Building Your Evidence: Non-Formulary (Not Covered) Medications And Step Therapy Requirements

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Have you ever tried to obtain financial coverage for a particular medication from an insurance company, only to be denied? It happens to the best of us, and it usually occurs due to a number of factors, such as an insurance company’s personal decision. One major reason coverage for a med may be denied by an insurance company pertains to the fact that it may be “non-formulary” and/or may have a step therapy (ST) requirement(s).

There are a number of things you may or may not know about how these denial decisions happen. The goal of this post is to cover why a medication may be denied in some instances and what you can do to prevent denials (as much as possible; in some cases, the denial may have nothing to do with you but a particular med, for example). No one likes to be denied, but it’s what you do after the denial that may make all the difference in the world.

So with that said, let’s get into the discussion.

what is a non-formulary medication? what does it mean for a med to be “not covered”?

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A non-formulary medication is one that lies outside the formulary of an insurance company. What is a formulary? A formulary is a list of approved medications that an insurance company provides its members. When you join an insurance company, as a member of that insurance company, you have approval for certain meds that insurance company deems allowable. The formulary or list does not include every med known to man, or every med available in the world, but it includes meds the company has selected. In many cases, these meds are usually ones that are inexpensive or the least expensive in terms of the med market.

So with that said, you may want a brand med that is a Tier 5, but the company will only cover Tier 1-3 meds, for example. The lower the tier, the lower the price. Tier 5 meds are usually brand medications (medications that have patented ingredients), while the lower tiers are usually generic medications (meds that copy the ingredients of brand meds but may alter them in some approved way; some meds are the same exact copies of their brand counterparts, while some are slightly different).

On the company formulary, you may notice a medication that is “non-formulary.” What this means is that the medicine is “Not Covered.” All the covered drugs are usually on the list, but if a Not Covered (NC) med is mentioned, it is likely to inform the members (including you) that is an unapproved med. What happens in the case of Not Covered meds is that an insurance company will require you to have tried and failed all covered drugs for your condition before granting coverage for a non-formulary or Not Covered med. Non-formulary and Not Covered mean the same; it’s just that one refers to the fact that the med may not be on the formulary (the med list) while the other refers to financial coverage. Different ways of saying the same thing essentially.

While there are different ways of saying a med is not covered, the requirement is the same: that is, you have to have tried and failed all covered drugs.

all means all: not covered meds require you to have tried all covered meds for your condition

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When it comes to Not Covered drugs, the requirement is literally true: you have to have tried ALL covered drugs. And yes, for those of you who may be wondering, “all means ALL.” No exceptions, unless you can prove it’s medically impossible for you to have tried a particular medication. And that documentation will have to come from your doctor. You can help by attending all doctor’s appointments and discussing your issues with a particular med with your doctor, but when all is said and done, your doctor is the medical expert who must make the case for you.

But, you cannot make a case for a Not Covered med without having tried all the covered meds on your insurance company’s formulary. And this is where the rubber meets the road, where the conflict begins, for doctors and insurance companies. A doctor has his or her expert medical opinion concerning a med you need to try but that med is too costly for the insurance company. Often, doctors will file requests for members and then get a denial letter stating why the insurance company doesn’t cover a particular med.

That denial letter will go something like this: “We regret to inform you that after a review, we cannot cover your requested med for the following reasons,” with a list of reasons that follow. One of the major reasons why a Not Covered (or non-formulary) med is denied is because all the covered drugs of a particular insurance company have not been tried and failed. And all means all! If the insurance company has 5 meds to try before they cover your requested med, and you have only tried 2 of them, you cannot expect the insurance company to approve your med request. All means all, every one of the covered meds must be tried before you can expect approval on a Not Covered or non-formulary medication.

And insurance companies are unrelenting about this expectation because they provide covered meds that are inexpensive and work for most members; if you try the covered meds and they do not work, and you report those to your doctor, the doctor can gather documentation from what you say and use this information to request a Not Covered med once all covered meds have been tried and failed.

By using the covered meds first, you are building a case for medical necessity with a Not Covered med. And in the world of insurance companies, documentation is key — for you as well as for them.

what is step therapy?

