The short answer
Step therapy is a type of prior authorization. It requires you to try a certain less expensive drug on your plan's list first, one proven effective for most people with your condition, before the plan will cover a more expensive one.
Your prescriber wrote one drug. Your plan wants you to try a different one first. That is not a judgement about your prescription. It is a rule about the order things happen in, and rules about order can be answered.
What is step therapy?
Step therapy requires you to try a certain less expensive drug on your plan's list before you can move up a step to a more expensive one. The cheaper drug has to be one proven effective for most people with your condition.
Some plans specify what the first step is. They may require you to try a generic drug or a biosimilar if one is available, or a biological product that is on their list.
Step therapy is prior authorization wearing a sequence. That is our reading rather than a rule anyone states, and three government facts produce it.
CMS calls step therapy a type of prior authorization. Prior authorization is approval a plan requires before it will cover a drug. And a formulary exception is the request that waives a utilization management requirement on a drug already on the list.
So the same door opens both, because they are the same kind of rule. Those three facts are the government's. Putting them together is ours.
Why must I try another drug first?
Plans use step therapy as one of a small group of rules, alongside prior authorization, quantity limits and medication safety checks such as Medication Therapy Management programs for complex health needs. Your plan may use some of them, all of them, or none.
The test the cheaper drug has to pass is worth reading closely. It must be proven effective for most people with your condition.
That phrase is doing something specific. It is a statement about a population rather than about you, and the exception route is the part of the rule that runs on your own clinical situation.
If you are starting new coverage there may be a short bridge. When your drug coverage begins, you may get a transition fill: a one-time 30-day supply of a drug you have been taking that your plan does not cover or requires step therapy or prior authorization for.
How do I get an exception?
You or your prescriber contacts the plan and asks for an exception to the step therapy requirement. Your prescriber then gives a statement supporting it, and that statement is what the plan actually decides on. Approval removes the step rather than postponing it.
If the exception is approved, your plan covers the more expensive drug even though you did not try the less expensive one first. The step is removed rather than postponed.
Three people are allowed to make the request: you, your prescriber, or your representative. A request for a benefit may be made verbally or in writing.
The formal name for what you are filing is a formulary exception, which is the request used to waive a requirement like this one. This publication's article on requesting a drug exception carries the whole process.
What does my doctor need to submit for a step therapy exception?
Your prescriber must give a statement supporting the request, and it has to include their belief in one of three things. Any one of the three carries it, because they are alternatives rather than a list your prescriber has to complete in full.
- It is medically necessary for you to be on the more expensive drug without trying the cheaper one first
- You will have adverse health effects if you take the less expensive drug
- The less expensive drug would be less effective
Notice what none of those say. None is about cost, and none asks you to argue anything. Each is a clinical judgement only your prescriber can make.
It also means the request cannot move until their office has written it, which is what the next section is about.
How long does a step therapy exception take?
Once your plan has your prescriber's supporting statement, it must give written notice of its decision within 72 hours for a standard request, or 24 hours for an expedited one. The first notice may be verbal if a written one follows within 3 calendar days.
The condition at the front of that is the part that matters. For a request involving an exception, the timeframes do not begin until your plan receives the statement from your prescriber.
So a request you filed a week ago may not be overdue. If the statement has not arrived at the plan, the deadline has not started counting.
So when nothing seems to be moving, the step that has not happened is at your prescriber's office. This publication's article on requesting a drug exception sets out the full clock, including payment requests and appeals.
Can I appeal a step therapy denial?
Yes. If your plan denies the request in whole or in part, you, your prescriber, or your representative may appeal by asking the plan for a standard or expedited redetermination. That is the first of five levels, and it goes back to your own plan.
You have 65 calendar days from the date of the notice to file it. That is the date printed on the letter, not the day you opened it.
The refusal letter is also the instruction sheet: an unfavourable decision contains the information you need to file. An expedited appeal may be verbal or written, while a standard one must be in writing unless your plan accepts verbal requests.
Your plan must then decide as quickly as your health requires, and no later than 7 calendar days for a standard appeal or 72 hours for an expedited one.
