This article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.
Abstract:
Infliximab is a chimeric monoclonal antibody that binds to tumor necrosis factor alpha (TNFa), which is believed to be critical to the human body’s reaction to inflammation. TNFa is a cytokine that is a key biologic response mediator found to be increased in such chronic and inflammatory disorders as Crohn’s disease and rheumatoid arthritis, among others.
Infliximab-dyyb is the second biosimilar of reference biologic Remicade™ (infliximab)
Infliximab-abda and infliximab axxq are other biosimilars of reference biologic Remicade™ (infliximab)
Documentation Requirements:
Medical records should include:
1) The basis for each diagnosis and that the diagnosis was made in accordance with recognized standards such as guidelines published by the American College of Rheumatology (ACR).
2) Height and weight when needed to determine appropriate dosing.
3) Evaluation for latent tuberculosis infection through medical evaluation and TB skin test (PPD). Treatment of latent tuberculosis infection should be initiated prior to therapy with infliximab.
4) Documentation of the disease specific relevant symptoms and signs which are both being treated and being followed to assess for response to treatment.
5) Documentation of Inadequate Response (includes lack of efficacy, adverse effects prohibiting further use of the drug or medical contraindications) to a 3 month trial of appropriately dosed and disease specific conventional (non-biologic) therapy).
Crohn’s disease: Relevant information includes the presence and severity of abdominal pain, diarrhea, extra-intestinal manifestations, enterocutaneous and/or rectovaginal fistulae. Retreatment of patients with Crohn’s disease will be covered when the medical record substantiates that the patient had a reduction in the clinical signs and symptoms of the disease after the initial treatment.
Plaque Psoriasis: For the treatment of plaque psoriasis, documentation to support that the conditions is chronic, severe, extensive or disabling could include percent body surface area (BSA) affected; Psoriasis Area Severity Index (PASI) score; Psoriasis Disability Index (PDI) score; and/or results from other psoriasis assessment tool(s). Infliximab given to treat plaque psoriasis should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Psoriasis patients should be monitored for nonmelanoma skin cancers, particularly those patients who have had prior prolonged phototherapy treatment.
Rheumatoid Arthritis: To support the continued use of infliximab beyond 30 weeks for the treatment of rheumatoid arthritis, the medical record must include evidence of at least 20% improvement in tender joint count and at least 20% improvement in swollen joint count. The patient’s medical record must document that the patient is also receiving methotrexate or clearly indicates the reason that the patient cannot take methotrexate.
Utilization:
Dose and frequency for infliximab and biosimilars, should be in accordance with the FDA label or recognized compendia (for off-label uses). When services are performed in excess of established parameters, they may be subject to review for medical necessity.
Services performed for excessive frequency are subject to denial as not medically necessary. Frequency is considered excessive when services are performed more frequently than recommended in the FDA-approved package insert.
Coding Information:
Claims submitted for treatment of pyoderma gangrenosum with coexisting inflammatory bowel disease must be submitted with a primary and a secondary ICD-10-CM code. If both the primary and secondary ICD-10-CM codes are not indicated on the claim, the service will be denied.
For claims submitted to the Part B MAC:
- Infliximab and biosimilars are available in 100-mg vials. The dosage associated with the HCPCS code is 10 mg. The number of units (rounded up to a whole unit) used, should be entered in Item 24G of the CMS 1500 claim form or the electronic equivalent.
- The following is an example of the correct reporting methodology for infliximab and biosimilars: If the dosage administered is 375 mg, 4 vials (or a total of 400 mg) will be used. Report this with a "40" in the units field. Since this will result in product wastage, the JW modifier should be applied to the amount of the drug or biological that is discarded and should be billed as a separate line item.
FDA and Compendia Review:
- American Society of Health-System Pharmacists, Inc. AHFS Drug Information®. Bethesda, MD: 2007.
- Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 09/05/2022.
- FDA label for infliximab-dyyb (Inflectra™). FDA Web site: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed on 06/08/2016
- FDA label for infliximab-abda (Renflexis). FDA Web site: https://www.accessdata.fda.gov/scripts/cder/daf/index. Accessed on 08/21/2017.
- FDA label for inflizimab-axxq (Avsola™). FDA Web site: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed on 07/14/2020.
- Lexi-Drugs Web site. http://online.lexi.com. Accessed 09/05/2022.
- Micromedex DrugDex®. Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 09/05/2022.
- National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 09/05/2022.
- U.S. Food and Drug Administration label approved 08/24/1998 accessed on line at
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ on 02/01/2008.
- United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.
