How to request a drug exception with Medicare

You send the request in and start counting the days. Nothing is running yet. The part that decides the answer is written by your prescriber, and until your plan has that, the deadline has not begun.

How do I request a drug exception?

You file the request with your plan, and three people are allowed to do it: you, your prescriber, or your representative. A request for a benefit can be made verbally or in writing. A request for payment must be in writing unless your plan accepts verbal ones.

An exception request is not its own separate thing. It is a type of coverage determination, which is the formal name for any decision your plan makes about a drug.

That matters because coverage determinations cover more ground than people expect. They include whether you have satisfied a prior authorization requirement, whether a quantity limit applies to you, whether you must try another drug first, and how much you are being asked to pay.

So if any of those has gone against you, the route out is the same route described on this page.

What is a formulary exception?

A formulary exception does two jobs, and the second one is the one almost nobody knows about. It is the request that gets an uncovered drug covered, and it is also the request that removes a rule attached to a drug that is already on your plan's list.

The first is the obvious one. You ask the plan to cover a Part D drug that is not on its formulary, which is the list of drugs that plan pays for.

The second is this. A formulary exception is also how you ask for a utilization management requirement to be waived on a drug that IS on the list, such as step therapy, prior authorization or a quantity limit.

There is a second kind of exception with a narrower job. A tiering exception asks for a non-preferred drug at the lower cost-sharing that applies to a preferred tier. It does not move the drug. It changes what you pay for it.

So one request type covers being refused a drug, being made to try another first, and being made to ask permission. That is worth knowing before you go looking for three different processes.

What does my doctor need to submit for a formulary exception?

An exception is granted when your plan decides the drug is medically necessary for you, and your prescriber must submit a supporting statement making that case. Without that statement there is no request for anyone to decide, which is why this step decides the timing of everything else.

What the statement has to say depends on which exception you are asking for, and the two lists are different.

For a formulary exception, the statement must indicate one of three things.

• That all covered Part D drugs on any tier would not be as effective, or would have adverse effects
• That the number of doses allowed under a dose restriction has been, or is likely to be, less effective
• That the alternatives on the formulary, or the ones required under step therapy, have been or are likely to be less effective or to have adverse effects

For a tiering exception, it must indicate that the preferred drug or drugs would not be as effective for treating your condition, that they would have adverse effects for you, or both.

Your prescriber may give the statement verbally or in writing, and if it is verbal the plan may require a written follow-up. In writing it can go on the Model Coverage Determination Request Form, on a form the plan provides, or on any other document your prescriber prepares, including a letter.

How long does an exception decision take?

Once the 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 can be verbal, so long as a written one is posted within 3 calendar days.

The clock belongs to your prescriber, not to you. This is our reading rather than a rule CMS states, and three of its own facts produce it.

The timeframes for a request involving an exception do not begin until the plan receives the prescriber's supporting statement. An exception is only granted where the plan judges the drug medically necessary, and only the prescriber can make that case. And the prescriber may give the statement verbally, with a written follow-up possibly required afterwards.

So the step you cannot do yourself is the step the deadline waits on. Those three facts are CMS's. Reading them as one is ours.

Here is what applies to what.

The request	The deadline	When the clock starts
Benefit, no exception involved	72 hours standard, 24 hours expedited	When the plan receives your request
Benefit, exception involved	72 hours standard, 24 hours expedited	When the plan receives the prescriber's statement
Payment involving an exception	14 calendar days	When the plan receives the request
Appeal of a refusal	7 calendar days standard, 72 hours expedited	When the plan receives the appeal

The second row is the one worth reading twice. Two identical deadlines, two different starting points.

What is an expedited request?

An expedited request is the faster track, and it cuts the standard 72 hours down to 24. The same three people can ask for it: you, your prescriber, or your representative. It is the same request rather than a separate process, so nothing your prescriber must write changes when you ask for speed.

The lever is available at both stages. A coverage determination can be expedited, and so can an appeal, where it takes the standard 7 calendar days down to 72 hours.

There is a practical difference in how you file. An expedited appeal may be requested verbally or in writing. A standard appeal must be in writing, unless your plan accepts verbal requests, which you can find out by calling the plan or reading your Evidence of Coverage.

That document is where your own plan's answer to that question is written down.

What if my exception is denied?

The refusal itself carries your next step, which is the part people miss while reading the bad news. If the plan's coverage determination is unfavourable, the decision contains the information you need to file a request for a redetermination with the plan.

The refusal itself carries your next step, which is the part people miss while reading the bad news.

You have 65 calendar days from the date of the notice to file that request. Read that as the date printed on the letter, not the day it reached you, because the two are rarely the same.

