits or credits; HDMA recommends the use of the 844 Product Transfer Account Adjustment (chargeback) transaction set for submission of chargeback claims and adjustments to a manufacturer. HDMA also recommends the use of the 849 Response to Product Transfer Account Adjustment (chargeback reconciliation) transaction set for settlement of chargeback claims and adjustments with a distributor.

The 812 transaction set is intended, therefore, for other types of debit and credit adjustments such as rebates, bill-back credits, returns, overcharges, (including shortage claims), undercharges, handling fees and damaged goods.

810 (Invoice)

The 810 Invoice EDI transaction set allows the sender to transmit pertinent information relative to the billing for goods and services provided between manufacturer and drug wholesaler. (It is not intended to be used for providing Debit/Credit Memo information; this data would be transmitted using the 812.)

The HDMA guidelines’ mapping of the 810 Invoice allows the sender to transmit all pertinent iinformation for the receiver to process in an automated environment. Upon receipt of a purchase order, the manufacturer will process, pick and ship the order and then electronically transmit an invoice to the wholesale distributor. To best use the electronic invoice, it is helpful for the distributor to receive it prior to receipt of the merchandise. This allows the distributor to implement an automatic reconciliation and payables process.

850 (Purchase Order)

The 850 Purchase Order EDI transaction set describes a customary and established business and industry practice relative to the placement of purchase orders for goods and services, usually submitted by a distributor to a manufacturer with quantities and other key data elements.

Note: This guideline does not provide support for Controlled Substance Ordering System (CSOS) orders; see HDMA Controlled Substance Ordering & Electronic Contract Re-submittal Guidelines for Electronic Data Interchange (EDI)(version released August 2006).

855 (Purchase Order Acknowledgement)

The Purchase Order Acknowledgment transaction is used by a manufacturer to respond to a distributor with order and order line item status, including item backordered, held, accepted or rejected etc.

Note: This guideline does not provide support for Controlled Substance Ordering System (CSOS) orders; see HDMA Controlled Substance Ordering & Electronic Contract Re-submittal Guidelines for Electronic Data Interchange (EDI)(version released August 2006).

856 (Ship Notice/Manifest)
This publication outlines the voluntary industry conventions and implementation guidelines for the ASC X12 approved 856 “Advance Ship Notice” (ASN) EDI standard used by manufacturers to send additional data to their distributor partners that they may need to document chain of custody for the movement of prescription drugs through the healthcare supply chain.

This ASN is not intended to serve as, or substitute for, the pedigree document itself. In addition to manufacturer product information, this publication includes information to support automated data collection technology, such as bar coding and/or radio frequency identification (RFID).

The following table captures HDMA’s recent updates to various EDI transaction guidelines, listing the major changes included since any prior release and the parties involved in the transaction.

Click here to see a larger version of this graphic.

IV. EDI Use Data

Which EDI transaction sets are exchanged by trading partners? Each year the Center for Healthcare Supply Chain Research, HDMA’s knowledge partner, collects information about the use of specific EDI transactions between distributors and manufacturers for its annual HDMA Factbook. Below are two tables that provide an idea of the usage of various EDI transactions between trading partners. 

The following Factbook data shows the percent of distributors that exchange each type of EDI transaction with suppliers. The green bar reflects data from all distributor survey respondents. The purple bar reflects only those distributor respondents with less than $1B in sales. Note that the data is from 2008.

Click here to see a larger version of this graphic.

The following manufacturer EDI data from 2008, published in the HDMA Factbook, indicates that all survey respondents use EDI for distributor/supplier/GPO trading partners. It also shows that 86 percent of the respondents use the Internet for EDI. 

The second chart addresses the specific transaction sets exchanged. All of the manufacturers surveyed exchange EDI 867, 852, 850, 849, 844 and 810 with distributors. Notably, all of the surveyed manufacturers that are not currently exchanging the 812 Credit/Debit Adjustment (17 percent) plan to do so in the next 12 months.

Click here to see a larger version of this graphic.

V. FAQ

Questions

Why should my organization use HDMA’s EDI Guidelines? How can I encourage my counterparts to use HDMA’s guidelines?

Identifiers

GLN/GTIN

What is a GLN?

How do I get a GLN?

Why should I switch from HIN to GLN?

Do GLNs need to be registered?

What is a GTIN®?

Why should I use GTIN?

