CPT code J3490, 11980 - important guidelines and tips


Effective for claims with dates of service on June 30, 2011, Medicare providers shall report one of the following HCPCS codes for PROVENGE®:

• C9273 - Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, including leukapheresis and all other preparatory procedures, per infusion, or

• J3490 – Unclassified Drugs, or

• J3590 – Unclassified Biologics.


NOTE: Contractors shall continue to process claims for HCPCS code C9273, J3490, and J3590, with dates of service June 30, 2011, as they do currently.

Example Billing/Coding Information

*   Supplied as a 100 mg/2 mL single-dose vial or as 500 mg/10 mL single-dose vial

j3490, C9399

Medication Description

Eteplirsen is designed to bind to exon 51 of dystrophin pre-mRNA, resulting in exclusion of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 51 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein

Quantity Limitations

Coverage is available for a maximum of 5,460 mg per each 6 months of therapy.

V. Coverage Duration

Coverage is available for a maximum of 6 month intervals. 

Coverage Renewal Criteria

Coverage can be renewed based upon the following:

*   Stabilization of disease, improvement in disease symptoms, or in absence of disease progression AND

*   Absence of unacceptable toxicity from the drug


While implantable estradiol pellets have been suggested as treatment for symptoms of menopause, there are no Food and Drug Administration (FDA)-approved, commercially available formulations of implantable estradiol pellets available in the United States. These formulations of estradiol have been shown to produce unpredictable serum concentrations of estrogen. The FDA's Fertility and Maternal Health Drugs Advisory Committee unanimously agreed to terminate compassionate investigative new drug (IND) programs for estrogen pellets as a last-resort treatment of menopausal disorder. 

Implantable testosterone pellets may be indicated as second-line testosterone replacement therapy for males. Testosterone implants (Testopel Pellets ®) are FDA approved and are commercially available in the United States. 


Androgens are primarily indicated in males as replacement therapy when congenital or acquired endogenous androgen absence or deficiency is associated with primary or secondary hypogonadism. Primary hypogonadism includes conditions such as: testicular failure due to cryptorchidism, bilateral torsion, orchitis, or vanishing testis syndrome; inborn errors in testosterone biosynthesis; or bilateral orchidectomy. Hypogonadotropic hypogonadism (secondary hypogonadism conditions include gonadotropin-releasing hormone (GnRH) deficiency or pituitary-hypothalamic injury as a result of surgery, tumors, trauma, or radiation, and are the most common forms of hypogonadism seen in older adults.

The diagnosis and establishment of hypogonadism may be made with any of the following combinations:

At least one low testosterone level (below the normal range for the laboratory) with elevated FSH and/or LH.

At least two testosterone levels both of which are less than normal based upon the laboratory reference range.

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 numbe

Adynovate (antihemophillic factor) Injection J3490 PBM

** Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications Pharmacy N/A
Adzenys XR (amphetamine extended-release  Orallydisintergrating tablet J8499 PBM

** Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications Pharmacy N/A Afinitor (everolimus) Oral J7527 PBM*

** Prior Authorization/ Notification Guidelines: Afinitor Pharmacy** Precertification Note: *Precertification through the PBM is only required for those Oral Oncology Drugs specifically listed in a Coverage Criteria/Guideline when the Member is age 19 years or older. All other oral chemotherapy drugs do not require precertification. Benefit Note: **NJ Small Members should refer to their  certificate of coverage for precertification guidelines and quantity limit guidelines. Afrezza (Insulin, human) Inhalation 

Alsuma (sumatriptan) Injection J3490 PBM

** Supply Limit Guidelines:Triptans Supply Limits 

** Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications Pharmacy N/A
Altoprev (lovastatin) tablet J3490 PBM 

** Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications Pharmacy N/A
Ambien (zolpidem tartrate) Tablet J8499 PBM

** Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications Pharmacy N/A
Ambien CR (zolpidem tartrate extendedrelease[ER]) Tablet J8499 PBM

** Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications Pharmacy N/A Amerge (naratriptan) Tablet J8499 PBM* ** Supply Limit Guidelines: Triptans Supply Limits Pharmacy** *Precertification Notes:

** Precertification through the PBM is only required for quantity requests exceeding the Triptan Ceiling Limit.

** NJ Plans do not require precertification. **Benefit Note: New York Plans and Products, Members should refer to their Certificate of Coverage as certain Triptan drugs are included in the select designated pharmacy program. Amevive
(alefacept) Injection, SQ Injection J0215 N/A N/A Medical N/A Aminolevulinic acid HCL Topical J7308 N/A N/A Medical N/A Amitiza (lubiprostone) Capsule J8499 PBM

