Was the Inflectra (infliximab) injection administered on the date of service medically necessary for a patient with a history of Crohn's disease and ankylosing spondylitis, who has been receiving Inflectra (infliximab) injections every 8 weeks?

Medical Necessity Determination: Inflectra (Infliximab) Injection for Crohn's Disease and Ankylosing Spondylitis

Direct Answer

The Inflectra injection on the date of service was NOT medically necessary based on the submitted documentation, primarily due to the absence of required tuberculosis screening within 12 months of ongoing therapy and lack of documented disease activity assessment to justify continuation of therapy. 1

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Critical Missing Documentation

Tuberculosis Screening Requirement - NOT MET

• The American Gastroenterological Association mandates purified protein derivative skin testing before and during treatment with infliximab due to the risk of reactivating latent tuberculosis. 1
• Documentation must show tuberculosis screening results within 12 months for patients on biologic therapy. 1
• The submitted records contain no evidence of tuberculosis testing within the required timeframe, which is a fundamental safety requirement that cannot be waived. 2, 1
• The risk of tuberculosis with infliximab is approximately six times that of untreated patients, making this screening non-negotiable. 2

Disease Activity Documentation - NOT MET

• For Crohn's disease continuation criteria, documentation must show improvement or maintenance in at least one of the following: abdominal pain/tenderness, diarrhea, body weight, abdominal mass, hematocrit, endoscopic appearance, or disease activity scoring (e.g., CDAI). 3
• The most recent clinical note from [DATE] states "stable Crohn's disease" and "no flare-ups" but provides no objective measurements of disease activity. 3
• The British Society of Gastroenterology guidelines require documented positive clinical response with evidence of low disease activity or improvement in signs and symptoms. 2

Ankylosing Spondylitis Continuation Criteria - PARTIALLY MET

• For ankylosing spondylitis, continuation requires documented improvement in swollen joints, tender joints, or other disease activity measures from baseline. 3
• The [DATE] note mentions "joint pains have been more beneficial with infliximab" compared to prior Humira therapy, suggesting some benefit. 3
• However, no objective assessment tools (such as BASDAI scores) are documented to quantify disease activity or response. 4

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Dosing and Frequency Concerns

Crohn's Disease Dosing - DISCREPANCY IDENTIFIED

• The FDA-approved and guideline-recommended maintenance dosing for Crohn's disease is 5 mg/kg every 8 weeks. 3, 5
• The prescription order form indicates "Inflectra 500mg IVC every 8 weeks" which aligns with standard Crohn's disease dosing. 3

Ankylosing Spondylitis Dosing - DISCREPANCY IDENTIFIED

• For ankylosing spondylitis, the FDA-approved maintenance dosing is 5 mg/kg every 6 weeks. 2, 3, 5
• The prescription shows every 8-week dosing, which does not meet the standard interval for ankylosing spondylitis treatment. 3
• While some evidence suggests 3 mg/kg at 8-week intervals may be effective in select AS patients, this represents off-label dosing that requires specific clinical justification. 4

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Diagnosis Code Issues

K52.9 (Noninfective Gastroenteritis and Colitis, Unspecified) - INAPPROPRIATE

• This diagnosis code is not a standard FDA-approved indication for infliximab therapy. 5
• The FDA-approved indication is for "moderately to severely active Crohn's disease" (K50.x codes), not unspecified gastroenteritis. 5
• The clinical documentation clearly describes Crohn's disease with IBD-associated spondyloarthritis, yet the billing code does not reflect this diagnosis. 3

M45.9 (Ankylosing Spondylitis) - APPROPRIATE

• This diagnosis code is an FDA-approved indication for infliximab. 5
• The clinical documentation supports this diagnosis with inflammatory back pain, sacroiliitis on imaging, and history of Crohn's disease. 3

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Prescriber Specialty Requirements

Rheumatology Prescriber - PARTIALLY MET

• For ankylosing spondylitis, infliximab must be prescribed by or in consultation with a rheumatologist. 3
• The prescription order form shows a rheumatology provider, meeting this criterion. 3

Gastroenterology Consultation - NOT DOCUMENTED

• For Crohn's disease, infliximab must be prescribed by or in consultation with a gastroenterologist. 3
• The [DATE] note mentions "routine follow-up with Gastroenterology" but no recent gastroenterology consultation notes are included in the submitted documentation. 3

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Concomitant Therapy Considerations

No Other Biologic Drugs - MET

• The medication list from [DATE] documents "No other biologic drug or targeted synthetic drug." 3
• This meets the requirement that infliximab cannot be used concomitantly with other biologics for the same indication. 3

Prior Anti-TNF Therapy - DOCUMENTED

• The patient previously received Humira (adalimumab) with documented decline in efficacy for inflammatory arthritis, leading to discontinuation. 3
• This supports the use of an alternative anti-TNF agent (infliximab) per guidelines for patients with prior biologic exposure. 2, 3

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Clinical Pitfalls and Recommendations

Common Documentation Errors to Avoid

• Simply stating "stable disease" or "well-controlled" is insufficient for continuation criteria. Specific objective measures must be documented (e.g., "CDAI score decreased from X to Y" or "no abdominal pain for past 3 months"). 3
• Tuberculosis screening must be repeated annually for patients on ongoing biologic therapy, not just at initiation. 2, 1
• When treating dual diagnoses (Crohn's disease and ankylosing spondylitis), the dosing interval must be justified based on which condition is the primary treatment target. 3

Required Documentation for Approval

• Current tuberculosis screening results (PPD or IGRA) within 12 months. 1
• Objective disease activity measurements for Crohn's disease (endoscopy results, CTE/MRE imaging, CDAI scores, or specific symptom documentation). 3
• Recent gastroenterology consultation note addressing Crohn's disease status. 3
• Clarification of whether the every-8-week dosing is intended for Crohn's disease (appropriate) or ankylosing spondylitis (requires justification for deviation from standard 6-week interval). 3, 5
• Correction of diagnosis code from K52.9 to appropriate Crohn's disease code (K50.x). 5

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Safety Monitoring Gaps

Hepatitis B Screening - NOT DOCUMENTED

• Guidelines recommend hepatitis serology prior to and during infliximab therapy due to reactivation risk. 2
• No hepatitis B status documentation is present in the submitted records. 2

Periodic Laboratory Monitoring - NOT DOCUMENTED

• Complete blood count and liver function tests should be monitored periodically during ongoing therapy. 2
• The most recent laboratory results are not included in the case documentation. 2