How do you make a GTIN (14 digit) from an NDC in 4-5-1, 5-4-1, or 5-3-2 format?

Can you show examples of a GTIN (14 digit) from an NDC in 4-5-1, 5-4-1, or 5-3-2 format?

340B

What is a 340B Identifier?

Why should I use a 340B Identifier?

General Questions on the Order-to-Cash Transactions

810/850/855/856

Should N2/N3/N4 segments be used? Under what conditions?

For the SAC segment, is there a specific list that indicates which service, promotion, allowance or charge code should be used for each particular tax on the transaction?

In the Allowance or Charge Indicator in the SAC segment, what is the No Allowance or Charge value used for?

In segments that have multiple pairs of qualifiers and identifiers (e.g., PO1, IT1, etc) does the order or position of the qualifiers matter?

850/855

What revisions are in the recent release of the guidelines for the 850?

When would you use an ST for Standing Order?

Can I use the 850 if I have a drop ship request?

What revisions are in the recent release of the guidelines for the 855?

Why should I receive an 855?

810

For the SAC segment is there a specific list which indicates which service, promotion, allowance, or charge code should be used for each particular tax on the transaction?

In the Allowance or Charge Indicator in the SAC segment what is the No Allowance or Charge value used for?

In segments that have multiple pairs of qualifiers and identifiers (e.g., PO1, IT1, etc.) does the order or position of the qualifiers matter?

856

What revisions are in the recent release of the guidelines for the 856?

Why should I use the 856? Why is it commonly called an ASN (Advance Ship Notice)?

How is serialization handled in the 856 Ship Notice?

Does this 856 guideline help the distributor with pedigree chain-of-custody tracking?

How would I communicate the information necessary for pedigree compliance?

Can I send a GS1 Electronic Product Code (EPC) in the 856?

I don’t understand the hierarchical level in the 856; can you describe them?

852/867

How often is an 852 sent and what is included?

What is included in the 867? What is not included?

Why is serialization provisioned for in both the 867 and the 844 Product Transfer Account Adjustment? Why doesn’t the data in these two transactions match?

Why use the GS1 Global Location Number (GLN)?

Where is the GLN used in these EDI sets, at the header or detail?

Does 867 data match 852 data?

How can EDI support forecasting?

Can you clarify data on unsaleable inventory? What is it and where is it communicated?

Are there any answers to blinding/blocking of 867 data? 

If I receive a chargeback for product that was short-shipped, which transaction should I use?

845/844/849

What is the relationship between the 845 Price Authorization/Acknowledgement Status, 844 Product Transfer Account Adjustment and 849 Response to Product Transfer Account Adjustment?

What revisions are in the recent release of the guidelines for the 844?

What revisions are in the recent release of the guidelines for the 845?

What revisions are in the recent release of the guidelines for the 845?

Can membership be reported in 845? 

How are contract types communicated in the 845?

Why are N3 and N4 optional in the 844?

How can I catch and communicate variances on address?

What is the use of negative numbers in the 867?

Is there a way to do credit/rebill on one transaction?

180/812

What can the 180 communicate?

Is the 180 multi-directional?

What is covered by the 180?  What is not covered?

Is the 180 effectively a recall notice?

What can the 812 communicate?

Does the 812 cover chargebacks?

Can the 812 cover rebates and bill-back credits?

How can I clarify actual returns versus mis-ships?

Can returns movement be identified by invoice date?

Can I use the 180 to report direct and indirect returns?

I am a pharmacist. Can I use the 180 to notify my third party of a return?

How do I communicate batch returns?

Can the 180 work with ERP systems, such as SAP?

How can I avoid multiple debit memos or multiple credits being recognized in my system if multiple 180s come in referencing the same batch number on a return?

If I break out multi-title returns into individual 180s, will I have visibility into the returning entity’s state to accommodate any state-specific return requirements?

How are customer detail entities identified in the multi-title process?

Would everything listed in the 180 theoretically be matched back in response on the 812?

How does the information conveyed in the 180 tie together with physical product movement?

How many serialized items can be reported on one 180?

How many customers can be listed on one 180?

Could the 812 be used in multiple scenarios, between multiple parties?

Answers

Q. Why should my organization use HDMA’s EDI Guidelines? How can I encourage my counterparts to use HDMA’s guidelines?
A. For trading partners that use EDI, HDMA’s EDI Guidelines are intended to help facilitate trading partners’ use of the transaction sets to improve business efficiencies by including codes and usage notes that streamline the flow of information and provide common descriptions of terms and identifiers.

