Physician Administered Drugs HCPCS & NDCs in HL7 v.2

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546 NDC Billing Issue was introduced by Joann Larson. FM would like to more fully describe the issues related to the association of HCPCS for Physican Administered Drugs (J-Codes) and the NDCs

Current description is: In the United States, the CMS and many states are requiring hospitals to report the NDC Quantity and Unit of Measure Qualifier on claims. This field will contain the NDC quantity and Unit of Measure of the drug identified by the NDC Code in FT1-29. For example, a Diltiazem injection is available in a 50mg/10ml vial. The NDC quantity would be 10 and the Unit of Measure Qualifier would be ML.

Issue Detail: The Deficit Reduction Act of 2005 (DRA) requires States to collect Medicaid rebates for certain physician-administered drugs. CMS and many states are requiring hospitals to begin reporting the NDC Code, NDC Unit Qualifier, and NDC Quantity on claims with discharges beginning on or after January 1, 2008 for certain drugs.

This may be an issue for other countries where information about relabling is reported.

Medicaid Drug Rebate Reporting On October 10, 2007, the NUBC adopted instructions for reporting NDC rebate information on the UB-04 paper format. Note that consideration of reporting compound drugs and reporting requirements for 340b entities was tabled at this time in part to obtain formal official input from CMS. The instructions are summarized as follows: Using the Revenue Description Field (Form Locator 43) on the UB-04: • Report the N4 qualifier in the first two (2) positions, left-justified. • Followed immediately by the 11 character National Drug Code number in the 5-4-2 format (no hyphens). • Immediately following the last digit of the NDC (no delimiter) the Unit of Measurement Qualifier. The Unit of Measurement Qualifier codes are as follows: F2 -International Unit GR-Gram ML-Milliliter UN- Unit • Immediately following the Unit of Measurement Qualifier, the unit quantity with a floating decimal for fractional units limited to 3 digits (to the right of the decimal). • Any spaces unused for the quantity are left blank. Note that the decision to make all data elements left-justified was made to accommodate the largest quantity possible.

Justification Detail: Currently applications receive charges for Medications from various Pharmacy applications. These charges are processed and ultimately are posted on the financial claims for reimbursement from various payors. The CMS required units can be different from the actual ordered units and will not be accepted for financial claims processing. This is a proposal to add field to the FT1 segment, to support the additional information required by the implementation of this regulation.

Below are excerpts from the email thread on the topic. From: Pam Morgan 2/26/08 Hi Susan, At X12 we include the HCPCS and HCPCS quantity (this would match the dose(s) for the HCPCS) and the NDC, NDC units, type of units (IU, ML, etc) knowing that the HCPCS and NDC units do not align so based on your question I would say yes the problem would be solved.

I offer the anecdotal reports that physicians are having a hard time knowing how to report NDC units but also some of our states report that with some training their providers now report accurate HCPCS and NDC units.

Susan Lepping FM Cochair to FM List 2/21/08

Hi Pam,

Thank you you the info you provided. Would the fact that X12 has changed the standard to require a HCPCS for every NDC, solve the following Use Case?

For the HCPCS J9265 Paclitaxel injection one unit of this HCPC has a dosage of 30 mg. This drug is a multi-source drug; it is made by many manufacturers. In order to administer this drug a provider may use vials from different manufacturers. Conceptually speaking a physician may use six 5 mg vials. Each from a different manufacturer. Each with its own unique NDC number. So, we have many NDCs for one unit of J9265, or more accurately six 5 mg vials each from a different manufacturer, that make up 1 unit, or 30 mg, of HCPC J9265. X12 has harmonized the 837's NDC units of measure with the NCPDP claim's units of measure. But this however doesn't help with the fact that a drugs HCPCS has a dosage "imbedded" in its quantity. In the above example, one unit of J9265 has 30 mg dosage. We will never have a one to one relationship with NDC number's dosage and HCPCS quantities.

From: Morgan, Pam [1] Sent: Wednesday, January 30, 2008 11:24 AM To: Strand, Jeff Subject: RE: HL7 and Physician Administered Drugs

X12 has changed the standard to require a HCPCS for every NDC, (current 4010 has one HCPCS for multi NDC if compounds). Some folks report they plan to use S5000 and S5001 (label drug/generic drug respectively) for everything. California plans to require the "real" HCPCS and expects correct NDC and units to go with. Training will be an issue.

X12 mapped to NCPDP so if you use that data element list and description you would have it. I have the crosswalks to and from X12/NCPDP if you want them

From: Strand, Jeff Sent: Tuesday, January 29, 2008 11:11 AM To: Morgan, Pam Cc: Kathleen Connor; McDaniel, Mary Kay Subject: HL7 and Physician Administered Drugs


The HL7 V2.7 committee is trying to define the data exchange to support Physician Administered Drugs - similar to what we have dealt with on the 837 realm.

I raised a concern that the billing systems of the physicians and hospitals may not have access to the sets of valid values that would be needed to support proper billing of these. Of particular concern was the ability of the physician/hospital billing system to give the proper Unit of Measure and the NDC Units. I know that FDB has a number of ways to indicate the measurement including the dosage form and the HCFA Unit Type. So the 4 specific values listed are either examples - to be cross-referenced with a valid code set - or are really not used. Do you happen to know exactly which FDB table should be compared? I went through the NDDF document and couldn't find anything that was absolutely perfect.

I know that interChange does not trust the physician supplied Unit of Measure and we will send drug rebate invoices based on what is on the drug file.

The other key issue is the NDC units. Again, here is an area where a Physician/Hospital billing system may have a very hard time supplying the proper NDC units that are in a vial of compounded anti-cancer drugs, especially if there are multiple active NDC's in the compound. The overwhelming evidence of claims received shows they bill the same units in the NDC units as they do in the HCPCS units - and that the Drug Labelers promptly dispute these invoices. I know some states are only working with the first NDC and ignoring the rest. But if we are going to build a trusted data exchange system, we need to be able to properly supply the vendors and billers with access to the right information so that it works completely.

Mary Kay indicated that you had done a significant amount of work in this area for the X12 group. I welcome any documentation or suggestions that you wish to share related to this data.

Again, it is not really the data definition that I question. It is preparing examples to show proper billing for multiple NDC's on a single HCPCS when the units are measured in different forms.

Do you have any documentation which may help?


Jeff Strand

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