1. What is an NDC?

“NDC” stands for National Drug Code. It is a unique, 3-segment numeric identifier assigned to each medication listed under Section 510 of the U.S. Federal Food, Drug and Cosmetic Act. The first segment of the NDC identifies the labeler (i.e., the company that manufactures or distributes the drug). The second segment identifies the product (i.e., specific strength, dosage form, and formulation of a drug). The third segment identifies the package size and type. For billing purposes, the Centers for Medicare & Medicaid Services (CMS) created an 11-digit NDC derivative, which necessitates padding of the labeler (5 positions), product (4 positions) or package (2 positions) segment of the NDC with a leading zero, thus resulting in a  fixed-length, 5-4-2 configuration. (See question 12 for details.)


2. When should NDCs be entered on claims?

Blue Cross and Blue Shield of Texas (BCBSTX) requests the use of NDCs and related information when drugs are billed on professional and ancillary electronic (ANSI 837P) and paper (CMS-1500) claims. Note: BCBSTX requires inclusion of the NDC along with the applicable Healthcare Common Procedure Coding System (HCPCS) or Current Procedural Terminology (CPT®’) code(s) on claim submissions for unlisted or ‘Not Otherwise Classified’ (NOC) or ‘Not Otherwise Specified’ (NOS) physician administered and physician supplied drugs.



3. Where do I find the NDC?

The NDC is usually found on the drug label or outer packaging. The number on the packaging may be less than 11 digits. An asterisk may appear as a placeholder for any leading zeros. The label also displays information about the NDC unit of measure for that drug.

4. If the medication comes in a box with multiple vials, should I use the NDC number on the box or the NDC number on the individual vial*

If the medication comes in a box with multiple vials, using the NDC on the box (outer packaging) is recommended.



5. Which NDC units of measure should I submit on BCBSTX claims to help ensure appropriate reimbursement?

Listed below are the preferred NDC units of measure and their descriptions:

* UN (Unit) – Powder for injection (needs to be reconstituted), pellet, kit, patch, tablet, device

* ML (Milliliter) – Liquid, solution, or suspension

* GR (Gram) – Ointments, creams, inhalers or bulk powder in a jar

* F2 (International Unit) – Products described as IU/vial or micrograms

Note: ME is also a recognized billing qualifier that may be used to identify milligrams as the NDC unit of measure; however, drug costs are generally created at the UN or ML level. If a drug product is billed using milligrams, it is recommended that the milligrams be billed in an equivalent decimal format of grams (GR). BCBSTX allows up to three decimals in the NDC Units (quantity or number of units) field.

Surgical Implanted Pain Medication Pumps (SIPMP) Compound Drug Billing Guidelines

The following billing guidelines must be followed when submitting claims for SIPMP compounded drug(s) refills in order to prevent the services from denying or being underpaid.

 • All services related to the SIPMP refill, programming, drug(s), and compounding must be submitted on the same claim for each date of service in order to be services from being denied or prevent a delay in payment.

 •Each compounded drug(s) used for the SIPMP refill must be submitted on a separate line of the claim with the 11-digit NDC Code assigned to each of the drug(s) used in the SIPMP refill.

• The accurate NDC quantity (with the amount converted based upon the NDC assigned unit of measure) must be submitted in the metric decimal quantity (up to 2 decimal spaces – i.e. 0.01)

• When the NDC quantity is converted and the metric decimal quantity is less than 2 decimal places, the NDC quantity must be rounded up to 0.01. (i.e. 0.007, 0.0012, 0.0004, etc)

• All compounded powder NDC codes are assigned a GR (Gram) unit of measurement, so the NDC quantity submitted must be for quantity amount based upon GR (Gram) unit of measure rounded up to 2 decimal quantities.

• If applicable, Florida Blue will allow a single ‘compounding fee’ up to $70.00 when submitted and billed appropriately. The compounding fee is reimbursing for any fees and/or supplies charges by the compounding pharmacy.

 • In order to be considered for payment of the compounding fee, the following instructions must be used when submitting the claim: • A separate line must be billed using the following data elements:

• HCPCS code = J3490

• NDC code = 00000000070

 • NDC quantity = 1

• HCPCS quantity = 1

The following is an example to provide guidance with submitting an electronic and paper claim:

• The following identifies the information that may be referenced on the invoice received from the compounding pharmacy identifying the drug and amounts used for the patient that came into the office 04/17/2014 to have their SIPMP programmed and refilled:

**Invoice Example #1

NDC CODE getting from DRUG

NDC code reporting on claim form

Reporting National Drug Code (NDC) on Claims

We require all clinician administered drugs billed on professional and outpatient hospital claims to be processed through the member’s medical benefits, and to include the NDCs for the drugs. Providers are required to report NDCs on claims with any associated HCPCS or CPT codes, including immunizations.

