REMICADE® Coding & Billing
REMICADE® Coding & Billing
This overview outlines information about reimbursement for REMICADE®, including coding and coverage for REMICADE® and its administration.
Third-party reimbursement is affected by many factors. This document and the information and assistance provided by Janssen CarePath are presented for informational purposes only. They do not constitute reimbursement or legal advice. Janssen CarePath does not promise or guarantee coverage, levels of reimbursement, or payment.
Similarly, all CPT®* and HCPCS codes are supplied for informational purposes only and represent no statement, promise, or guarantee, expressed or implied, by Janssen or its third-party service providers that these codes will be appropriate or that reimbursement will be made. The fact that a drug, device, procedure, or service is assigned an HCPCS code and a payment rate does not imply coverage by the Medicare program, but indicates only how the product, procedure, or service may be paid if covered by the Medicare program.
Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. Accordingly, the information may not be correct or comprehensive. Janssen and its third-party service providers strongly recommend you consult your payer for its most current coverage, reimbursement, and coding policies. Janssen and its third-party service providers make no representations or warranties, expressed or implied, as to the accuracy of the information provided. In no event shall the third-party service providers or Janssen, or their employees or agents, be liable for any damages resulting from or relating to any information provided by, or accessed to or through, Janssen CarePath. All HCPs and other users of this information agree that they accept responsibility for the use of this program.
*CPT® – Current Procedural Terminology. CPT® is a registered trademark of the American Medical Association, 2019.
Overview of Reimbursement for REMICADE®
The product-specific HCPCS code for REMICADE® is J1745, infliximab, 10 mg. It is important to note that this code represents 1/10th of a vial. You should be sure to bill 10 units of J1745 on the claim form when indicating that a single 100-mg vial of REMICADE® was used.
1 vial = 10 units
2 vials = 20 units
3 vials = 30 units
Medicare uses CPT codes 96413 and 96415 to describe the first and subsequent hours, respectively, of the infusion procedure associated with therapy with REMICADE® in the physician office setting. Commercial payers may use these codes or alternate codes 96365 and 96366.
Hospital claims should use CPT codes 96413 and 96415 to describe administration of REMICADE®. The descriptions for the most commonly used codes to describe first and subsequent hours of administration of REMICADE® are:
Chemotherapy administration, intravenous infusion technique, up to one hour, single or initial substance
Chemotherapy administration, intravenous infusion technique, each additional hour, single or initial substance (list separately in addition to code 96413 for initial hour of infusion services)
Non-Medicare payer policies regarding the use of 96413 and 96415 may vary. Alternatively, some may prefer use of CPT codes 96365 (IV infusion, for therapy, prophylaxis, or diagnosis [specify substance or drug]; initial, up to 1 hour) and 96366 (IV infusion, for therapy, prophylaxis, or diagnosis [specify substance or drug]; each additional hour). List separately in addition to code for primary procedure.
Please consult your local payer for specific coding policies or call Janssen CarePath for assistance at 877-CarePath (877-227-3728).
Be sure to consult your payer for specific coding requirements for REMICADE®.
You should know that there is a demonstrated history of paid claims for REMICADE® for all payer types, including Medicare, Medicaid, and commercial plans. Coverage varies by carrier and individual patient case.
There are comprehensive, published Medicare Part A and Part B coverage policies specific to REMICADE®. Copies of coverage policies are available on your regional Medicare Administrative Contractor (MAC) website.
You can bill most payers electronically for REMICADE® and its associated services.
Documentation of Services
Keep the following tips in mind to help ensure that your documentation is thorough and accurate:
- When billing for evaluation and management (E&M) services in addition to administration of REMICADE®, be sure that the E&M services are separately identifiable and medically necessary and that justification is noted in the patient record
- Correct use of modifiers is important—make sure modifiers are accurate and appropriately reflected in the patient record
- Always verify payer rules for the billing of E&M codes
Reimbursement Support Through Janssen CarePath
Janssen CarePath provides information and assistance regarding coding, coverage, and claims process related to REMICADE®. In addition, we can also investigate specialty pharmacies 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, 8:00 AM - 8:00 PM ET.
REMICADE® is indicated for:
- Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy
- Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD
Pediatric Crohn's Disease
- Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age or older with moderately to severely active CD who have had an inadequate response to conventional therapy
- Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy
Pediatric Ulcerative Colitis
- Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy
- Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX)
- Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis (PsA)
- Reducing signs and symptoms in patients with active ankylosing spondylitis (AS)
- The treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.
- REMICADE® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician
Patients treated with REMICADE® (infliximab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue REMICADE® if a patient develops a serious infection or sepsis.
Reported infections include:
- Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with REMICADE®.1,2 Treatment for latent infection should be initiated prior to treatment with REMICADE®.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, and cryptococcosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
- Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella, Listeria, and Salmonella.
The risks and benefits of treatment with REMICADE® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with REMICADE®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.
Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with REMICADE® included pneumonia, cellulitis, abscess, and skin ulceration.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including REMICADE®. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.
Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including REMICADE®. These cases have had a very aggressive disease course and have been fatal. The majority of reported REMICADE® cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with REMICADE® at or prior to diagnosis. Carefully assess the risks and benefits of treatment with REMICADE®, especially in these patient types.
In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including REMICADE®, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with REMICADE® was similar to that expected in the general population whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).
Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapy, including REMICADE®. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
A population-based retrospective cohort study found a 2- to 3-fold increase in the incidence of invasive cervical cancer in women with rheumatoid arthritis treated with REMICADE® compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between REMICADE® and cervical cancer cannot be excluded. Periodic screening should continue in women treated with REMICADE®.
REMICADE® is contraindicated in patients with moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose have been observed in these patients. REMICADE® should be used with caution and only after consideration of other treatment options. Patients should be monitored closely. Discontinue REMICADE® if new or worsening CHF symptoms appear. REMICADE® should not be (re)administered to patients who have experienced a severe hypersensitivity reaction or to patients with hypersensitivity to murine proteins or other components of the product.
HEPATITIS B REACTIVATION
TNF inhibitors, including REMICADE®, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating REMICADE®. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing REMICADE® for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with REMICADE®. Discontinue REMICADE® in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of REMICADE® and monitor patients closely.
Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported in patients receiving REMICADE® postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, REMICADE® should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to REMICADE® therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of REMICADE® in patients who develop significant hematologic abnormalities.
REMICADE® has been associated with hypersensitivity reactions that differ in their time of onset. Anaphylaxis, acute urticaria, dyspnea, and hypotension have occurred in association with infusions of REMICADE®. Medications for the treatment of hypersensitivity reactions should be available.
CARDIOVASCULAR AND CEREBROVASCULAR REACTIONS DURING AND AFTER INFUSION
Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of REMICADE® infusion. Cases of transient visual loss have been reported during or within 2 hours of REMICADE® infusion. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.
TNF inhibitors, including REMICADE®, have been associated with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering REMICADE® in patients with these disorders and consider discontinuation if these disorders develop.
Treatment with REMICADE® may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
In clinical trials, the most common REMICADE® adverse reactions occurring in >10% of patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.
USE WITH OTHER DRUGS
Concomitant use of REMICADE® with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as REMICADE® is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.
LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS
Live vaccines or therapeutic infectious agents should not be given with REMICADE® due to the possibility of clinical infections, including disseminated infections.
Bring pediatric patients up to date with all vaccinations prior to initiating REMICADE®. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to REMICADE®.
1. American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med. 2000;161:S221-S247.
2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.