** Prior Authorization/Medical Necessity Guidelines: Amitiza (lubiprostone) Pharmacy N/A Amlodipine/ Atorvastatin (generic) Tablets J8499 N/A N/A Pharmacy N/A 

Not Otherwise Classified (NOC) HCPCS Code): Billing Tips

Recently, Wisconsin Physicians Service (WPS) Medicare Part B received an inquiry regarding the use of HCPCS code J3490 (a Not Otherwise Classified (NOC) Code). The following are tips to help you when billing J3490.

In order for WPS 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), and
  • The method of administration; and
  • 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.

Procedure Code Category Example Documentation Requirements Unclassified drug codes • J3490 — Unlisted drugs

• J7999 — Compounded drug, not otherwise classified

• A4641 — Radiopharmaceutical, diagnostic, not otherwise classified Paper claim submitters

• UB-04 Form: Report the unlisted J code in Form Locator 44 and units in Form Locator 46. To report NDC: In form Locator 43 enter the N4 qualifier immediately followed by 11 digit  NDC number without hyphens — left justified. NDC will be followed immediately by the qualifier for dispensing unit measure followed by quantity.

Electronic claim submitters

• 837P , version 5010: Report the unlisted J code in the SV101-2, loop 2400 and the NDC Number with N4 qualifier in the LIN segment, loop 2410. When reporting NDC the CTP segment is required — both CTP04 (NDC count) and CTP05 (unit of measure). 837I, version 5010: Report the unlisted J code in the SV202-2, loop 2400 and the NDC Number with N4 qualifier in the LIN segment, loop 2410. When reporting NDC in LIN segment the CTP segment is required — both CTP04 (NDC count) and CTP05 (unit of measure).

As you may know, pricing for NOC J-codes is determined by the information provided on 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. Medicare payment varies depending on the strength given. In this situation, providers should list the name of the drug, strength of the drug, the amount of the drug administered and the method of administration.
When billing Medicare for a NOC J-code, you can determine if the drug comes in different strengths by accessing the ASP NOC pricing files. You can access the files on the Centers for Medicare & Medicaid Services (CMS) website

How should I submit compounded drugs administered via implanted pump?

Submit a single, combined line item for all drugs with HCPCS code J3490. Combine the charges for all drugs.

Electronic claims:
  • Indicate the name(s) and dose(s) of each drug being submitted in the documentation record
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).

All of the following information is required to be submitted for reimbursement of a compound drug or any drug billed with unclassified drug codes:

• Valid NDC for each active ingredient utilizing the 11 digit numeric format
• NDC Description
• NDC quantity using an AWP unit price (AWPU) associated with the NDC submitted for the dose administered to the member.

Example of information required to accompany an unclassified drug:

HCPCS Code NDC NDC Description NDC Quantity*

J3490 00409156029 Bupivacaine, 0.50% 1ml 10.00 

Are you a provider billing unlisted J-Codes? 

In most instances, NDC numbers are assigned a CPT or HCPCS code. Most injectable medications begin with a “J”, but this is not always the case. It is important that claims be submitted with the most accurate information when billing for injectable medications that are administered in the office during a patient’s visit.

In an effort to ensure providers are billing appropriately and are being reimbursed properly, beginning February 1, 2009, Blue Cross and Blue Shield of Oklahoma (BCBSOK) will begin checking the NDC numbers billed with an unlisted J-Code to ensure these codes are being billed correctly.

What does this mean for our providers?

 If a claim is submitted using an unlisted J-Code (e.g. J3490) and a valid CPT/HCPCS code exists for the drug being administered, BCBSOK will deny the service line and request the provider to resubmit using the correct CPT/HCPCS code.

If a claim is submitted with an unlisted J-Code (e.g. J3490) and there is no other CPT/HCPCS code for the drug being administered, the provider will need to provide the necessary information on the claim for BCBSOK to properly adjudicate the service line. If the claim is received without the necessary information, the service line may be denied and sent back to the provider with a request to resubmit the service along with the necessary information. 

o Necessary information needed to process valid unlisted J-Codes:

ƒ NDC Number
ƒ Drug Name
ƒ Dosage administered (e.g. 5 mg, 10 mg, etc.)
ƒ Include how the number of units being billed on the claim is being administered (e.g. 5 mg = 1 unit, 10 mg = 5 units, etc.)
ƒ Strength of drug administered (e.g. 25 mg/ml, 10 mg/10 ml, etc.)
ƒ Single dose vial or Multi-dose vial

Please Note: An NDC number can only be used for a maximum of two (2) years after it becomes obsolete. 