(HCPCS codes beginning with the letter “A” are excluded from this requirement). Failure to report an NDC on these claims will result in automatic rejections.

Providers should use the following billing guidelines to report NDCs on professional CMS-1500 claims:

• NDC code editing will apply to any clinician administer drug billed on the claim, including immunizations. The claim must include any associated HCPCS or CPT code (except HCPCS codes beginning with the letter “A”).

• Each clinician administered drug must be billed on a separate line item.

• Claims that do not meet the requirements will be rejected and returned on your “Not Accepted” report. Units indicated would be “1” or in accordance with the dosage amount specified in the descriptor of the HCPCS/CPT code appended for the individual drug.

• Providers may bill multiple lines with the same CPT or HCPCS code to report different NDCs.

• The following NDC edits will apply to electronic and paper claims that require an NDC but no valid NDC was included on the claim.

– NDCREQD – NDC CODE REQUIRED

– INVNDC – INVALID NDC

For Hardcopy Claims

• On the CMS-1500 claim form, report the NDC in the shaded area of Box 24A. We follow the CMS guidelines when reporting the NDC. The NDC should be preceded with the qualifier N4 and followed immediately by a valid CMS 11-digit NDC code fixed length 5-4-2 (no hyphens), e.g. N49999999999. The drug quantity and measurement/qualifier should be included.

• On the UB-04 claim form, report the NDC and the quantity in Box 43 (description field). We follow the CMS guidelines when reporting the NDC. The NDC should be preceded with the qualifier N4 and followed immediately by a valid CMS 11-digit NDC code fixed length 5-4-2 (no hyphens), e.g. N49999999999. The drug quantity and measurement/qualifier should be included.

For Electronic Claims

Report the 11- digit NDC in loop 2410, Segment LIN03 of the 837. The NDC will be validated during processing. The corresponding quantity and unit(s) of measure should be reported in loop 2410 CTP04 and CTP05-1. Available measures of units include the international unit, gram, milligram, milliliter and unit.



Where do I enter NDC data on a paper claim (CMS-1500)?

In the shaded portion of line-item field 24A-24G, enter NDC qualifier N4 (left-justified), immediately followed by the NDC. Enter one space for separation. Next enter the appropriate qualifier for the correct dispensing NDC unit of measure (UN, ML, GR or F2). Following this, enter the quantity (number of NDC units).

 Can you give a billing example?

HCPCS code J9400 provides a good billing example. A patient receives Ziv-Alfibercept ZALTRAP 400 MG. Zaltrap is available as 200 MG per 8 ML (25 MG per ML) solution, single-use vial, NDC 00024-5841-01.

For this sample scenario:

* The NDC is 00024-5841-01 (the qualifier is N4)

* The unit of measure is ML

* The quantity (number of J-code units administered) is 400

* The quantity (number of NDC units administered) is 16

On the CMS-1500, the data would be entered as follows: N400024584101 ML16



Are there any special software requirements to consider when NDCs are included on electronic claims?

If you have converted to ANSI 5010, there should be no additional software requirements. Please verify with your software vendor to confirm that your Practice Management System accepts and transmits the NDC data fields appropriately. If you use a billing service or clearinghouse to submit electronic claims on your behalf, please check with them to ensure that NDC data is not manipulated or dropped inadvertently.

Billing with National Drug Codes (NDCs) Guideline from BCBSTX

Blue Cross and Blue Shield of Texas (BCBSTX) does not require inclusion of the National Drug Code (NDC) along with the applicable Healthcare Common Procedure Coding System (HCPCS) or Current Procedural Terminology (CPT®) code(s), except on claim submissions for unlisted or “Not Otherwise Classified” (NOC) physician-administered and physician-supplied home infusion therapy drugs.

BCBSTX currently accepts NDC for billing of all physician-administered and physician-supplied drugs in accordance with the NDC schedule posted on the BCBSTX Provider website under “Drugs”. Including the NDC on claims helps provide a more consistent pricing methodology for payment and will also facilitate better management of drug-associated costs. For information about how to add the additional NDC and other required elements, please refer to the BCBSTX Provider website at bcbstx.com/provider. BCBSTX will continue to accept the HCPCS or CPT code elements without NDC information (excluding unlisted or “Not Otherwise Classified” drugs).

