Cigna Unveils National Coverage Policy for Adolescent Depression Including TMS!

Evernorth celebrates a major landmark

This is the 901st post I've done on The Frontier Psychiatrist newsletter, and it does seem fitting that it's about progress. Also, here is a photo of Batz Maru for not reason other than my daughter loves San Rio.

Today, I was alerted that my favorite health insurance company—and yes, I have a favorite, despite everything I've learned as a parent of twins—Cigna, made progress in its coverage policies. As a regular critic of health plan policies, I love when I have something good to talk about, instead. I am enthusiastic about pointing out when a health plan makes excellent decisions. I'll begin with a little background about what this treatment even is;

Transcranial magnetic stimulation (TMS) uses an electromagnet to re-synchronize brain networks, and this process treats depression. It also treats OCD, and it is likely to be able to treat other conditions as well. I've written about this a lot before.

I even run a clinic that offers this treatment already and is in-network with CIGNA. here's a link if you happen to have this insurance, and you have an adolescent with depression:

I'll explain why I am excited. Transcranial magnetic stimulation (TMS) has been an FDA-approved treatment since 2008. This past year, one device manufacturer, Neuronetics, obtained an FDA label for the use of rTMS for adolescents 15 and up to treat their major depressive disorder.

There's something different about this FDA label for adolescents; it's different from all previous FDA labeling on TMS. At this point, extensive FDA guidance documents are available on the topic. The history, with visuals, has been extensively documented.

The FDA label regulates marketing, not clinical practice, but insurance tends to follow the FDA and will rarely approve treatments in broader populations than the FDA was willing to sign off on.

Here is what the “Indication For Use” submitted to the FDA, and approved, said in 2008 when TMS was first approved by Neuronetics, for a device they called the “NeuroStar”:

NeuroStar TMS Therapy is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode.

And here is what the adolescent label says…for extra verisimilitude, I’m going to use a screenshot, so we can really feel how indicated for use we are talking about:

It's indicated as an adjunct for the treatment of major depressive disorder. To explain, it's an adjunct to the standard of care, which, by the way, includes both psychotherapy and oral medications, but not necessarily both.

I've described previously how psychotherapy is a first-line treatment for youth, and so the thing that's missing from that indication for use is the following sentence:

Which is in the original FDA label in adults.

This means TMS in adolescence is approved as a first-line treatment, not one you can only market for use after other failed treatments. The first day an adolescent shows up to a doctor, you can start them on standard-of-care therapy, which could be talk therapy, and add TMS to that as the biological intervention.

There's a really good reason to think it should be a first-line treatment. The reason is that all of the oral medications in the treatment of depression in adolescence have suicidal ideation as a side effect. TMS does not have suicidal ideation as a side effect. There is no black box warning on transcranial magnetic stimulation for adolescents. There is a black box warning on every drug we could prescribe adolescents for their depression.

To say this very plainly, transcranial magnetic stimulation is the only antidepressant modality in adolescence, other than psychotherapy, that doesn't run the risk of increasing their suicidal thoughts. It is intended to be administered along with the standard of care, which, as a child psychiatrist, I'm here to tell you is psychotherapy.

We've been limping along with oral medications that increase the risk of suicidal thinking for teenagers because we didn't have other good options for their depression.

Until now!

WE HAVE AN OPTION TO TREAT ADOLESCENT DEPRESSION THAT DOESN'T INCREASE THE RISK OF THINKING ABOUT SUICIDE MORE!

This is the actual black box warning we are dealing with when it comes to “all medicines to treat depression in kids:”

I wrote about my personal experience in childhood with this very adverse effect before:

Zoloft

So it's very, very, very, very, very, very, very exciting as a Child Psychiatrist, and as a parent, and as a person who used to be a suicidal child, to have an option that doesn't make that problem worse.

CIGNA has been at the forefront of excellent decisions about coverage for TMS nationally, and their inclusion of transcranial magnetic stimulation as a covered treatment down to age 15 in keeping with the FDA lower limit is one step in a much better direction. They also cover OCD treatment nationally!

I have one quibble—of course, I have plenty of quibbles. I'm like a quibble Factory. However, in this case, my quibble is not just about wanting to get paid to treat more people with more TMS; it's about reducing the risk of bad outcomes in adolescents in keeping with what the FDA has already signed off on.

The CIGNA/Evernorth coverage policy does not mirror the FDA clearance. It includes additional language that I don't think should be there, and I'm am here to encourage my colleagues at all health plans to update their coverage policy promptly, because not only is it not keeping with the evidence, nor with the FDA approval, but frankly, it opens them up to tremendous liability:

I’m going to zoom in, with bold text, on a sentence there:

“for an adolescent age 15–17: failure of two trials of antidepressant medications”

This is asking for trouble. They could've just followed the FDA label and covered it when the FDA says it is indicated for treatment in children. To ensure it's not handed out willy-nilly, they could've stated that it needs to be administered as an adjuvant to the standard of care, which includes psychotherapy. Instead, they require two prior trials of antidepressant medications that didn’t help.