Back to Top ^

Identifiers
GLN/GTIN

Q: What is a GLN?
A: A Global Location Number (GLN) is a 13-digit identifier used to identify locations or legal entities in the supply chain. It is made up of a GS1 Company Prefix, Location Reference and Check Digit. Visit the GS1 US website for more information.

Q: How do I get a GLN?
A: Each company that has a valid GS1 Company Prefix can assign GLNs to their own locations. For more information, refer to the GLN Allocation Rules, published by GS1 US.

Q: Why should I switch from HIN to GLN?
A: Use of any unique identifier is up to individual trading partners and is a business decision to be mutually agreed upon by trading partners.

Q: Do GLNs need to be registered?
A: No, but the benefits are limited if GLN information is not shared with trading partners through the GLN Registry. Most Provider GLNs are assigned and registered at the same time using the GLN Registry functionality. See the GS1 US GLN registry for more information.

Once assigned, GLNs should be listed in the GLN Registry by the assigning company.  Note that a company needs to pay a separate membership fee to belong to the GS1 US GLN Registry. See the GS1 US GLN registry for more information. 

Q: What is a GTIN®?
A: Global Trade Item Number® (GTIN®) is an eight-, 12-, 13- or 14-digit identifier used to uniquely identify any trade item (a product or service that can be priced, ordered or sold) in the supply chain. It is made up of a GS1 US or UPC Company Prefix followed by an Item Reference Number and a Check Digit. Visit the GS1 US website for more information.

Q: Why should I use GTIN?
A: The use of any identifier is a business decision to be mutually agreed upon by trading partners. GTIN is widely recognized as a global and unique standard identifier for individual items. See the GS1 US GTIN Executive Summary for more information.

Q: How do you make a GTIN (14 digit) from an NDC in 4-5-1, 5-4-1, or 5-3-2 format?
A:   See the five steps below:

Step One: Begin with the “(01)” Application Identifier, which indicates that the following 14 digits will be a GTIN.

Note: The “(01)” is technically not part of “making a GTIN.” The “(01)” is part of “making a GS1-128 bar code.” The GTIN is only 14 digits and the “(01)” indicates that a GTIN is going to be the next 14 digits that follow it.

Step Two: After the GTIN Application Identifier, Position One is the Indicator digit. This digit is zero through eight. It will vary according to the packaging level.

Step Three:
The next two positions (2 and 3) must be “03” for products identified by NDCs (or NHRICs). A numeric digit “3” in Position Three indicates that the 10 digits in Positions Four through Thirteen are a NDC (or NHRIC).

Step Four:
The NDC (or NHRIC) number consists of a variable length “Labeler Code”on the left (assigned by the FDA; either four or five digits long) and a variable length “Product/Package Code”on the right (assigned by the holder of the “Labeler Code,” either five or six digits long).

Step Five:
Position Fourteen is a Check Digit for the entire GTIN. This number is calculated using the 13 preceding digits.
For more information, see the GS1 US GTIN Supplier Tool Kit or the document, “Three steps to create the 12-digit GTIN from a NDC or NHRIC,” published by GS1 US.

Q: Can you show examples of a GTIN (14 digit) from an NDC in 4-5-1, 5-4-1, or 5-3-2 format?
A: In the examples below letters are used to illustrate the construction of the GTIN-14 to not confuse with the fixed numbers that need to be added. Note that according to GS1 US, a company should register their FDA labeler code with GS1 US and pay a membership fee to receive their official GS1 Company Prefix.
4-5-1   AAAA-BBBBB-P translates to    I 03 AAAAB-BBBBP C
5-4-1   AAAAA-BBBB-P translates to    I 03 AAAAA-BBBBP C
5-3-2   AAAAA-BBB-PP translates to    I 03 AAAAA-BBBPP C

Note: Actual GTINs do not have a dash in them. The human readable representation under a bar code symbol sometimes, but not always, has the dash.

  • The “I” is the GS1 US indicator, which can be used to show different pack levels of the product (i.e., bottle, inner pack, case, pallet, etc.)
  • The “03” is a fixed string reserved by GS1 US to make the FDA labeler code unique in the GTIN-14.
  • The “C” is the check digit for the entire number, including the indicator, “03,” and the NDC. For a guide to the calculation of the check digit, refer to this GS1 US Web page.