Anthem Blue Cross and Blue Shield (Anthem) has received numerous providers submitting claims for Bevacizumab (also know commercially as Avastin) using the following codes improperly. Please see the approved Medicare Billing guidelines below. 

• J3490 or J3590 are approved and valid codes for Bevacizumab when treating neovascular age-related macular degeneration (AMD) by an Ophthalmologist. The administration CPT code for the administration of J3490 or J3590 is 67038

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 

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 

ICD-10 Codes that Support Medical Necessity

C75.1 Malignant neoplasm of pituitary gland
C75.2 Malignant neoplasm of craniopharyngeal duct
D35.2 Benign neoplasm of pituitary gland
D35.3 Benign neoplasm of craniopharyngeal duct
E23.6 Other disorders of pituitary gland
E29.1 Testicular hypofunction
E30.0 Delayed puberty
N44.00 - N44.04 - Opens in a new window Torsion of testis, unspecified - Torsion of appendix epididymis
N45.1 - N45.3 - Opens in a new window Epididymitis - Epididymo-orchitis
N50.0 Atrophy of testis
N51 Disorders of male genital organs in diseases classified elsewhere
Q53.00 - Q53.02 - Opens in a new window Ectopic testis, unspecified - Ectopic testes, bilateral
Q53.10 - Q53.12 - Opens in a new window Unspecified undescended testicle, unilateral - Ectopic perineal testis, unilateral
Q53.20 - Q53.22 - Opens in a new window Undescended testicle, unspecified, bilateral - Ectopic perineal testis, bilateral
Q53.9 Undescended testicle, unspecified
Z85.47 Personal history of malignant neoplasm of testis
Z90.721 Acquired absence of ovaries, unilateral
Z90.722 Acquired absence of ovaries, bilateral

Z90.79 Acquired absence of other genital organ(s)

Usage of J3490 - Treatment of Males with Low testosterone

Coverage Indications, Limitations, and/or Medical Necessity

Noridian has noted a rapid increase in the use of testosterone supplements that exceed the expected use in the Medicare population based on current published data. According to a Health Technology Assessment on Testosterone Testing from the Washington State Health Care Authority, the presence of low serum testosterone is 9.0% in men aged 45 to 54 years, 16.5% in men aged 55 to 64 years, and 18.3% in men aged 65 to 74 years. These estimates were derived from the National Health and Nutrition Examination Survey III (NHANESIII), which defined low testosterone levels as < 300 nanogram per deciliter (ng/dL) (10.4 nanomoles per liter [nmol/L]). The diagnosis of hypogonadism depends on measuring the total, free and/or biologically active testosterone; sex hormone binding globulin (SHBG) and the pituitary axis. Male hormone is bound to SHBG, and SHBG tends to rise with age, lowering the free testosterone level. Testosterone level accuracy varies among labs with different assays, and can be affected by chronic diseases, age, levels of binding, measurement variables, testing accuracy, etc. Estimates of the low end of testosterone depend on the method and accuracy of testing and can be as low as 160 ng/dl. Decisions on hypogonadism depend on both repeated hormone testing and a group of clinical symptoms. Neither alone is adequate for defining hypogonadism.

Testosterone levels are controlled by interaction of the testicular-pituitary-hypothalamic axis. Primary hypogonadism is failure of the testes to produce testosterone (for a number of reasons) and is usually accompanied by elevated LH and/or FSH. Secondary hypogonadism is disruption of the testicular-pituitary-hypothalamic pathway and may be due to pituitary or hypothalamic axis damage including systemic illness and genetic aberration. Age related hypogonadism (e.g. lower testosterone in the older male population) is not necessarily a disease and may be asymptomatic and / or may be related or associated with many chronic illnesses. “Low T Syndrome” or “Low T” is not a syndrome and may be an incidental finding or lab error. Low serum testosterone alone does not constitute a diagnosis of androgen deficiency or clinical hypogonadism. Diagnosis of a clinical condition requires the presence of certain characteristic symptoms as well as an abnormally low serum testosterone. 

