Example of information required to accompany an unclassified drug:
HCPCS Code NDC NDC Description NDC Quantity*
J3490 00409156029 Bupivacaine, 0.50% 1ml 10.00 J9999 55566830101 Degarelix 1 UN 1.00 J3490 00409427001 Lidocaine 1ml
6.50
*Two decimals. NDC quantity is based upon the numeric quantity administered to the patient based upon the unit of measurement (AWPU). The standard unit of measurement (UOM) codes are:
F2 = International Unit
GR=Gram
ML = Milliliter
UN = Unit
HCPCS Code NDC Description NDC Quantity*
J3490 00000000070 Compounding Fee 1
J3490 38779067303 Morphine 50mg/ml 2.00
J3490 38779052403 Bupivacaine 20mg/ml 0.80
J3490 38779056106 Clonidine 1mg/ml 0.04
*Two decimals. NDC quantity is based upon the numeric quantity administered to the patient based upon the unit of measurement (AWPU). The standard unit of measurement (UOM) codes are:
F2 = International Unit
GR=Gram
ML = Milliliter
UN = Unit
Note: The HCPCS codes are more generic than NDC numbers as the HCPCS only describe drug and billing units. The NDC number is an 11-digit 3 segment unique identifier that identifies the pharmaceutical vendor, product, and trade package size.
I am not getting paid when I submit HCPCS code J3490 with the drug name and NDC number. Why?
HCPCS code J3490 is a non-specific code that should be used only when another ‘J’ code does not describe the drug being administered (i.e., CMS has not assigned a specific ‘J’ code to the drug used). The appropriate ‘J’ code should be used if one has been assigned to the drug. For the drug with no assigned ‘J’ code, the name, strength of the drug (if applicable) and the actual dosage administered must be indicated on the CMS-1500 form in Block 19 or Block 24 (listed with the procedure code). If the drug is compounded, the invoice/acquisition cost must be included with the description. This would ensure proper adjudication of your claim for J3490.
If the name, strength and dosage administered of the drug are not all listed, the claim will be denied for lack of information necessary to process the claim. At present, Railroad Medicare cannot identify a drug by only the NDC number.
Submit a single, combined line item for all drugs with HCPCS code J3490. Combine the charges for all drugs.
- Indicate the name(s) and dose(s) of each drug being submitted in the documentation record
- Indicate ‘compunded drugs, invoice attached’ in Item 19 of the CMS-1500 Claim Form
- Abbreviations are acceptable, but must use industry acceptable abbreviations (e.g., ‘MS’ for morphine sulphate)
- Billed amount must be the invoice price for the compounded drug(s). To indicate this, we suggest using ‘INV’ next to the price (e.g., INV $250.00).
Payment for drugs, biologicals and radiopharmaceuticals under the OPPS is inclusive of both the acquisition cost and the associated pharmacy overhead or nuclear medicine handling cost. Hospitals should include these costs in their line-item charges for drugs, biologicals, and radiopharmaceuticals.
Under the OPPS, if commercially available products are being mixed together to facilitate their concurrent administration, the hospital should report the quantity of each product (reported by HCPCS code) used in the care of the patient.
Alternatively, if the hospital is compounding drugs that are not a mixture of commercially available products, but are a different product that has no applicable HCPCS code, then the hospital should report an appropriate unlisted drug code (J9999 or J3490). In these situations, it is not appropriate to bill HCPCS code C9399. HCPCS code C9399, Unclassified drug or
biological, is for new drugs and biologicals that are approved by FDA on or after January 1, 2004, for which a specific HCPCS code has not been assigned.
The HCPCS code list of retired codes and new HCPCS codes reported under the hospital OPPS is published quarterly via Recurring Update Notifications. The latest payment rates associated with each APC and HCPCS code may be found in the most current Addendum A and Addendum B, respectively that can be found under the CMS quarterly provider updates on the CMS Web site at:
Please note: The new compounded drug code, Q9977 – Compounded Drug, Not Otherwise Classified, is not a replacement for existing codes. It is intended to distinguish compounded drugs (which may include biologicals) from other “not otherwise classified” codes such as J3490, J3590, J7799, J9999 and existing specific codes for compounded nebulized drugs.
The implementation of Q9977 as a means of identifying compounded drug claims does not affect existing payment policy for compounded drugs as outlined in the “Medicare Claims Processing Manual,” Chapter 17, Section 20.1.2