Back to Top ^

340B

Q: What is a 340B Identifier?
A: The 340B identifier is assigned to entities eligible for the 340B Drug Discount Program, which is managed by the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA).

Q: Why should I use a 340B Identifier?
A: OPA requests covered entities to maintain current records (name, address, etc.) in the OPA database. Correctly identifying eligible entities is important because it has pricing and eligibility implications for the manufacturer and end customer, as well as auditing implications for manufacturers, distributors and the end customer in the supply chain.

Back to Top ^

General Questions on the Order-to-Cash Transactions
810/850/855/856

Q: Should N2/N3/N4 segments be used?  Under what conditions?
A: The N2/N3/N4 segments can be used. They are useful in situations where there is no shared identification code that can be used in the N103/N104 pair, such as drop shipments. If there is a common and understood identifier for use in the N1 segment, these segments do not add value and simply cause more data transmission size.

Q: For the SAC segment, is there a specific list that indicates which service, promotion, allowance or charge code should be used for each particular tax on the transaction?
A: There is no specific list. Tax requirements vary; usage should be discussed with and mutually agreed upon by trading partners.

Q: In the Allowance or Charge Indicator in the SAC segment, what is the No Allowance or Charge value used for?
A: As the SAC rolls into the TDS segment, it is important to clarify intent with trading partners.

Q: In segments that have multiple pairs of qualifiers and identifiers (e.g., PO1, IT1, etc) does the order or position of the qualifiers matter?
A: Technically, no. Practically, it is important to clarify intent with trading partners.

Back to Top ^

850/855

Q: What revisions are in the recent release of the guidelines for the 850?
A: The recent release of the 850 contains the following revisions:

  • Provisioned for GTIN (Global Trade Identification Number) and GLN (Global Location Number) identifiers from GS1 US at all package levels;
  • Added Units of Measure codes for consistency across transactions; and,
  • Added PER for communication of name and telephone number and email address of information contacts.

Q: When would you use an ST for Standing Order?
A: An example would be a regularly scheduled order on the 15th of every month. Use of this code could add value by communicating when a back-ordered product becomes available.

Q: Can I use the 850 if I have a drop ship request?
A: Yes, the 850 allows for drop ship. The drop ship location is communicated in the N1 segment, with ST (Ship To) in N101 and the appropriate location code and identifier in N104. There is a business case example of this at the end of the 850 guideline.

Q: What revisions are in the recent release of the guidelines for the 855?
A: The recent release of the 855 contains the following revisions:

  • Provisioned for GTIN (Global Trade Identification Number) and GLN (Global Location Number) identifiers from GS1 US at all package levels;
  • Added the ability to send confirmations, cancellations, re-submissions and seller-initiated changes;
  • Added code for the Bill-To Party;
  • Added PER for communication of name and telephone number and e-mail address of information contacts;
  • Added codes for consistency in Units of Measure;
  • Added codes to the ACK segment to allow the indication acceptance or rejection of an item; and,
  • Removed references to Automatic Replenishment.

Q: Why should I receive an 855?
A: You should receive an 855 in response to your 850 to ensure that the supplier has received and processed your 850. In addition, the 855 can contain important information about the product you ordered, such as if it was back-ordered or on hold. There is a business case example of this at the end of the 855 guideline.

Back to Top ^

810

Q: For the SAC segment is there a specific list which indicates which service, promotion, allowance, or charge code should be used for each particular tax on the transaction?
A: There is no specific list.  Tax requirements vary; usage should be discussed with and mutually agreed upon by trading partners.

Q: In the Allowance or Charge Indicator in the SAC segment what is the No Allowance or Charge value used for?
A: As the SAC rolls into the TDS segment, it is important to clarify intent with trading partners.

Q: In segments that have multiple pairs of qualifiers and identifiers (e.g., PO1, IT1, etc.) does the order or position of the qualifiers matter?
A: Technically, no. Practically, it is important to clarify intent with trading partners.

Back to Top ^

856

Q: What revisions are in the recent release of the guidelines for the 856?
A: The recent release of the 856 contains the following revisions:

  • Provisioned for GTIN (Global Trade Identification Number) and GLN (Global Location Number) identifiers from GS1 US at all package levels;
  • Added an additional level (for inner pack);
  • Added the ability to use GS1 US EPC for serialization*;
  • Added Units of Measure codes for consistency across transactions;
  • Added PER for communication of name and telephone number and email address of information contacts; and,
  • Added additional MAN segments and explanatory notes for their use.