You, your prescriber or your representative can file it. The plan must then decide as quickly as your health requires, and no later than 7 calendar days for a standard request or 72 hours for an expedited one.

If that goes against you too, the ladder continues. There are five levels in all: a redetermination from your plan, a reconsideration by an Independent Review Entity, a decision by the Office of Medicare Hearings and Appeals, a review by the Medicare Appeals Council, and judicial review in Federal district court.

At each level you get a decision letter telling you how to move to the next. Before you start, Medicare's own instruction is to ask your provider or supplier for any information that may help your case.

What this means for you

An exception is a clinical argument rather than a form to be filled in correctly. Your plan grants it when it judges the drug medically necessary for you, and your prescriber is the only person who can make that case, which is why they belong in this from the start.

One request type does more than its name suggests. A formulary exception gets an uncovered drug covered and gets step therapy, prior authorization or a quantity limit waived on a drug already on the list.

The timing turns on one fact. For a request involving an exception, the clock does not start when you file. It starts when your plan receives your prescriber's statement, and then it runs 72 hours, or 24 if expedited.

If you are refused, the letter tells you what to do next and you have 65 calendar days from the date on it, counted from the date printed on the notice rather than the day it reached you.

For what prior authorization is and why your plan applied it, read this publication's article on Part D prior authorization. For being made to try another drug first, read the article on step therapy.

FAQ

Who is allowed to ask for an exception?

Three parties: you, your prescriber, or your representative. CMS states this for coverage determinations generally, and an exception request is a type of coverage determination, so the same rule applies. A request for a benefit may be made verbally or in writing.

A standard request for payment must be in writing unless your plan accepts verbal requests, which is something your plan or your Evidence of Coverage will tell you. The same three parties may also file the appeal if the request is refused.

It is worth knowing that your prescriber can start the process, because the supporting statement has to come from them in any case, and involving them at the beginning avoids a second round of contact later.

What is the difference between a formulary exception and a tiering exception?

A formulary exception is used to get a Part D drug that is not on your plan's list covered. It is also used to have a utilization management requirement waived on a drug that IS on the list, such as step therapy, prior authorization or a quantity limit.

A tiering exception is narrower: it asks the plan to charge you the lower cost-sharing that applies to a preferred tier for a drug sitting on a non-preferred tier.

It does not move the drug to a different tier and it does not change whether the drug is covered. The prescriber's supporting statement has to say different things for each, so the two are not interchangeable even though both are called exceptions.

Why has my plan not decided yet?

The most likely answer is that the clock has not started. CMS states that for requests involving exceptions, the adjudication timeframes do not begin until the plan receives the supporting statement from your prescriber. So a request filed on Monday with no statement behind it is not a request the plan is late on.

Once the statement arrives, the plan must give written notice within 72 hours for a standard request or 24 hours for an expedited one, and it may give the first notice verbally provided a written one is posted within 3 calendar days. So a wait that looks unexplained usually means the statement has not reached the plan yet.

How fast is an expedited request, and who can ask for one?

An expedited request cuts the standard 72 hour decision to 24 hours at the coverage determination stage. At the appeal stage it cuts the standard 7 calendar days to 72 hours. The same three people can request it: you, your prescriber, or your representative.

There is also a filing difference worth knowing: an expedited appeal may be requested verbally or in writing, while a standard appeal must be in writing unless your plan accepts verbal requests. Your Evidence of Coverage says whether yours does. Payment requests run on a different timeframe again, at 14 calendar days from the date your plan receives the request.

How long do I have to appeal a refusal?

CMS states that a redetermination request must be filed with the plan within 65 calendar days from the date of the notice of the coverage determination.

Two details in that sentence do real work. The count runs from the date printed on the notice, not from the day it arrived in your post, so a letter that sat unopened has been using up your window.

And the notice itself contains the information you need to file, which means the refusal letter is the instruction sheet rather than just the bad news. The deadline is set out on CMS's own redetermination page, which is the source cited below.

What happens if the plan refuses my appeal too?

There are five levels of appeal in a Medicare drug plan, and if you disagree with the decision at any level you can usually go to the next one. Level one is the redetermination by your plan. Level two is a reconsideration by an Independent Review Entity, which is not your plan.

Level three is a decision by the Office of Medicare Hearings and Appeals. Level four is a review by the Medicare Appeals Council. Level five is judicial review in Federal district court.

At each level you receive a decision letter with instructions for moving to the next, so you are never left guessing what the next step is. Medicare's instruction before you start is to ask your provider or supplier for anything that may help your case.