Claims should be submitted with the exact NDC that appears on the product administered. The NDC is found on the medication’s packaging and must be submitted in the 5digit-4digit-2digit format. Please note: A drug’s container label may display less than 11 NDC digits. An asterisk may appear in either a product code or package code as a place holder for any leading zeros. Zeros must be added to each section to make 11 digits total when submitting the NDC code on the claim to BCBSTX. Decimal points are acceptable in the NDC unit field. Each container label displays the appropriate unit of measure for that drug.

Please remember the following to help ensure proper submission of valid NDCs and related information: The NDC must be submitted along with the applicable HCPCS or CPT procedure code(s).

The NDC must be in the proper format (11 numeric characters, no spaces or special characters). The NDC must be active for the date of service.

The appropriate qualifier, unit of measure, number of units, and price per unit also must be included, as indicated below.

BCBSTX utilizes a claims payment audit process (during initial claim payment and post payment) to validate the number of units administered against the submitted charges of medications. This audit process applies to claims for medications billed with Healthcare Common Procedure Coding System (HCPCS) codes, Current Procedural Terminology (CPT®) code(s), and National Drug Code (NDC). The audit reviews claims to identify possible overbilling errors that exceed standard dosing thresholds. It may result in denying the portion of these claims that exceeds maximum dosing levels based on the product labeling, Food and Drug Administration (FDA) dosing guidelines; peer reviewed or published medical literature for each drug.

PAPER CLAIM GUIDELINES

In the shaded portion of the line-item field 24A-24G on the CMS-1500, enter the qualifier N4 (left-justified), immediately followed by the NDC.* Next, enter the appropriate qualifier for the correct dispensing unit (F2 – international unit mainly used for Factor VIII-Antihemophilic Factor; GR – gram, generally used for ointments, creams, inhaler or bulk powder in a jar; ML – milliliter, if drug comes in a vial in liquid form; UN – unit, if drug comes in a vial in powder form and has to be reconstituted; followed by the quantity and the price per unit, as indicated in the example below.

*Note: The HCPCS/CPT code corresponding to the NDC is entered in field 24D.



EXAMPLE NDC BILLING SCENARIO

To assist you with billing with NDCs, below is an example scenario.

What was administered?

In our sample scenario, a patient received Decitabine 50 mg.

What’s on the package label?

The NDC is found on the medication’s packaging. The drug’s container label may display less than 11

NDC digits. An asterisk may appear in either a product code or package code as a place holder for any leading zeros. Each container label displays the appropriate unit of measure for that drug.

Decitabine is supplied in a single-dose 50mg per vial. Here is an example of the NDC information that you may see when you are preparing to bill: 62856-0600-01 Dacogen, 50mg SOLR Unit of Measure = UN


What to include on the claim:

When entered on your claim, the NDC must follow the 5digit-4digit-2digit format, any leading zeros must be added to each segment to make 11 digits total. The NDC must be in the proper format (11 numeric characters, no spaces or special characters).


For our example scenario:

The NDC is 62856-0600-01 (the qualifier is N4)

The unit of measure is UN, since the drug came in a single dose and does not specify the ML The quantity (number of NDC units administered) is 1

The quantity (number of J-code units administered) is 1 The HCPCS code is J0894

Current Procedural Terminology (CPT®), copyright 2008, by the American Medical Association (AMA). CPT is a registered trademark of the AMA.

NDC Billing Instructions

Molina EDI Help Desk is reporting claims are being rejected because more than one NDC code is being billed on one service line. Below you will find instructions on billing multiple NDC codes for the same drug on a claim. For more detailed information on billing NDC codes, please see the BMS website at www.wvdhhr.org/bms. On this site, you will find a listing of drug codes and whether or not they require a NDC, Frequently Asked Questions, a provider notice and a list of manufacturers that participate in the rebate program.

Multiple NDCs

At times, it may be necessary for providers to report multiple NDCs for a single procedure code. For codes that involve multiple NDCs (other than compounds, see BMS website), providers must bill the procedure code with KP modifier and the corresponding procedure code, NDC qualifier, NDC, NDC unit qualifier and NDC units. The claim line must be billed with the charge for the amount of the drug dispensed for the NDC identified on the line. The second line item with the same procedure code must be billed utilizing KQ modifier, the procedure code units, charge and NDC information for this portion of the drug.