*Note: EPC use may require a change to ISA 16: component element separator. EPC includes the colon character, so ISA 16 must not use that character.

Q: Why should I use the 856? Why is it commonly called an ASN (Advance Ship Notice)?
A: In an automated business environment, the 856 provides advance information on shipments from suppliers to better plan workloads and automate the receipt-of-goods process. Timing for sending and receiving Advance Ship Notice transactions is critical. The key word here is ‘‘advance.’’ The receiver must have ample time to process the transmission prior to the arrival of the shipment. All information in the EDI transaction and on the container labels must be accurate. Therefore, the latest the ship notice should be sent is at the time of shipment. The implementation of this transaction often involves transmitting multiple times during the day as shipping occurs.

Q: How is serialization handled in the 856 Ship Notice?

A: Serial numbers are recorded in REF segments, with qualifier SE, using the GS1 pure identity EPC URI. This is expected to handle the SSCC and SGTIN constructs. Visit the GS1 Tag Data Standards for more information on the pure identity EPC URI.

SSCC data in the current format can continue to be recorded in the MAN segments, with the qualifier GM.

Q: Does this 856 guideline help the distributor with pedigree chain-of-custody tracking?
A: Yes, this guideline outlines the voluntary industry conventions and implementation guidelines for the 856 used by manufacturers to send to their distributor partners additional data they may need to document chain of custody for the movement of prescription drugs through the healthcare supply chain. This ASN can facilitate the population of customers’ computer systems with product and shipping data, which may then be used to create a drug pedigree document to accompany the product to the point of dispensing.

Note: The ASN is not intended to serve as, or substitute for, the pedigree document itself.  In addition to manufacturer product information, this publication includes information to support automated data collection technology, such as bar coding and/or radio frequency identification (RFID).

Q: How would I communicate the information necessary for pedigree compliance?
A: The 856 guideline includes three examples, each describes how to send the identifiers for the lowest trackable unit of product shipped.

Q: Can I send a GS1 Electronic Product Code (EPC) in the 856?
A: Yes, using the REF segment at Item Level of the 856. You would put code SE (Serial Number) in REF 01 and the EPC code in REF 03.

Q: I don’t understand the hierarchical level in the 856; can you describe them?
A: A complete description, including a graphic, of the levels and their use can be found in the 856 guideline. Some examples are reference numbers, pallets on a truck, products on a pallet, casepacks or individual items. The shipment information is divided into layers or levels to match the physical characteristics of the shipment load.

The diagram below shows how the six possible levels in the HDMA 856 could be used. In each level, additional appropriate information would be provided in other segments in that particular level.

The HL segment is the key to which level is being described.

HL01: A sequence number for that HL segment.
HL02: The sequence number of the parent of that level.
HL03: The code identifying the level; for example, S for Shipment Level, or O for Order Level.
HL04: A code of 0 indicates no lower levels (children), code 1 indicates lower levels (children)

Back to Top ^

852/867

Q: How often is an 852 sent and what is included?
A: It is recommended that this transaction set be sent on a daily or weekly basis. Each 852 transaction set should list the product activity for all of a supplier’s SKUs in one distribution center. Product activity such as customer sales, returns, product transfers, drop-shipments, planned/forecasted order quantities, order line count by product and lost sales data may be provided. This information enables the manufacturer to plan, ship or propose inventory quantities at predetermined intervals based on changes in product activity, such as quantity on hand and quantity sold.

Q: What is included in the 867? What is not included?
A: These guidelines provide the capability to send detailed or summary sales reports by customer, product and contract. This 867 Product Transfer and Resale Report transaction set may be used by a healthcare distributor to report sales transactions to a manufacturer. This transaction is not to be used for the reporting of returns from the distributor to the manufacturer. A return from the distributor to the manufacturer is reported through the 180 Return Merchandise Authorization transaction. It is recommended that the 867 should only be used to reflect actual product movement, and not financial transactions (e.g., credit and rebill or inventory adjustments). Additionally, a potential use of 867 for Market Intelligence Data is supported in these guidelines. For a given product (brand or generic), this would provide the manufacturer with data indicating the amount of ordered product, how much the manufacturer supplied and what the total sales were for applications of molecular generic equivalent, similar disease state or therapeutic equivalent.