These trials of antidepressant medications, by definition, come with that black box warning for increased suicidality. To quote the FDA:

• Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with MDD and other psychiatric disorders.

• Anyone considering the use of an antidepressant in a child or adolescent for any clinical use must balance the risk of increased suicidality with the clinical need.

Now, we can, in good faith, discuss all day long whether TMS should be sooner or later in treatment algorithms, and I have strongly advocated that it be sooner. I have advocated that it be sooner because it's more effective, more cost-effective, safer, and all sorts of other arguments. However, adults don't have an excessive risk of suicidal ideation and an associated FDA-black box warning to contend with.

In adolescence, we very much do. If you're an insurance company, do you really want to be in the position of demanding that the children take drugs that have a risk of suicidal thoughts before we offer them a treatment that doesn't have a risk of increased suicidality? Because what does that sound like? It is a lawsuit waiting to happen.

I will also comment: Does anyone on earth think Owen Muir, M.D., your author, will not be called an expert witness in such a legal matter? Or will this article documenting the risk-benefit profile of these two treatments not be included in the evidence? Is there any chance anyone at your insurance company subscribes to this newsletter? Is this going to show up in discovery?

Of course, it will be.

If I'm a class action ERISA attorney, and I know this is out there because? I will forward this to everybody I know at every insurance company. Once the extremely predictable lawsuit happens, I can go to discovery, find this article in an inbox, find the proof that it was opened, and then prove that they knew this was a problem well before my lawsuit.

This covered policy is an excellent step in the right direction, but I also think it's a time bomb. Conveniently, it's easy to defuse:

All you have to do is make transcranial magnetic stimulation, along with standard of care treatment what you cover. We need to acknowledge that oral medications have risks in adolescents that aren't present in adults. Those risks are more serious and have a black box warning for suicidality, so maybe we should do an end-run around the coverage policy that forces children to take drugs that are more dangerous than treatments that are now approved and safer.

To make everyone’s life easier, I did a rewrite of the CIGNA/Evernorth coverage policy to avoid this series of angry and very sympathetic parent lawsuits and predictably withering coverage in the NY Times and WSJ that would inevitably follow:

Initial Transcranial Magnetic Stimulation (TMS) for Treatment of Major Depressive Disorder (TFP Revised Edition).

An initial regimen (i.e., 30-36 treatments) of transcranial magnetic stimulation administered in an outpatient office setting using a U.S. Food and Drug Administration (FDA) -approved device is considered medically necessary for major depressive disorder when an individual meets ALL of the following criteria:

• age 15 years or older

• diagnosis of major depressive disorder (unipolar), moderate-to-severe, single or recurrent episode or acute relapse, without psychosis, as defined by the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders

• During the current episode of depression, ALL of the following criteria are met for those 18 and up:

• an adequate trial of an evidence-based psychotherapy known to be effective in the

  treatment of major depressive disorder without significant improvement in depressive symptoms

• validated depression monitoring scales are administered at the beginning and the end of the initial and each subsequent course of TMS

Coverage Criteria by Age Group:

• For individuals aged 18 and older:

  • Documented inadequate response to two or more antidepressant medication trials from different pharmacologic classes

  • Inadequate response to an evidence-based psychotherapy trial.

• For individuals aged 15–18:

  • No requirement for prior medication or psychotherapy failure

  • TMS is covered as an adjunctive treatment in combination with either:

    • An FDA-approved antidepressant medication; or

    • An evidence-based psychotherapy known to be effective in depression is coadministered along with the initiation of rTMS treatment.

*NOTE: A failed antidepressant medication trial is defined as EITHER of the following:

• use of an antidepressant medication at adequate therapeutic doses for at least four weeks with no significant reduction in depressive symptoms

• use of an antidepressant medication with documented intolerance or medical contraindication

Thank you all for reading, and I hope this moves the needle. By the way, those who are managing this is problematic for CIGNA, imagine every other insurance company who doesn't have any coverage whatsoever for this treatment and their policy. For those health plans, I think they're even more exposed to liability, not only for a coverage policy that adds additional risk, but for ERISA fiduciary breach. Another major health plan already covers this, what's your excuse?

I want point out that these health coverage policies are really hard to get right. And we should celebrate, like I'm doing today, when a coverage policy gets incrementally better.

CIGNA has proven again and again that at least when it comes to transcranial magnetic stimulation, it's on the forefront of appropriate coverage policies. Today, they've made it even easier for families with children suffering from treatment resistant depression to access that life-saving care.