Biologic and infusion therapy appeal letter template
A free, fillable biologic and infusion therapy appeal letter you can copy, complete, and send. It is built on the structure that actually wins biologic and infusion therapy appeals, not a generic reconsideration request.
The biologic and infusion therapy appeal letter template
Copy the template below and replace every bracketed field with your details. Keep it to one or two pages plus attachments.
[Date] [Your full name] [Your address] [Your phone] · [Your email] [Insurer name], Appeals Department [Appeals address from your denial letter] Re: Appeal of biologic and infusion therapy denial Member: [Patient name] · Member ID: [Member ID] · Group: [Group #] Claim #: [Claim #] · Date(s) of service: [Date of service] Denial date: [Denial date] · Denial/reason code: [Code] To the Appeals Department: I am formally appealing [Insurer]'s [denial date] denial of [service or medication]. I request that the denial be overturned and the biologic and infusion therapy approved. 1. The denial. [Insurer] denied this biologic and infusion therapy stating, verbatim: "[paste the exact denial language from your letter]." 2. Why the denial is incorrect. [State, in one or two sentences, why the service is medically necessary for your condition, and answer the specific reason the plan gave.] 3. The controlling standard. [See the standard for this denial type below, then cite it here.] 4. The evidence. I am attaching: - A letter of medical necessity from my treating provider addressing each clinical criterion; - [Your supporting records: see the document checklist below]; - The clinical guidelines and records that support coverage. 5. My request. I request a full reversal of this denial and approval of [service or medication] within the timeframe required by law. If the denial is upheld, please provide in writing the specific clinical criteria used, the credentials of the reviewing clinician, and instructions for independent external review. Under 29 C.F.R. 2560.503-1 (employer plans) or 45 C.F.R. 147.136 (ACA plans), please also provide all documents and records relevant to this claim. Sincerely, [Patient name / authorized representative]
The controlling standard for biologic and infusion therapy denials
Plan drug policies typically require a specific diagnosis, disease severity measures, a trial of conventional therapy (step therapy), tuberculosis and hepatitis screening, and prescriber specialty. Many states limit step therapy and require exception processes; federal rules for ACA plans require an exceptions process for non-formulary drugs (45 CFR 156.122(c)). Medicare Part B covers physician-administered biologics under medical necessity; Part D covers self-administered ones under formulary rules with a 60-day redetermination window (42 CFR 423.582). Criteria must be disclosed on request (29 CFR 2560.503-1(m)(8)).
What makes a biologic and infusion therapy appeal letter win
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.
The letters that get overturned share a structure: they quote the denial, rebut the plan's specific criteria point by point, cite the controlling standard above, attach a treating-provider letter of medical necessity, and make a clear demand for reversal. Generic letters that simply ask the plan to reconsider do not move reviewers.
Documents to attach
- 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
Skip the blank page
Apellica builds the full biologic and infusion therapy appeal for you, with the criteria rebuttal, the controlling-standard citation, and the medical-necessity evidence pack assembled. $0 upfront, pay only if we win.
Build my appeal free →Biologic and infusion therapy appeal: frequently asked questions
my insurer wants me to fail a cheaper drug first. Do I have to?
Not always. Plans must have an exception process, and many states require an override when the required drug was already tried, is contraindicated, or is expected to be ineffective. The prescriber's letter should say which of those applies and why.
Why was my biologic denied when my doctor prescribed it?
Most denials are documentation gaps: a missing severity score, an undocumented prior drug, or a screening lab not on file. The plan's policy tells you exactly which item is missing; request it.
my insurer moved my infusions out of the hospital. Can I appeal the site of care?
Yes. Site-of-care denials are appealable. The record needs to show why the hospital setting is medically required, for example prior infusion reactions or complex comorbidities.
Is a biosimilar the same drug?
A biosimilar is highly similar to the reference biologic with no clinically meaningful difference, per FDA. Plans may prefer one. If a switch caused loss of response or an adverse reaction, that history is the basis for an exception.