Q: Why is serialization provisioned for in both the 867 and the 844 Product Transfer Account Adjustment? Why doesn’t the data in these two transactions match?
A: Since the 844 and 867 can be used as stand-alone transactions, serial numbers need to be sent in each transaction. Systems that track chargeback (844) data and product transfer or sales (867) data do not necessarily communicate, so they do not necessarily match. The 867 and 852 Product Activity Data share product movement information. The 844 shows sales to customers that can be checked against 810 Invoice data.

Q: Why use the GS1 Global Location Number (GLN)?
A: The GS1 Global Location Number (GLN) was developed to address challenges in the industry with location identification. The GLN is included to meet the needs of the organizations that have chosen it as a common way to identify locations. 

Q: Where is the GLN used in these EDI sets, at the header or detail?
A: Both. HDMA is using the UL code to provision for GLN in the identifier list in certain segments (N103) and the LU code in others, depending on the code lists.

Q: Does 867 data match 852 data?
A: In theory, 867 data should match 852 data. However, the timing of reporting affects the ability to match data, and the granularity of data reported is not necessarily the same in the two transaction sets. Data is sometimes blocked on the 867, which also would prevent matching. Drop-ship reporting is another exception. Summary product movement is reported on the 852. The same granularity would need to be reported on 867 for the data to match.

Q: How can EDI support forecasting?
A: Forecasting can be supported with sales data from the 867. The 867 provides the current state sales detail and the 852 shows a snapshot of inventory position. Note that the EDI 830 (Planning Schedule with Release Capability) allows for transfer of an actual forecast. Although HDMA has not produced an implementation guideline for the 830, there is an existing Voluntary Interindustry Commerce Solutions (VICS) guideline for this transaction based on Accredited Standards Committee (ASC) X12 standards.

Q: Can you clarify data on unsaleable inventory? What is it and where is it communicated?
A: Returns may be unsaleable for a variety of reasons, including product nearing or past expiration or being recalled or withdrawn. Per HDMA’s EDI guidelines, you can use the 852, which shows total quantities, to communicate additions or returns (e.g. as a result of shelf-sweeping) to unsaleable inventory or levels of unsaleable inventory. You can use the 867, which shows transactional detail, to report returns to saleable inventory, or returns to unsaleable inventory. In both cases, use of the guidelines should be based on your trading partner’s information needs.


Q: Are there any answers to blinding/blocking of 867 data? 
A: On some downstream product transfer data there is some ZIP code visibility to three or five digits while others are blank. Access to data depends on the contractual relationship with trading partners and may be an example of opportunity for communication.

Q: If I receive a chargeback for product that was short-shipped, which transaction should I use?
A: The credit would appear on the 867 (as a negative number) and reverse the chargeback on a credit/rebill in the 844, but the credit is communicated on the 812 Credit/Debit Adjustment.

Back to Top ^

845/844/849

Q: What is the relationship between the 845 Price Authorization/Acknowledgement Status, 844 Product Transfer Account Adjustment and 849 Response to Product Transfer Account Adjustment?
A: Simply stated, the 845 is sent by the manufacturer (or agent) to the distributor to indicate a bid award on a contract or a change notification on a contract. The 844 is the chargeback claim relating to pre-authorized product transfer actions; it can provide the distributor with an electronic mechanism to request reimbursement from the manufacturer. The 844 chargeback transaction also can be used by the distributor to send an electronic credit memo (reverse chargeback) to the manufacturer in cases where a previously “charged back” product has been returned by the eligible customer to the distributor or manufacturer. The 849 is the response to the chargeback claim, sent by the manufacturer to the distributor as an electronic credit document.

Q: What revisions are in the recent release of the guidelines for the 844?
A: The recent release of the 844 contains the following revisions:

  • Additional codes have been added to identify third-party pharmacy billing and eligible entities.
  • Certain usage notes have been added or edited to clarify definitions or use.
  • The guideline allows for serialization data to be incorporated.
  • The 2009 edition includes additional methods to indicate the transaction type. Indicators for an original submission, a resubmission, a credit and rebill or a reissue are now accommodated in two ways: either at the header level, when all lines relate to one transaction type, or at the line level, when one chargeback may contain various transaction types. A new qualifier has been added to the header to notify upon receipt if the transaction type is identified at the header or line level.

