Learn CPT Code J3490 medicare reimbursement guidelines for drugs with unclassified NDC numbers.

J3490 is a HCPCS Code. The Healthcare Common Prodecure Coding System (HCPCS) is a collection of codes that represent procedures, supplies, products and services which may be provided to Medicare beneficiaries and to individuals enrolled in private health insurance programs.

For new FDA approved drugs, biologicals and radio pharmaceuticals with no specific HCPCS code assigned yet, HCPCS code C9399 should be billed. C-Codes are for new drugs and biologicals and are generally replaced or expire after a year. If a drug or biological does not have an established or valid HCPCS code it should be billed with a not otherwise classified (NOC) code. NOC codes are for 'unclassified drugs' or 'not otherwise classified' drugs (J3490) and biologics (J3590).

HCPCS Code J3490 is used for non-coded drugs unlisted NDC number. J3490 is a non-specific code that should be used only when another J-Code does not describe the drug being administered (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.

J3490 Unclassified Drugs & Injections

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).

J3490 Medicare Reimbursement and Coverage

CMS Medicare offers two codes for unlisted drugs: J9999 Unclassified Chemotherapy Drugs and J3490 Unclassified drugs for others. The more commonly used unlisted drug code is J3490. With an unlisted drug code, it is needed to document the importance of trying this new drug and record it in the chart notes. If the physician tried listed drugs and they didn't work, you need to make sure the claim includes that information.

HCPCS Code J3490 Medicare Reimbursement Billing Guidelines

The main drugs that now require unlisted codes are Neulasta and Faslodex, both of which are non-chemotherapy drugs and therefore require J3490. The two main chemotherapy drugs that require J9999 are Velcade and Oxaliplatin.

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. In order for Medicare to correctly reimburse NOC J3490, providers must indicate the following in the electronic narrative, line level 2400 loop NTE segment, or Item 19 of the CMS 1500 form:
  • The name of the drug
  • The total dosage (plus strength of dosage, if appropriate)
  • The method of administration
  • List the units of service as one in 2400/SV1-04 data element of the ANSI X12 4010A1 or in item 24G of the CMS 1500 form.

J3490 CPT Code use for Drugs without NDC number listed

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.

For billing of compounded drugs administered via implanted pump, submit a single combined line item for all drugs with HCPCS Code J3490 and bill the combined charges for all drugs.

Pricing for NOC J-codes is determined by the Average Sales Price (ASP) NOC pricing file. If the ASP NOC file lists the strength for a drug on the file, this indicates that the drug comes in different strengths. Depending on the strength, Medicare payment varies.

For Electronic Claims
Indicate the name(s) and dose(s) of each drug being submitted in the documentation record.

For Paper Claims
  • Indicate Compounded 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)
Inappropriately using C9399 when a NOC code (J3490 or J3590) should be used is a billing error and may result in a claims payment error or overpayment. CMS has tasked all A/B MACs, including CGS, to assist with reducing the national claims payment error rate.

The following are examples of drugs inappropriately billed using C9399 that should have been billed using J3490, J3590 or the specific assigned 'J' HCPCS codes:
  • Morphine Sulfate (J2270) – up to 10mg
  • Diltiazem HCL (J3490) – unclassified drugs
  • Propofol (J3490) – unclassified drugs

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