HCPCS J1745; Injection, Infliximab, 10mg - JF Part B

In order to fulfill its contractual obligation with CMS, Noridian Healthcare Solutions (Noridian), your Medicare Contractor, performs pre-payment reviews in accordance with CMS direction. CMS is required by the Social Security Act to ensure that payment is made only for those medical services that are reasonable and necessary. Medical review assesses submitted documentation to validate provider compliance with Medicare payment rules and regulations, including coverage, coding and billing guidelines.

This is to update providers of the claim review findings for HCPCS J1745 Injection, infliximab, 10mg. The results of this focused review are not a reflection on providers' competence as a health care professional or the quality of care provided to patients. Specifically, the results are based on the documentation requested by Medicare and/or your facility's compliance with the required documentation.

The Jurisdiction F, Part B Medical Review Department is conducting a Targeted Probe and Educate (TPE) review of HCPCS J1745 Injection, infliximab, 10mg. The quarterly edit effectiveness results from January 1, 2024, to March 31, 2024 are as follows:

Top Denial Reasons

• The documentation submitted does not support medical necessity.
• The documentation submitted was incomplete and/or insufficient.
• Failure to return records

Educational Resources

• Determination of Approved and Accepted Off-label Drug Indications
• Drugs, Biologicals and Injections
• How to Respond to ADR

Education

Infliximab is an injectable antibody that blocks the effects of tumor necrosis factor alpha (TNF alpha), a substance made by cells of the body that has an important role in promoting inflammation. Specifically, infliximab is used for treating the inflammation of Crohn's disease, rheumatoid arthritis, and psoriatic arthritis. Infliximab is administered by intravenous infusion, and dosage varies depending on the condition being treated. Dosage may range from 3 mg/kg of body weight (rheumatoid arthritis) to 5 mg/kg of body weight for moderate to severe Crohn's disease.

If the dosage for the drug under review is outside the allowed amount per the drug compendium, submit documentation to support medical necessity of this dose variance (I.E. Clinical trial, article, studies, etc), In the absence of a drug specific NCD/LCD or other Medicare instructions, CMS has established five drug compendia as authoritative sources as drug compendia including:

• American Hospital Formulary Service-Drug Information (AHFS-DI)
• National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium
• Micromedex DrugDex
• Clinical Pharmacology
• Lexi-Drugs

Dosage in Adult Crohn's Disease

The recommended dosage of REMICADE is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adults with moderately to severely active CD or fistulizing CD. For adult patients who respond and then lose their response, consideration may be given to treatment with 10 mg/kg every 8 weeks. Patients who do not respond by Week 14 are unlikely to respond with continued dosing and consideration should be given to discontinue REMICADE in these patients.

Dosage in Adult Ulcerative Colitis

The recommended dosage of REMICADE is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of adult patients with moderately to severely active UC.

Dosage in Rheumatoid Arthritis

The recommended dosage of REMICADE is 3 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 3 mg/kg every 8 weeks thereafter for the treatment of moderately to severely active RA. REMICADE should be given in combination with methotrexate. For patients who have an incomplete response, consideration may be given to adjusting the dosage up to 10 mg/kg every 8 weeks or treating as often as every 4 weeks bearing in mind that risk of serious infections is increased at higher doses per infusion or more frequent dosing.

Dosage in Ankylosing Spondylitis

The recommended dosage of REMICADE is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 6 weeks thereafter for the treatment of active AS.

Dosage in Psoriatic Arthritis

The recommended dosage of REMICADE is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of PsA. REMICADE can be used with or without methotrexate.

Dosage in Plaque Psoriasis

The recommended dosage of REMICADE in adult patients is 5 mg/kg given as an intravenous induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg every 8 weeks thereafter for the treatment of chronic severe (i.e., extensive and/or disabling) PS.