Is continuation of Remicade (Infliximab) Q6 weeks for the diagnosis of ulcerative colitis medically necessary without documentation of the last Hepatitis B (Hep B) or Tuberculosis (TB) testing?

Continuation of Remicade Cannot Be Certified Without Documentation of Hepatitis B and Tuberculosis Testing

Continuation of Remicade (infliximab) every 6 weeks for ulcerative colitis is NOT medically necessary without current documentation of Hepatitis B and TB screening, as these are mandatory safety requirements before initiating or continuing biologic therapy. 1

Mandatory Screening Requirements Before Biologic Therapy

The British Society of Gastroenterology explicitly requires baseline screening tests for second-line therapy including:

• Hepatitis B and C virus serology (surface antigen, surface antibody, and core antibody) 1
• Tuberculosis screening with clinical risk stratification, chest X-ray, and interferon-gamma release assay (such as QuantiFERON-gold) 1
• These tests must be documented before starting treatment with biologics like infliximab 1

Why This Documentation Is Non-Negotiable

Hepatitis B Reactivation Risk

• Infliximab can cause HBV reactivation in patients with chronic or resolved HBV infection, potentially leading to fulminant hepatitis 1
• If hepatitis B surface antigen is positive, HBV DNA must be quantified and concurrent antiviral therapy is required before continuing infliximab 1
• The screening requirement exists to identify patients who need prophylactic antiviral therapy (such as entecavir) to prevent life-threatening hepatic decompensation 2

Tuberculosis Reactivation Risk

• Anti-TNF therapy carries substantial risk of TB reactivation, including disseminated and miliary tuberculosis 3
• A documented case demonstrates that even with negative QuantiFERON testing, a clear history of household TB exposure led to miliary TB after infliximab initiation 3
• Ideally, anti-tuberculous treatment or prophylaxis for active or latent TB should be started prior to commencing immunomodulators 1

Annual Repeat Testing Requirement

For patients already on biologic therapy:

• Screening labs (HIV, hepatitis A and B, and TB testing) should be repeated annually in patients who require biologic treatment for >1 year until treatment is completed 1
• This ensures ongoing safety monitoring for patients on chronic immunosuppression 1

Clinical Context of This Case

While this patient appears to be responding well to Remicade (clinical remission, weight gain, improved symptoms):

• The patient has 2-4 bowel movements daily with mucus, suggesting ongoing disease activity despite "likely clinical remission" 4
• History of CMV colitis indicates significant immunosuppression risk 1
• Colonoscopy is planned in 4 weeks, which is appropriate for disease monitoring 1

Recommendation for Certification

The authorization should be held pending documentation of:

1. Most recent Hepatitis B serology results (HBsAg, anti-HBs, anti-HBc) with dates 1
2. Most recent TB screening results (chest X-ray and interferon-gamma release assay) with dates 1
3. If these tests were performed at treatment initiation but are >1 year old, repeat testing is indicated before continuing therapy 1

Common Pitfall to Avoid

Do not assume prior testing was adequate simply because the patient is already on infliximab. The case of miliary TB despite negative QuantiFERON demonstrates that initial screening can miss patients at risk, particularly when exposure history is not adequately assessed 3. Annual repeat testing exists specifically to catch delayed seroconversion or new exposures 1.

The request for additional information from the provider is appropriate and should be maintained until documentation is provided. Patient safety requirements for biologic therapy are non-negotiable regardless of clinical response 1.