Natalizumab (CPB 0751, reviewed 2025-12-02)

REQUIREMENTS: - Immediately: Billing team must implement mandatory precertification workflow for all natalizumab (Tysabri and Tyruko) claims. Contact information: (866) 752-7021 or fax (888) 267-3277. - Immediately: Update billing system to require JCV antibody testing (CPT 86711) documentation before processing any natalizumab claim for initial approval. - Immediately: Verify prescriber specialty in EMR/billing system — only gastroenterologists for Crohn's disease and neurologists for multiple sclerosis may prescribe natalizumab. Flag claims from other specialties for manual review. - By 2025-12-02: Update encounter forms and billing templates to require documentation of: (1) prior biologic therapy use (CD only), (2) JCV antibody test results, (3) disease activity baseline metrics, and (4) clinical response evidence (remission or low disease activity). - By 2025-12-02: Billing team must update quantity/dosage limits in billing software to enforce 300 mg IV infusion every 4 weeks per FDA-approved labeling. Flag claims exceeding this frequency for denial. - By 2025-12-02: Configure system to deny natalizumab claims if combined with immunosuppressants (6-mercaptopurine, azathioprine, cyclosporine, methotrexate) or TNF-alpha inhibitors (adalimumab, infliximab). These combinations are experimental/unproven. - By 2025-12-02: For Crohn's disease claims, add system alerts requiring discontinuation if: (1) no therapeutic benefit by 12 weeks, or (2) patient cannot taper off oral corticosteroids within 6 months, or (3) additional steroid use exceeds 3 months in calendar year. - Immediately: Stop billing CPT 87798 and 87801 (PCR testing of cerebrospinal fluid for JC polyomavirus) for pre-treatment diagnosis — policy identifies this as unproven and not medically necessary. Deny these codes when submitted. - Immediately: Do not bill pro-angiogenic factor MMP9 biomarker testing — policy identifies as experimental/investigational. - By 2025-12-02: Providers and billing team must use Statement of Medical Necessity (SMN) precertification forms available through Specialty Pharmacy Precertification portal. - By 2025-12-02: Billing team must verify site of care compliance per Aetna's Utilization Management Policy on Site of Care for Specialty Drug Infusions (reference CPB separate policy). Route claims to approved infusion centers only. - Failure to obtain precertification or provide required documentation will result in claim denials. Non-compliant prescriber claims will be rejected at submission.