Step Therapy: What It Is and How to Get an Exception

Step therapy, sometimes called fail first, requires you to try one or more less expensive drugs before your insurer will cover the drug your doctor originally prescribed. If you have ever been told your prescription requires step therapy, here is what that means and what you can do about it.

How step therapy works

Your insurer has determined that for your condition, a lower-cost drug should be tried first. You must document that you tried the required first-line drug (or drugs) and that it was either ineffective or caused unacceptable side effects before the insurer will approve coverage of the prescribed drug.

Step therapy protocols are written into clinical coverage policies and vary by insurer, by drug, and by diagnosis. What triggers step therapy for one plan may not trigger it for another.

The problems with step therapy

Step therapy delays treatment. Trying an ineffective drug for 30 to 90 days before being allowed to move to the appropriate treatment has real clinical consequences, particularly for conditions like mental health disorders, autoimmune diseases, and chronic pain.

The step requirement sometimes makes no clinical sense. Your physician may have specific reasons for prescribing a particular drug including prior treatment history, drug interactions, or contraindications for the step drugs that the insurer's algorithm does not know about.

How to get a step therapy exception

Most states have step therapy exception laws requiring insurers to provide an exception process. Federally, the 21st Century Cures Act requires step therapy exceptions for Medicare Advantage plans.

Your physician must submit the exception request with clinical documentation explaining why step therapy is inappropriate for you. Strong grounds for an exception include prior treatment with the step drug that was ineffective or caused adverse effects, a contraindication to the step drugs, and clinical evidence that your condition would deteriorate during the required trial period.

The exception request must be specific. A letter saying the prescribed drug is the best choice is less effective than a letter saying the step drugs are contraindicated because of diagnosis X or that the patient previously failed step drug Y in year Z at dose A.

Appeals and state protections

If the exception is denied, you can appeal. Many states require expedited exception decisions within 24 to 72 hours for urgent situations. If your state has step therapy reform legislation, your insurer may have shorter timelines and clearer criteria for granting exceptions than federal minimum standards require.

Ask your physician's office whether they have experience filing step therapy exceptions. Practices that treat conditions commonly subject to step therapy protocols often have staff who specialize in this process.

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Bill Advantage is a document literacy tool. Nothing in this article constitutes legal or medical advice.