Meds & Biologics
Getting a denial letter for a biologic medication you need is one of the most stressful experiences in managing inflammatory bowel disease (IBD). You are not alone in dealing with this. Research published in the American College of Gastroenterology journal found that 15.2% of IBD patients on biologics faced an initial prior authorization rejection, and those patients waited an average of 60.5 days for approval compared to 23.1 days for patients approved on the first attempt. That delay has real clinical consequences. A separate multicenter study found that prior authorization complications increased IBD-related healthcare utilization within 180 days by 12.9% and corticosteroid dependence at 90 days by 14.1%. The good news: most denials can be overturned with a well-organized appeal. This guide walks you through the process.
Why Biologics Get Denied
Insurance companies deny biologic prior authorization requests for a handful of common reasons. Understanding the specific reason behind your IBD insurance denial is the first step in building an effective appeal.
Formulary restrictions mean the insurer prefers a different biologic than the one your gastroenterologist prescribed. Your plan may cover Humira but not Remicade, or vice versa, regardless of which medication your doctor believes is right for you. Step therapy mandates, sometimes called "fail first" requirements, force patients to try cheaper medications before the insurer will approve a biologic. For IBD patients, this often means being required to take corticosteroids or immunomodulators first. According to the Crohn's & Colitis Foundation, over 40% of patients with Crohn's disease and ulcerative colitis have had to try and fail on one or more drugs before accessing the treatment their provider originally prescribed. Insufficient documentation is another frequent cause, where the insurer claims the submitted records do not demonstrate medical necessity.
Your denial letter is required to state the specific reason your claim was rejected. Read it carefully, because your entire appeal strategy should be built around addressing that stated reason.
Building Your Appeal: The Letter of Medical Necessity
The letter of medical necessity is the centerpiece of a biologic prior authorization appeal for IBD. In most cases, your gastroenterologist's office will write and submit this letter, but you should understand what goes into it and actively participate in the process.
A strong letter of medical necessity should include your complete diagnosis with ICD-10 codes, a detailed history of your disease course including hospitalizations and complications, documentation of every previous medication you have tried along with the reasons each one failed or was contraindicated, current lab results and endoscopy findings that demonstrate active disease, and peer-reviewed literature supporting the prescribed biologic for your specific situation. The Crohn's & Colitis Foundation provides downloadable appeal letter templates that your doctor's office can customize. These templates are available in Word format and cover scenarios including step therapy appeal for IBD and requests when a Crohn's biologic is denied due to formulary preference.
Your GI's office is your most important ally in this process. Ask them directly whether they have experience with prior authorization appeals for the specific medication you need, such as prior authorization for Remicade or Humira. Many GI offices have staff members who specialize in insurance navigation, and a peer-to-peer review, where your gastroenterologist speaks directly with the insurance company's medical reviewer, can resolve denials that paperwork alone cannot.
Tracking Your Symptoms to Strengthen Your Case
One area where patients can directly contribute to their appeal is through consistent symptom documentation. Objective records of your disease activity, including flare frequency, symptom severity, and the impact on daily functioning, provide concrete evidence that strengthens a letter of medical necessity. Aidy's medical reports can help you compile this kind of documented symptom history, giving your care team data they can reference when arguing that your current treatment is inadequate or that a specific biologic is medically necessary.
Internal and External Review: Your Rights
Federal law under the Affordable Care Act guarantees your right to appeal any insurance denial. The process has two stages. First, you file an internal appeal, which asks the insurance company to reconsider its decision. You have 180 days from receiving your denial notice to file this appeal. If your health situation is urgent, you can request an expedited internal review.
If the internal appeal is denied, you have the right to an external review, where an independent third party evaluates whether the insurer's denial was justified. External reviewers must reach a decision within 45 days for standard cases, or within 72 hours for urgent, expedited cases. The external reviewer's decision is binding on the insurance company.
Your state may offer consumer assistance programs that can help you navigate this process. The Crohn's & Colitis Foundation's IBD Help Center (888-694-8872) can also answer questions and direct you to resources specific to your insurance type, whether private, Medicare, or Medicaid.
What to Do Right Now
If you have received a biologic denial, start by requesting the full denial letter and noting the deadline for your appeal. Contact your GI's office immediately and ask them to begin preparing a letter of medical necessity. Gather your medical records, including lab results, imaging, and procedure reports. Keep a written log of every phone call with your insurer, including the date, representative name, and reference number.
If you are about to start a biologic and want to prepare, begin tracking your symptoms consistently now. Having weeks or months of documented disease activity available before a prior authorization is submitted makes denial less likely in the first place, and gives your care team stronger evidence if an appeal becomes necessary.