STELARA® Coding & Billing

STELARA® Coding & Billing

This overview outlines the key points you need to know about reimbursement for STELARA®, including:

  • Coding for STELARA®
  • Reimbursement support

Coverage policies may vary by insurer or even between plans offered by the same insurer.

Patient insurance benefits investigation is provided by contracted service providers for Janssen CarePath, which is operated by Johnson & Johnson Health Care Systems Inc. on behalf of Janssen Pharmaceuticals, Inc. and Janssen Biotech, Inc. (Janssen). In this regard, Janssen CarePath assists healthcare providers in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer, and patient information provided by the healthcare provider under appropriate authorization following the provider's exclusive determination of medical necessity. This reimbursement support service has no independent value to providers apart from the product and is included within the cost of the product. While Janssen CarePath attempts to provide correct information, they make no representations or warranties, expressed or implied, as to the accuracy of the information. In no event shall Janssen CarePath, Janssen, or its employees or agents be liable for any damages resulting from or relating to the services. All providers and other users of this information agree that they accept responsibility for the use of this service. Importantly, insurance verification is the ultimate responsibility of the provider.

Third-party reimbursement is affected by many factors. The content provided is for informational purposes only and is not intended to provide reimbursement or legal advice and does not promise or guarantee coverage, levels of reimbursement, payment, or charge. Similarly, all CPT®* and HCPCS codes are supplied for informational purposes only and represent no promise or guarantee that these codes will be appropriate or that reimbursement will be made. It is not intended to increase or maximize reimbursement by any payer. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. We strongly recommend that you consult with your payer organization(s) for local or actual coverage and reimbursement policies and with your internal reimbursement specialist for any reimbursement or billing questions.

*CPT® copyright 2016 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association.

Coding for Crohn’s Disease

Induction Dosing – IV Infusion

National Drug Code (NDC)

10-digit NDC for Ordering 11-digit NDC for Billing Description
57894-054-27 57894-0054-27 130 mg vial
Single-use vial containing 130 mg (26 mL) of ustekinumab for intravenous infusion

HCPCS Codes

Site of Care Payer Claims July 1, 2017 up to the assignment of a permanent HCPCS code Permanent National Code
Physician Office Commercial May adopt temporary Q code Q9989, ustekinumab for intravenous injection, 1 mg, or continue to use J3590, Unclassified biologics The permanent HCPCS code is anticipated to be issued for first use on January 1, 2018.
Medicare Temporary Q code, Q9989, ustekinumab for intravenous injection, 1 mg, replaces J3590, effective July 1 - December 31, 2017
HOPD Commercial May adopt temporary Q code Q9989, ustekinumab for intravenous injection, 1 mg, or continue to use J3590, Unclassified biologics
Medicare Temporary Q code, Q9989, ustekinumab for intravenous injection, 1 mg, replaces C9487, effective July 1 - December 31, 2017

Contact local payer or Janssen CarePath at 877-CarePath for assistance understanding payer policies.

Maintenance Dosing – SC Injection

National Drug Code (NDC)

10-digit NDC for Ordering 11-digit NDC for Billing Description
57894-061-03 57894-0061-03 90 mg prefilled syringe
Single-use syringe containing 90 mg ustekinumab for subcutaneous injection

HCPCS Code

The product-specific HCPCS code for STELARA® injection is J3357, ustekinumab, for subcutaneous injection, 1 mg.

One 90 mg prefilled syringe = 90 units

Please see the STELARA® Reimbursement Guide for more information on coding and sample claim forms.

Coding for Plaque Psoriasis and Psoriatic Arthritis

National Drug Code (NDC)

10-digit NDC for Ordering 11-digit NDC for Billing Description
57894-060-02 57894-0060-02 45 mg/0.5 mL single-dose vial
57894-060-03 57894-0060-03 45 mg/0.5 mL single-dose prefilled syringe
57894-061-03 57894-0061-03 90 mg/mL single-dose prefilled syringe

HCPCS Code

The product-specific HCPCS code for STELARA® injection is J3357, ustekinumab, for subcutaneous injection, 1 mg.

One 45 mg single-dose vial = 45 units
Two 45 mg single-dose vials = 90 units
One 45 mg prefilled syringe = 45 units
One 90 mg prefilled syringe = 90 units

This sample claim form is provided to assist you in understanding the requirements and filing information for the CMS-1500.

Please see the STELARA® 45 mg Vial Guide for more information on coding and sample claim forms.

Please consult your local payer for specific coding policies or call Janssen CarePath for assistance at 877-CarePath (877-227-3728).

Reimbursement Support Through Janssen CarePath

Janssen CarePath provides information and assistance regarding coding, coverage, and claims processing related to STELARA®. In addition, Janssen CarePath can also investigate specialty pharmacy options that may be available to simplify product procurement and billing for healthcare providers. Finally, Janssen CarePath can provide reimbursement information and support directly to patients.

Janssen CarePath Care Coordinators are available to help answer your questions at 877-CarePath (877-227-3728), Monday-Friday, 8 AM - 8 PM ET.

Indications

STELARA® (ustekinumab) is indicated for the treatment of adult patients with active psoriatic arthritis. STELARA® can be used alone or in combination with methotrexate (MTX).

STELARA® (ustekinumab) is indicated for the treatment of patients 12 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

STELARA® (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who:

  • have failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker, or
  • failed or were intolerant to treatment with one or more TNF blockers.

For psoriatic arthritis:

STELARA®, available as 45 mg and 90 mg, is a subcutaneous injection intended for use under the guidance and supervision of a physician with patients who will be closely monitored and have regular follow-up visits with a physician. If a physician determines that it is appropriate, a patient may self-inject or a caregiver may inject STELARA® after proper training in subcutaneous injection technique. Patients should be instructed to follow the directions provided in the Medication Guide.

