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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.
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. 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.
Periodic screening should continue in women treated with REMICADE ® . The use of REMICADE ® at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure.
Janssen’s unbranded Infliximab is REMICADE®without the brand name1-3 Produced from the same cell line and at the same manufacturing sites as REMICADE® Offering the same affordability and patient support programs as REMICADE® Available in the same strength, samedosage form, and sameroute of administration as REMICADE® Approved for all the same
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.
In clinical trials, the most common adverse reactions occurring in >10% of REMICADE ® -treated patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.
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.
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.
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.
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®.
You can bill most payers electronically for REMICADE ® and its associated services.
Based on compendia review, ICD-10 code I47.2 has been added to the Group 3 list effective for dates of service on or after 05/01/2021.
Infliximab-abda and infliximab axxq are other biosimilars of reference biologic Remicade™ (infliximab)
Infliximab is a genetically engineered chimeric human/mouse monoclonal antibody (cA2) against tumor necrosis factor alfa (TNF-alfa), a key mediator of mucosal inflammation. Increased levels of TNF-alfa are found in the intestinal mucosa and stool of patients with active Crohn's disease and in the joints of rheumatoid arthritis patients. Elevated TNF-alfa concentrations are also involved in ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. TNF-alfa activity is neutralized by cA2 antibody binding to the soluble and transmembrane forms which blocks the binding of TNF-alfa with its receptors. Activities inhibited by anti-TNF-alfa antibodies include induction of interleukins, enhancement of leukocyte migration, and expression of adhesion molecules. In vitro studies have demonstrated that cells expressing transmembrane TNF-alfa bound by infliximab are lysed by complement or effector cells. In animal models, antibodies to TNF-alfa were shown to prevent or reduce inflammation.1
In general, Medicare covers outpatient (Part B) drugs that are furnished “incident to” a physician’s service provided that the drugs are not usually self-administered by the patients who take them. See the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals
The safety and efficacy of infliximab was assessed in two randomized, double-blind, placebo-controlled clinical studies in 728 patients with moderately to severely active ulcerative colitis (UC) with an inadequate response to conventional oral therapies.1 ,28 Concomitant treatment with stable doses of aminosalicylates, corticosteroids and/or immunomodulatory agents was permitted. Corticosteroid taper was permitted after week 8. In both studies, patients were randomized to receive either placebo, 5 mg/kg infliximab or 10 mg/kg infliximab at weeks 0, 2, 6, 14, and 22.
The safety and efficacy of infliximab in Crohn's disease was assessed in a randomized, double-blind, placebo-controlled dose ranging study of 108 patients with moderate to severe active Crohn's disease.9 All patients had experienced an inadequate response to prior conventional therapies, including corticosteroids, 5-aminosalicylates (5-ASA) and/or 6-mercaptopurine/azathioprine (6-MP/AZA). Concurrent use of stable dose regimens of corticosteroids, 5-ASA, 6-MP and or AZA was permitted during the study. Initially, patients were randomized to receive a single intravenous dose of placebo, or 5, 10, or 20 mg/kg of infliximab. The primary endpoint was the proportion of patients who experienced a clinical response, defined as a decrease in Crohn's disease Activity Index (CDAI) by > 70 points from baseline at the 4-week evaluation without an increase in Crohn's disease medications or surgery. Patients who responded at week 4 were followed to week 12. Secondary endpoints included the proportion of patients who were in clinical remission at week 4, and clinical response over time. At week 4, four of twenty-five (17%) of the placebo patients achieved a clinical response vs. twenty-two of twenty-seven (81%) of the patients receiving 5 mg/kg infliximab (p<0.001). One of twenty-five (4%) placebo patients and thirteen of twenty-seven (48%) patients receiving 5 mg/kg infliximab achieved a CDAI < 150 (scores below 150 indicate remission) at week 4 (p<0.001). The proportion of patients responding gradually diminished over the 12 weeks of the evaluation period. There was no evidence of a dose response; doses higher than 5 mg/kg did not result in a greater proportion of responders. During the 12-week period following infusion, patients treated with infliximab compared to placebo demonstrated improvement in outcomes measured by the Inflammatory Bowel Disease Questionnaire (32 vs. 5, p=0.001). In the second phase, 29 patients who did not respond to the single dose of 5, 10, or 20 mg/kg of infliximab and 19 patients who initially received placebo entered the open label phase. All patients received a single 10 mg/kg dose of infliximab 4 weeks after the initial dose. Ten of twenty-nine (34%) patients who received infliximab initially vs. 11 of 19 (58%) who received placebo initially experienced a response 4 weeks after receiving open label infliximab (p=0.014).
The safety and efficacy of infliximab when given in conjunction with methotrexate (MTX) were assess ed in a multicenter, randomized, double-blind, placebo-controlled study of 428 patients with active rheumatoid arthritis despite treatment with MTX.29 All patients received MTX for greater than or equal to 6 months and were on a stable dose of at least 12.5 mg/week for 4 weeks prior to study entry. All patients continued their stable dose of MTX and folic acid. Patients were randomized to received placebo, 3 mg/kg or 10 mg/kg of infliximab by intravenous infusion at weeks 0, 2 and 6 followed by additional infusions every four or eight weeks thereafter. The primary endpoint was the proportion of patients at week 54 who attained an improvement in signs and symptoms as measured by the American College of Rheumatology criteria, (ACR 20). At week 54, 42/86 (49%) of patients treated every 8 weeks with 3 mg/kg of infliximab plus MTX attained an ACR 20 compared with 17/88 (19%) of patients treated with placebo plus MTX
Z79.02 Long term (current) use of antithrombotics/an... Z79.1 Long term (current) use of non-steroidal anti... Z79.2 Long term (current) use of antibiotics. Z79.3 Long term (current) use of hormonal contracep... Z79.4 Long term (current) use of insulin.
The 2022 edition of ICD-10-CM Z51.81 became effective on October 1, 2021.
A code also note instructs that 2 codes may be required to fully describe a condition but the sequencing of the two codes is discretionary, depending on the severity of the conditions and the reason for the encounter.