Is Renflexis (infliximab-abda) infusion medically necessary for treating ulcerative pancolitis without complications?

Medical Necessity Determination for Renflexis (Infliximab-abda) Infusion

The Renflexis infusion on 4/24/25 is NOT medically necessary as documented because critical safety requirements are missing: there is no confirmation of negative tuberculosis testing within 12 months prior to this specific dose, and no documentation of clinical response or disease activity assessment to justify continuation therapy.

Critical Missing Documentation

Tuberculosis Screening Requirement

• All patients must have documented negative TB testing within 12 months of initiating or continuing infliximab therapy due to the 4-5 fold increased risk of tuberculosis reactivation 1, 2
• The prior authorization from reference case #8440455 specifically flagged this issue: "Documentation should confirm negative TB testing within the past 6 months" and recommended non-certification until provided 3
• While the case notes reference "Order Comments: within one year for continuing therapy, and the results are negative," there is no actual documentation of when TB testing was performed or the results for this patient 3
• The FDA label for Renflexis explicitly requires TB evaluation prior to initiating and periodically during therapy 2

Clinical Response Documentation Requirement

• For continuation therapy, patients must demonstrate either maintenance of remission OR positive clinical response with improvement in disease activity markers 1, 3
• The AGA guidelines specify that continuation requires documented improvement in: stool frequency, rectal bleeding, urgency, C-reactive protein, fecal calprotectin, endoscopic appearance, or disease activity scores 1
• The clinical documentation states only "Renflexis administered IV. Toi well. Departed in stable condition" with no assessment of disease activity, symptoms, or treatment response [@case summary@]
• There is no documentation of baseline disease severity, current symptoms, or objective measures (CRP, fecal calprotectin, endoscopy findings) to justify ongoing therapy [@case summary@]

Appropriate Dosing and Timing Considerations

Maintenance Regimen Verification

• The FDA-approved maintenance dosing for ulcerative colitis is 5 mg/kg IV every 8 weeks 2
• The patient received 600 mg (calculated as 5 mg/kg for approximately 120 kg body weight), which is appropriate [@case summary@]
• Previous doses documented on 05/09/2025 and 08/01/2025 from reference case #8534891 suggest this is maintenance therapy, but the 4/24/25 date appears inconsistent with an 8-week schedule [@case summary@]

Specialist Prescriber Requirement Met

• The ordering provider is Betty K Moore, NP, with specialty in Gastroenterology, which meets the requirement that infliximab must be prescribed by or in consultation with a gastroenterologist 3, 2

Additional Safety Concerns

Concomitant Biologic Therapy

• Patients cannot use infliximab concomitantly with other biologic drugs for the same indication 1, 3
• There is no documentation confirming the patient is not on other biologics [@case summary@]

Infection Screening

• Active sepsis is an absolute contraindication to infliximab administration 1
• There is no documentation of infection screening prior to this infusion [@case summary@]

Ancillary Code Medical Necessity

J7050 (Normal Saline Solution 250cc)

• This code is medically necessary as the FDA label requires dilution of reconstituted Renflexis to 250 mL with sterile 0.9% Sodium Chloride Injection 2
• The dilution is mandatory for proper administration and cannot be omitted 2

Chemotherapy Administration Codes (96413,96415)

• These codes are appropriate for infliximab infusion administration 3
• The infusion must be administered over at least 2 hours per FDA requirements 2

Recommendation for Certification

To certify this service as medically necessary, the following documentation must be provided:

1. Tuberculosis screening results (TST or IGRA) performed within 12 months of the 4/24/25 infusion date, with negative results or documentation of completed latent TB treatment if positive 1, 2

2. Clinical response documentation showing either:

   • Maintenance of clinical remission, OR
   • Improvement in at least one disease activity parameter: stool frequency, rectal bleeding, urgency, CRP, fecal calprotectin, endoscopic findings, or validated disease activity score (Mayo score, UCEIS) 1, 3

3. Confirmation that the patient is not receiving other concurrent biologic therapy for ulcerative colitis 1, 3

4. Verification that the patient had no active infection at time of infusion 1, 2

Without this documentation, the service should remain non-certified as the safety requirements and continuation criteria have not been met, despite ulcerative pancolitis being an FDA-approved indication for Renflexis.