Billing and Coding: Infliximab and biosimilars

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 RemicadeTM
(infliximab)

Infliximab-abda and infliximab axxq are other biosimilars of reference
biologic RemicadeTM (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) Weight when needed to determine appropriate dosing.  
3) Evaluation for latent tuberculosis infection through medical evaluation and
TB test. 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:**

  1. 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.  
  

  2. 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.  Effective July 1, 2023, the JZ modifier should be reported on all claims that bill for infliximab and biosimilars when there are no discarded amounts from single-dose containers or single-use packages.

**FDA and Compendia Review:**

  1. American Society of Health-System Pharmacists, Inc. _AHFS Drug Information ._ Bethesda, MD: 2007.
  2. Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 09/05/2022.
  3. FDA label for infliximab-dyyb (InflectraTM). FDA Web site: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed on 06/08/2016
  4. FDA label for infliximab-abda (Renflexis). FDA Web site: https://www.accessdata.fda.gov/scripts/cder/daf/index. Accessed on 08/21/2017.
  5. FDA label for inflizimab-axxq (AvsolaTM). FDA Web site: https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed on 07/14/2020.
  6. Lexi-Drugs Web site. http://online.lexi.com. Accessed 09/05/2022.
  7. Micromedex DrugDex. Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 09/05/2022.
  8. National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 09/05/2022.
  9. 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.

  10. United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.