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Step Therapy is often found as “ST” on formulary lists. Usually you’ll see a medication or medical device such as a continuous glucose monitor like the Dexcom G6, Dexcom G7, or the Freestyle Libre) and then the letters “ST” beside it. “ST” is the acronym used for “Step Therapy.” Step Therapy is a requirement for a medication or medical device that requires you to have used certain other meds or devices before you can use the preferred one in question.

When it comes to continuous glucose monitors or CGMs such as the Dexcom G6, Dexcom G7, and the Freestyle Libre, Step Therapy requirements mandate that the patient use insulin. So, if you are not currently utilizing insulin, you are free to apply for these CGMs, but don’t hold your breath: you are more likely to win the Powerball than you are to be approved for CGMS in the absence of insulin.

Depending on the particular insurance company, you may have to be currently taking an insulin medication such as Metformin, for example. Check your insurance company’s drug list (formulary) to find out if you’re interested in using CGMs for continuous glucose monitoring.

Step Therapy is a fitting name for the definition. What do you think of when you hear the word “step”? Usually, you think of steps on a porch, for example, where you go up one step, then another, and then another, until you get to the top of the steps and onto the porch where you can sit or go inside. The rungs of a ladder come to mind too, where you start at the bottom and then climb all the way up to the top. Step Therapy refers to “therapy,” here meaning therapeutics (medications), and the word “step” gives the connotation of progressing from the bottom step to the next step, all the way to the top: step 1, step 2, step 3, and so on.

And when it comes to medications, step therapy requires you to have tried certain meds before progressing to others. When it comes to brand medications with famous names we would recognize, step therapy requirements mandate you try generic meds (lower-tier meds that are more affordable for insurance companies) before trying the more expensive ones. Insurance companies have to balance their financial budgets, too (you didn’t think you were the only one balancing a budget, did you?).

being proactive: How to Make the case for a not covered (non-formulary) med

At this point, you may be asking, “Okay, so I want to get a med that is Not Covered; how do I make a case for the Not Covered med?” That’s a great question to ask, and one to which I have an answer.

First, you should get a copy of your insurance company’s formulary. This would be a great thing to have when you visit your doctor so that you can discuss the idea of taking meds on the list. For example, if you check your insurance company’s formulary and you discover that Nurtec is not covered, then check the formulary to see what alternatives are covered and then discuss starting those with your doctor. Some doctors want to just go ahead and file for the Not Covered med and “see what happens,” but this approach leaves you open to first, being denied immediately, and second, having to try the covered alternatives post-denial decision.

Why not go ahead and try them first thing to build your case for the Not Covered med? Tell your doctor you would like for him or her to consider the covered alternatives to the preferred med and that your insurance company requires you to take all covered meds before getting approved for a non-formulary med.

Call your insurance company and ask customer service if the med you want is covered or not covered. They will be able to tell you this information, as well as whether or not the med has a copay (if it’s covered). The medication could be excluded from coverage, which means the insurance company won’t cover it for any reason.

By trying the list of covered meds, you can make a case medically for why you need to take the Not Covered med. It is important to have this kind of paper trail because, without it, a number of insurance companies will not approve coverage for a non-formulary med. And, without it, you can expect to find yourself on the losing end of the decision. That’s the last thing anyone wants.

When it comes to meds, remember that at least a one-month trial is best. Always talk to your doctor before starting a med (or stopping a med routine), as the doctor can tell you what to do in these cases. However, read up on your insurance policy to find out if you need a one-month trial of a particular med or even longer in some cases. Remember, the goal of taking covered meds and documenting the side effects and your general feeling while on them is for the express purpose of presenting this info to the insurance company when you have finished using all the covered meds and your provider prepares to file for the Not Covered med. So with that said, the more details you can provide about your experience on the med, the better.

Keep in mind that any insurance company has the right to deny a Not Covered or non-formulary med, even if you have tried every covered med on the formulary. However, it is a more difficult thing to do if you have documentation that makes the case for medical necessity of a Not Covered med because all covered meds have been tried and failed. And “medical necessity” is a two-word phrase that insurance companies live by.