Your healthcare provider prescribes a medication, but the insurance plan says you must try a different drug first. This requirement is commonly known as step therapy. It is also sometimes called a fail-first requirement, although that phrase can make the process sound more dramatic than it always is.
Step therapy generally requires treatment to begin with one or more medications preferred by the health plan. Coverage for another medication may become available when the preferred treatment is ineffective, causes adverse effects, is contraindicated, or is otherwise inappropriate.
The Centers for Medicare & Medicaid Services describes step therapy as a form of prior authorization that begins with a preferred treatment and progresses to another therapy when necessary.1
Why Do Health Plans Use Step Therapy?
Health plans may use step therapy to encourage the use of treatments that:
- Have established evidence of effectiveness
- Are recommended earlier in treatment guidelines
- Have a well-understood safety profile
- Are available as lower-cost generics
- Provide similar clinical value at a lower cost
The required first-step medication is not necessarily inferior. It may be a widely used treatment that works well for many patients.
However, no single medication is appropriate for everyone. That is why exception and appeal processes matter.
What Counts as Trying a Medication?
The answer depends on the health plan's criteria. The plan may require documentation of:
- The medication name
- A minimum treatment duration
- A particular dose
- Lack of effectiveness
- Intolerance or adverse effects
- A contraindication
- A clinical reason the treatment should be avoided
Simply listing a medication in the patient's chart may not establish that the requirement was completed. The records should ideally explain when it was taken, how long it was used, what happened, and why it was stopped.
What Does “Tried and Failed” Mean?
In insurance terminology, treatment failure usually means that a medication did not produce an adequate clinical response after an appropriate trial. It does not mean that the patient failed.
A previous treatment may also satisfy a step requirement when it caused a significant adverse effect or could not be used safely.
Language matters. Patients are not failed experiments wandering around in lab coats. The treatment was unsuccessful or unsuitable, not the person.
Can Step Therapy Be Bypassed?
Sometimes. The prescriber may request an exception when the required medication:
- Was previously ineffective
- Caused an adverse reaction
- Is contraindicated
- Interacts with another necessary medication
- Is not appropriate because of the patient's medical history
- Is expected to worsen the patient's condition
- Is not suitable for the patient's diagnosis or age
- Would create a risk from interrupting an effective current treatment
The precise exception rules depend on the health plan and applicable law.
What Should Patients Do?
Ask the health plan or pharmacy:
- Which medication must be tried first?
- How long must it be used?
- Does the plan see a previous claim for that medication?
- What documentation is required?
- Can the prescriber request an exception?
- What is the appeal process?
Then review your medication history with your prescriber and pharmacist. Patients often forget treatments used several years earlier or remember a brand name without knowing the generic name. Pharmacy records can help reconstruct the history, although older records may not always be available.
What If the Patient Is Already Stable on the Medication?
Tell the prescriber and health plan that the medication is being continued rather than newly started. Some coverage rules distinguish between new therapy and continuation of treatment. Documentation of clinical response, improvement, adherence, and previous treatment history may be important.
Do not stop an effective medication solely because a claim rejected without first discussing the situation with the prescriber.
The Bottom Line
Step therapy means the insurance plan generally wants the patient to use a preferred treatment before it covers another option. When the preferred treatment is inappropriate, the prescriber may be able to request an exception or appeal. The key is clear documentation showing why the required step should not apply to that particular patient.
Frequently Asked Questions
Is step therapy the same as prior authorization?
Step therapy is a specific type of prior authorization. Instead of just reviewing clinical information, it requires that one or more preferred medications be tried first before the plan covers the requested drug.
Does step therapy mean the first medication is worse?
Not necessarily. It's often a widely used, well-studied, lower-cost option that works well for many patients — it just may not be the right fit for every individual.
What if I already tried the required medication years ago?
Ask your pharmacist and prescriber to help reconstruct that history. Pharmacy fill records can sometimes document a past trial even if it's not in your current chart, though older records aren't always available.
Should I stop my current medication if a refill is rejected for step therapy?
No — don't stop an effective medication because of a claim rejection. Talk to your prescriber first about continuation-of-therapy documentation or an exception request.
When a medication is blocked by step therapy, ask for the exact required treatment, the minimum trial duration, and the documentation needed for an exception. The phrase “try something else first” rarely tells the whole story.
References
- Centers for Medicare & Medicaid Services. Step therapy as a utilization management and prior authorization tool. cms.gov/newsroom/fact-sheets
- National Council on Aging. Step therapy and how enrollees can request an exception. ncoa.org/article/part-b-step-therapy-ma
- HealthCare.gov. Formulary exceptions and appeal rights. healthcare.gov/appeal-insurance-company-decision