Beyond that there are five levels in all, running from your plan through an Independent Review Entity, the Office of Medicare Hearings and Appeals, the Medicare Appeals Council, and a Federal district court, with a decision letter at each level telling you how to reach the next.
What this means for you
Step therapy is a rule about sequence, not a verdict on your prescription. It asks you to try a cheaper drug that is proven effective for most people with your condition before the plan will cover a more expensive one.
CMS calls it a type of prior authorization, which is why the same exception route answers both.
The exception turns on three things your prescriber can state, and any one of them carries it. If it is approved, the plan covers the more expensive drug without you having tried the cheaper one at all.
The clock does not begin when you file. It begins when your plan has your prescriber's statement, and then runs 72 hours, or 24 if expedited.
If you are refused you have 65 calendar days from the date on the letter, and the letter itself tells you how to file. For the full process, read this publication's article on requesting a drug exception. For the related rule that asks permission rather than order, read the article on Part D prior authorization.
FAQ
Is step therapy the same as prior authorization?
CMS describes step therapy as a type of prior authorization, so they are related rather than identical. Prior authorization is approval your plan requires before it will cover certain drugs.
Step therapy is that idea applied to an order of treatment: you try a certain less expensive drug on the plan's list first, one proven effective for most people with your condition, before you can move up a step to a more expensive drug.
The practical consequence of them being the same family is that the same route answers both. A formulary exception is the request used to have a utilization management requirement waived on a drug that is already on the plan's list, and step therapy is one of the requirements it can waive.
What counts as the cheaper drug I have to try?
That depends on your plan, and Medicare names two common cases. Some plans may require you to try a generic drug or a biosimilar, if one is available.
Others may require you to try a biological product that is on their own list of covered drugs. The common thread is that the first step has to be a drug on the plan's list that has been proven effective for most people with your condition.
It is worth reading that standard carefully, because it is a statement about a population rather than about you specifically, and the gap between those two is exactly what the exception process exists to handle.
What if I already tried that drug and it did not work?
That is one of the three things your prescriber can state to support an exception. The statement must include their belief that it is medically necessary for you to be on the more expensive drug without trying the less expensive one first.
Or that you will have adverse health effects from the less expensive drug. Or that the less expensive drug would be less effective. Any one of those three supports the request on its own.
History with the drug is the kind of clinical detail that belongs in that statement, and your prescriber is the only person who can put it there, which is why the request usually depends on their office rather than on yours.
If the exception is approved, do I still have to try the cheaper drug?
No. Medicare states that if the exception is approved, your plan will cover the more expensive drug even if you did not try the less expensive drug first. The step is removed rather than deferred, so there is no later obligation to work back through it.
This is worth knowing because the word exception can sound temporary, as though it buys time rather than settles the matter. What it changes is whether the requirement applies to you at all for that drug.
If your plan later changes its list or its rules, that is a separate event with its own notice, and this publication's article on whether your drug is covered explains how those changes reach you.
How long should I expect to wait?
Once your plan has your prescriber's supporting statement, it must give written notice of its decision within 72 hours for a standard request, or 24 hours for an expedited one. The first notice may be verbal, provided a written one is posted within 3 calendar days. The important condition is at the front of that sentence.
CMS states that for requests involving exceptions, the adjudication timeframes do not begin until the plan receives the supporting statement from the prescriber. So a long wait often means the statement has not arrived yet, which is a step that sits with your prescriber rather than with your plan.
Can my doctor appeal for me if the exception is refused?
Yes. If the plan denies the request in whole or in part, the enrollee, the enrollee's prescriber, or the enrollee's representative may appeal by requesting a standard or expedited redetermination.
The request must be filed within 65 calendar days from the date of the notice of the coverage determination, which is the date printed on the letter rather than the day it arrived.
An expedited request may be made verbally or in writing; a standard request must be in writing unless your plan accepts verbal requests, and your Evidence of Coverage will say whether yours does. The plan must then decide no later than 7 calendar days for a standard request, or 72 hours for an expedited one.