Q: What revisions are in the recent release of the guidelines for the 845?
A: The 2008 update contains the following revisions:

  • Additional codes have been added to identify third-party pharmacy billing and eligible entities.
  • Certain usage notes have been added or edited to clarify definitions or use.

Q: What revisions are in the recent release of the guidelines for the 845?
A: The 2009 edition contains the following revisions:

  • Additional codes have been added to identify third-party pharmacy billing and eligible entities.
  • Certain usage notes have been added or edited to clarify definitions or use.
  • This edition also includes additional methods to indicate the transaction type. Indicators for an original submission, a resubmission, a credit and rebill or a reissue are now accommodated in two ways: either at the header level, when all lines relate to one transaction type, or at the line level, when one chargeback may contain various transaction types. A new qualifier has been added to the header to notify upon receipt if the transaction type is identified at the header or line level.

Q: Can membership be reported in 845? 
A: Yes.
The 816 might be a good option for the future since it contains a hierarchical structure. (The current method in the 845 relies on text fields to communicate name, address, city, state and ZIP code information.) The 816 could streamline membership with the 845 used to communicate changes; however, based on current use of the 816 primarily from GPO to manufacturer, it will take time to coordinate efforts and further develop an implementation process for trading partners. 

Q: How are contract types communicated in the 845?
A: Codes are provided in the REF segment.

Q: Why are N3 and N4 optional in the 844?
A: If you are not doing membership, you may not have information. If using N103/104, the codes should give sufficient information to identify location by address.
           
Q: How can I catch and communicate variances on address?
A: If the location identifier provided in 844 doesn’t match the location identifier in the 845 — because trading partners use different identification schemes (for example, HIN versus GLN) — the situation should be handled through internal reference tables by trading partners.

 Q: What is the use of negative numbers in the 867?
A: In the example of a chargeback for product that was shorted, credit on the 867 would show as a negative number and the reverse chargeback on the 844. Remember that credit and rebills belong in the 844, not in the 867.

Q: Is there a way to do credit/rebill on one transaction?
A: Yes. The 2009 edition includes additional methods to indicate the transaction type. Indicators for an original submission, a resubmission, a credit and rebill or a reissue are now accommodated in two ways: either at the header level, when all lines relate to one transaction type, or at the line level, when one chargeback may contain various transaction types. A new qualifier has been added to the header to notify upon receipt if the transaction type is identified at the header or line level.

Back to Top ^

180/812

Q: What can the 180 communicate?
A: The Return Merchandise Authorization and Notification transaction set may be used to report the following information:

    • A return authorization request by a distributor, third party or customer to the manufacturer;
    • The response to a return authorization request by the manufacturer or third party;
    • A notification of a return not requiring authorization;
      • By a manufacturer for a recall
      • By a distributor or third party to the manufacturer
    • The response to the notification of a return.

Q: Is the 180 multi-directional?
A: Yes. It can be used to request authorization or to notify and then to respond to request or notification.
Code applicability and usage varies depending on direction. Use caution when developing mapping.

Q: What is covered by the 180?  What is not covered?
A: The 180 is intended to communicate a physical return to the manufacturer or their third party, and the 812 is intended to be the credit/debit adjustment. The 180 is intended to cover the manufacturer/agent’s response to a return authorization request. The 180 is not intended to cover returns from end customers to distributors, which would be covered in the 867.

Q: Is the 180 effectively a recall notice?
A: No. Although it can communicate a recall or withdrawal as a return reason code, it is not appropriate for use as the sole means of product recall notification. (HDMA’s Product Recall and Withdrawal Notification Guidelines offer sample recall notification templates and other resources for reference.)

Q: What can the 812 communicate?
A: The 812 Credit/Debit Adjustment transaction set can be used bidirectionally for any debit or credit memo between a wholesaler and a manufacturer or their reverse distributor or agent.

Q: Does the 812 cover chargebacks?
A: No. The 812 Credit/Debit Adjustment is not intended for chargeback-related debits or credits. HDMA recommends the use of the 844 Product Transfer Account Adjustment (chargeback) transaction set for submission of chargeback claims and adjustments to a manufacturer. Additionally, HDMA recommends the 849 Response to Product Transfer Account Adjustment (chargeback reconciliation) transaction set for settlement of chargeback claims and adjustments with a wholesaler.