For plaque psoriasis:

STELARA®, available as 45 mg and 90 mg, is a subcutaneous injection intended for use under the guidance and supervision of a physician with patients who will be closely monitored and have regular follow-up visits with a physician. In adolescent patients, it is recommended that STELARA® be administered by a healthcare provider. If a physician determines that it is appropriate, a patient may self-inject or a caregiver may inject STELARA® after proper training in subcutaneous injection technique. Patients should be instructed to follow the directions provided in the Medication Guide.

For Crohn’s disease:

STELARA® for intravenous infusion is available as a 130 mg/26 mL (5 mg/mL) single-dose vial. It must be diluted, prepared, and infused by a healthcare professional for Crohn’s disease.

STELARA®, available as 90 mg, is a subcutaneous injection intended for use under the guidance and supervision of a physician with patients who will be closely monitored and have regular follow-up. If a physician determines that it is appropriate, a patient may self-inject or a caregiver may inject STELARA® after proper training in subcutaneous injection technique. Patients should be instructed to follow the directions provided in the Medication Guide.

Important Safety Information For STELARA®

Infections

STELARA® (ustekinumab) may increase the risk of infections and reactivation of latent infections. Serious bacterial, fungal, and viral infections, some requiring hospitalization, were reported. In patients with psoriasis, serious infections included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections. In patients with psoriatic arthritis, serious infections included cholecystitis. In patients with Crohn’s disease, serious or other clinically significant infections included anal abscess, gastroenteritis, ophthalmic herpes, pneumonia, and Listeria meningitis.

Treatment with STELARA® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STELARA® in patients with a chronic infection or a history of recurrent infection.

Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with STELARA® and consider discontinuing STELARA® for serious or clinically significant infections until the infection resolves or is adequately treated.

Theoretical Risk for Vulnerability to Particular Infections

Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria, Salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with STELARA® may be susceptible to these types of infections. Appropriate diagnostic testing should be considered, e.g., tissue culture, stool culture, as dictated by clinical circumstances.

Pre-Treatment Evaluation of Tuberculosis (TB)

Evaluate patients for TB prior to initiating treatment with STELARA®. Do not administer STELARA® to patients with active tuberculosis infection. Initiate treatment of latent TB before administering STELARA®. Closely monitor patients receiving STELARA® for signs and symptoms of active TB during and after treatment.

Malignancies

STELARA® is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among patients who received STELARA® in clinical studies. The safety of STELARA® has not been evaluated in patients who have a history of malignancy or who have a known malignancy.

There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA® who had risk factors for developing non-melanoma skin cancer (NMSC). All patients receiving STELARA®, especially those >60 years or those with a history of PUVA or prolonged immunosuppressant treatment, should be monitored for the appearance of NMSC.

Hypersensitivity Reactions

STELARA® is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or excipients. Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA®. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STELARA®.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

One case of reversible posterior leukoencephalopathy syndrome (RPLS) was observed in clinical studies of psoriasis and psoriatic arthritis. No cases of RPLS were observed in clinical studies of Crohn’s disease. If RPLS is suspected, administer appropriate treatment and discontinue STELARA®. RPLS is a neurological disorder, which is not caused by an infection or demyelination. RPLS can present with headache, seizures, confusion, and visual disturbances. RPLS has been associated with fatal outcomes.

Immunizations

Prior to initiating therapy with STELARA®, patients should receive all age-appropriate immunizations recommended by current guidelines. Patients being treated with STELARA® should not receive live vaccines. BCG vaccines should not be given during treatment or within one year of initiating or discontinuing STELARA®. Exercise caution when administering live vaccines to household contacts of STELARA® patients, as shedding and subsequent transmission to STELARA® patients may occur. Non-live vaccinations received during a course of STELARA® may not elicit an immune response sufficient to prevent disease.

Concomitant Therapies

The safety of STELARA® in combination with other immunosuppressive agents or phototherapy was not evaluated in clinical studies of psoriasis. Ultraviolet-induced skin cancers developed earlier and more frequently in mice. In psoriasis studies, the relevance of findings in mouse models for malignancy risk in humans is unknown. In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of STELARA®. In Crohn’s disease studies, concomitant use of 6-mercaptopurine, azathioprine, methotrexate and corticosteroids did not appear to influence the overall safety or efficacy of STELARA®.

Allergen Immunotherapy

STELARA® may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.

Most Common Adverse Reactions

The most common adverse reactions (≥3% and higher than that with placebo) in adults from psoriasis clinical studies for STELARA® 45 mg, STELARA® 90 mg, or placebo were: nasopharyngitis (8%, 7%, 8%), upper respiratory tract infection (5%, 4%, 5%), headache (5%, 5%, 3%), and fatigue (3%, 3%, 2%), respectively. The safety profile in adolescents with plaque psoriasis through Week 60 was similar to that of adults with plaque psoriasis. In psoriatic arthritis (PsA) studies, a higher incidence of arthralgia and nausea was observed in patients treated with STELARA® when compared with placebo (3% vs 1% for both). In Crohn’s disease induction studies, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 8 for STELARA® 6 mg/kg intravenous single infusion or placebo included: vomiting (4% vs 3%). In the Crohn’s disease maintenance study, common adverse reactions (3% or more of patients treated with STELARA® and higher than placebo) reported through Week 44 were: nasopharyngitis (11% vs 8%), injection site erythema (5% vs 0%), vulvovaginal candidiasis/mycotic infection (5% vs 1%), bronchitis (5% vs 3%), pruritus (4% vs 2%), urinary tract infection (4% vs 2%) and sinusitis (3% vs 2%).

Please see full Prescribing Information and Medication Guide for STELARA®. Provide the Medication Guide to your patients and encourage discussion.

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