Is medical necessity met for Infliximab 670mg IV every 5 weeks for 7 infusions, along with codes 96413, 96415, 96375, J1200, and J2919, for a patient with Rheumatoid arthritis?

Medical Necessity Assessment for Infliximab in Rheumatoid Arthritis

Medical necessity is NOT met for the requested infliximab regimen without documented evidence of inadequate response to methotrexate at therapeutic doses for at least 3 months. 1

Critical Missing Documentation

The authorization request lacks essential prerequisites mandated by rheumatology treatment guidelines:

• No documentation of prior methotrexate trial: EULAR guidelines explicitly require that infliximab should only be commenced after patients respond insufficiently to methotrexate and/or other conventional synthetic DMARDs (csDMARDs). 2, 1

• No disease activity scores provided: Moderate-to-severe disease activity must be documented using validated instruments (such as DAS28, CDAI, or SDAI) to establish medical necessity for biologic therapy. 2, 1

• No evidence of therapeutic methotrexate dosing: Trial of methotrexate at ≥15-25 mg/week for ≥3 months must be documented before initiating infliximab. 1

Guideline-Mandated Treatment Sequence

The 2021 American College of Rheumatology and 2014 EULAR guidelines establish a clear treatment hierarchy:

• First-line therapy: Methotrexate monotherapy is strongly recommended as initial treatment for DMARD-naive patients with moderate-to-high disease activity. 2

• Second-line consideration: Biologic DMARDs like infliximab should only be added after documented inadequate response to methotrexate and/or other csDMARDs, with or without glucocorticoids. 2, 1

• Combination requirement: Infliximab must be given in combination with methotrexate for rheumatoid arthritis, not as monotherapy. 2, 1

Dosing Concerns with Requested Regimen

The requested dosing of 670mg (7mg/kg) every 5 weeks deviates from FDA-approved and guideline-recommended parameters:

• FDA-approved dosing: 3 mg/kg at weeks 0,2, and 6, then every 8 weeks thereafter for rheumatoid arthritis. 3

• Standard dosing per guidelines: 3 mg/kg every 8 weeks in combination with methotrexate is the established regimen. 1

• Dose escalation criteria: Escalation to 10 mg/kg or interval shortening to every 4 weeks may only be considered after establishing incomplete response to standard dosing. 1, 4

• The requested 7mg/kg dose and 5-week interval: This represents dose intensification without documented trial of standard dosing, which violates step-wise treatment protocols. 1

Required Documentation for Approval

To establish medical necessity, the following must be provided:

• Disease activity documentation: Current DAS28, CDAI, or SDAI scores demonstrating moderate-to-severe active RA. 2, 1

• Methotrexate trial documentation: Evidence of therapeutic methotrexate dosing (≥15-25 mg/week) for ≥3 months with inadequate response. 2, 1

• Functional status: Documentation of functional impairment and quality of life impact. 2

• Contraindications to methotrexate: If methotrexate was not tried, documented contraindications or intolerance must be provided. 2

Common Pitfalls to Avoid

Skipping conventional DMARD therapy: The most significant error in this request is attempting to initiate biologic therapy without documented conventional DMARD failure. This violates all major rheumatology guidelines and represents inappropriate resource utilization. 2, 1

Inappropriate dosing from the start: Requesting intensified dosing (7mg/kg every 5 weeks) without first establishing response to standard dosing (3mg/kg every 8 weeks) is not supported by evidence or guidelines. 1, 3

Monotherapy consideration: If approved, infliximab must be combined with methotrexate, as monotherapy is associated with increased immunogenicity and treatment failure. 2, 4

Safety Monitoring Requirements

If infliximab is eventually deemed appropriate after proper documentation:

• Baseline screening: PPD or interferon-gamma release assay for tuberculosis, hepatitis B and C screening, CBC, liver function tests are mandatory before initiation. 2

• Ongoing monitoring: Periodic history and physical examination, consideration of yearly PPD, and periodic CBC and liver function tests. 2

• Infusion reaction monitoring: While routine vital sign monitoring during every infusion is common practice, it has limited value in predicting acute infusion reactions and should be performed primarily when reactions occur. 5

Recommendation for Resubmission

The request should be denied and resubmitted with:

1. Documented trial of methotrexate at therapeutic doses (≥15-25 mg/week) for ≥3 months with inadequate response, OR documented contraindications to methotrexate. 2, 1

2. Current disease activity scores using validated instruments demonstrating moderate-to-severe disease. 2, 1

3. Request for standard FDA-approved dosing (3 mg/kg every 8 weeks) rather than intensified dosing. 1, 3

4. Confirmation that methotrexate will be continued concurrently with infliximab. 2, 1