Biologic and infusion therapy denials
Biologics such as adalimumab, infliximab, vedolizumab, ustekinumab, and rituximab are denied at prior authorization for step-therapy, missing labs, or diagnosis mismatch, and later for site of care or dose escalation. The appeal is a documentation exercise against the plan's own criteria.
What gets denied
- First biologic for Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, or psoriasis
- Switch to a second biologic after the first stops working
- Dose escalation or interval shortening beyond the label
- Infusion at a hospital outpatient department instead of home or a standalone center
- Biosimilar substitution disputes
Common denial reasons
- Step therapy: conventional drugs (methotrexate, mesalamine, steroids) not tried or not documented
- Disease activity scores or lab markers missing from the record
- Diagnosis code does not match the labeled indication
- TB or hepatitis B screening not on file
- Plan prefers a different biologic or a biosimilar first
How we approach the appeal
Get the plan's drug policy and match every criterion to a page in the chart: diagnosis, severity score, prior drugs with dates and outcomes, screening labs, prescriber specialty. Where step therapy is the reason, use the plan's exception process and, where applicable, the state step-therapy law that requires an override when the required drug was tried, is contraindicated, or is expected to be ineffective. For a switch after loss of response, document the objective loss of response. Ask for a peer-to-peer with a reviewer in the same specialty.
Untreated inflammatory disease supports an expedited appeal: decision within 72 hours. Internal appeal filing window: at least 180 days for commercial and employer plans; 65 days for Medicare Advantage; 60 days for Part D. External review: within 4 months of the final internal denial for ACA-covered plans (45 CFR 147.136).
Biologics are priced in the thousands of dollars per dose; a denied year of therapy is commonly a five-figure sum at billed charges.
- · The denial letter with the criterion or policy cited
- · Specialist's notes with diagnosis and disease-activity measures
- · Prior medication history with dates, doses, and outcomes
- · TB, hepatitis, and other screening results
- · The plan's drug policy and formulary exception form
Biologic and infusion therapy denial? Let's appeal it.
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Start Your AppealThis page provides general information about appeal strategy. It is not legal advice. Outcomes depend on documentation, plan terms, and timing.