Many of the symptoms are not specific to, and not directly correlated to specific levels of testosterone. Guidelines from the Endocrine Society suggest some of the following symptoms may be related to low serum testosterone but may also have many other causes in the elderly population:

More Specific Signs / Symptoms 

Incomplete or delayed sexual development; eunuchoidism

Reduced sexual desire (libido) and activity

Breast discomfort, gynecomastia

Loss of body (axillary and pubic) hair, reduced shaving

Very small (Especially < mL) or shrinking testes

Inability to father children

Low or zero sperm count

Height loss, low-trauma fracture, low bone mineral density

Hot flushes, sweats

Less Specific Signs/Symptoms

Decreased energy, motivation, initiative and self confidence

Feeling sad or blue, depressed mood, dysthymia

Poor concentration and memory

Sleep disturbance, increased sleepiness

Mild anemia

Reduced muscle bulk and strength

Increased fat or increased body mass index

Diminished physical or work performance

Noridian expects that the evaluation of primary hypogonadism be undertaken with at least 2 separate serum testosterone levels taken on two different days in the morning (when testosterone secretion is highest) , and / or two morning levels of “free” or bioavailable testosterone) and LH or FSH levels. Elevated LH /FSH confirms primary hypogonadism and the potential need for replacement hormone. If the two testosterone determinations are low AND the LH/FSH levels are also low, pituitary disease (including a serum prolactin) or chronic diseases should be assessed before making a diagnosis of age related low testosterone. Only patients with low testosterone associated significant symptoms should be considered for treatment. A comprehensive examination is required to evaluate for medications or chronic diseases known to cause decreased energy, memory problems, impotence and mental health problems.

Noridian would consider the low testosterone related symptoms from the nonspecific and specific groups described above to be documented in the chart along with two low testosterone levels drawn on two mornings and a single LH or FSH to demonstrate the need for testosterone therapy in the age related group of symptomatic androgen deficiency. Documentation of the symptoms, signs, physical examination and lab tests must be available in the chart if requested.

Treatment of symptoms associated with low testosterone is controversial. It is not certain if low testosterone is the cause of the symptoms, a marker for underlying chronic diseases, or the effect of the symptoms-and there is a considerable placebo effect. Long term effects of testosterone on the geriatric population are mixed but are being studied by the NIH. Long term use of testosterone can damage the hypothalamic-pituitary-testicular axis and lead to permanent testicular failure.

Testosterone replacement therapy is contraindicated in patients with breast cancer and untreated prostate cancer. There are recent FDA listed warnings about thromboembolic disease, increase in erythrocythemia, and hypertension. The clinical records shall reflect that these issues were discussed with the patient before initiating therapy. Some physicians recommend obtaining baseline PSA testing and ongoing monitoring to test for prostate cancer.

Long term testosterone therapy will shrink testicular tissue and can lead to infertility, and therefore would be contraindicated in those interested in reproduction.

Where replacement is indicated, the dose of replacement therapy should be the least amount necessary to obtain a serum testosterone in the low normal range. Testosterone replacement can be administered by many routes. The current preferred routes are by transdermal preparations. Since topical or transdermal agents are administered daily in low dose, the risk of supraphysiological or subtherapeutic levels is minimized. The use of topical agents is thought to minimize adverse events. Indeed, in series examining the toxicity of topical agents, adverse events are nearly nonexistent when administered by these routes (Steidle et al., 2003). The main disadvantage of the topical agents are their high cost ($100 to $150 per month), substantially higher than self-administered injection therapy, and the potential risk of inadvertent transfer of hormone to women or children through skin contact. There is no evidence that unusually high doses-or higher than published frequencies of administration-are any more effective than doses established by the FDA and could lead to increased side effects. Ongoing monitoring of hormone levels and side effects are necessary.


Group 1 Paragraph: N/A

Group 1 Codes:

ICD-10 Codes that Support Medical Necessity

Group 1 Paragraph: N/A

Group 1 Codes:
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Group 1Codes

D35.2 Benign neoplasm of pituitary gland
E23.0 Hypopituitarism
E23.1 Drug-induced hypopituitarism
E23.3 Hypothalamic dysfunction, not elsewhere classified
E23.6 Other disorders of pituitary gland
E23.7 Disorder of pituitary gland, unspecified
E29.1 Testicular hypofunction
E29.8 Other testicular dysfunction
E89.5 Postprocedural testicular hypofunction

N50.89 Other specified disorders of the male genital organs

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