Q. Can the 812 cover rebates and bill-back credits?
A: Yes, the 812 Credit/Debit Adjustment is intended for many types of debit and credit adjustments such as rebates, bill-back credits, returns, overcharges, (including shortage claims), undercharges, handling fees and damaged goods. The 812 Credit/Debit Adjustment should be used in these cases instead of the 810 Invoice so that the 810 Invoice contains only original billing for products and services.

Q: How can I clarify actual returns versus mis-ships?
A: The 180 now includes codes for wrong goods/not ordered (WG) and several for damaged product in the RDR segment. 

Q: Can returns movement be identified by invoice date?
A: No, returns are not tied to the invoice date.

Q: Can I use the 180 to report direct and indirect returns?
A: Yes.

Q: I am a pharmacist. Can I use the 180 to notify my third party of a return?
A: Yes, the 180 Return Merchandise Authorization and Notification EDI transaction set may satisfy a request for returns, authorization or disposition of the return, notification of return or notification of consumer return. Check with your third party as you would with any communications protocol.

Q: How do I communicate batch returns?
A: Based on the structure of the document and ANSI ASC X12 specifications, the 180 can communicate the returning entity and the individual product details down to a serial number. To report multiple returning entities to the store detail level with multiple individual product returns, the recommended process involves sending multiple 180 documents “tied together” with a batch reference number. The BGN02 Reference Identification contains a usage note to include the “Returning Party's unique reference number to each 180,” and the N901 includes a Reference Identification Qualifier of BT to indicate a batch number. This identifier would be used to tie a batch of returns from multiple customers. There is no limit on the number of 180s that can be sent in a transmission. Until the ANSI ASC X12 specifications are amended, this is the best possible solution identified by the eCommerce Task Force.

Q: Can the 180 work with ERP systems, such as SAP?
A: It is a standard map which can be configured for various middleware applications that exist in various ERP systems, including SAP. 

Q: How can I avoid multiple debit memos or multiple credits being recognized in my system if multiple 180s come in referencing the same batch number on a return?
A: This will be an important consideration during the systems integration period. Debits and credits can be aggregated to avoid duplication.

Q: If I break out multi-title returns into individual 180s, will I have visibility into the returning entity’s state to accommodate any state-specific return requirements?
A: There is an indicator in the RDR04 in the 180 transaction to indicate a state with particular requirements.

Q: How are customer detail entities identified in the multi-title process?
A: There are multiple identifier code qualifiers listed in the N1 segments in both the 180 and 812  to accommodate the entity code used, including DUNS, DUNS+4, DEA, HIN, GLN and identifiers assigned by the seller, seller’s agent, buyer or buyer’s agent.

Q:  Would everything listed in the 180 theoretically be matched back in response on the 812?
A: There is a way at the line level to detail most of the scenarios and reasons listed in the 180. Some of the information may not need to be communicated back on the 812 but, for example, there is a way in the 812 to explain a variance on the credit issued due to a quantity difference in what was initially submitted on the 812.

Q: How does the information conveyed in the 180 tie together with physical product movement?
A: Product flow may not necessarily connect. The 180 is meant to convey information about a product return, but it is not necessarily connected to a particular shipment of returns. The 812 is meant to convey several types of debit and credit adjustments such as rebates, bill-back credits, returns, overcharges, (including shortage claims), undercharges, handling fees and damaged goods, and is likewise not necessarily tied to a particular shipment of returns. There is more room for product detail in both of these transactions, including product serialization.

Q: How many serialized items can be reported on one 180?
A: There is no limit to the number of individual serialized items reported on one 180.

Q: How many customers can be listed on one 180?
A: One N1 loop can be used to cover pharmacy or retail or distributor returns, and another N1 loop can be used to cover 3PL returns. To report multiple returns from multiple customers with detail, send several 180s and tie them together with one batch number. (See related question).

Q: Could the 812 be used in multiple scenarios, between multiple parties?
A: Yes, it could be used between manufacturers and retailers, manufacturers and distributors, manufacturers and their reverse distributor/agents, reverse distributors and other reverse distributors, etc.

Back to Top ^

 
 
© Copyright Healthcare Distribution Management Association.
All rights reserved.
HDMA: M | C | D
Do you have suggestions
for our site?
URL: